ReferenceCitation: Azria D, Jacot W, Prost P, Culine S, Ychou M, Lemanski C, Dubois JB. [Gemcitabine and ionizing radiations: radiosensitization or radio-chemotherapy combination]. Bull Cancer. 2002 Apr;89(4):369-79. Review. French.

ReferenceCitation: Caffo O, Fellin G, Graffer U, Valduga F, Bolner A, Luciani L, Tomio L, Galligioni E. Phase I study of gemcitabine and radiotherapy plus cisplatin after transurethral resection as conservative treatment for infiltrating bladder cancer. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1310-6.

ReferenceCitation: Chauvet B, Brewer Y, Félix-Faure C, Davin JL, Choquenet C, Reboul F. Concurrent cisplatin and radiotherapy for patients with muscle invasive bladder cancer who are not candidates for radical cystectomy. J Urol. 1996 Oct;156(4):1258-62.

ReferenceCitation: Chauvet B, Davin JL, Alfonsi M, Berger C, Vincent P, Reboul F. [Conservative treatment of bladder cancers with radiotherapy and concurrent chemotherapy: results and perspectives]. Cancer Radiother. 1998 Sep-Oct;2(5):499-504. Review. French.

ReferenceCitation: Choudhury A, Swindell R, Logue JP, Elliott PA, Livsey JE, Wise M, Symonds P, Wylie JP, Ramani V, Sangar V, Lyons J, Bottomley I, McCaul D, Clarke NW, Kiltie AE, Cowan RA. Phase II study of conformal hypofractionated radiotherapy with concurrent gemcitabine in muscle-invasive bladder cancer. J Clin Oncol. 2011 Feb 20;29(6):733-8. doi: 10.1200/JCO.2010.31.5721. Epub 2011 Jan 4.

ReferenceCitation: Dunst J, Sauer R, Schrott KM, Kühn R, Wittekind C, Altendorf-Hofmann A. Organ-sparing treatment of advanced bladder cancer: a 10-year experience. Int J Radiat Oncol Biol Phys. 1994 Sep 30;30(2):261-6.

ReferenceCitation: Ensign LG, Gehan EA, Kamen DS, Thall PF. An optimal three-stage design for phase II clinical trials. Stat Med. 1994 Sep 15;13(17):1727-36.

ReferenceCitation: Fechner G, Perabo FG, Schmidt DH, Haase L, Ludwig E, Schueller H, Blatter J, Mller SC, Albers P. Preclinical evaluation of a radiosensitizing effect of gemcitabine in p53 mutant and p53 wild type bladder cancer cells. Urology. 2003 Feb;61(2):468-73.

ReferenceCitation: Hagan MP, Winter KA, Kaufman DS, Wajsman Z, Zietman AL, Heney NM, Toonkel LM, Jones CU, Roberts JD, Shipley WU. RTOG 97-06: initial report of a phase I-II trial of selective bladder conservation using TURBT, twice-daily accelerated irradiation sensitized with cisplatin, and adjuvant MCV combination chemotherapy. Int J Radiat Oncol Biol Phys. 2003 Nov 1;57(3):665-72.

ReferenceCitation: Herman JM, Smith DC, Montie J, Hayman JA, Sullivan MA, Kent E, Griffith KA, Esper P, Sandler HM. Prospective quality-of-life assessment in patients receiving concurrent gemcitabine and radiotherapy as a bladder preservation strategy. Urology. 2004 Jul;64(1):69-73.

ReferenceCitation: Housset M, Maulard C, Chretien Y, Dufour B, Delanian S, Huart J, Colardelle F, Brunel P, Baillet F. Combined radiation and chemotherapy for invasive transitional-cell carcinoma of the bladder: a prospective study. J Clin Oncol. 1993 Nov;11(11):2150-7.

ReferenceCitation: Kent E, Sandler H, Montie J, Lee C, Herman J, Esper P, Fardig J, Smith DC. Combined-modality therapy with gemcitabine and radiotherapy as a bladder preservation strategy: results of a phase I trial. J Clin Oncol. 2004 Jul 1;22(13):2540-5.

ReferenceCitation: Lagrange JL, Bascoul-Mollevi C, Geoffrois L, Beckendorf V, Ferrero JM, Joly F, Allouache N, Bachaud JM, Chevreau C, Kramar A, Chauvet B; Study Group on Genito-Urinary Tumors. Quality of life assessment after concurrent chemoradiation for invasive bladder cancer: results of a multicenter prospective study (GETUG 97-015). Int J Radiat Oncol Biol Phys. 2011 Jan 1;79(1):172-8. doi: 10.1016/j.ijrobp.2009.10.038. Epub 2010 Apr 10.

ReferenceCitation: Lawrence TS, Chang EY, Hahn TM, Shewach DS. Delayed radiosensitization of human colon carcinoma cells after a brief exposure to 2',2'-difluoro-2'-deoxycytidine (Gemcitabine). Clin Cancer Res. 1997 May;3(5):777-82.

ReferenceCitation: Moore MJ, Tannock IF, Ernst DS, Huan S, Murray N. Gemcitabine: a promising new agent in the treatment of advanced urothelial cancer. J Clin Oncol. 1997 Dec;15(12):3441-5.

ReferenceCitation: Rödel C, Grabenbauer GG, Kühn R, Papadopoulos T, Dunst J, Meyer M, Schrott KM, Sauer R. Combined-modality treatment and selective organ preservation in invasive bladder cancer: long-term results. J Clin Oncol. 2002 Jul 15;20(14):3061-71.

ReferenceCitation: Sangar VK, McBain CA, Lyons J, Ramani VA, Logue JP, Wylie JP, Clarke NW, Cowan RA. Phase I study of conformal radiotherapy with concurrent gemcitabine in locally advanced bladder cancer. Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):420-5.

ReferenceCitation: Shewach DS, Hahn TM, Chang E, Hertel LW, Lawrence TS. Metabolism of 2',2'-difluoro-2'-deoxycytidine and radiation sensitization of human colon carcinoma cells. Cancer Res. 1994 Jun 15;54(12):3218-23.

ReferenceCitation: Shipley WU, Kaufman DS, Tester WJ, Pilepich MV, Sandler HM; Radiation Therapy Oncology Group. Overview of bladder cancer trials in the Radiation Therapy Oncology Group. Cancer. 2003 Apr 15;97(8 Suppl):2115-9. Review.

ReferenceCitation: Stadler WM, Kuzel T, Roth B, Raghavan D, Dorr FA. Phase II study of single-agent gemcitabine in previously untreated patients with metastatic urothelial cancer. J Clin Oncol. 1997 Nov;15(11):3394-8.

ReferenceCitation: Stein JP, Lieskovsky G, Cote R, Groshen S, Feng AC, Boyd S, Skinner E, Bochner B, Thangathurai D, Mikhail M, Raghavan D, Skinner DG. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol. 2001 Feb 1;19(3):666-75.

ReferenceCitation: Tester W, Caplan R, Heaney J, Venner P, Whittington R, Byhardt R, True L, Shipley W. Neoadjuvant combined modality program with selective organ preservation for invasive bladder cancer: results of Radiation Therapy Oncology Group phase II trial 8802. J Clin Oncol. 1996 Jan;14(1):119-26.

ReferenceCitation: Advanced Bladder Cancer Meta-analysis Collaboration. Neoadjuvant chemotherapy in invasive bladder cancer: a systematic review and meta-analysis. Lancet. 2003 Jun 7;361(9373):1927-34. Review.

ReferenceCitation: Vogelzang NJ, Stadler WM. Gemcitabine and other new chemotherapeutic agents for the treatment of metastatic bladder cancer. Urology. 1999 Feb;53(2):243-50. Review.

ReferenceCitation: von der Maase H, Hansen SW, Roberts JT, Dogliotti L, Oliver T, Moore MJ, Bodrogi I, Albers P, Knuth A, Lippert CM, Kerbrat P, Sanchez Rovira P, Wersall P, Cleall SP, Roychowdhury DF, Tomlin I, Visseren-Grul CM, Conte PF. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol. 2000 Sep;18(17):3068-77.

ReferenceCitation: Azria D, Riou O, Rebillard X, Thezenas S, Thuret R, Fenoglietto P, Pouessel D, Culine S. Combined chemoradiation therapy with twice-weekly gemcitabine and cisplatin for organ preservation in muscle-invasive bladder cancer: long-term results of a phase 1 trial. Int J Radiat Oncol Biol Phys. 2014 Mar 15;88(4):853-9. doi: 10.1016/j.ijrobp.2013.11.016. Epub 2013 Dec 21.

family: Azria

full_name: David Azria

given: David

family: Riou

full_name: Olivier Riou

given: Olivier

family: Rebillard

full_name: Xavier Rebillard

given: Xavier

family: Thezenas

full_name: Simon Thezenas

given: Simon

family: Thuret

full_name: Rodolphe Thuret

given: Rodolphe

family: Fenoglietto

full_name: Pascal Fenoglietto

given: Pascal

family: Pouessel

full_name: Damien Pouessel

given: Damien

family: Culine

full_name: Stephane Culine

given: Stephane

journal_name: International Journal of Radiation Oncology*Biology*Physics

oa_host_type: repository

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

title: Combined Chemoradiation Therapy With Twice-Weekly Gemcitabine and Cisplatin for Organ Preservation in Muscle-Invasive Bladder Cancer: Long-Term Results of a Phase 1 Trial

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

title: A Randomized Phase II Trial Evaluating an Organ-conserving Strategy With Radiotherapy + CDDP + Gemcitabine vs Radiotherapy + CDDP in Muscle-infiltrative Bladder Cancer

summary: If radical cystectomy remains the standard of care for muscle invasive bladder cancer, consequences of this surgical procedure are often harsh. Over the past years, concurrent chemo-radiotherapy has imposed itself as an alternative treatment. Published data on concomitant radiochemotherapy (radiotherapy/cisplatin or radiotherapy/cisplatin/5-fluorouracil combinations) showed local control rates with bladder preservation at 5 years ranging from 40% to 65% according to the disease stage, and overall survival probabilities ranging from 40% to 50% at 5 years. In order to improve local and systemic prognosis, evaluation of other chemotherapy agents with higher radiosensitizing effect, such as gemcitabine, is justified. Gemcitabine possesses its own anti-cancer activities on urothelial diseases and has a synergetic activity with cisplatin. The investigators completed a monocenter phase I study combining radiotherapy, cisplatin, and twice-weekly gemcitabine, and determined a recommended dose of gemcitabine 25 mg/m². The objective of the present study is to evaluate the combination of radiotherapy + cisplatin + gemcitabine in terms of disease-free survival in non metastatic muscle invasive urothelial cancer patients.


acronym: ENVOL

summary:
Glaucoma is a neurodegenerative disease representing the second cause of blindness worldwide. IOP (Intra occular pressure) is the most common risk factor, but not the only one as it is observed for normal tension glaucoma. Some studies have reported lesions of the optical pathways on MRI examination MRI 3T (Magnetic Resonance Imaging 3 Telsa), by increasing spatial resolution and DTI (diffusion tensor Imaging)with fractional anisotropy could help us to analyze visual pathways and to determine the association with neurodegenerative diseases as Alzheimer.

The investigators propose to compare volume and structure of the visual pathways between glaucoma patients and healthy subjects matched on age and sex.

Glaucoma is a neurodegenerative disease characterized by loss of retinal ganglion cells, visual field deterioration and optic nerve cupping. Some studies have suggested that all the visual pathways could be damaged in glaucoma. Recently, a German study proved a significant reduction of volume of the optic radiations in glaucoma versus healthy subjects in MRI 3T. Some authors have also suggested that glaucoma could share similarities with the other neurodegenerative diseases like Alzheimer's disease. MRI 3T and DTI allow studying visual pathways with a high level of spatial resolution.Fractional anisotropy is a tag of microstructure.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Tellouck L, Durieux M, Coupé P, Cougnard-Grégoire A, Tellouck J, Tourdias T, Munsch F, Garrigues A, Helmer C, Malet F, Dartigues JF, Dousset V, Delcourt C, Schweitzer C. Optic Radiations Microstructural Changes in Glaucoma and Association With Severity: A Study Using 3Tesla-Magnetic Resonance Diffusion Tensor Imaging. Invest Ophthalmol Vis Sci. 2016 Dec 1;57(15):6539-6547. doi: 10.1167/iovs.16-19838.

name: CHU de Bordeaux, Service d'Ophtalmologie, Bordeaux, France 2University of Bordeaux, Bordeaux, France 3INSERM, U1219-Bordeaux Population Health Research Center, Bordeaux, France

family: Tellouck

full_name: Laury Tellouck

given: Laury

sequence: first

family: Durieux

full_name: Muriel Durieux

given: Muriel

sequence: additional

name: Université de Bordeaux, LaBRI, UMR 5800, PICTURA, Talence, France 6CNRS, LaBRI, UMR 5800, PICTURA, Talence, France

family: Coupé

full_name: Pierrick Coupé

given: Pierrick

family: Cougnard-Grégoire

full_name: Audrey Cougnard-Grégoire

given: Audrey

full_name: Joy Tellouck

given: Joy

name: University of Bordeaux, Bordeaux, France 4CHU de Bordeaux, Service de Neuro-Imagerie, Bordeaux, France 7INSERM, U1215, Neurocentre Magendie, Bordeaux, France

family: Tourdias

full_name: Thomas Tourdias

given: Thomas

family: Munsch

full_name: Fanny Munsch

given: Fanny

family: Garrigues

full_name: Arnaud Garrigues

given: Arnaud

family: Helmer

full_name: Catherine Helmer

given: Catherine

name: Centre d'Ophtalmologie Point Vision, Bordeaux, France

family: Malet

full_name: Florence Malet

given: Florence

family: Dartigues

full_name: Jean-François Dartigues

given: Jean-François

family: Dousset

full_name: Vincent Dousset

given: Vincent

family: Delcourt

full_name: Cécile Delcourt

given: Cécile

family: Schweitzer

full_name: Cédric Schweitzer

given: Cédric

bso_classification: Medical research

currency_apc_doaj: USD

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Investigative Opthalmology & Visual Science

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

version: submittedVersion

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

publisher: Association for Research in Vision and Ophthalmology (ARVO)

lead_sponsor: University Hospital, Bordeaux

location_facility: Service d'ophtalmologie Hôpital Pellegrin

lead_sponsor_type: academique

status_simplified: Completed


type: Other Identifier

title: Longitudinal Assessment of the Effect of Bariatric Surgery on Arterial Function and Blood Pressure Target Organs Damage

acronym: BASTOD

summary:
Introduction:

Obesity is a major public health problem, associated with many morbidities, including metabolic and cardiovascular disease (CVD). High blood pressure (hypertension) is the most common comorbidity and one of the major risk factors for CVD and kidney failure. It has been described an almost linear relationship between body mass index (BMI) and the level of blood pressure (BP), but the mechanisms underlying this relationship are complex and incompletely understood : activation of renin-angiotensin-aldosterone and sympathetic nervous systems, alterations in systemic hemodynamics and arterial parameters; a significant correlation between overall and / or visceral obesity and arterial stiffness assessed by carotid-femoral pulse wave velocity (PWV) has been observed.

By its effectiveness in terms of magnitude and sustainability of weight loss, bariatric surgery is becoming increasingly important in the management of obesity and the prevention of its comorbidities. It reduces all-cause as well as CV mortality. Bariatric surgery allows a resolution of the metabolic syndrome (in 2 out of 3 patients) and diabetes (in 5 out of 6 patients), but its effect on blood pressure remains inconstant and transient. The reasons for this limitation and the detailed effects of bariatric surgery on hemodynamics and arterial parameters have been poorly studied. Of note, a reduction in left ventricular hypertrophy, an improvement in diastolic dysfunction and aortic distensibility assessed by ultrasound or MRI have been observed.

lead_sponsor: University Hospital, Montpellier

intervention_type: Procedure


design_allocation: Randomized

intervention_type: Drug

study_type: Interventional

lead_sponsor: Bioprojet

primary_purpose: Treatment

type: EudraCT Number

source: euctr

title: Minimum Effective Dose-Finding Study of BF2.649, in Patients With Moderate to Severe OSA, Experiencing EDS Despite Regular Use of nCPAP, and Patients Having Refused This Therapy - Randomized, Double Blind Study With BF2.649 or Placebo

summary: Prospective, multicenter, double-blind, phase II, randomized, dose-response study in 5 parallel groups (dose-range).

lead_sponsor_type: industriel


title: Assessment of Three-dimensional Vision Alteration in Parkinson Disease.

summary:
Parkinson's disease is characterized by motor deficits, improved by dopaminergic intakes. Besides motor symptoms, visual troubles are observed in patients with Parkinson's disease, in particular spatial orientation problems including 3D vision. However, although these visual disturbances are commonly reported by the patients and their family in our clinical experience, they have not been the subject of specific clinical studies yet.

Parkinsonian patients report deficits in 3D vision leading to a loss of visuomotor ability, locomotor functions and to falls. Despite these frequent complaints, little is known about 3D vision in Parkinson's disease. The investigators want in this project to precisely estimate 3D deficits in parkinsonian patients by assessing their psychophysical performances in 3D vision tasks to compare to age matched control subjects' performances.

primary_purpose: Basic Science

ReferenceType: result

ReferenceCitation: Séverac Cauquil A, Ory-Magne F, Jardiné V, Galitzky M, Rosito M, Brefel-Courbon C, Celebrini S. Parkinson's patients can rely on perspective cues to perceive 3D space. Brain Res. 2017 May 15;1663:161-165. doi: 10.1016/j.brainres.2017.03.017. Epub 2017 Mar 19.

family: Séverac Cauquil

full_name: Alexandra Séverac Cauquil

given: Alexandra

family: Ory-Magne

full_name: Fabienne Ory-Magne

given: Fabienne

family: Jardiné

full_name: Vincent Jardiné

family: Galitzky

full_name: Monique Galitzky

given: Monique

family: Rosito

full_name: Maxime Rosito

given: Maxime

family: Brefel-Courbon

full_name: Christine Brefel-Courbon

given: Christine

family: Celebrini

full_name: Simona Celebrini

given: Simona

bso_classification: Biology (fond.)

journal_name: Brain Research

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Parkinson’s patients can rely on perspective cues to perceive 3D space

lead_sponsor: University Hospital, Toulouse

intervention_type: Other


title: Thérapie Cellulaire au Cours Des Syndromes d'Insuffisance en Cellules Souches Limbiques

summary: Transplantation of allogeneic or autologous limbal epithelial stem cells cultured on human amniotic membrane with no feeders in eyes with total limbal deficiency. Prospective non-comparative monocentric study.

study_start_date_type: Actual

ReferenceType: background

ReferenceCitation: Borderie VM, Ghoubay D, Georgeon C, Borderie M, de Sousa C, Legendre A, Rouard H. Long-Term Results of Cultured Limbal Stem Cell Versus Limbal Tissue Transplantation in Stage III Limbal Deficiency. Stem Cells Transl Med. 2019 Dec;8(12):1230-1241. doi: 10.1002/sctm.19-0021. Epub 2019 Sep 5.

ipd_sharing: No

lead_sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts


title: Pharmacokinetics of 20 mg BF2.649 in Single Dose, in Subjects With Normal Renal Function Compared to Subject With Impaired Renal Function

summary: This is an open, parallel group study in subjects with normal renal function compared to those with renal dysfunction.

design_allocation: Non-Randomized


title: NAVADYN11 : Hemodynamic Impact of a New Ventilatory Support Mode With Diaphragmatic Synchronization

summary:
Despite spectacular advances since the 90s mechanical ventilation used in intensive care units are amply associated with cardio-respiratory complications: nosocomial pneumonia, lung parenchyma lesions induced by ventilation, hemodynamic instability and ultimately to a significant morbidity and mortality.

NAVA (Neurally Adjusted Assist Ventilation) ventilatory support, provides synchronous support, proportionate to patient's respiratory efforts. More "physiological", this mode would decline its efficacy on patient hemodynamic response. However, to date, no study has focused on hemodynamic impact of NAVA. This is precisely the purpose of NAVADYN11 study, which aims to assess NAVA efficacy on cardiac index in pediatric intensive care unit.

status: Terminated

primary_purpose: Health Services Research

ReferenceCitation: Liet JM, Barrière F, Gaillard-Le Roux B, Bourgoin P, Legrand A, Joram N. Physiological effects of invasive ventilation with neurally adjusted ventilatory assist (NAVA) in a crossover study. BMC Pediatr. 2016 Nov 8;16(1):180.

lead_sponsor: Nantes University Hospital

status_simplified: Unknown


summary: Epidemiological study of Ozurdex® in sites treating patients with retinal vein occlusion.

ReferenceCitation: Korobelnik JF, Kodjikian L, Delcourt C, Gualino V, Leaback R, Pinchinat S, Velard ME. Two-year, prospective, multicenter study of the use of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in the clinical setting in France. Graefes Arch Clin Exp Ophthalmol. 2016 Dec;254(12):2307-2318. Epub 2016 Jun 11.

lead_sponsor: Allergan


title: Impact of Ambulatory Antibiotics Use on Nasal Carriage of Methicillin-resistant Staphylococci in Community Patients : the StaphMRG Study

acronym: StaphMRG

summary: In this prospective, observational, multicentric open study, the investigators will compare the acquisition rates of methicillin-resistant staphylococci (coagulase-negative staphylococci and Staphylococcus aureus) nasal carriage in community patients receiving an ambulatory antibiotic treatment by either a β-lactam (amoxicillin-clavulanate or penicillins M), a macrolide, a synergistin or a fluoroquinolone.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Bichat-Claude Bernard teaching hospital (AP-HP) and Xavier Bichat medical school (Denis Diderot - Paris 7 university)


title: High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery

acronym: Optiflow

summary: The main objective of this study is to evaluate the gas exchange (ventilation-perfusion ratio) with the system Optiflow® compared to facial mask among patients having an acute respiratory failure after cardiac surgery.

primary_purpose: Other

intervention_type: Device


title: Therapeutic Efficacy of Tiludronic Acid on Inner Ear Involvement in Advanced Otosclerosis

acronym: OTOPHOS

summary: The aim of this study is to assess the efficacy of a biphosphonate (tiludronic acid, Skelid®, Sanofi-Aventis) in the treatment of inner ear involvement in advanced otosclerosis


title: Biological Efficacy of Twice Daily Aspirin in Type 2 Diabetic Patients With Coronary Artery Disease

summary: The aim of the study is to evaluate platelet function variations according to the delay since last aspirin intake (12 vs 24 hours)in a population of diabetic patients with previous Coronary Artery Disease.

lead_sponsor: Hopital Lariboisière

location_facility: Department of Cardiology-Lariboisiere Hospital-Assistance Publique-Hôpitaux de Paris


title: Wean Obese Study : Determination of the Optimal Spontaneous Breathing Trial for Obese Patient

summary: The decision to extubate a patient after acute respiratory failure is based on clinical observation and measurement of pulmonary mechanics. Current extubation criteria(tidal volume, respiratory frequency...) lack of specificity. The best way to evaluate and predict patients breathing abilities after extubation is to challenge him to a spontaneous breathing trial (SBT) with endotracheal tube in place immediately before extubation to predict the patient's ability to breathe spontaneously after extubation. The intention is to approximate, while the patient is still intubated, the work of breathing that will be required of the patient after extubation. Different approaches of ventilatory settings are currently used for the preextubation SBT, whether pressure support ventilation (PSV), continuous positive airway pressure (CPAP), or spontaneous ventilation through an endotracheal tube (T piece), all supported by literature with different benefits. To the investigators knowledge, few studies define which mode of ventilation most closely approximates the work of breathing during spontaneous respiration after extubation, and none have studied a specific population of obese patient in respiratory weaning. The main objective of the investigators study is to determine, between five different SBT, which one is the best to approximate the work of breathing of obese patient after extubation.

primary_purpose: Diagnostic

ReferenceCitation: Mahul M, Jung B, Galia F, Molinari N, de Jong A, Coisel Y, Vaschetto R, Matecki S, Chanques G, Brochard L, Jaber S. Spontaneous breathing trial and post-extubation work of breathing in morbidly obese critically ill patients. Crit Care. 2016 Oct 27;20(1):346.

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


title: Phenotypic and Genotypic Studies in Congenital and Early Onset Ataxias

acronym: ATAXIC

summary:
Congenital ataxias (CA) are rare, non progressive diseases, characterized by psychomotor retardation, hypotonia followed by ataxia. The presence of the "molar tooth" on MRI allowed to define Joubert syndrome, a peculiar form of CA. Apart from this group, CA are mostly associated with cerebellar atrophy or hypoplasia without molar tooth on MRI. CA are a clinically as well as genetically heterogeneous group of diseases. Early-onset ataxias are progressive but may be difficult to distinguish from CA in the first years of the disease. To date, few genes responsible for CA have been identified: ABC7 (X-linked CA associated with sideroblastic anemia), SLC9A6 (X-linked CA associated with severe mental retardation, autism and epilepsy), GPR56 (CA associated with polymicrogyria), ATCAY (pure CA in Cayman isolate); the involvement of the ATCAY and ABC7 genes has never been assessed in a large cohort of CA patients.

Primary objective:

To assess the frequency of mutations of the ATCAY and ABC7 genes in patients affected with non Joubert congenital or early-onset ataxia.

Secondary objective:

To identify new loci and/or genes responsible for CA To further describe the clinical phenotype of the CA and to assess the frequency of the various clinical types (pure CA/CA associated with spasticity/ syndromic CA, congenital/early-onset CA, sporadic/familial CA).

To describe the clinical phenotype of CA related to mutations in one of analysed genes.

intervention_type: Genetic


title: Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens

summary:
The objective of this study is to evaluate clinical outcomes following sub-2 mm micro-incision cataract surgery (MICS) and intraocular lens (IOL) implantation. This study is evaluated in two Phases

V4 (6M) endpoint: primary analysis
V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis

lead_sponsor: Bausch & Lomb Incorporated


title: Study of Wind Reed Instruments' Fungal Contamination and Its Immunological and Clinical Consequences for Musicians.

summary: On the basis of 2 cases of immunologically-induced lung disease in 2 saxophonists, the investigators supposed that wind reed instruments could be contaminated with molds. The investigators led a study on 40 musicians playing a wind reed instrument to analyze instruments' fungal contamination and its immunological and clinical consequences for musicians.

ReferenceCitation: Lodha S, Sharma OP. Hypersensitivity pneumonitis in a saxophone player. Chest. 1988 Jun;93(6):1322.

ReferenceCitation: Metzger F, Haccuria A, Reboux G, Nolard N, Dalphin JC, De Vuyst P. Hypersensitivity pneumonitis due to molds in a saxophone player. Chest. 2010 Sep;138(3):724-6. doi: 10.1378/chest.09-2991.

family: Metzger

full_name: Flora Metzger

given: Flora

family: Haccuria

full_name: Amaryllis Haccuria

given: Amaryllis

family: Reboux

full_name: Gabriel Reboux

given: Gabriel

family: Nolard

full_name: Nicole Nolard

given: Nicole

family: Dalphin

full_name: Jean-Charles Dalphin

given: Jean-Charles

family: De Vuyst

full_name: Paul De Vuyst

given: Paul

journal_name: Chest

title: Hypersensitivity Pneumonitis Due to Molds in a Saxophone Player

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility: Centre Hospitalier Universitaire Saint Jacques

intervention_type: Biological


title: Effect of S.Cerevisiae vs Placebo on the Improvement of Gastrointestinal Disorders,Especially During Irritable Bowel Syndrome. Randomized, Double-blind Study

summary: The main purpose of this study is the effect of the probiotic yeast Saccharomyces cerevisiae CNCM I-3856 on abdominal pain or intestinal discomfort in patients presenting with the irritable bowel syndrome (IBS)

primary_purpose: Supportive Care

ReferenceCitation: Spiller R, Pélerin F, Cayzeele Decherf A, Maudet C, Housez B, Cazaubiel M, Jüsten P. Randomized double blind placebo-controlled trial of Saccharomyces cerevisiae CNCM I-3856 in irritable bowel syndrome: improvement in abdominal pain and bloating in those with predominant constipation. United European Gastroenterol J. 2016 Jun;4(3):353-62. doi: 10.1177/2050640615602571. Epub 2015 Aug 21. Erratum in: United European Gastroenterol J. 2017 Mar;5(2):304.

name: Nottingham Digestive Diseases Biomedical Research Unit, Nottingham Digestive Diseases Centre, Nottingham, United Kingdom

family: Spiller

full_name: Robin Spiller

given: Robin

name: Lesaffre Human Care, Lesaffre Group, Marcq en Baroeul, France

family: Pélerin

full_name: Fanny Pélerin

given: Fanny

family: Cayzeele Decherf

full_name: Amélie Cayzeele Decherf

given: Amélie

name: Biofortis–Mérieux NutriSciences, Saint-Herblain, France

family: Maudet

full_name: Corinne Maudet

given: Corinne

family: Housez

full_name: Béatrice Housez

given: Béatrice

family: Cazaubiel

full_name: Murielle Cazaubiel

given: Murielle

family: Jüsten

full_name: Peter Jüsten

given: Peter

journal_name: United European Gastroenterology Journal

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Randomized double blind placebo-controlled trial ofSaccharomyces cerevisiaeCNCM I-3856 in irritable bowel syndrome: improvement in abdominal pain and bloating in those with predominant constipation

lead_sponsor: Lesaffre International

intervention_type: Dietary Supplement


type: Registry Identifier

title: Pilot Study of Real Time MR Temperature Monitoring of Multipolar Radiofrequency Ablation of Large Hepatocellular Carcinomas (≥ 5 CM)-ARMTICH STUDY

acronym: ARMTICH

summary:
Object of the study:

To assess the effectiveness of MR temperature monitoring of RFA of large hepatocellular carcinomas (HCC) (≥ 5 cm) in terms of complete tumor necrosis rate achieved and in term of reduction of the number of procedure required to obtain complete ablation of the tumors.

Experimental plan :

This pilot study consist to perform in a single center a single procedure of the multipolar RF ablation under MR temperature monitoring for the treatment of up to three HCC with diameter ranging from 5 cm and 10 cm in 20 inoperable patients. The main judgement criterion of the study will be the rate of complete ablation one month after one RFA procedure performed under MR temperature monitoring. The secondary criteria are, the 2-years local recurrence rate (after the first initial RF ablation procedure performed under MR temperature imaging ± additional RF ablation procedures under ultrasound monitoring in case of remnant viable foci of tumor), the potential reduction of the number of RF procedures required to achieve complete necrosis and the complication rate of RF ablation procedure performed under MR temperature monitoring.

In exploratory attempt, the study will include comparative assessment of these criteria with a historic leg of patients previously treated by the same operator in the same center for similar large tumor by multipolar RFA but using exclusively ultrasound monitoring.

ReferenceCitation: N'Kontchou G, Mahamoudi A, Aout M, Ganne-Carrié N, Grando V, Coderc E, Vicaut E, Trinchet JC, Sellier N, Beaugrand M, Seror O. Radiofrequency ablation of hepatocellular carcinoma: long-term results and prognostic factors in 235 Western patients with cirrhosis. Hepatology. 2009 Nov;50(5):1475-83. doi: 10.1002/hep.23181.

ReferenceCitation: Seror O, N'Kontchou G, Ibraheem M, Ajavon Y, Barrucand C, Ganne N, Coderc E, Trinchet JC, Beaugrand M, Sellier N. Large (>or=5.0-cm) HCCs: multipolar RF ablation with three internally cooled bipolar electrodes--initial experience in 26 patients. Radiology. 2008 Jul;248(1):288-96. doi: 10.1148/radiol.2481071101. Epub 2008 May 15.

ReferenceCitation: Seror O, Lepetit-Coiffé M, Quesson B, Trillaud H, Moonen CT. Quantitative magnetic resonance temperature mapping for real-time monitoring of radiofrequency ablation of the liver: an ex vivo study. Eur Radiol. 2006 Oct;16(10):2265-74. Epub 2006 Apr 11.

ReferenceCitation: Seror O, Lepetit-Coiffé M, Le Bail B, de Senneville BD, Trillaud H, Moonen C, Quesson B. Real time monitoring of radiofrequency ablation based on MR thermometry and thermal dose in the pig liver in vivo. Eur Radiol. 2008 Feb;18(2):408-16. Epub 2007 Sep 26.

ReferenceCitation: Lepetit-Coiffé M, Laumonier H, Seror O, Quesson B, Sesay MB, Moonen CT, Grenier N, Trillaud H. Real-time monitoring of radiofrequency ablation of liver tumors using thermal-dose calculation by MR temperature imaging: initial results in nine patients, including follow-up. Eur Radiol. 2010 Jan;20(1):193-201. doi: 10.1007/s00330-009-1532-1. Epub 2009 Aug 6.


title: Oligomeric Alpha-synuclein Levels as a Biomarker for Multiple System Atrophy

acronym: BIOAMS

summary: The main objectives are to determine on one hand whether oligomeric alpha-synuclein levels are increased in MSA patients compared to controls and on other hand whether there is a good agreement between cerebrospinal fluid (CSF) and plasma levels.


title: Double-blind, Placebo Controlled, Randomized Multiple Ascending Dose Study in Fed Conditions for Ten Days Dosing Regimen With a Loading Dose to Evaluate the Safety, the Tolerability and the Pharmacokinetics of Oral Fexinidazole in 36 Healthy Male Sub-Saharan Volunteers.

summary: This trial will study the tolerability and pharmacokinetic of fexinidazole using two different dosage regimen of repeated administrations. The drug is administered to human healthy volunteers of sub-saharan origin together with food, once a day during 10 days, with a loading dose during 4 days.

ipd_sharing: Undecided

lead_sponsor: Drugs for Neglected Diseases


title: Open Randomized Study on the Efficacy of corticoïd Infiltration Versus Physiological Solution Infiltration Versus Feigning of Infiltration Via Sacro-coccygien Hiatus Versus Natural Evolution in Discal Sciatica

acronym: Hiatus

summary: The specific aim of this study is to determine whether a medical intervention improve status of patients with discal sciatica and if yes which type of intervention.


title: Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty: Randomized- Controlled- Trial Double Blind Monocentric Study, Against Placebo

acronym: TAPlastie

summary:
Abdominoplasty is a major cosmetic surgery with a painful post operative period. Recently more and more anaesthetists are turning to regional analgesia for anterior abdominal wall surgery namely the Transversus Abdominis Plane (TAP) Block with or without ultrasound guidance.

The aim of this study is to evaluate the analgesic effect of TAP block ultrasound guided in post operative period of abdominoplasty.

location_facility: CHU de Bordeaux, Centre François-Xavier Michelet


title: Feasibility Study: Cognitive Effect of Repetitive Transcranial Magnetic Stimulation (rTMS)on add-on in Patients With Early Alzheimer's Disease

acronym: ALSTIMAG

summary:
The aim is to examine the effect of Repetitive Transcranial Magnetic Stimulation (rTMS) applied at the anodic left Cortex DorsoLateral PreFrontal (CDLPF) of patients with early Alzheimer's disease (AD).

This study included 15 patients treated with rTMS and whose medication reference is stabilized for 3 months by IAChE. Patients with early AD or related disease will be selected in the MCRR of Besançon and the psychiatric department of the University Hospital of Besançon. After giving informed consent, patients will be evaluated by a psychiatrist using the Mattis Clinical Demantia Rate (CDR), the Hamilton Depression Rating Scale (HDRS), State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI) and Hamilton Anxiety Scale (HAMA). The complete assessment takes 40 minutes. A second evaluation will be realized by a neuropsychologist takes around 120 minutes using Mattis CDR, Grober Free and Cued Selective Reminding Test, Trail Making Test (TMT), Crossing of Test (COT), Isaacs Set Test (STI) , Clock-Drawing Test (COT), Signoret's Battery of Cognitive Efficacy (BEC96), Rey-complex figure test-copy and Picture naming 80 items test (DO80).

Each rTMS session runs 20 minutes during which pulse trains of 5 seconds of 10 Hz spaced 25 seconds (2 trains of pulses per minute or 40 pulse trains per session) will be delivered. A psychometric assessment will be conducted again at the end of treatment week and one month after stopping treatment. A neuropsychometric assessment will be conducted one month after stopping the treatment. Scales of comfort and acceptability will also be proposed to the patient to determine whether any gene is caused by this treatment. Moreover a questionnaire will be proposed to the caregivers (at baseline, at the end of the treatment and 1, 2, 3 and 4 weeks after stopping the sessions) using Resource Utilisation Dementia (RUD), Apathy Inventory (AI), Activities of Daily Living (ADL) scale, Instrumental Activities of Daily Living (IADL) scale, Quality of Life in Alzheimer's disease (QoL-AD) scale, Questionnaire of recent change of the personality (CP6).

The population of this study will be comprised of patients between 60 to 85 years-old with early Alzheimer's characterized according to NINCDS-ADRADA criteria. These patients will be recruited on a voluntary basis, after notification and consent in the research center. This study was conducted over a period of 15 months.

ReferenceCitation: Haffen E, Chopard G, Pretalli JB, Magnin E, Nicolier M, Monnin J, Galmiche J, Rumbach L, Pazart L, Sechter D, Vandel P. A case report of daily left prefrontal repetitive transcranial magnetic stimulation (rTMS) as an adjunctive treatment for Alzheimer disease. Brain Stimul. 2012 Jul;5(3):264-266. doi: 10.1016/j.brs.2011.03.003. Epub 2011 Mar 30.

family: Haffen

full_name: Emmanuel Haffen

given: Emmanuel

family: Chopard

full_name: Gilles Chopard

given: Gilles

family: Pretalli

full_name: Jean-Baptiste Pretalli

given: Jean-Baptiste

family: Magnin

full_name: Eloi Magnin

given: Eloi

family: Nicolier

full_name: Magali Nicolier

given: Magali

family: Monnin

full_name: Julie Monnin

given: Julie

family: Galmiche

full_name: Jean Galmiche

given: Jean

family: Rumbach

full_name: Lucien Rumbach

given: Lucien

family: Pazart

full_name: Lionel Pazart

given: Lionel

family: Sechter

full_name: Daniel Sechter

given: Daniel

family: Vandel

full_name: Pierre Vandel

given: Pierre

journal_name: Brain Stimulation

lead_sponsor: Pierre Vandel, MD PhD

location_facility: Psychiatric Department of CHU of Besancon


title: Flexible urétéroscopy Versus Extracorporeal Shockwave Lithotripsy in 5 to 20 mm Renal Calculi, Efficacity Prospective Randomized Trial

summary: Flexible ureteroscopy is a recent procedure to treat renal stone. Extracorporeal shockwave lithotripsy was the gold standard treatment for calculi between 5 and 20 mm. In literature, the two procedures are available to treat these stones with a good stone free rate. There is no prospective randomized study comparing these two treatments. Our study will define with a good level of evidence which technique is the best with regard to the stone free rate, secondary procedure rate and adverse effect.

ReferenceCitation: Ravier E, Abid N, Ruffion A, Fassi-Fehri H, Buron C, Ganne C, Mallet A, Martin X. [Effectiveness of flexible ureteroscopy versus extracorporeal shock wave lithotripsy for kidney stones treatment]. Prog Urol. 2015 Apr;25(5):233-9. doi: 10.1016/j.purol.2015.01.005. Epub 2015 Jan 29. French.

family: Ravier

full_name: E. Ravier

given: E.

family: Abid

full_name: N. Abid

given: N.

family: Ruffion

full_name: A. Ruffion

given: A.

family: Fassi-Fehri

full_name: H. Fassi-Fehri

given: H.

family: Buron

full_name: C. Buron

given: C.

family: Ganne

full_name: C. Ganne

family: Mallet

full_name: A. Mallet

family: Martin

full_name: X. Martin

given: X.

journal_name: Progrès en Urologie

title: Efficacité de l’urétéroscopie souple versus lithotritie extracorporelle dans le traitement des calculs du rein

lead_sponsor: Hospices Civils de Lyon

location_facility: Service d'urologie, Hôpital Edouard Herriot


title: The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects

summary:
The purpose of this study is to determine the effect of theobromine on blood lipid parameters in healthy subjects. Secondary objectives are to determine the effect of cocoa and an interaction effect of cocoa and theobromine on blood lipid parameters.

Hypothesis: theobromine has a positive effect on blood lipid parameters.

primary_purpose: Prevention

ReferenceCitation: Neufingerl N, Zebregs YE, Schuring EA, Trautwein EA. Effect of cocoa and theobromine consumption on serum HDL-cholesterol concentrations: a randomized controlled trial. Am J Clin Nutr. 2013 Jun;97(6):1201-9. doi: 10.3945/ajcn.112.047373. Epub 2013 Apr 17.

family: Neufingerl

full_name: Nicole Neufingerl

given: Nicole

family: Zebregs

full_name: Yvonne EMP Zebregs

given: Yvonne EMP

family: Schuring

full_name: Ewoud AH Schuring

given: Ewoud AH

family: Trautwein

full_name: Elke A Trautwein

given: Elke A

journal_name: The American Journal of Clinical Nutrition

oa_colors: green hybrid

evidence: open (via free pdf)

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

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Unilever R&D


title: Prospective Observatory of Endoscopic Mucosal Colonic Resection and Polypectomy Under Aspirin : the "OPERA" Study

acronym: OPERA

summary:
The endoscopic management of patients on anti platelet agents is a wide problem more and more common, with prevalence of patients on this type of therapy steadily increasing. The risk of bleeding on antiplatelet during an endoscopic examination can be major. The risk of cardiovascular thrombotic accident in dirty shutdown of anti platelet, was recently described as significant (4-5%). Current recommendations for polypectomy allow the gesture as aspirin and are based on literature data scarce, often retrospective. Such work may be for a lack of increased bleeding risk during a colonic polypectomy under aspirin. There is to date no significant data published on the implementation of the endoscopic mucosal resection (mucosectomy) under aspirin. It is necessary to achieve a national multicenter observational study on a large scale in the daily practice of colonic polypectomy / mucosectomy in patient taking aspirin.

The aim of the study is to determine the incidence of immediate and delayed bleeding colonic polypectomy and mucosectomy with aspirin. The patients undergoing colonoscopy and taking a long-term aspirin therapy and presenting a major risk of thromboembolism or medium will incluables. Inclusion will be achieved for those patients receiving aspirin colonoscopy after signing a specific consent. Polypectomy will be possible according to the recommendations of the French Society of Digestive Endoscopy. Upon discovery of a lesion to be resected by mucosectomy, the patient will benefit from the mucosectomy. The study is observational, multicenter, prospective, national. The polypectomies / colonic mucosectomies will be made using the conventional techniques and the current recommendations. The immediate and delayed hemorrhage meet specific definitional criteria. The number of patients to be included will be 1000. The duration of the study inclusions will be 36 months. The trial will be conducted in full compliance with laws, regulations and ethical aspects.

It is expected in this work that the incidence of post-polypectomy bleeding under aspirin is the same. The rate of bleeding reported in the post mucosectomy size is higher compared to the polypectomy: it is however expected that the rate of bleeding in the post mucosectomy with or without aspirin is indifferent. It will follow a recommendation of French society adapted to endoscopy for this type of procedure

lead_sponsor: Société Française d'Endoscopie Digestive


title: Randomized Phase III Trial Comparing Conventional Vitamin D Supplementation vs. Vitamin D Supplementation Tailored to Vitamin D Deficiency in Breast Cancer Patients Treated by Neoadjuvant or Adjuvant Chemotherapy.

acronym: VITACAL

summary: The purpose of this study is to compare normalization of vitamin D serum level after 6 months of vitamin D supplementation adjusted to baseline vitamin D serum level vs.conventional vitamin D supplementation.

ReferenceCitation: Jacot W, Firmin N, Roca L, Topart D, Gallet S, Durigova A, Mirr S, Abach L, Pouderoux S, D'Hondt V, Bleuse JP, Lamy PJ, Romieu G. Impact of a tailored oral vitamin D supplementation regimen on serum 25-hydroxyvitamin D levels in early breast cancer patients: a randomized phase III study. Ann Oncol. 2016 Jul;27(7):1235-41. doi: 10.1093/annonc/mdw145. Epub 2016 Mar 30.

family: Jacot

full_name: W. Jacot

given: W.

family: Firmin

full_name: N. Firmin

family: Roca

full_name: L. Roca

given: L.

family: Topart

full_name: D. Topart

given: D.

family: Gallet

full_name: S. Gallet

given: S.

family: Durigova

full_name: A. Durigova

family: Mirr

full_name: S. Mirr

family: Abach

full_name: L. Abach

family: Pouderoux

full_name: S. Pouderoux

family: D'Hondt

full_name: V. D'Hondt

given: V.

family: Bleuse

full_name: J.P. Bleuse

family: Lamy

full_name: P.J. Lamy

family: Romieu

full_name: G. Romieu

given: G.

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

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


title: Evaluation of the Efficacy of Cobedding in Daily Weight Gain of Neonate Twins

acronym: Cobedding

summary: Cobedding consists of associating twins in a common cocoon in order to maintain links developed in utero and reduce the stress of premature birth. The aim of this randomized, controlled prospective study is to compare efficacy (in term of newborn daily weight gain) and safety of cobedding versus single-bedding of preterm twins.


summary:
Purpose:

To assess the functional and anatomical outcome of primary vitrectomy without scleral buckling for rhegmatogenous retinal detachment (RRD) in highly myopic eyes with axial length over 30 mm.

Methods Design: Retrospective single center series. Setting: University Hospital. Patients: High myopic patients treated with primary vitrectomy without scleral buckling for a rhegmatogenous retinal detachment.

Outcome measures: Anatomical success rate with complete reattachment of the retina without silicone oil tamponade and postoperative best-corrected visual acuity (BCVA).

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire Dijon


type: Other Grant/Funding Number

title: "Effect of Citrulline Supplementation on Muscle Strength in Elderly Institutionalized Subjects Undergoing an Exercise Training Programme. "

acronym: CITREX

summary: The aim of this study is to assess the effect of citrulline supplementation on muscle strength in elderly institutionalized subjects undergoing a resistance exercise training program. The primary endpoint is the outcome of maximum strength of knee extensor muscles.


title: Screening for Thoracic Aortic Aneurysm Among a Cohort of Patients With a Degenerative Abdominal Aortic Aneurysm : Prevalence, Description of the Different Thoracic Aortic Phenotypes by Aortic Volumetric Numerized Imaging and Their Relationship With Epidemiologic, Clinical, Biological and Genetic Factors

summary: Many publications deal with the natural history of aortic aneurysms in literature. Except for connective tissue disorders as Marfan or Loeys-Dietz syndrome, aortic aneurysms are a complex multifactorial disease with genetic and environmental risk factors. Susceptibility loci identified in thoracic aortic aneurysms (TAA) and abdominal aortic aneurysms (AAA) do not overlap, suggesting that different genetic risk factors contribute to these two forms of aneuryms. With a higher prevalence correlated to ageing (5%), AAA is usually presented as the degenerative form of the disease. However, a recent epidemiologic study by Olsson et al. has revealed an increasing incidence of thoracic aortic disease among older individuals (70+/-12 years) with 60% of aneurysmal rupture or dissection at diagnosis, and a 1.7 :1 male-to-female ratio compared to 6:1 in AAA. From this current knowledge arises the concept of diffuse or plurisegmental degenerative aneurysmal aortic disease, poorly explored so far. As regards to the prevention policy, there is a consensus statement in which ultrasonography screening for AAA is recommended for all individuals aged > 60 years (particularly in men who have ever smoked) and for those aged > 50 years with family history of AAA. Nevertheless, screening for a concomittant thoracic location of the disease (except thoracoabdominal aneurysm) is not yet required, whereas it could change the prognosis of the patients and influence their management.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique Hopitaux de Marseille


title: COMPARATIVE STUDY OF DIAGNOSTIC VALUE FOR THE ECHOTIP® PROCORE™ 22 Gauge NEEDLE VERSUS ECHOTIP® 22 Gauge IN THE DIAGNOSIS OF PANCREATIC SOLID TUMORS UNDER ENDOSCOPIC ULTRASONOGRAPHY : THE "PICORE" STUDY

acronym: PICORE

summary:
The negative predictive value of fine needle aspiration under ultrasound endoscopy (EUS) for the diagnostic of solid pancreatic masses is 70% on average in the current literature with 22 gauge needles. There is a wide variability of this rate across studies (from 38 to 92%). In case of negativity of the biopsy, the risk of missing a pancreatic cancer whose prognosis is severe and extensive treatment, remains important. To improve the sensitivity of EUS echo endoscopy, several methods were used. A new needle (Echo Tip ® HD ProCore ™) has received CE Mark in the field of EUS. This instrument combines the comfortable and handy size of 22 Gauge and innovative design (window lateralized bevel) with in vitro studies obtaining core biopsy. In addition, a single pass through the tumor is achieved with this hand against several (2-3 minimum) with the current hardware. The theoretical goal is to have a tissue material more abundant during the sampling, without increasing morbidity and increase the diagnostic accuracy. A preliminary prospective study with this material has shown interesting results (increase the diagnostic accuracy of 15%).

To determine the diagnostic gain with this new hand, it seemed essential to propose a prospective comparative study (22 gauge needle ProCore ™ versus the old EchoTip ® 22-Gauge) randomized (randomization of the order of the needles) in crossover (on the same lesion) in samples of pancreatic solid tumors. The caliber of 22 gauge is the gauge most often used for punctures under ultrasound endoscopy, resulting in less morbidity. Puncture by the 2 needles on the same injury can limit the effect of variability between patients and thereby have a better power for the investigators study without increasing the risk of complications (the needle ProCore ™ does not require that one pass through the tumor). The study of pancreatic solid tumors is one that poses the biggest diagnostic problem still present in the investigators daily practice. The aim of this study is to compare the diagnostic accuracy of the needle ProCore™ versus EchoTip® in etiological cyto histological diagnostic for pancreatic solid tumors under EUS.

ReferenceCitation: Vanbiervliet G, Napoléon B, Saint Paul MC, Sakarovitch C, Wangermez M, Bichard P, Subtil C, Koch S, Grandval P, Gincul R, Karsenti D, Heyries L, Duchmann JC, Bourgaux JF, Levy M, Calament G, Fumex F, Pujol B, Lefort C, Poincloux L, Pagenault M, Bonin EA, Fabre M, Barthet M. Core needle versus standard needle for endoscopic ultrasound-guided biopsy of solid pancreatic masses: a randomized crossover study. Endoscopy. 2014 Dec;46(12):1063-70. doi: 10.1055/s-0034-1377559. Epub 2014 Aug 6.

name: Université de Nice Sophia Antipolis, Faculté de Médecine and Centre Hospitalier Universitaire de l’Archet 2, Pôle digestif, Nice, France

family: Vanbiervliet

full_name: Geoffroy Vanbiervliet

given: Geoffroy

name: Hôpital Privé Mermoz, Gastroentérologie, Lyon, France

family: Napoléon

full_name: Bertrand Napoléon

given: Bertrand

name: Centre Hospitalier Universitaire Pasteur, Anatomopathologie, Nice, France

family: Saint Paul

full_name: Marie Saint Paul

given: Marie

name: Centre Hospitalier Universitaire Cimiez, Département de la recherche clinique, Nice, France

family: Sakarovitch

full_name: Charlotte Sakarovitch

given: Charlotte

name: Centre Hospitalier Universitaire de Poitiers, Gastroentérologie, Poitiers, France

family: Wangermez

full_name: Marc Wangermez

given: Marc

name: Hôpitaux Universitaires de Genève, Gastroentérologie, Genève, Switzerland

family: Bichard

full_name: Philippe Bichard

given: Philippe

name: Centre hospitalier Universitaire du Haut-Lévêque, Gastroentérologie, Pessac, France

family: Subtil

full_name: Clément Subtil

given: Clément

name: Centre hospitalier Universitaire de Besançon, Gastroentérologie, Besançon, France

family: Koch

full_name: Stéphane Koch

given: Stéphane

name: Assistance publique des hôpitaux de Marseille, Hôpital de la Timone, Gastroentérologie, Marseille, France

family: Grandval

full_name: Philippe Grandval

name: Hospices civils de Lyon, Gastroentérologie, Lyon, France

family: Gincul

full_name: Rodica Gincul

given: Rodica

name: Clinique de Bercy, Pôle digestif, Charenton le Pont, France

family: Karsenti

full_name: David Karsenti

given: David

name: Assistance publique des hôpitaux de Marseille, Hôpital de la Conception, Gastroentérologie, Marseille, France

family: Heyries

full_name: Laurent Heyries

given: Laurent

name: Centre Hospitalier Général de Compiègne, Gastroentérologie, Compiègne, France

family: Duchmann

full_name: Jean-Christophe Duchmann

given: Jean-Christophe

name: Centre Hospitalier Universitaire Carémeau, Gastroentérologie, Nîmes, France

family: Bourgaux

full_name: Jean Bourgaux

given: Jean

name: Assistance Publique des hôpitaux de Paris, Hôpital Mondor, Gastroentérologie, Créteil, France

family: Levy

full_name: Michaël Levy

given: Michaël

name: Centre Hospitalier Universitaire de la Cavale Blanche, Gastroentérologie, Brest, France

family: Calament

full_name: Gilles Calament

given: Gilles

family: Fumex

full_name: Fabien Fumex

given: Fabien

family: Pujol

full_name: Bertrand Pujol

family: Lefort

full_name: Christine Lefort

given: Christine

name: Centre Hospitalier Universitaire Estaing, Gastroentérologie, Clermont Ferrand, France

family: Poincloux

full_name: Laurent Poincloux

name: Centre Hospitalier Universitaire de Pontchaillou, Gastroentérologie, Rennes, France

family: Pagenault

full_name: Maël Pagenault

given: Maël

name: Assistance publique des hôpitaux de Marseille, Hôpital Nord, Gastroentérologie, Marseille, France

family: Bonin

full_name: Eduardo Bonin

given: Eduardo

name: Gustave Roussy, Pathologie Morphologique, Villejuif, France

family: Fabre

full_name: Monique Fabre

given: Monique


title: INFLUENCE OF POLYPHENOLS ON OXIDATIVE STRESS IN HEALTHY INDIVIDUALS WITH HIGH METABOLISM RISK: RELATIONSHIP WITH THE MECHANISMS OF INSULIN RESISTANCE

acronym: POLYOXRESIST

summary: Diet and nutrition play an essential role in the development and the clinical expression of the most common health problems. Overeating and obesity induce oxidative stress, which has been proposed to be a pathogenic mechanism leading to insulin resistance, type 2 diabetes (T2D) and associated cardiovascular complications. The main objective of the proposed research is to evaluate the beneficial effects of polyphenolic compounds derived from red grape marc extracts on the cascade of events leading from overeating to oxidative stress and insulin resistance. For that, we will study free radicals production, inflammatory markers, adipokines, mitochondrial function, insulin sensitivity and energy substrate utilization in healthy volunteers at risk for insulin resistance and T2D (1st degree relatives of T2D patients with associated overweight). These volunteers will be randomized between a placebo and a polyphenol group for 9 weeks. The demonstration of the beneficial effects of polyphenols will be sensitized by high-fructose feeding for the last 6 days of the protocol.

ReferenceCitation: Hokayem M, Blond E, Vidal H, Lambert K, Meugnier E, Feillet-Coudray C, Coudray C, Pesenti S, Luyton C, Lambert-Porcheron S, Sauvinet V, Fedou C, Brun JF, Rieusset J, Bisbal C, Sultan A, Mercier J, Goudable J, Dupuy AM, Cristol JP, Laville M, Avignon A. Grape polyphenols prevent fructose-induced oxidative stress and insulin resistance in first-degree relatives of type 2 diabetic patients. Diabetes Care. 2013 Jun;36(6):1454-61. doi: 10.2337/dc12-1652. Epub 2012 Dec 28.

family: Hokayem

full_name: M. Hokayem

given: M.

family: Blond

full_name: E. Blond

given: E.

family: Vidal

full_name: H. Vidal

given: H.

family: Lambert

full_name: K. Lambert

given: K.

family: Meugnier

full_name: E. Meugnier

family: Feillet-Coudray

full_name: C. Feillet-Coudray

given: C.

family: Coudray

full_name: C. Coudray

family: Pesenti

full_name: S. Pesenti

given: S.

family: Luyton

full_name: C. Luyton

family: Lambert-Porcheron

full_name: S. Lambert-Porcheron

family: Sauvinet

full_name: V. Sauvinet

given: V.

family: Fedou

full_name: C. Fedou

family: Brun

full_name: J.-F. Brun

family: Rieusset

full_name: J. Rieusset

given: J.

family: Bisbal

full_name: C. Bisbal

family: Sultan

full_name: A. Sultan

given: A.

family: Mercier

full_name: J. Mercier

family: Goudable

full_name: J. Goudable

family: Dupuy

full_name: A.-M. Dupuy

family: Cristol

full_name: J.-P. Cristol

family: Laville

full_name: M. Laville

family: Avignon

full_name: A. Avignon

journal_name: Diabetes Care

oa_colors: green other

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

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

title: Grape Polyphenols Prevent Fructose-Induced Oxidative Stress and Insulin Resistance in First-Degree Relatives of Type 2 Diabetic Patients


title: Use of Biological Mesh Versus Standard Wound Care in Infected Incisional Ventral Hernias: a Multicenter Randomized Controlled Trial, the SIMBIOSE Study

acronym: SIMBIOSE

summary: The SIMBIOSE trial is a large multicenter phase III prospective randomized controlled single blinded trial comparing the use of biological mesh versus traditional wound care without biological mesh in patients with an infected incisional ventral hernia. The primary endpoint is 6-month infectious and/or wound morbidity. Secondary endpoints are wound infection rate at 45 days, 3 months and 1 year, recurrent hernia rates at 1, 2 and 3 years, postoperative pain, quality of life, time to healing, need for wound reoperation, impact of the cross-linked mesh structure, and medico-economic evaluation. One hundred patients need to be included.

ReferenceCitation: Mariette C, Briez N, Denies F, Dervaux B, Duhamel A, Guilbert M, Bruyère E, Robb WB, Piessen G; FRENCH. Use of biological mesh versus standard wound care in infected incisional ventral hernias, the SIMBIOSE study: a study protocol for a randomized multicenter controlled trial. Trials. 2013 May 7;14:131. doi: 10.1186/1745-6215-14-131.

family: Mariette

full_name: Christophe Mariette

given: Christophe

family: Briez

full_name: Nicolas Briez

given: Nicolas

family: Denies

full_name: Fanette Denies

given: Fanette

family: Dervaux

full_name: Beno�t Dervaux

given: Beno�t

family: Duhamel

full_name: Alain Duhamel

given: Alain

family: Guilbert

full_name: Marie Guilbert

given: Marie

family: Bruy�re

full_name: Emilie Bruy�re

given: Emilie

family: Robb

full_name: William B Robb

given: William B

family: Piessen

full_name: Guillaume Piessen

given: Guillaume

currency_apc_doaj: GBP

journal_name: Trials

license: cc-by

license_normalized: cc-by

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

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: University Hospital, Lille

location_facility: Claude Huriez Hospital, University hospital


title: Randomized Control Study : Safety and Efficacy of Carbohydrate Drink Ingested Two Hours Before Upper Endoscopy Under General Anaesthesia

acronym: ENDOGLUcide

summary: In several national anaesthesia societies, clear fluids are allowed up to 2 hours before general anaesthesia (GA) and light meals up to 6h. Because of aspiration risk, strict fasting remains routine. Recently, surgical studies proved that pre-operative carbohydrate-rich drink reduces preoperative discomfort without affecting gastric fluid volume and acidity.The aim of this study was to show the effects of preanaesthetic oral fluid in patients undergoing upper endoscopy without emergency. The expected efficacy is a reduction of the preoperative discomfort. The investigators thus propose a randomised prospective open-label study to assess efficacy of preanaesthetic oral glucose drink in patients undergoing upper endoscopy without emergency. Study compare two groups : group "drink" (200 ml of fruit juice without pulp ± 200 ml of coffee or tea, 2 at 4 hours before the induction of anaesthesia) and group "overnight fasting".Discomfort was measured at 2 hours before GA (H-2), just before GA (H0) and 4h after anaesthesia (H+4). Each item (anxiety, thirst, hunger, nervousness, tiredness, nausea) was estimated by visual analogue scale (VAS from 0 to 100mm) and handgrip strength by dynamometer. Gastroenterologist assessed the quality of endoscopy (VAS), gastric residual fluid and acidity.The main aim of this study was to assess in patients referred for upper endoscopy under general anaesthesia, the effect of carbohydrate drink on preanaesthetic discomfort. Secondary purpose were to compare quality of endoscopy, residual gastric volumes, gastric acidity and incidence of side effects. 118 patients will be included in the study. A stratification will be made on the type of endoscopy.

lead_sponsor: University Hospital, Caen


title: Phase 2, Monocentric, Single Blind Study, Comparing the Efficacy and Tolerance of a Dipyridamole/Adenosine Combination Given Intravenously, as a Slow Bolus and at Low Doses to Adenosine Alone for Coronary Flow Reserve Assessment (in Patients With Stable Ischemic Heart Disease) Using Transthoracic Echodoppler

summary: The purpose of this study is to evaluate the efficacy and tolerance of a dipyridamole/adenosine combination given intravenously, as a slow bolus and at low doses to adenosine alone (given at its recommended dosage adjusted to patients' weight) for coronary flow reserve assessment (in 60-75 patients with stable ischemic heart disease) using transthoracic echodoppler

status: Unknown status

enrollment_type: Anticipated

lead_sponsor: Adenobio N.V


acronym: DORESI

title: Study on Dose-response to Bronchodilator Then Bronchodilator Dose-finding Using the Flow Interruption Technique in Children Aged 2.5 TO 6 Years

summary:
In older children and adults, bronchodilator (BD) dose-effect relationship is part of the characteristics of asthma disease. There are no data on BD dose-response relationship in wheezy preschool children whose disease pathophysiology is poorly understood, but may, in part, takes on the characteristics of asthma.

The investigators assume that 1) in young children interrupter resistance (Rint) could be used to measure a BD effect 2) the response to BD may vary depending on the dose used 3) the dose-response relationship could depend on the environment and gene polymorphism ADBR2.

This is a prospective phase II study on dose-response relationship and description of the dose-response curve design using a "sparse" and a modeling approach MCP-Mod.

The dose-response relationship will be modeled by sparse data. The investigators will test two doses per child in four designs that will be drawn. These doses will be assessed using Rint technique by a person blinded to the actual dose delivered to the child.

Measurements of 90 children will estimate E0, Imax and D50 (pharmacokinetic constants) with an accuracy of 3.5%, 8.9% and 25.7% respectively.

The bronchodilator used in the study is the Salbutamol as Ventolin ® (GSK) suspension for inhalation as an aerosol at a dose of 100μg per puff. Ventolin ® is used as part of the MA (No. 344 387-3)


title: Identification of Biomarkers in Patients With Autosomal Dominant Cerebellar Ataxia

acronym: BIOSCA

summary: Autosomal dominant cerebellar ataxias (ADCA) are a group of neurodegenerative disorders that are clinically and genetically various. BIOSCA study aims to identify markers of the metabolism (energy production inside the cells) in the blood and the brain of ADCA 1,2,3 and 7 patients and control subjects, in the perspective of future therapeutic trials.

ReferenceCitation: Adanyeguh IM, Henry PG, Nguyen TM, Rinaldi D, Jauffret C, Valabregue R, Emir UE, Deelchand DK, Brice A, Eberly LE, Öz G, Durr A, Mochel F. In vivo neurometabolic profiling in patients with spinocerebellar ataxia types 1, 2, 3, and 7. Mov Disord. 2015 Apr 15;30(5):662-70. doi: 10.1002/mds.26181. Epub 2015 Mar 15.

name: INSERM U 1127, Sorbonne Universités, UPMC Univ Paris Institut du Cerveau et de la Moelle épinière, ICM; Paris France

family: Adanyeguh

full_name: Isaac M. Adanyeguh

given: Isaac M.

name: Center for Magnetic Resonance Research, University of Minnesota; Minneapolis MN United States

family: Henry

full_name: Pierre-Gilles Henry

given: Pierre-Gilles

family: Nguyen

full_name: Tra M. Nguyen

given: Tra M.

family: Rinaldi

full_name: Daisy Rinaldi

given: Daisy

family: Jauffret

full_name: Celine Jauffret

given: Celine

name: Center for NeuroImaging Research, Institut du Cerveau et de la Moelle épinière; Paris France

family: Valabregue

full_name: Romain Valabregue

given: Romain

family: Emir

full_name: Uzay E. Emir

given: Uzay E.

family: Deelchand

full_name: Dinesh K. Deelchand

given: Dinesh K.

family: Brice

full_name: Alexis Brice

given: Alexis

name: Division of Biostatistics; School of Public Health, University of Minnesota; Minneapolis MN USA

family: Eberly

full_name: Lynn E. Eberly

given: Lynn E.

family: Öz

full_name: Gülin Öz

given: Gülin

name: Assistance Publique-Hôpitaux de Paris, Fédération de Génétique, La Pitié-Salpêtrière University Hospital; Paris France

family: Durr

full_name: Alexandra Durr

given: Alexandra

family: Mochel

full_name: Fanny Mochel

given: Fanny

journal_name: Movement Disorders

version: acceptedVersion

ReferenceCitation: Adanyeguh IM, Perlbarg V, Henry PG, Rinaldi D, Petit E, Valabregue R, Brice A, Durr A, Mochel F. Autosomal dominant cerebellar ataxias: Imaging biomarkers with high effect sizes. Neuroimage Clin. 2018 Jun 14;19:858-867. doi: 10.1016/j.nicl.2018.06.011. eCollection 2018.

apc_source: openAPC

family: Perlbarg

full_name: Vincent Perlbarg

given: Vincent

family: Petit

full_name: Elodie Petit

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

ReferenceCitation: Garali I, Adanyeguh IM, Ichou F, Perlbarg V, Seyer A, Colsch B, Moszer I, Guillemot V, Durr A, Mochel F, Tenenhaus A. A strategy for multimodal data integration: application to biomarkers identification in spinocerebellar ataxia. Brief Bioinform. 2018 Nov 27;19(6):1356-1369. doi: 10.1093/bib/bbx060.

name: Bioinformatics and Biostatistics Core Facility of the Brain and Spine Institute, La Pitié-Salpêtriére Hospital, Paris, France

name: ICANalytics department, institute of cardiometabolism and nutrition, Paris, France

name: SpectMet platform of the MedDay Pharmaceuticals company, Paris, France

name: Institut Pasteur, Statistical Genetics group, Bioinformatics/Biostatistics Core Facility

name: Pitié-Salpêtriére University Hospital in Paris

name: University Pierre and Marie Curie (UPMC) and the Pitié-Salpêtriére University Hospital

name: L2S Laboratory at CentraleSupélec, France

ReferenceCitation: Faber J, Schaprian T, Berkan K, Reetz K, França MC Jr, de Rezende TJR, Hong J, Liao W, van de Warrenburg B, van Gaalen J, Durr A, Mochel F, Giunti P, Garcia-Moreno H, Schoels L, Hengel H, Synofzik M, Bender B, Oz G, Joers J, de Vries JJ, Kang JS, Timmann-Braun D, Jacobi H, Infante J, Joules R, Romanzetti S, Diedrichsen J, Schmid M, Wolz R, Klockgether T. Regional Brain and Spinal Cord Volume Loss in Spinocerebellar Ataxia Type 3. Mov Disord. 2021 Oct;36(10):2273-2281. doi: 10.1002/mds.28610. Epub 2021 May 5.

name: DZNE, German Center for Neurodegenerative Diseases  Bonn Germany

name: Department of Neurology University Hospital Bonn  Bonn Germany

name: Department of Neurology RWTH Aachen University  Bonn Germany

name: JARA‐Brain Institute Molecular Neuroscience and Neuroimaging, Forschungszentrum Jülich  Jülich Germany

name: Brazilian Institute of Neuroscience and Neurotechnology (BRAINN)  Campinas Brazil

name: Department of Neurology University of Campinas  Campinas Brazil

name: Department of Neurology Xiangya Hospital, Central South University  Changsha China

name: Department of Radiology Xiangya Hospital, Central South University  Changsha People's Republic of China

name: Department of Neurology Radboud University Medical Centre, Donders Institute for Brain, Cognition and Behaviour  Nijmegen The Netherlands

name: Sorbonne Université, Paris Brain Institute, AP‐HP, INSERM, CNRS, Pitié‐Salpêtrière University Hospital  Paris France

name: Ataxia Centre, Department of Clinical and Movement Neurosciences UCL Queen Square Institute of Neurology  London United Kingdom

name: National Hospital for Neurology and Neurosurgery University College London Hospitals NHS Foundation Trust  London United Kingdom

name: Department of Neurodegenerative Diseases and Hertie‐Institute for Clinical Brain Research University of Tübingen  Tübingen Germany

name: German Centre for Neurodegenerative Diseases (DZNE)  Tübingen Germany

name: Department of Diagnostic and Interventional Neuroradiology University Hospital Tübingen  Tübingen Germany

name: Center for Magnetic Resonance Research, Department of Radiology University of Minnesota  Minneapolis Minnesota USA

name: Department of Neurology University of Groningen, University Medical Center Groningen  Groningen The Netherlands

name: Department of Neurology Goethe University  Frankfurt am Main Germany

name: Department of Neurology Essen University Hospital  Essen Germany

name: Department of Neurology University Hospital of Heidelberg  Heidelberg Germany

name: Neurology Service, University Hospital Marques de Valdecilla‐IDIVAL, University of Cantabria, Centro de Investigacion Biomedica en Red de Enfermedades Neurodegenerativas (CIBERNED)  Santander Spain

name: Brain Mind Institute, Departmentof Computer Science, Department of Statistics University of Western Ontario  London Canada

name: Institute of Medical Biometry, Informatics and Epidemiology University Hospital Bonn  Bonn Germany

repository_institution: University College London - UCL Discovery

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

ReferenceCitation: Coarelli G, Darios F, Petit E, Dorgham K, Adanyeguh I, Petit E, Brice A, Mochel F, Durr A. Plasma neurofilament light chain predicts cerebellar atrophy and clinical progression in spinocerebellar ataxia. Neurobiol Dis. 2021 Jun;153:105311. doi: 10.1016/j.nbd.2021.105311. Epub 2021 Feb 23.


title: Assessing the Impact of Isokinetic Muscular Strengthening in Eccentric Mode in the Medical Treatment of Knee Osteoarthritis.

acronym: ISOGO

summary:
Knee osteoarthritis (O.A. from now on) is associated to muscular weakness of inferior limbs, especially the quadriceps; leading to disease progression. Advantages of muscular strength training for the treatment of this kind of O.A. is now well established. In this therapeutic field, isokinetic exercises seem to have a better efficiency than other, more frequently used, kinds of exercises such as isometric or isotonic exercises.

Functional impairment caused by knee O.A. is mainly affecting walking. Walking induces muscles to work in eccentric mode.

The hypothesis of this study is that muscular strengthening using isokinetic exercises in eccentric mode would have a more important benefit than isokinetic exercises in concentric mode. Such an hypothesis, if verified, could lead to a better management of rehabilitative knee exercises in the treatment of knee O.A.

study_completion_date_type: Anticipated

ReferenceCitation: Jegu AG, Pereira B, Andant N, Coudeyre E. Effect of eccentric isokinetic strengthening in the rehabilitation of patients with knee osteoarthritis: Isogo, a randomized trial. Trials. 2014 Apr 2;15:106. doi: 10.1186/1745-6215-15-106.

family: Jegu

full_name: Anne-Gaëlle Jegu

given: Anne-Gaëlle

family: Pereira

full_name: Bruno Pereira

given: Bruno

family: Andant

full_name: Nicolas Andant

given: Nicolas

family: Coudeyre

full_name: Emmanuel Coudeyre

given: Emmanuel

lead_sponsor: University Hospital, Clermont-Ferrand


title: Extracorporeal Membrane Oxygenation(ECMO) for Severe Acute Respiratory Distress Syndrome (ARDS)

acronym: EOLIA

summary: This international multicenter, randomized, open trial will evaluate the impact of Extracorporeal Membrane Oxygenation (ECMO), instituted early after the diagnosis of acute respiratory distress syndrome (ARDS) not evolving favorably after 3-6 hours under optimal ventilatory management and maximum medical treatment, on the morbidity and mortality associated with this disease.

ReferenceCitation: Combes A, Hajage D, Capellier G, Demoule A, Lavoué S, Guervilly C, Da Silva D, Zafrani L, Tirot P, Veber B, Maury E, Levy B, Cohen Y, Richard C, Kalfon P, Bouadma L, Mehdaoui H, Beduneau G, Lebreton G, Brochard L, Ferguson ND, Fan E, Slutsky AS, Brodie D, Mercat A; EOLIA Trial Group, REVA, and ECMONet. Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome. N Engl J Med. 2018 May 24;378(21):1965-1975. doi: 10.1056/NEJMoa1800385.

ReferenceCitation: Schmidt M, Combes A. Influence of ventilatory strategy on the PRESERVE mortality risk score: response to Camporota et al. Intensive Care Med. 2014 Jun;40(6):916. doi: 10.1007/s00134-014-3284-x. Epub 2014 Apr 10.

family: Schmidt

full_name: Matthieu Schmidt

given: Matthieu

family: Combes

full_name: Alain Combes

given: Alain

journal_name: Intensive Care Medicine

ReferenceCitation: Schmidt M, Pellegrino V, Combes A, Scheinkestel C, Cooper DJ, Hodgson C. Mechanical ventilation during extracorporeal membrane oxygenation. Crit Care. 2014 Jan 21;18(1):203. doi: 10.1186/cc13702. Review.

family: Pellegrino

full_name: Vincent Pellegrino

family: Scheinkestel

full_name: Carlos Scheinkestel

given: Carlos

family: Cooper

full_name: D Cooper

given: D

family: Hodgson

full_name: Carol Hodgson

given: Carol

journal_name: Critical Care

ReferenceCitation: Schmidt M, Zogheib E, Rozé H, Repesse X, Lebreton G, Luyt CE, Trouillet JL, Bréchot N, Nieszkowska A, Dupont H, Ouattara A, Leprince P, Chastre J, Combes A. The PRESERVE mortality risk score and analysis of long-term outcomes after extracorporeal membrane oxygenation for severe acute respiratory distress syndrome. Intensive Care Med. 2013 Oct;39(10):1704-13. doi: 10.1007/s00134-013-3037-2. Epub 2013 Aug 2.

family: Zogheib

full_name: Elie Zogheib

given: Elie

family: Rozé

full_name: Hadrien Rozé

given: Hadrien


title: Prospective, Longitudinal and National Follow-up Program of Adult Patients With Somatotropic Hormone Deficiency for Whom Substituting Treatment by Norditropin SimpleXx Was Started

summary: This study is conducted in Europe. The aim of this study is to extract data from the French National Registry holding information about patients having initiated growth hormone therapy with the objective to describe patients receiving growth hormone therapy, assess efficacy and safety of somatropin (Norditropin® SimpleXx®) and evaluate treatment compliance.

ReferenceCitation: Borson-Chazot F, Chabre O, Salenave S, Klein M, Brac de la Perriere A, Reznik Y, Kerlan V, Hacques E, Villette B. Adherence to growth hormone therapy guidelines in a real-world French cohort of adult patients with growth hormone deficiency. Ann Endocrinol (Paris). 2021 Feb;82(1):59-68. doi: 10.1016/j.ando.2020.11.007. Epub 2020 Dec 5.

family: Borson-Chazot

full_name: Françoise Borson-Chazot

given: Françoise

family: Chabre

full_name: Olivier Chabre

given: Olivier

family: Salenave

full_name: Sylvie Salenave

given: Sylvie

family: Klein

full_name: Marc Klein

given: Marc

family: Brac de la Perriere

full_name: Aude Brac de la Perriere

given: Aude

family: Reznik

full_name: Yves Reznik

given: Yves

family: Kerlan

full_name: Véronique Kerlan

given: Véronique

family: Hacques

full_name: Evguenia Hacques

given: Evguenia

family: Villette

full_name: Béatrice Villette

given: Béatrice

journal_name: Annales d'Endocrinologie

lead_sponsor: Novo Nordisk A/S


title: A Prospective, Multicentric, Randomized Trial Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy

acronym: Nutri-DPC

summary:
Pancreaticoduodenectomy is a major surgery burdened by important morbidity and mortality partially related to the altered nutritional status of the patients. The perioperative malnutrition is a major risk factor of postoperative complications and worsens the prognosis of the patients. The perioperative artificial nutrition has for objectives to correct the preoperative malnutrition, and to maintain the nutritional status in the post-operative period. The current guidelines in surgery are in favour of a realisation of a perioperative artificial nutrition support that privilege the enteral nutrition. However, after pancreaticoduodenectomy, the total parenteral nutrition remains most usually used in the early postoperative period, although rare studies suggest a benefit of the enteral nutrition in term of reduction of the post-operative complications. Indeed, no recommendation was formulated concerning early enteral nutrition after pancreaticoduodenectomy because few studies were realized on its profits.

The data of the literature report rates of complications (essentially major) from 49 % to 59 % after major digestive surgery (not only pancreatic) on patients having received a total parenteral nutrition versus rates from 34 to 43.8 % in patients having received an early enteral nutrition.

A preliminary prospective study realized in the investigators centre showed a rate of 74 % complication versus 44 %, respectively in the total parenteral nutrition and early enteral nutrition groups (50 patients in every group, with p < 0.01. All the complications were listed prospectively).

Hypothesis :

The early enteral nutrition will allow, after pancreaticoduodenectomy, a decrease of, at least, 19 % complications of any stage according to the classification of Dindo-Clavien (59 % versus 40 %).

location_facility: Unité de Chirurgie Hépatobiliaire et Pancréatique Hopital Edouard Herriot


title: French National Longitudinal Prospective Follow-up of Children Born Small for Gestational Age and Treated With Norditropin SimpleXx (French Health Authorities Commitment)

summary: This study is conducted in Europe. The aim of the study is to describe the patient population and therapeutic practices (study phase I), assess efficacy on growth and adult height and assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II)


title: Invasiveness and Chemoresistance of Cancer Stem Cells in Colon Cancer: Molecular Characterization and Implications for Therapeutic Strategies

summary: The main objective of this study is to identify and characterize subpopulations of cells with invasive capacity in colorectal cancer from primary tumor, blood and metastatic samples.

ReferenceCitation: Grillet F, Bayet E, Villeronce O, Zappia L, Lagerqvist EL, Lunke S, Charafe-Jauffret E, Pham K, Molck C, Rolland N, Bourgaux JF, Prudhomme M, Philippe C, Bravo S, Boyer JC, Canterel-Thouennon L, Taylor GR, Hsu A, Pascussi JM, Hollande F, Pannequin J. Circulating tumour cells from patients with colorectal cancer have cancer stem cell hallmarks in ex vivo culture. Gut. 2017 Oct;66(10):1802-1810. doi: 10.1136/gutjnl-2016-311447. Epub 2016 Jul 25.

family: Grillet

full_name: Fanny Grillet

given: Fanny

family: Bayet

full_name: Elsa Bayet

given: Elsa

family: Villeronce

full_name: Olivia Villeronce

given: Olivia

family: Zappia

full_name: Luke Zappia

given: Luke

family: Lagerqvist

full_name: Ebba Louise Lagerqvist

given: Ebba Louise

family: Lunke

full_name: Sebastian Lunke

given: Sebastian

family: Charafe-Jauffret

full_name: Emmanuelle Charafe-Jauffret

given: Emmanuelle

family: Pham

full_name: Kym Pham

given: Kym

family: Molck

full_name: Christina Molck

given: Christina

family: Rolland

full_name: Nathalie Rolland

given: Nathalie

family: Bourgaux

full_name: Jean François Bourgaux

given: Jean François

family: Prudhomme

full_name: Michel Prudhomme

given: Michel

family: Philippe

full_name: Claire Philippe

given: Claire

family: Bravo

full_name: Sophie Bravo

given: Sophie

family: Boyer

full_name: Jean Christophe Boyer

given: Jean Christophe

family: Canterel-Thouennon

full_name: Lucile Canterel-Thouennon

given: Lucile

family: Taylor

full_name: Graham Roy Taylor

given: Graham Roy

family: Hsu

full_name: Arthur Hsu

given: Arthur

family: Pascussi

full_name: Jean Marc Pascussi

given: Jean Marc

family: Hollande

full_name: Frédéric Hollande

given: Frédéric

family: Pannequin

full_name: Julie Pannequin

given: Julie

journal_name: Gut

evidence: open (via page says license)

repository_institution: University of Melbourne - Minerva Access

repository_institution: University of Oxford - Oxford Academic Notes & Queries

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

title: Circulating tumour cells from patients with colorectal cancer have cancer stem cell hallmarks inex vivoculture

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_facility: CHU de Nîmes - Hôpital Universitaire Carémeau


title: Non Opioid Treatment for Experimental Dyspnea

acronym: Nefopel

summary: The purpose of this protocol is to test the effects of the non opioid nefopam on experimental dyspnea and on the counterirritation (ie inhibition of one pain by another pain) induced by dyspnea in healthy subjects.

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: Oculomotor Recording in the Contribution to the Early Differential Diagnosis of Dementia With Lewy Bodies and Alzheimer's Disease

acronym: OculoMacl

summary:
The aim of this study is to determine whether saccadic eye movement recording may help in the discrimination between Lewy body dementia and Alzheimer disease, in the early stages of the disease.

Study type: Interventional Study design: Intervention Model: Single group assignment Primary purpose: Diagnostic

location_facility: Assistance Publique Hôpitaux de Paris - Pitié-Salpetriere hospital


title: Predictive Factors of the Treatment Failure in HCV Mono-infected Patients Treated With Pegylated-interferon/Ribavirin/Telaprevir.

acronym: GENUPI

summary:
The purpose of the study is to

1- detect and quantify HCV-PI resistant mutants with ultra-deep pyrosequencing (UDPS) technology, 2 - detect SNPs in P-glyocoprotein and CYP3A genes, in HCV mono-infected patients under/after Telaprevir treatment.

lead_sponsor: Association HGE CHU Bordeaux Sud


title: Evaluation of Effect of Low and High-frequencies of Repetitive Transcranial Magnetic Stimulation (rTMS) by the Suppression of P50 Evoked Potential Component (rTMS-P50)

summary:
The repetitive transcranial magnetic stimulation (rTMS) is a recent technique that has demonstrated its efficiency in both depression and schizophrenia. However if its efficiency has been recognized by the scientific community and the clinicians, its action on neurons and cerebral networks remains debated.

In the motor regions, the different rTMS studies generally use frequencies of stimulation of 1 to 40 Hz with differential effects; the low frequencies being associated with an inhibitory effect whereas highest frequencies have rather some facilitator effects as attested by the motor responses. What is valid for the motor system is not however necessarily applicable to other cerebral regions that have different neuronal organizations. If it is easy to observe these opposite effects of rTMS on the motor system (presence or absence of movements), these potential effects on more integrated cortex involved in high level functions have not been proved.

One of the possibilities to interpret the effects of the rTMS in no-motor cerebral regions would be to study the modifications of the EEG before and after rTMS and to see if a differential effect of the high and low frequencies of stimulation exists. Up to now, the studies having coupled these two techniques have observed modifications of the brain electric activity only during some seconds to minutes after rTMS, what appears in contrast with the clinical effects observed after a long delay (several days).

The contribution of our research resides in the use of the paradigm of suppression of P50 evoked potential component before and after rTMS tested with low and high frequencies of stimulation. This paradigm consists in two identical auditory stimuli presented at a very short interval (generally 500 milliseconds), the second sound generating a P50 wave of weaker amplitude than the first or being completely abolished in healthy subjects. However, this effect that has been well studied could result from an inhibitory action due to the gabaergic interneurons on the pyramidal neurons of the cortex. Thus, the investigators hypothesize that high frequency rTMS would have a facilitator effect on temporal lobe and so would induce no suppression of the P50 after-rTMS whereas low frequency rTMS would induce an inhibitory effect marked by a greater suppression of the P50.

Methods: 30 healthy subjects (of which 16 women) will be included after written consent. They will receive after randomization 2 sessions of rTMS in cross over at 1Hz and 20Hz at 30 days interval. An EEG and a P50 evoked potential will be done before and after rTMS. The site of stimulation will be determined by neuronavigation and will correspond to the maximal activation cluster generated by a language task during functional magnetic resonance imaging. The main judgment criterion is the S2/S1 ratio of the P50. The potential secondary effects will be evaluated (UKU adapted). The secondary criteria are the comparisons before and after rTMS of EEG spectrums in the alpha, beta and gamma bands.

location_facility: Caen University Hospital, department of psychiatry and explorations fonctionnelles neurologiques


title: Dietetic and Hygiene Measures in Metabolic Neuropathies: the Neurodiet Study

summary: Metabolic disorders such as diabetes mellitus, glucose intolerance and possibly metabolic syndrome can induce a peripheral neuropathy. To investigate the effect of physical training and diet education on neuropathic symptoms and neurophysiological parameters of patients with metabolic neuropathies.

lead_sponsor: Henri Mondor University Hospital

intervention_type: Behavioral


acronym: LIFSCREEN

summary: The purpose of this study is to compare the diagnostic efficacy of two follow-up schedules for the early detection of cancers in the population under study on cancer incidence at 3 years.

ReferenceCitation: Caron O, Frebourg T, Benusiglio PR, Foulon S, Brugières L. Lung Adenocarcinoma as Part of the Li-Fraumeni Syndrome Spectrum: Preliminary Data of the LIFSCREEN Randomized Clinical Trial. JAMA Oncol. 2017 Dec 1;3(12):1736-1737. doi: 10.1001/jamaoncol.2017.1358.

name: Département de Médecine Oncologique,Gustave Roussy Hôpital Universitaire, Villejuif, France

family: Caron

full_name: Olivier Caron

given: Olivier

name: Normandie University, INSERM U1245, Rouen, France

name: Department of Genetics, Rouen University Hospital, Rouen, France

family: Frebourg

full_name: Thierry Frebourg

given: Thierry

family: Benusiglio

full_name: Patrick R. Benusiglio

given: Patrick R.

name: Service de Biostatistique et d’Epidémiologie, Gustave Roussy, Villejuif, France

name: CESP Centre for Research in Epidemiology and Population Health, INSERM U1018, Paris-Sud University, Villejuif, France

family: Foulon

full_name: Stéphanie Foulon

given: Stéphanie

name: Département de Cancérologie de l’enfant et de l’adolescent,Gustave Roussy Hôpital Universitaire, Villejuif, France

family: Brugières

full_name: Laurence Brugières

given: Laurence

journal_name: JAMA Oncology

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Development and Validation of a Limb Volumetry Technique Applicable in Daily Clinical Practice Using Self Positioning 3D Laser Scanning:Reproductibility and Comparison to the Reference Method

summary:
Volumetry is essential for the diagnosis and follow-up of patients with limb edema. The objective of this project is the validation of real-time reconstruction and calculation of limb volume using a 3D laser scanner.

Water - displacement volumetry (water-filled boot) is the reference method with known accuracy and reproducibility, but is not commonly used in clinical practice because it is cumbersome, difficult, and time-consuming. The most commonly used method remains segmental limb perimetry with a tape measure, followed by volume calculation using the truncated cones formula, thus excluding de facts extremities (hands and feet) which can neither be likened to cones nor easily measured.

Quantification limb volume and volume changes is essential for the diagnosis and follow-up of patients with chronic venous insufficiency or lymphedema, two very common pathological conditions. It is mandatory for the evaluation of therapeutic approaches.

The present study will use an innovative technology of volume acquisition by freehand laser scanning with a hand-held camera with Quantification limb volume and volume changes is essential for the diagnosis and follow-up of patients with chronic venous insufficiency or lymphedema, two very common pathological conditions. It is mandatory for the evaluation of therapeutic approaches.

The present study will use an innovative technology of volume acquisition by freehand laser scanning with a hand-held camera with real-time 3D reconstruction.

Its advantages are non-contact, accurate and detailed quantification of edema, including extremities, allowing to assess the magnitude and topography of physiological, pathological, or treatment - induced volume changes. This approach will ultimately provide data that will used for designing personalized limb compression ortheses.

lead_sponsor: University Hospital, Montpellier


title: A Single-Center, Randomized, Double-Blind, Single and Multiple Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food) and Pharmacodynamics of RO5508887 Following Oral Administration in Healthy Subjects.

summary: This randomized, double-blind, placebo-controlled, cross-over study will assess the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. In Part 1, subjects will be randomized to receive single ascending doses of either RO5508887 or placebo. In Part 2, subjects will receive a single dose of RO5508887 on two occasions, with or without food. Anticipated time on study is up to 12 weeks.

lead_sponsor: Hoffmann-La Roche


title: Behavioural and Metabolic Consequences of Increasing Eating Frequency

acronym: SAFRAN

summary:
In this study, the investigators are interested in assessing the effects of the isocaloric increase of eating frequency on appetite and metabolism. How the consumption of an isocaloric breakfast in four intakes vs. one can modify satiety and appetite control in lean and obese subjects through :

the physiological consequences : difference in postprandial kinetics of glucose, non esterified fatty acid, triglyceride, the secretion of satiety gut hormone (insulin, ghrelin, leptin and cholescystokinine (CCK), peptide YY (PYY), glucagon-like peptide-1 (GLP-1), nutrients oxidative fate and plasmatic oxidative stress (Malondialdehyde (MDA), glutathion, lipid hydroperoxides)
eating behavior during an ad libitum buffet test meal

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre Hospitalier Lyon Sud - Centre de Recherche en Nutrition Humaine


title: Effects of NMBA on the Alteration of Transpulmonary Pressures at the Early Phase of ARDS

summary:
Mortality in Acute Respiratory Distress Syndrome is high (40 to 60 %). Protective mechanical ventilation, until 2010, was the cornerstone of the ARDS therapeutic strategies. Recently, a prospective multicenter study demonstrates that a 48h continuous infusion of neuromuscular blocking agents (NMBA) have a positive impact on mortality of ARDS patients. (Papazian et al. ACURASYS Study. NEJM 2010; 363:1107-16). The mechanisms through which NMBAs could improve survival remain speculative. They are as follows:

reduction of the consumption of oxygen linked to ventilatory workload;
increase of chest wall compliance improving mechanical ventilation during ARDS and better adaptation to the protective ventilation strategy;
anti-inﬂammatory effect contributing to a reduction in pulmonary inﬂammation and improvement in oxygenation,
reduction of the variations of transpulmonary pressure (TPP) by the way of better synchronisation between patient and the ventilator.

The use of NMBA could also reduce the ventilator induced lung injury by a better control of TPP.


title: Study of Circulating Tumor Cells Before and After Treatment in Patients With Metastatic Melanoma.

summary:
Circulating tumor cells (CTC) are the subject of increasing interest in clinical oncology as a prognostic factor and predictor of therapeutic response. The detection of CTC by immunomagnetic method has proved its reliability and its usefulness for monitoring breast cancer, colon and prostate in the metastatic and immunomagnetic detection system (CellSearch, Veridex LLC) was approved by the FDA in these indications. However, to date there is no reliable method to detect CTCs in melanoma (CMC). Studies based on PCR amplification of mRNA by reverse specific melanoma is disappointing. Recently, a new detection system of CMC immunomagnetic was presented (CellSearch, Veridex LLC, United States). This system has the advantage of combining immunomagnetic selection step and a step of identifying by immunofluorescence. A preclinical study on serial dilutions of melanoma cells has shown encouraging results. The investigators propose a prospective study of the CellSearch system in patients with melanoma.

Primary objective: To determine the effect of treatment on the number of circulating melanoma cells in patients with metastatic melanoma.

Secondary objectives:

determine the percentage of patients with metastatic melanoma with melanoma cells circulating
seek a relationship between the number of circulating melanoma cells and prognosis in patients with metastatic melanoma
seek a relationship between the change in the number of circulating melanoma cells before / after treatment and tumor response in patients with metastatic melanoma

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Evaluation of Psychological Defense Mechanisms Used by Liver Transplant Patients on Their Somatic Psychological and Social Outcome. Research for Protective or Vulnerability Factors.

acronym: GHEPA

summary:
Organ transplantation has a special place in the medical field. It symbolizes a medicine whose limits always seem to be repelled. Because transplantation is unusual, it places people in front of outstanding issues which he has to cope with his personality and history. Factors involved in the psychology of patient presenting with graft are past and present psychic functioning, object relations, experience of transplantation itself and quality of social environment.

Before or after graft defense mechanisms can be so intense that they can make the patient unable to overcome the graft. Yet as a pathological mechanism that denial was considered beneficial provided it is short.

The aim of this study is to evaluate on psychopathological influence of psychological defense mechanisms used by liver transplant patients on their somatic psychological and social outcome.