title: Randomized Phase II Trial Assessing the Combination of Nexavar® (Sorafenib), and Gemcitabine/Oxaliplatin in Patients Treated for Advanced (Unresectable/Metastatic) Hepatocellular Carcinoma.

summary:
RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as gemcitabine hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether sorafenib tosylate is more effective when given with or without gemcitabine hydrochloride and oxaliplatin in treating patients with liver cancer.

PURPOSE: This randomized phase II trial is studying sorafenib tosylate to see how well it works when given with or without gemcitabine hydrochloride and oxaliplatin in treating patients with locally advanced, unresectable, or metastatic liver cancer.

ReferenceCitation: Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16.

ReferenceCitation: Blay JY, Bonvalot S, Casali P, Choi H, Debiec-Richter M, Dei Tos AP, Emile JF, Gronchi A, Hogendoorn PC, Joensuu H, Le Cesne A, McClure J, Maurel J, Nupponen N, Ray-Coquard I, Reichardt P, Sciot R, Stroobants S, van Glabbeke M, van Oosterom A, Demetri GD; GIST consensus meeting panelists. Consensus meeting for the management of gastrointestinal stromal tumors. Report of the GIST Consensus Conference of 20-21 March 2004, under the auspices of ESMO. Ann Oncol. 2005 Apr;16(4):566-78. Review. Erratum in: Ann Oncol. 2005 Jun;16(6):993. Mac Clure, J [corrected to McClure, J].

ReferenceCitation: Blay JY, Landi B, Bonvalot S, Monges G, Ray-Coquard I, Duffaud F, Bui NB, Bugat R, Chayvialle JA, Rougier P, Bouché O, Bonichon F, Lassau N, Vanel D, Nordlinger B, Stoeckle E, Meeus P, Coindre JM, Scoazec JY, Emile JF, Ranchère D, Le Cesne A. [Recommendations for the management of GIST patients]. Bull Cancer. 2005 Oct;92(10):907-18. French.

ReferenceCitation: Lassau N, Lamuraglia M, Leclère J, Rouffiac V. [Functional and early evaluation of treatments in oncology: interest of ultrasonographic contrast agents]. J Radiol. 2004 May;85(5 Pt 2):704-12. French.

ReferenceCitation: Lassau N, Chami L, Péronneau P. [Current events about echography in 2006: position of the ultrasound functional imaging for the early evaluation of targeted therapeutics]. Bull Cancer. 2006 Dec;93(12):1207-11. Review. French.

ReferenceCitation: Lassau N, Lamuraglia M, Chami L, Leclère J, Bonvalot S, Terrier P, Roche A, Le Cesne A. Gastrointestinal stromal tumors treated with imatinib: monitoring response with contrast-enhanced sonography. AJR Am J Roentgenol. 2006 Nov;187(5):1267-73.

ReferenceCitation: Lamuraglia M, Escudier B, Chami L, Schwartz B, Leclère J, Roche A, Lassau N. To predict progression-free survival and overall survival in metastatic renal cancer treated with sorafenib: pilot study using dynamic contrast-enhanced Doppler ultrasound. Eur J Cancer. 2006 Oct;42(15):2472-9. Epub 2006 Sep 11. Erratum in: Eur J Cancer. 2007 May;43(8):1336.

ReferenceCitation: Escudier B, Lassau N, Angevin E, Soria JC, Chami L, Lamuraglia M, Zafarana E, Landreau V, Schwartz B, Brendel E, Armand JP, Robert C. Phase I trial of sorafenib in combination with IFN alpha-2a in patients with unresectable and/or metastatic renal cell carcinoma or malignant melanoma. Clin Cancer Res. 2007 Mar 15;13(6):1801-9.


title: Pharmacokinetic Evaluation of an Intensified and Decreasing Dosing Regimen of Mycophenolate Sodium in Combination With Tacrolimus During the First 3 Months Post Kidney Transplant (the myFORTic Study)

summary:
Mycophenolate acid (MPA) has been developed and approved in combination with cyclosporine and has been used in kidney transplantation for more than a decade. At present, combination of tacrolimus and mycophenolate acid tends to be considered as the standard of care for maintenance immunosuppression in kidney transplantation. Mainly due to a different effect on the entero-hepatic recycling pathway, cyclosporine and tacrolimus differently interfere with MPA clearance. When used with tacrolimus, MPA dosage has thus to be adjusted and cannot be extrapolated from what is recommended for a cyclosporine-based treatment. However, there is currently no clear guideline for MPA dosing when this drug is used in combination with tacrolimus. This is potentially detrimental for patients since under-or overexposure of MPA has been clinically linked to the outcome of transplantation.

The purpose of this study is to pharmacologically validate an original MPA dosing regimen in combination with tacrolimus within the three months post-kidney transplant. This regimen consists in an intensified dosing of mycophenolate sodium during the earliest period of transplantation in order to rapidly reach the appropriate MPA blood exposure followed by a gradual decrease in dose in order to prevent MPA overexposure.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Departement of Nephrology CHU Saint-Etienne

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Completed


title: Long-term Outcome of Idiopathic Macular Hole Surgery

summary: The purpose of this study is to evaluate the role of cataract surgery and cystoid macular edema (CME) on reopening of idiopathic macular holes (IMH).

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Passemard M, Yakoubi Y, Muselier A, Hubert I, Guillaubey A, Bron AM, Berrod JP, Creuzot-Garcher C. Long-term outcome of idiopathic macular hole surgery. Am J Ophthalmol. 2010 Jan;149(1):120-6. doi: 10.1016/j.ajo.2009.08.003. Epub 2009 Oct 20.

family: Passemard

full_name: Marie Passemard

given: Marie

sequence: first

family: Yakoubi

full_name: Younes Yakoubi

given: Younes

sequence: additional

family: Muselier

full_name: Aurore Muselier

given: Aurore

family: Hubert

full_name: Isabelle Hubert

given: Isabelle

family: Guillaubey

full_name: Alexandre Guillaubey

given: Alexandre

family: Bron

full_name: Alain M. Bron

given: Alain M.

family: Berrod

full_name: Jean Paul Berrod

given: Jean Paul

family: Creuzot-Garcher

full_name: Catherine Creuzot-Garcher

given: Catherine

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: American Journal of Ophthalmology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Centre Hospitalier Universitaire Dijon


title: Evaluation of Radioligand Uptake (FP-CIT) of Dopamine Transporters in Patients Suffering From Parkinson's Disease With or Without Pain

summary: About 46% of patients suffering from Parkinson's disease present pain disorders. Parkinson disease is characterized by loss of dopaminergic neurons. The aim of this study is to assess the relationship between the loss of dopaminergic neurons and the existence of pain in Parkinson's disease. Using single photon emission computerized tomography (SPECT) imaging (123I FP-CIT, which binds dopamine transporter) and the determination of subjective pain threshold, the investigators will establish correlations between dopaminergic degeneration and pain perception.

design_allocation: Non-Randomized

primary_purpose: Basic Science

ReferenceType: result

ReferenceCitation: Dellapina E, Pellaprat J, Adel D, Llido J, Harroch E, Martini JB, Kas A, Salabert AS, Ory-Magne F, Payoux P, Brefel-Courbon C. Dopaminergic denervation using [(123)I]-FPCIT and pain in Parkinson's disease: a correlation study. J Neural Transm (Vienna). 2019 Mar;126(3):279-287. doi: 10.1007/s00702-019-01974-5. Epub 2019 Jan 31.

family: Dellapina

full_name: Estelle Dellapina

given: Estelle

family: Pellaprat

full_name: Jean Pellaprat

given: Jean

family: Adel

full_name: Djilali Adel

given: Djilali

family: Llido

full_name: Jerome Llido

given: Jerome

family: Harroch

full_name: Estelle Harroch

family: Martini

full_name: Jean Baptiste Martini

given: Jean Baptiste

family: Kas

full_name: Aurélie Kas

given: Aurélie

family: Salabert

full_name: Anne Sophie Salabert

given: Anne Sophie

family: Ory-Magne

full_name: Fabienne Ory-Magne

given: Fabienne

family: Payoux

full_name: Pierre Payoux

given: Pierre

family: Brefel-Courbon

full_name: Christine Brefel-Courbon

given: Christine

journal_name: Journal of Neural Transmission

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Dopaminergic denervation using [123I]-FPCIT and pain in Parkinson’s disease: a correlation study

lead_sponsor: University Hospital, Toulouse


title: Study Comparing Laparoscopy Versus Laparotomy in the Treatment of Colorectal Endometriosis

summary: Study hypothesis: equivalency of laparoscopic compared to laparotomic colorectal resection for endometriosis on digestive, gynaecologic, general symptoms and quality of life. Morbidity and fertility outcomes will also be evaluated.Primary purpose of the protocol is the evaluation of dyschesia.

status: Unknown status

study_completion_date_type: Anticipated

design_allocation: Randomized

ReferenceCitation: Touboul C, Ballester M, Dubernard G, Zilberman S, Thomin A, Daraï E. Long-term symptoms, quality of life, and fertility after colorectal resection for endometriosis: extended analysis of a randomized controlled trial comparing laparoscopically assisted to open surgery. Surg Endosc. 2015 Jul;29(7):1879-87. doi: 10.1007/s00464-014-3880-4. Epub 2014 Oct 8.

family: Touboul

full_name: Cyril Touboul

given: Cyril

family: Ballester

full_name: Marcos Ballester

given: Marcos

family: Dubernard

full_name: Gil Dubernard

given: Gil

family: Zilberman

full_name: Sonia Zilberman

given: Sonia

family: Thomin

full_name: Anne Thomin

given: Anne

family: Daraï

full_name: Emile Daraï

given: Emile

journal_name: Surgical Endoscopy

publisher_dissemination: Springer

publisher_group: Springer

lead_sponsor: Tenon Hospital, Paris

location_facility: Tenon Hospital, Departement of Obstetrics and Gynecology

intervention_type: Procedure

status_simplified: Unknown


title: Interest of the Dosage of CA 15-3 in CSF for Diagnosing Carcinomatous Meningitis in Breast Cancer

summary:
RATIONALE: Studying samples of cerebrospinal fluid from patients with cancer or meningeal syndrome may help doctors identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying cerebrospinal fluid samples in diagnosing carcinomatous meningitis in patients with cancer or meningeal syndrome.

primary_purpose: Diagnostic

lead_sponsor: Centre Oscar Lambret

intervention_type: Other

lead_sponsor_type: industriel


title: Hemodynamic Stability During Carotid Endarterectomy Under General Anesthesia in Elderly Patients: Comparison LENOXe™ (xénon 100% v/v) Versus SEVOFLURANE

summary: The purpose of this study is to compare the hemodynamics effects of two usual hypnotic agents (LENOXe ™ (xenon 100 % v/v) and sevoflurane) during a general anesthesia for carotid endarterectomy in elderly patients. The hypothesis is that the use of the LENOXe ™ (xenon 100 % v/v) allows to obtain per-operating hemodynamic stability non inferior than with sevoflurane.

lead_sponsor: Air Liquide Santé International


title: Prospective Evaluation Among Patients Infected by HIV 1 in Virological Failure Owing to Lack of Compliance, of the Benefit in Terms of Compliance of an Optimised Antiretroviral Treatment Containing Enfuvirtide (Fuzeon) Associated With Two Active Molecules

acronym: AMPHORE

summary: In case of lack of compliance in HIV1 patients, the investigators hope to prove that enfuvirtide injection during almost 3 months, with nurse help at home and therapeutic education may contribute to obtain a good compliance more than 95% in these patients.

status: Terminated

time_perspective: Prospective

lead_sponsor: University Hospital, Rouen


title: Front-line Combination Therapy of Sunitinib Malate Plus Chemotherapy With Leucovorin/5-Fluorouracil and Irinotecan (FOLFIRI) for Rectal Cancer Patients With Synchronous Non-Resectable Metastases: A Phase II Non Controlled Study. (SUREMETS)

summary:
RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) together with sunitinib malate may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving sunitinib malate together with combination chemotherapy works as front-line therapy in treating patients with metastatic rectal cancer that cannot be removed by surgery.

status: Withdrawn

lead_sponsor: Federation Francophone de Cancerologie Digestive


summary: Primary objective : To increase the 3 year progression-free survival from 40% to 60%. Patients included : metastatic, cerebral primitive neuroectodermal tumors in children aged over 5 years.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


summary: Evaluation of the effectiveness of escitalopram on depressive symptoms after 3 months in patients with head and neck squamous cell carcinomas (oral cavity, larynx, oropharynx and hypopharynx) and with an HADS total score > 11


title: Study of Natural Killer Cells Function in Untreated Patients With Chronic Lymphocytic Leukemia

acronym: LLC-NK

summary:
Purpose:

The involvement of Natural Killer cells (NK) in the efficiency of the treatment in lymphoma and the beginning of new therapies based on function and activation of NK, justify an improvement of knowledge about the status of the population of NK (number, function, genic expression) in Chronic Lymphocytic Leukemia (CLL).

lead_sponsor: Institut Paoli-Calmettes


title: Predictive Value of FDG-TEP During Exclusive Chemo-Radiotherapy (CRT) in Patients With Oesophageal Carcinoma Cancer on the One-Year Survival (RTEP3)

summary:
The poor prognosis in the early-stage of oesophageal carcinoma cancer is due to potential worsening of the disease (local relapse, metastasis), to insufficient efficacy and toxicity of actual treatments.

FDG-PET is a medical imaging modality allowing the quantification of the tumour glucose consumption. Then, this exam is used for pathology staging, target volume definition for RT, and treatment efficiency few months after CRT. Our assumption is that an FDG-PET exam during the course of CRT might be predictive of the treatment efficiency few months later.

In this study, we propose to perform 4 FDG-PET: first "PET1" before chemo-radiotherapy, second "PET2" during the chemo-radiotherapy (see RTEP1), third and fourth "PET3" "PET4" 3month and 12 month after the end of radiotherapy.

We will investigate the performances of FDG-PET performed during CRT for the prediction of the one-year patient heath outcome. If the predictive value of TEP2 is confirmed, we would be able to optimize the planning treatment during the course of the therapy.

ReferenceCitation: Nkhali L, Thureau S, Edet-Sanson A, Doyeux K, Benyoucef A, Gardin I, Michel P, Vera P, Dubray B. FDG-PET/CT during concomitant chemo radiotherapy for esophageal cancer: Reducing target volumes to deliver higher radiotherapy doses. Acta Oncol. 2015 Jun;54(6):909-15. doi: 10.3109/0284186X.2014.973062. Epub 2014 Nov 24.

family: Nkhali

full_name: Lamyaa Nkhali

given: Lamyaa

family: Thureau

full_name: Sébastien Thureau

given: Sébastien

family: Edet-Sanson

full_name: Agathe Edet-Sanson

given: Agathe

family: Doyeux

full_name: Kaya Doyeux

given: Kaya

family: Benyoucef

full_name: Ahmed Benyoucef

given: Ahmed

family: Gardin

full_name: Isabelle Gardin

given: Isabelle

family: Michel

full_name: Pierre Michel

family: Vera

full_name: Pierre Vera

family: Dubray

full_name: Bernard Dubray

given: Bernard

journal_name: Acta Oncologica

oa_host_type: repository

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

host_type: repository

license: cc-by

license_normalized: cc-by

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

version: submittedVersion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Palie O, Michel P, Ménard JF, Rousseau C, Rio E, Bridji B, Benyoucef A, Meyer ME, Jalali K, Bardet S, M'vondo CM, Olivier P, Faure G, Itti E, Diana C, Houzard C, Mornex F, Di Fiore F, Vera P. The predictive value of treatment response using FDG PET performed on day 21 of chemoradiotherapy in patients with oesophageal squamous cell carcinoma. A prospective, multicentre study (RTEP3). Eur J Nucl Med Mol Imaging. 2013 Sep;40(9):1345-55. doi: 10.1007/s00259-013-2450-7. Epub 2013 May 29.

family: Palie

full_name: Odré Palie

given: Odré

family: Ménard

full_name: Jean-François Ménard

given: Jean-François

family: Rousseau

full_name: Caroline Rousseau

given: Caroline

family: Rio

full_name: Emmanuel Rio

given: Emmanuel

family: Bridji

full_name: Boumédiene Bridji

given: Boumédiene

family: Meyer

full_name: Marc-Etienne Meyer

given: Marc-Etienne

family: Jalali

full_name: Khadija Jalali

given: Khadija

family: Bardet

full_name: Stéphane Bardet

given: Stéphane

family: M’Vondo

full_name: Che Mabubu M’Vondo

given: Che Mabubu

journal_name: European Journal of Nuclear Medicine and Molecular Imaging


title: Determination Study of Dry Beriberi in Patients Native to the Comoro Archipelago, in Mayotte (MABECO).

acronym: MABECO

summary: The purpose of this study is to assess the existence of a genetic factor, suspected to be involved, aside from likely food deficiency contribution, in occurrence of dry beriberi, in patients who experienced dry beriberi and in a case group composed of 3 people, free from beriberi, within the same household.

lead_sponsor: Groupe Hospitalier Sud Reunion


title: Importance in Type 1 Diabetes Patients of an Optimized Control of Post-Prandial Glycaemia on Oxidant Stress Prevention

acronym: ITOPOS

summary:
The aim of this study is to determine whether postprandial hyperglycaemia plays an important role in oxidative stress phenomena and influences their harmful effects on the arterial wall.

25 type 1 diabetic patients practicing FIT and with an HbA1c value of 8 percent or less at the beginning of the study will be recruited. The 25 control subjects will be recruited after the patients, so that they can be paired by age and sex.

Patients will be randomized via an alternative cross over study design for 2 periods of 3 months, i.e. preprandial or postprandial injection of an ultra fast acting analog. During the 6 months of the study, slow acting analog doses will be adjusted on the basis of basal glycaemia values. The fast acting analog doses will be adjusted on the basis of an optimized algorithm available on each patient's PDA phone electronic diary.

Blood and urine samples will be collected at M0, M3 and M6 to evaluate the stress oxidant grade and its consequence on atherogenesis:

Oxidative Stress evaluation: plasma parameters (lipid peroxide derivatives, semicarbazide sensitive oxidase amine activity), erythrocyte and leukocyte cell parameters (reduced and oxidised glutathion, dismutase superoxide activity (SOD) Cu and Mn dependent, glutathion peroxidase, and catalase), urinary parameters (isoprostane F2) Evaluation of consequences of oxidative stress on atherogenesis processes: inflammatory parameters (CRP, TNFa, IL 6), adhesion molecules (VCAM 1, ICAM 1, P selectine), adipokines (leptine, resistine, adiponectine), coagulation factors (PAI 1), platelet and endothelial microparticles, The pre and postprandial glycaemic stability of each patient will be monitored using PDA phone systems, and HbA1c will be measured at M0, M3 and M6.

Expected results and outcomes:

It is important to know if, in patients with comparable glycaemic stability, these two insulin treatment regimens are associated with significant differences in oxidative stress and anti oxidant defenses.

These results may help us to define a postprandial insulin treatment regimen (which is more flexible as regards meals) or a preprandial insulin treatment regimen (less flexible for meals but maybe less harmful in terms of limitation of oxidative stress).

primary_purpose: Prevention

lead_sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète


title: Characterization of Low Density Lipoprotein and Mechanism of the Pro Aggregant Effect Through Oxidant Stress and Lipid Exchange

acronym: ECLIPSE

summary: Case control design: lipidomic study in 12 type 2 diabetics with metabolic syndrome, 12 metabolic syndrome without diabetes, 12 subjects with type 1 diabetes and 12 controls

ReferenceCitation: Colas R, Sassolas A, Guichardant M, Cugnet-Anceau C, Moret M, Moulin P, Lagarde M, Calzada C. LDL from obese patients with the metabolic syndrome show increased lipid peroxidation and activate platelets. Diabetologia. 2011 Nov;54(11):2931-40. doi: 10.1007/s00125-011-2272-8. Epub 2011 Aug 17.

family: Colas

full_name: R. Colas

given: R.

family: Sassolas

full_name: A. Sassolas

given: A.

family: Guichardant

full_name: M. Guichardant

given: M.

family: Cugnet-Anceau

full_name: C. Cugnet-Anceau

given: C.

family: Moret

full_name: M. Moret

family: Moulin

full_name: P. Moulin

given: P.

family: Lagarde

full_name: M. Lagarde

family: Calzada

full_name: C. Calzada

journal_name: Diabetologia

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

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

repository_normalized: HAL

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

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

repositories:
HAL
PubMed Central

location_facility: Fédération d'Endocrinologie-Diabétologie-Maladies métaboliques-Nutrition - Hôpital Cardiovasculaire et Pneumologique


title: Morphological and Functional Evaluation of Buttock Lipoatrophy Treatment With Stabilized Hyaluronic Acid of Non-animal Origin (Macrolane); a Baseline-controlled Single-centre Study.

summary: The study is being undertaken to establish the effectiveness and safety of Macrolane volume restoration factor 30 (VRF30) when used for treatment of HIV-infected subjects with buttocks lipoatrophy.

lead_sponsor: Q-Med AB

intervention_type: Device


title: NOCETER, a Multicenter Double Blind Placebo-controlled Randomized Trial: Reduction of CEsareans in Post TERm Pregnancies: Impact of Outpatient Cervical Ripening With NO Donors

acronym: NOCETER

summary: The purpose of this trial is to determine whether cervical ripening with isosorbide mononitrate reduce caesarean section in women with post term pregnancies.

ReferenceCitation: Schmitz T, Fuchs F, Closset E, Rozenberg P, Winer N, Perrotin F, Verspyck E, Azria E, Carbonne B, Lepercq J, Maillard F, Goffinet F; Groupe de Recherche en Obstétrique et Gynécologie (GROG). Outpatient cervical ripening by nitric oxide donors for prolonged pregnancy: a randomized controlled trial. Obstet Gynecol. 2014 Dec;124(6):1089-1097. doi: 10.1097/AOG.0000000000000544.

family: Schmitz

full_name: Thomas Schmitz

given: Thomas

family: Fuchs

full_name: Florent Fuchs

given: Florent

family: Closset

full_name: Emmanuel Closset

family: Rozenberg

full_name: Patrick Rozenberg

given: Patrick

family: Winer

full_name: Norbert Winer

given: Norbert

family: Perrotin

full_name: Franck Perrotin

given: Franck

family: Verspyck

full_name: Eric Verspyck

given: Eric

family: Azria

full_name: Elie Azria

given: Elie

family: Carbonne

full_name: Bruno Carbonne

given: Bruno

family: Lepercq

full_name: Jacques Lepercq

given: Jacques

family: Maillard

full_name: Françoise Maillard

given: Françoise

family: Goffinet

full_name: François Goffinet

given: François

journal_name: Obstetrics & Gynecology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Outpatient Cervical Ripening by Nitric Oxide Donors for Prolonged Pregnancy

lead_sponsor: Assistance Publique - Hôpitaux de Paris


title: The Evaluation of UTERO - Placental 3D Doppler Examination Potential Interest for Pre- Eclampsia Screening During Pregnancy. Observational Study in 100 Women at High Risk for Pre- Eclampsia and 70 Low Risk Women.

summary: Pre-eclampsia and intra uterine growth restriction (IUGR) represent major complications for pregnant women, with a high related maternal and fetal morbidity and mortality. It is now widely admitted that these pathologies, which can concern up to 7% of pregnancies, are in relation with hypo-perfusion of the placenta because of an early deficient trophoblast invasion and uterine vascular remodelling.Advances in ultrasound imaging now permit non invasive 3D volume and Doppler signal quantification using automatic acquisitions.Quantitative comparison of volumes and Doppler parameters between control pregnancies and IUGR ought to confirm the theory of UTERO-placental hypo-perfusion. This technique might allow an earlier prediction for IUGR. The aim of this study is to evaluate the interest of 3D Doppler quantification as a new screening tool for pre eclampsia and IUGR.

location_facility: Hôpital LARIBOISIERE Service de gynécologie- obstétrique


title: Tolerance and Acceptability of Colonoscopy Under Sedation by an Equimolar Mixture of Oxygen and Nitrous Oxide. Comparison With General Anesthesia in a Randomized, Multicentric Study.

acronym: KALINAG

summary: The aim of this study was to compare the analgesia provided by nitrous oxide/oxygen sedation or general anesthesia for colonoscopy

ReferenceType: background

ReferenceCitation: Trojan J, Saunders BP, Woloshynowych M, Debinsky HS, Williams CB. Immediate recovery of psychomotor function after patient-administered nitrous oxide/oxygen inhalation for colonoscopy. Endoscopy. 1997 Jan;29(1):17-22.


title: Evaluation of Predictive Proteic Profile on Mortality in the Acute Phase of Septic Shock in Cancer Patients

acronym: PROTEOHSEPS

summary: The mortality induced by infections in onco-hematological patients is abnormally high at the acute phase of septic shock. Consequently, it is important to detect the population with a high risk of short term mortality among patients with a septic shock. The aim of this study is the evaluation of predictive proteic profile on the short term mortality in the acute phase of septic shock in cancer patients.


title: Randomized Phase III Trial Evaluating the Importance of Nephrectomy in Patients Presenting With Metastatic Renal Cell Carcinoma Treated With Sunitinib

acronym: CARMENA

summary: The study compare the standard treatment with nephrectomy + sunitinib to treatment with sunitinib alone without nephrectomy. This study will be the first trial on this competitive context

study_start_date_type: Actual

ReferenceCitation: Méjean A, Ravaud A, Thezenas S, Colas S, Beauval JB, Bensalah K, Geoffrois L, Thiery-Vuillemin A, Cormier L, Lang H, Guy L, Gravis G, Rolland F, Linassier C, Lechevallier E, Beisland C, Aitchison M, Oudard S, Patard JJ, Theodore C, Chevreau C, Laguerre B, Hubert J, Gross-Goupil M, Bernhard JC, Albiges L, Timsit MO, Lebret T, Escudier B. Sunitinib Alone or after Nephrectomy in Metastatic Renal-Cell Carcinoma. N Engl J Med. 2018 Aug 2;379(5):417-427. doi: 10.1056/NEJMoa1803675. Epub 2018 Jun 3.

name: From the Departments of Urology (A.M., M.-O.T.) and Medical Oncology (S.O.), Hôpital Européen Georges-Pompidou, Assistance Publique–Hôpitaux de Paris (AP-HP), Université Paris–Descartes, and Paris Descartes Necker–Cochin Clinical Research Unit, AP-HP (S.C.), Paris, the Department of Medical Oncology, Bordeaux University Hospital (A.R.), the Department of Medical Oncology, Hôpital Saint André, Centre Hospitalier Universitaire (CHU) de Bordeaux (M.G.-G.), and the Department of Urology, CHU de Bordeaux and...

family: Méjean

full_name: Arnaud Méjean

given: Arnaud

family: Ravaud

full_name: Alain Ravaud

given: Alain

family: Thezenas

full_name: Simon Thezenas

given: Simon

family: Colas

full_name: Sandra Colas

given: Sandra

family: Beauval

full_name: Jean-Baptiste Beauval

given: Jean-Baptiste

family: Bensalah

full_name: Karim Bensalah

given: Karim

family: Geoffrois

full_name: Lionnel Geoffrois

given: Lionnel

family: Thiery-Vuillemin

full_name: Antoine Thiery-Vuillemin

given: Antoine

family: Cormier

full_name: Luc Cormier

given: Luc

family: Lang

full_name: Hervé Lang

given: Hervé

family: Guy

full_name: Laurent Guy

given: Laurent

family: Gravis

full_name: Gwenaelle Gravis

given: Gwenaelle

family: Rolland

full_name: Frederic Rolland

given: Frederic

family: Linassier

full_name: Claude Linassier

given: Claude

family: Lechevallier

full_name: Eric Lechevallier

family: Beisland

full_name: Christian Beisland

given: Christian

family: Aitchison

full_name: Michael Aitchison

given: Michael

family: Oudard

full_name: Stephane Oudard

given: Stephane

family: Patard

full_name: Jean-Jacques Patard

given: Jean-Jacques

family: Theodore

full_name: Christine Theodore

given: Christine

family: Chevreau

full_name: Christine Chevreau

family: Laguerre

full_name: Brigitte Laguerre

given: Brigitte

family: Hubert

full_name: Jacques Hubert

ReferenceCitation: León L, García-Figueiras R, Suárez C, Arjonilla A, Puente J, Vargas B, Méndez Vidal MJ, Sebastiá C. Recommendations for the clinical and radiological evaluation of response to treatment in metastatic renal cell cancer. Target Oncol. 2014 Mar;9(1):9-24. doi: 10.1007/s11523-013-0304-7. Epub 2013 Dec 12. Review. Erratum in: Target Oncol. 2014 Jun;9(2):181. García-Figueras, Roberto [corrected to García-Figueiras, Roberto].


title: First Pilot Study Evaluating the Life Span of Autologous Cultured Red Blood Cells (cRBC) Generated From Peripheral Stem Cells in Three Healthy Volunteers - Feasibility Study

summary:
To study the in vivo life span in healthy volunteers of red blood cells generated in vitro from autologous peripheral stem cells. The study will be carried out in 4 phases :

production in vitro of the equivalent of 1 ml of blood, i.e. 5x10e9 enucleated RBC from mononuclear cells isolated from an HSC graft obtained from a healthy volunteers donor.
labeling of these cRBC with 51 Cr
reinjection of the autologous cRBC
follow up of the receivers for a maximum 33 days to measure the half-life span of the injected cells.

primary_purpose: Health Services Research

ReferenceCitation: Giarratana MC, Rouard H, Dumont A, Kiger L, Safeukui I, Le Pennec PY, François S, Trugnan G, Peyrard T, Marie T, Jolly S, Hebert N, Mazurier C, Mario N, Harmand L, Lapillonne H, Devaux JY, Douay L. Proof of principle for transfusion of in vitro-generated red blood cells. Blood. 2011 Nov 10;118(19):5071-9. doi: 10.1182/blood-2011-06-362038. Epub 2011 Sep 1.

name: UPMC Paris 06, UMR_S938 CDR Saint-Antoine, Prolifération et Différenciation des Cellules Souches, Paris, France;

name: Inserm, UMR_S938, Prolifération et Différenciation des Cellules Souches, Paris, France;

family: Giarratana

full_name: Marie-Catherine Giarratana

given: Marie-Catherine

name: EFS Ile de France, Unité d'Ingénierie et de Thérapie Cellulaire, Créteil, France;

name: UPEC, Université Paris Est Créteil, France;

family: Rouard

full_name: Hélène Rouard

given: Hélène

name: AP-HP Hôpital St Antoine, Service de Médecine Nucléaire, Paris, France;

family: Dumont

full_name: Agnès Dumont

given: Agnès

name: Inserm U473, Hôpital du Kremlin-Bicêtre, Kremlin-Bicêtre, France;

family: Kiger

full_name: Laurent Kiger

name: CNRS URA 2581, Institut Pasteur, Molecular Immunology of Parasites Unit, Paris, France;

family: Safeukui

full_name: Innocent Safeukui

given: Innocent

family: Le Pennec

full_name: Pierre-Yves Le Pennec

given: Pierre-Yves

name: IRSN, BP 17, Fontenay-aux-Roses, France;

family: François

full_name: Sabine François

given: Sabine

name: UPMC Université Paris 06; ERL Inserm U1057/UMR7203; FMPMC, Paris, France;

family: Trugnan

full_name: Germain Trugnan

given: Germain

family: Peyrard

full_name: Thierry Peyrard

given: Thierry

family: Marie

full_name: Tiffany Marie

given: Tiffany

family: Jolly

full_name: Séverine Jolly

given: Séverine

family: Hebert

full_name: Nicolas Hebert

given: Nicolas

family: Mazurier

full_name: Christelle Mazurier

given: Christelle

name: AP-HP, Hôpital Saint-Antoine, Service de Biochimie A, Paris, France;

family: Mario

full_name: Nathalie Mario

given: Nathalie

family: Harmand

full_name: Laurence Harmand

given: Laurence

name: AP-HP, Hôpital Trousseau, Service d'Hématologie Biologique, Paris, France; and

family: Lapillonne

full_name: Hélène Lapillonne

family: Devaux

full_name: Jean-Yves Devaux

given: Jean-Yves

name: AP-HP, Hôpital St Antoine, Service d'Hématologie et Immunologie Biologiques, Paris, France

family: Douay

full_name: Luc Douay

journal_name: Blood

title: Proof of principle for transfusion of in vitro–generated red blood cells

ReferenceCitation: Abbruzzese G, Cossu G, Balocco M, Marchese R, Murgia D, Melis M, Galanello R, Barella S, Matta G, Ruffinengo U, Bonuccelli U, Forni GL. A pilot trial of deferiprone for neurodegeneration with brain iron accumulation. Haematologica. 2011 Nov;96(11):1708-11. doi: 10.3324/haematol.2011.043018. Epub 2011 Jul 26.

publisher: Ferrata Storti Foundation (Haematologica)

location_facility: Hopital Saint Antoine, Service hématologie et therapie cellulaire


type: Other Identifier

title: Prospective Multicenter, Non-interventional Study to Evaluate the Impact of the Introduction of Interferon Beta-1 b Treatment on Daily Life Activities in Patients at High Risk of Developing Multiple Sclerosis After a First Clinical Demyelinating Event or Having Received a Confirmed Diagnosis of RRMS

summary: To evaluate the evolution of the impact on daily life activities over the first 12 months following the introduction of interferon beta-1b treatment in patients presenting RRMS or patients at high risk of developing Multiple Sclerosis after a first clinical demyelinating event

lead_sponsor: Bayer


title: Long Term Clinical Evaluation of AutoFlow Mode During Assist-Controlled Ventilation in ICU Patients

acronym: AFON

summary: The purpose of this study is to evaluate the long term use of AutoFlow mode during mechanical ventilation in ICU patients

primary_purpose: Supportive Care

lead_sponsor: Centre Hospitalier Victor Dupouy


title: A Comparative Study of Structural and Functional Arterial Properties After an Ischaemic Stroke or an Acute Coronary Syndrome

acronym: AVC/SCA

summary:
A pilot, prospective, comparative study. To include both male and female patients who have presented an ischaemic stroke (full stroke or TIA) or an ACS, 5 to 30 days prior to inclusion.

The proposed study aims to investigate and analyse the differences in functional and structural arterial properties between the patients who presented an ischaemic stroke and those who presented ACS. The hypothesis is that the patients in both groups will present differences partly in terms of their "traditional" cardiovascular risk factors, but also in terms of their arterial properties. All of the confounding factors studied (cardiovascular risk factors, treatments) will be taken into account in order to explain the differences in the arterial properties found between the two groups. Furthermore, the prevalence of signs and symptoms in the two populations will be studied.

ReferenceCitation: Barone-Rochette G, Vanzetto G, Detante O, Quesada JL, Hommel M, Mallion JM, Baguet JP. Imaging of functional and structural alterations of large arteries after acute ischaemic atherothrombotic stroke or acute coronary syndromes. Arch Cardiovasc Dis. 2014 Aug-Sep;107(8-9):443-51. doi: 10.1016/j.acvd.2014.05.007. Epub 2014 Jul 10.

family: Barone-Rochette

full_name: Gilles Barone-Rochette

given: Gilles

family: Vanzetto

full_name: Gerald Vanzetto

given: Gerald

family: Detante

full_name: Olivier Detante

given: Olivier

family: Quesada

full_name: Jean-Louis Quesada

given: Jean-Louis

family: Hommel

full_name: Marc Hommel

given: Marc

family: Mallion

full_name: Jean-Michel Mallion

given: Jean-Michel

family: Baguet

full_name: Jean-Philippe Baguet

given: Jean-Philippe

journal_name: Archives of Cardiovascular Diseases

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: University Hospital, Grenoble


title: 3D Evaluation of Postural Balance of the Adult Affected by Postural Trouble, Using EOS™ Images and 3D-reconstructions With Regard to Gravity Line.

acronym: POSTURADULT

summary: Description of the geometrical configuration of the skeleton with regard to gravity line by patients suffering from spinal disorders that may induce postural troubles

ReferenceCitation: Dubousset J, Charpak G, Skalli W, Kalifa G, Lazennec JY. [EOS stereo-radiography system: whole-body simultaneous anteroposterior and lateral radiographs with very low radiation dose]. Rev Chir Orthop Reparatrice Appar Mot. 2007 Oct;93(6 Suppl):141-3. French.

ReferenceCitation: Schwab F, Lafage V, Boyce R, Skalli W, Farcy JP. Gravity line analysis in adult volunteers: age-related correlation with spinal parameters, pelvic parameters, and foot position. Spine (Phila Pa 1976). 2006 Dec 1;31(25):E959-67.

ReferenceCitation: Skalli W, Zeller RD, Miladi L, Bourcereau G, Savidan M, Lavaste F, Dubousset J. Importance of pelvic compensation in posture and motion after posterior spinal fusion using CD instrumentation for idiopathic scoliosis. Spine (Phila Pa 1976). 2006 May 20;31(12):E359-66.

ReferenceCitation: El Fegoun AB, Schwab F, Gamez L, Champain N, Skalli W, Farcy JP. Center of gravity and radiographic posture analysis: a preliminary review of adult volunteers and adult patients affected by scoliosis. Spine (Phila Pa 1976). 2005 Jul 1;30(13):1535-40.

ReferenceCitation: Rillardon L, Campana S, Mitton D, Skalli W, Feydy A. [Evaluation of the intervertebral disc spaces with a low dose radiographic system]. J Radiol. 2005 Mar;86(3):311-9. French.

ReferenceCitation: Dubousset J, Charpak G, Dorion I, Skalli W, Lavaste F, Deguise J, Kalifa G, Ferey S. [A new 2D and 3D imaging approach to musculoskeletal physiology and pathology with low-dose radiation and the standing position: the EOS system]. Bull Acad Natl Med. 2005 Feb;189(2):287-97; discussion 297-300. Review. French.

ReferenceCitation: Vialle R, Levassor N, Rillardon L, Templier A, Skalli W, Guigui P. Radiographic analysis of the sagittal alignment and balance of the spine in asymptomatic subjects. J Bone Joint Surg Am. 2005 Feb;87(2):260-7.

ReferenceCitation: Parent S, Labelle H, Skalli W, de Guise J. Vertebral wedging characteristic changes in scoliotic spines. Spine (Phila Pa 1976). 2004 Oct 15;29(20):E455-62.

ReferenceCitation: Faro FD, Marks MC, Pawelek J, Newton PO. Evaluation of a functional position for lateral radiograph acquisition in adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2004 Oct 15;29(20):2284-9.

ReferenceCitation: Steib JP, Dumas R, Mitton D, Skalli W. Surgical correction of scoliosis by in situ contouring: a detorsion analysis. Spine (Phila Pa 1976). 2004 Jan 15;29(2):193-9.

ReferenceCitation: Gangnet N, Pomero V, Dumas R, Skalli W, Vital JM. Variability of the spine and pelvis location with respect to the gravity line: a three-dimensional stereoradiographic study using a force platform. Surg Radiol Anat. 2003 Nov-Dec;25(5-6):424-33. Epub 2003 Sep 16.

ReferenceCitation: Dumas R, Steib JP, Mitton D, Lavaste F, Skalli W. Three-dimensional quantitative segmental analysis of scoliosis corrected by the in situ contouring technique. Spine (Phila Pa 1976). 2003 Jun 1;28(11):1158-62.

ReferenceCitation: Rajnics P, Templier A, Skalli W, Lavaste F, Illés T. The association of sagittal spinal and pelvic parameters in asymptomatic persons and patients with isthmic spondylolisthesis. J Spinal Disord Tech. 2002 Feb;15(1):24-30.

ReferenceCitation: Legaye J, Duval-Beaupère G, Hecquet J, Marty C. Pelvic incidence: a fundamental pelvic parameter for three-dimensional regulation of spinal sagittal curves. Eur Spine J. 1998;7(2):99-103.

ReferenceCitation: Jackson RP, Peterson MD, McManus AC, Hales C. Compensatory spinopelvic balance over the hip axis and better reliability in measuring lordosis to the pelvic radius on standing lateral radiographs of adult volunteers and patients. Spine (Phila Pa 1976). 1998 Aug 15;23(16):1750-67.

ReferenceCitation: Gelb DE, Lenke LG, Bridwell KH, Blanke K, McEnery KW. An analysis of sagittal spinal alignment in 100 asymptomatic middle and older aged volunteers. Spine (Phila Pa 1976). 1995 Jun 15;20(12):1351-8.

ReferenceCitation: Mitton D, Zhao K, Bertrand S, Zhao C, Laporte S, Yang C, An KN, Skalli W. 3D reconstruction of the ribs from lateral and frontal X-rays in comparison to 3D CT-scan reconstruction. J Biomech. 2008;41(3):706-10. Epub 2007 Nov 5.

ReferenceCitation: Rousseau MA, Laporte S, Chavary-Bernier E, Lazennec JY, Skalli W. Reproducibility of measuring the shape and three-dimensional position of cervical vertebrae in upright position using the EOS stereoradiography system. Spine (Phila Pa 1976). 2007 Nov 1;32(23):2569-72.

ReferenceCitation: Gille O, Champain N, Benchikh-El-Fegoun A, Vital JM, Skalli W. Reliability of 3D reconstruction of the spine of mild scoliotic patients. Spine (Phila Pa 1976). 2007 Mar 1;32(5):568-73.

ReferenceCitation: Hemophilia: state of the art in 1982. Vox Sang. 1983;45(1):93-5.

ReferenceCitation: Dumas R, Aissaoui R, Mitton D, Skalli W, de Guise JA. Personalized body segment parameters from biplanar low-dose radiography. IEEE Trans Biomed Eng. 2005 Oct;52(10):1756-63.

ReferenceCitation: Le Bras A, Laporte S, Bousson V, Mitton D, De Guise JA, Laredo JD, Skalli W. 3D reconstruction of the proximal femur with low-dose digital stereoradiography. Comput Aided Surg. 2004;9(3):51-7.

ReferenceCitation: Pomero V, Mitton D, Laporte S, de Guise JA, Skalli W. Fast accurate stereoradiographic 3D-reconstruction of the spine using a combined geometric and statistic model. Clin Biomech (Bristol, Avon). 2004 Mar;19(3):240-7.

ReferenceCitation: Parent S, Labelle H, Skalli W, de Guise J. Thoracic pedicle morphometry in vertebrae from scoliotic spines. Spine (Phila Pa 1976). 2004 Feb 1;29(3):239-48.

ReferenceCitation: Dumas R, Le Bras A, Champain N, Savidan M, Mitton D, Kalifa G, Steib JP, de Guise JA, Skalli W. Validation of the relative 3D orientation of vertebrae reconstructed by bi-planar radiography. Med Eng Phys. 2004 Jun;26(5):415-22.

ReferenceCitation: Le Bras A, Laporte S, Mitton D, de Guise JA, Skalli W. 3D detailed reconstruction of vertebrae with low dose digital stereoradiography. Stud Health Technol Inform. 2002;91:286-90.

ReferenceCitation: Laporte S, Skalli W, de Guise JA, Lavaste F, Mitton D. A biplanar reconstruction method based on 2D and 3D contours: application to the distal femur. Comput Methods Biomech Biomed Engin. 2003 Feb;6(1):1-6.

ReferenceCitation: Mitulescu A, Skalli W, Mitton D, De Guise JA. Three-dimensional surface rendering reconstruction of scoliotic vertebrae using a non stereo-corresponding points technique. Eur Spine J. 2002 Aug;11(4):344-52. Epub 2002 Jun 26.

ReferenceCitation: Mitulescu A, Semaan I, De Guise JA, Leborgne P, Adamsbaum C, Skalli W. Validation of the non-stereo corresponding points stereoradiographic 3D reconstruction technique. Med Biol Eng Comput. 2001 Mar;39(2):152-8.

ReferenceCitation: Kalifa G, Charpak Y, Maccia C, Fery-Lemonnier E, Bloch J, Boussard JM, Attal M, Dubousset J, Adamsbaum C. Evaluation of a new low-dose digital x-ray device: first dosimetric and clinical results in children. Pediatr Radiol. 1998 Jul;28(7):557-61.

lead_sponsor: University Hospital, Bordeaux

location_facility: Unité de Pathologie Rachidienne Tripode CHU Pellegrin, Place Amélie Raba-Léon


title: Interest of Measuring the Systolic Pressure Index in Assessing the Risk of Cardiovascular Events Peri-operatively in the Surgery, Settled Out of Cardiovascular Surgery

acronym: IPS

summary: To investigate whether the presence of a Systolic pressure index (<0.9 or> 1.4) is a marker of risk of cardiovascular events after peri-operative high-risk surgery outside the cardiac and vascular surgery.

lead_sponsor: University Hospital, Limoges

location_facility: Explorations fonctionnelles vasculaires et angiologie (Hôpital Dupuytren)


title: Open Multicenter Study of Lithium in Patients With Amyotrophic Lateral Sclerosis LISLA

acronym: LISLA

summary: The purpose of the study is to determine whether lithium is safe and effective in the treatment of ALS


title: Medical and Economic Evaluation of FORESEAL Versus the Current Therapeutic Approach (Stapling Alone or Associated With Tissue Sealant) in Terms of Air Leakage Duration After Lung Resection for Cancer.

acronym: SPIRAL

summary:
The aim of this study is to compare the efficacy of FORESEAL with stapling alone or associated with tissue sealant or glue in terms of air leakage duration after lung resection for cancer.

Hypothesis: to show a significant difference of 1 day in the average duration of air leakage between the 2 groups with a standard deviation of 3 (α =0.05 and β=0.10).

ReferenceCitation: Fleisher AG, Evans KG, Nelems B, Finley RJ. Effect of routine fibrin glue use on the duration of air leaks after lobectomy. Ann Thorac Surg. 1990 Jan;49(1):133-4.

ReferenceCitation: Macchiarini P, Wain J, Almy S, Dartevelle P. Experimental and clinical evaluation of a new synthetic, absorbable sealant to reduce air leaks in thoracic operations. J Thorac Cardiovasc Surg. 1999 Apr;117(4):751-8.

ReferenceCitation: Porte HL, Jany T, Akkad R, Conti M, Gillet PA, Guidat A, Wurtz AJ. Randomized controlled trial of a synthetic sealant for preventing alveolar air leaks after lobectomy. Ann Thorac Surg. 2001 May;71(5):1618-22.

ReferenceCitation: Wain JC, Kaiser LR, Johnstone DW, Yang SC, Wright CD, Friedberg JS, Feins RH, Heitmiller RF, Mathisen DJ, Selwyn MR. Trial of a novel synthetic sealant in preventing air leaks after lung resection. Ann Thorac Surg. 2001 May;71(5):1623-8; discussion 1628-9.

ReferenceCitation: Fabian T, Federico JA, Ponn RB. Fibrin glue in pulmonary resection: a prospective, randomized, blinded study. Ann Thorac Surg. 2003 May;75(5):1587-92.

ReferenceCitation: Thomas P, Massard G, Porte H, Doddoli C, Ducrocq X, Conti M. A new bioabsorbable sleeve for lung staple-line reinforcement (FOREseal): report of a three-center phase II clinical trial. Eur J Cardiothorac Surg. 2006 Jun;29(6):880-5. Epub 2006 May 3.

ReferenceCitation: Abolhoda A, Liu D, Brooks A, Burt M. Prolonged air leak following radical upper lobectomy: an analysis of incidence and possible risk factors. Chest. 1998 Jun;113(6):1507-10.

ReferenceCitation: Stéphan F, Boucheseiche S, Hollande J, Flahault A, Cheffi A, Bazelly B, Bonnet F. Pulmonary complications following lung resection: a comprehensive analysis of incidence and possible risk factors. Chest. 2000 Nov;118(5):1263-70.

ReferenceCitation: Varela G, Jiménez MF, Novoa N, Aranda JL. Estimating hospital costs attributable to prolonged air leak in pulmonary lobectomy. Eur J Cardiothorac Surg. 2005 Feb;27(2):329-33.

ReferenceCitation: Mouritzen C, Drömer M, Keinecke HO. The effect of fibrin glueing to seal bronchial and alveolar leakages after pulmonary resections and decortications. Eur J Cardiothorac Surg. 1993;7(2):75-80.

ReferenceCitation: Wong K, Goldstraw P. Effect of fibrin glue in the reduction of postthoracotomy alveolar air leak. Ann Thorac Surg. 1997 Oct;64(4):979-81.

ReferenceCitation: Tansley P, Al-Mulhim F, Lim E, Ladas G, Goldstraw P. A prospective, randomized, controlled trial of the effectiveness of BioGlue in treating alveolar air leaks. J Thorac Cardiovasc Surg. 2006 Jul;132(1):105-12.

ReferenceCitation: Rami R, Mateu M. Surgical sealant for preventing air leaks after pulmonary resections in patients with lung cancer. Cochrane Database Syst Rev. 2001;(4):CD003051. Review. Update in: Cochrane Database Syst Rev. 2005;(3):CD003051.

ReferenceCitation: Belboul A, Dernevik L, Aljassim O, Skrbic B, Rådberg G, Roberts D. The effect of autologous fibrin sealant (Vivostat) on morbidity after pulmonary lobectomy: a prospective randomised, blinded study. Eur J Cardiothorac Surg. 2004 Dec;26(6):1187-91.


title: Randomized Trial Evaluating the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Patient Treated for Breast or Prostate Cancer.

summary:
Taxotere® can induce nails changes like dyschromia, hematoma, lines of Beau-Reil (signing the stop of the epithelial proliferation), abscess, or pain. In this context, this randomized, monocentric phase III trial evaluates the cryotherapy, using frozen glove, in the prevention of nails toxicity induced by Taxotere® in patient treated for breast or prostate cancer.

Primary objective:

Demonstrate a reduction of the nails toxicity using frozen glove during chemotherapy with Taxotere®.

Secondary objectives:

Analysis of time of protection against onycholysis Estimation of the efficiency of cryotherapy, and impact on quality of life Tolerance and compliance of the frozen glove


title: Renal HYPODYSPLASIA;Study of Familial Cases and Search for Predisposing Genes

acronym: HDR

summary: Evaluation of the frequency of familial cases of renal HYPODYSPLASIA


title: Comparative Performances of CT-arthrography, MRI and MR-arthrography in the Preoperative Assessment of the Rotator Cuff Tendon Tears, Surgical Observations Being Used as a Standard.

acronym: COIFFE

summary: At this point in time the approach to the diagnosis of rotator cuff tendon tears is not consensual. The French surgeons, considering they have a good experience of this method, preferably use a shoulder CT-arthrography. Whereas in the United States surgeons rather rely on MRI or MR-arthrography of the shoulder. However, nobody can say which of these three examinations is most precise and gives the best information. We proposed to carry out the three examinations at the same time in a large number of patients who needed to be operated for a rotator cuff tendon tear and then to compare the results of each of these examinations with the operative observations.

location_facility: Hopital LARIBOISIERE Service de Radiologie Ostéo-Articulaire


title: Phenotypic and Genotypic Identification and Characterization of MYH9-related Constitutional Thrombocytopenia

summary:
The research involves the establishment of a cohort including as much as possible cases of macrothrombocytopenia related to a "MYH9 syndrome" and the study of mutations and polymorphisms of MYH9 gene in all these patients. As MYH9 syndrome is an autosomal dominant disorder, patients should be heterozygous for a MYH9 gene mutation.

The main goal of our project is looking for correlations between genotype and phenotype. It is planned to characterize the phenotype and genotype of a cohort of patients, including family members that will be addressed during the study in order to better understand the platelet disorder and improve the epidemiological knowledge of MYH9 syndrome. The data will be recorded in a database.


title: Phase I-II Study Evaluating Combined Treatment of Cetuximab and Trastuzumab in Metastatic Pancreatic Cancer Patients Progressing After Gemcitabine Based Chemotherapy.(THERAPY)

acronym: THERAPY

summary:
RATIONALE: Monoclonal antibodies, such as cetuximab and trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving cetuximab together with trastuzumab may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of trastuzumab when given together with cetuximab and to see how well it works in treating patients with metastatic pancreatic cancer that progressed after previous treatment with gemcitabine.

ReferenceCitation: Assenat E, Azria D, Mollevi C, Guimbaud R, Tubiana-Mathieu N, Smith D, Delord JP, Samalin E, Portales F, Larbouret C, Robert B, Bibeau F, Bleuse JP, Crapez E, Ychou M, Pèlegrin A. Dual targeting of HER1/EGFR and HER2 with cetuximab and trastuzumab in patients with metastatic pancreatic cancer after gemcitabine failure: results of the "THERAPY"phase 1-2 trial. Oncotarget. 2015 May 20;6(14):12796-808.

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

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle


title: The Early Origins of Cardiovascular Disease : the Consequence of Growth Restriction During Foetal Life and Infancy on Cardiovascular Structure and Function in Adulthood

summary:
Small body size at birth, slow weight gain during infancy and increase in body mass index after 2 years are independent risk factors for cardiovascular disease and the metabolic syndrome. There is a large gap in our understanding of how early growth affects the cardiovascular system. Possible mechanisms include alterations in body composition, in cardiac structure, in vascular function, in renal function and epigenetic processes.

The Objective is to determine how size at birth and growth during infancy and childhood affect: body composition, cardiac structure and function, vascular and endothelial function, renal function, metabolic status and transcriptional and epigenetic characteristics.

lead_sponsor: Danone Institute International


title: Research for Predictive Biologic Parameters of Cutaneous Hypersensitivity After Brachytherapy in Breast Cancer

summary:
25 patients, treated by brachytherapy in a phase II study "Mammosite" (from 2003 to 2005), will be asked to attend a clinical exam in order to evaluate the late cutaneous toxicity due to brachytherapy.

During this consultation, a blood sample will be taken for analysis ( rate of CD8 T-Lymphocyte Apoptosis)

lead_sponsor: Centre Oscar Lambret


title: Executive Control Analysis in Patients Suffering From Parkinson Disease and Treated by Deep Brain Stimulation (Chronometric and Electromyographic Approach During a Simon Task)

summary:
Different results have recently led to question the classical notion according to which the motor and cognitive deficits in Parkinson's disease are tied to a thalamo-cortical inhibition due to the degeneration of the dopaminergic nigro-striatal pathways. Instead, Parkinsons's disease seems accompanied by an increase in motor cortical activity.

A reaction time task, known as the "Simon task" in the literature, allows one to study the influence of irrelevant visual information on decision making. In the most common version of this task (used in the prosed study), the subjects have to choose between a left- and a right-hand keypress according to the color of a visual signal presented either to the left or to the right of a fixation. The to be established association is said "congruent" when the response is ipsilateral to the stimulus and "incongruent" when the response is contralateral to the stimulus. In healthy volunteers, EMG investigations have revealed that in a significant numbers of trials, the contraction of the response agonist is preceded by a infra-liminal contraction of the agonist involved in the non-required response. Such "partial errors" demonstrate that the nervous system is able to detect, abort and correct a part of its errors, thereby revealing the existence of an on-line executive control in simple decision tasks. Behavioral studies performed in Parkinson disease patients, suggest that these patients may experience a deficit in such a control.

The present study aims at testing this hypothesis by assessing the effect of subthalamic stimulation on the patients' performance in a Simon task.

lead_sponsor: Assistance Publique Hopitaux De Marseille

location_facility: Assistance Publique-Hopitaux de Marseille

intervention_type: Behavioral


title: Closed-loop Delivery of Propofol and Remifentanil: Sparing Effect of Esmolol

summary: Main objective is to evaluate the sparing effect of esmolol on the required doses of propofol and remifentanil

lead_sponsor: Hopital Foch


title: Manteau 2007 SJ "LYMA" "Randomized, Open-label, Phase III Study Efficacy of Rituximab Maintenance Therapy in Patients 18 to 65 Years , First-line Treatment for MCL

summary: Randomized, open-label, phase III study to evaluate the efficacy of rituximab maintenance therapy in patients aged between 18 and 65 years inclusive undergoing first-line treatment for mantle cell lymphoma and exhibiting a response after autologous transplantation.

ReferenceCitation: Le Gouill S, Thieblemont C, Oberic L, Moreau A, Bouabdallah K, Dartigeas C, Damaj G, Gastinne T, Ribrag V, Feugier P, Casasnovas O, Zerazhi H, Haioun C, Maisonneuve H, Houot R, Jardin F, Van Den Neste E, Tournilhac O, Le Dû K, Morschhauser F, Cartron G, Fornecker LM, Canioni D, Callanan M, Béné MC, Salles G, Tilly H, Lamy T, Gressin R, Hermine O; LYSA Group. Rituximab after Autologous Stem-Cell Transplantation in Mantle-Cell Lymphoma. N Engl J Med. 2017 Sep 28;377(13):1250-1260. doi: 10.1056/NEJMoa1701769.

family: Le Gouill

full_name: Steven Le Gouill

given: Steven

family: Thieblemont

full_name: Catherine Thieblemont

given: Catherine

family: Oberic

full_name: Lucie Oberic

given: Lucie

family: Moreau

full_name: Anne Moreau

given: Anne

family: Bouabdallah

full_name: Krimo Bouabdallah

given: Krimo

family: Dartigeas

full_name: Caroline Dartigeas

given: Caroline

family: Damaj

full_name: Gandhi Damaj

given: Gandhi

family: Gastinne

full_name: Thomas Gastinne

given: Thomas

family: Ribrag

full_name: Vincent Ribrag

given: Vincent

family: Feugier

full_name: Pierre Feugier

given: Pierre

family: Casasnovas

full_name: Olivier Casasnovas

family: Zerazhi

full_name: Hacène Zerazhi

given: Hacène

family: Haioun

full_name: Corinne Haioun

given: Corinne

family: Maisonneuve

full_name: Hervé Maisonneuve

given: Hervé

family: Houot

full_name: Roch Houot

given: Roch

family: Jardin

full_name: Fabrice Jardin

given: Fabrice

family: Van Den Neste

full_name: Eric Van Den Neste

given: Eric

family: Tournilhac

full_name: Olivier Tournilhac

family: Le Dû

full_name: Katell Le Dû

given: Katell

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Cartron

full_name: Guillaume Cartron

given: Guillaume

family: Fornecker

full_name: Luc-Matthieu Fornecker

given: Luc-Matthieu

family: Canioni

full_name: Danielle Canioni

given: Danielle

family: Callanan


title: Closed-Loop Delivery of Propofol and Remifentanil: Sparing Effect of Dexmedetomidine

summary: The main objective if to evaluate the sparing effect of dexmedetomidine on the doses of propofol and remifentanil.


title: Assessment of Complications, Quality of Life and Easiness of Use of Implantable Central Venous Access Ports : Cohort and Prospective Study

acronym: CCI

summary: This is a prospective, descriptive and observational study of the anticancer center practice


title: Real-Time PCR for the Detection of Vaginal Group B Streptococcus Carriage at Delivery : a Medico-Economic and Feasibility Study

acronym: BBFAST

summary: Group B streptococcus infections may be serious for the neonates. The infection can occur during the birth, by contact with the genital area. That is why the detection of this bacteria is systematically realised in pregnant women between 34 and 37 weeks of amenorrhea in order to give prophylactic antibiotic treatment in case or positive carriage. This strategy presents 2 disadvantages : (1) detection of the group B streptococcus at 34 and 37 weeks of amenorrhea in not predictive of a carriage at delivery, (2) many pregnant women escape from systematic screening, leading to a systematic antibiotic treatment, which means useless costs, and useless antibiotic exposure with resistant bacteria selection. Real time polymerase chain reaction (PCR) allows a rapid detection anytime with no specific microbiological qualification. The aim of the study is to assess the economic outcomes of this strategy and the epidemiological values for St Etienne hospital.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne


title: Adult Intracranial Ependydomas : Prognostic and Diagnostic Factors Assessment and Molecular Characterization

summary: Adult intracranial ependymoma is a relatively rare brain tumour entity, accounting for 2-5% of all intracranial neoplasms. The pertinent prognostic factors as well as the pattern of recurrence remain to be elucidated. According to several recent reports, the prognostic value of Karnofski performance status, tumour location, the extent of surgical removal, histological grade and even postoperative radiotherapy remain controversial. As a consequence, optimal therapeutic management of adult intracranial ependymomas remains an ongoing debate. For this reason, a retrospective study conducted by the French society of neurosurgery (SFNC), neuropathology (SFNP) and the association of the neuro-oncologists of French expression (ANOCEF) was undertaken and allowed to collect 258 cases coming from 25 centers, initially diagnosed as intracranial ependymomas between 1990 and 2004. Clinical and follow-up data of these patients are known and the paraffin embedded samples as well as the frozen tissues available have been centralized. Central pathological review of these 258 cases was conducted by two senior neuropathologists and confirmed the diagnosis of ependymoma in 152 cases, thus constituting the most important series of the literature. Few molecular studies were carried out on ependymomas. The investigators have the opportunity, based on this important series, to determine the clinicopathological criteria and the molecular markers who will allow a better characterization of the diagnosis and the prognosis of these tumors.

location_facility: Assistance Publique Hopitaux de Marseille


title: Study Characterizing the Impact of Different Therapeutic Strategies on Event Occurrence at 2 Years, 5 Years, 10 Years, and 15 Years, According to Prognostic Groups in Patients With Hodgkin Lymphoma

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving drugs in different combinations may kill more cancer cells. It is not yet know which treatment regimen is more effective in treating Hodgkin lymphoma.

PURPOSE: This phase III trial is studying three different therapy regimens to compare how well they work in treating patients with previously untreated Hodgkin lymphoma.

ipd_sharing: Undecided

lead_sponsor: French Innovative Leukemia Organisation

location_facility: FILO French Innovative Leukemia Organization


acronym: LU-PUCE

summary: Lupus erythematosus systemic is an auto-immune disease the evaluation of the activity of which remains very difficult because of an heterogeneousness of the clinical and biological symptoms. The aim of this study is to develop objective, specific and not invasive methods of evaluation of the activity and the forecast of the disease by using an analysis of the transcriptome on circulating blood. A transcriptomic analysis will be realized in parallel by the usual clinico-biological follow-up at the patients affected by systemic lupus, while the diagnosis before treatment, then during every revaluation of the disease during the period of the study. The already treated patients can also be included in this study.

ReferenceCitation: Jourde-Chiche N, Whalen E, Gondouin B, Speake C, Gersuk V, Dussol B, Burtey S, Pascual V, Chaussabel D, Chiche L. Modular transcriptional repertoire analyses identify a blood neutrophil signature as a candidate biomarker for lupus nephritis. Rheumatology (Oxford). 2017 Mar 1;56(3):477-487. doi: 10.1093/rheumatology/kew439.

family: Jourde-Chiche

full_name: Noémie Jourde-Chiche

given: Noémie

family: Whalen

full_name: Elizabeth Whalen

given: Elizabeth

family: Gondouin

full_name: Bertrand Gondouin

given: Bertrand

family: Speake

full_name: Cate Speake

given: Cate

family: Gersuk

full_name: Vivian Gersuk

given: Vivian

family: Dussol

full_name: Bertrand Dussol

family: Burtey

full_name: Stephane Burtey

given: Stephane

family: Pascual

full_name: Virginia Pascual

given: Virginia

family: Chaussabel

full_name: Damien Chaussabel

given: Damien

family: Chiche

full_name: Laurent Chiche

given: Laurent

journal_name: Rheumatology

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

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

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Chiche L, Jourde-Chiche N, Whalen E, Presnell S, Gersuk V, Dang K, Anguiano E, Quinn C, Burtey S, Berland Y, Kaplanski G, Harle JR, Pascual V, Chaussabel D. Modular transcriptional repertoire analyses of adults with systemic lupus erythematosus reveal distinct type I and type II interferon signatures. Arthritis Rheumatol. 2014 Jun;66(6):1583-95. doi: 10.1002/art.38628.

name: Benaroya Research Institute, Seattle, Washington, and Aix-Marseille University and Hôpital de la Conception, APHM; Marseille France

name: Benaroya Research Institute, Seattle, Washington, Baylor Institute for Immunologic Research, Dallas, Texas, and Aix-Marseille University and Hôpital de la Conception, APHM; Marseille France

name: Benaroya Research Institute; Seattle, Washington

family: Presnell

full_name: Scott Presnell

given: Scott

family: Dang

full_name: Kristen Dang

given: Kristen

name: Baylor Institute for Immunologic Research; Dallas, Texas

family: Anguiano

full_name: Esperanza Anguiano

title: Modular Transcriptional Repertoire Analyses of Adults With Systemic Lupus Erythematosus Reveal Distinct Type I and Type II Interferon Signatures


title: Use of Bispectral Index to Assess Depth of Sedation in Ventilated Patients in the Prehospital Setting

acronym: OHBIS

summary: To evaluate the effectiveness of use of the bispectral index for monitoring of depth of sedation in ventilated patients during their prehospital management by a physician- staffed EMS. Hypothesis: there is a correlation between BIS and sedation scores.

lead_sponsor: Beaujon Hospital


title: Investigations of New Markers in Patients With Shock

summary: Shock is a severe deficiency in oxygen at the cell level which could lead to the death.The study was aimed at finding markers of treatment response in patients with shock, with a better accuracy than that of lactate actually used : hypoxia-inducible factor (HIF), circulating DNA (cDNA), and plasma from cells (MPs).

intervention_type: Biological


title: Impact of the Human Papillomavirus (HPV) Status in Carcinologic Prognosis of Oropharynx Squamous Cell Carcinoma.

acronym: Papillophar

summary:
High risk papillomavirus (HR-HPV) have an oncogenic role in Oropharyngeal squamous cell carcinomas (OP-SCC) in at least 25% of the cases and the prevalence is increasing. HPV+ might be more chemo and radio sensible with a better prognosis (disease-free survival (DFS) and overall survival (OS) as compared to HPV negative OP-SCC ; hypothesis : 2y DFS > 20% improvement). The principal objective is to determine the impact of the status of HR-HPV in the prognosis of the OP-SCC. The principal criteria is the 2-years DFS.

Secondary objective : virologic characteristics of HPV+ tumors.


title: Phase 2 Single- Arm Studies of Temozolomide in Combination With Topotecan in Refractory and Relapsed Neuroblastoma and Other Paediatric Solid Tumours

summary: The purpose of the study is to determine whether the combination of Hycamtin (Topotecan) and Temozolomide is effective in the treatment of relapsed and refractory neuroblastoma and other paediatric solid tumors.

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris


title: Comparison of the Efficacy and Safety of Varenicline Versus Placebo for Smoking Cessation Among HIV-infected Patients. A Randomized Double Blind Controlled Trial

acronym: Inter-ACTIV

summary: Cigarette smoking is a major cause of illness among HIV-infected patients (non-AIDS defining malignancies (especially lung cancer), non-AIDS bacterial infections and cardio-vascular diseases). Approximately 50% of HIV-infected patients are regular tobacco smokers. Tobacco smoking cessation has well known benefits on mortality and morbidity in the general population where tobacco cessation assistance programs are increasingly implemented. However, smoking cessation interventions have never been evaluated among HIV-infected patients. This trial aims at evaluating the efficacy and safety of varenicline for smoking cessation compared with placebo.

ReferenceCitation: Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10:CD006219. doi: 10.1002/14651858.CD006219.pub4. Review.

name: Nuffield Department of Primary Care Health Sciences; University of Oxford; Oxford UK

family: Hartmann-Boyce

full_name: Jamie Hartmann-Boyce

given: Jamie

family: Theodoulou

full_name: Annika Theodoulou

given: Annika

name: Public Health, Epidemiology and Biostatistics; University of Birmingham; Birmingham UK

family: Farley

full_name: Amanda Farley

given: Amanda

name: Wolfson Institute of Preventive Medicine; Barts & The London School of Medicine and Dentistry, Queen Mary University of London; London UK

family: Hajek

full_name: Peter Hajek

given: Peter

family: Lycett

full_name: Deborah Lycett

given: Deborah

family: Jones

full_name: Laura L Jones

given: Laura L

family: Kudlek

full_name: Laura Kudlek

given: Laura

family: Heath

full_name: Laura Heath

family: Hajizadeh

full_name: Anisa Hajizadeh

given: Anisa

family: Schenkels

full_name: Marika Schenkels

given: Marika

family: Aveyard

full_name: Paul Aveyard

given: Paul

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Mercié P, Arsandaux J, Katlama C, Ferret S, Beuscart A, Spadone C, Duvivier C, Reynes J, Wirth N, Moinot L, Bénard A, Zucman D, Duval X, Molina JM, Spire B, Fagard C, Chêne G; ANRS 144 Inter-ACTIV study group. Efficacy and safety of varenicline for smoking cessation in people living with HIV in France (ANRS 144 Inter-ACTIV): a randomised controlled phase 3 clinical trial. Lancet HIV. 2018 Mar;5(3):e126-e135. doi: 10.1016/S2352-3018(18)30002-X. Epub 2018 Jan 9.

family: Mercié

full_name: Patrick Mercié

given: Patrick

family: Arsandaux

full_name: Julie Arsandaux

given: Julie

family: Katlama

full_name: Christine Katlama

given: Christine

family: Ferret

full_name: Samuel Ferret

given: Samuel

family: Beuscart

full_name: Aurélie Beuscart

given: Aurélie

family: Spadone

full_name: Christian Spadone

given: Christian

family: Duvivier

full_name: Claudine Duvivier

given: Claudine

family: Reynes

full_name: Jacques Reynes

given: Jacques

family: Wirth

full_name: Nathalie Wirth

given: Nathalie

family: Moinot

full_name: Laetitia Moinot


title: Role of Combined Intervention of Physical Activity and Nutrition in Metabolic Syndrome Treatment on Cardio-vascular Risk and Muscular- Skeletal Functions in Human Subject. Analysis of Patient's Compliance in Patient's Follow-up.

summary:
Metabolic syndrome has been defined as a group of associated risk factors for cardio-vascular diseases and diabetes. It is usually treated with an association of restrictive diet, physical exercise and drugs. Nevertheless the type of exercise associated to reduction in cardio-vascular risks is not yet fully defined. Long term effects of such hygienic-diet programs are of great importance since it is well-known that compliance to such treatment are of short duration, namely when subjects return in routine life. Metabolic syndrome volunteer subjects (n=90), aged 50 to 70 yrs will be randomly assigned to 3 groups of investigation.One group will perform mostly resistance activity, a second mainly endurance activity and the third one will be composed of subjects not exercising a lot. All subjects will have the same restrictive diet (500-700 kcal/d) After the initial training (3 weeks), they will return home with diet and physical program advises (personal compliance). They will be followed for one year (at 3, 6 and 12 months) Such a design may allow to find out the type of activity and power that are the best to reduce metabolic syndrome parameters and cardio-vascular risk factors.

The primary outcome variable is the reduction in abdominal circumference, which is the main criteria of MS.

ReferenceCitation: Vinet A, Obert P, Courteix D, Chapier R, Lesourd B, Verney J, Dutheil F, Walther G. Different modalities of exercise improve macrovascular function but not microvascular function in metabolic syndrome: The RESOLVE randomized trial. Int J Cardiol. 2018 Sep 15;267:165-170. doi: 10.1016/j.ijcard.2018.05.073. Epub 2018 May 23.

family: Vinet

full_name: Agnès Vinet

given: Agnès

family: Obert

full_name: Philippe Obert

given: Philippe

family: Courteix

full_name: Daniel Courteix

given: Daniel

family: Chapier

full_name: Robert Chapier

given: Robert

family: Lesourd

full_name: Bruno Lesourd

given: Bruno

family: Verney

full_name: Julien Verney

given: Julien

family: Dutheil

full_name: Frédéric Dutheil

given: Frédéric

family: Walther

full_name: Guillaume Walther

given: Guillaume

journal_name: International Journal of Cardiology

ReferenceCitation: Lanhers C, Walther G, Chapier R, Lesourd B, Naughton G, Pereira B, Duclos M, Vinet A, Obert P, Courteix D, Dutheil F. Long-term cost reduction of routine medications following a residential programme combining physical activity and nutrition in the treatment of type 2 diabetes: a prospective cohort study. BMJ Open. 2017 Apr 16;7(4):e013763. doi: 10.1136/bmjopen-2016-013763.

family: Lanhers

full_name: Charlotte Lanhers

given: Charlotte

family: Naughton

full_name: Geraldine Naughton

given: Geraldine

family: Pereira

full_name: Bruno Pereira

family: Duclos

full_name: Martine Duclos

given: Martine

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

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

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

ReferenceCitation: Boudet G, Walther G, Courteix D, Obert P, Lesourd B, Pereira B, Chapier R, Vinet A, Chamoux A, Naughton G, Poirier P, Dutheil F. Paradoxical dissociation between heart rate and heart rate variability following different modalities of exercise in individuals with metabolic syndrome: The RESOLVE study. Eur J Prev Cardiol. 2017 Feb;24(3):281-296. doi: 10.1177/2047487316679523. Epub 2016 Nov 19.

name: University Clermont Auvergne, Laboratory of Metabolic Adaptations to Exercise in Physiological and Pathological conditions (AME2P, EA3533), France

name: University Hospital of Clermont Ferrand (CHU), Preventive and Occupational Medicine, France

name: University of Avignon, LaPEC EA4278, France

name: University Hospital of Clermont Ferrand (CHU), Clinical Research and Innovation Direction, France

name: Australian Catholic University, School of Exercise Science, Faculty of Health, Australia

name: Centre de recherche de l’Institut Universitaire de Cardiologie et de Pneumologie de Québec, Canada

name: Faculté de Pharmacie, Université Laval, Canada

name: CNRS, UMR 6024, Physiological and Psychosocial Stress, University Clermont Auvergne, France

journal_name: European Journal of Preventive Cardiology

ReferenceCitation: Courteix D, Valente-dos-Santos J, Ferry B, Lac G, Lesourd B, Chapier R, Naughton G, Marceau G, João Coelho-e-Silva M, Vinet A, Walther G, Obert P, Dutheil F. Multilevel Approach of a 1-Year Program of Dietary and Exercise Interventions on Bone Mineral Content and Density in Metabolic Syndrome--the RESOLVE Randomized Controlled Trial. PLoS One. 2015 Sep 16;10(9):e0136491. doi: 10.1371/journal.pone.0136491. eCollection 2015. Erratum in: PLoS One. 2015;10(10):e0140307.

repository_institution: Australian Catholic University - Research Bank

title: Multilevel Approach of a 1-Year Program of Dietary and Exercise Interventions on Bone Mineral Content and Density in Metabolic Syndrome – the RESOLVE Randomized Controlled Trial

ReferenceCitation: Walther G, Obert P, Dutheil F, Chapier R, Lesourd B, Naughton G, Courteix D, Vinet A. Metabolic syndrome individuals with and without type 2 diabetes mellitus present generalized vascular dysfunction: cross-sectional study. Arterioscler Thromb Vasc Biol. 2015 Apr;35(4):1022-9. doi: 10.1161/ATVBAHA.114.304591. Epub 2015 Feb 5.

name: From the Avignon University, LAPEC EA4278, Avignon, France (G.W., P.O., A.V.); Blaise Pascal University, Laboratory Metabolic Adaptations to Exercise in Physiological and Pathological Conditions (AME2P, EA3533), Clermont-Ferrand, France (F.D., B.L., D.C.); University Hospital of Clermont-Ferrand (CHU), Clermont-Ferrand, France (F.D., B.L.); Omental—Thermalia Center, Châtelguyon, France (R.C.); and School of Exercise Science, Australian Catholic University, Melbourne, Victoria, Australia (P.O., F.D.,...

journal_name: Arteriosclerosis, Thrombosis, and Vascular Biology

title: Metabolic Syndrome Individuals With and Without Type 2 Diabetes Mellitus Present Generalized Vascular Dysfunction

ReferenceCitation: Serrano-Ferrer J, Walther G, Crendal E, Vinet A, Dutheil F, Naughton G, Lesourd B, Chapier R, Courteix D, Obert P. Right ventricle free wall mechanics in metabolic syndrome without type-2 diabetes: effects of a 3-month lifestyle intervention program. Cardiovasc Diabetol. 2014 Aug 3;13:116. doi: 10.1186/s12933-014-0116-9.

ReferenceCitation: Vinet A, Obert P, Dutheil F, Diagne L, Chapier R, Lesourd B, Courteix D, Walther G. Impact of a lifestyle program on vascular insulin resistance in metabolic syndrome subjects: the RESOLVE study. J Clin Endocrinol Metab. 2015 Feb;100(2):442-50. doi: 10.1210/jc.2014-2704. Epub 2014 Oct 29.

name: Avignon University (A.V., P.O., L.D., G.W.), LAPEC EA4278, F-84000 Avignon, France

name: School of Exercise Science (P.O., F.D., D.C.), Australian Catholic University, Melbourne, 3065 Australia

name: Laboratory of Metabolic Adaptations to Exercise in Physiological and Pathological Conditions (F.D., B.L., D.C.), EA3533, F-63000 Clermont-Ferrand, France

name: University Hospital of Clermont-Ferrand (F.D., B.L.), CHU G. Montpied, F-63000 Clermont-Ferrand, France

name: Omental (R.C.)—Thermalia Center, F-63140 Châtelguyon, France

journal_name: The Journal of Clinical Endocrinology & Metabolism

title: Impact of a Lifestyle Program on Vascular Insulin Resistance in Metabolic Syndrome Subjects: The RESOLVE Study

ReferenceCitation: Dutheil F, Walther G, Chapier R, Mnatzaganian G, Lesourd B, Naughton G, Verney J, Fogli A, Sapin V, Duclos M, Vinet A, Obert P, Courteix D, Lac G. Atherogenic subfractions of lipoproteins in the treatment of metabolic syndrome by physical activity and diet - the RESOLVE trial. Lipids Health Dis. 2014 Jul 11;13:112. doi: 10.1186/1476-511X-13-112.

title: Atherogenic subfractions of lipoproteins in the treatment of metabolic syndrome by physical activity and diet – the RESOLVE trial

ReferenceCitation: Dutheil F, Lac G, Lesourd B, Chapier R, Walther G, Vinet A, Sapin V, Verney J, Ouchchane L, Duclos M, Obert P, Courteix D. Different modalities of exercise to reduce visceral fat mass and cardiovascular risk in metabolic syndrome: the RESOLVE randomized trial. Int J Cardiol. 2013 Oct 9;168(4):3634-42. doi: 10.1016/j.ijcard.2013.05.012. Epub 2013 May 25.

title: Different modalities of exercise to reduce visceral fat mass and cardiovascular risk in metabolic syndrome: the RESOLVE* randomized trial


title: In Vivo SPECT Imaging of Vesicular Acetylcholine and Dopamine Transporters in Dementia With Lewy Bodies: Applying in Diagnostic and Identification of Pathological Subtypes.

acronym: IBVM/DATSCAN

summary:
The general aim of this research project is to determine the relationships between alterations of central cholinergic (ACh) and dopaminergic (DA) systems and neurobehavioral features of dementias with Lewy bodies (DLB).

Both clinical and neurochemical data support the view that DLB is not a homogeneous entity and it can be hypothesized that differential alterations of central ACh systems (i.e. anterior vs posterior vs striatal interneurons) in association or not with a DA nigrostriatal dysfunction could partly support the clinical heterogeneity observed in this disease. ACh in vivo imaging has been relatively underutilized to date and to our knowledge only on the postsynaptic side. Furthermore, ACh/DA interactions and their relationships with the symptomatology of DLB and related pathologies (PDD) had never been investigated.

location_facility: Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux


title: A Wireless Lingual Feedback Device to Reduce Overpressures in Seated Posture: A Feasibility Study

summary:
This study evaluates the feasibility of a biofeedback system aimed at reducing overpressures during seated posture. The system consists of (1) a pressure sensors map, (2) a laptop that couples sensors with actuators, (3) a Tongue Display Unit (TDU) consisting of a wireless circuit embedded in a dental retainer with a matrix of electrodes. The principle of this biofeedback system consists in (1) detecting overpressures in people who are seated over long periods of time, (2) estimating a postural change that could reduce these overpressures and (3) communicating this change through directional information transmitted by the TDU.

It is hypothesized that overpressures are diminished after biofeedback.

time_perspective: Cross-Sectional

lead_sponsor: TIMC-IMAG


title: Measurement of Exhaled NO and Bronchial Provocation Test With Mannitol as a Predictor of Response to Inhaled Corticosteroids in Chronic Cough

acronym: MANOTOUX

summary:
Chronic cough is defined by its persistence beyond 8 weeks. Many conditions can explain the existence of a bronchial inflammation. In the management of chronic cough, the search for bronchial hyperreactivity (HRB) is recommended. The treatment relies primarily on the prescription of inhaled corticosteroids. It has been shown recently that the existence of an HRB with Methacholine (bronchial provocation test used in routine) does predict the effectiveness of inhaled corticosteroid treatment in no more than 50% of cases.

It is now possible to assess the bronchial inflammation by rapid, non-invasive and reproducible tests such that the fraction of exhaled nitric oxide (FeNO) and bronchial provocation test with mannitol. In a retrospective study, it was shown that an increased value of FeNO (cut-off > 35 ppb) predicts a positive response to treatment with a sensitivity of 90% and a specificity of 80%.


title: Master Study of the EVIA DR-T/DR/SR-T/SR Pacemaker

summary: The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and subsequently adjusts the pacing output.

lead_sponsor: Biotronik SE & Co. KG


summary: Vulvovaginal candidiasis (VVC) is a common infection among women that is associated with considerable morbidity and health-care cost. 75% of women will suffer of Candida infection for at least one time in their life. 20% of women who suffer from VVC will have ≥ 4 episodes of VVC during the one year prior to the survey. 80% of these VVC are caused by Candida albicans. Current treatments, based on imidazoles, face many failures or recurrences. The type of probiotic Lactobacillus may participate in the prevention of recurrent vulvo-vaginitis in reducing the proliferation of intestinal Candida albicans, its adherence to the vaginal walls, the potentiation of its propagation. The primary objective of this study was to investigate if our supplementary treatment could improve the initial cure rate after vaginal econazole therapy.

lead_sponsor: PiLeJe

intervention_type: Dietary Supplement


title: Continuous Preperitoneal Versus Epidural Infusion of Local Anesthetic for Enhanced Postoperative Recovery Following Open Colorectal Surgery

summary: The purpose of this study is to compare the continuous preperitoneal infusion of local anesthetic and continuous epidural analgesia for postoperative pain management in fast-track open colorectal surgery.

ReferenceCitation: Jouve P, Bazin JE, Petit A, Minville V, Gerard A, Buc E, Dupre A, Kwiatkowski F, Constantin JM, Futier E. Epidural versus continuous preperitoneal analgesia during fast-track open colorectal surgery: a randomized controlled trial. Anesthesiology. 2013 Mar;118(3):622-30. doi: 10.1097/ALN.0b013e3182800d94.

family: Jouve

full_name: Philippe Jouve

family: Bazin

full_name: Jean-Etienne Bazin

given: Jean-Etienne

family: Petit

full_name: Antoine Petit

given: Antoine

name: Professor, Department of Anesthesiology and Critical Care Medicine, Rangueil Hospital, University Hospital of Toulouse, Toulouse, France.

family: Minville

full_name: Vincent Minville

given: Vincent

family: Gerard

full_name: Adeline Gerard

given: Adeline

name: Staff Surgeon, Department of Digestive Surgery, Estaing Hospital, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.

family: Buc

full_name: Emmanuel Buc

given: Emmanuel

family: Dupre

full_name: Aurelien Dupre

given: Aurelien

name: Statistician, Department of Biostatistics, Centre Jean Perrin, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France

family: Kwiatkowski

full_name: Fabrice Kwiatkowski

given: Fabrice

family: Constantin

full_name: Jean-Michel Constantin

given: Jean-Michel

name: Staff Anesthesiologist and Assistant Professor, Department of Anesthesiology and Critical Care Medicine.

family: Futier

full_name: Emmanuel Futier

journal_name: Anesthesiology

title: Epidural versus Continuous Preperitoneal Analgesia during Fast-track Open Colorectal Surgery

lead_sponsor: University Hospital, Clermont-Ferrand


title: Identification of Protective and Worsening Steatohepatitis (NASH) Factors by Microarray in Morbid Obesity Patients

summary: The main aim of this work will be to identify a profile of gene expression by microarray in the liver which might allow to differentiate obese subjects having a normal liver from those with steatohepatitis or steatosis.

primary_purpose: Screening

lead_sponsor: Centre Hospitalier Universitaire de Nice


title: Randomized Controlled Study Versus Placebo Evaluating Effectiveness of Gelsemium Sempervirens (5CH et 15CH) on Provoked Anticipatory Anxiety, in Healthy Volunteers

acronym: ANXIHOMEV

summary: To evaluate the effectiveness of Gelsemium sempervirens 5CH et 15CH on anticipatory provoked anxiety, in healthy volunteers.

ReferenceCitation: Binsard AM, Guillemain J, Platel A, Savini EC, Tetau M. Etude psychopharmacologique de dilution homéopathiques de Gelsemium et d'Ignatia. Ann Homeop Fr. 22: 35-50; 1980.

ReferenceCitation: Nasolotsiry E. Raveloson ; R. Rasoloherimampiononiaina ; A. Ramialiharisoa. Indication homéopathique en prémédication anesthésique. Correspondance homéoweb.

lead_sponsor: University Hospital, Grenoble


title: Study of Methylphenidate to Treat Gait Disorders And Attention Deficit In Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentric Trial

acronym: PARKGAIT-II

summary: Therapeutic management of gait disorders in very advanced Parkinson's disease (PD) patients can sometimes be disappointing, since dopaminergic drug treatments and subthalamic nucleus (STN) stimulation are more effective for limb-related Parkinsonian signs than for gait disorders. Gait disorders could be also partly related to noradrenergic system impairment, pharmacological modulation of both dopamine and noradrenaline pathways could potentially improve the symptomatology. The investigators have demonstrated using an open label study on 17 advanced PD patients that chronic, high doses of methylphenidate (MPD) improved gait, freezing of gait, motor symptoms and attention in the absence of L-Dopa and increased the intensity of response of these symptoms to L-Dopa (Devos et al., 2007). The investigators aimed to confirm their results using a randomized, double-blind, placebo-controlled, parallel-group, multicentric trial. The investigators will assess the clinical value of chronic, high doses (1 mg/kg/day) of MPD vs placebo in 88 non demented PD patients suffering from severe gait disorders with freezing despite their use of optimal dopaminergic doses and eventually STN stimulation parameters. Efficacy will be assessed directly and on video in the absence of L-Dopa and again after acute administration of the drug, both before and after a 3-month course of MPD, using Stand Walk Sit test (primary criteria), the "Freezing Of Gait trajectory", RGSE scale, the UPDRS scores, the dyskinesia rating scale, Achiron scales and using auto-questionnaires of Giladi, ABC scale and PDQ 39. Attention will be assessed using reactions times. Drowsiness will be assessed using Epworth and Parkinson's disease Sleep Scales. Apathy and depression will be monitored with Lille Apathy Rating Scale, MADRS, BPRS, MINI and psychiatric interview. Cardiologic and general tolerance will be also monitored. This study could lead to propose methylphenidate with a good efficacy/ risk balance in advanced PD patients suffering from severe gait disorders with freezing of gait, drowsiness and attention deficit.

ReferenceCitation: Devos D, Krystkowiak P, Clement F, Dujardin K, Cottencin O, Waucquier N, Ajebbar K, Thielemans B, Kroumova M, Duhamel A, Destée A, Bordet R, Defebvre L. Improvement of gait by chronic, high doses of methylphenidate in patients with advanced Parkinson's disease. J Neurol Neurosurg Psychiatry. 2007 May;78(5):470-5. Epub 2006 Nov 10.

ReferenceCitation: Moreau C, Meguig S, Corvol JC, Labreuche J, Vasseur F, Duhamel A, Delval A, Bardyn T, Devedjian JC, Rouaix N, Petyt G, Brefel-Courbon C, Ory-Magne F, Guehl D, Eusebio A, Fraix V, Saulnier PJ, Lagha-Boukbiza O, Durif F, Faighel M, Giordana C, Drapier S, Maltête D, Tranchant C, Houeto JL, Debû B, Azulay JP, Tison F, Destée A, Vidailhet M, Rascol O, Dujardin K, Defebvre L, Bordet R, Sablonnière B, Devos D; Parkgait-II Study Group. Polymorphism of the dopamine transporter type 1 gene modifies the treatment response in Parkinson's disease. Brain. 2015 May;138(Pt 5):1271-83. doi: 10.1093/brain/awv063. Epub 2015 Mar 23.

family: Moreau

full_name: Caroline Moreau

given: Caroline

family: Meguig

full_name: Sayah Meguig

given: Sayah

family: Corvol

full_name: Jean-Christophe Corvol

given: Jean-Christophe

family: Labreuche

full_name: Julien Labreuche

family: Vasseur

full_name: Francis Vasseur

given: Francis

family: Duhamel

full_name: Alain Duhamel

given: Alain

family: Delval

full_name: Arnaud Delval

given: Arnaud

family: Bardyn

full_name: Thomas Bardyn

given: Thomas

family: Devedjian

full_name: Jean-Christophe Devedjian

family: Rouaix

full_name: Nathalie Rouaix

given: Nathalie

family: Petyt

full_name: Gregory Petyt

given: Gregory

family: Brefel-Courbon

full_name: Christine Brefel-Courbon

given: Christine

family: Ory-Magne

full_name: Fabienne Ory-Magne

given: Fabienne

family: Guehl

full_name: Dominique Guehl

given: Dominique

family: Eusebio

full_name: Alexandre Eusebio

given: Alexandre

family: Fraix

full_name: Valérie Fraix

given: Valérie

family: Saulnier

full_name: Pierre-Jean Saulnier

given: Pierre-Jean

family: Lagha-Boukbiza

full_name: Ouhaid Lagha-Boukbiza

given: Ouhaid

family: Durif

full_name: Frank Durif

given: Frank

family: Faighel

full_name: Mirela Faighel

given: Mirela

family: Giordana

full_name: Caroline Giordana

family: Drapier

full_name: Sophie Drapier

given: Sophie

title: Polymorphism of the dopamine transporter type 1 gene modifies the treatment response in Parkinson’s disease

ReferenceCitation: Dujardin K, Tard C, Duhamel A, Delval A, Moreau C, Devos D, Defebvre L. The pattern of attentional deficits in Parkinson's disease. Parkinsonism Relat Disord. 2013 Mar;19(3):300-5. doi: 10.1016/j.parkreldis.2012.11.001. Epub 2012 Nov 27.

ReferenceCitation: Moreau C, Delval A, Defebvre L, Dujardin K, Duhamel A, Petyt G, Vuillaume I, Corvol JC, Brefel-Courbon C, Ory-Magne F, Guehl D, Eusebio A, Fraix V, Saulnier PJ, Lagha-Boukbiza O, Durif F, Faighel M, Giordana C, Drapier S, Maltête D, Tranchant C, Houeto JL, Debû B, Sablonniere B, Azulay JP, Tison F, Rascol O, Vidailhet M, Destée A, Bloem BR, Bordet R, Devos D; Parkgait-II study group. Methylphenidate for gait hypokinesia and freezing in patients with Parkinson's disease undergoing subthalamic stimulation: a multicentre, parallel, randomised, placebo-controlled trial. Lancet Neurol. 2012 Jul;11(7):589-96. doi: 10.1016/S1474-4422(12)70106-0. Epub 2012 Jun 1. Erratum in: Lancet Neurol. 2012 Aug;11(8):658. Lancet Neurol. 2016 Mar;15(3):241. Erratum in: Lancet Neurol. 2016 Mar;15(3):241.

location_facility: Service de Neurologie, Clinique Neurologique, EA 2683, IFR 114


title: Assessment of New Blood Culture Methods on the Microbiological Documentation of Febrile Neutropenia

acronym: HEMATOCPLUS

summary:
Febrile neutropenia are microbiologically documented in only 30% of the cases, and almost exclusively by blood cultures. The reasons for this low documentation are likely multiple: (1) some of these fevers are of non-infectious origin. (2) The bacterial inoculum present in the blood may be low and consequently undetectable by conventional blood cultures.

The primary objective of the study is to assess new blood culture procedures and technics, in order to improve the diagnostic yield of blood cultures during febrile neutropenic episodes.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hematology Department, Paris 12 University Hospital Henri Mondor


title: Comparison of the Hemoglobin Results Obtained With the Masimo SpHb™ Device and the Clinical Laboratory Measurement

summary: The purpose of this study is to compare the hemoglobin results obtained with the Masimo SpHb™ device and the Clinical Laboratory.


title: Diffuse Large B Cell Non-Hodgkin's Lymphoma in the Vulnerable/Frail Elderly. A Multicentric Randomized Phase II Trial With Emphasis on Geriatric Assessment and Quality of Life

summary:
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, prednisone, and liposome-encapsulated doxorubicin citrate, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether rituximab and combination chemotherapy are more effective when given together with or without liposome-encapsulated doxorubicin citrate in treating older patients with diffuse large B-cell non-Hodgkin lymphoma.

PURPOSE: This randomized phase II trial is studying the side effects of giving rituximab together with cyclophosphamide, vincristine sulfate, and prednisone with or without liposome-encapsulated doxorubicin citrate and to see how well it works in treating older patients with stage II, stage III, or stage IV diffuse large B-cell non-Hodgkin lymphoma.

lead_sponsor: Institut Bergonié


title: Comparative, Randomized, Double-blind Study of the Efficacy of Eductyl® Versus Placebo for Treatment of Patients With Dyschesia Treated by Rectal Rehabilitation

acronym: Eductyl

summary: The purpose of this study is to assess the efficacy of Eductyl versus placebo for treatment of patients with dyschesia treated by rectal rehabilitation.

ReferenceCitation: Cotelle O, Cargill G, Marty MM, Bueno L, Cappelletti MC, Colangeli-Hagège H, Savarieau B, Ducrotté P. A concomitant treatment by CO2-releasing suppositories improves the results of anorectal biofeedback training in patients with dyschezia: results of a randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2014 Jun;57(6):781-9. doi: 10.1097/DCR.0000000000000098.

family: Cotelle

full_name: Odile Cotelle

given: Odile

family: Cargill

full_name: Guillaume Cargill

given: Guillaume

family: Marty

full_name: Marc M. L. Marty

given: Marc M. L.

family: Bueno

full_name: Lionel Bueno

given: Lionel

family: Cappelletti

full_name: Max Claude Cappelletti

given: Max Claude

family: Colangeli-Hagège

full_name: Hélène Colangeli-Hagège

given: Hélène

family: Savarieau

full_name: Bernard Savarieau

given: Bernard

family: Ducrotté

full_name: Philippe Ducrotté

given: Philippe

journal_name: Diseases of the Colon & Rectum

title: A Concomitant Treatment by CO2-Releasing Suppositories Improves the Results of Anorectal Biofeedback Training in Patients With Dyschezia

lead_sponsor: Laboratoires Techni Pharma