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.


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

status: Unknown status

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Gustave Roussy, Cancer Campus, Grand Paris

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Unknown


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).

status: Completed

study_completion_date_type: Actual

primary_purpose: Basic Science

lead_sponsor: Institut Paoli-Calmettes

intervention_type: Other

status_simplified: Completed


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.

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

ReferenceType: derived

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.

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.

lead_sponsor: Centre Henri Becquerel

lead_sponsor_type: industriel


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

enrollment_type: Actual

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.

lead_sponsor: Hospices Civils de Lyon

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

intervention_type: Procedure


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: Galderma R&D

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.

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

status: Terminated

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.

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.

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.

lead_sponsor: Etablissement Français du Sang

location_facility: Hopital Saint Antoine, Service hématologie et therapie cellulaire

intervention_type: Biological


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.

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

design_allocation: Non-Randomized

primary_purpose: Diagnostic

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.

ReferenceType: result

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.

time_perspective: Retrospective

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.

ipd_sharing: No

lead_sponsor: French Innovative Leukemia Organisation


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

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.

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.


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).


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.

ReferenceCitation: Prétet JL, Dalstein V, Touzé A, Beby-Defaux A, Soussan P, Jacquin É, Birembaut P, Clavel C, Mougin C, Rousseau A, Lacau Saint Guily J; Papillophar Study Group. High levels of HPV16-L1 antibody but not HPV16 DNA load or integration predict oropharyngeal patient outcome: The Papillophar study. Clin Exp Med. 2022 Feb 23. doi: 10.1007/s10238-022-00796-2. [Epub ahead of print]


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.

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.

lead_sponsor: ANRS, Emerging Infectious Diseases


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.

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.

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.

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.

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.

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.

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.

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.

lead_sponsor: University Hospital, Clermont-Ferrand


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.

ReferenceCitation: Cooke G, Watson C, Deckx L, Pirotta M, Smith J, van Driel ML. Treatment for recurrent vulvovaginal candidiasis (thrush). Cochrane Database Syst Rev. 2022 Jan 10;1:CD009151. doi: 10.1002/14651858.CD009151.pub2. Review.

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.


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.

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.

lead_sponsor: University Hospital, Lille

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: 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.

lead_sponsor: Laboratoires Techni Pharma


title: The Comparability of Bispectral Index and Neurosense During Total Intravenous Anesthesia and Balanced Anesthesia

summary: The assessment of anesthesia depth was based, until recently, on the evolution of hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems, Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland Medical Devices Inc., Cleveland, OH 44103, USA). The goal of this study is to compare both monitoring modalities during anesthesia.

ReferenceCitation: Zikov T, Bibian S, Dumont GA, Huzmezan M, Ries CR. Quantifying cortical activity during general anesthesia using wavelet analysis. IEEE Trans Biomed Eng. 2006 Apr;53(4):617-32.


title: Combination of Continuous Low Doses of Vinorelbine, Cyclophosphamide and Interferon Alpha 2b for Antiangiogenic/Antivascular Effect in Adult Advanced Neoplasm

summary:
Purpose:

This phase I trial estimates the antiangiogenic and antivascular effect of 4 different levels of continuous low doses of the combination of Vinorelbine, Cyclophosphamide and Interferon alpha 2b (" metronomic chemotherapy ")in adult advanced neoplasm.

This study is non randomized, monocentric, and with a pharmacodynamic part.

Primary objective:

Estimation of the toxicity of the combination of continuous low doses of Vinorelbine, Cyclophosphamide and Interferon alpha 2b.

Secondary objectives:

Estimation of the antiangiogenic and/or antivascular effect (VEGF measurement) in radiography (DEC-MRI), biology and immunohistochemistry of the treatment.

lead_sponsor: Institut Paoli-Calmettes


title: Breastmilk or Oral Sucrose Solution in Preterm Neonates for Procedural Pain: a Randomized, Controlled Study

acronym: BMoS

summary:
Hypothesis: Breastmilk has a more powerful analgesic effect than oral sucrose to avoid procedural pain in preterm neonates.

The objective is to test this hypothesis in a randomized, controlled study using a standardized and validated pain scale (DAN). The sample size is 21 preterm infants in each two groups. The main end point is a reduction of the risk to have a DAN superior to 1 from 80% with oral sucrose to 40% with breastmilk.

ReferenceCitation: Schollin J. Analgesic effect of expressed breast milk in procedural pain in neonates. Acta Paediatr. 2004 Apr;93(4):453-5.

ReferenceCitation: Carbajal R, Veerapen S, Couderc S, Jugie M, Ville Y. Analgesic effect of breast feeding in term neonates: randomised controlled trial. BMJ. 2003 Jan 4;326(7379):13.

ReferenceCitation: Carbajal R, Paupe A, Hoenn E, Lenclen R, Olivier-Martin M. [APN: evaluation behavioral scale of acute pain in newborn infants]. Arch Pediatr. 1997 Jul;4(7):623-8. French.

lead_sponsor: Centre Hospitalier Intercommunal Creteil

location_facility: Centre Hospitalier Intercommunal de Creteil


title: Evaluation of Ischemic Preconditioning in Patients Undergoing Major Liver Resection With Intermittent Pedicular Clamping: A Multicentric Randomized Trial

acronym: HECLA

summary:
To evaluate the accuracy of ischemic preconditioning (IPC) as a protective maneuver against ischemia/reperfusion lesion in patients undergoing major liver resection with intermittent portal triad Clamping (IPTC).

Summary Background Data: For sake of safety and to avoid excessive blood loss during parenchymal transection, vascular inflow occlusion is an effective trick but may cause ischemic damage to the remnant liver and can lead to liver failure in case of chronic liver disease. IPTC has been proven to be superior to continuous hepatic pedicle clamping as it preserve liver remnant from severe ischemia/reperfusion lesion, so does IPC. Yet, if IPC is beneficial if liver resection is performed under IPTC has never been demonstrated in a randomised controlled trial (RCT). The investigators designed a RCT to assess the impact of IPC in patient undergoing major liver resection with intermittent vascular inflow occlusion.

ReferenceCitation: Scatton O, Zalinski S, Jegou D, Compagnon P, Lesurtel M, Belghiti J, Boudjema K, Lentschener C, Soubrane O. Randomized clinical trial of ischaemic preconditioning in major liver resection with intermittent Pringle manoeuvre. Br J Surg. 2011 Sep;98(9):1236-43. doi: 10.1002/bjs.7626. Epub 2011 Jul 11.


title: Assistance Robotics for the Surgical Treatment of the Abdominal Wall Hernia

acronym: ARTE

summary:
The aim of this study is to prove the superiority of the robotic assistance in laparoscopic repair of abdominal wall hernias .

In this monocentric randomized controlled trial, the use of the DA VINCI robot might reduce the post-operative pain of the patient resulting in a 40% reduction of morphine consumption.


type: Registry Identifier

title: A Multicentric Phase III Trial Evaluating the Impact of a Radiation Boost (16Gy) After Breast Conserving Surgery and a Whole Breast Irradiation (50Gy) for DCIS

acronym: BONBIS

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether whole-breast radiation therapy is more effective when given with or without additional radiation therapy to the tumor in treating patients with ductal carcinoma in situ.

PURPOSE: This randomized phase III trial is studying breast-conserving surgery followed by whole-breast radiation therapy to see how well it works when given with or without additional radiation therapy to the tumor in treating women with ductal carcinoma in situ.

status: Active, not recruiting

ReferenceCitation: Azria D, Gourgou S, Sozzi WJ, Zouhair A, Mirimanoff RO, Kramar A, Lemanski C, Dubois JB, Romieu G, Pelegrin A, Ozsahin M. Concomitant use of tamoxifen with radiotherapy enhances subcutaneous breast fibrosis in hypersensitive patients. Br J Cancer. 2004 Oct 4;91(7):1251-60.

ReferenceCitation: Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Wárlám-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. Epub 2007 Jun 18.

ReferenceCitation: EORTC Breast Cancer Cooperative Group; EORTC Radiotherapy Group, Bijker N, Meijnen P, Peterse JL, Bogaerts J, Van Hoorebeeck I, Julien JP, Gennaro M, Rouanet P, Avril A, Fentiman IS, Bartelink H, Rutgers EJ. Breast-conserving treatment with or without radiotherapy in ductal carcinoma-in-situ: ten-year results of European Organisation for Research and Treatment of Cancer randomized phase III trial 10853--a study by the EORTC Breast Cancer Cooperative Group and EORTC Radiotherapy Group. J Clin Oncol. 2006 Jul 20;24(21):3381-7. Epub 2006 Jun 26.

ReferenceCitation: Bijker N, Peterse JL, Duchateau L, Julien JP, Fentiman IS, Duval C, Di Palma S, Simony-Lafontaine J, de Mascarel I, van de Vijver MJ. Risk factors for recurrence and metastasis after breast-conserving therapy for ductal carcinoma-in-situ: analysis of European Organization for Research and Treatment of Cancer Trial 10853. J Clin Oncol. 2001 Apr 15;19(8):2263-71.

ReferenceCitation: Cutuli B, Cohen-Solal-le Nir C, de Lafontan B, Mignotte H, Fichet V, Fay R, Servent V, Giard S, Charra-Brunaud C, Lemanski C, Auvray H, Jacquot S, Charpentier JC. Breast-conserving therapy for ductal carcinoma in situ of the breast: the French Cancer Centers' experience. Int J Radiat Oncol Biol Phys. 2002 Jul 15;53(4):868-79.

ReferenceCitation: Cutuli B, Fourquet A, Luporsi E, Arnould L, Caron Y, Cremoux Pd, Dilhuydy JM, Fondrinier E, Fourme E, Giard-Lefevre S, Blanc-Onfroy ML, Lemanski C, Mauriac L, Sigal-Zafrani B, Tardivon A, This P, Tunon de Lara C, Kirova Y, Fabre N; Federation of French Cancer Centres (FNCLCC), et le groupe de travail SOR. [Standards, Options and Recommendations for the management of ductal carcinoma in situ of the breast (DCIS): update 2004]. Bull Cancer. 2005 Feb;92(2):155-68. French.

ReferenceCitation: Emdin SO, Granstrand B, Ringberg A, Sandelin K, Arnesson LG, Nordgren H, Anderson H, Garmo H, Holmberg L, Wallgren A; Swedish Breast Cancer Group. SweDCIS: Radiotherapy after sector resection for ductal carcinoma in situ of the breast. Results of a randomised trial in a population offered mammography screening. Acta Oncol. 2006;45(5):536-43.

ReferenceCitation: Ernster VL, Barclay J, Kerlikowske K, Grady D, Henderson C. Incidence of and treatment for ductal carcinoma in situ of the breast. JAMA. 1996 Mar 27;275(12):913-8.

ReferenceCitation: Fine JP. Regression modeling of competing crude failure probabilities. Biostatistics. 2001 Mar;2(1):85-97.

ReferenceCitation: Fisher B, Dignam J, Wolmark N, Wickerham DL, Fisher ER, Mamounas E, Smith R, Begovic M, Dimitrov NV, Margolese RG, Kardinal CG, Kavanah MT, Fehrenbacher L, Oishi RH. Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial. Lancet. 1999 Jun 12;353(9169):1993-2000.

ReferenceCitation: Fisher B, Land S, Mamounas E, Dignam J, Fisher ER, Wolmark N. Prevention of invasive breast cancer in women with ductal carcinoma in situ: an update of the National Surgical Adjuvant Breast and Bowel Project experience. Semin Oncol. 2001 Aug;28(4):400-18.

ReferenceCitation: Gagliardi G, Lax I, Söderström S, Gyenes G, Rutqvist LE. Prediction of excess risk of long-term cardiac mortality after radiotherapy of stage I breast cancer. Radiother Oncol. 1998 Jan;46(1):63-71.

ReferenceCitation: Ho AY, Atencio DP, Peters S, Stock RG, Formenti SC, Cesaretti JA, Green S, Haffty B, Drumea K, Leitzin L, Kuten A, Azria D, Ozsahin M, Overgaard J, Andreassen CN, Trop CS, Park J, Rosenstein BS. Genetic predictors of adverse radiotherapy effects: the Gene-PARE project. Int J Radiat Oncol Biol Phys. 2006 Jul 1;65(3):646-55.

ReferenceCitation: Houghton J, George WD, Cuzick J, Duggan C, Fentiman IS, Spittle M; UK Coordinating Committee on Cancer Research; Ductal Carcinoma in situ Working Party; DCIS trialists in the UK, Australia, and New Zealand. Radiotherapy and tamoxifen in women with completely excised ductal carcinoma in situ of the breast in the UK, Australia, and New Zealand: randomised controlled trial. Lancet. 2003 Jul 12;362(9378):95-102.

ReferenceCitation: Omlin A, Amichetti M, Azria D, Cole BF, Fourneret P, Poortmans P, Naehrig D, Miller RC, Krengli M, Gutierrez Miguelez C, Morgan D, Goldberg H, Scandolaro L, Gastelblum P, Ozsahin M, Dohr D, Christie D, Oppitz U, Abacioglu U, Gruber G. Boost radiotherapy in young women with ductal carcinoma in situ: a multicentre, retrospective study of the Rare Cancer Network. Lancet Oncol. 2006 Aug;7(8):652-6.

ReferenceCitation: Ozsahin M, Crompton NE, Gourgou S, Kramar A, Li L, Shi Y, Sozzi WJ, Zouhair A, Mirimanoff RO, Azria D. CD4 and CD8 T-lymphocyte apoptosis can predict radiation-induced late toxicity: a prospective study in 399 patients. Clin Cancer Res. 2005 Oct 15;11(20):7426-33.

ReferenceCitation: Solin LJ, Fourquet A, Vicini FA, Haffty B, Taylor M, McCormick B, McNeese M, Pierce LJ, Landmann C, Olivotto IA, Borger J, Kim J, de la Rochefordiere A, Schultz DJ. Mammographically detected ductal carcinoma in situ of the breast treated with breast-conserving surgery and definitive breast irradiation: long-term outcome and prognostic significance of patient age and margin status. Int J Radiat Oncol Biol Phys. 2001 Jul 15;50(4):991-1002.

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

intervention_type: Radiation

status_simplified: Ongoing


title: Association of Rituximab to Plasma Exchange in Adult Acquired Idiopathic Thrombotic Thrombocytopenic Purpura

acronym: PTTritux

summary:
Multicentric non-randomized phase II opened prospective study (10 centres involved).

Primary endpoint:

To evaluate the kinetics of B-cell depletion by rituximab and its pharmacokinetics in patients treated with rituximab in association with plasma exchanges.

Secondary endpoints:

To evaluate the tolerance of rituximab, the volume of plasma and the number of plasma exchange sessions required to achieve a durable complete remission, and to determinate the duration of B-cell depletion.
To evaluate the incidence of persistent severe acquired ADAMTS13 deficiency following treatment with rituximab, as well as the incidence of relapses.

ReferenceCitation: Benhamou Y, Paintaud G, Azoulay E, Poullin P, Galicier L, Desvignes C, Baudel JL, Peltier J, Mira JP, Pène F, Presne C, Saheb S, Deligny C, Rousseau A, Féger F, Veyradier A, Coppo P; French Reference Center for Thrombotic Microangiopathies. Efficacy of a rituximab regimen based on B cell depletion in thrombotic thrombocytopenic purpura with suboptimal response to standard treatment: Results of a phase II, multicenter noncomparative study. Am J Hematol. 2016 Dec;91(12):1246-1251. doi: 10.1002/ajh.24559. Epub 2016 Nov 8.


title: Methodological Evaluation of Fluor 18 Labelled Fluoromisonidazole ([18F]-FMISO) Positon Emission Tomography-Computed Tomography (PET-CT) for Non Operated Glioblastoma

acronym: MISOGLIO

summary:
Hypoxia is recognized to be an independent predictor of clinical outcome in oncology. PET using [18F]-FMISO has been described to be useful for the non invasive assessment of hypoxia in cancer. The use of this radiotracer for brain tumours is very limited and there is no standard to acquire and quantify [18F]-FMISO uptake. So there is a need for a methodological evaluation of this PET tracer The purpose of this research is to define optimal parameters for acquisition and data exploitation to quantify [18F]-FMISO uptake and so predict clinical outcome in glioblastomas.

Low sensitivity to radiation of glioblastoma is partly caused by hypoxia. Hypoxia in tumours is not predicted by tumour size. Detecting and monitoring tissue oxygenation are of great interest to modify therapeutic strategies, including local dose escalation for radiotherapy or select chemotherapeutic agents with better impact in glioblastomas.

PET with appropriate radiotracers, especially [18F]-FMISO, enables non-invasive assessment of hypoxia. [18F]-FMISO only accumulates in viable hypoxic cells. So, it has been demonstrated that PET using 18F-FMISO is suitable to localize and quantify hypoxia. But there isn't any optimal acquisition protocol or standardized images quantification treatment. Thus, the interpretation of [18F]-FMISO PET images and the predictive value of [18F]-FMISO SUV (Standardized Uptake Value) remain unclear explaining the need of methodological approaches.

lead_sponsor: University Hospital, Bordeaux


title: Phase II Study of Evaluation of Fractionated Radio-immunotherapy With 90Y-DOTA-hLL2 as a Consolidation Therapy After First Line of Chemotherapy in Patients Older Than 60 With Disseminated Diffuse Large B-cell Lymphoma

summary:
Phase II, multi-centric, open-label, study.

Disseminated diffuse large B-cell lymphoma in patients older than 60: evaluation of fractionated radio-immunotherapy with 90Y-DOTA-hLL2 as a consolidation therapy after first line of chemotherapy.

ReferenceCitation: Kraeber-Bodere F, Pallardy A, Maisonneuve H, Campion L, Moreau A, Soubeyran I, Le Gouill S, Tournilhac O, Daguindau E, Jardel H, Morineau N, Bouabdallah K, Gyan E, Moles MP, Gressin R, Berthou C, Sadot S, Moreau P, Deau B, Bodet-Milin C, Cazeau AL, Garin E, Salaun PY, Vuillez JP, Gouilleux-Gruart V, Barbet J, Wegener WA, Goldenberg DM, Lamy T, Soubeyran P. Consolidation anti-CD22 fractionated radioimmunotherapy with (90)Y-epratuzumab tetraxetan following R-CHOP in elderly patients with diffuse large B-cell lymphoma: a prospective, single group, phase 2 trial. Lancet Haematol. 2017 Jan;4(1):e35-e45. doi: 10.1016/S2352-3026(16)30168-5. Epub 2016 Dec 8.

lead_sponsor: French Innovative Leukemia Organisation


title: Randomised, Controlled, Clinical Study to Compare the Effect of a Combination of Enamel Matrix Proteins and Straumann Bone Ceramic With Autogenous Bone in Deep-wide Intrabony Defects

summary: Randomised, controlled, clinical study to compare the effect of the combination of bone ceramic and enamel matrix proteins (test) versus autogenous bone graft alone (control) in the treatment of deep-wide intrabony defects

lead_sponsor: Institut Straumann AG

location_facility: Hôtel-Dieu, Université Paris 7 Denis Diderot


title: A National, Multicenter, Non-comparative Study Evaluating the Efficacy of the Combination of Levofloxacin (500 mg) and Rifampicin (600 or 900 mg Depending on Weight) Administered Once Daily by Oral Route, as Replacement of Empirical Antibiotic Therapy Given Intravenously With a Total Duration of 6 Weeks of the Antibiotic Therapy, in the Treatment of OsteoArticular Prosthetic Infections (OAPI), With a Two-stage Revision of the Prosthesis.

summary:
The primary objective is: to assess the microbiological success of the combination of levofloxacin and rifampicin, administered for 32 to 37 days, as oral replacement therapy of an empirical antibiotic therapy of a maximum of 5 to 10 days given intravenously, in the treatment of OsteoArticular Prosthetic Infections (OAPI), with a two-stage revision of the prosthesis.

The secondary endpoints are:

To assess the rate of clinical failure 12 months after the reimplantation of the prosthesis.
To assess the joint mobility function score 12 months after the reimplantation of the prosthesis.
To assess the safety of the combination of levofloxacin and rifampicin.
To investigate prognostic factors for success after the end of treatment and at 12 months after the reimplantation of the prosthesis.

lead_sponsor: Sanofi


title: Systematic Nutritional Care in Patients Receiving First-line Chemotherapy for Metastatic Gynecologic Cancer in a Phase II Study

summary:
RATIONALE: Learning about the effect of nutritional supplements on quality of life in patients receiving chemotherapy for cancer may help doctors plan the best treatment.

PURPOSE: This randomized phase II trial is studying nutritional supplements to see how well they work in improving quality of life during first-line chemotherapy in patients with metastatic gynecologic cancer.

lead_sponsor: Centre Oscar Lambret


title: Polymorphisms of Genes Controlling Alveolar Development and Risk of Bronchopulmonary Dysplasia

acronym: GENBPD

summary:
Despite considerable obstetric and neonatal advances in the care of very low birth weight (VLBW) neonates, bronchopulmonary dysplasia (BPD) continues to occur among 20 to 40% of surviving infants, and new ways for combatting this disease must be found. BPD appears to result from arrested lung development, but its etiology has not yet been fully established. Besides the role of the exposure of the immature lung to injurious factors in the development of BPD, a genetic susceptibility for BPD in preterm infants was recently evidenced. Taking advantage of new genomic technologies, the objective of the investigators' project is to identify predisposing human genetic variants through:

a genome-wide association (GWA) study in VLBW neonates,
a candidate-gene association study, including selection of single nucleotide polymorphisms (SNPs) found in (a) and
functional studies of any SNP found to be convincingly associated with BPD in (a) and (b).

ReferenceCitation: Hadchouel A, Decobert F, Franco-Montoya ML, Halphen I, Jarreau PH, Boucherat O, Martin E, Benachi A, Amselem S, Bourbon J, Danan C, Delacourt C. Matrix metalloproteinase gene polymorphisms and bronchopulmonary dysplasia: identification of MMP16 as a new player in lung development. PLoS One. 2008 Sep 11;3(9):e3188. doi: 10.1371/journal.pone.0003188.


title: ANRS HC20 Pilot Study, Multicenter, Assessing the Effectiveness of an Optimized Anti HCV (360μg/Week Induction of PegIFN-alpha2a + 18mg/kg/j of RBV for 6 Months and Then Depending on the Virological Response to S12, Elongation up S72 to the Dual Anti HCV, With Accompanying Measures) on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV.

acronym: ETOC

summary: The purpose of this study is to assess the effectiveness of an optimized anti HCV treatment (360μg per week of PegIFN-alpha2a + 18mg/kg/j of Ribavirin for 6 months.

ReferenceCitation: Laird ME, Mohsen A, Duffy D, Mamdouh R, LeFouler L, Casrouge A, El-Daly M, Rafik M, Abdel-Hamid M, Soulier A, Pawlotsky JM, Hézode C, Rosa I, Renard P, Mohamed MK, Bonnard P, Izopet J, Mallet V, Pol S, Albert ML, Fontanet A. Apolipoprotein H expression is associated with IL28B genotype and viral clearance in hepatitis C virus infection. J Hepatol. 2014 Oct;61(4):770-6. doi: 10.1016/j.jhep.2014.05.040. Epub 2014 Jun 4.

lead_sponsor: ANRS, Emerging Infectious Diseases

location_facility: Hôpital Tenon Service des Maladies Infectieuses


title: Study Aiming at Researching Diagnostic Markers for the Recognition of Precancerous States, Tracking, Follow-up, and the Identification of New Therapeutic Targets for Mesothelioma in Patients With Atypical Mesothelial Hyperplasia.

summary:
RATIONALE: Studying levels of mesothelin and osteopontin in samples of blood from patients with mesothelioma or atypical mesothelial hyperplasia may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at mesothelin and osteopontin as diagnostic markers in patients with mesothelioma or atypical hyperplasia.

lead_sponsor: University Hospital, Caen


title: Study Evaluating the Prognostic and Predictive Value of Response to First-Line Chemotherapy by Detection of Circulating Tumor Cells (CTC) in Patients With Metastatic Breast Cancer

summary:
RATIONALE: Measuring blood levels of tumor cells in patients with breast cancer may help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is looking at blood levels of tumor cells in predicting response in patients receiving first-line chemotherapy for stage IV breast cancer.

lead_sponsor: Institut Curie


title: Colon and Breast Cancer Diagnostics. Clinical Protocol Associated With Cancer of the Breast.

summary:
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor and blood samples from women with breast cancer.


title: Prospective Multicenter Study of Genetic Factors Predictive of the Pharmacodynamics of Trastuzumab in Patients With Metastatic Breast Cancer

summary:
RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying the side effects of trastuzumab in treating women with metastatic breast cancer.

lead_sponsor: Centre Antoine Lacassagne


title: Factors Associated With the Variance of Oral Methadone Dosage at Steady State of Maintenance Treatment: Description of Bio-markers of Phenotype and Genotype.

acronym: METHADOSE

summary: The purpose of this study is to describe clinical, pharmacokinetic and genetic factors associated with the variance of oral methadone dosage for patients at the steady state of heroin dependence maintenance treatment. The hypothesis is that the investigators can predict 70% of the variance with few factors, including CYP 3A4 function measured with oral midazolam challenge.

ReferenceCitation: Hajj A, Ksouda K, Peoc'h K, Curis E, Messali A, Deveaux LL, Bloch V, Prince N, Mouly S, Scherrmann JM, Lépine JP, Laplanche JL, Drici MD, Vorspan F. KCNH2 polymorphism and methadone dosage interact to enhance QT duration. Drug Alcohol Depend. 2014 Aug 1;141:34-8. doi: 10.1016/j.drugalcdep.2014.04.027. Epub 2014 May 14.

ReferenceCitation: Icick R, Peoc'h K, Ksouda K, Bloch V, Laplanche JL, Lépine JP, Bellivier F, Vorspan F. OPRM1 polymorphism and lifetime suicide attempts among stabilized, methadone-maintained outpatients. Psychiatry Res. 2014 Aug 15;218(1-2):259-60. doi: 10.1016/j.psychres.2014.04.035. Epub 2014 Apr 24.

ReferenceCitation: Mouly S, Bloch V, Peoc'h K, Houze P, Labat L, Ksouda K, Simoneau G, Declèves X, Bergmann JF, Scherrmann JM, Laplanche JL, Lepine JP, Vorspan F. Methadone dose in heroin-dependent patients: role of clinical factors, comedications, genetic polymorphisms and enzyme activity. Br J Clin Pharmacol. 2015 Jun;79(6):967-77. doi: 10.1111/bcp.12576.

ReferenceCitation: Karsinti E, Fortias M, Dupuy G, Ksouda K, Laqueille X, Simonpoli AM, Touzeau D, Avril E, Orizet C, Belforte B, Coeuru P, Polomeni P, Icick R, Jarroir M, Bloch V, Scott J, Lépine JP, Bellivier F, Vorspan F. Anxiety disorders are associated with early onset of heroin use and rapid transition to dependence in methadone maintained patients. Psychiatry Res. 2016 Nov 30;245:423-426. doi: 10.1016/j.psychres.2016.04.064. Epub 2016 Jul 19.

ReferenceCitation: Marie-Claire C, Crettol S, Cagnard N, Bloch V, Mouly S, Laplanche JL, Bellivier F, Lepine JP, Eap C, Vorspan F. Variability of response to methadone: genome-wide DNA methylation analysis in two independent cohorts. Epigenomics. 2016 Feb;8(2):181-95. doi: 10.2217/epi.15.110. Epub 2016 Jan 21.

ReferenceCitation: Icick R, Peoc'h K, Karsinti E, Ksouda K, Hajj A, Bloch V, Prince N, Mouly S, Bellivier F, Lépine JP, Laplanche JL, Vorspan F. A cannabinoid receptor 1 polymorphism is protective against major depressive disorder in methadone-maintained outpatients. Am J Addict. 2015 Oct;24(7):613-20. doi: 10.1111/ajad.12273. Epub 2015 Sep 1.

ReferenceCitation: Icick R, Vorspan F, Karsinti E, Ksouda K, Lépine JP, Brousse G, Mouly S, Bellivier F, Bloch V. Gender-specific study of recurrent suicide attempts in outpatients with multiple substance use disorders. J Affect Disord. 2018 Dec 1;241:546-553. doi: 10.1016/j.jad.2018.08.076. Epub 2018 Aug 13.


summary: Hip or knee arthroplasties allow a relief of pain and a good functional habilitative at patients suffering from degenerative osteoarthritis of these articulations with medium and long-term good results. The main objective of this study is to compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques thanks to an innovative technology of ambulatory analysis of walking.

lead_sponsor: Assistance Publique Hopitaux De Marseille


summary: The aim of the study is to realize a bilateral transplantation of upper limbs. The first objective is functional but there are aesthetic and psychologic imperatives too. This open and descriptive study needs compatible donor and recipient. The sample should be realized simultaneously and the transplantation should be made by two coordinated teams according to this sequence : osteosynthesis, vascular anastomosis, sutures of tendons and nervous sutures. An immunosuppressant treatment should be initialized from the beginning of the intervention and continued for life. Rejections should be screened by regular clinical and histological examinations.


title: A Cluster-Randomized Two-Period Cross-Over Study Comparing Routine and on-Demand Prescription of Chest Radiographs in Mechanically Ventilated Adults : the RARE Study

acronym: RARE

summary: Current guidelines recommend Routine daily chest radiographs (CXRs) for mechanically ventilated patients in intensive care units (ICUs). However, some ICUs have shifted to an On-demand strategy, in which this CXR is only prescribed if warranted by the patient's status at the morning physical examination. Here the investigators compared Routine and On-demand strategies in 21 French ICUs. The working hypothesis was that CXR prescriptions would fall by at least 20% with the On-demand strategy, with no reduction in quality of care.

ReferenceCitation: Hejblum G, Chalumeau-Lemoine L, Ioos V, Boëlle PY, Salomon L, Simon T, Vibert JF, Guidet B. Comparison of routine and on-demand prescription of chest radiographs in mechanically ventilated adults: a multicentre, cluster-randomised, two-period crossover study. Lancet. 2009 Nov 14;374(9702):1687-93. doi: 10.1016/S0140-6736(09)61459-8. Epub 2009 Nov 4.


title: Post Traumatic Stress Disorder and Neural Mechanisms Involved in Its Treatment

summary: The post traumatic stress disorder PTSD arises when the physiological response to stress does not come to its term. This study aims to explore the cognitive, psycho physiological and cerebral mechanisms involved in PTSD, in fear conditioning and face matching tasks, before and after treatment.PTSD patients will be recruited by Pr Jean-Claude Samuelian in his service at the Conception Hospital and by Pr Jean-Michel Azorin in his service at the Sainte Marguerite Hospital (Marseille) and will undergo either CBT or EMDR within those same services. The tasks they will be asked to perform will study the psycho physiological, cognitive and central mechanisms involved in PTSD and its treatment. All in all, 17 healthy controls will be recruited as well as 17 PTSD patients for each of the two treatment group.In terms of perspectives, this study would help isolate neural systems functionally involved in PTSD and its treatment. A better knowledge of those mechanisms would set room for the optimization of the current PTSD treatment.


title: A Prospective, Randomized, Open-label, Multicenter Study Evaluating the Effects on Cognitive Functions of Adjuvant Endocrine Therapy in Postmenopausal Women With Breast Cancer.

summary:
RATIONALE: Estrogen can cause the growth of breast cancer cells. Aromatase inhibitors, such as letrozole, anastrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Hormone therapy, using tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether aromatase inhibitors or tamoxifen citrate have less effect on memory in patients receiving treatment for breast cancer.

PURPOSE: This randomized phase III trial is studying letrozole, anastrozole, or exemestane to see how they effect memory compared with tamoxifen citrate in treating postmenopausal women with breast cancer.