title: A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node

summary:
RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection.

PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases.

ReferenceCitation: Galimberti V, Cole BF, Viale G, Veronesi P, Vicini E, Intra M, Mazzarol G, Massarut S, Zgajnar J, Taffurelli M, Littlejohn D, Knauer M, Tondini C, Di Leo A, Colleoni M, Regan MM, Coates AS, Gelber RD, Goldhirsch A; International Breast Cancer Study Group Trial 23-01. Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel-node micrometastases (IBCSG 23-01): 10-year follow-up of a randomised, controlled phase 3 trial. Lancet Oncol. 2018 Oct;19(10):1385-1393. doi: 10.1016/S1470-2045(18)30380-2. Epub 2018 Sep 5.

family: Galimberti

full_name: Viviana Galimberti

given: Viviana

family: Cole

full_name: Bernard F Cole

given: Bernard F

family: Viale

full_name: Giuseppe Viale

given: Giuseppe

family: Veronesi

full_name: Paolo Veronesi

given: Paolo

family: Vicini

full_name: Elisa Vicini

given: Elisa

family: Intra

full_name: Mattia Intra

given: Mattia

family: Mazzarol

full_name: Giovanni Mazzarol

given: Giovanni

family: Massarut

full_name: Samuele Massarut

given: Samuele

family: Zgajnar

full_name: Janez Zgajnar

given: Janez

family: Taffurelli

full_name: Mario Taffurelli

given: Mario

family: Littlejohn

full_name: David Littlejohn

given: David

family: Knauer

full_name: Michael Knauer

given: Michael

family: Tondini

full_name: Carlo Tondini

given: Carlo

family: Di Leo

full_name: Angelo Di Leo

given: Angelo

family: Colleoni

full_name: Marco Colleoni

given: Marco

family: Regan

full_name: Meredith M Regan

given: Meredith M

family: Coates

full_name: Alan S Coates

given: Alan S

family: Gelber

full_name: Richard D Gelber

given: Richard D

family: Goldhirsch

full_name: Aron Goldhirsch

given: Aron

family: Boyle

full_name: Fran Boyle

given: Fran

family: Jerusalem

full_name: Guy Jerusalem

given: Guy

family: Stahel

full_name: Rolf Stahel

given: Rolf

family: Aebi

full_name: Stefan Aebi

given: Stefan

ReferenceCitation: Galimberti V, Cole BF, Zurrida S, Viale G, Luini A, Veronesi P, Baratella P, Chifu C, Sargenti M, Intra M, Gentilini O, Mastropasqua MG, Mazzarol G, Massarut S, Garbay JR, Zgajnar J, Galatius H, Recalcati A, Littlejohn D, Bamert M, Colleoni M, Price KN, Regan MM, Goldhirsch A, Coates AS, Gelber RD, Veronesi U; International Breast Cancer Study Group Trial 23-01 investigators. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol. 2013 Apr;14(4):297-305. doi: 10.1016/S1470-2045(13)70035-4. Epub 2013 Mar 11. Erratum in: Lancet Oncol. 2013 Jun;14(7):e254.

title: Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23–01): a phase 3 randomised controlled trial

location_country:
Italy
Brazil
Peru
Switzerland
France
Belgium
Australia
New Zealand
Denmark
Slovenia

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Westmead Institute for Cancer Research at Westmead Hospital

location_facility: Oncology Institute of Southern Switzerland

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Sydney Cancer Centre at Royal Prince Alfred Hospital

location_facility: Centro di Riferimento Oncologico - Aviano


type: Other Identifier

title: A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)

acronym: ORIGIN

summary:
The primary objectives of the ORIGIN study were:

To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes;
To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes.

The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce:

total mortality (all causes);
the risk of diabetic microvascular outcomes;
the rate of progression of IGT or IFG to type 2 diabetes.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Origin Trial Investigators, Gerstein H, Yusuf S, Riddle MC, Ryden L, Bosch J. Rationale, design, and baseline characteristics for a large international trial of cardiovascular disease prevention in people with dysglycemia: the ORIGIN Trial (Outcome Reduction with an Initial Glargine Intervention). Am Heart J. 2008 Jan;155(1):26-32, 32.e1-6. Epub 2007 Nov 26.

ReferenceCitation: Hanefeld M, Koehler C, Hoffmann C, Wilhelm K, Kamke W, Gerstein H. Effect of targeting normal fasting glucose levels with basal insulin glargine on glycaemic variability and risk of hypoglycaemia: a randomized, controlled study in patients with early Type 2 diabetes. Diabet Med. 2010 Feb;27(2):175-80. doi: 10.1111/j.1464-5491.2009.02915.x.

ReferenceCitation: Badings EA, Dyal L, Schoterman L, Lok DJ, Stoel I, Gerding MN, Gerstein HC, Tijssen JG. Strategies to detect abnormal glucose metabolism in people at high risk of cardiovascular disease from the ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial population. J Diabetes. 2011 Sep;3(3):232-7. doi: 10.1111/j.1753-0407.2011.00124.x.

ReferenceCitation: Ramachandran A, Riddle MC, Kabali C, Gerstein HC; ORIGIN Investigators. Relationship between A1C and fasting plasma glucose in dysglycemia or type 2 diabetes: an analysis of baseline data from the ORIGIN trial. Diabetes Care. 2012 Apr;35(4):749-53. doi: 10.2337/dc11-1918. Epub 2012 Feb 8.

ReferenceType: result

ReferenceCitation: ORIGIN Trial Investigators, Gerstein HC, Bosch J, Dagenais GR, Díaz R, Jung H, Maggioni AP, Pogue J, Probstfield J, Ramachandran A, Riddle MC, Rydén LE, Yusuf S. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med. 2012 Jul 26;367(4):319-28. doi: 10.1056/NEJMoa1203858. Epub 2012 Jun 11.

The ORIGIN Trial Investigators

sequence: first

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: New England Journal of Medicine

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

repositories_institution: University of Zurich - Zurich Open Repository and Archive

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Basal Insulin and Cardiovascular and Other Outcomes in Dysglycemia

ReferenceCitation: ORIGIN Trial Investigators, Bosch J, Gerstein HC, Dagenais GR, Díaz R, Dyal L, Jung H, Maggiono AP, Probstfield J, Ramachandran A, Riddle MC, Rydén LE, Yusuf S. n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia. N Engl J Med. 2012 Jul 26;367(4):309-18. doi: 10.1056/NEJMoa1203859. Epub 2012 Jun 11.

title: n–3 Fatty Acids and Cardiovascular Outcomes in Patients with Dysglycemia

ReferenceType: derived

ReferenceCitation: Pigeyre M, Hess S, Gomez MF, Asplund O, Groop L, Paré G, Gerstein H. Validation of the classification for type 2 diabetes into five subgroups: a report from the ORIGIN trial. Diabetologia. 2021 Oct 21. doi: 10.1007/s00125-021-05567-4. [Epub ahead of print]

family: Pigeyre

full_name: Marie Pigeyre

given: Marie

family: Hess

full_name: Sibylle Hess

given: Sibylle

sequence: additional

family: Gomez

full_name: Maria F. Gomez

given: Maria F.

family: Asplund

full_name: Olof Asplund

given: Olof

family: Groop

full_name: Leif Groop

given: Leif

family: Paré

full_name: Guillaume Paré

given: Guillaume

family: Gerstein

full_name: Hertzel Gerstein

given: Hertzel

journal_name: Diabetologia

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Validation of the classification for type 2 diabetes into five subgroups: a report from the ORIGIN trial

ReferenceCitation: Wang A, Gerstein HC, Lee SF, Hess S, Paré G, Rydén L, Mellbin LG. Testosterone and sex hormone-binding globulin in dysglycemic women at high cardiovascular risk: A report from the Outcome Reduction with an Initial Glargine Intervention trial. Diab Vasc Dis Res. 2021 Mar-Apr;18(2):14791641211002475. doi: 10.1177/14791641211002475.

name: Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden

family: Wang

full_name: Anne Wang

given: Anne

name: Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada

name: Department of Medicine, McMaster University, Hamilton, ON, Canada

full_name: Hertzel C Gerstein

given: Hertzel C

family: Lee

full_name: Shun Fu Lee

given: Shun Fu

name: R&D, Translational Medicine & Early Development, Biomarkers & Clinical Bioanalyses, Sanofi Aventis Deutschland GmbH, Frankfurt, Germany

name: Heart and Vascular Theme, Karolinska University Hospital, Stockholm, Sweden

family: Rydén

full_name: Lars Rydén

ReferenceCitation: Pigeyre M, Sjaarda J, Chong M, Hess S, Bosch J, Yusuf S, Gerstein H, Paré G. ACE and Type 2 Diabetes Risk: A Mendelian Randomization Study. Diabetes Care. 2020 Apr;43(4):835-842. doi: 10.2337/dc19-1973. Epub 2020 Feb 4.

title: ACE and Type 2 Diabetes Risk: A Mendelian Randomization Study

ReferenceCitation: Thériault S, Sjaarda J, Chong M, Hess S, Gerstein H, Paré G. Identification of Circulating Proteins Associated With Blood Pressure Using Mendelian Randomization. Circ Genom Precis Med. 2020 Feb;13(1):e002605. doi: 10.1161/CIRCGEN.119.002605. Epub 2020 Jan 12.

name: Population Health Research Institute, David Braley Cardiac, Vascular and Stroke Research Institute (S.T., J.S., M.C., H.G., G.P.), McMaster University, Hamilton, ON, Canada.

name: Department of Molecular Biology, Medical Biochemistry and Pathology, Laval University, Quebec City, Canada (S.T.).

name: Department of Pathology and Molecular Medicine (J.S., M.C., G.P), McMaster University, Hamilton, ON, Canada.

name: R&D, Translational Medicine and Early Development, Biomarkers and Clinical Bioanalyses, Sanofi Aventis Deutschland GmbH Frankfurt, Germany (S.H.).

journal_name: Circulation: Genomic and Precision Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Identification of Circulating Proteins Associated With Blood Pressure Using Mendelian Randomization

ReferenceCitation: Gerstein HC, Paré G, McQueen MJ, Lee SF, Bangdiwala SI, Kannt A, Hess S; ORIGIN Trial Investigators. Novel Biomarkers for Change in Renal Function in People With Dysglycemia. Diabetes Care. 2020 Feb;43(2):433-439. doi: 10.2337/dc19-1604. Epub 2019 Nov 14.

title: Novel Biomarkers for Change in Renal Function in People With Dysglycemia

ReferenceCitation: Pigeyre M, Sjaarda J, Mao S, Chong M, Hess S, Yusuf S, Gerstein H, Paré G. Identification of Novel Causal Blood Biomarkers Linking Metabolically Favorable Adiposity With Type 2 Diabetes Risk. Diabetes Care. 2019 Sep;42(9):1800-1808. doi: 10.2337/dc18-2444. Epub 2019 Jun 24.

ReferenceCitation: Cukierman-Yaffe T, Bosch J, Jung H, Punthakee Z, Gerstein HC. Hypoglycemia and Incident Cognitive Dysfunction: A Post Hoc Analysis From the ORIGIN Trial. Diabetes Care. 2019 Jan;42(1):142-147. doi: 10.2337/dc18-0690. Epub 2018 Nov 13.

title: Hypoglycemia and Incident Cognitive Dysfunction: A Post Hoc Analysis From the ORIGIN Trial

ReferenceCitation: Mohammadi-Shemirani P, Sjaarda J, Gerstein HC, Treleaven DJ, Walsh M, Mann JF, McQueen MJ, Hess S, Paré G. A Mendelian Randomization-Based Approach to Identify Early and Sensitive Diagnostic Biomarkers of Disease. Clin Chem. 2019 Mar;65(3):427-436. doi: 10.1373/clinchem.2018.291104. Epub 2018 Oct 18.

name: Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada

name: Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada

name: Department of Medical Sciences, McMaster University, Hamilton Ontario, Canada

name: Department of Medicine, McMaster University, Hamilton Health Sciences, Hamilton, Ontario, Canada

name: Division of Nephrology, Department of Medicine, McMaster University, Hamilton, Ontario, Canada

name: Department of Pathology and Molecular Medicine, McMaster University, Michael G. DeGroote School of Medicine, Hamilton, Ontario, Canada

name: Sanofi Aventis Deutschland GmbH, Research and Development Division, Translational Medicine and Early Development, Biomarkers and Clinical Bioanalyses, Frankfurt, Germany

name: Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada

title: A Mendelian Randomization-Based Approach to Identify Early and Sensitive Diagnostic Biomarkers of Disease

ReferenceCitation: Morieri ML, Gao H, Pigeyre M, Shah HS, Sjaarda J, Mendonca C, Hastings T, Buranasupkajorn P, Motsinger-Reif AA, Rotroff DM, Sigal RJ, Marcovina SM, Kraft P, Buse JB, Wagner MJ, Gerstein HC, Mychaleckyj JC, Parè G, Doria A. Genetic Tools for Coronary Risk Assessment in Type 2 Diabetes: A Cohort Study From the ACCORD Clinical Trial. Diabetes Care. 2018 Nov;41(11):2404-2413. doi: 10.2337/dc18-0709. Epub 2018 Sep 27.

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

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repositories_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

title: Genetic Tools for Coronary Risk Assessment in Type 2 Diabetes: A Cohort Study From the ACCORD Clinical Trial

ReferenceCitation: Birkeland KI, Grill V, Wium C, McQueen MJ, Lopez-Jaramillo P, Lee SF, Gerstein HC. The association of basal insulin treatment versus standard care with outcomes in anti-GAD positive and negative subjects: A post-hoc analysis of the ORIGIN trial. Diabetes Obes Metab. 2019 Feb;21(2):429-433. doi: 10.1111/dom.13528. Epub 2018 Oct 3.

name: Department of Transplantation Medicine, Institute of Clinical Medicine; University of Oslo and Oslo University Hospital; Oslo Norway

name: Department of Endocrinology; St. Olav's Hospital; Trondheim Norway

name: Institute of Clinical and Molecular Medicine; Norwegian University of Science and Technology; Trondheim Norway

name: Department of Endocrinology, Morbid Obesity and Preventive Medicine; Oslo University Hospital; Oslo Norway

name: Department of Pathology and Molecular Medicine, Population Health Research Institute; McMaster University Hamilton Health Sciences; Hamilton Ontario Canada

name: Research Institute, FOSCAL, Bucaramanga, Colombia and Universidad Tecnológica Equinoccial; Facultad de Ciencias de la Salud Eugenio Espejo; Quito Ecuador

name: Department of Statistics, Population Health Research institute; McMaster University, Hamilton Health Sciences; Hamilton Ontario Canada

name: Department of Medicine, Population Health Research institute; McMaster University, Hamilton Health Sciences; Hamilton Ontario Canada

repository_institution: University of Oslo - Duo Research Archive

repositories_institution: University of Oslo - Duo Research Archive

ReferenceCitation: Sjaarda J, Gerstein H, Chong M, Yusuf S, Meyre D, Anand SS, Hess S, Paré G. Blood CSF1 and CXCL12 as Causal Mediators of Coronary Artery Disease. J Am Coll Cardiol. 2018 Jul 17;72(3):300-310. doi: 10.1016/j.jacc.2018.04.067. Epub 2018 Jul 9.

journal_name: Journal of the American College of Cardiology

title: Blood CSF1 and CXCL12 as Causal Mediators of Coronary Artery Disease

ReferenceCitation: Gerstein HC, Ferrannini E, Riddle MC, Yusuf S; ORIGIN Trial Investigators. Insulin resistance and cardiovascular outcomes in the ORIGIN trial. Diabetes Obes Metab. 2018 Mar;20(3):564-570. doi: 10.1111/dom.13112. Epub 2017 Oct 8.

name: Population Health Research Institute; Hamilton Health Sciences and McMaster University; Hamilton Ontario Canada

name: Institute of Clinical Physiology, National Research Council (CNR); Pisa Italy

name: Oregon Health and Science University; Portland Oregon

title: Insulin resistance and cardiovascular outcomes in the ORIGIN trial

ReferenceCitation: Papademetriou V, Nylen ES, Doumas M, Probstfield J, Mann JFE, Gilbert RE, Gerstein HC. Chronic Kidney Disease, Basal Insulin Glargine, and Health Outcomes in People with Dysglycemia: The ORIGIN Study. Am J Med. 2017 Dec;130(12):1465.e27-1465.e39. doi: 10.1016/j.amjmed.2017.05.047. Epub 2017 Aug 31.

ReferenceCitation: Yates T, Davies MJ, Jung H, Bosch J, Spinas GA, Sreenan S, Commerford P, Gerstein HC; ORGIN investigators. Effect of insulin glargine on recreational physical activity and TV viewing: Analysis of the randomised ORIGIN trial. Diabetes Res Clin Pract. 2017 Oct;132:137-143. doi: 10.1016/j.diabres.2017.07.035. Epub 2017 Jul 31.

repository_institution: University of Leicester - Leicester Research Archive

repositories_institution: University of Leicester - Leicester Research Archive

ReferenceCitation: Rautio A, Boman K, Gerstein HC, Hernestål-Boman J, Lee SF, Olofsson M, Mellbin LG. The effect of basal insulin glargine on the fibrinolytic system and von Willebrand factor in people with dysglycaemia and high risk for cardiovascular events: Swedish substudy of the Outcome Reduction with an Initial Glargine Intervention trial. Diab Vasc Dis Res. 2017 Jul;14(4):345-352. doi: 10.1177/1479164117703034. Epub 2017 Apr 12.

name: Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden

name: Department of Medicine, Sunderby Hospital, Luleå, Sweden

name: Research Unit, Skellefteå Hospital, Skellefteå, Sweden

name: Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada

name: Unit of Cardiology, Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden

ReferenceCitation: Gerstein HC, Paré G, McQueen MJ, Lee SF, Hess S; ORIGIN Trial Investigators. Validation of the ORIGIN Cardiovascular Biomarker Panel and the Value of Adding Troponin I in Dysglycemic People. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2251-2257. doi: 10.1210/jc.2017-00273.

name: Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario L8S 4K1, Canada

name: Thrombosis and Atherosclerosis Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario L8S 4K1, Canada

name: Sanofi Aventis Deutschland GmbH, Research and Development Division, Translational Medicine and Early Development, Biomarkers and Clinical Bioanalyses, Frankfurt 65926, Germany

journal_name: The Journal of Clinical Endocrinology & Metabolism

ReferenceCitation: Gerstein HC, Pare G, Hess S, Ford RJ, Sjaarda J, Raman K, McQueen M, Lee S, Haenel H, Steinberg GR; ORIGIN Investigators. Growth Differentiation Factor 15 as a Novel Biomarker for Metformin. Diabetes Care. 2017 Feb;40(2):280-283. doi: 10.2337/dc16-1682. Epub 2016 Dec 14.

title: Growth Differentiation Factor 15 as a Novel Biomarker for Metformin

ReferenceCitation: ORIGIN Trial Investigators. Cardiovascular and Other Outcomes Postintervention With Insulin Glargine and Omega-3 Fatty Acids (ORIGINALE). Diabetes Care. 2016 May;39(5):709-16. doi: 10.2337/dc15-1676. Epub 2015 Dec 17.

title: Cardiovascular and Other Outcomes Postintervention With Insulin Glargine and Omega-3 Fatty Acids (ORIGINALE)

ReferenceCitation: Gerstein HC, Paré G, McQueen MJ, Haenel H, Lee SF, Pogue J, Maggioni AP, Yusuf S, Hess S; Outcome Reduction With Initial Glargine Intervention Trial Investigators. Identifying Novel Biomarkers for Cardiovascular Events or Death in People With Dysglycemia. Circulation. 2015 Dec 15;132(24):2297-304. doi: 10.1161/CIRCULATIONAHA.115.015744. Epub 2015 Oct 30.

name: From Population Health Research Institute (H.C.G., G.P., M.J.M., S.F.L., J.P., S.Y.) and Thrombosis and Atherosclerosis Research Institute (G.P.), Hamilton Health Sciences and McMaster University, Ontario, Canada; Sanofi Aventis Deutschland GmbH R&D Division Diabetes (H.H., S.H.), Frankfurt, Germany; and ANMCO Research Centre (A.P.M.), Florence, Italy.

title: Identifying Novel Biomarkers for Cardiovascular Events or Death in People With Dysglycemia

ReferenceCitation: Cukierman-Yaffe T, Bosch J, Diaz R, Dyal L, Hancu N, Hildebrandt P, Lanas F, Lewis BS, Marre M, Yale JF, Yusuf S, Gerstein HC; ORIGIN Investigators. Effects of basal insulin glargine and omega-3 fatty acid on cognitive decline and probable cognitive impairment in people with dysglycaemia: a substudy of the ORIGIN trial. Lancet Diabetes Endocrinol. 2014 Jul;2(7):562-72. doi: 10.1016/S2213-8587(14)70062-2. Epub 2014 Jun 2.

ReferenceCitation: ORIGIN trial investigators, Gilbert RE, Mann JF, Hanefeld M, Spinas G, Bosch J, Yusuf S, Gerstein HC. Basal insulin glargine and microvascular outcomes in dysglycaemic individuals: results of the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial. Diabetologia. 2014 Jul;57(7):1325-31. doi: 10.1007/s00125-014-3238-4. Epub 2014 Apr 26.

ReferenceCitation: Lopez-Jaramillo P, Cohen DD, Gómez-Arbeláez D, Bosch J, Dyal L, Yusuf S, Gerstein HC; ORIGIN Trial Investigators. Association of handgrip strength to cardiovascular mortality in pre-diabetic and diabetic patients: a subanalysis of the ORIGIN trial. Int J Cardiol. 2014 Jun 15;174(2):458-61. doi: 10.1016/j.ijcard.2014.04.013. Epub 2014 Apr 13.

title: Association of handgrip strength to cardiovascular mortality in pre-diabetic and diabetic patients: A subanalysis of the ORIGIN trial

ReferenceCitation: Lamy A, Tong W, Jung H, Gafni A, Singh K, Tyrwhitt J, Yusuf S, Gerstein HC; ORIGIN Investigators. Cost implications of the use of basal insulin glargine in people with early dysglycemia: the ORIGIN trial. J Diabetes Complications. 2014 Jul-Aug;28(4):553-8. doi: 10.1016/j.jdiacomp.2014.02.012. Epub 2014 Mar 2.

journal_name: Journal of Diabetes and its Complications

title: Cost implications of the use of basal insulin glargine in people with early dysglycemia: The ORIGIN trial

ReferenceCitation: Bordeleau L, Yakubovich N, Dagenais GR, Rosenstock J, Probstfield J, Chang Yu P, Ryden LE, Pirags V, Spinas GA, Birkeland KI, Ratner RE, Marin-Neto JA, Keltai M, Riddle MC, Bosch J, Yusuf S, Gerstein HC; ORIGIN Trial Investigators. The association of basal insulin glargine and/or n-3 fatty acids with incident cancers in patients with dysglycemia. Diabetes Care. 2014;37(5):1360-6. doi: 10.2337/dc13-1468. Epub 2014 Feb 26.

title: The Association of Basal Insulin Glargine and/or n-3 Fatty Acids With Incident Cancers in Patients With Dysglycemia

ReferenceCitation: ORIGIN Trial Investigators, Mellbin LG, Rydén L, Riddle MC, Probstfield J, Rosenstock J, Díaz R, Yusuf S, Gerstein HC. Does hypoglycaemia increase the risk of cardiovascular events? A report from the ORIGIN trial. Eur Heart J. 2013 Oct;34(40):3137-44. doi: 10.1093/eurheartj/eht332. Epub 2013 Sep 2.

title: Does hypoglycaemia increase the risk of cardiovascular events? A report from the ORIGIN trial

ReferenceCitation: ORIGIN Trial Investigators. Characteristics associated with maintenance of mean A1C<6.5% in people with dysglycemia in the ORIGIN trial. Diabetes Care. 2013 Oct;36(10):2915-22. doi: 10.2337/dc12-2238. Epub 2013 May 8.

title: Characteristics Associated With Maintenance of Mean A1C <6.5% in People With Dysglycemia in the ORIGIN Trial

ReferenceCitation: Lonn EM, Bosch J, Diaz R, Lopez-Jaramillo P, Ramachandran A, Hâncu N, Hanefeld M, Krum H, Ryden L, Smith S, McQueen MJ, Dyal L, Yusuf S, Gerstein HC; GRACE and ORIGIN Investigators. Effect of insulin glargine and n-3FA on carotid intima-media thickness in people with dysglycemia at high risk for cardiovascular events: the glucose reduction and atherosclerosis continuing evaluation study (ORIGIN-GRACE). Diabetes Care. 2013 Sep;36(9):2466-74. doi: 10.2337/dc12-2129. Epub 2013 Apr 5.

title: Effect of Insulin Glargine and n-3FA on Carotid Intima-Media Thickness in People With Dysglycemia at High Risk for Cardiovascular Events

location_country:
Finland
Bermuda
Romania
Australia
Russian Federation
Denmark
India
Spain
Croatia
France
Lithuania
Poland
Slovakia
Norway
Argentina
Canada
Korea, Republic of
Turkey
Colombia
South Africa
Chile
Sweden
Switzerland
Netherlands
Philippines
Hungary
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Venezuela
Israel
Belarus
Estonia
Latvia

location_facility:
Sanofi-Aventis Aministrative Office
Makati City
Sanofi-Aventis Administrative Office


title: Phase I/II Randomized, Double Blind, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Subcutaneous Bay 50-4798 Administration in Patients With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to Patients on HAART Alone.

summary: The purpose of this study is to evaluate the safety of the experimental drug Bay 50-4798 in HIV positive patients receiving HAART and to test the drug's effect on the CD4+ T-cell count.

lead_sponsor: Bayer

location_country:
United States
United Kingdom
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: European Study Group For Pancreatic Cancer - Trial 3

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective, or whether chemotherapy is more effective than observation, in treating pancreatic cancer after surgery.

PURPOSE: Phase III trial to compare the effectiveness of two chemotherapy regimens with no further therapy in treating patients who have completely resected pancreatic cancer.

enrollment_type: Anticipated

ReferenceCitation: Neoptolemos JP, Moore MJ, Cox TF, Valle JW, Palmer DH, McDonald AC, Carter R, Tebbutt NC, Dervenis C, Smith D, Glimelius B, Charnley RM, Lacaine F, Scarfe AG, Middleton MR, Anthoney A, Ghaneh P, Halloran CM, Lerch MM, Oláh A, Rawcliffe CL, Verbeke CS, Campbell F, Büchler MW; European Study Group for Pancreatic Cancer. Effect of adjuvant chemotherapy with fluorouracil plus folinic acid or gemcitabine vs observation on survival in patients with resected periampullary adenocarcinoma: the ESPAC-3 periampullary cancer randomized trial. JAMA. 2012 Jul 11;308(2):147-56. doi: 10.1001/jama.2012.7352. Erratum in: JAMA. 2012 Nov 14;308(18):1861.

family: Neoptolemos

full_name: John P. Neoptolemos

given: John P.

family: Moore

full_name: Malcolm J. Moore

given: Malcolm J.

family: Cox

full_name: Trevor F. Cox

given: Trevor F.

family: Valle

full_name: Juan W. Valle

given: Juan W.

family: Palmer

full_name: Daniel H. Palmer

given: Daniel H.

family: McDonald

full_name: Alexander C. McDonald

given: Alexander C.

family: Carter

full_name: Ross Carter

given: Ross

family: Tebbutt

full_name: Niall C. Tebbutt

given: Niall C.

family: Dervenis

full_name: Christos Dervenis

given: Christos

family: Smith

full_name: David Smith

given: David

family: Glimelius

full_name: Bengt Glimelius

given: Bengt

family: Charnley

full_name: Richard M. Charnley

given: Richard M.

family: Lacaine

full_name: François Lacaine

given: François

family: Scarfe

full_name: Andrew G. Scarfe

given: Andrew G.

family: Middleton

full_name: Mark R. Middleton

given: Mark R.

family: Anthoney

full_name: Alan Anthoney

given: Alan

family: Ghaneh

full_name: Paula Ghaneh

given: Paula

family: Halloran

full_name: Christopher M. Halloran

given: Christopher M.

family: Lerch

full_name: Markus M. Lerch

given: Markus M.

family: Oláh

full_name: Attila Oláh

given: Attila

family: Rawcliffe

full_name: Charlotte L. Rawcliffe

given: Charlotte L.

family: Verbeke

full_name: Caroline S. Verbeke

given: Caroline S.

family: Campbell

full_name: Fiona Campbell

given: Fiona

family: Büchler

full_name: for the European Study Group for Pancreatic Cancer

title: Effect of Adjuvant Chemotherapy With Fluorouracil Plus Folinic Acid or Gemcitabine vs Observation on Survival in Patients With Resected Periampullary Adenocarcinoma

ReferenceCitation: Neoptolemos JP, Stocken DD, Bassi C, Ghaneh P, Cunningham D, Goldstein D, Padbury R, Moore MJ, Gallinger S, Mariette C, Wente MN, Izbicki JR, Friess H, Lerch MM, Dervenis C, Oláh A, Butturini G, Doi R, Lind PA, Smith D, Valle JW, Palmer DH, Buckels JA, Thompson J, McKay CJ, Rawcliffe CL, Büchler MW; European Study Group for Pancreatic Cancer. Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial. JAMA. 2010 Sep 8;304(10):1073-81. doi: 10.1001/jama.2010.1275.

title: Adjuvant Chemotherapy With Fluorouracil Plus Folinic Acid vs Gemcitabine Following Pancreatic Cancer Resection

ReferenceCitation: Jones RP, Psarelli EE, Jackson R, Ghaneh P, Halloran CM, Palmer DH, Campbell F, Valle JW, Faluyi O, O'Reilly DA, Cunningham D, Wadsley J, Darby S, Meyer T, Gillmore R, Anthoney A, Lind P, Glimelius B, Falk S, Izbicki JR, Middleton GW, Cummins S, Ross PJ, Wasan H, McDonald A, Crosby T, Ting Y, Patel K, Sherriff D, Soomal R, Borg D, Sothi S, Hammel P, Lerch MM, Mayerle J, Tjaden C, Strobel O, Hackert T, Büchler MW, Neoptolemos JP; European Study Group for Pancreatic Cancer. Patterns of Recurrence After Resection of Pancreatic Ductal Adenocarcinoma: A Secondary Analysis of the ESPAC-4 Randomized Adjuvant Chemotherapy Trial. JAMA Surg. 2019 Nov 1;154(11):1038-1048. doi: 10.1001/jamasurg.2019.3337.

name: The Royal Liverpool University Hospital, Liverpool, England

name: University of Liverpool, Liverpool, England

name: The Clatterbridge Cancer Centre, Wirral, England

name: University of Manchester/The Christie, Manchester, England

name: Manchester University Foundation Trust, Manchester, England

name: Weston Park Hospital, Sheffield, England

name: St. James's University Hospital, Leeds, England

name: Clinical Research Sörmland, Karolinska Institutet, Stockholm, Sweden

name: Clinical Research Sörmland, University of Uppsala, Uppsala, Sweden

name: Bristol Haematology and Oncology Centre, Bristol, England

name: University of Hamburg Medical Institutions UKE, Hamburg, Germany

name: Royal Surrey County Hospital, Guildford, England

name: The Beatson West of Scotland Cancer Centre, Glasgow, Scotland

name: Queen Elizabeth Hospital, Birmingham, England

name: Jersey General Hospital, Jersey, England

name: University Hospital Coventry, Coventry, England

name: Greifswald University, Medicine, Greifswald, Germany

name: University Hospital Munich, Ludwig-Maximilians-University Munich, Germany

name: University of Heidelberg, Heidelberg, Germany

repository_institution: The University of Manchester - Research Explorer

ReferenceCitation: Ghaneh P, Kleeff J, Halloran CM, Raraty M, Jackson R, Melling J, Jones O, Palmer DH, Cox TF, Smith CJ, O'Reilly DA, Izbicki JR, Scarfe AG, Valle JW, McDonald AC, Carter R, Tebbutt NC, Goldstein D, Padbury R, Shannon J, Dervenis C, Glimelius B, Deakin M, Anthoney A, Lerch MM, Mayerle J, Oláh A, Rawcliffe CL, Campbell F, Strobel O, Büchler MW, Neoptolemos JP; European Study Group for Pancreatic Cancer. The Impact of Positive Resection Margins on Survival and Recurrence Following Resection and Adjuvant Chemotherapy for Pancreatic Ductal Adenocarcinoma. Ann Surg. 2019 Mar;269(3):520-529. doi: 10.1097/SLA.0000000000002557.

location_country:
Italy
Sweden
Switzerland
United Kingdom
Germany
Finland
France
Japan
Greece
Hungary
Australia
Canada
Czech Republic

location_facility: Institute of Oncology at Prince of Wales Hospital

location_facility: British Columbia Cancer Agency - Vancouver Island Centre

location_facility: Ottawa Hospital Regional Cancer Centre - General Campus

location_facility: British Columbia Cancer Agency - Centre for the Southern Interior

location_facility: London Regional Cancer Program at London Health Sciences Centre

location_facility: Cancer Research Institute at Queen's University

location_facility: Institute for Clinical and Experimental Medicine

location_facility: McGill Cancer Centre at McGill University

location_facility: Edmond Odette Cancer Centre at Sunnybrook

location_facility: Cross Cancer Institute at University of Alberta

location_facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital


title: A Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Plus BCG Versus Placebo Plus BCG as a Post-Surgical Treatment for Stage IV Melanoma

summary: This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.

status: Unknown status

ReferenceCitation: Faries MB, Mozzillo N, Kashani-Sabet M, Thompson JF, Kelley MC, DeConti RC, Lee JE, Huth JF, Wagner J, Dalgleish A, Pertschuk D, Nardo C, Stern S, Elashoff R, Gammon G, Morton DL; MMAIT-IV Clinical Trial Group. Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases. Ann Surg Oncol. 2017 Dec;24(13):3991-4000. doi: 10.1245/s10434-017-6072-3. Epub 2017 Oct 10.

family: Faries

full_name: Mark B. Faries

given: Mark B.

family: Mozzillo

full_name: Nicola Mozzillo

given: Nicola

family: Kashani-Sabet

full_name: Mohammed Kashani-Sabet

given: Mohammed

family: Thompson

full_name: John F. Thompson

given: John F.

family: Kelley

full_name: Mark C. Kelley

given: Mark C.

family: DeConti

full_name: Ronald C. DeConti

given: Ronald C.

family: Lee

full_name: Jeffrey E. Lee

given: Jeffrey E.

family: Huth

full_name: James F. Huth

given: James F.

family: Wagner

full_name: Jeffrey Wagner

given: Jeffrey

family: Dalgleish

full_name: Angus Dalgleish

given: Angus

family: Pertschuk

full_name: Daniel Pertschuk

given: Daniel

family: Nardo

full_name: Christopher Nardo

given: Christopher

family: Stern

full_name: Stacey Stern

given: Stacey

family: Elashoff

full_name: Robert Elashoff

given: Robert

family: Gammon

full_name: Guy Gammon

given: Guy

family: Morton

full_name: Donald L. Morton

given: Donald L.

journal_name: Annals of Surgical Oncology

ReferenceCitation: Hoshimoto S, Faries MB, Morton DL, Shingai T, Kuo C, Wang HJ, Elashoff R, Mozzillo N, Kelley MC, Thompson JF, Lee JE, Hoon DS. Assessment of prognostic circulating tumor cells in a phase III trial of adjuvant immunotherapy after complete resection of stage IV melanoma. Ann Surg. 2012 Feb;255(2):357-62. doi: 10.1097/SLA.0b013e3182380f56.

family: Hoshimoto

full_name: Sojun Hoshimoto

given: Sojun

family: Shingai

full_name: Tatsushi Shingai

given: Tatsushi

family: Kuo

full_name: Christine Kuo

given: Christine

title: Assessment of Prognostic Circulating Tumor Cells in a Phase III Trial of Adjuvant Immunotherapy After Complete Resection of Stage IV Melanoma

location_country:
Italy
Brazil
United States
Switzerland
Netherlands
Germany
France
Israel
Ireland
Australia
New Zealand
Canada
United Kingdom

location_facility: The Cancer Cener at Hackensack University Medical Center

location_facility: University of Texas - MD Anderson Cancer Center

location_facility: St. Louis University Health Sciences Center

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: University of Arkansas for Medical Sciences

location_facility: Central Arkansas Veterans Healthcare System

location_facility: University of Pennsylvania Cancer Center

location_facility: Cedars Sinai Comprehensive Cancer Center

location_facility: Intermountain Health Care- Mckay-Dee Hospital

location_facility: Arthur G. James Cancer Hospital - Ohio State University

location_facility: Sidney Kimmel Comprehensive Cancer Center

location_facility: UCSF Cancer Center and Cancer Research Institute

location_facility: Lineberger Comprehensive Cancer Center, UNC

location_facility: The Cancer Institute at Good Samaritan Medical Center


title: Apport de l'optimisation posologique individualisée d'amikacine guidée par un logiciel de modélisation pharmacocinétique chez les patients en choc septique  : Essai clinique randomisé, contrôlé, en ouvert

acronym:
AMINO BESTDOSE

 AMINO BESTDOSE

source: euctr

lead_sponsor: CHU de NIMES

status: Ongoing

lead_sponsor_type: academique

status_simplified: Ongoing


title:
Prevention of post-operative Atrial Fibrillation by BOTulinum toxin injections into epicardial fat pads around pulmonary veins in patients undergoing cardiac surgery

 Prévention de la Fibrillation Atriale postopératoire par l’injection de Toxine BOtulique autour des veines pulmonaires chez les patients ayant une chirurgie cardiaque

acronym:
BOTAF

 BOTAF

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title:
AntiCoagulants et COGnition (essai ACCOG) : Essai contrôlé randomisé en simple aveugle comparant les effets neurocognitifs du rivaroxaban par rapport à un antagoniste de la vitamine K

 AntiCoagulants et COGnition (essai ACCOG) : Essai contrôlé randomisé en simple aveugle comparant les effets neurocognitifs du rivaroxaban par rapport à un antagoniste de la vitamine K

acronym:
ACCOG

 ACCOG

lead_sponsor: CHU ANGERS


title:
Intranasal Sufentanyl analgesia Versus Morphine IV in Emergency room.

 Analgésie au Sufentanyl par voie Intra Nasale Versus Morphine IV aux Urgences

acronym:
ALGOFINE 2

 ALGOFINE 2

lead_sponsor: University Hospital Grenoble


title:
Evaluation of the efficacy and safety of aprepitant in the management of vaso-occlusive crisis in sickle cell children: randomized, single-center, randomized, phase IIb/III prospective study

 Evaluation de l’efficacité et de la tolérance de l’aprépitant dans la prise en charge de la crise vaso-occlusive chez l’enfant drépanocytaire : étude prospective monocentrique randomisée, de phase IIb/III

acronym: DREPADOL

lead_sponsor: Centre Hospitalier Intercommunal de Créteil

status: Not Authorised

status_simplified: Unknown


title: A phase II single-arm trial evaluating safety and efficacy of Durvalumab in ECOG Performance Status 2-3, treatment-naive, patients  with stage IV Non-Small Cell Lung Cancer (NSCLC) and high PD-L1 tumor expression

lead_sponsor: IFCT


title:
Cell therapy in Critical Limb Ischemia by implantation of allogeneic umbilical cord-derived mesenchymal stem cells

 Thérapie cellulaire allogénique de l’ischémie critique des membres inférieurs par implantation de cellules souches mésenchymateuses de cordon ombilical.

acronym:
CLI

 CLI

lead_sponsor: Centre Hospitalier Universitaire de Reims


title: Phase II, randomized, multicentric, clinical trial of a therapeutic vaccination, with ex vivo generated autologous Dentritic Cells pulsed with HIV lipopetides, combined or not with a TLR-3 agonist (poly-ICLC, Hiltonol), in the control of viral replication following antiretroviral treatment interruption in HIV-1 infected patients

lead_sponsor: Inserm-ANRS


title:
Study phase II open label study using triheptanoin in patients with a deficiency of glmucose transporter type 1 (GLUT-1)

 Etude de phase II en ouvert utilisant la triheptanoïne chez des patients souffrant d'un déficit en transporteur de glucose de type 1 (GLUT-1)

acronym: GLUTHEP

lead_sponsor: INSERM

status: Prematurely Ended


title: ANTIBIOTIC THERAPY IN RESPIRATORY TRACT INFECTIONS: AIR. A controlled randomized, open label, multicenter, non-inferiority trial evaluating an individualized antibiotic duration treatment strategy based on patient clinical response, evaluated through connected devices, for community acquired pneumonia in community setting

acronym: AIR

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS


title:
Pharmacokinetics of Tranexamic Acid after oral, intramuscular or intravenous administration: a prospective, randomised, cross-over trial in healthy volunteers.

 Pharmacocinétique de l'acide tranexamique après administration orale, intramusculaire ou intraveineuse : étude pharmacocinétique prospective randomisée chez le volontaire sain

acronym: PharmacoTXA

lead_sponsor: London School of Hygiene and Tropical Medicine


title: Multicenter Open label Phase 2 study of Isatuximab plus Pomalidomide and Dexamethasone with Carfilzomib in Relapsed or Refractory Multiple Myeloma

lead_sponsor: CHU de Poitiers


title:
A phase II study assessing safety and efficacy of Cabozantinib for advanced or metastatic cervical carcinoma after platinum treatment failure

 Etude de phase II évaluant l’efficacité et la tolérance du Cabozantinib dans le traitement du cancer du col avancé ou métastatique après échec d’un traitement par sel de platine

lead_sponsor: Centre François Baclesse


title:
A Phase 1/2, Open-Label, Multicenter Study of INCB000928
 Administered as a Monotherapy in Participants With Anemia Due to
 Myelodysplastic Syndromes or Multiple Myeloma

lead_sponsor: Incyte Corporation


title: A phase II single-group assignment, multicenter study of efficacy and safety of lorlatinib monotherapy after failure of first-line tyrosine kinase inhibitor in patients with advanced ROS1-positive non-small cell Lung cancer (ALBATROS)


title:
Effets de l’osmothérapie continue par sérum salé hypertonique sur le devenir des patients traumatisés crâniens - Etude multicentrique, prospective, contrôlée, randomisée, en simple aveugle avec évaluation en insu du critère principal
 Continuous Osmotherapy in traumatic Brain Injured patients « COBI »

acronym: COBI

lead_sponsor: CHU de Nantes


summary: The purpose of this study is to determine the optimal dosage of YM598 for slowing down disease progression in patients with rising PSA after initial therapy for localized prostate cancer.

status: Terminated

lead_sponsor: Astellas Pharma Inc

location_country:
United Kingdom
France
Poland
Belgium
Spain
Germany
Czech Republic

location_facility: Department of Urology, Bristol Royal Infirmary

location_facility: Regional Hospital, Department of Urology

location_facility: Department of Urology, Norfolk & Norwich Hospital

location_facility: Klinik u. Poliklinik für Urologie, Philipps Universität, Baldingerstraße

location_facility: Hospital Universitario Principe de Asturias, Servicio de Urología, Ctra.

location_facility: Complejo Hospitaliaro Juan Canalejo, Servicio de Urología

location_facility: Klinik und Poliklinik für Urologie, Universitätsklinikum Carl-Gustav-Carus

location_facility: Department of Urology, Gartnavel Hospital

location_facility: Oncology Center, Department of Urinary Tract Cancer

location_facility: Bielanski Hospital, Department of Urology

location_facility: Fundacion Hospital Alcorcón, Servicio Urología

location_facility: Department of Urology, Taunton & Somerset Hospital


title:
A Double blind randomized phase III study of pravastatin vs placebo as primary prevention of severe subcutaneous breast fibrosis in hyper-radiosensitive identified patients with breast cancer

 Etude en double aveugle de phase III, randomisée, évaluant l’efficacité de la pravastatine vs placebo  en prévention primaire de fibrose radio-induite sévère chez les patientes atteintes d’un cancer du sein à haut risque de fibrose mammaire

acronym:
PRAVAPREV-01

 PRAVAPREV-01

lead_sponsor: Institut Regional du Cancer de Montpellier


title: A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging, Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Patients With Moderate to Severe Pulmonary Arterial Hypertension

summary: The purpose of this study is to determine if treating patients suffering from moderate to severe pulmonary arterial hypertension with BSF 208075 will improve the patients' ability to exercise.

lead_sponsor: Gilead Sciences

location_country:
Italy
Germany
France
Belgium
Australia
United States

location_facility: University of California San Diego Medical Center

location_facility: University of Colorado Health Sciences Center

location_facility: University of Bologna - Institute of Cardiology

location_facility: University of California - San Francisco

location_facility: Los Angeles County Harbor-UCLA Medical Center


title: A 12-Week Multicentre, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Placebo in Patients > 6 years of age with EB simplex generalized severe

acronym: EB

lead_sponsor: CHU NICE


title: A Double-Blind, Placebo-Controlled, Add-On Clinical Trial of the Safety, Pharmacokinetics and Efficacy of Lamictal in Pediatric Age Subjects (1-24 Months)

summary: This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to the current therapy of pediatric patients age 1-24 months old with partial seizures. The medication used in this study has been approved by FDA for the adjunctive treatment of partial seizures in patients 2 years and older.

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Lebanon
Netherlands
Spain
France
Lithuania
Slovakia
Hungary
Australia
Portugal
Estonia
United States
Latvia
Turkey


title:
Comparison of pharmacokinetic (PK) levels before and after conversion from twice-daily tacrolimus to once-daily extended-release tacrolimus (LCPT) in diabetic transplant recipients

 Comparaison de la pharmacocinétique avant et après la conversion du tacrolimus en 2 prises à l’ENVARSUS® (tacrolimus en 1 prise à libération prolongée) après une greffe Rein- Pancréas simultanée

acronym: SPK-PK


title:
Nanoparticle reirradiation and hypofractionated protontherapy of pan-tumor relapse: non-randomized phase II study.

 Réirradiation par nanoparticules et protonthérapie hypofractionnée des rechutes pan-tumeurs : étude de phase II non randomisée.

acronym:
NANOPRO

 NANOPRO


title: A study of enfortumab vedotin (ASG-22CE) as monotherapy or in combination with other anticancer therapies for the treatment of urothelial cancer

lead_sponsor: Seagen Inc.


title:
Prospective pilot study evaluating a therapeutic synergy between the infusion of CMV-specific immunoglobulins and the level before transplantation of negative gamma delta Vdelta 2 T lymphocytes expressing CD16 in patients seropositive for CMV as preventive treatment for CMV infection by

 Etude pilote prospective évaluant une synergie thérapeutique entre la perfusion d'immunoglobulines spécifiques du CMV et le taux avant la greffe des lymphocytes T gamma delta V delta 2 négatifs exprimant le CD16 chez les patients séropositifs pour le CMV en traitement préventif d'une infection à CMV en transplantation rénale.

acronym:
SYNTAGME

 SYNTAGME

lead_sponsor: CHU de Bordeaux


title: Sécurité et tolérance des beta-bloquants cardiosélectifs au cours de la Broncho-Pneumopathie Chronique Obstructive (Reactive Airway Diseases And beta-Blockers : RADAB)

acronym: RADAB

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title: Etude du lien entre les marqueurs biologiques, la fatigue et les troubles cognitifs au cours de la sclérose en plaques de diagnostic récent et traitée par Interféron Bêta 1a SC (Rebif 44)

acronym: BIOCOG

lead_sponsor: Centre Hospitalier de Nancy


title: A Randomized, Double-Blind, Cross-Over Study Comparing the Pharmacodynamic Response in Subjects with Acute Coronary Syndrome Receiving 14 Days 10-mg Maintenance Dose Prasugrel (LY640315) versus 14 Days 150-mg Maintenance Dose Clopidogrel After Using a 900-mg Loading Dose of Clopidogrel to Reduce Ongoing Platelet Activation – The ACAPULCO Study

acronym: ACAPULCO Study

lead_sponsor: Eli Lilly and Company


title: Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de la RMN multimodale dans l'analyse des lésions de sclérose en plaques : étude longitudinale sur 3 ans d'une cohorte de 50 patients après un premier évènement ("CIS" patients) à haut risque de développer une sclérose en plaques.

acronym: USPIO-CIS

lead_sponsor: C.H.U. de RENNES


title: Multicenter Phase III Randomized Trial Comparing Doxorubicin and Cyclophosphamide Followed By Docetaxel (AC-T) With Doxorubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab (Herceptin)(AC-TH) and With Docetaxel, Carboplatin and Trastuzumab (TCH) In The Adjuvant Treatment Of Node Positive and High Risk Node Negative Patients With Operable Breast Cancer Containing The HER2 Alteration

summary:
Primary objective:

Compare disease-free survival in women with human epidermal growth factor receptor 2 (HER2)-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin, cyclophosphamide, and docetaxel with or without trastuzumab (Herceptin) vs trastuzumab, docetaxel, and carboplatin.

Secondary objective:

Compare overall survival of participants treated with these regimens.
Compare the toxic effects (including cardiac) of these regimens in these participants.
Compare quality of life of participants treated with these regimens.
Compare pathologic and molecular markers for predicting efficacy of these regimens in these participants.
For substudy: Compare peripheral levels of shed HER2-neu extracellular domain with fluorescence in situ hybridization in predicting outcome in participants treated with these regimens.

ReferenceCitation: Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, Mackey J, Glaspy J, Chan A, Pawlicki M, Pinter T, Valero V, Liu MC, Sauter G, von Minckwitz G, Visco F, Bee V, Buyse M, Bendahmane B, Tabah-Fisch I, Lindsay MA, Riva A, Crown J; Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011 Oct 6;365(14):1273-83. doi: 10.1056/NEJMoa0910383.

ReferenceCitation: Au HJ, Eiermann W, Robert NJ, Pienkowski T, Crown J, Martin M, Pawlicki M, Chan A, Mackey J, Glaspy J, Pintér T, Liu MC, Fornander T, Sehdev S, Ferrero JM, Bée V, Santana MJ, Miller DP, Lalla D, Slamon DJ; Translational Research in Oncology BCIRG 006 Trial Investigators. Health-related quality of life with adjuvant docetaxel- and trastuzumab-based regimens in patients with node-positive and high-risk node-negative, HER2-positive early breast cancer: results from the BCIRG 006 Study. Oncologist. 2013;18(7):812-8. doi: 10.1634/theoncologist.2013-0091. Epub 2013 Jun 28.

ReferenceCitation: Perez EA, Press MF, Dueck AC, Jenkins RB, Kim C, Chen B, Villalobos I, Paik S, Buyse M, Wiktor AE, Meyer R, Finnigan M, Zujewski J, Shing M, Stern HM, Lingle WL, Reinholz MM, Slamon DJ. Immunohistochemistry and fluorescence in situ hybridization assessment of HER2 in clinical trials of adjuvant therapy for breast cancer (NCCTG N9831, BCIRG 006, and BCIRG 005). Breast Cancer Res Treat. 2013 Feb;138(1):99-108. doi: 10.1007/s10549-013-2444-y. Epub 2013 Feb 19.

ReferenceCitation: Press MF, Sauter G, Buyse M, Bernstein L, Guzman R, Santiago A, Villalobos IE, Eiermann W, Pienkowski T, Martin M, Robert N, Crown J, Bee V, Taupin H, Flom KJ, Tabah-Fisch I, Pauletti G, Lindsay MA, Riva A, Slamon DJ. Alteration of topoisomerase II-alpha gene in human breast cancer: association with responsiveness to anthracycline-based chemotherapy. J Clin Oncol. 2011 Mar 1;29(7):859-67. doi: 10.1200/JCO.2009.27.5644. Epub 2010 Dec 28.

ReferenceCitation: Stern HM, Gardner H, Burzykowski T, Elatre W, O'Brien C, Lackner MR, Pestano GA, Santiago A, Villalobos I, Eiermann W, Pienkowski T, Martin M, Robert N, Crown J, Nuciforo P, Bee V, Mackey J, Slamon DJ, Press MF. PTEN Loss Is Associated with Worse Outcome in HER2-Amplified Breast Cancer Patients but Is Not Associated with Trastuzumab Resistance. Clin Cancer Res. 2015 May 1;21(9):2065-74. doi: 10.1158/1078-0432.CCR-14-2993. Epub 2015 Feb 3.

ReferenceCitation: Press MF, Sauter G, Buyse M, Fourmanoir H, Quinaux E, Tsao-Wei DD, Eiermann W, Robert N, Pienkowski T, Crown J, Martin M, Valero V, Mackey JR, Bee V, Ma Y, Villalobos I, Campeau A, Mirlacher M, Lindsay MA, Slamon DJ. HER2 Gene Amplification Testing by Fluorescent In Situ Hybridization (FISH): Comparison of the ASCO-College of American Pathologists Guidelines With FISH Scores Used for Enrollment in Breast Cancer International Research Group Clinical Trials. J Clin Oncol. 2016 Oct 10;34(29):3518-3528. doi: 10.1200/JCO.2016.66.6693.

name: Michael F. Press, Denice D. Tsao-Wei, Yanling Ma, Ivonne Villalobos, and Anaamika Campeau, University of Southern California Norris Comprehensive Cancer Center; Dennis J. Slamon, Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA; Nicholas Robert, Virginia Cancer Specialists/US Oncology Research Network, Fairfax, VA; Vicente Valero, The University of Texas MD Anderson Cancer Center, Houston, TX; Guido Sauter and Martina Mirlacher, University of Hamburg, Hamburg;...

family: Press

full_name: Michael F. Press

given: Michael F.

family: Sauter

full_name: Guido Sauter

given: Guido

family: Buyse

full_name: Marc Buyse

given: Marc

family: Fourmanoir

full_name: Hélène Fourmanoir

given: Hélène

family: Quinaux

full_name: Emmanuel Quinaux

given: Emmanuel

family: Tsao-Wei

full_name: Denice D. Tsao-Wei

given: Denice D.

family: Eiermann

full_name: Wolfgang Eiermann

given: Wolfgang

family: Robert

full_name: Nicholas Robert

given: Nicholas

family: Pienkowski

full_name: Tadeusz Pienkowski

given: Tadeusz

family: Crown

full_name: John Crown

given: John

family: Martin

full_name: Miguel Martin

given: Miguel

family: Valero

full_name: Vicente Valero

given: Vicente

family: Mackey

full_name: John R. Mackey

given: John R.

family: Bee

full_name: Valerie Bee

given: Valerie

family: Ma

full_name: Yanling Ma

given: Yanling

family: Villalobos

full_name: Ivonne Villalobos

given: Ivonne

family: Campeau

full_name: Anaamika Campeau

given: Anaamika

family: Mirlacher

full_name: Martina Mirlacher

given: Martina

family: Lindsay

full_name: Mary-Ann Lindsay

given: Mary-Ann

family: Slamon

full_name: Dennis J. Slamon

given: Dennis J.

journal_name: Journal of Clinical Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

publisher: American Society of Clinical Oncology (ASCO)

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Czech Republic
Taiwan
India
Spain
Uruguay
Croatia
France
Poland
Slovakia
Argentina
Canada
Slovenia
Korea, Republic of
Turkey
Colombia
South Africa
Sweden
Hong Kong
Switzerland
Bulgaria
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Brazil
Lebanon
Mexico
Venezuela
Israel
Tunisia
Egypt
New Zealand
Estonia


title: SAFETY STUDY OF IGNG, A NEW LIQUID PREPARATION OF HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE, WHEN ADMINISTERED TO PRIMARY IMMUNODEFICIENT PATIENTS, AT A PROGRESSIVELY INCREASED FLOW RATE

lead_sponsor: LFB BIOTECHNOLOGIES


title: A Phase III Double-Blind, Randomized, Placebo-Controlled Study of Erythropoietin When Used as an Adjuvant to Radiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may help prevent or treat cancer-related anemia. It is not yet known whether radiation therapy is more effective with or without epoetin alfa in treating head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating patients who have head and neck cancer.

ReferenceCitation: Bourhis J, Lapeyre M, Tortochaux J, Rives M, Aghili M, Bourdin S, Lesaunier F, Benassi T, Lemanski C, Geoffrois L, Lusinchi A, Verrelle P, Bardet E, Julieron M, Wibault P, Luboinski M, Benhamou E. Phase III randomized trial of very accelerated radiation therapy compared with conventional radiation therapy in squamous cell head and neck cancer: a GORTEC trial. J Clin Oncol. 2006 Jun 20;24(18):2873-8.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Switzerland
Netherlands
France
Israel
Hungary
Belgium
Australia
Spain
Germany
United Kingdom

location_facility:
Algemeen Ziekenhuis Middelheim
Newcastle Mater Misericordiae Hospital
Clinique Sainte Elisabeth
Hopital de Jolimont
Cliniques Universitaires Saint-Luc
U.Z. Gasthuisberg
Hospital de la Santa Cruz I Sant Pau
Radiotherapeutisch Instituut Limburg
Institut Jules Bordet
Ospedale San Giovanni
Rambam Medical Center
Radius Hungaricus Oncology Group
Beatson Oncology Centre
Institut Gustave Roussy
Universitaetsklinikum Charite

intervention_type: Radiation


title: Prophylactic Cranial Irradiation In Extensive Disease Small Cell Lung Cancer

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy to the brain may be effective in preventing brain metastases. It is not yet known if radiation therapy is effective following chemotherapy in preventing brain metastases.

PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in preventing brain metastases in patients who have received chemotherapy for extensive-stage small cell lung cancer.

ReferenceCitation: Slotman BJ, Mauer ME, Bottomley A, Faivre-Finn C, Kramer GW, Rankin EM, Snee M, Hatton M, Postmus PE, Collette L, Senan S. Prophylactic cranial irradiation in extensive disease small-cell lung cancer: short-term health-related quality of life and patient reported symptoms: results of an international Phase III randomized controlled trial by the EORTC Radiation Oncology and Lung Cancer Groups. J Clin Oncol. 2009 Jan 1;27(1):78-84. doi: 10.1200/JCO.2008.17.0746. Epub 2008 Dec 1. Erratum in: J Clin Oncol. 2009 Feb 20;27(6):1002.

name: From the Radiation Oncology, VU University Medical Center; Pulmonary Diseases, VU University Medical Center, Amsterdam; Arnhem's Radiotherapeutisch Instituut, Arnhem, the Netherlands; European Organisation for the Research and Treatment of Cancer (EORTC) Headquarters, Statistics Department; EORTC Headquarters, Quality of Life Department, Brussels, Belgium; Clinical Oncology, Christie Hospital, Manchester; Cancer Medicine, University of Dundee Ninewells Hospital, Dundee; Clinical Oncology, Cookridge...

family: Slotman

full_name: Berend J. Slotman

given: Berend J.

family: Mauer

full_name: Murielle E. Mauer

given: Murielle E.

family: Bottomley

full_name: Andrew Bottomley

given: Andrew

family: Faivre-Finn

full_name: Corinne Faivre-Finn

given: Corinne

family: Kramer

full_name: Gijs W.P.M. Kramer

given: Gijs W.P.M.

family: Rankin

full_name: Elaine M. Rankin

given: Elaine M.

family: Snee

full_name: Michael Snee

given: Michael

family: Hatton

full_name: Matthew Hatton

given: Matthew

family: Postmus

full_name: Pieter E. Postmus

given: Pieter E.

family: Collette

full_name: Laurence Collette

given: Laurence

family: Senan

full_name: Suresh Senan

given: Suresh

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: publishedVersion

evidence: oa repository (via pmcid lookup)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Prophylactic Cranial Irradiation in Extensive Disease Small-Cell Lung Cancer: Short-Term Health-Related Quality of Life and Patient Reported Symptoms—Results of an International Phase III Randomized Controlled Trial by the EORTC Radiation Oncology and Lung Cancer Groups

ReferenceCitation: Slotman B, Faivre-Finn C, Kramer G, et al.: A randomized trial of prophylactic cranial irradiation (PCI) versus no PCI in extensive disease small cell lung cancer after a response to chemotherapy (EORTC 08993-22993). [Abstract] J Clin Oncol 25 (Suppl 18): A-4, 2s, 2007.

ReferenceCitation: Slotman B, Faivre-Finn C, Kramer G, Rankin E, Snee M, Hatton M, Postmus P, Collette L, Musat E, Senan S; EORTC Radiation Oncology Group and Lung Cancer Group. Prophylactic cranial irradiation in extensive small-cell lung cancer. N Engl J Med. 2007 Aug 16;357(7):664-72.

ReferenceCitation: Slotman BJ, Faivre-Finn C, Kramer GWPM, et al.: Prophylactic cranial irradiation (PCI) in extensive stage small cell lung cancer (ES-SCLC) (EORTC 22993-08993). [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-7, S4, 2007.

ReferenceCitation: Bernhardt D, Adeberg S, Bozorgmehr F, Opfermann N, Hoerner-Rieber J, Repka MC, Kappes J, Thomas M, Bischoff H, Herth F, Heußel CP, Debus J, Steins M, Rieken S. Nine-year Experience: Prophylactic Cranial Irradiation in Extensive Disease Small-cell Lung Cancer. Clin Lung Cancer. 2017 Jul;18(4):e267-e271. doi: 10.1016/j.cllc.2016.11.012. Epub 2016 Dec 2.

family: Bernhardt

full_name: Denise Bernhardt

given: Denise

family: Adeberg

full_name: Sebastian Adeberg

given: Sebastian

family: Bozorgmehr

full_name: Farastuk Bozorgmehr

given: Farastuk

family: Opfermann

full_name: Nils Opfermann

given: Nils

family: Hoerner-Rieber

full_name: Juliane Hoerner-Rieber

given: Juliane

family: Repka

full_name: Michael C. Repka

given: Michael C.

family: Kappes

full_name: Jutta Kappes

given: Jutta

family: Thomas

ReferenceCitation: Slotman BJ, Faivre-Finn C, Kramer GW, Rankin E, Snee M, Hatton M, Postmus PE, Collette L, Musat E, Senan S. [Prophylactic cranial irradiation in patients with extensive disease caused by small-cell lung cancer responsive to chemotherapy: fewer symptomatic brain metastases and improved survival]. Ned Tijdschr Geneeskd. 2008 Apr 26;152(17):1000-4. Dutch.

location_country:
Italy
Netherlands
Cyprus
France
Poland
Israel
Hungary
Belgium
Egypt
Turkey
Germany
United Kingdom

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: Edinburgh Cancer Centre at Western General Hospital

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Nijmegen Cancer Center at Radboud University Medical Center

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Cookridge Hospital at Leeds Teaching Hospital NHS Trust

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Velindre Cancer Center at Velindre Hospital

location_facility: Royal Marsden NHS Foundation Trust - Surrey


title: Nouvelle stratégie de traitement de la polyangeite microscopique, de la periartérite noueuse et du syndrome de la churg-strauss sans facteur de mauvais pronostic : Etude prospective multicentrique randomisée en double aveugle.

acronym: CHUSPAN 2


title: Intérêt de la Tomographie par Émission de Positons avec la 3’-désoxy-3’-[18F]-fluoro-thymidine (18F-FLT) pour l’obtention d’une cartographie de l’activité mitotique  myéloïde corps entier dans les syndromes myélofibroses.

acronym: FLT MYELOPROLIFERATION

lead_sponsor: Accelerator Advanced Application


title: Essai de phase II, randomisé multicentrique, évaluant l'efficacité d'une chimiothérapie standard à base de fluoropyrimidine associée au cétuximab ou au bévacizumab, chez des patients kras sauvage, atteints d'un cancer colorectal métastatique, en progression après une 1ere ligne de traitement avec bévacizumab.

lead_sponsor: Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC)


title: Effet de l’espacement des doses d’anti-TNF sur l’activité inflammatoire chez des polyarthrites rhumatoïdes en rémission ou en faible activité inflammatoire : essai randomisé contrôlé.

acronym: STRASS


title: Effet d’un agoniste du récepteur au GLP1 (Exenatide) sur le contenu en triglycérides intramyocardique chez le patient obèse diabétique.

lead_sponsor: ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE


title: Essai prospectif randomisé, en double aveugle, comparant la Nalbuphine à l'association Hydroxyzine-Salbutamol dans la dystocie de démarrage.

acronym: Nalbuphine-vs Hydroxyzine-Salbutamol

lead_sponsor: Hôpital FOCH


title: Etude pharmacocinétique de l’équivalence de la biodisponibilité entre Nebcinal® 150mg/3ml administré par Aeroneb® Idehaler® et Tobi® 300mg/5ml administré par Pari LC Plus ® /Pulmoaid ® chez des patients atteints de mucoviscidose.

lead_sponsor: EREMPHARMA SAS


title: RANDOMIZED TRIAL OF SURGERY VERSUS RADIOTHERAPY IN PATIENTS WITH STAGE IIIa NON-SMALL CELL LUNG CANCER AFTER A RESPONSE TO INDUCTION-CHEMOTHERAPY

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether chemotherapy followed by surgery with or without radiation therapy is more effective than chemotherapy followed by radiation therapy alone in treating non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy followed by surgery with or without radiation therapy to that of chemotherapy followed by radiation therapy alone in treating patients who have stage III non-small cell lung cancer.

ReferenceCitation: Van Meerbeeck JP, De Pauw R, Tournoy K. What is the optimal treatment of stage IIIA-N2 non-small-cell lung cancer after EORTC 08941? Expert Rev Anticancer Ther. 2008 Feb;8(2):199-206. doi: 10.1586/14737140.8.2.199. Review.

ReferenceCitation: van Meerbeeck JP, Kramer GW, Van Schil PE, Legrand C, Smit EF, Schramel F, Tjan-Heijnen VC, Biesma B, Debruyne C, van Zandwijk N, Splinter TA, Giaccone G; European Organisation for Research and Treatment of Cancer-Lung Cancer Group. Randomized controlled trial of resection versus radiotherapy after induction chemotherapy in stage IIIA-N2 non-small-cell lung cancer. J Natl Cancer Inst. 2007 Mar 21;99(6):442-50.

ReferenceCitation: Kramer GW, Legrand CL, van Schil P, Uitterhoeve L, Smit EF, Schramel F, Biesma B, Tjan-Heijnen V, van Zandwijk N, Splinter T, Giaccone G, van Meerbeeck JP; EORTC-Lung Cancer Group. Quality assurance of thoracic radiotherapy in EORTC 08941: a randomised trial of surgery versus thoracic radiotherapy in patients with stage IIIA non-small-cell lung cancer (NSCLC) after response to induction chemotherapy. Eur J Cancer. 2006 Jul;42(10):1391-8.

ReferenceCitation: Van Meerbeeck JP, Kramer GW, Legrand C, et al.: Does downstaging in patients (pts) with IIIA-N2 non-small cell lung cancer (NSCLC) and a response to induction chemotherapy (ICT) influence outcome with surgery (S) or radiotherapy (RT)? An exploratory analysis of EORTC 08941. [Abstract] J Clin Oncol 24 (Suppl 18): A-7047, 375s, 2006.

ReferenceCitation: Van Meerbeeck JP, Kramer G, Van Schil PE, et al.: A randomized trial of radical surgery (S) versus thoracic radiotherapy (TRT) in patients (pts) with stage IIIA-N2 non-small cell lung cancer (NSCLC) after response to induction chemotherapy (ICT) (EORTC 08941). [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA7015, 624s, 2005.

ReferenceCitation: Van Schil P, Van Meerbeeck J, Kramer G, Splinter T, Legrand C, Giaccone G, Manegold C, van Zandwijk N. Morbidity and mortality in the surgery arm of EORTC 08941 trial. Eur Respir J. 2005 Aug;26(2):192-7.

ReferenceCitation: van Meerbeeck JP, Kramer GWPM, van Schil PEY, et al.: Induction chemotherapy (CT) in stage IIIA-N2 non-small cell lung cancer (NSCLC):an analysis of different regimens used in EORTC 08941. [Abstract] Lung Cancer 41 (Suppl 2): A-O-273, S79, 2003.

ReferenceCitation: van Schil PE, van Meerbeeck JP, Kramer G, et al.: Surgery after induction chemotherapy: morbidity and mortality in the first 100 patients of the surgery arm of EORTC 08941 trial. [Abstract] Lung Cancer 41 (Suppl 2): A-O-147, S45, 2003.

ReferenceCitation: Splinter TA, Kirkpatrick A, Van Meerbeeck J, et al.: Randomized trial of surgery versus radiotherapy in patients with stage IIIA non-small cell lung cancer after a response to induction chemotherapy. Intergroup study 08941. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A1742, 453a, 1998.

location_country:
Italy
Netherlands
France
Belgium
United Kingdom

location_facility: University Hospital - Rotterdam Dijkzigt

location_facility: Twee Steden Ziekenhuis Vestiging Tilburg

location_facility: CHR - Clinique Saint Joseph - Hopital de Warqueguies


title: Efficacité et tolérance du Pazopanib dans les tumeurs desmoides : essai de phase 2 randomisé

acronym: DESMOPAZ

lead_sponsor: Institut Bergonié


title: A RANDOMISED TRIAL OF CHEMOTHERAPY WITH OR WITHOUT GRANULOCYTE COLONY-STIMULATING FACTOR IN OPERABLE OSTEOSARCOMA

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether chemotherapy and surgery plus G-CSF is more effective than chemotherapy and surgery alone in treating patients with osteosarcoma.

PURPOSE: Randomized phase III trial to compare the effectiveness combination chemotherapy and surgery with or without G-CSF in treating patients who have newly diagnosed osteosarcoma.

ReferenceCitation: Lewis IJ, Nooij MA, Whelan J, Sydes MR, Grimer R, Hogendoorn PC, Memon MA, Weeden S, Uscinska BM, van Glabbeke M, Kirkpatrick A, Hauben EI, Craft AW, Taminiau AH; MRC BO06 and EORTC 80931 collaborators; European Osteosarcoma Intergroup. Improvement in histologic response but not survival in osteosarcoma patients treated with intensified chemotherapy: a randomized phase III trial of the European Osteosarcoma Intergroup. J Natl Cancer Inst. 2007 Jan 17;99(2):112-28.

ReferenceCitation: Lewis IJ, Nooij M: Chemotherapy at standard or increased dose intensity in patients with operable osteosarcoma of the extremity: a randomised controlled trial conducted by the European Osteo Sarcoma Intergroup (ISRCTN 86294690). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-3281, 816, 2003.

location_country:
Saudi Arabia
United Kingdom
Netherlands
France
Belgium
Portugal
Denmark
Slovenia

location_facility: Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa

location_facility: King Faisal Specialist Hospital and Research Centre

intervention_type: Procedure


title:
Randomized controlled clinical trial investigating Erlotinib for the treatment of chronic hepatitis C virus infection

 Evaluation de l'efficacité antivirale et de la tolerance à court terme de l'erlotinib chez les patients infectés par le VHC genotype1_Etude de preuve de concept

lead_sponsor: Hôpitaux Universitaires de Strasbourg


title: Phase I-II trial of gemcitabine plus nab-paclitaxel (GemBrax) followed by FOLFIRINOX as first-line treatment of patients with metastatic pancreatic adenocarcinoma

acronym: GABRINOX

lead_sponsor: Institut Régional de Cancerologie de Montpellier - Val d’Aurelle


title:
Cognitive remediation in Attention Deficit Disorder with or without Hyperactivity (ADHD) children : Comparison between three therapeutic strategies : cognitive remediation with a virtual classroom software and methylphenidate and supportive psychotherapy

 Remédiation cognitive et Trouble Déficit de l’Attention avec ou sans Hyperactivité (TDAH) chez l’enfant : comparaison de trois prises en charge : Remédiation cognitive par un logiciel de classe virtuelle versus méthylphénidate ou psychothérapie de soutien.

acronym:
RECOGNITA

 RECOGNITA


title: A multicenter, open-label, Prospective, randomized parallel group Phase III study investigating the benefit on Renal function of a CNI-free regimen with MyfOrtic® (mycophenolate sodium) and Certican® (everolimus) in coMparison to therapy with CErTican® (everolimus) and Prograf® (tacrolimus) in de novo rEnal transplant patients at 12 months post transplantation

lead_sponsor: CHU DE POITIERS


title: Activity of Regorafenib in combination with modified Gemcitabine - Oxaliplatin Chemotherapy (mGEMOX) in patients with advanced Biliary Tract Cancer (BTC): A Phase Ib-II trial

acronym: BREGO

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


title: An open label  non randomized access study of  Trametinib for patients with advanced unresectable (stage IIIc) or distant metastatic (stage IV) BRAF V600E/K mutation positive cutaneous melanoma

lead_sponsor: Laboratoire GlaxoSmithKline


title:
Pilot feasibility study of fertility preservation by ovarian stimulation associated with tamoxifen and oocyte or embryo freezing prior chemotherapy for breast cancer.

 Etude pilote de faisabilité de PReservation de la fErtilité par Stimulation ovarienne associée à du tAmoxifène et conGElation ovocytaire ou embryonnaire avant chimiothérapie pour cancer du sein.

acronym: PRESAGE

lead_sponsor: INSTITUT DE CANCEROLOGIE DE L'OUEST


title:
Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study)

 ESSAI EN OUVERT, D’INTERRUPTION RANDOMISEE DE TRAITEMENT, PERMETTANT D’EVALUER L’EFFICACITE DE L’AZITHROMYCINE DANS LE TRAITEMENT DE LA DILATATION DE BRONCHES HORS MUCOVISCIDOSE CHEZ L’ENFANT  (ETUDE AZI-STOP)

acronym:
AZI-STOP study

 ETUDE AZI-STOP


title: Multicentre, open-label, phase I/IIa clinical study of an immunoprotective  therapeutic vaccine candidate (VAC-3S) in Human Immunodeficiency Virus type 1 (HIV-1) chronically infected patients virologically controlled on antiretroviral therapy (ART) who rose an immune response to VAC-3S during IVVAC-3S/P1.

lead_sponsor: InnaVirVax


title: A prospective randomized controlled multicentre trial comparing half-dose photodynamic therapy (PDT) with high-density subthreshold micropulse laser treatment in patients with chronic central serous chorioretinopathy (CSC).

lead_sponsor: Centre Hospitalier Intercommunal de Créteil


title: Multicenter, randomized, double-blind, two-period, placebo controlled, forced-titration proof of concept crossover study to compare QGC001 with placebo in patients with grade I or II essential hypertension

lead_sponsor: Quantum Genomics


title: A PHASE II DOUBLE-BLIND VEHICLE-CONTROLLED CROSSOVER SINGLE DOSE (400 µG) V0147 GEL EFFECT AND TOLERANCE STUDY IN SPINAL CORD INJURED PATIENTS WITH ERECTILE DYSFUNCTION

lead_sponsor: PIERRE FABRE MEDICAMENT


title:
PETALS study : PEgylated interferon-alpha2a and TAsigna® for first Line therapy of Philadelphia chromosome-positive chronic phase CML patientS

 Etude randomisée de phase III, comparant le taux de réponse moléculaire 4.5 à 12 mois chez des patients atteints de leucémie myéloïde chronique en phase chronique (LMC PC), de novo, chromosome Philadelphie positive, traités par nilotinib 600mg par jour versus nilotinib 600mg par jour plus Interféron-alpha 2a pégylé (PEG-IFN) Protocole PETALS  PEgylated interferon-alpha2a and TAsigna® for first Line therapy of chronic phase CML patientS

acronym:
PETALS

 PETALS

lead_sponsor: Hospices Civils de Lyon


title: Intérêt du contrôle Raisonné de l’Inflation Hydro-Sodée en Réanimation– protocole IRIHS-RÉA.  Etude multicentrique randomisée.

acronym: IRIHS-RÉA

lead_sponsor: CHU de Nantes


title:
Effect of early use of levosimendan versus placebo on top of a conventional strategy of inotrope use on a combined morbidity-mortality endpoint in patients with cardiogenic shock. LevoHeartShock Study.

 Effet de l’utilisation précoce du levosimendan versus placebo en plus d’une stratégie conventionnelle d’utilisation des inotropes sur un critère composite de morbidité-mortalité dans le choc cardiogénique. Protocole LEVOHEARTSHOCK.

acronym:
LevoHearShock

 LevoHeartShock

lead_sponsor: CHRU de Nancy


title: Lean body mass normalization of oxaliplatin based chemotherapy for stage III colon cancer patients treated in adjuvant satting: Impact on Oxaliplatin induced sensitive neurotoxicity. A multicenter phase II randomized trial

acronym: LEANOX

lead_sponsor: Institut régional du Cancer de Montpellier


title:
Efficacy of adjuvant Imatinib in patients with intermediate-risk gastrointestinal stromal tumor with a high-risk Genomic Grade Index. Multicenter, prospective, randomized study.

 Evaluation de l’efficacité d’un traitement adjuvant par Imatinib chez les patients porteurs d’une tumeur stromale gastro-intestinale de risque intermédiaire présentant un Genomic Index de mauvais pronostic. Etude multicentrique, prospective, randomisée.

acronym:
GI-GIST

 GI-GIST

lead_sponsor: Assistance Publique Hôpitaux de MARSEILLE


title:
Assessment of Beta blocker interruption after uncomplicated mYocardial infarction on Safety and Symptomatic cardiac events requiring hospitalization: The ABYSS Study

 Evaluation de l'arrêt de l'administration de bêta-bloquant après un infarctus du myocarde non compliqué sur l'incidence des évènements cardiaques symptomatiques nécessitant une hospitalisation. Etude ABYSS

acronym: ABYSS

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title: Etude multicentrique de phase II évaluant une supplémentation en vitamine D à haute dose dans la correction de la carence vitaminique D des patientes prises en charge par chimiothérapie adjuvante pour un cancer du sein.

acronym: OPTIVIT

lead_sponsor: ICM- VAL D’AURELLE


title: Phase III Trial to assess impact of ultra-long versus long down-regulation protocol on IVF/ICSI outcomes in infertile women presenting with adenomyosis.

acronym: ADENOFIV

lead_sponsor: University Hospital Toulouse


title:
A Phase 2 Open-Label Study to Evaluate the Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in patients with Behçet disease : STELABEC

 STELABEC : Etude ouverte de phase 2 évaluant l'efficacité et la tolérance de l'ustekinumab, anticorps monoclonal humain anti-IL-12/IL-23, chez les patients atteints de maladie de Behçet.

acronym: STELABEC


title:
L-carnitine as an adjunct treatment for septic shock patients with acute kidney injury: a multicentre, randomized, 2-parallel group, superiority trial

 L-carnitine comme traitement complémentaire pour les patients en choc septique avec insuffisance rénale aigüe : une étude de supériorité, multicentrique, randomisée, à deux groupes parallèles

acronym:
CARNISAVE

 CARNISAVE

lead_sponsor: CHU de Nîmes


title:
RETINO 2018 : Ocular conservative treatment for retinoblastoma: efficacy of the new management strategies and visual outcome.

 RETINO 2018 :Traitements conservateurs du rétinoblastome: efficacité des nouvelles stratégies et devenir visuel.

acronym:
RETINO 2018

 RETINO 2018

lead_sponsor: Institut Curie


title:
Evaluation of perioperative eltrombopag for the management of elective surgery and invasive acts in patients with inherited thrombocytopenia

 Evaluation de l’ELtrombopag en Peri-Opératoire lors de chirurgies et actes invasifs programmés chez les patients ayant une Thrombopénie constitutionnelle

acronym:
ELPOT

 ELPOT

lead_sponsor: CHU Toulouse


title:
NA

 Etude de la réponse clinique et biologique à l’administration répétée d’interleukine-2 à faible dose chez des patients présentant un diabète de type 1 ayant gardé une sécrétion résiduelle d’insuline

acronym:
DFIL2-REP

 DFIL2-REP


title:
IMPACT OF 5% LIDOCAINE MEDICATED PLASTER ON ALLODYNIC SYMPTOMS OF LOCALIZED NEUROPATHIC PAIN AFTER KNEE SURGERY. A prospective, randomized, placebo controlled study in parallel groups.

 Impact de l’utilisation de patch de Lidocaïne 5% sur les douleurs neuropathiques à type d’allodynie après chirurgie du genou
 Étude prospective, randomisée, en double aveugle, contrôlée versus placebo

lead_sponsor: CHU Clermont-Ferrand


title:
Multicentric non-randomized phase II of pembrolizumab in combination with etoposide-cisplatin-based chemotherapy in first-line advanced small cell ovarian carcinoma of hypercalcemic type

 Etude de phase II, multicentrique, évaluant le pembrolizumab en combinaison à une chimiothérapie à base d’étoposide-cisplatine (PAVEP) en première intention chez des patientes atteintes d’un carcinome à petites cellules avancé de l’ovaire (stades II-IV) de type hypercalcémique.

acronym: PembroSCCOHT

lead_sponsor: ARCAGY-GINECO


title:
A multicentric randomized phase II/III evaluating TSR-042 (anti-PD-1 mAb) in combination with Niraparib (parpi) versus Niraparib alone compared to chemotherapy in the treatment of metastatic or recurrent endometrial or ovarian carcinosarcoma after at least one line of chemotherapy

 Etude de phase II/III, randomisée, multicentrique évaluant le TSR-042 (anti-PD-1 mAb) associé au Niraparib versus le Niraparib seul comparé à la chimiothérapie chez des patientes atteintes d’un carcinosarcome métastasique ou en récidive de l’ovaire ou de l’endomètre après une chimiothérapie de première intention

acronym: ROCSAN


title: Altération de la Réponse dopaminergique à l'Administration de Psychostimulants par Inhibition de la Dopamine beta-hydroxylase. Exploration par TEP du mécanisme d'action d'une nouvelle stratégie thérapeutique chez les cocaïnomanes. (Acronyme : RAPID)

acronym: RAPID


title: A phase II randomized trial comparing alpelisib and fulvestrant versus chemotherapy as maintenance therapy in patients with PIK3CA mutated advanced breast cancer

acronym: SAFIR PI3K

lead_sponsor: UNICANCER


title: Adjuvant  immunotherapy after salvage surgery in head and neck squamous cell carcinoma : phase 2 trial evaluating the efficacy and the toxicity of nivolumab alone, and of the combination nivolumab and ipilimumab

lead_sponsor: Gustave Roussy


title:
Not done

 Comparaison des effets rénaux des solutés de remplissage vasculaire PlASmalyte Viaflo et NaCl 0,9 % au cours de la réanimation de patients TRAUmatisés graves.

acronym: ASTRAU


title:
Evaluation of a stategy based on the 3-month screening biopsy to optimize the immunosuppression in renal transplantation

 Evaluation de la biopsie de dépistage des 3 mois pour optimiser l’immunosuppression des transplantés rénaux - Etude I4BiS (Infiltrat Inflammatoire Intragreffon Infraclinique et Biopsie de dépiStage)

acronym:
I4BIS

 I4BIS


title:
Evaluation of the efficacy, safety and tolerability of alisporivir for the treatment of hospitalised patients with infections due to SARS-CoV-2 (COVID-19).
 A randomised, open-label, proof of concept, Phase 2 study.

 Evaluation de l’efficacité, la sécurité et la tolérance de l'alisporivir chez des patients hospitalisés pour une infection par le SARS- CoV-2 (COVID-19).
 Étude de faisabilité de phase 2, randomisée, en ouvert.

acronym: CYCLOVID

lead_sponsor: Assistance Publique - Hôpitaux Paris


title:
Evaluation of the 64Cu-ATSM PET-CT as a predictor of the response to neo-adjuvant treatment in locally advanced rectal cancers

 Evaluation de la TEP-TDM au 64Cu-ATSM comme facteur prédictif de la réponse au traitement néo-adjuvant dans les cancers localement avancés du rectum

acronym:
TEP-64Cu-ATSM-Rectum

 TEP-64Cu-ATSM-Rectum

lead_sponsor: INSTITUT DE CANCEROLOGIE DE L'OUEST


title:
Treatment of the oral aphtose récidivante and idiopathique of the adult by probiotics
 Double-blind randomized interventional study versus placebo

acronym: Aphtose

lead_sponsor: CHU NICE


title:
A phase III randomized trial evaluating chemotherapy followed by pelvic reirradiation versus chemotherapy alone as pre-operative treatment for  locally recurrent rectal cancer
 (GRECCAR – PRODIGE – FRENCH)

 Etude randomisée de phase III comparant chimiothérapie suivie d’une ré-irradiation pelvienne versus chimiothérapie seule en traitement préopératoire des récidives locorégionales des cancers du rectum
 (GRECCAR-PRODIGE-FRENCH)

acronym:
GRECCAR 15

 GRECCAR 15

lead_sponsor: CHU DE BORDEAUX


title: « Mécanismes de résilience neuronale dans la maladie d'Alzheimer et ses variantes focales: une étude TEP/IRM »

acronym: PET-AL

lead_sponsor: INSERM


title:
Influence des dermocorticoïdes sur la densité minérale osseuse chez les patients atteints de pemphigoïde bulleuse

 Influence des dermocorticoïdes sur la densité minérale osseuse chez les patients atteints de pemphigoïde bulleuse

acronym: DERMOS

lead_sponsor: CHU Amiens Picardie


title:
Efficacy of a personalized caplacizumab regimen based on ADAMTS-13 activity monitoring in adult acquired thrombotic thrombocytopenic purpura: A phase II, multicenter non-inferiority single-arm study

 Efficacité d'un schéma posologique personnalisé de caplacizumab basé sur la surveillance de l'activité ADAMTS13 chez l'adulte atteint de purpura thrombopénique thrombotique acquis (PTTa): étude de non-infériorité de phase II, multicentrique à un seul bras

acronym:
CAPLAVIE

 CAPLAVIE

lead_sponsor: CHU de Rouen


title:
Non-inferiority of intranasal fentanyl versus oral morphine sulfate in the treatment of pain in pediatric trauma : a controled randomized , single blind study

 Etude randomisée contrôlée en simple aveugle évaluant la non infériorité du Fentanyl intranasal versus sulfate de morphine per os dans le traitement de la douleur en traumatologie pédiatrique

acronym:
FINDOL

 FINDOL

lead_sponsor: University Hospital of Montpellier


title: Efficiency of an antibioprophylaxy (levofloxacin) in patient treated by azacitidine

acronym: AZABAC

lead_sponsor: Centre Henri Becquerel


title:
Dosage optimization of piperacillin/tazobactam in ICU patients based on therapeutic drug monitoring of amikacin - OPTIMA

 Optimisation du dosage de pipéracilline tazobactam en fonction du monitoring thérapeutique de l’amikacine chez les patients de réanimation - OPTIMA

acronym: OPTIMA

lead_sponsor: Hospices Civils de Lyon


title:
Assesment of Propofol sedation during intra tracheal surfactant administration by the LISA method (Less Invasive Surfactant Administration)

 Evaluation de la sédation au Propofol lors de l’administration intra-trachéale d’un surfactant par la méthode LISA (administration moins invasive de surfactants)

acronym: PROLISA

lead_sponsor: CHU Grenoble-Alpes


title: Phase I-II study of nivolumab in combination with temozolomide and radiotherapy in children and adolescents with newly diagnosed high-grade glioma

acronym: NIVOGLIO


title: A Phase II, multi-centre study, to evaluate the efficacy and safety of osimertinib treatment for patients with EGFR-mutated  non-small cell lung cancer (NSCLC)  with Brain or Leptomeningeal metastases

lead_sponsor: IFCT


title:
Study the diffusion kinetics of gadolinium at the perilymph of the inner ear structures to patients Meniere's disease

 Etude de la cinétique de diffusion du gadolinium au niveau des structures périlymphatiques de l’oreille interne pour des patients atteints de maladie de Ménière

acronym:
PROSPER

 PROSPER

lead_sponsor: University Hospital Grenoble


title: BLINAtumomab after R-CHOP debulking therapy for patients with Richter Transformation.

acronym:
FILOCLL13-BLINART

 FILOCLL13-BLINART

lead_sponsor: FILO


title: Autologous transplantation of Adipose tissue derived mesenchymal Stroma/stem Cells (ASC) in patients with critical limb ischemia: a phase II study (ACellDream 2).

acronym: ACellDREAM 2

lead_sponsor: University Hospital Toulouse


title: Effets du L-ThreoDOPS à long terme (3 mois) sur l’hypotension orthostatique et certains symptômes non moteurs dans l’atrophie multisystématisée (AMS) : étude comparative avec tirage au sort versus placebo

acronym: DOPS-AMS

lead_sponsor: CHU de Toulouse


title:
Antibioprophylaxis for excision-graft surgery in burn patient: a multicenter randomized double-blind study

 Antibioprophylaxie pour la chirurgie d'excision-greffe chez le patient brûlé : Etude multicentrique, randomisée et en double aveugle

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (APHP)


title: Effets très précoces d’une dose de charge de rosuvastatine sur la fonction endothéliale

acronym: STATEND

lead_sponsor: CHU DE CLERMONT FERRAND


title: Peri-operative association of immunotherapy (pre-operative association of nivolumab and ipilimumab, post-operative nivolumab alone) in localized microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) oeso-gastric adenocarcinoma: An open-label GERCOR phase II study

acronym: NEONIPIGA D18-02

lead_sponsor: GERCOR


title: Effect of GLP-1 on angiogenesis: "Angiosafe T2D study 1"

acronym: ANGIOSAFE 1

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title:
Safety of Intraperitoneal (IP) OXAliplatin (OXA) in Association With Systemic FOLFIRI Bevacizumab Chemotherapy in Patients With Peritoneal Carcinosis ( IPOXA )

 IPOXA, Essai de Phase I/II en escalade de dose visant à évaluer la tolérance de l’administration Intra-péritonéale (IP) d’OXAliplatine (OXA) en association avec une chimiothérapie systémique de type FOLFIRI Bevacizumab chez des patients atteints de carcinose péritonéale d’origine colorectale de résécabilité incertaine

acronym:
IPOXA

 IPOXA


title:
Hypertrophic CARdiomyopathy symptom release by alpha stimulant MIDOdrine

 Diminution des symptômes de la cardiomyopathie hypertrophique par le chlorhydrate de midodrine

acronym:
Light-CARMIDO

 Light-CARMIDO

lead_sponsor: CHU de Bordeaux


title:
A Prospective study evaluating the effect of ocrelizumab on brain innate immune Microglial cells Activation in Multiple Sclerosis using PET-MRI with 18F-DPA714

 Une étude prospective évaluant l'effet de l'ocrélizumab sur l'activation des cellules microgliales du système immunitaire inné dans le cerveau des patients atteints de sclérose en plaques

acronym: INN-MS


title:
PREMETHEP : Multimetabolic 18F-Fluorodeoxyglucose (FDG) and 18F-Fluorocholine (FCH) Positron Emission Tomography (PET) as an early predictive factor of overall survival in patients with  advanced hepatocellular carcinoma treated with sorafenib.

 Caractérisation multi-métabolique par Tomographie par Emission de Positons (TEP) au 18F-Fluorodésoxyglucose (FDG) et à la 18F-Fluorocholine (FCH) pour prédire la survie des patients présentant un carcinome hépatocellulaire avancé traité par Sorafenib.

acronym:
PREMETHEP

 PREMETHEP

lead_sponsor: Centre Georges-François Leclerc


title:
Phase I/II dose-finding, safety and efficacy study of radium-223 dichloride (XOFIGO®) in renal cell carcinoma patients with bone metastases

 Etude de phaseI/II de recherche de dose, d’évaluation de la tolérance et de l’efficacité d’un traitement par radium-223 dichlorure (XOFIGO®) chez des patients avec un carcinome rénal à cellules claires (CRCC) avec métastases osseuses.

acronym:
EIFFEL

 EIFFEL

lead_sponsor: A.R.T.I.C. (Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie )


title: ETUDE MULTICENTRIQUE RANDOMISEE, DE PHASE III, COMPARANT L’IMMUNOGENICITE D’UN SCHEMA VACCINAL RENFORCE CONTRE LE VHB (40 µg à S0, S4, et S24), A UN SCHEMA CLASSIQUE (20 µg à S0, S4, et S24), CHEZ DES PATIENTS INFECTES PAR LE VIH N’AYANT PAS REPONDU A UNE PREMIERE VACCINATION ET A UNE INJECTION DE RAPPEL

acronym: B-BOOST

lead_sponsor: ANRS


title: Placenta accreta : analyse en échographie de contraste en population à haut risque

acronym: Placenta Accreta

lead_sponsor: CHRU de TOURS


title:
.

 Comparaison de l'efficacité analgésique de dexaméthasone péri-nerveuse versus intraveineuse en adjuvant de l'anesthésie loco-régionale pour la chirurgie de l'avant-pied

acronym: ADRIATIC

lead_sponsor: CHU de Clermont-Ferrand


title: Etude en double aveugle versus placebo  de l’efficacité et de la tolérance de Cirkan® sur la symptomatologie fonctionnelle veineuse éprouvée (C0s à C3s) par les patientes obèses

lead_sponsor: PIERRE FABRE MEDICAMENT


title: Maintaining or Stopping immunosuppressive Therapy in patients with ANCA vasculitis and End-stage Renal disease: a prospective, multicenter, randomized, open-label, clinical trial

acronym: MASTER-ANCA

lead_sponsor: Centre Hospitalier Départemental Vendée de la Roche sur Yon


title: Labetalol versus MgSO4 for the Prevention of Eclampsia Trial

acronym: LAMPET


title: Etude pharmacocinétique, prospective, ouverte, de la diffusion de l’Ertapénème dans le muscle par microdialyse chez des patients de réanimation sous ventilation mécanique, recevant ou non des vasopresseurs

lead_sponsor: Assistance Publique Hopitaux de marseille


title: Essai thérapeutique de phase IIA évaluant l'efficacité du Bortezomib (velcade) chez les patients atteints de la maladie de Waldenstrom en phase avancée


title:
111In-DTPA-exendine 4 PET/CT in patients with AHH – a prospective comparative evaluation of preoperative imaging

 Comparaison prospective de l’imagerie ciblée du récepteur du GLP-1 (technique à l’étude) par rapport à l’imagerie ciblée au
 récepteur de la somatostatine (technique standard), dans le bilan préopératoire chez les patients atteints de AHH (hypoglycémie
 hyper insulinique endogène de l’adulte) et notamment d’un insulinome.

acronym: BetaCure

lead_sponsor: Centre Hospitalier Régional Universitaire Lille


title: Analgésie inhalatoire par protoxyde d'azote vs anesthésie locale, pour le recueil ovocytaire en Assistance Médicale à la Procréation. Etude contrôlée, randomisée et prospective

acronym: KALOVAL


title: RECIST 1.1 and iRECIST evaluation for patients with deficient MMR and/or MSI Metastatic Colorectal Cancer treated with nivolumab and ipilimumab. A GERCOR open-label phase II study NIPICOL C17-01

acronym: NIPICOL


title: Effets du méthylphénidate dans le Trouble Déficitaire d’Attention avec Hyperactivité : Etude longitudinale en imagerie par résonance magnétique chez l’enfant

lead_sponsor: CHU d'Amiens


title: Etude de l'effet de la pioglitazone dans l'ataxie de Friedreich : étude "preuve de concept"

acronym: ACTFRIE


title:
A phase II/III multicentric randomized trial, compared abiraterone + dexamethasone versus standard abiraterone + prednisone in patients resistant-castration in metastatic prostate cancer

 Essai de phase II/III multicentrique randomisé, comparant un traitement par abiraterone + dexamethasone versus la poursuite du traitement standard par abiraterone + prednisone, au moment de la progression biologique sous abiraterone + prednisone, chez des patients ayant un cancer de prostate métastatique en première ligne de résistance à la castration.

acronym: ABIDEX

lead_sponsor: L'Institut Mutualiste Montsouris


title: Essai de phase II évaluant l'association de FOLFOX et CETUXIMAB avec radiothérapie concomitante en traitement des cancers de l'oesophage de stade III

acronym: ERAFOX


title: Lavage Bronchiolo-Alvéolaire sous ventilation non Invasive et sédation intra veineuse en objectif de concentration au Propofol chez le malade en insuffisance Respiratoire Aiguë. Etude Randomisée Contrôlée

acronym: SEDA-FIBRO


title: A Phase II, Multicentre, Double-blind, Placebo Controlled, Pilot Study to Evaluate the Safety and Efficacy of CUV1647 Administered as A Subcutaneous Bioresorbable 16mg Implant in Patients Undergoing Photodynamic Therapy (PDT) utilising Porfimer Sodium

acronym: Phase II PDT Pilot Study

lead_sponsor: Clinuvel Pharmaceuticals Limited


title: Etude de phase 3 comparant une chimiothérapie d'induction séquentielle systématique à une chimiothérapie d'induction séquentielle conditionnelle chez des patients atteints d'une Leucémie Aigüe Myéloïde du groupe CBF


title:
Infections urinaires masculines à entérobactéries productrices de bêta-lactamase à spectre étendue avec résistance associée  aux fluoroquinolones et au cotrimoxazole : efficacité clinique de fosfomycine trométamol per os

 Infections urinaires masculines à entérobactéries productrices de bêta-lactamase à spectre étendue avec résistance associée  aux fluoroquinolones et au cotrimoxazole : efficacité clinique de fosfomycine trométamol per os

acronym:
FOSF’HOM

 FOSF’HOM

lead_sponsor: CHRU de Besançon


title: Efficacité de l'infiltration tissulaire peropératoire par la ropivacaïne (Naropeine®) dans la chirurgie thyroïdienne : étude randomisée, en double aveugle versus placebo

acronym: MORFREE


title: ASSESMENT OG EFFICACY AND TOLERABILITY OF INHABLED TOBRAMYCIN VS PLACEBO IN CYSTIC FIBROSIS PATIENTS REVEIVING ANTIBIOTHERAPY FOR 28 DAYS FOR PSEUDOMONAS AERUGINOSA PRIMO COLONISATION.

acronym: NEBCINAL 01-07

lead_sponsor: Laboratoire Erempharma


title:
Multicentre, randomized, controlled, open-label, multi-centre medico-economic study evaluating the efficacy of adding zoledronic acid to Stereotaxic radiotherapy in the treatment of vertebral metastases

 Etude médico-économique multicentrique de phase III, randomisée, contrôlée, en ouvert, évaluant l’efficacité de l’ajout de l’acide ZOlédronique à la radiothérapie STERéotaxique dans le traitement des métastases vertébrales

acronym: ZOSTER

lead_sponsor: INSTITUT DE CANCEROLOGIE DE L'OUEST


title: Traitement par Sandostatine LP remplaçant le traitement par Sandostatine SC chez les enfants présentant un hyperinsulinisme congénital résistant au diazoxide.

acronym: HI_SANDO LP

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title:
Trial Of Imatinib After Ponatinib Induction (Tipi) - A multicentre, open label phase II trial evaluating the safety and efficacy of ponatinib induction followed by imatinib maintenance in adult patients with Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), all risk scores, ≤65 years

 TIPI - Trial Of Imatinib After Ponatinib Induction - Etude multicentrique de Phase II menée en ouvert évaluant la tolérance et l’efficacité d’un traitement d’induction par ponatinib suivi d’une phase de consolidation par imatinib chez des patients adultes atteints de leucémie myéloïde chronique en phase chronique (LMC PC), tous scores de risque et âgés ≤ 65 ans

acronym:
TIPI

 TIPI

lead_sponsor: Centre Léon Bérard


title: DETECTION OF ACUTE RENAL FAILURE IN CRITICALLY ILL PATIENTS: A prospective evaluation of cystatin C diagnostic performance

lead_sponsor: CHU Saint-Etienne