title: A Prospective, Multi-center, Randomized, Double-blind Trial to Assess the Effectiveness and Safety of 12 Versus 30 Months of Dual Antiplatelet Therapy in Subjects Undergoing Percutaneous Coronary Intervention With Either Drug-eluting Stent or Bare Metal Stent Placement for the Treatment of Coronary Artery Lesions

summary: The DAPT Study is a double blind randomized controlled trial intended to determine the appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication) as well as the safety and effectiveness of dual antiplatelet therapy to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents. Similar analysis will be conducted in a smaller cohort of bare metal coronary stent - treated subjects.

ReferenceCitation: Berg DD, Yeh RW, Mauri L, Morrow DA, Kereiakes DJ, Cutlip DE, Gao Q, Jarolim P, Michelson AD, Frelinger AL 3rd, Cange AL, Sabatine MS, O'Donoghue ML. Biomarkers of platelet activation and cardiovascular risk in the DAPT trial. J Thromb Thrombolysis. 2021 Apr;51(3):675-681. doi: 10.1007/s11239-020-02221-5.

family: Berg

full_name: David D. Berg

given: David D.

family: Yeh

full_name: Robert W. Yeh

given: Robert W.

family: Mauri

full_name: Laura Mauri

given: Laura

family: Morrow

full_name: David A. Morrow

given: David A.

family: Kereiakes

full_name: Dean J. Kereiakes

given: Dean J.

family: Cutlip

full_name: Donald E. Cutlip

given: Donald E.

family: Gao

full_name: Qi Gao

given: Qi

family: Jarolim

full_name: Petr Jarolim

given: Petr

family: Michelson

full_name: Alan D. Michelson

given: Alan D.

family: Frelinger

full_name: Andrew L. Frelinger

given: Andrew L.

suffix: III

family: Cange

full_name: Abby L. Cange

given: Abby L.

family: Sabatine

full_name: Marc S. Sabatine

given: Marc S.

family: O’Donoghue

full_name: Michelle L. O’Donoghue

given: Michelle L.

journal_name: Journal of Thrombosis and Thrombolysis

title: Biomarkers of platelet activation and cardiovascular risk in the DAPT trial

ReferenceCitation: Stefanescu Schmidt AC, Steg PG, Yeh RW, Kereiakes DJ, Tanguay JF, Hsieh WH, Massaro JM, Mauri L, Cutlip DE; DAPT Investigators. Interruption of Dual Antiplatelet Therapy Within Six Months After Coronary Stents (from the Dual Antiplatelet Therapy Study). Am J Cardiol. 2019 Dec 15;124(12):1813-1820. doi: 10.1016/j.amjcard.2019.09.006. Epub 2019 Sep 26.

family: Stefanescu Schmidt

full_name: Ada C. Stefanescu Schmidt

given: Ada C.

family: Steg

full_name: Philippe Gabriel Steg

given: Philippe Gabriel

family: Tanguay

full_name: Jean-Francois Tanguay

given: Jean-Francois

family: Hsieh

full_name: Wen-Hua Hsieh

given: Wen-Hua

family: Massaro

full_name: Joseph M. Massaro

given: Joseph M.

ReferenceCitation: Berry NC, Kereiakes DJ, Yeh RW, Steg PG, Cutlip DE, Jacobs AK, Abbott JD, Hsieh WH, Massaro JM, Mauri L; DAPT Study Investigators. Benefit and Risk of Prolonged DAPT After Coronary Stenting in Women. Circ Cardiovasc Interv. 2018 Aug;11(8):e005308. doi: 10.1161/CIRCINTERVENTIONS.117.005308.

name: Department of Cardiovascular Medicine, Brigham and Women’s Hospital, Boston, MA (N.C.B., L.M.).

name: Harvard Medical School, Boston, MA (N.C.B., L.M., D.E.C., R.W.Y.).

name: Baim Institute for Clinical Research, Boston, MA (N.C.B., L.M., D.E.C., R.W.Y., W.-H.H., J.M.M.).

name: The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K).

name: The Smith Center for Outcomes Research in Cardiology (R.W.Y.), Beth Israel Deaconess Medical Center, Boston, MA.

name: Université Paris-Diderot, Sorbonne Paris Cité, INSERM Unité-1148, Département Hospitalo-Universitaire Fibrosis Inflammation Remodeling, and Hôpital Bichat, Assistance Publique–Hôpitaux de Paris, France (P.G.S.).

name: National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, United Kingdom (P.G.S.).

name: Division of Cardiology, Department of Medicine (D.E.C.)

name: Boston University School of Medicine, Boston, MA (A.K.J.).

name: Rhode Island Hospital, Brown University School of Medicine (J.D.A.).

name: Boston University School of Public Health, MA (J.M.M.).

name: on behalf of the DAPT Study Investigators

title: Benefit and Risk of Prolonged DAPT After Coronary Stenting in Women

ReferenceCitation: Yeh RW, Kereiakes DJ, Steg PG, Cutlip DE, Croce KJ, Massaro JM, Mauri L; DAPT Study Investigators. Lesion Complexity and Outcomes of Extended Dual Antiplatelet Therapy After Percutaneous Coronary Intervention. J Am Coll Cardiol. 2017 Oct 31;70(18):2213-2223. doi: 10.1016/j.jacc.2017.09.011.

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Secemsky EA, Yeh RW, Kereiakes DJ, Cutlip DE, Cohen DJ, Steg PG, Cannon CP, Apruzzese PK, D'Agostino RB Sr, Massaro JM, Mauri L; Dual Antiplatelet Therapy (DAPT) Study Investigators. Mortality Following Cardiovascular and Bleeding Events Occurring Beyond 1 Year After Coronary Stenting: A Secondary Analysis of the Dual Antiplatelet Therapy (DAPT) Study. JAMA Cardiol. 2017 May 1;2(5):478-487. doi: 10.1001/jamacardio.2017.0063.

name: Division of Cardiology, Massachusetts General Hospital, Boston 2Harvard Medical School, Boston, Massachusetts 3Center for Clinical Biometrics, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts 4Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts 5Baim Institute for Clinical Research, Boston, Massachusetts

name: Harvard Medical School, Boston, Massachusetts 4Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts 5Baim Institute for Clinical Research, Boston, Massachusetts 6Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts

name: Christ Hospital Heart and Vascular Center, Cincinnati, Ohio 8Lindner Center for Research and Education, Cincinnati, Ohio

name: Harvard Medical School, Boston, Massachusetts 5Baim Institute for Clinical Research, Boston, Massachusetts 6Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts

name: Saint Luke’s Mid America Heart Institute, Kansas City, Missouri10University of Missouri–Kansas City School of Medicine, Kansas City, Missouri

name: Université Paris-Diderot, Institut National de la Santé et de la Récherche Médicale U-1148, Hôpital Bichat, Paris, France 12Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique, Hôpitaux de Paris, Paris, France 13National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, England

name: Harvard Medical School, Boston, Massachusetts 5Baim Institute for Clinical Research, Boston, Massachusetts 14Division of Cardiology, Brigham and Women’s Hospital, Boston, Massachusetts

name: Baim Institute for Clinical Research, Boston, Massachusetts

name: Baim Institute for Clinical Research, Boston, Massachusetts 15Boston University School of Public Health, Boston, Massachusetts

name: Harvard Medical School, Boston, Massachusetts 3Center for Clinical Biometrics, Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts 5Baim Institute for Clinical Research, Boston, Massachusetts 14Division of Cardiology, Brigham and Women’s Hospital, Boston, Massachusetts

name: for the Dual Antiplatelet Therapy (DAPT) Study Investigators

ReferenceCitation: Stefanescu Schmidt AC, Kereiakes DJ, Cutlip DE, Yeh RW, D'Agostino RB Sr, Massaro JM, Hsieh WH, Mauri L; DAPT Investigators. Myocardial Infarction Risk After Discontinuation of Thienopyridine Therapy in the Randomized DAPT Study (Dual Antiplatelet Therapy). Circulation. 2017 May 2;135(18):1720-1732. doi: 10.1161/CIRCULATIONAHA.116.024835. Epub 2017 Feb 22.

name: From Massachusetts General Hospital, Boston (A.C.S.S.); Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute), Boston, MA (A.C.S.S., D.E.C., R.W.Y., R.B.D’A., J.M.M., W.-H.H., L.M.); Brigham and Women’s Hospital, Boston, MA (A.C.S.S., L.M.); Christ Hospital, Heart and Vascular Center and Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); and Beth Israel Deaconess Medical Center, Boston, MA (D.E.C., R.W.Y.).

ReferenceCitation: Resor CD, Nathan A, Kereiakes DJ, Yeh RW, Massaro JM, Cutlip DE, Gabriel Steg P, Hsieh WH, Mauri L; Dual Antiplatelet Therapy Study Investigators. Impact of Optimal Medical Therapy in the Dual Antiplatelet Therapy Study. Circulation. 2016 Oct 4;134(14):989-998. Epub 2016 Aug 30.

ReferenceCitation: Kereiakes DJ, Yeh RW, Massaro JM, Cutlip DE, Steg PG, Wiviott SD, Mauri L; DAPT Study Investigators. DAPT Score Utility for Risk Prediction in Patients With or Without Previous Myocardial Infarction. J Am Coll Cardiol. 2016 May 31;67(21):2492-502. doi: 10.1016/j.jacc.2016.03.485. Epub 2016 Apr 1.

title: DAPT Score Utility for Risk Prediction in Patients With or Without Previous Myocardial Infarction

ReferenceCitation: Yeh RW, Secemsky EA, Kereiakes DJ, Normand SL, Gershlick AH, Cohen DJ, Spertus JA, Steg PG, Cutlip DE, Rinaldi MJ, Camenzind E, Wijns W, Apruzzese PK, Song Y, Massaro JM, Mauri L; DAPT Study Investigators. Development and Validation of a Prediction Rule for Benefit and Harm of Dual Antiplatelet Therapy Beyond 1 Year After Percutaneous Coronary Intervention. JAMA. 2016 Apr 26;315(16):1735-49. doi: 10.1001/jama.2016.3775. Erratum in: JAMA. 2016 Jul 19;316(3):350. JAMA. 2016 Jul 19;316(3):350.

name: Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts2Harvard Medical School, Boston, Massachusetts3Harvard Clinical Research Institute, Boston, Massachusetts

name: Harvard Medical School, Boston, Massachusetts3Harvard Clinical Research Institute, Boston, Massachusetts4Cardiology Division, Massachusetts General Hospital, Boston

name: Christ Hospital Heart and Vascular Center, Cincinnati, Ohio6Lindner Center for Research and Education, Cincinnati, Ohio

name: Harvard Medical School, Boston, Massachusetts7Harvard T. H. Chan School of Public Health, Boston, Massachusetts

name: Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom9National Institute for Health Research Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester,

name: Saint Luke’s Mid America Heart Institute, Kansas City, Missouri11University of Missouri-Kansas City School of Medicine, Kansas City, Missouri12Washington University in St Louis, School of Medicine, St Louis, Missouri

name: Université Paris-Diderot, INSERM U-1148, Hôpital Bichat, Paris, France14Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique, Hôpitaux de Paris, Paris, France15National Heart and Lung Institute, Institute of Card

name: Harvard Medical School, Boston, Massachusetts3Harvard Clinical Research Institute, Boston, Massachusetts16Beth Israel Deaconess Medical Center, Boston, Massachusetts

name: Sanger Heart and Vascular Institute, Carolinas HealthCare System, Charlotte, North Carolina

name: Institut Loraine du Coeur et des Vaisseaux, University Hospital of Nancy-Brabois, Vandoeuvre-les-Nancy, France

name: Cardiovascular Center, Onze-Lieve-Vrouwziekenhuis Hospital, Aalst, Belgium

name: Harvard Clinical Research Institute, Boston, Massachusetts

name: Harvard Clinical Research Institute, Boston, Massachusetts20Boston University School of Public Health, Boston, Massachusetts

name: Harvard Medical School, Boston, Massachusetts3Harvard Clinical Research Institute, Boston, Massachusetts21Brigham and Women’s Hospital, Boston, Massachusetts

repository_institution: University of Leicester - Leicester Research Archive

repositories_institution: University of Leicester - Leicester Research Archive

ReferenceCitation: Meredith IT, Tanguay JF, Kereiakes DJ, Cutlip DE, Yeh RW, Garratt KN, Lee DP, Steg PG, Weaver WD, Holmes DR Jr, Brindis RG, Trebacz J, Massaro JM, Hsieh WH, Mauri L; DAPT Study Investigators. Diabetes Mellitus and Prevention of Late Myocardial Infarction After Coronary Stenting in the Randomized Dual Antiplatelet Therapy Study. Circulation. 2016 May 3;133(18):1772-82. doi: 10.1161/CIRCULATIONAHA.115.016783. Epub 2016 Mar 18. Erratum in: Circulation. 2016 May 31;133(22):e671.

name: From Monash Heart and Monash University, Melbourne, Australia (I.T.M., W.-H.H.); Montreal Heart Institute, Université de Montréal, Québec, Canada (J.-F.T.); The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K.); Beth Israel Deaconess Medical Center, Boston, MA (D.E.C.); Harvard Clinical Research Institute, Boston, MA (D.E.C., R.W.Y., J.M.M., L.M.); Harvard Medical School, Boston, MA (D.E.C., R.W.Y., L.M.); The Smith Center for...

ReferenceCitation: Hermiller JB, Krucoff MW, Kereiakes DJ, Windecker S, Steg PG, Yeh RW, Cohen DJ, Cutlip DE, Massaro JM, Hsieh WH, Mauri L; DAPT Study Investigators. Benefits and Risks of Extended Dual Antiplatelet Therapy After Everolimus-Eluting Stents. JACC Cardiovasc Interv. 2016 Jan 25;9(2):138-47. doi: 10.1016/j.jcin.2015.10.001.

title: Benefits and Risks of Extended Dual Antiplatelet Therapy After Everolimus-Eluting Stents

ReferenceCitation: Mauri L, Elmariah S, Yeh RW, Cutlip DE, Steg PG, Windecker S, Wiviott SD, Cohen DJ, Massaro JM, D'Agostino RB Sr, Braunwald E, Kereiakes DJ; DAPT Study Investigators. Causes of late mortality with dual antiplatelet therapy after coronary stents. Eur Heart J. 2016 Jan 21;37(4):378-85. doi: 10.1093/eurheartj/ehv614. Epub 2015 Nov 18.

title: Causes of late mortality with dual antiplatelet therapy after coronary stents

ReferenceCitation: Kereiakes DJ, Yeh RW, Massaro JM, Driscoll-Shempp P, Cutlip DE, Steg PG, Gershlick AH, Darius H, Meredith IT, Ormiston J, Tanguay JF, Windecker S, Garratt KN, Kandzari DE, Lee DP, Simon DI, Iancu AC, Trebacz J, Mauri L; DAPT Study Investigators. Stent Thrombosis in Drug-Eluting or Bare-Metal Stents in Patients Receiving Dual Antiplatelet Therapy. JACC Cardiovasc Interv. 2015 Oct;8(12):1552-62. doi: 10.1016/j.jcin.2015.05.026. Erratum in: JACC Cardiovasc Interv. 2015 Dec 21;8(14):1913.

title: Stent Thrombosis in Drug-Eluting or Bare-Metal Stents in Patients Receiving Dual Antiplatelet Therapy

ReferenceCitation: Yeh RW, Kereiakes DJ, Steg PG, Windecker S, Rinaldi MJ, Gershlick AH, Cutlip DE, Cohen DJ, Tanguay JF, Jacobs A, Wiviott SD, Massaro JM, Iancu AC, Mauri L; DAPT Study Investigators. Benefits and Risks of Extended Duration Dual Antiplatelet Therapy After PCI in Patients With and Without Acute Myocardial Infarction. J Am Coll Cardiol. 2015 May 26;65(20):2211-21. doi: 10.1016/j.jacc.2015.03.003. Epub 2015 Mar 15.

ReferenceCitation: Kereiakes DJ, Yeh RW, Massaro JM, Driscoll-Shempp P, Cutlip DE, Steg PG, Gershlick AH, Darius H, Meredith IT, Ormiston J, Tanguay JF, Windecker S, Garratt KN, Kandzari DE, Lee DP, Simon DI, Iancu AC, Trebacz J, Mauri L; Dual Antiplatelet Therapy (DAPT) Study Investigators. Antiplatelet therapy duration following bare metal or drug-eluting coronary stents: the dual antiplatelet therapy randomized clinical trial. JAMA. 2015 Mar 17;313(11):1113-21. doi: 10.1001/jama.2015.1671. Erratum in: JAMA. 2015 Jun 2;313(21):2185. JAMA. 2016 Jul 5;316(1):105. JAMA. 2016 Jul 5;316(1):105.

name: The Christ Hospital Heart and Vascular Center, Cincinnati, Ohio2Lindner Research Center, Cincinnati, Ohio

name: Harvard Clinical Research Institute, Boston, Massachusetts4Massachusetts General Hospital, Boston

name: Harvard Clinical Research Institute, Boston, Massachusetts5Boston University, Boston, Massachusetts

name: Harvard Clinical Research Institute, Boston, Massachusetts6Beth Israel Deaconess Medical Center, Boston, Massachusetts

name: Université Paris-Diderot, Paris, France8Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Paris, France9National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom

name: Department of Cardiovascular Sciences, University of Leicester and National Institute of Health Research Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester, Leicester, United Kingdom

name: Vivantes Neukoelln Medical Center, Berlin, Germany

name: Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada

name: Bern University Hospital, Bern, Switzerland

name: Piedmont Heart Institute, Atlanta, Georgia

name: Stanford University, Stanford, California

name: University Hospitals Case Medical Center, Cleveland, Ohio

name: Heart Institute, Cluj-Napoca, Romania23Iuliu Ha?ieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania

name: Jan Pawel II Hospital Krakow, Krakow, Poland

name: Harvard Clinical Research Institute, Boston, Massachusetts22Brigham and Women’s Hospital, Boston, Massachusetts

title: Antiplatelet Therapy Duration Following Bare Metal or Drug-Eluting Coronary Stents

ReferenceCitation: Yeh RW, Czarny MJ, Normand SL, Kereiakes DJ, Holmes DR Jr, Brindis RG, Weaver WD, Rumsfeld JS, Roe MT, Kim S, Driscoll-Shempp P, Mauri L. Evaluating the generalizability of a large streamlined cardiovascular trial: comparing hospitals and patients in the dual antiplatelet therapy study versus the National Cardiovascular Data Registry. Circ Cardiovasc Qual Outcomes. 2015 Jan;8(1):96-102. doi: 10.1161/CIRCOUTCOMES.114.001239. Epub 2014 Nov 16.

name: From the Cardiology Division, Department of Medicine, Massachusetts General Hospital (R.W.Y), Department of Health Care Policy (Biostatistics) (S.-L.T.N.), and Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women’s Hospital (L.M.), Harvard Medical School, Boston, MA (R.W.Y., S.-L.T.N., L.M.); Harvard Clinical Research Institute, Boston, MA (R.W.Y., P.D.S., L.M.); Cardiology Division, Department of Medicine, Johns Hopkins Hospital, Johns Hopkins University School of Medicine...

journal_name: Circulation: Cardiovascular Quality and Outcomes

title: Evaluating the Generalizability of a Large Streamlined Cardiovascular Trial

ReferenceCitation: Mauri L, Kereiakes DJ, Yeh RW, Driscoll-Shempp P, Cutlip DE, Steg PG, Normand SL, Braunwald E, Wiviott SD, Cohen DJ, Holmes DR Jr, Krucoff MW, Hermiller J, Dauerman HL, Simon DI, Kandzari DE, Garratt KN, Lee DP, Pow TK, Ver Lee P, Rinaldi MJ, Massaro JM; DAPT Study Investigators. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med. 2014 Dec 4;371(23):2155-66. doi: 10.1056/NEJMoa1409312. Epub 2014 Nov 16.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repositories_institution: University Library Bern - BORIS - Bern Open Repository and Information System

title: Twelve or 30 Months of Dual Antiplatelet Therapy after Drug-Eluting Stents

ReferenceCitation: Matteau A, Yeh RW, Kereiakes D, Orav EJ, Massaro J, Steg PG, Normand SL, Cutlip DE, Mauri L. Frequency of the use of low- versus high-dose aspirin in dual antiplatelet therapy after percutaneous coronary intervention (from the Dual Antiplatelet Therapy study). Am J Cardiol. 2014 Apr 1;113(7):1146-52. doi: 10.1016/j.amjcard.2013.10.015. Epub 2013 Nov 8.

title: Frequency of the Use of Low- Versus High-Dose Aspirin in Dual Antiplatelet Therapy After Percutaneous Coronary Intervention (from the Dual Antiplatelet Therapy Study)

ReferenceCitation: Mauri L, Kereiakes DJ, Normand SL, Wiviott SD, Cohen DJ, Holmes DR, Bangalore S, Cutlip DE, Pencina M, Massaro JM. Rationale and design of the dual antiplatelet therapy study, a prospective, multicenter, randomized, double-blind trial to assess the effectiveness and safety of 12 versus 30 months of dual antiplatelet therapy in subjects undergoing percutaneous coronary intervention with either drug-eluting stent or bare metal stent placement for the treatment of coronary artery lesions. Am Heart J. 2010 Dec;160(6):1035-41, 1041.e1. doi: 10.1016/j.ahj.2010.07.038.

location_country:
United States
France
Czechia
Poland
Romania
Hungary
Australia
New Zealand
Germany
United Kingdom

location_facility: Institutul de Boli Cardiovasculare si Transplant Targu Mures

location_facility: Great Lakes Heart & Vascular Institute, PC

location_facility: St. Vincent Heart Center of Indiana, LLC

location_facility: Capital Cardiovascular Research Institute

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Klinikai Kozpont

location_facility: SPSK nr 2 Pomorskiej Akademii Medycznej w Szczecinie

location_facility: Central Minnesota Heart Center at St. Cloud Hospital

location_facility: University of Oklahoma Health Sciences Center

location_facility: Methodist DeBakey Heart & Vascular Center

location_facility: UMDNJ - Robert Wood Johnson Medical School

location_facility: Midwest Cardiovascular Research and Education Foundation

location_facility: Northwest Indiana Cardiovascular Physicians, P.C.

location_facility: St. Vincent Hospital/ Providence Heart Hospital

location_facility: Oregon Health & Sciences University Hospital

location_facility: Henry Ford Hospital Heart & Vascular Institute

location_facility: Institutul de Urgenta pentru Boli Cardiovasculare Prof. Dr.

location_facility: Torrance Memorial Medical Center / Vasek Polak Research Program

location_facility: Polsko-Amerykanskie Kliniki Serca.American Heart of Poland S

location_facility: Institutul Inimii Niculae Stancioiu Cluj-Napoca

location_facility: University Hospital of Coventry and Warwickshire

location_facility: Universitaetsklinikum Schleswig-Holstein - PS

location_facility: University Hospital of Leicester Glenfield Hospital

location_facility: Centrul Clinic de Urgenta de Boli Cardiovasculare al Armatei

location_facility: University of Arkansas (Central VA) for Medical Science

location_facility: The Foundation for Cardiovascular Medicine

location_facility: Uniwersyteck Szpital Klin. w Bialymstoku

location_facility: California Cardiovascular Consultants/ Washington Hospital

location_facility: St. Luke's Hospital Mid America Heart Institute

location_facility: Heartland Education and Research Foundation

location_facility: Wielospecj. Szpital Miejski im.dr.E.Warminskiego-SPZOZ

location_facility: Inst. Urgenta Boli Cardiovasculare Prof. Dr. C.C. Iliescu

location_facility: Veteran's Affairs Medical Center- Dallas

location_facility: Bay Area Cardiology Associates/ Brandon Regional Hospital

location_facility: Spitalul Clinic Universitar de Urgenta Bucuresti

location_facility: Cardiovascular Associates of the Delaware Valley, PA

location_facility: Donald Guthrie Foundation for Education and Research

location_facility: Black Hills Research- Rapid City Regional

location_facility: Instytut Kardiologii im. Kardynala St. Wyszynskiego

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet

location_facility: Frederick C Smith Clinic dba Smith Clinic


title: Dilatation Versus Endoscopic Laser Resection in Simple Benign Tracheal Stenosis : a Randomized Controlled Trial

acronym: AERATE

summary: Multicenter randomized controlled trial comparing endoscopic laser resection vs dilatation in benign tracheal stenosis.

study_start_date_type: Anticipated

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_country: Canada France

location_facility: Hôpital Larrey, University Hospital of Toulouse

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


title: A Prospective Single Arm Clinical Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation

acronym: FASTR-AF

summary: The objective of this study is to characterize the performance of the DiamondTemp Ablation System for its intended use.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country: France Czechia

location_facility:
Na Homolce
Clinique Pasteur
CHRU de Nancy
Clnique du Tonkin

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceType: derived

ReferenceCitation: Gerard E, Zohar S, Thai HT, Lorenzato C, Riviere MK, Ursino M. Bayesian dose regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics. Biometrics. 2021 Feb 2. doi: 10.1111/biom.13433. [Epub ahead of print]

name: Centre de Recherche des Cordeliers Sorbonne Université Inserm, Université de Paris Paris F‐75006 France

name: Oncology Biostatistics, Biostatistics and Programming Department Sanofi R&D Vitry‐sur‐Seine France

name: Statistical Methodology Group, Biostatistics and Programming Department Sanofi R&D Chilly‐Mazarin France

family: Gerard

full_name: Emma Gerard

given: Emma

sequence: first

family: Zohar

full_name: Sarah Zohar

given: Sarah

sequence: additional

name: Translation Disease Modeling, Digital and Data Science Sanofi R&D Chilly‐Mazarin France

family: Thai

full_name: Hoai‐Thu Thai

given: Hoai‐Thu

family: Lorenzato

full_name: Christelle Lorenzato

given: Christelle

family: Riviere

full_name: Marie‐Karelle Riviere

given: Marie‐Karelle

name: F‐CRIN PARTNERS Platform, AP‐HP Université de Paris Paris France

family: Ursino

full_name: Moreno Ursino

given: Moreno

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Biometrics

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: Cornell University - arXiv

repository_normalized: arXiv

version: submittedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

intervention_type: Drug

status: Terminated

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi

location_country:
United States
France

location_facility:
Investigational Site Number 8400001
Investigational Site Number 2500003
Investigational Site Number 2500004
Investigational Site Number 2500001

ipd_sharing: Yes

type: EudraCT Number

type: Other Identifier

source: euctr

title: An Open-label, First-in-human, Dose Escalation Study of SAR440234 Administered as Single Agent by Intravenous Infusion in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), or High Risk Myelodysplasia (HR-MDS)

summary:
Primary Objective:

Dose escalation: To determine the maximum tolerated dose (MTD) of SAR440234 administered as a single agent in patients with R/R AML (relapsed or refractory acute myeloid leukemia), HR-MDS (high risk myelodysplastic syndrome), or B-ALL (B-cell acute lymphoblastic leukemia), and determine the recommended phase 2 dose (RP2D) for the subsequent Expansion part.
Expansion part: To assess the activity of single agent SAR440234 at the RP2D in patients with R/R AML or HR-MDS.

Secondary Objective:

To characterize the safety profile including cumulative adverse drug reactions.
To evaluate the potential immunogenicity of SAR440234.
To assess any preliminary evidence of hematologic response in the Dose Escalation Part.

status_simplified: Unknown


title: A Phase II Study of Selinexor (KPT-330) in Patients With Advanced Thymic Epithelial Tumour (TET) Progressing After Primary Chemotherapy.

acronym: TET-SEL

summary:
The aim of the study is to determine the efficacy of selinexor in adults with TETs determined by overall response rate (RECIST 1.1) in two parallel cohorts of patients with advanced thymomas or thymic carcinomas. The study is an international, multicenter, open label phase II trial using Simons two stage design. The study population is adults with histologically confirmed, advanced, inoperable TETs who are progressing after treatment with least one platinum containing chemotherapy regimen.

This study is comprised of 2 similar phase II tirals, one running in EU (25 patients) and one running in US (25 patients).

There are two study arms:

Arm A: Thymoma

Stage 1: 15 patients
Stage 2: 10 patients

Arm B: Thymic carcinoma

Stage 1: 15 patients
Stage 2: 10 patients

status: Unknown status

lead_sponsor: Morten Mau-Soerensen

location_country: Denmark France

location_facility:
Rigshospitalet
Hospices Civils de Lyon
Intitut Gustave Roussy
Intitut Curie


title: A Study to Investigate the Genetic Variation of Dopamine Pathway Associated With the Observed Effects of a New Treatment in Former Studies in Patients With Chronic Pain

summary: Patients having completed former trials T1001-01 or T1001-02 will undergo one blood sampling for genotyping purposes. In addition they will compete the personality questionnaires they had completed in the former trial.

primary_purpose: Basic Science

location_country: Belgium France

location_facility:
Institut Curie
Eurofins Optimed
CIC Clermont-Ferrand CHU G. Montpied
ATC SA

intervention_type: Other


title: IPS-II Study: Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) - A Pilot Study.

acronym: IPS-II

summary:
Targeted Lung Denervation (TLD) Therapy will be a safe method to ablate the airway nerve trunks that travel parallel to and outside of the main bronchi and into the lungs to achieve targeted lung denervation and potentially improve breathing and quality of life for patients suffering from COPD.

Use of the IPS System will be technically feasible in accessing the target treatment location and delivering RF energy to the target treatment location.

lead_sponsor: Nuvaira, Inc.

location_country: Austria France

location_facility: Centre Hospitalier et Universitaire de Grenoble


title: European Phase-IIb Clinical Trial Evaluating Efficacy of Low Dose rhIL-2 in Patients With Recently-diagnosed Type 1 Diabetes DIABIL-2

summary:
Type 1diabetes (T1D) is caused by autoimmune destruction of the pancreatic islet ß-cells, leading to an absolute deficiency in insulin.

In health, regulatory T cells (Tregs) suppress immune responses against normal tissues, and likewise prevent autoimmune diseases. Tregs are insufficient in T1D.

The investigators previously showed that administration of low doses of IL-2 induces selective expansion and activation of Tregs in mice and humans.

The investigators hypothesize that Tregs expansion and activation with low doses of IL2 could block the ongoing autoimmune destruction of insulin producing cells in patients with recently diagnosed T1D.

status: Active, not recruiting

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_country: Sweden Switzerland Netherlands France Belgium Germany

location_facility: UZ - Diabetes voor Kinderen en Adolescenten-Leuven

location_facility: Endocrinologie-Diabétologie-Maladies de la nutrition, Centre Hospitalier Lyon-Sud

location_facility: Service de pédiatrie 1CHU de HAUTEPIERRE

location_facility: Centre d'Investigations Cliniques, HÔPITAL CIVIL

location_facility: CIC pédiatrique Hôpital Necker Enfants Malades

location_facility: Structure d'Endocrinologie-Diabète-Nutrition et Addictologie HOPITAUX UNIVERSITAIRES NHC

location_facility: Endocrinologie gynécologie diabétologie pédiatriques, Hôpital Universitaire Necker Enfants Malades.

location_facility: Hopital G&R Laënnec , Endocrinologie, Maladies Métaboliques et Nutrition

location_facility: Service d'Endocrinologie pédiatrique - HFME

location_facility: Service de Nutrition - Maladies Métaboliques - Endocrinologie HOPITAL DE LA CONCEPTION

location_facility: Service d'endocrinologie, diabétologie, maladies métaboliques, et nutrition, CHU de Bordeaux, Hôpital Haut Levêque

location_facility: Pediatric Department, Centre Hospitalier Régional de la Citadelle

location_facility: Service d' Endocrinologie Diabétologie CHRU DE RENNES

location_facility: Service d'Endocrinologie Pédiatrique, Hôpital d'enfants Robert Debré

location_facility: Center for Pediatric and Adolescent Diabetes Care and Research

location_facility: CIC Paris-Est (Adultes), Hôpitaux Universitaires Pitié-Salpêtrière, Charles Foix

location_facility: CHRU de Lille, Hôpital Claude Huriez Service d'endocrinologie

location_facility: Service Pédiatrie - Gastro-entérologie, Hépatologie, Nutrition, Diabétologie, Hôpital des Enfants Pôle Enfants

location_facility: Dept. of Clinical Sciences Lund University, Skåne University Hospital.

location_facility: Centre d'Investigations Cliniques, CHU-HOPITAL HAUTEPIERRE

location_facility: Institute of Diabetes Research, Helmholtz Zentrum München

location_facility: Service d' Endocrinologie, maladies métaboliques HOPITAL NORD

location_facility: CIC Pédiatrique, Hôpital d'enfants Robert Debré

location_facility: Service d' Endocrinologie HOPITAL CAVALE BLANCHE

location_facility: Division of Endocrinology and Diabetology, Department of Internal Medicine II, University Hospital of Freiburg

location_facility: Unité d'Endocrinologie et Diabétologie Pédiatriques, CHU de Marseille, Hôpital La Timone Enfants

location_facility: Division of Endocrinology, Diabetology and Metabolic Diseases, University Hospital of Freiburg, Department for children and adolescents

location_facility: Endocrinology and Diabetes department, University Hospital of Basel

location_facility: Service Diabétologie -Endocrinologie, CHU Jean Minjoz


title: OpT2mise Glucose Control in Type 2 DM With Insulin Pump Therapy

summary: The purpose of this study is to evaluate the comparative effectiveness of insulin pump therapy versus multiple daily injections in insulin-taking type 2 Diabetes Mellitus who are sub optimally controlled with multiple daily injections (MDI).

ReferenceCitation: Chlup R, Runzis S, Castaneda J, Lee SW, Nguyen X, Cohen O. Complex Assessment of Metabolic Effectiveness of Insulin Pump Therapy in Patients with Type 2 Diabetes Beyond HbA1c Reduction. Diabetes Technol Ther. 2018 Feb;20(2):153-159. doi: 10.1089/dia.2017.0283. Epub 2017 Dec 7.

name: Department of Physiology, Faculty of Medicine and Dentistry, Palacký University, Olomouc, Czech Republic.

name: IInd Department of Medicine, Teaching Hospital, Olomouc, Czech Republic.

name: Department of Diabetes Moravsky Beroun, Institute Paseka, Paseka, Czech Republic.

family: Chlup

full_name: Rudolf Chlup

given: Rudolf

name: Medtronic, Sarl, Tolochenaz, Switzerland.

family: Runzis

full_name: Sarah Runzis

name: Medtronic, Bakken Research Center, Maastricht, The Netherlands.

family: Castaneda

full_name: Javier Castaneda

given: Javier

family: Lee

full_name: Scott W. Lee

given: Scott W.

family: Nguyen

full_name: Xuan Nguyen

given: Xuan

family: Cohen

full_name: Ohad Cohen

given: Ohad

journal_name: Diabetes Technology & Therapeutics

oa_colors: green other

evidence: open (via free pdf)

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

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

ReferenceCitation: Metzger M, Castañeda J, Reznik Y, Giorgino F, Conget I, Aronson R, de Portu S, Runzis S, Lee SW, Cohen O. Factors associated with improved glycemic control following continuous subcutaneous insulin infusion therapy in patients with type 2 diabetes uncontrolled with bolus-basal insulin regimens: An analysis from the OpT2mise randomized trial. Diabetes Obes Metab. 2017 Oct;19(10):1490-1494. doi: 10.1111/dom.12960. Epub 2017 Jul 25.

name: Diabetes Clinic; Clalit Health Services; Jerusalem Israel

family: Metzger

full_name: Muriel Metzger

given: Muriel

name: Medtronic Bakken Research Center; Maastricht The Netherlands

family: Castañeda

full_name: Javier Castañeda

name: Department of Endocrinology; University of Caen Côte de Nacre Regional Hospital Center; Caen France

family: Reznik

full_name: Yves Reznik

given: Yves

name: Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, Department of Emergency and Organ Transplantation; University of Bari Aldo Moro; Bari Italy

family: Giorgino

full_name: Francesco Giorgino

given: Francesco

name: Diabetes Unit, Endocrinology and Nutrition Department; University Hospital Clinic; Barcelona Spain

family: Conget

full_name: Ignacio Conget

given: Ignacio

name: LMC Diabetes & Endocrinology; Toronto Ontario Canada

family: Aronson

full_name: Ronnie Aronson

given: Ronnie

name: Medtronic International Trading Sàrl; Tolochenaz Switzerland

family: de Portu

full_name: Simona de Portu

given: Simona

name: Medtronic Diabetes; Northridge California

name: Institute of Endocrinology; Chaim Sheba Medical Center; Tel Hashomer Israel

ReferenceCitation: Reznik Y, Cohen O, Aronson R, Conget I, Runzis S, Castaneda J, Lee SW; OpT2mise Study Group. Insulin pump treatment compared with multiple daily injections for treatment of type 2 diabetes (OpT2mise): a randomised open-label controlled trial. Lancet. 2014 Oct 4;384(9950):1265-72. doi: 10.1016/S0140-6736(14)61037-0. Epub 2014 Jul 2.

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Clinical Professor Department of Medicine University of Calgary

location_facility: Universita di Perugia - Ospedale S.M. Della Misericordia

location_facility: Canadian Centre for Research on Diabetes

location_facility: Péterfy Hospital and Emergency Center Diabetes Outpatient Clinic

location_facility: Università degli Studi di Bari - Policlinico Universitario

location_facility: IJsselland Ziekenhuis Poli Interne geneeskunde

location_facility: Clinic for Endocrinology, Diabetes and Metabolic Diseases

location_facility: McGill University, McGill Nutrition and Food Science Centre

location_facility: Endocrinologist, 202-301 Columbia Street East

location_facility: Chaim Sheba Medical center Endocrinology unit

location_facility: Zentrum für Diabetes und Gefäßerkrankungen


lead_sponsor: QED Therapeutics, Inc.

location_country:
Italy
United States
Netherlands
Germany
France
Belgium
Puerto Rico
Spain
Canada
United Kingdom

acronym: PROOF 302

location_facility: UChicago Medicine Duchossois Center for Advanced Medicine (DCAM) - Hyde Park

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Ospedale di Trento - Presidio Ospedaliero Santa Chiara

location_facility: Tulane University/Southeastern Louisiana VA Health Care

location_facility: Caritas-Krankenhaus St. Josef Klinik für Urologie

location_facility: Azienda Ospedaliero - Universitaria San Luigi Gonzaga

location_facility: Centre de Lutte Contre le Cancer - Centre Léon Bérard

location_facility: Zuyderland Medisch Centrum Sittard-Geleen

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: Saint Louis University- SLUCare Academic Pavilion

location_facility: Institut de Cancerologie Strasbourg Europe

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Northwestern University Feinberg School of Medicine

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata

location_facility: Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari

location_facility: Associated Medical Professionals - Syracuse

location_facility: Nebraska Cancer Specialists - Midwest Cancer Center

location_facility: Marien Hospital Herne - Universitätsklinikum der Ruhr-Universität Bochum

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Houston Methodist Hospital- Department of Urology

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

location_facility: The Ohio State University College of Medicine

ipd_sharing: Undecided

title: Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations (PROOF 302)

summary: This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of infigratinib (an oral targeted FGFR1-3 inhibitor) versus placebo, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations, and gene fusions or rearrangements) who have disease that is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer post radical cystectomy or upper tract urothelial cancer post distal ureterectomy and/or nephrectomy. Study treatment is randomized 1:1 between infigratinib or placebo with treatment up to 1 year or until invasive local, distal, or metastatic disease recurrence confirmed by independent imaging reviewer.


title: Safety of a Management Strategy Based on Colour Doppler ULTrasound and D-Dimer Testing for the Diagnosis Exclusion of RECurrent Deep Vein Thrombosis of the Lower Limbs. The ULTREC Project

acronym: ULTREC

summary:
The purpose is to assess the safety of a management strategy based on colour doppler ultrasound (CDUS) and D-Dimer test results for the diagnosis exclusion of recurrent deep vein thrombosis (DVT) of the lower limbs.

DVT recurrence requires using anticoagulant treatment to prevent thrombosis progression. Given an increased bleeding risk with prolonged treatment, an accurate diagnosis for recurrence is needed. However, the diagnosis of a new thrombosis in a previously involved leg is difficult. Imaging modalities and criteria that are currently used for the diagnosis may be equivocal and unable to discriminate between an old clot and a new one recently developed at the same site. An increase in vein diameter after vein compression by the ultrasound probe was suggested as a diagnostic criterion for a new DVT. This method has many limitations in clinical practice, mainly a lack of availability of a previous measurement and a poor inter-observer agreement.

Colour Doppler ultrasound enables to study both the thrombus and the blood flow characteristics that might help to overcome these limitations. CDUS is a well-known method for the diagnosis of vascular diseases and is used in every day clinical practice for the diagnosis of a first DVT and DVT recurrence but CDUS has never been assessed for DVT recurrence in a study. The diagnosis of DVT recurrence may be easily established using the same criteria as for a first DVT episode. Our hypothesis is that CDUS associated with D-Dimer can safely rule out the diagnosis of DVT recurrence while maintaining a good specificity.

The strategy consists in performing first a CDUS that helps to classify patients as having (positive CDUS) or not having (negative CDUS) a new thrombosis. In the case of an equivocal CDUS, a D-Dimer test is performed. If the D-dimer is normal, the diagnosis of DVT recurrence is ruled out and the patient is not treated. If the D-dimer is abnormal, the diagnosis cannot be excluded nor confirmed and a second CDUS is performed on D7±2. Meanwhile, patients are not treated by anticoagulants. An unchanged CDUS on D7±2 qualifies patients as free from a new DVT and they are not treated. Conversely a change in CDUS qualifies patients as having a new DVT which requires anticoagulant treatment.

All patients have a 3-month follow-up for the assessment of potential venous thromboembolic events.

primary_purpose: Diagnostic

ReferenceType: background

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ReferenceCitation: Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, Huisman M, King CS, Morris TA, Sood N, Stevens SM, Vintch JRE, Wells P, Woller SC, Moores L. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb;149(2):315-352. doi: 10.1016/j.chest.2015.11.026. Epub 2016 Jan 7. Erratum in: Chest. 2016 Oct;150(4):988.

ReferenceCitation: Le Gal G, Righini M, Roy PM, Sanchez O, Aujesky D, Perrier A, Bounameaux H. Value of D-dimer testing for the exclusion of pulmonary embolism in patients with previous venous thromboembolism. Arch Intern Med. 2006 Jan 23;166(2):176-80.

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family: LE GAL

full_name: G. LE GAL

given: G.

family: KOVACS

full_name: M. J. KOVACS

given: M. J.

family: CARRIER

full_name: M. CARRIER

given: M.

family: DO

full_name: K. DO

given: K.

family: KAHN

full_name: S. R. KAHN

given: S. R.

family: WELLS

full_name: P. S. WELLS

given: P. S.

family: ANDERSON

full_name: D. A. ANDERSON

given: D. A.

family: CHAGNON

full_name: I. CHAGNON

given: I.

family: SOLYMOSS

full_name: S. SOLYMOSS

given: S.

family: CROWTHER

full_name: M. CROWTHER

family: RIGHINI

full_name: M. RIGHINI

family: PERRIER

full_name: A. PERRIER

given: A.

family: WHITE

full_name: R. H. WHITE

given: R. H.

family: VICKARS

full_name: L. VICKARS

given: L.

family: RODGER

full_name: M. RODGER

journal_name: Journal of Thrombosis and Haemostasis

ReferenceCitation: Linkins LA, Stretton R, Probyn L, Kearon C. Interobserver agreement on ultrasound measurements of residual vein diameter, thrombus echogenicity and Doppler venous flow in patients with previous venous thrombosis. Thromb Res. 2006;117(3):241-7. Epub 2005 Mar 21.

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ReferenceCitation: Prandoni P, Lensing AW, Bernardi E, Villalta S, Bagatella P, Girolami A; DERECUS Investigators Group. The diagnostic value of compression ultrasonography in patients with suspected recurrent deep vein thrombosis. Thromb Haemost. 2002 Sep;88(3):402-6.

ReferenceCitation: Prandoni P, Tormene D, Dalla Valle F, Concolato A, Pesavento R. D-dimer as an adjunct to compression ultrasonography in patients with suspected recurrent deep vein thrombosis. J Thromb Haemost. 2007 May;5(5):1076-7. Epub 2007 Mar 15.

ReferenceCitation: Rathbun SW, Whitsett TL, Raskob GE. Negative D-dimer result to exclude recurrent deep venous thrombosis: a management trial. Ann Intern Med. 2004 Dec 7;141(11):839-45.

ReferenceCitation: Schulman S, Granqvist S, Holmström M, Carlsson A, Lindmarker P, Nicol P, Eklund SG, Nordlander S, Lärfars G, Leijd B, Linder O, Loogna E. The duration of oral anticoagulant therapy after a second episode of venous thromboembolism. The Duration of Anticoagulation Trial Study Group. N Engl J Med. 1997 Feb 6;336(6):393-8.

ReferenceCitation: Tan M, Velthuis SI, Westerbeek RE, VAN Rooden CJ, VAN DER Meer FJ, Huisman MV. High percentage of non-diagnostic compression ultrasonography results and the diagnosis of ipsilateral recurrent proximal deep vein thrombosis. J Thromb Haemost. 2010 Apr;8(4):848-50. doi: 10.1111/j.1538-7836.2010.03758.x.

ReferenceCitation: Tan M, Bornais C, Rodger M. Interobserver reliability of compression ultrasound for residual thrombosis after first unprovoked deep vein thrombosis. J Thromb Haemost. 2012 Sep;10(9):1775-82. doi: 10.1111/j.1538-7836.2012.04827.x.

ReferenceCitation: Tan M, Mol GC, van Rooden CJ, Klok FA, Westerbeek RE, Iglesias Del Sol A, van de Ree MA, de Roos A, Huisman MV. Magnetic resonance direct thrombus imaging differentiates acute recurrent ipsilateral deep vein thrombosis from residual thrombosis. Blood. 2014 Jul 24;124(4):623-7. doi: 10.1182/blood-2014-04-566380. Epub 2014 Jun 13.

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ReferenceCitation: Westerbeek RE, Van Rooden CJ, Tan M, Van Gils AP, Kok S, De Bats MJ, De Roos A, Huisman MV. Magnetic resonance direct thrombus imaging of the evolution of acute deep vein thrombosis of the leg. J Thromb Haemost. 2008 Jul;6(7):1087-92. doi: 10.1111/j.1538-7836.2008.02986.x. Epub 2008 Jul 1.

lead_sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

location_facility: Cabinet libéral Besancon - polyclinique des Fleurs

location_facility: Centre Hospitalier Universitaire François Mitterrand

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer

location_facility: Centre hospitalier Universitaire Cavale Blanche

location_facility: Centre de medicine vasculaire interventionnel

location_facility: Centre Hospitalier Universitaire Rangueil

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Centre Hospitalier Universitaire de Grenoble


title: Venetoclax in Chronic Lymphocytic Leukemia Effectiveness and Real-life Treatment Management

acronym: VERONE

summary: This study will evaluate real-life effectiveness and use in participants starting venetoclax treatment for Chronic Lymphocytic Leukemia (CLL).

study_type: Observational

time_perspective: Prospective

lead_sponsor: AbbVie

location_facility: CH de la Haute-Saône - Vesoul /ID# 205150

location_facility: CH de Saint-Malo - Hôpital Broussais /ID# 169935

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 200192

location_facility: CHRU Nancy - Hôpitaux de Brabois /ID# 170855

location_facility: CH Roubaix - Hopital Victor Provo /ID# 170909

location_facility: CHU Strasbourg - Hopital Civil /ID# 200195

location_facility: Centre Hospitalier de CHOLET /ID# 171215

location_facility: CH Libourne - Hopital Robert Boulin /ID# 170739

location_facility: CH Cornouailles - Site Quimper-Laennec /ID# 169937

location_facility: CHU de Besancon - Jean Minjoz /ID# 170721

location_facility: CH Cannes - les Broussailles /ID# 201108

location_facility: Hopital d'Instruction des Armées PERCY /ID# 170740

location_facility: CHRU de Brest - Hopital Morvan /ID# 169457

location_facility: CHRU Tours - Hopital Bretonneau /ID# 169469

location_facility: CH Pontoise - Hopital René Dubos /ID# 201329

location_facility: Institut de Cancérologie du Gard /ID# 171207

location_facility: Centre Hospitalier de la Cote /ID# 170735

location_facility: Centre Hospitalier de Perpignan /ID# 170743

location_facility: CHR Orleans - Hopital de la Source /ID# 169453

location_facility: CH de Bourg-en Bresse - Hopital Fleyriat /ID# 170017

location_facility: CHI POISSY-ST GERMAIN - Centre de Coordination en Cancérologie /ID# 169966

location_facility: CHU Amiens-Picardie Site Sud /ID# 170724

location_facility: AP-HM - Hopital de la Conception /ID# 201981

location_facility: CHR Metz-Thionville - Hopital Bel-Air /ID# 170722

location_facility: CH Annecy Genevois Site Annecy /ID# 200826

location_facility: Institut de Cancérologie du Gard /ID# 169975

location_facility: CH Pontoise - Hopital René Dubos /ID# 170720

location_facility: CHU Reims - Hôpital Robert Debre /ID# 170917

location_facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 169941

location_facility: Centre Hospitalier de Versailles André Mignot /ID# 169950

location_facility: Hopital Saint Vincent de Paul /ID# 169956

location_facility: CHU de La Réunion sites Sud - Saint-Pierre /ID# 204093

location_facility: CHU Grenoble - Hopital Michallon /ID# 170741

location_facility: CH CARCASSONNE - Antoine Gayraud /ID# 202530

location_facility: Clinique Pole santé République /ID# 204658


title: A Randomized Multicenter Phase III Trial Evaluating the Interest of Imatinib Treatment Maintenance or Interruption After 3 Years of Adjuvant Treatment in Patients With Gastrointestinal Stromal Tumours (GIST)

acronym: ImadGist

summary:
This is a 2 arms study concerning patients with primary GIST who followed an Imatinib adjuvant treatment for 3 years after surgery and who have a high risk of recurrence.

In the first arm, patients will continue Imatinib treatment for 3 more years, allowing to determine if the continuation of this treatment is efficient for disease control, in terms of Disease Free Survival improvement.

In the second arm, patients will discontinue the Imatinib treatment, as standard practice. This arm will allow to determine if the re-introduction of Imatinib at relapse is still an efficient treatment for the control of disease.

primary_purpose: Prevention

ReferenceCitation: Blackstein ME, Blay JY, Corless C, Driman DK, Riddell R, Soulières D, Swallow CJ, Verma S; Canadian Advisory Committee on GIST. Gastrointestinal stromal tumours: consensus statement on diagnosis and treatment. Can J Gastroenterol. 2006 Mar;20(3):157-63.

ReferenceCitation: Blanke CD, Demetri GD, von Mehren M, Heinrich MC, Eisenberg B, Fletcher JA, Corless CL, Fletcher CD, Roberts PJ, Heinz D, Wehre E, Nikolova Z, Joensuu H. Long-term results from a randomized phase II trial of standard- versus higher-dose imatinib mesylate for patients with unresectable or metastatic gastrointestinal stromal tumors expressing KIT. J Clin Oncol. 2008 Feb 1;26(4):620-5. doi: 10.1200/JCO.2007.13.4403.

ReferenceCitation: Blanke CD, Rankin C, Demetri GD, Ryan CW, von Mehren M, Benjamin RS, Raymond AK, Bramwell VH, Baker LH, Maki RG, Tanaka M, Hecht JR, Heinrich MC, Fletcher CD, Crowley JJ, Borden EC. Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033. J Clin Oncol. 2008 Feb 1;26(4):626-32. doi: 10.1200/JCO.2007.13.4452.

ReferenceCitation: Blay JY, von Mehren M, Blackstein ME. Perspective on updated treatment guidelines for patients with gastrointestinal stromal tumors. Cancer. 2010 Nov 15;116(22):5126-37. doi: 10.1002/cncr.25267. Review.

ReferenceCitation: Blay JY, Le Cesne A, Ray-Coquard I, Bui B, Duffaud F, Delbaldo C, Adenis A, Viens P, Rios M, Bompas E, Cupissol D, Guillemet C, Kerbrat P, Fayette J, Chabaud S, Berthaud P, Perol D. Prospective multicentric randomized phase III study of imatinib in patients with advanced gastrointestinal stromal tumors comparing interruption versus continuation of treatment beyond 1 year: the French Sarcoma Group. J Clin Oncol. 2007 Mar 20;25(9):1107-13.

ReferenceCitation: Casali PG, Jost L, Reichardt P, Schlemmer M, Blay JY; ESMO Guidelines Working Group. Gastrointestinal stromal tumors: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol. 2008 May;19 Suppl 2:ii35-8. doi: 10.1093/annonc/mdn080.

ReferenceCitation: ClinicalTrials.gov. Imatinib mesilate or observation only in treating patients who have undergone surgery for localized gastrointestinal stromal tumor. NCT identifier: NCT00103168. 13-12-2009. Ref Type: Online Source

ReferenceCitation: ClinicalTrials.gov. Five year adjuvant imatinib mesilate (Gleevec®) in gastrointestinal stromal tumor (GIST). NCT Identifier: NCT00867113. 24-8-2011. Ref Type: Online Source

ReferenceCitation: Corless CL, Heinrich MC. Molecular pathobiology of gastrointestinal stromal sarcomas. Annu Rev Pathol. 2008;3:557-86. Review.

ReferenceCitation: Corless CL, Barnett CM, Heinrich MC. Gastrointestinal stromal tumours: origin and molecular oncology. Nat Rev Cancer. 2011 Nov 17;11(12):865-78. doi: 10.1038/nrc3143. Review.

ReferenceCitation: Dematteo RP, Ballman KV, Antonescu CR, Maki RG, Pisters PW, Demetri GD, Blackstein ME, Blanke CD, von Mehren M, Brennan MF, Patel S, McCarter MD, Polikoff JA, Tan BR, Owzar K; American College of Surgeons Oncology Group (ACOSOG) Intergroup Adjuvant GIST Study Team. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Mar 28;373(9669):1097-104. doi: 10.1016/S0140-6736(09)60500-6. Epub 2009 Mar 18. Erratum in: Lancet. 2009 Aug 8;374(9688):450.

ReferenceCitation: DeMatteo RP, Lewis JJ, Leung D, Mudan SS, Woodruff JM, Brennan MF. Two hundred gastrointestinal stromal tumors: recurrence patterns and prognostic factors for survival. Ann Surg. 2000 Jan;231(1):51-8.

ReferenceCitation: Dematteo RP, Heinrich MC, El-Rifai WM, Demetri G. Clinical management of gastrointestinal stromal tumors: before and after STI-571. Hum Pathol. 2002 May;33(5):466-77.

ReferenceCitation: Demetri GD, von Mehren M, Blanke CD, Van den Abbeele AD, Eisenberg B, Roberts PJ, Heinrich MC, Tuveson DA, Singer S, Janicek M, Fletcher JA, Silverman SG, Silberman SL, Capdeville R, Kiese B, Peng B, Dimitrijevic S, Druker BJ, Corless C, Fletcher CD, Joensuu H. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med. 2002 Aug 15;347(7):472-80.

ReferenceCitation: Demetri GD, von Mehren M, Antonescu CR, DeMatteo RP, Ganjoo KN, Maki RG, Pisters PW, Raut CP, Riedel RF, Schuetze S, Sundar HM, Trent JC, Wayne JD. NCCN Task Force report: update on the management of patients with gastrointestinal stromal tumors. J Natl Compr Canc Netw. 2010 Apr;8 Suppl 2:S1-41; quiz S42-4.

ReferenceCitation: Patrikidou A, Chabaud S, Ray-Coquard I, Bui BN, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Domont J, Pérol D, Blay JY, Le Cesne A; French Sarcoma Group. Influence of imatinib interruption and rechallenge on the residual disease in patients with advanced GIST: results of the BFR14 prospective French Sarcoma Group randomised, phase III trial. Ann Oncol. 2013 Apr;24(4):1087-93. doi: 10.1093/annonc/mds587. Epub 2012 Nov 21.

ReferenceCitation: Gold JS, Gönen M, Gutiérrez A, Broto JM, García-del-Muro X, Smyrk TC, Maki RG, Singer S, Brennan MF, Antonescu CR, Donohue JH, DeMatteo RP. Development and validation of a prognostic nomogram for recurrence-free survival after complete surgical resection of localised primary gastrointestinal stromal tumour: a retrospective analysis. Lancet Oncol. 2009 Nov;10(11):1045-52. doi: 10.1016/S1470-2045(09)70242-6. Epub 2009 Sep 28.

ReferenceCitation: H.Joensuu, M.Eriksson, J.Hatrmann, K.Sundby Hall, J.Schutte, A. Reichardt, M.Schlemmer, E. Wardelmann, G.Ramadori, S. E. Al-Batran B. E. Nilsson O. Monge R. Kallio, and M.Sarlomo-Rikala, P. Bono M. Leinonen P. Hohenberger T. Alvegard P. Reichardt. Three years of imatinib improves survival for high-risk gastrointestinal stromal tumours. ASCO 2011 . 2011. Ref Type: Abstract

ReferenceCitation: Heinrich MC, Corless CL, Demetri GD, Blanke CD, von Mehren M, Joensuu H, McGreevey LS, Chen CJ, Van den Abbeele AD, Druker BJ, Kiese B, Eisenberg B, Roberts PJ, Singer S, Fletcher CD, Silberman S, Dimitrijevic S, Fletcher JA. Kinase mutations and imatinib response in patients with metastatic gastrointestinal stromal tumor. J Clin Oncol. 2003 Dec 1;21(23):4342-9.

ReferenceCitation: Hirota S, Isozaki K, Moriyama Y, Hashimoto K, Nishida T, Ishiguro S, Kawano K, Hanada M, Kurata A, Takeda M, Muhammad Tunio G, Matsuzawa Y, Kanakura Y, Shinomura Y, Kitamura Y. Gain-of-function mutations of c-kit in human gastrointestinal stromal tumors. Science. 1998 Jan 23;279(5350):577-80.

ReferenceCitation: Jiang WZ, Guan GX, Lu HS, Yang YH, Kang DY, Huang HG. Adjuvant imatinib treatment after R0 resection for patients with high-risk gastrointestinal stromal tumors: a median follow-up of 44 months. J Surg Oncol. 2011 Dec;104(7):760-4. doi: 10.1002/jso.22010. Epub 2011 Jun 28.

ReferenceCitation: Joensuu,H. and Ericksson,M.H.J. (2011). Twelve versus 36 monts of adjuvant imatinib as treatment of operable GIST with high risk of recurrence: Final results of a randomized trial (SSGXVIII/AIO). J. Clin. Oncol.

ReferenceCitation: Joensuu H, Vehtari A, Riihimäki J, Nishida T, Steigen SE, Brabec P, Plank L, Nilsson B, Cirilli C, Braconi C, Bordoni A, Magnusson MK, Linke Z, Sufliarsky J, Federico M, Jonasson JG, Dei Tos AP, Rutkowski P. Risk of recurrence of gastrointestinal stromal tumour after surgery: an analysis of pooled population-based cohorts. Lancet Oncol. 2012 Mar;13(3):265-74. doi: 10.1016/S1470-2045(11)70299-6. Epub 2011 Dec 6. Review.

ReferenceCitation: Le Cesne,A., Ray-Coquard,I.L., Bui Nguyen,B., Adenis,A., Rios,M., Bertucci,F., Duffaud,F., Cupissol,D., Chevreau,C., Bompas,E., Cioffi,A., Chabaud,S., Perol,D., and Blay,J. (2011). Time to secondary resistance (TSR) after interruption of imatinib (IM) in advanced GIST: Updated results of the prospective French Sarcoma Group randomized phase III trial on long-term survival. ASCO Meeting Abstracts 29, 10015.

ReferenceCitation: Le Cesne A, Ray-Coquard I, Bui BN, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Cioffi A, Emile JF, Chabaud S, Pérol D, Blay JY; French Sarcoma Group. Discontinuation of imatinib in patients with advanced gastrointestinal stromal tumours after 3 years of treatment: an open-label multicentre randomised phase 3 trial. Lancet Oncol. 2010 Oct;11(10):942-9. doi: 10.1016/S1470-2045(10)70222-9. Epub 2010 Sep 21.

ReferenceCitation: Pisters PW, Colombo C. Adjuvant imatinib therapy for gastrointestinal stromal tumors. J Surg Oncol. 2011 Dec;104(8):896-900. doi: 10.1002/jso.22002. Review.

ReferenceCitation: Ray-Coquard,I.L., Bin Bui,N., Adenis,A., Rios,M., Bertucci,F., Chabaud,S., Perol,D., Blay,J., Le Cesne,A., and Groupe Sarcome Francais & Groupe d'Etude des Tumeurs Osseuses (GSF-GETO) (2010). Risk of relapse with imatinib (IM) discontinuation at 5 years in advanced GIST patients: Results of the prospective BFR14 randomized phase III study comparing interruption versus continuation of IM at 5 years of treatment: A French Sarcoma Group Study. ASCO Meeting Abstracts 28, 10032.

ReferenceCitation: Tryggvason G, Gíslason HG, Magnússon MK, Jónasson JG. Gastrointestinal stromal tumors in Iceland, 1990-2003: the icelandic GIST study, a population-based incidence and pathologic risk stratification study. Int J Cancer. 2005 Nov 1;117(2):289-93.

ReferenceCitation: Tzen CY, Wang JH, Huang YJ, Wang MN, Lin PC, Lai GL, Wu CY, Tzen CY. Incidence of gastrointestinal stromal tumor: a retrospective study based on immunohistochemical and mutational analyses. Dig Dis Sci. 2007 Mar;52(3):792-7.

ReferenceCitation: Verweij J, Casali PG, Zalcberg J, LeCesne A, Reichardt P, Blay JY, Issels R, van Oosterom A, Hogendoorn PC, Van Glabbeke M, Bertulli R, Judson I. Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial. Lancet. 2004 Sep 25-Oct 1;364(9440):1127-34.

lead_sponsor: Centre Leon Berard

location_facility: Centre Hospitalier Universitaire La Timone

location_facility: Centre Hospitalier universitaire Robert Debré

location_facility: Institut de cancérologie LUCIEN NEUWIRTH

location_facility: Centre Régional de Lutte contre le Cancer de Montpellier


type: Registry Identifier

title: AURORA: A Phase 3 Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis

summary: The AURORA study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult subjects with NASH.

lead_sponsor: Tobira Therapeutics, Inc.

location_country:
Peru
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
France
Poland
Norway
Argentina
Canada
Slovenia
Chile
Hong Kong
Switzerland
Singapore
Hungary
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Georgia
New Zealand
Spain
Latvia

location_facility: Hospital Professor Doutor Fernando Fonseca

location_facility: University of Louisville Physicians - University Medical Associates (UMA)

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: Clinical Research Associates of South Florida

location_facility: Digestive Health Associates of Texas-Rockwall

location_facility: FSBI "Federal Siberian Scientific Clinical Center of FMBA"

location_facility: I.M. Sechenov First Moscow State Medical University

location_facility: Sklifosovsky Scientific Research Institution of Emergency Care

location_facility: Hospital Clinico Universitario de Valencia

location_facility: South Florida Center of Gastroenterology, PA

location_facility: Centre hospitalier universitaire de Poitiers

location_facility: Rambam Health Care Campus - Rambam Medical Center

location_facility: Groupe Hospitalier - Hôpitaux Universitaires Pitie-Salpetriere - Charles-Foix - Pitie-Salpetriere

location_facility: National Diabetes and Obesity Research Institute

location_facility: Michael E. DeBakey VA Medical Center (MEDVAMC)

location_facility: Gastroenterology Associates of Northern Virginia

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spólka Partnerska

location_facility: Centre Hospitalier Universitaire Grenoble

location_facility: Centrum Medycyny i Stomatologii Silesia Med

location_facility: Centre HospitalierUniversitaire de Caen - Hopital Cote de Nacre

location_facility: Hospital Clínico Universitario Virgen de la Victoria

location_facility: Hospital Santa Luzia de Viana do Castelo

location_facility: Prince of Wales Hospital, Dept. of Medicine and Therapeutics

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: ClinTrial-UD Institute of Infectology, Clinical Pharmacology and Allergology

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

location_facility: Wojewódzki Specjalistyczny Szpital im. dr Wl. Bieganskiego w Lodzi

location_facility: Bruce W. Carter Department of Veterans Affairs Medical Center

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Gastroenterology Consultants of Clearwater

location_facility: Barts Health NHS Trust The Royal London Hospital

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Gastroenterology Associates - Crystal River

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: Hull and East Yorkshire Hospitals NHS Trust

location_facility: Center Hospitalier Universitaire d'Angers

location_facility: Diabetes & Glandular Disease Clinic, P.A. (DGD)

location_facility: Chang Gung Medical Foundation-LinKou Branch

location_facility: University of Iowa Hospitals and Clinics

location_facility: Adult Gastroenterology Associates-Gen1 Research

location_facility: Baylor Scott & White All Saints Medical Center - Ft. Worth

location_facility: Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet; Szent Laszlo Korhaz

location_facility: Centre Hospitalier Regional et Universitaire de Besançon Hôpital Jean-Minjoz

location_facility: Azienda Ospedaliera S. Orsola - Malpighi

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Azienda Ospedaliero-Universitaria "Maggiore della Carità"

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Gastroenterology Associates of Central Georgia

location_facility: Univerzitetni klinicni center Ljubljana (University Clinical Center Ljubljana)

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Synexus Lancashire Clinical Research Centre

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: Ziv Medical Center-Endocrinology & Diabates Center ZIv MC

location_facility: Centre Hospitalier Universitaire de Nice Hôpital l'Archet

location_facility: Kansas City Veterans Affairs Medical Center

location_facility: Consultorio Médico Dr. Alma Laura Ladron de Guevara

location_facility: University of San Francisco, Fresno Medical Education Program

location_facility: Hospital das Clínicas da Faculdade de Medicina da Riberao Preto da Universidade de São Paulo

location_facility: The State University of New York, University at Buffalo

location_facility: Washington University School of Medicine

location_facility: Nottingham Digestive Diseases Biomedical Research Unit

location_facility: Privat Institution Educational Organization of Higher Education "Medical University "Reaviz"

location_facility: Stanford School of Medicine, Center for Clinical Sciences Research

location_facility: Gemeinschaftspraxis Drs. Denger und Pfitzner

location_facility: Innovative Medical Research of South Florida, Inc.

location_facility: Pécsi Tudományegyetem, Klinikai Központ, I.sz.Belgyógyászati Klinika

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Gastrointestinal and Liver disease consultants

location_facility: Centre Hospitalier Universitaire Hopital Henri Mondor

location_facility: Hospital Universitario Nuestra Senora de Valme

location_facility: Objective GI D/B/A North Alabama GI Research Center

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino

location_facility: University Hospitals of North Midlands NHS Trust

location_facility: Unità Operativa Complessa Medicina Interna a indirizzo Metabolico Nutrizionale

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Gastroenterology Associates of Fairfield County

location_facility: Synexus Clinical Research GmbH, Prüfzentrum Frankfurt

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankhen

location_facility: The University of North Carolina at Chapel Hill

location_facility: Eastern Pennsylvania Gastroenterology and Liver Specialist

location_facility: Gastroenterology Associates of Pensacola

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: Consultorio Dra. Maria Sarai Gonzalez Huezo

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: GI Specialists of Georgia - Marietta Office

location_facility: Centro de Investigaciones Clínicas Viña del Mar

location_facility: University General Hospital of Alexandroupolis

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Spitalul Clinic Jude¿ean de Urgen¿a Cluj-Napoca

location_facility: Gastroenterology Consultants of Southwest Virginia

location_facility: Southern California Kaiser Permanente, Los Angeles Medical Center

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Synexus North Teesside Clinical Research Centre

location_facility: Synexus Merseyside Clinical Research Centre

location_facility: Hospital da Senhora da Oliveira - Guimarães

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus

location_facility: University General Hospital of Patras Panagia I Voithia

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Specjalistyczna Praktyka Lekarska WAMED Zawiercie

location_facility: Centro Hospitalar Lisboa Central - Hospital Capuchos

location_facility: Luton and Dunstable Hospital NHS Foundation Trust

location_facility: Hospital das Clínicas da Universidade Federal de Minas Gerais

location_facility: North-Western State Medical University named after I.I. Mechnikov

location_facility: Faculdade de Medicina de São José do Rio Preto Hospital de Base

location_facility: Marshall University Department of Clinical and Translational Sciences

location_facility: Medical Professional Clinical Research Center, INC

location_facility: Smolensk City Hospital 1, Department of Infectious Diseases

location_facility: William Osler Health Centre, Brampton Memorial Hospital Campus

location_facility: NYU Langone Health - Perlmutter Cancer Center

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: SYNEXUS Magyarország Kft. - Budapest DRS

location_facility: Synexus Clinical Research GmbH, Prüfzentrum Berlin

location_facility: Veterans Affairs Greater Los Angeles Healthcare System

location_facility: Szabolcs - Szatmár - Bereg Megyei Kórházak és Egyetemi Oktatókórház

location_facility: University Hospital of South Manchester NHS Foundation Trust

location_facility: Main Line Gastroenterology Associates, P.C.

location_facility: Rutgers University New Jersey Medical School

location_facility: U.O.C. Gastroenterologia ed Epatologia Azienda Ospedaliera Universitaria Policlinico Federico II

location_facility: Divisione di Gastro-Epatologia, Università di Torino Ospedale S. Giovanni Battista

location_facility: Moscow Regional Research and Clinical Institute M.F. Vladimirsky

location_facility: Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. O Fodor

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Trinity Universal Research Associates, Inc

location_facility: Synexus Manchester Clinical Research Centre

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Digestive Health Specialists of the Southeast

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Consorci Hospital General Universitari de València

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Hospital Universitário Clementino Fraga Filho da Universidade Federal do Rio de Janeiro

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Texas Digestive Disease Consultants - Fort Worth

location_facility: Hospital General Universitario de Alicante

location_facility: Southern California Permanente Medical Group

location_facility: UT-Memphis, Methodist University Hospital

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft

location_facility: Centre Hospitalier Universitaire de Rouen CHU de Rouen Hopital Charles-Nicolle

location_facility: Polo Universitario - L'Azienda Ospedaliera Luigi Sacco

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

location_facility: The Ohio University - Gastroenterology, Hepatology

location_facility: Complejo Asistencial Universitario de León

location_facility: Ruane Medical and Liver Health Institute

location_facility: University of Texas Southwestern Medical Center

location_facility: Digestive Healthcare of Georgia - Atlanta

location_facility: Gastroenterology Associates of Western Colorado

location_facility: Advanced Clinical Research - Center for Digestive Health


title: Effects of Home Pulmonary Rehabilitation in Patients With Chronic Respiratory Failure and Nutritional Depletion.

summary:
Title : Effects of home pulmonary rehabilitation in patients with chronic respiratory failure and nutritional depletion.

This is a randomized controlled, open clinical trial with two groups.

first group, 100 patients : control group, patients followed with no add-on intervention
Second group, 100 patients : rehabilitation group with education, oral supplements, exercise and androgenic steroids.

ReferenceCitation: Veale D, Chailleux E, Taytard A, Cardinaud JP. Characteristics and survival of patients prescribed long-term oxygen therapy outside prescription guidelines. Eur Respir J. 1998 Oct;12(4):780-4.

ReferenceCitation: Rönning O. Alterations in craniofacial morphogenesis induced by parenterally administered papain. An experimental study on the rat. Suom Hammaslaak Toim. 1971;67:Suppl 3:3-96.

ReferenceCitation: Chailleux E, Fauroux B, Binet F, Dautzenberg B, Polu JM. Predictors of survival in patients receiving domiciliary oxygen therapy or mechanical ventilation. A 10-year analysis of ANTADIR Observatory. Chest. 1996 Mar;109(3):741-9.

ReferenceCitation: Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Report of the Medical Research Council Working Party. Lancet. 1981 Mar 28;1(8222):681-6.

ReferenceCitation: Okubadejo AA, Paul EA, Jones PW, Wedzicha JA. Does long-term oxygen therapy affect quality of life in patients with chronic obstructive pulmonary disease and severe hypoxaemia? Eur Respir J. 1996 Nov;9(11):2335-9.

ReferenceCitation: Barnes PJ. Novel approaches and targets for treatment of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1999 Nov;160(5 Pt 2):S72-9. Review.

ReferenceCitation: Hunter AM, Carey MA, Larsh HW. The nutritional status of patients with chronic obstructive pulmonary disease. Am Rev Respir Dis. 1981 Oct;124(4):376-81.

ReferenceCitation: Schols AM, Soeters PB, Dingemans AM, Mostert R, Frantzen PJ, Wouters EF. Prevalence and characteristics of nutritional depletion in patients with stable COPD eligible for pulmonary rehabilitation. Am Rev Respir Dis. 1993 May;147(5):1151-6.

ReferenceCitation: Schols AM. Nutrition in chronic obstructive pulmonary disease. Curr Opin Pulm Med. 2000 Mar;6(2):110-5. Review.

ReferenceCitation: Schols AM, Mostert R, Soeters PB, Greve LH, Wouters EF. Nutritional state and exercise performance in patients with chronic obstructive lung disease. Thorax. 1989 Nov;44(11):937-41.

ReferenceCitation: Pison CM, Cano NJ, Chérion C, Caron F, Court-Fortune I, Antonini MT, Gonzalez-Bermejo J, Meziane L, Molano LC, Janssens JP, Costes F, Wuyam B, Similowski T, Melloni B, Hayot M, Augustin J, Tardif C, Lejeune H, Roth H, Pichard C; IRAD Investigators. Multimodal nutritional rehabilitation improves clinical outcomes of malnourished patients with chronic respiratory failure: a randomised controlled trial. Thorax. 2011 Nov;66(11):953-60. doi: 10.1136/thx.2010.154922. Epub 2011 Jun 23.

family: Pison

full_name: C. M. Pison

given: C. M.

family: Cano

full_name: N. J. Cano

given: N. J.

family: Cherion

full_name: C. Cherion

given: C.

family: Caron

full_name: F. Caron

given: F.

family: Court-Fortune

full_name: I. Court-Fortune

family: Antonini

full_name: M.-T. Antonini

family: Gonzalez-Bermejo

full_name: J. Gonzalez-Bermejo

given: J.

family: Meziane

full_name: L. Meziane

family: Molano

full_name: L. C. Molano

given: L. C.

family: Janssens

full_name: J.-P. Janssens

family: Costes

full_name: F. Costes

family: Wuyam

full_name: B. Wuyam

given: B.

family: Similowski

full_name: T. Similowski

given: T.

family: Melloni

full_name: B. Melloni

family: Hayot

full_name: M. Hayot

family: Augustin

full_name: J. Augustin

family: Tardif

full_name: C. Tardif

family: Lejeune

full_name: H. Lejeune

given: H.

family: Roth

full_name: H. Roth

family: Pichard

full_name: C. Pichard

journal_name: Thorax

repository_institution: University of Oxford - Oxford Academic Notes & Queries

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - ENS-LYON

location_facility: University Hospital Arnaud de Villeneuve

location_facility: Departement of Medicine, University Hospital of Genève


title: A Cohort Study of Patients With Metastatic Colorectal Cancer Treated With Avastin® as First-line Therapy for Liver Metastases Considered as Potentially Resectable

acronym: PICASSO

summary: This observational study will evaluate the efficacy and safety of bevacizumab as first-line treatment in participants with colorectal cancer and potentially resectable liver metastases.

lead_sponsor: Hoffmann-La Roche

location_facility: Polyclinique Du Languedoc; Chimiotherapie

location_facility: Hopital De La Croix Rousse;Hepato Gastro Entero

location_facility: Hopital Du Haut-Leveque; Gastro-Enterologie

location_facility: C.H. Du Pays D'aix En Provence Service du Dr Blanc

location_facility: CMCO De La Cote D Opale; Auberge De Jour

location_facility: Centre Hospitalier de L'Agglomeration Montargeoise; Medecine Polyvalente A Orientation Mi & Cancero

location_facility: Chu La Miletrie; Gastro Enterologie Endoscopies

location_facility: Hopital De L Archet;Gastro Nutrition Oncologie

location_facility: Hopital Charles Nicolle; Endoscopies Digestives

location_facility: Clinique Du Parc Imperial; Chimiotherapie

location_facility: CHU Henri Mondor; Service d'Oncologie Medicale

location_facility: Hopital Albert Michallon; Gastro Enterologie

location_facility: Clinique Champeau Mediterranee; Radiotherapie Oncologie

location_facility: Hopital Rene Dubos; Service de Medecine Generale & de Gastro-Enterologie

location_facility: CH Du Cotentin Site De Cherbourg; Hopital De Jour

location_facility: Centre Azureen De Cancerologie; Cons externes

location_facility: Ctre Hosp St Joseph Et St Luc; Gastro Enterologie Endoscopie

location_facility: Clinique Armoricaine Radiologie; Hopital de Jour

location_facility: CH Bretagne Sud Site Bodelio; Oncologie Radiotherapie

location_facility: Clinique Saint Hilaire; Sce Chimiotherapie

location_facility: Clinique Des 4 Pavillons; Chimiotherapie

location_facility: Hopital Yves Le Foll; Hepatologie Gastro Enterologie

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Ghi Le Raincy Montfermeil; Radiotherapie Oncologie

location_facility: Clinique Saint Faron; Sce Oncologie Radiotherapie

location_facility: Ghi Le Raincy Montfermeil; Gastro Medecine Interne

location_facility: Ctre Radiotherapie Joseph Belot; Hematologie

location_facility: Hopital Simone Veil Eaubonne; Hopital De Jour

location_facility: Chp Saint Gregoire; Cancerologie Radiotherapie

location_facility: GH Paris Saint Joseph; Hopital De Jour Oncologie

location_facility: Centre Hospitalier General; Oncologie Medicale

location_facility: Clinique Sainte Marguerite; Oncologie Medicale

location_facility: Hopital Clinique Claude Bernard; Oncologie Medicale

location_facility: Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie

location_facility: Chi Poissy Saint Germain En Laye; Centre Coordination Cancerologie

location_facility: Polyclinique Sainte Marguerite; Chimiotherapie

location_facility: Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

location_facility: Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

location_facility: Clinique Pasteur; Oncologie Medicale, Hematologie

location_facility: Ch De Montelimar; Gastro Enterologie Oncologie

location_facility: Hopital Victor Jousselin; Gastro Enterologie

location_facility: Hopital Des Diaconesses; Hopital De Jour

location_facility: Memorial France Etats Unis; Hopital De Jour

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie

location_facility: Hopital Alpha Sante De Hayange; Medecine B

location_facility: CH Dptal Les Oudairies; Gastro Enterologie

location_facility: Clinique De L Europe; Radiotherapie Chimiotherapie

location_facility: Clinique Chir De L Orangerie; Chimiotherapie

location_facility: Ch Lyon Sud; Gastro Secteur Jules Courmont

location_facility: Hopital Jacques Lacarin; Hopital De Jour

location_facility: Polyclin Bordeaux Nord Aquitaine; Gastro Enterologie

location_facility: Infirmerie Protestante; Endos Digestive Coelioscopie

location_facility: CH Dptal Les Oudairies; Hematologie Oncologie

location_facility: Ch De Longjumeau; Hopital De Jour Et Semaine

location_facility: Ch Jean Rougier; Oncologie Gastro Enterologie

location_facility: HOP Prive Arras Les Bonnettes; Chimiotherapie

location_facility: Clinique De La Sauvegarde; Chimiotherapie

location_facility: Fondation Hopital Saint Joseph; Gastro-Enterologie

location_facility: Polyclinique de Blois; Chimiotherapie Ambulatoire

location_facility: Ch Pitie Salpetriere; Oncologie Medicale


title: A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE)

acronym: EMBRACE

summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients of black race with systemic lupus erythematosus (SLE; lupus).

ReferenceCitation: Ginzler E, Guedes Barbosa LS, D'Cruz D, Furie R, Maksimowicz-McKinnon K, Oates J, Santiago MB, Saxena A, Sheikh S, Bass DL, Burriss SW, Gilbride JA, Groark JG, Miller M, Pierce A, Roth DA, Ji B; At the time of the study. EMBRACE: Phase 3/4, Randomized, 52-Week Study of Belimumab Efficacy and Safety in Patients of Black African Ancestry With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2021 Jun 23. doi: 10.1002/art.41900. [Epub ahead of print]

ReferenceCitation: Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3). pii: e001747. doi: 10.1136/rmdopen-2021-001747.

family: Brunner

full_name: Hermine I Brunner

given: Hermine I

family: Abud-Mendoza

full_name: Carlos Abud-Mendoza

given: Carlos

family: Mori

full_name: Masaaki Mori

given: Masaaki

family: Pilkington

full_name: Clarissa A Pilkington

given: Clarissa A

family: Syed

full_name: Reema Syed

given: Reema

family: Takei

full_name: Syuji Takei

given: Syuji

family: Viola

full_name: Diego O Viola

given: Diego O

family: Furie

full_name: Richard A Furie

given: Richard A

family: Navarra

full_name: Sandra Navarra

given: Sandra

family: Zhang

full_name: Fengchun Zhang

given: Fengchun

family: Bass

full_name: Damon L Bass

given: Damon L

family: Eriksson

full_name: Gina Eriksson

given: Gina

family: Hammer

full_name: Anne E Hammer

given: Anne E

family: Ji

full_name: Beulah N Ji

given: Beulah N

family: Okily

full_name: Mohamed Okily

given: Mohamed

full_name: David A Roth

given: David A

family: Quasny

full_name: Holly Quasny

given: Holly

family: Ruperto

full_name: Nicolino Ruperto

given: Nicolino

currency_apc_doaj: GBP

journal_name: RMD Open

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

ipd_sharing_description: IPD for this study is available via the Clinical Study Data Request site

lead_sponsor: Human Genome Sciences Inc., a GSK Company

location_country:
Brazil
South Africa
France
United States
United Kingdom
Colombia


title: SMILE Study: Effectiveness and Safety of STYLAGE® M Lidocaïne for Lips' Volume Augmentation and/or Redefinition of the Outline of the Lips

acronym: SMILE

summary:
STYLAGE® M Lidocaine is a hyaluronic acid injectable gel CE (conformité européenne)-marketed since 2009 . It is indicated for the outline of the lips and/or for lips augmentation in lips mucosa. It is also indicated to fill skin depressions on the face. Lidocaine is intended to reduce the pain associated with the injection.

The aim of SMILE study is to demonstrate that STYLAGE® M Lidocaine is non-inferior to an active comparator that has shown its effectiveness in lips' volume augmentation and restoration in improving the aesthetic appearance of the lips evaluated by subjects.

In this study, 92 healthy volunteers between 18 and 65 years old, who expressed the wish for augmentation or restoration of the volume of the lips and/or lips' outline redefinition, confirmed by investigators at inclusion, who have given his/her informed consent and who met all the eligibility criteria, will be enrolled.

Subjects will randomly receive STYLAGE® M Lidocaïne or the active comparator (ratio 1:1) injection in the lips at first visit on Day 0. At second visit, one month after Day 0, an optional touch-up injection could be performed according to subject's and investigator's opinions and if the subject is still eligible.

Subjects will have a total of 6 visits over a 12 months follow-up period and a screening visit prior to first injection.

Proportion of subjects having a global aesthetic improvement of their lips (blinded self-evaluation), 3 months after treatment initiation will be assessed and compared between the two groups. This will also be done during the other visits (1, 6, 9 and 12 months after treatment initiation). Global aesthetic improvement according to blinded independent evaluator, subjects' satisfaction, pain during injection and safety parameters will also be assessed during the study period.

lead_sponsor: Laboratoires Vivacy

location_country: France Poland

location_facility:
Eurofins Dermscan Poland
Eurofins Dermscan Pharmascan


title: A Phase 1/2, Multicenter, Open-label, Dose-confirmation Trial to Evaluate the Safety and Preliminary Efficacy of DYN101 in Participants 2 to 17 Years of Age With Centronuclear Myopathy Caused by Mutations in MTM1 or DNM2

acronym: DyNaMic

summary: There are no available treatments aside from supportive care for patients with Centronuclear myopathy (CNM). This trial will assess the safety and tolerability as well as pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of DYN101 in participants 2 to 17 years of age with CNM caused by mutations in DNM2 or MTM1.The trial will consist of a pre-screening consent, a screening period, a run-in period (if applicable), and a Part 1 of 12 weeks with weekly infusion of DYN101 to evaluate safety and tolerability as well as PK, PD and preliminary efficacy. The dose level may need adjustment based on the Part 1 results of the current study and available data from the Unite-CNM study (DYN101-C101, NCT04033159). If a dose adjustment is needed, Part 2 will be conducted in the same participants and the newly selected dose level will be used to assess whether efficacy is seen after an additional 12 weeks of treatment. As this trial is investigational, there is no defined, expected benefit for subjects who participate in this trial except a better knowledge of their disease.

status: Not yet recruiting

ReferenceCitation: Tasfaout H, Buono S, Guo S, Kretz C, Messaddeq N, Booten S, Greenlee S, Monia BP, Cowling BS, Laporte J. Antisense oligonucleotide-mediated Dnm2 knockdown prevents and reverts myotubular myopathy in mice. Nat Commun. 2017 Jun 7;8:15661. doi: 10.1038/ncomms15661.

lead_sponsor: Dynacure

location_country: Germany France

location_facility:
I-Motion Institute - Trousseau Hospital
Universitätsklinikum Essen


title: A Study on Genetic Alterations (Polymorphism) in Key Genes in the Kynurenine Pathway on Suicidal Behavior

acronym: SuiKYN

summary: Current research has shown that an imbalance in the Kinurenine pathway plays a role in the physiopathology of neurogenerative and mental disorders (with a decrease in neuroprotective metabolites and an increase in neurotoxic products). So far the research has concentrated on the enzymes IDO, KAT, KMO, 3HAO and QPRT which are the key players in this pathway. Several polymorphisms affecting these enzymes have been associated with certain disorders characterized by a deregulation of the inflammation and immune response (McCauley et al 2009,Tardito et al 2013, Lee et al 2014), but no studies have ever tried to find a link between these enzymes and suicidal behavior. The investigators hypothesize that people who have attempted to commit suicide will have pro-inflammatory genetic variations affecting the kynurenine pathway.

time_perspective: Retrospective

lead_sponsor: Centre Hospitalier Universitaire de Nīmes

location_country: France Spain

location_facility: Centre Hospitalier Universitaire de Nîmes

intervention_type: Genetic


title: Stress Induced by the COVID-19 Pandemic and Nonconfinement: Study of Anxiety Factors and Potential Effects on Immunity.

acronym: SCEI

summary: The aim of this project is to evaluate the impact of pandemic and nonconfinement related to anxiety and eventual immune diseases with several standardized questionnaires : Implant Stability Quotient (ISQ) , Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire -9 (PHQ-9), Post Traumatic Stress Disorder-8 (PTSD-8), and Experiences in Close Relationship Scale (ECRS).

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_country:
United Kingdom
France

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

location_facility: Centre de Recherche et d'Innovation Clinique

intervention_type: Diagnostic Test


title: Role of Nasal Dysbiosis in Parkinson Disease

acronym: SMELLPARK

summary: Olfactory dysfunction is frequent in Parkinson Disease (PD) and may be present years before the motor symptoms appear. The early olfactory dysfunction could result from environmental factors acting through the nasal cavity such as microbial communities. In across-sectional bicentric study, groups of 160 PD patients and 160 controls will be compared for nasal microbiota composition according to their geographical origin. We will search an association between microbiota and the presence of an olfactory deficit, cognitive deficit and thymic disorder.

time_perspective: Cross-Sectional

lead_sponsor: Institut Pasteur

location_country: France Guadeloupe

location_facility:
Pitie-Salpetriere Hospital
Centre Hospitalier Universitaire