title: A Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)

summary: The purpose of this study is to compare two ways of using anti-HIV drugs to help health care providers and patients decide how to best use anti-HIV treatments over many years. Many health care providers now treat patients with daily drugs to keep the viral load as low as possible. This approach helps patients with CD4 counts less than 200-250 cells/mm3 live longer without serious diseases. But it is not known if this is the best way to treat patients with higher CD4 counts. There is information suggesting that these patients may be able to wait to use anti-HIV drugs while CD4 counts are above 250 cells/mm3. Because this study will be carried out over several years, it will provide information on the long-term advantages and disadvantages of these two treatment strategies.

ReferenceCitation: Lederman MM, Valdez H. Immune restoration with antiretroviral therapies: implications for clinical management. JAMA. 2000 Jul 12;284(2):223-8.

ReferenceCitation: Carpenter CC, Cooper DA, Fischl MA, Gatell JM, Gazzard BG, Hammer SM, Hirsch MS, Jacobsen DM, Katzenstein DA, Montaner JS, Richman DD, Saag MS, Schechter M, Schooley RT, Thompson MA, Vella S, Yeni PG, Volberding PA. Antiretroviral therapy in adults: updated recommendations of the International AIDS Society-USA Panel. JAMA. 2000 Jan 19;283(3):381-90. Review.

ReferenceCitation: Mocroft A, Katlama C, Johnson AM, Pradier C, Antunes F, Mulcahy F, Chiesi A, Phillips AN, Kirk O, Lundgren JD. AIDS across Europe, 1994-98: the EuroSIDA study. Lancet. 2000 Jul 22;356(9226):291-6.

ReferenceCitation: Tebas P, Henry K, Mondy K, Deeks S, Valdez H, Cohen C, Powderly WG. Effect of prolonged discontinuation of successful antiretroviral therapy on CD4+ T cell decline in human immunodeficiency virus-infected patients: implications for intermittent therapeutic strategies. J Infect Dis. 2002 Sep 15;186(6):851-4. Epub 2002 Aug 28. Erratum in: J Infect Dis 2002 Oct 15;186(8):1198.

ReferenceCitation: Yerly S, Kaiser L, Perneger TV, Cone RW, Opravil M, Chave JP, Furrer H, Hirschel B, Perrin L. Time of initiation of antiretroviral therapy: impact on HIV-1 viraemia. The Swiss HIV Cohort Study. AIDS. 2000 Feb 18;14(3):243-9.

ReferenceCitation: Borges ÁH, Neuhaus J, Sharma S, Neaton JD, Henry K, Anagnostou O, Staub T, Emery S, Lundgren JD; INSIGHT SMART; START Study Groups. The Effect of Interrupted/Deferred Antiretroviral Therapy on Disease Risk: A SMART and START Combined Analysis. J Infect Dis. 2019 Jan 7;219(2):254-263. doi: 10.1093/infdis/jiy442.

ReferenceCitation: Castillo-Mancilla JR, Phillips AN, Neaton JD, Neuhaus J, Collins S, Mannheimer S, Pett S, Touzeau-Römer V, Polizzotto MN, Lundgren JD, Gardner EM; INSIGHT SMART Study Group. Association of Suboptimal Antiretroviral Therapy Adherence With Inflammation in Virologically Suppressed Individuals Enrolled in the SMART Study. Open Forum Infect Dis. 2017 Dec 22;5(1):ofx275. doi: 10.1093/ofid/ofx275. eCollection 2018 Jan.

ReferenceCitation: Larson GS, Carey C, Grarup J, Hudson F, Sachi K, Vjecha MJ, Gordin F; INSIGHT Group. Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials. Clin Trials. 2016 Apr;13(2):127-36. doi: 10.1177/1740774515625974. Epub 2016 Feb 8.

ReferenceCitation: Nordell AD, McKenna M, Borges ÁH, Duprez D, Neuhaus J, Neaton JD; INSIGHT SMART, ESPRIT Study Groups; SILCAAT Scientific Committee. Severity of cardiovascular disease outcomes among patients with HIV is related to markers of inflammation and coagulation. J Am Heart Assoc. 2014 May 28;3(3):e000844. doi: 10.1161/JAHA.114.000844.

ReferenceCitation: Lucas GM, Cozzi-Lepri A, Wyatt CM, Post FA, Bormann AM, Crum-Cianflone NF, Ross MJ; INSIGHT SMART Study Group. Glomerular filtration rate estimated using creatinine, cystatin C or both markers and the risk of clinical events in HIV-infected individuals. HIV Med. 2014 Feb;15(2):116-23. doi: 10.1111/hiv.12087. Epub 2013 Sep 11.

ReferenceCitation: Baker JV, Brummel-Ziedins K, Neuhaus J, Duprez D, Cummins N, Dalmau D, DeHovitz J, Lehmann C, Sullivan A, Woolley I, Kuller L, Neaton JD, Tracy RP; INSIGHT SMART Study Team. HIV replication alters the composition of extrinsic pathway coagulation factors and increases thrombin generation. J Am Heart Assoc. 2013 Jul 29;2(4):e000264. doi: 10.1161/JAHA.113.000264.

ReferenceCitation: Hoy J, Grund B, Roediger M, Ensrud KE, Brar I, Colebunders R, Castro ND, Johnson M, Sharma A, Carr A; INSIGHT SMART Body Composition Substudy Group. Interruption or deferral of antiretroviral therapy reduces markers of bone turnover compared with continuous therapy: The SMART body composition substudy. J Bone Miner Res. 2013 Jun;28(6):1264-74. doi: 10.1002/jbmr.1861.

ReferenceCitation: Zetterberg E, Neuhaus J, Baker JV, Somboonwit C, Llibre JM, Palfreeman A, Chini M, Lundgren JD; INSIGHT SMART Study Group. Platelet count kinetics following interruption of antiretroviral treatment. AIDS. 2013 Jan 2;27(1):59-68. doi: 10.1097/QAD.0b013e32835a104d.

ReferenceCitation: Mocroft A, Neuhaus J, Peters L, Ryom L, Bickel M, Grint D, Koirala J, Szymczak A, Lundgren J, Ross MJ, Wyatt CM; INSIGHT SMART Study Group; ESPRIT Study Group. Hepatitis B and C co-infection are independent predictors of progressive kidney disease in HIV-positive, antiretroviral-treated adults. PLoS One. 2012;7(7):e40245. Epub 2012 Jul 20.

ReferenceCitation: Baker JV, Neuhaus J, Duprez D, Cooper DA, Hoy J, Kuller L, Lampe FC, Liappis A, Friis-Moller N, Otvos J, Paton NI, Tracy R, Neaton JD; INSIGHT SMART Study Group. Inflammation predicts changes in high-density lipoprotein particles and apolipoprotein A1 following initiation of antiretroviral therapy. AIDS. 2011 Nov 13;25(17):2133-42. doi: 10.1097/QAD.0b013e32834be088.

ReferenceCitation: Mocroft A, Lifson AR, Touloumi G, Neuhaus J, Fox Z, Palfreeman A, Vjecha MJ, Hodder S, De Wit S, Lundgren JD, Phillips AN; INSIGHT SMART Study Group. Haemoglobin and anaemia in the SMART study. Antivir Ther. 2011;16(3):329-37. doi: 10.3851/IMP1746.

ReferenceCitation: Duprez DA, Neuhaus J, Tracy R, Kuller LH, Deeks SG, Orkin C, Stoehr A, Woolley IJ, Neaton JD; INSIGHT SMART Group. N-terminal-proB-type natriuretic peptide predicts cardiovascular disease events in HIV-infected patients. AIDS. 2011 Mar 13;25(5):651-7. doi: 10.1097/QAD.0b013e32834404a1.

ReferenceCitation: Lampe FC, Duprez DA, Kuller LH, Tracy R, Otvos J, Stroes E, Cooper DA, Hoy J, Paton NI, Friis-Møller N, Neuhaus J, Liappis AP, Phillips AN; INSIGHT SMART Study Group. Changes in lipids and lipoprotein particle concentrations after interruption of antiretroviral therapy. J Acquir Immune Defic Syndr. 2010 Jul;54(3):275-84.

ReferenceCitation: Dore GJ, Soriano V, Rockstroh J, Kupfer B, Tedaldi E, Peters L, Neuhaus J, Puoti M, Klein MB, Mocroft A, Clotet B, Lundgren JD; SMART INSIGHT study group. Frequent hepatitis B virus rebound among HIV-hepatitis B virus-coinfected patients following antiretroviral therapy interruption. AIDS. 2010 Mar 27;24(6):857-65. doi: 10.1097/QAD.0b013e328334bddb.

ReferenceCitation: Rodger AJ, Fox Z, Lundgren JD, Kuller LH, Boesecke C, Gey D, Skoutelis A, Goetz MB, Phillips AN; INSIGHT Strategies for Management of Antiretroviral Therapy (SMART) Study Group. Activation and coagulation biomarkers are independent predictors of the development of opportunistic disease in patients with HIV infection. J Infect Dis. 2009 Sep 15;200(6):973-83. doi: 10.1086/605447.

ReferenceCitation: Grund B, Peng G, Gibert CL, Hoy JF, Isaksson RL, Shlay JC, Martinez E, Reiss P, Visnegarwala F, Carr AD; INSIGHT SMART Body Composition Substudy Group. Continuous antiretroviral therapy decreases bone mineral density. AIDS. 2009 Jul 31;23(12):1519-29. doi: 10.1097/QAD.0b013e32832c1792.

ReferenceCitation: Duprez DA, Kuller LH, Tracy R, Otvos J, Cooper DA, Hoy J, Neuhaus J, Paton NI, Friis-Moller N, Lampe F, Liappis AP, Neaton JD; INSIGHT SMART Study Group. Lipoprotein particle subclasses, cardiovascular disease and HIV infection. Atherosclerosis. 2009 Dec;207(2):524-9. doi: 10.1016/j.atherosclerosis.2009.05.001. Epub 2009 May 13.

ReferenceCitation: Mocroft A, Wyatt C, Szczech L, Neuhaus J, El-Sadr W, Tracy R, Kuller L, Shlipak M, Angus B, Klinker H, Ross M; INSIGHT SMART Study Group. Interruption of antiretroviral therapy is associated with increased plasma cystatin C. AIDS. 2009 Jan 2;23(1):71-82. doi: 10.1097/QAD.0b013e32831cc129.

ReferenceCitation: Fox Z, Phillips A, Cohen C, Neuhaus J, Baxter J, Emery S, Hirschel B, Hullsiek KH, Stephan C, Lundgren J; SMART Study Group. Viral resuppression and detection of drug resistance following interruption of a suppressive non-nucleoside reverse transcriptase inhibitor-based regimen. AIDS. 2008 Nov 12;22(17):2279-89. doi: 10.1097/QAD.0b013e328311d16f.

ReferenceCitation: Tedaldi E, Peters L, Neuhaus J, Puoti M, Rockstroh J, Klein MB, Dore GJ, Mocroft A, Soriano V, Clotet B, Lundgren JD; SMART Study Group and International Network for Strategic Initiatives in Global HIV Trials (INSIGHT). Opportunistic disease and mortality in patients coinfected with hepatitis B or C virus in the strategic management of antiretroviral therapy (SMART) study. Clin Infect Dis. 2008 Dec 1;47(11):1468-75. doi: 10.1086/593102.

ReferenceCitation: Kuller LH, Tracy R, Belloso W, De Wit S, Drummond F, Lane HC, Ledergerber B, Lundgren J, Neuhaus J, Nixon D, Paton NI, Neaton JD; INSIGHT SMART Study Group. Inflammatory and coagulation biomarkers and mortality in patients with HIV infection. PLoS Med. 2008 Oct 21;5(10):e203. doi: 10.1371/journal.pmed.0050203.

ReferenceCitation: SMART Study Group, El-Sadr WM, Grund B, Neuhaus J, Babiker A, Cohen CJ, Darbyshire J, Emery S, Lundgren JD, Phillips A, Neaton JD. Risk for opportunistic disease and death after reinitiating continuous antiretroviral therapy in patients with HIV previously receiving episodic therapy: a randomized trial. Ann Intern Med. 2008 Sep 2;149(5):289-99.

ReferenceCitation: Strategies for Management of Anti-Retroviral Therapy/INSIGHT; DAD Study Groups. Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients. AIDS. 2008 Sep 12;22(14):F17-24. doi: 10.1097/QAD.0b013e32830fe35e.

ReferenceCitation: Gordin FM, Roediger MP, Girard PM, Lundgren JD, Miro JM, Palfreeman A, Rodriguez-Barradas MC, Wolff MJ, Easterbrook PJ, Clezy K, Slater LN. Pneumonia in HIV-infected persons: increased risk with cigarette smoking and treatment interruption. Am J Respir Crit Care Med. 2008 Sep 15;178(6):630-6. doi: 10.1164/rccm.200804-617OC. Epub 2008 Jul 10.

ReferenceCitation: Phillips AN, Carr A, Neuhaus J, Visnegarwala F, Prineas R, Burman WJ, Williams I, Drummond F, Duprez D, Belloso WH, Goebel FD, Grund B, Hatzakis A, Vera J, Lundgren JD. Interruption of antiretroviral therapy and risk of cardiovascular disease in persons with HIV-1 infection: exploratory analyses from the SMART trial. Antivir Ther. 2008;13(2):177-87.

ReferenceCitation: Strategies for Management of Antiretroviral Therapy (SMART) Study Group, Lundgren JD, Babiker A, El-Sadr W, Emery S, Grund B, Neaton JD, Neuhaus J, Phillips AN. Inferior clinical outcome of the CD4+ cell count-guided antiretroviral treatment interruption strategy in the SMART study: role of CD4+ Cell counts and HIV RNA levels during follow-up. J Infect Dis. 2008 Apr 15;197(8):1145-55. doi: 10.1086/529523.

ReferenceCitation: Strategies for Management of Antiretroviral Therapy (SMART) Study Group, Emery S, Neuhaus JA, Phillips AN, Babiker A, Cohen CJ, Gatell JM, Girard PM, Grund B, Law M, Losso MH, Palfreeman A, Wood R. Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART study. J Infect Dis. 2008 Apr 15;197(8):1133-44. doi: 10.1086/586713.

ReferenceCitation: Carr A, Grund B, Neuhaus J, El-Sadr WM, Grandits G, Gibert C, Prineas RJ; SMART Study Investigators. Asymptomatic myocardial ischaemia in HIV-infected adults. AIDS. 2008 Jan 11;22(2):257-67.

ReferenceCitation: Burman WJ, Grund B, Roediger MP, Friedland G, Darbyshire J, Wu AW; SMART Study Group. The impact of episodic CD4 cell count-guided antiretroviral therapy on quality of life. J Acquir Immune Defic Syndr. 2008 Feb 1;47(2):185-93.

ReferenceCitation: Strategies for Management of Antiretroviral Therapy (SMART) Study Group, El-Sadr WM, Lundgren J, Neaton JD, Gordin F, Abrams D, Arduino RC, Babiker A, Burman W, Clumeck N, Cohen CJ, Cohn D, Cooper D, Darbyshire J, Emery S, Fätkenheuer G, Gazzard B, Grund B, Hoy J, Klingman K, Losso M, Markowitz N, Neuhaus J, Phillips A, Rappoport C. CD4+ count-guided interruption of antiretroviral treatment. N Engl J Med. 2006 Nov 30;355(22):2283-96.

lead_sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

location_country:
Luxembourg
Spain
Italy
United Kingdom
Lithuania
United States
Peru
Belgium
Japan
Poland
Austria
Australia
Argentina
Puerto Rico
Israel
Norway
Brazil
Canada
Martinique
Switzerland
Germany
Ireland
Estonia
New Zealand
Thailand
France

location_facility: Kaiser Permanente-Fremont/Hayward Medical Centers

location_facility: Ambulatorio de Imunodeficiencias Secundarias/Der30

location_facility: HIV Care Program, Windsor Regional Hospital

location_facility: Dr. Melanie Thompson and Dr. Annette Bernard (Private Practice)

location_facility: Cobb-Douglas County Infectious Disease Clinic

location_facility: St. Joseph's Health Care Centre of London

location_facility: KU Medical School-Wichita, Midtown Clinic

location_facility: Southern Illinois University (SIU) School of Medicine

location_facility: The Research & Education Grp / Oregon Hlth Sci Univ

location_facility: AID Atlanta/Morehouse Med School Ryan White Cl

location_facility: Cassiano Antonio de Moraes University Hospital

location_facility: Providence Hosp- Newland Med Assoc. Inc.

location_facility: Vernon J. Harris East End Community Health Care Ct

location_facility: The Research & Education Group / The R & E Grp Office

location_facility: Centre Hospitalier Universitaire Sart-Tilman

location_facility: Montreal Chest Institute/Royal Victoria Hospital

location_facility: SOCDU Malattie Infettive Ospedale Civile Asti

location_facility: AIDS Research Consortium of Atlanta (ARCA) Central

location_facility: National Centre in HIV Epidemiology and Clinical Research

location_facility: Hawthorn House, Birmingham Heartlands NHS Trust

location_facility: Universita degli Studi di Modena e Reggio Emilia

location_facility: Cooper Hospital Early Intervention Program

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Klinikum der Ruprecht-Karis-Universitat (U. Hospital)

location_facility: Hospital Universitario Principe de Asturias

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Servizio Regionale di Immunologia Clinica e Tipizz

location_facility: Hospital Interzonall de San Juan de Dios

location_facility: Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

location_facility: Dekalb County Health Dept Infectious Disease

location_facility: HIV Services Clinic/Family Practice Medical Center

location_facility: Wayne State Univ / Medical College of Ohio at Toledo

location_facility: Centro de Pesquisa Clinical do Hospital Guilherme

location_facility: AIDS Medical Center, International Medical Center

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Infectious Disease Associates of Virginia

location_facility: The Caldecot Centre, Kings College Hospital NHS Tr

location_facility: Centre hospitalier de l'universite Laval (CHUL)

location_facility: Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit

location_facility: Watford Sexual Health Center;Watford General Hosp

location_facility: Los Angeles Gay and Lesbian Community Service Ctr

location_facility: Treasure Coast Infectious Disease Consultants

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Dept. of Infection and Tropical Medicine - Royal Hallamshire Hospital

location_facility: Hospital Universitario Professor Edgard Santos

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Community Research Initiatives of New England

location_facility: Universidade Federal De Sao Paulo-Hospital Sao Paulo

location_facility: University Of Wisconsin Hospital and Clinics/CORNET, HIV Care Program

location_facility: University of Mississippi Medical Center

location_facility: Klinik fur Dermatologie, Venerologie, Allergologie

location_facility: Center for Prevention and Treatment of Infections

location_facility: Victoria General Hospital, Q.E. II Health Sciences

location_facility: Michigan State University Infectious Diseases Clinic

location_facility: The Research & Education Group / Multomah Cnty Hlth Dept

location_facility: Instituto de Malattie Infettive e Tropicali

location_facility: The Rsch & Ed Grp / Providence Portland Med Ctr

location_facility: Homerton University Hospital NHS Foundation Trust

location_facility: New Jersey Community Research Initiative

location_facility: Recherche Clinique Centre Medical Halles de Saint-

location_facility: Johann Wolfgang Goethe University Hospital

location_facility: Centro de Referencia e Treinamento DST/AIDS

location_facility: McGuire VA / Division of Infectious Diseases

location_facility: Klein and Slotten Associates / AIDS Research Alliance

location_facility: Washington Reg AIDS Prog / Dept of Infect Dis

location_facility: Christiana Care Health Services HIV Program George

location_facility: Cross Over Clinic / Div of Infectious Diseases

location_facility: University of Vienna Medical School, AKH

location_facility: The Rsch & Ed Grp / Legacy Cln at Good Samaritan

location_facility: U.O. Malattie Infettive, H.S.Maria Annunziata

location_facility: T1 Coleridge Unit, North Middlesex Hospital


title: Care-related Pain and Discomfort in Children and Adults With Motor Disorder in Medical Establishments

acronym: DIS-HANDI

summary:
The combination of motor disabilities, chronic pain, cognitive disabilities limiting the possibilities of communications and repeated potentially painful rehabilitation, exposes patients with motor disabilities to a high risk of induced pain in the specialized establishments. Induced pain is difficult to detect and is therefore little assessed and treated. Currently, little is known about the prevalence and conditions of occurrence of such induced pain as the clinical characteristics of patients (children, adults, severity of disability), the types of care and the nature of the institutional admission (medical or medico-social). Secondary objectives are to identify risk factors related to the induced pain and patient characteristics, as well as to create an easy-to-use weekly continuous pain assessment tool in a routine clinical set-up.

All daily life procedures or treatment carried out in children and adults with motor disability are collected for 5 days and 1 night. Collected data are clinical and demographic characteristics of patients, the intensity of the pain assessed by the care professional (FLACC-r) or the patient himself (VAS).

Clinically, the uncomfortable and painful procedures and risk factors for pain identified by this study will help the development of targeted preventive measures within institutions. Meanwhile, the study should sensitize Breton teams involved with regards to the induced pain, leading them to observe the behavior of patients, to admit any pain related to an act of daily life, and to ask for the medical profession to anticipate the painful experience.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: University Hospital, Brest

location_facility: Centre de Rééducation fonctionnelle de Kerpape

lead_sponsor_type: academique

status_simplified: Unknown


status: Completed

primary_purpose: Treatment

intervention_type: Drug

acronym: CAROLINA

title: A Multicentre, International, Randomised, Parallel Group, Double Blind Study to Evaluate Cardiovascular Safety of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk.

study_completion_date_type: Actual

lead_sponsor: Boehringer Ingelheim

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Verhagen C, Janssen J, Minderhoud CA, van den Berg E, Wanner C, Passera A, Johansen OE, Biessels GJ. Chronic kidney disease and cognitive decline in patients with type 2 diabetes at elevated cardiovascular risk. J Diabetes Complications. 2022 Oct;36(10):108303. doi: 10.1016/j.jdiacomp.2022.108303. Epub 2022 Aug 31.

ReferenceCitation: Verhagen C, Janssen J, Biessels GJ, Johansen OE, Exalto LG. Females with type 2 diabetes are at higher risk for accelerated cognitive decline than males: CAROLINA-COGNITION study. Nutr Metab Cardiovasc Dis. 2022 Feb;32(2):355-364. doi: 10.1016/j.numecd.2021.10.013. Epub 2021 Oct 27.

ReferenceCitation: Biessels GJ, Verhagen C, Janssen J, van den Berg E, Wallenstein G, Zinman B, Espeland MA, Johansen OE. Effects of linagliptin vs glimepiride on cognitive performance in type 2 diabetes: results of the randomised double-blind, active-controlled CAROLINA-COGNITION study. Diabetologia. 2021 Jun;64(6):1235-1245. doi: 10.1007/s00125-021-05393-8. Epub 2021 Feb 9.

ReferenceCitation: Rosenstock J, Kahn SE, Johansen OE, Zinman B, Espeland MA, Woerle HJ, Pfarr E, Keller A, Mattheus M, Baanstra D, Meinicke T, George JT, von Eynatten M, McGuire DK, Marx N; CAROLINA Investigators. Effect of Linagliptin vs Glimepiride on Major Adverse Cardiovascular Outcomes in Patients With Type 2 Diabetes: The CAROLINA Randomized Clinical Trial. JAMA. 2019 Sep 24;322(12):1155-1166. doi: 10.1001/jama.2019.13772. Erratum in: JAMA. 2019 Dec 3;322(21):2138.

ReferenceCitation: Janssen J, van den Berg E, Zinman B, Espeland MA, Geijselaers SLC, Mattheus M, Johansen OE, Biessels GJ. HbA(1c), Insulin Resistance, and β-Cell Function in Relation to Cognitive Function in Type 2 Diabetes: The CAROLINA Cognition Substudy. Diabetes Care. 2019 Jan;42(1):e1-e3. doi: 10.2337/DC18-0914.

ReferenceCitation: Biessels GJ, Janssen J, van den Berg E, Zinman B, Espeland MA, Mattheus M, Johansen OE; CAROLINA® investigators. Rationale and design of the CAROLINA® - cognition substudy: a randomised controlled trial on cognitive outcomes of linagliptin versus glimepiride in patients with type 2 diabetes mellitus. BMC Neurol. 2018 Jan 15;18(1):7. doi: 10.1186/s12883-018-1014-7.

ReferenceCitation: Marx N, Rosenstock J, Kahn SE, Zinman B, Kastelein JJ, Lachin JM, Espeland MA, Bluhmki E, Mattheus M, Ryckaert B, Patel S, Johansen OE, Woerle HJ. Design and baseline characteristics of the CARdiovascular Outcome Trial of LINAgliptin Versus Glimepiride in Type 2 Diabetes (CAROLINA®). Diab Vasc Dis Res. 2015 May;12(3):164-74. doi: 10.1177/1479164115570301. Epub 2015 Mar 15.

ReferenceCitation: Chilton R. Linagliptin versus glimepiride add-on for the long-term treatment of Type 2 diabetes mellitus. Expert Rev Endocrinol Metab. 2013 Jul;8(4):345-349. doi: 10.1586/17446651.2013.811849.

enrollment_type: Actual

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Japan
Philippines
Romania
South Africa
Czechia
Hong Kong
Portugal
Russian Federation
Australia
Argentina
Tunisia
India
Israel
Mexico
Norway
Malaysia
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Taiwan
Greece
Georgia
Ireland
New Zealand
Finland
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Lausmed Kft. Outpatient Unit of Internal Medicine

location_facility: Bodø Legesenter AS, avd. for med. studier

location_facility: National Institute of Endocrinology, Tbilisi

location_facility: Donetsk Regional Clinical Hosp, Therapy Department

location_facility: Pusan National University Yangsan Hospital

location_facility: Albany Medical Center / Albany Medical College

location_facility: Emergency County Clinical Hospital, Sibiu

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: Consultorios Asociados de Endocrinología e Invest Clínica

location_facility: Fundación Centro de Investigaciones Biomédicas Riescard

location_facility: Centro de Estudos em Diabetes e Hipertensão

location_facility: Ivano-Frankivsk City Central Clinical Hospital

location_facility: Centro de Investigaciones Clínicas del Litoral

location_facility: SC Medical Centre "Sanatatea Ta" SRL, Bucharest

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: State Healthcare Institution, Regional hospital #2

location_facility: LLC Clinic of new technologies of medicine

location_facility: Internal & Diabetology Ambulance, Prostejov

location_facility: Japan Community Health care Organization Nihonmatsu Hospital

location_facility: Northeast Clinical Research of San Antonio, LLC

location_facility: San Diego Sports Medicine and Family Health Center

location_facility: John H. Stroger Jr. Hospital of Cook Country

location_facility: Seoul National University Bundang Hospital

location_facility: The Chaim Sheba Medical Center Tel Hashomer

location_facility: Keimyung University Dongsan Medical Center

location_facility: Instituto de Molestias Cardiovasculares - IMC

location_facility: Southgate Medical Group/ Southgate Medical Park

location_facility: University General Hospital of Thessaloniki AHEPA

location_facility: Instituto Cardiovascular de Corrientes Juana Francisca Cabra

location_facility: Clinic for Cardiology "Sertse i sudyny", Kiev

location_facility: Klinische Forschung Management & Services GmbH

location_facility: Diabetologicka ambulancia MUDr. Lucia Gajdosikova s.r.o.

location_facility: University of Texas Southwestern Medical Center

location_facility: Internal & Diabetology Ambulance, Jablonec nad Nisou

location_facility: Diabetes and Endocrine Center of Orlando

location_facility: University Diabetes and Endocrine Consultants

location_facility: Instituto de Investigaciones Clínicas de Bahía Blanca

location_facility: National Center for Diabetes Research Ltd., Tbilisi

location_facility: Edith Wolfson Medical Center, Diabetic Unit, Holon

location_facility: Edinger Medical Group and Research Center

location_facility: Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã

location_facility: Hospital Strakonice, Internal Department

location_facility: Univ.Multiprofile Hospital "Dr. Georgy Stranski" EAD, Pleven

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Centro Cientifico Asistencial Jose Luis Accini

location_facility: Hospital Universitário João de Barros Barreto

location_facility: Noordwest Ziekenhuisgroep, location Den Helder

location_facility: Fundacion del Caribe de Investigacion Biomedica

location_facility: National Health Insurance Service Ilsan Hospital

location_facility: Kovai Diabetes Speciality Centre & Hospital

location_facility: M V Hospital For Diabetes and Diabetes Research Centre

location_facility: Multiprofile Hospital for Active Treatment "Zaritza Johanna"

location_facility: Hop St Dié des Vosges, Diabéto, St Dié des Vosges

location_facility: Limited Liability Company "CENTER DIABET", Samara

location_facility: DIASTYLE s.r.o., Diabetology Outpatient Department

location_facility: MEDIVASA s.r.o., Outpatient Clinic, Zilina

location_facility: The Methodist Hospital d/b/a HMRI CCAT at Pearland

location_facility: Instituto de Hematología y Medicina Clínica Dr. Rubén Davoli

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: MMU City Outpatient Clinic no. 20, Saratov

location_facility: Centro de Investigacion Cardiometabolica de Aguascalientes

location_facility: Clinical Trials of St. Jude Heritage Med. Group

location_facility: centro de Diagnostico Cardiologico para la Investigacion Bio

location_facility: Quality of Life Medical & Research Center

location_facility: Tristan Medical Enterprises, PC dba Regeneris

location_facility: Clinical Research Advantage, Inc./Rita B. Chuang, MD, LLC

location_facility: IFG Institut für Gesundheitsförderung GmbH

location_facility: Bangalore Diabetes Centre (BDC)- Medisys Clinical Research

location_facility: Hospital de Servicios Médicos Godoy Ltda

location_facility: Irmandade da Santa Casa de Misericórdia de São Paulo - IPEC - Instituto de Pesquisa Clínica

location_facility: Unidad de Investigacion Clinica Cardiometabolica de Occident

location_facility: General Hopsital of Thessaloniki "Ippokrateio"

location_facility: Internal & Diabetology Ambulance Dr. Vrkoc, Ostrava

location_facility: State Institution "Central Clinical Hospital of RAS", Moscow

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: General Hospital Subotica, Internal Medicine

location_facility: Consulta Privada Maria Loreto Aguirre Coveña

location_facility: The University of North Carolina at Chapel Hill

location_facility: Detweiler Family Medicine & Associates, PC

location_facility: City Clinical Hospital No. 6 of MoH of Udmurt Republic

location_facility: Grant Medical Foundation, Ruby Hall Clinic

location_facility: Instituto Estadual de Diabetes e Endocrinologia

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião

location_facility: Multiprofile Hospital for Active Treatment

location_facility: South Carolina Nephrology and Hypertension Center, Inc

location_facility: Forusakutten - Kolibri Medical, Avd. Stavanger

location_facility: Taipei Medical University-Shuang Ho Hospital

location_facility: Centro De Especialidades Medicas Santa Maria S.A.C

location_facility: Instituto de Investigaciones Clinicas de Rosario

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Centro de Investigaciones Médicas METABOLICARE SAC

location_facility: CAB Mercey Y, MG, St Genies des Fontaines

location_facility: Daishinkai Medical Corporation Ookuma Hospital

location_facility: Pharmacotherapy Research Associates, Inc

location_facility: Royal Brisbane & Women's Hospital-Endocrinology

location_facility: Dr. Samuel Diosszilagyi Hospital and Outpatient Clinic, Mako

location_facility: New England Center for Clinical Research, Inc

location_facility: Shree Krishna Hospital and Heart Care Centre, Ahmedabad

location_facility: Sunil's Diabetes care and Research Centre

location_facility: Grof Esterhazy Hospital and Outpatient Clinic

location_facility: Institut für Stoffwechselforschung, Frankfurt

location_facility: PFÜTZNER Science & Health Institute GmbH

location_facility: Yalamanchi Hospitals & Research Centres Pvt Ltd.

location_facility: CIIGMA Institute of Medical Sciences Pvt Ltd

location_facility: Zhordania Institute of Human Reproduction, Tbilisi

location_facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

location_facility: Office of Dr. Craig S. Thompson, MD, LLC

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Castlerock Clinical Research Consultants, LLC

location_facility: Clinical Medical Center Zvezdara, Belgrade

location_facility: Global Hospital- Superspeciality & Transplant Centre

location_facility: Saitama Medical Cooperative Association Hanyu General Hospital

location_facility: Diamed Clinical Research Services Pvt. Ltd.

location_facility: UNIENDO Unidad Integral de Endocrinologia

location_facility: Military Medical Academy, Clin. Endocrinology & Metab. Dis.

location_facility: Vinnitsia Regional Endocrinology Dispensary

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Chemotherapy & Immunotherapy Clinic 'Medulla', Tbilisi

location_facility: Instituto Delgado de Investigacion Medica

location_facility: Policlinico Universitario Mater Domini, Universita di Catanzaro

summary: The aim of the study is to investigate the longterm impact on cardiovascular morbidity and mortality, relevant efficacy parameters (e.g., glycaemic parameters) and safety (e.g., weight and hypoglycaemia) of treatment with linagliptin in patients with type 2 diabetes at elevated cardiovascular risk receiving usual care, and compare outcome against glimepiride.

lead_sponsor_type: industriel

status_simplified: Completed


primary_purpose: Prevention

acronym: PERASTUN

title: Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers

lead_sponsor: University Hospital, Tours

type: Other Identifier

ReferenceType: background

ReferenceCitation: Poon LC, Syngelaki A, Akolekar R, Lai J, Nicolaides KH. Combined screening for preeclampsia and small for gestational age at 11-13 weeks. Fetal Diagn Ther. 2013;33(1):16-27. doi: 10.1159/000341712. Epub 2012 Sep 13.

ReferenceCitation: Ayala DE, Ucieda R, Hermida RC. Chronotherapy with low-dose aspirin for prevention of complications in pregnancy. Chronobiol Int. 2013 Mar;30(1-2):260-79. doi: 10.3109/07420528.2012.717455. Epub 2012 Sep 24.

ReferenceCitation: Plasencia W, Maiz N, Poon L, Yu C, Nicolaides KH. Uterine artery Doppler at 11 + 0 to 13 + 6 weeks and 21 + 0 to 24 + 6 weeks in the prediction of pre-eclampsia. Ultrasound Obstet Gynecol. 2008 Aug;32(2):138-46. doi: 10.1002/uog.5402.

location_country: France Martinique

location_facility: Service de gynécologie-obstétrique, Hôpital Couple Enfant, CHRU de Grenoble

location_facility: Service de gynécologie-obstétrique, CHR Le Mans

location_facility: Service de Gynécologie-Obstétrique, Hôpital Porte Madeleine, CHR d'Orléans

location_facility: Service de Gynécologie-Obstétrique, Hôpital d'Estaing, CHU de Clermont-Ferrand

location_facility: Service de Gynécologie-Obstétrique, Groupe Hospitalier Pellegrin, CHRU de Bordeaux

location_facility: Service de Gynécologie-Obstétrique, Hôpital Arnaud de Villeneuve, CHRU de Montpellier

location_facility: Service de gynécologie-obstétrique, Hôpital Mère-Enfant, CHRU de Nantes

location_facility: Service de Gynécologie-Obstétrique, Hôpital Paule de Viguier, CHU de Toulouse

location_facility: Service de gynécologie-obstétrique, Maison de la Femme de la Mère et de l'Enfant, CHU de Fort de France

location_facility: Centre de dépistage PRIMA FACIE, Hôpital Necker, APHP

location_facility: Service de Gynécologie-Obstétrique, Hôpital Carémeau, CHRU de Nîmes

location_facility: Service de Gynécologie-Obstétrique, HFME, Hospices Civils de Lyon

location_facility: Service de gynécologie-obstétrique, Polyclinique de l'Atlantique

location_facility: Service de Gyénécologie-Obstétrique, Hôpital Jeanne de Flandre, CHRU de Lille

location_facility: Service de Gynécologie-Obstetrique, Centre Olympe de Gouges, CHRU de Tours

location_facility: Service de gynécologie-obstétrique, Polyclinique du PARC

summary: The objective of this study is to test the efficacy of low-dose aspirin (160 mg/day), given bedtime and started early during pregnancy (≤ 15 +6 weeks of gestation) in nulliparous pregnant women selected as "high-risk" by the presence of a bilateral uterine artery notch and/or bilateral uterine artery PI ≥ 1.7 during the first trimester ultrasound scan (11-13+6 weeks), to prevent the occurrence of pre-eclampsia or small for gestational age at birth.


title: Microparticle's Procoagulant Activity to Identify Patients With Cancer and a High Risk for Venous Thrombosis

acronym: MICA

summary: Cancer patients are at increased risk of deep venous thrombosis and pulmonary embolism, collectively termed venous thromboembolism (VTE). Risk assessment scores for VTE in cancer patients have been previously developed by the groups of Khorana and Vienna CATS. However, routine thromboprophylaxis for ambulatory cancer patients based on these scores is currently not recommended. In the investigators prospective, observational cohort study, the investigators aim to identify cancer patients at high risk for VTE based on clinical characteristics, coagulation biomarkers and the coagulant activity of tissue factor bearing microparticles.

ReferenceCitation: van Es N, Di Nisio M, Cesarman G, Kleinjan A, Otten HM, Mahé I, Wilts IT, Twint DC, Porreca E, Arrieta O, Stépanian A, Smit K, De Tursi M, Bleker SM, Bossuyt PM, Nieuwland R, Kamphuisen PW, Büller HR. Comparison of risk prediction scores for venous thromboembolism in cancer patients: a prospective cohort study. Haematologica. 2017 Sep;102(9):1494-1501. doi: 10.3324/haematol.2017.169060. Epub 2017 May 26.

lead_sponsor: Harry R. Buller

location_country: Mexico France Netherlands Italy

location_facility:
VU medical center
Hopital Louis Mourier
Academic Medical Center
University Medical Center Groningen
Slotervaart hospital
Instituto Nacional de Cancerología
Hospital D'Annunziata


title: Clinical Trial Protocol for Therapeutic MRI-guided High Intensity Focused Ultrasound Ablation of Uterine Fibroids

summary:
This study is to confirm the safety and technical effectiveness of MRI guided High Intensity Focused Ultrasound (HIFU) in ablating uterine tissue associated with symptomatic leiomyomas. The importance of this therapy is that it offers a non-invasive, uterine sparing procedure for the treatment of uterine fibroids in pre- and peri- menopausal women.

MRI guided high intensity focused ultrasound uses ultrasound to heat and thermally ablate fibroid tissue. The MRI system identifies the ultrasound path and monitors heat rise in the fibroid tissue. The goal of the study is to show treatment safety and technical effectiveness. MR-guided HIFU will be performed in patients who pass inclusion/exclusion criteria. Safety, quality of life, and imaging endpoints will be evaluated in all study patients.

The goal of this study is to demonstrate that:

The safety profile is acceptable (safety)
Actual MR-HIFU ablated volumes (as measured with contrast enhanced MRI) match the intended volumes (technical effectiveness)
When intended, volumes greater than 20% of the fibroid volume can be successfully ablated (technical effectiveness)

The investigators' hypothesis is that greater than 70% of fibroids will have concordance between intended lesion volume and actual lesion volume while maintaining an acceptable safety profile.

ReferenceCitation: Spies JB, Coyne K, Guaou Guaou N, Boyle D, Skyrnarz-Murphy K, Gonzalves SM. The UFS-QOL, a new disease-specific symptom and health-related quality of life questionnaire for leiomyomata. Obstet Gynecol. 2002 Feb;99(2):290-300.

ReferenceCitation: Stewart EA, Gedroyc WM, Tempany CM, Quade BJ, Inbar Y, Ehrenstein T, Shushan A, Hindley JT, Goldin RD, David M, Sklair M, Rabinovici J. Focused ultrasound treatment of uterine fibroid tumors: safety and feasibility of a noninvasive thermoablative technique. Am J Obstet Gynecol. 2003 Jul;189(1):48-54.

ReferenceCitation: Hindley J, Gedroyc WM, Regan L, Stewart E, Tempany C, Hynyen K, Mcdannold N, Inbar Y, Itzchak Y, Rabinovici J, Kim HS, Geschwind JF, Hesley G, Gostout B, Ehrenstein T, Hengst S, Sklair-Levy M, Shushan A, Jolesz F. MRI guidance of focused ultrasound therapy of uterine fibroids: early results. AJR Am J Roentgenol. 2004 Dec;183(6):1713-9. Erratum in: AJR Am J Roentgenol. 2005 Jan;184(1):348. Hynnen, Kullvro [corrected to Hynyen, Kullervo]; Macdanold, Nathan [corrected to Mcdannold, Nathan]; Kim, Kevin [corrected to Kim, Hyun S]; Gostout, Brian [corrected to Gostout, Bobbie].

ReferenceCitation: Leon-Villapalos J, Kaniorou-Larai M, Dziewulski P. Full thickness abdominal burn following magnetic resonance guided focused ultrasound therapy. Burns. 2005 Dec;31(8):1054-5. Epub 2005 Jun 20.

ReferenceCitation: Fennessy FM, Tempany CM. MRI-guided focused ultrasound surgery of uterine leiomyomas. Acad Radiol. 2005 Sep;12(9):1158-66. Review.

ReferenceCitation: Stewart EA, Rabinovici J, Tempany CM, Inbar Y, Regan L, Gostout B, Hesley G, Kim HS, Hengst S, Gedroyc WM. Clinical outcomes of focused ultrasound surgery for the treatment of uterine fibroids. Fertil Steril. 2006 Jan;85(1):22-9. Erratum in: Fertil Steril. 2006 Apr;85(4):1072. Gastout, Bobbie [corrected to Gostout, Bobbie]; Gedroye, Wladyslaw M [corrected to Gedroyc, Wladyslaw M].

ReferenceCitation: Fennessy FM, Tempany CM, McDannold NJ, So MJ, Hesley G, Gostout B, Kim HS, Holland GA, Sarti DA, Hynynen K, Jolesz FA, Stewart EA. Uterine leiomyomas: MR imaging-guided focused ultrasound surgery--results of different treatment protocols. Radiology. 2007 Jun;243(3):885-93. Epub 2007 Apr 19.

ReferenceCitation: Mara M, Fucikova Z, Maskova J, Kuzel D, Haakova L. Uterine fibroid embolization versus myomectomy in women wishing to preserve fertility: preliminary results of a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2006 Jun 1;126(2):226-33. Epub 2005 Nov 15.

lead_sponsor: Philips Healthcare

location_country:
Germany
Korea, Republic of
France
Netherlands

location_facility:
Hospital St. Andre
Samsung Medical Center
University Hospital Schleswig-Holstein
University Medical Center

intervention_type: Device


title: Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Symptomatic Pulmonary Hypertension Associated With Sickle Cell Disease

summary: The study will assess the effect of bosentan on pulmonary vascular resistance and exercise capacity in Sickle Cell Disease (SCD) patients diagnosed with Pulmonary Hypertension. It consists of 3 phases: screening, treatment and follow-up. During the screening visit, the study doctor will decide if patients meet the study requirements. All potential patients will have a diagnosis of increased pulmonary artery pressures that is shown by right heart catheterization conducted shortly prior to start of study treatment. Patients will be asked to perform exercise capacity test (walking as far as possible for 6 minutes). Following the baseline visit the treatment phase consists of 4 additional clinic visits during which the good and bad effects of the drug are reviewed and exercise capacity test will be repeated. Patients will be treated for 16 weeks. Blood samples will be collected every month, or more often, if needed. At the end of the study some of the patients will be asked to repeat the right heart catheterization. All patients will repeat an exercise capacity test. After completion of the study, patients will have the option of enrolling in a long-term follow-up study where all patients will receive active drug. Patients electing not to participate in the extension study will be followed up for safety assessments for about 28 days after the end of the study treatment.

status: Terminated

ReferenceCitation: Barst RJ, Mubarak KK, Machado RF, Ataga KI, Benza RL, Castro O, Naeije R, Sood N, Swerdlow PS, Hildesheim M, Gladwin MT; ASSET study group*. Exercise capacity and haemodynamics in patients with sickle cell disease with pulmonary hypertension treated with bosentan: results of the ASSET studies. Br J Haematol. 2010 May;149(3):426-35. doi: 10.1111/j.1365-2141.2010.08097.x. Epub 2010 Feb 17.

lead_sponsor: Actelion

location_country:
Netherlands
United States
United Kingdom
France

location_facility: The Methodist Hospital/Baylor College of Medicine; Pulmonary and Critical Care Medicine

location_facility: University of Tennessee Health Science Center

location_facility: Duke University Medical Center; Duke University Health Systems

location_facility: Henry Ford Hospital; Dept. of Pulmonology

location_facility: Amsterdam Medical Center, Department of Hematology

location_facility: Virginia Commonwealth University Medical Center

location_facility: Royal Free Hospital, Rheumatology Department

location_facility: Boston Medical Center/Boston University School of Medicine

location_facility: Harper University Hospital/Wayne State University

location_facility: University of Texas Medical School; Division of Pulmonary and Critical Care Medicine

location_facility: Royal Hallamshire Hospital, Pulmonary Vascular Medicine

location_facility: Columbia University Medical Center; Pediatric Cardiology

location_facility: University of Colorado Health Sciences Center


title: Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Symptomatic Pulmonary Arterial Hypertension Associated With Sickle Cell Disease

summary: The study will assess the effect of bosentan on pulmonary vascular resistance and exercise capacity in sickle cell disease (SCD) patients diagnosed with pulmonary arterial hypertension. It consists of 3 phases: Screening, Treatment and Follow-up. During the Screening visit, the study doctor will decide if patients meet the study requirements. All potential patients will have a diagnosis of increased pulmonary artery pressures that is shown by right heart catheterization conducted shortly prior to start of study treatment. Patients will be asked to perform exercise capacity test (walking as far as possible for 6 minutes). Following the Baseline visit, the treatment phase consists of 4 additional clinic visits during which the good and bad effects of the drug are reviewed and exercise capacity test will be repeated. Patients will be treated for 16 weeks. Blood samples will be collected every month, or more often, if needed. At the end of the study, patients will be asked to repeat the right heart catheterization and exercise capacity test. After completion of the study, patients will have the option of enrolling in a long-term follow-up study where all patients will receive active drug. Patients electing not to participate in the extension study will be followed up for safety assessments for about 28 days after the end of the study treatment.


title: Characterisation of Patients With Severe Asthma in Primary and Secondary Care Settings in Europe Reported to be Eligible for Biological Therapy

acronym: RECOGNISE

summary: This is a multi-country, multicentre, observational cross-sectional one-visit study of patients suffering from severe asthma in primary and secondary care settings in Europe

time_perspective: Retrospective

lead_sponsor: AstraZeneca

location_country: Poland Slovenia Greece Italy Netherlands Spain Hungary France Romania Germany Bulgaria Czechia


acronym: REVRI

title: Phase II Study Evaluating the Efficacy of Lenalidomide in Association With Rituximab in Refractory or Relapse of Primary Central Nervous System Lymphoma (PCNSL)

lead_sponsor: Institut Curie

ReferenceType: result

ReferenceCitation: Ghesquieres H, Chevrier M, Laadhari M, Chinot O, Choquet S, Moluçon-Chabrot C, Beauchesne P, Gressin R, Morschhauser F, Schmitt A, Gyan E, Hoang-Xuan K, Nicolas-Virelizier E, Cassoux N, Touitou V, Le Garff-Tavernier M, Savignoni A, Turbiez I, Soumelis V, Houillier C, Soussain C. Lenalidomide in combination with intravenous rituximab (REVRI) in relapsed/refractory primary CNS lymphoma or primary intraocular lymphoma: a multicenter prospective 'proof of concept' phase II study of the French Oculo-Cerebral lymphoma (LOC) Network and the Lymphoma Study Association (LYSA)†. Ann Oncol. 2019 Apr 1;30(4):621-628. doi: 10.1093/annonc/mdz032.

location_facility:
Institut Bergonié
Chu Michallon
CHU Amiens -Hôpital Sud
Hôpital de la Pitié Salpétrière
Centre Léon Bérard
CHU Bretonneau - Centre Henry Kaplan
CHRU Lille - Hôpital Claude Huriez
Centre Henri Becquerel
CHU Estaing
Hôpital Central
Chu La Timone
Institut curie - Hôpital René Huguenin

summary:
Because Primary Central Nervous System Lymphoma (PCNSL) are mainly diffuse large B-cell lymphoma of the activated B cells (ABC) type, the investigators hypothesize that the synergy of lenalidomide with rituximab shown in systemic non-Hodgkin's lymphoma (NHL) could be observed in PCNSL.

This study will assess the efficiency of the the combination of lenalidomide and rituximab in relapsed/refractory PCNSL, and the efficiency of a maintenance treatment with lenalidomide alone in maintaining the response.


title: Salvage Cryoablation of the Prostate (SCAP) vs High Intensity Focal Ultrasounds (HIFU) for Recurrent Prostate Cancer After Radiation Therapy

acronym: SALVPROST

summary:
The evidence base relating to the use of SCAP and HIFU is poor, with significant uncertainties relating to long-term oncological outcomes. One of the main limitations when the few studies reported are analyzed is the lack of information about the histopathology both before starting treatment and at the time of recurrence after cryotherapy. The vast majority of studies refer only to BCR-free survival as end point, thus limiting interpretation of real oncological performance of this technique. Furthermore, side effects vary widely from study to study and there are uncertainties about the real morbidity associated to cryotherapy in the salvage setting.

Another important hot issue in this scenario is the potential benefit that new imaging and diagnosis techniques (MRI, targeted biopsy, PSMA) may add for a more accurate indication. This could provide the possibility of better results for SCAP. The clinical value of this new diagnostic tools is unknown in this scenario and needs to be explored.

study_start_date_type: Anticipated

status: Recruiting

ipd_sharing: Undecided

lead_sponsor: University Hospital Virgen de las Nieves

location_country: France Spain

location_facility: Hospital Universitario Virgen de las Nieves

intervention_type: Procedure

status_simplified: Ongoing


title: Performances of Estimated Glomerular Filtration Rate Equations in Kidney Transplant Recipients

summary: Accurate estimation of the glomerular filtration rate (GFR) is crucial for the management of kidney recipients, since it is the most predictive parameter of allograft failure that drives patient monitoring and decision-making. Standard and recent race-free GFR equations have been developed in native kidneys, but their performances in transplant kidney population remains unknown. We aimed at developing a kidney-transplant-specific GFR equation, and comparing its performance to standard GFR equations.

ipd_sharing: No

lead_sponsor: Paris Translational Research Center for Organ Transplantation

location_country:
Croatia
United States
Italy
France

location_facility: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

location_facility: Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School of Medicine, University of Zagreb

location_facility: William J. von Liebig Centre for Transplantation and Clinical Regeneration, Mayo Clinic

location_facility: Department of Transplantation, Nephrology and Clinical Immunology, Hospices Civils de Lyon

location_facility: Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris

location_facility: Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris

location_facility: Nephrology, Dialysis and Renal Transplantation Department, Hôpital Nord, CHU de Saint-Etienne, Jean Monnet University, Université de Lyon

location_facility: Department of Nephrology and Organ Transplantation, CHU Rangueil

location_facility: Department of Nephrology, Centre Hospitalier Universitaire, Montpellier

location_facility: Kidney Transplant Department, Tenon Hospital, Assistance Publique - Hôpitaux de Paris

intervention_type: Other


title: A Two Part, Multi-Centre, Randomized, Placebo-Controlled, Double-Blind Study of TRK-170 for the Treatment of Crohn's Disease

summary:
In Crohn's Disease Patients

To evaluate the efficacy of TRK-170
To evaluate the PK characteristics of TRK-170
To assess the safety of TRK-170

lead_sponsor: Toray Industries, Inc

location_country:
Poland
Romania
Serbia
Latvia
Czech Republic
Ukraine
Sweden
Hungary
France
Belgium
Norway
Netherlands
Bulgaria

location_facility:
Poland
Romania
Serbia
Latvia
The Netherlands
Czech Republic
Ukraine
Hungary
France
Belgium
Norway
Sweden
Bulgaria


title: An Open-label, Single Treatment, Safety and Efficacy, Long-term Study of Deferiprone in Subjects With Friedreich's Ataxia

summary:
The primary objective of this study is to evaluate the long-term safety and tolerability of deferiprone in subjects with Friedreich's ataxia (FRDA).

The secondary objective is to evaluate the long-term efficacy of deferiprone for the treatment of FRDA.

The tertiary objectives are to evaluate the effect of deferiprone on:

cardiac function,
quality of life, and
functional status.

design_allocation: Non-Randomized

lead_sponsor: ApoPharma

location_country: France Italy Spain Belgium

location_facility: Fondazione IRCCS Istituto Neurologico "C. Besta"

location_facility: La Fundacion Para la Investigacion Biomedica


title: International Multicenter Study of Ventilator Associated Tracheobronchitis.

acronym: TAVeM

summary:
Justification and background Ventilator-associated complications (VACs) are those complications that develop during a period of intubation of a patient . Pneumonia is the second most frequent infectious complication in the hospital, and ranks first in ICU, whose risk is increased more than 20 times by the presence of invasive mechanical ventilation and is called ventilator-associated pneumonia (VAP) . Whereas the information published regarding VAP in terms of diagnosis, treatment and impact on the outcome of critically ill patients is enormous.Ventilator-associated tracheobronchitis (VAT) incidence is lacking and complicated in part, since the definition remains controversial. In addition, the significance of tracheobronchial colonization as a risk factor for subsequent lower respiratory tract infection remains unclear . The upper and lower airways can become colonized . Several factors have been taken into account and do not differ from those involved in VAT and VAP development in patients under mechanical ventilation.

Definition VAT diagnosis is controversial and represents an actual problem in order to define the real incidence of VAT , There is currently no valid, reliable definition for VAT, and even the most widely-used VAT criteria and definitions are neither sensitive nor specific. The diagnosis of VAT is considered when a patient under invasive mechanical ventilation starts with fever, leukocytosis and new or increased purulent secretions by the endotracheal tube. A particular difficulty with much commonly used VAT definition (in order to distinguish from VAP) is the key point of the absence of pulmonary consolidation. Evidence suggests that chest radiograph findings do not accurately role out VAP. A taskforce on hospital-acquired pneumonia, and VAP has been recently published (European Respiratory Society (ERS), European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and European Society of Intensive Care Medicine (ESICM)). Nosocomial tracheobronchitis definition includes occurrence of purulent tracheal secretion after ≥48 h of hospitalisation or mechanical ventilation plus ≥2 of the following: fever (≥38.5°C) or hypothermia (<36°C), leukocytosis (≥12 × 109/L), significant bacteriologic counts in respiratory secretions (≥103 cfu/mL for protected brush specimen (PBS) and ≥105 cfu/mL for endotracheal aspirates); absence of new pulmonary infiltrates compatible with pneumonia and absence of other causes of fever are mandatory. This definition needs to be further validated and can overdiagnose the incidence of VAT (and overuse of antibiotics) because the positive culture of respiratory secretions is not a mandatory item RATIONALE Given the possible high incidence of VAT, and its importance as a risk factor for VAP, and a potential target to treat in order to reduce VAP incidence, a large multicentre

ReferenceCitation: Martin-Loeches I, Torres A, Povoa P, Zampieri FG, Salluh J, Nseir S, Ferrer M, Rodriguez A; TAVeM study Group. The association of cardiovascular failure with treatment for ventilator-associated lower respiratory tract infection. Intensive Care Med. 2019 Dec;45(12):1753-1762. doi: 10.1007/s00134-019-05797-6. Epub 2019 Oct 16.

ReferenceCitation: Martin-Loeches I, Povoa P, Rodríguez A, Curcio D, Suarez D, Mira JP, Cordero ML, Lepecq R, Girault C, Candeias C, Seguin P, Paulino C, Messika J, Castro AG, Valles J, Coelho L, Rabello L, Lisboa T, Collins D, Torres A, Salluh J, Nseir S; TAVeM study. Incidence and prognosis of ventilator-associated tracheobronchitis (TAVeM): a multicentre, prospective, observational study. Lancet Respir Med. 2015 Nov;3(11):859-68. doi: 10.1016/S2213-2600(15)00326-4. Epub 2015 Oct 22.

lead_sponsor: Corporacion Parc Tauli

location_country: Brazil Portugal Spain Ecuador Argentina France Colombia Bolivia

location_facility: Corporació Sanitària I Universitaria Parc Taulí - Hospital de Sabadell


title: European, Observational, Prospective Study to Evaluate the Benefit/Risk of Vandetanib in RET Mutation Negative and Positive Patients With Symptomatic, Aggressive, Sporadic, Unresectable, Locally Advanced/Metastatic Medullary Thyroid Cancer

summary: This is a European multinational, multicenter, non-interventional (observational) and prospective study. It is carried on to confirm in real life conditions the benefit/risk of vandetanib (CAPRELSA™) 300 mg, both in RET negative and RET positive patients with symptomatic, aggressive, sporadic, unresectable, locally advanced/metastatic MTC.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Luxembourg
Spain
Italy
United Kingdom
Netherlands
France
Belgium
Germany

location_facility:
investigational Site Spain
investigational Site France
investigational Site Netherlands
investigational Site Belgium
investigational Site Luxembourg
investigational Site Italy
investigational Site United Kingdom
investigational Site Germany


title: A Multicenter, Randomized, Double-Masked, 3 Parallel Arms, Placebo Controlled Study to Assess the Efficacy and Safety of NOVA22007 1mg/mL (Ciclosporin/Cyclosporine) Eye Drops, Emulsion Administered in Paediatric Patients With Active Severe Vernal Keratoconjunctivitis With Severe Keratitis

summary: The objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day in patients with severe vernal keratoconjunctivitis after 4 months of treatment.

lead_sponsor: Santen SAS

location_country:
Croatia
Portugal
Spain
Greece
Italy
Hungary
United States
France
India
Israel
Germany

location_facility: New Delhi, National Capitol Territory, IN


title: A Phase 2b Randomized Trial of JX-594 (Vaccinia GM-CSF / TK-deactivated Virus) Plus Best Supportive Care Versus Best Supportive Care in Patients With Advanced Hepatocellular Carcinoma Who Have Failed Sorafenib Treatment

acronym: TRAVERSE

summary: This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more effective in improving survival than best supportive care in patients with advanced Hepatocellular Carcinoma (HCC) who have failed sorafenib.

ReferenceCitation: Moehler M, Heo J, Lee HC, Tak WY, Chao Y, Paik SW, Yim HJ, Byun KS, Baron A, Ungerechts G, Jonker D, Ruo L, Cho M, Kaubisch A, Wege H, Merle P, Ebert O, Habersetzer F, Blanc JF, Rosmorduc O, Lencioni R, Patt R, Leen AM, Foerster F, Homerin M, Stojkowitz N, Lusky M, Limacher JM, Hennequi M, Gaspar N, McFadden B, De Silva N, Shen D, Pelusio A, Kirn DH, Breitbach CJ, Burke JM. Vaccinia-based oncolytic immunotherapy Pexastimogene Devacirepvec in patients with advanced hepatocellular carcinoma after sorafenib failure: a randomized multicenter Phase IIb trial (TRAVERSE). Oncoimmunology. 2019 Jun 3;8(8):1615817. doi: 10.1080/2162402X.2019.1615817. eCollection 2019.

lead_sponsor: Jennerex Biotherapeutics

location_country:
Taiwan
Hong Kong
Canada
Korea, Republic of
United States
France
Germany

location_facility: Hôpital Saint Antoine, CPP Ile de France V

location_facility: Centre Hospitalier Universitaire Hôpital Saint André

location_facility: The Methodist Hospital Department of Surgery

location_facility: Moores University of California San Diego Cancer Center

location_facility: Pusan National University Yangsan Hospital

location_facility: Klinikum Rechts der Isar der Technischen Universität München

location_facility: Severance Hospital,Yonsei University Health System

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital Civil

location_facility: University Hospitals Case Medical Center

intervention_type: Biological


title: Bacterial DNA Detection as a Diagnostic Tool of Infection in Critical Ill Patients With SIRS

summary:
Sepsis is a common cause of morbidity and death in intensive care units. Clinical and laboratory signs of systemic inflammation, including changes in body temperature, tachycardia, or leukocytosis, are neither sensitive nor specific enough for the diagnosis of sepsis. The diagnosis of sepsis is difficult, because clinical signs are unspecific. These signs include tachycardia, leucocytosis, tachypnoea, and pyrexia, which are collectively termed a systemic inflammatory response syndrome (SIRS). SIRS is very common in critically ill patients, being found in various conditions including trauma, surgery, burns, pancreatitis, post-cardiac arrest syndrome, cardiac surgery. Microbiological culture can be used to distinguish sepsis from non-infectious conditions. However, this method lacks sensitivity and specificity, and there is often a substantial time delay. So these signs can also be misleading because critically ill patients often present with the systemic inflammatory response syndrome without infection. This issue is of paramount importance, since therapy and outcome differ greatly between patients with and those without sepsis; clinicians are often prone to overuse antibiotic therapy being afraid of not treating a potential infection or superinfection. Moreover, the widespread use of antibiotics for all such patients is likely to increase antibiotic resistance, toxicity, and costs. On the opposite, any delay in administration of antibiotics can be extremely detrimental for the infected patient with an exponential increase of the odd ratio for death. Search for early biomarker tools for the diagnosis of infection, initially promising, are quite challenged and controversial nowadays because they can be more related to the inflammation response, irrespective to the insult. Furthermore up to 40% of the infections remain strongly suspected but not bacteriologically documented. Persisting researches are ongoing to find new markers to better discriminate SIRS related to infection process from to SIRS not related to infection. Cytokine profiles using multiplex analysis seems more related to the severity of the SIRS than the trigger of the SIRS (infectious or non infectious diseases). Thus, new tools have been developed to identify bacteria by detecting their DNA by various techniques. These techniques have many potential interests over conventional microbiologic tests by decreasing turnaround time (within a few hours 2-6 hours), reducing inhibitory effects of prior use of antibiotics, detection of slow or fastidious growing organisms. However these tests remain to be validated in a clinical setting.

The goal of the current study is to evaluate the diagnostic value of plasma detection of bacterial DNA in ICU patients with a clinical suspicion of bacterial infection.

lead_sponsor: Delafontaine Hospital

location_facility:
Pasteur Institute
Saint louis Hospital
Jacques Cartier Institute
Delafontaine Hospital
Saint Joseph Hospital


title: An Extension to Study Protocol CVAL489K2302 to Evaluate the Long Term Safety, Tolerability and Efficacy of Valsartan in Children 6 to 17 Years of Age With Hypertension, Versus Enalapril Treatment for 14 Weeks, or Combined With Enalapril Versus Enalapril for 66 Weeks in Chronic Kidney Disease Patients.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Poland
Italy
Hungary
United States
France
India
Turkey
Belgium
Germany

location_facility:
Sites in Belgium
Sites in France
Sites in Turkey
Sites in Hungary
Sites in India
Sites in Italy
Sites in Germany
Sites in Poland
Sites in USA

summary: The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.


title: PREPIC 2 : Interruption of Inferior Vena Cava by a Retrievable Filter for the Prevention of Recurrent Pulmonary Embolism : a Randomised, Open Label Study

summary: The purpose of this study is to assess efficacy and safety of optional vena cava filter implanted 3 months in prevention of recurrent pulmonary embolism in patients presenting with acute pulmonary embolism associated with thrombotic risk factors

ReferenceCitation: Decousus H, Leizorovicz A, Parent F, Page Y, Tardy B, Girard P, Laporte S, Faivre R, Charbonnier B, Barral FG, Huet Y, Simonneau G. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis. Prévention du Risque d'Embolie Pulmonaire par Interruption Cave Study Group. N Engl J Med. 1998 Feb 12;338(7):409-15.

ReferenceCitation: PREPIC Study Group. Eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: the PREPIC (Prevention du Risque d'Embolie Pulmonaire par Interruption Cave) randomized study. Circulation. 2005 Jul 19;112(3):416-22. Epub 2005 Jul 11.

ReferenceCitation: Mismetti P, Laporte S, Pellerin O, Ennezat PV, Couturaud F, Elias A, Falvo N, Meneveau N, Quere I, Roy PM, Sanchez O, Schmidt J, Seinturier C, Sevestre MA, Beregi JP, Tardy B, Lacroix P, Presles E, Leizorovicz A, Decousus H, Barral FG, Meyer G; PREPIC2 Study Group. Effect of a retrievable inferior vena cava filter plus anticoagulation vs anticoagulation alone on risk of recurrent pulmonary embolism: a randomized clinical trial. JAMA. 2015 Apr 28;313(16):1627-35. doi: 10.1001/jama.2015.3780.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Service d'Accueil des Urgences, CHU de Clermont Ferrand

location_facility: Service de Medecine Interne et Maladies Vasculaires, CHU de Montpellier

location_facility: Service de Medecine Interne et Vasculaire, CHU de Nancy

location_facility: Service d'Urgences et de Réanimation Medicale, CHU de Saint-Etienne

location_facility: Service de Médecine Vasculaire, CHU Amiens

location_facility: Service d'Urgences Soins Intensifs cardiologiques, CHU de Lille

location_facility: Service de Médecine Vasculaire, CH Toulon

location_facility: Département de Pneumologie, Hôpital Européen Georges Pompidou, AP HP

location_facility: Service de Pneumologie, Hôpital Antoine Beclere

location_facility: Service de Medecine et Therapeutique - CHU de Saint-Etienne

location_facility: Département de Medecine Interne et Pneumologie, CHU de Brest

location_facility: Unité de Médecine Vasculaire, CHU de Grenoble

location_facility: Service d'Accueil des Urgences, CHU d'Angers


title: Spartalizumab and Low-dose PAzopanib in Refractory or Relapsed Solid TumOrs of Pediatric and Young Adults

acronym: SPARTO

summary:
Immunotherapies have revolutionized medical oncology following the remarkable and, in some cases, unprecedented outcomes observed in certain groups of patients with cancer. However results in adults and mainly in pediatric cancer are still disappointing.

Modulators of angiogenesis, such as VEGF, have a broad range of diverse effects on the immune system and the tumor micro-environment that are mainly immunosuppressive. In patients with early-stage disease, anti-VEGF therapy can lead to antitumor effects by modulating immune mechanisms - provided that therapy is maintained for an adequate length and tumors are sufficiently immunogenic. Nevertheless, blocking angiogenic molecules using a strategy based on a single therapeutic approach is likely insufficient to generate a complete or robust immune response against cancer, especially in patients with advanced-stage disease.

Based on the results of previous studies which evaluated the safety profile of spartalizumab, of pazopanib and the combination of antiangiogenic agents with checkpoint inhibitors, a study combining spartalizumab and low-dose pazopanib in refractory or relapsed solid tumors of pediatric and young adults is proposed. This study will include 2 separate cohorts:

the pediatric cohort will consist of a phase I study (dose-finding and expansion phases) combining pazopanib at a fixed dose of 225 mg/m2 and spartalizumab with four potential candidate doses (2, 3, 4 and 6 mg/kg).
the young adult cohort will consist of a phase II study combining pazopanib at a fixed dose of 400 mg and spartalizumab at the RP2D of 400 mg every 4 weeks.

status: Not yet recruiting

lead_sponsor: University Hospital, Bordeaux

location_facility: Institut Curie - Centre D'Oncologie SIREDO

location_facility: CHU d'Angers - Unité d'Hématologie et d'Oncologie pédiatrique

location_facility: Institut d'Hématologie et d'Oncologie Pédiatrique (IHOP) - Oncologie pédiatrique

location_facility: CHU de Bordeaux - Unité d'Hématologie et d'Oncologie pédiatrique

location_facility: Centre Oscar Lambret - Oncologie pédiatrie

location_facility: APHM Hôpital des Enfants La Timone - Hématologie Oncologie Pédiatrique


status: Active, not recruiting

acronym: MOVIE

title: A Phase I/II Basket Trial Evaluating a Combination of Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumour

lead_sponsor: UNICANCER

location_facility: Institut de Cancérologie de l'Ouest - Site Paul Papin

location_facility: Institut de Cancérologie de l'Ouest - Site René Gauducheau

summary: This is a phase I/II national, multicentre, multiple cohort, prospective open-label, non-randomised and non-comparative study, to evaluate the safety and activity of metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy for the treatment of advanced solid tumours.


title: Combination of MK3475 and Metronomic Cyclophosphamide in Patients With Advanced Sarcomas : Multicentre Phase II Trial

acronym: PEMBROSARC

summary: This is a multicenter study assessing the efficacy of different therapeutic strategy in patients with advanced sarcomas.

ReferenceCitation: Spalato-Ceruso M, Bouteiller F, Guegan JP, Toulmonde M, Bessede A, Kind M, Cousin S, Buy X, Palussiere J, Le Loarer F, Dadone-Montaudie B, Pulido M, Italiano A. Pembrolizumab combined with low-dose cyclophosphamide and intra-tumoral injection of the toll-like receptor 4 agonist G100 in patients with advanced pretreated soft tissue sarcoma: results from the PEMBROSARC basket study. J Hematol Oncol. 2022 Oct 27;15(1):157. doi: 10.1186/s13045-022-01377-2.

ReferenceCitation: Italiano A, Bessede A, Pulido M, Bompas E, Piperno-Neumann S, Chevreau C, Penel N, Bertucci F, Toulmonde M, Bellera C, Guegan JP, Rey C, Sautès-Fridman C, Bougoüin A, Cantarel C, Kind M, Spalato M, Dadone-Montaudie B, Le Loarer F, Blay JY, Fridman WH. Pembrolizumab in soft-tissue sarcomas with tertiary lymphoid structures: a phase 2 PEMBROSARC trial cohort. Nat Med. 2022 Jun;28(6):1199-1206. doi: 10.1038/s41591-022-01821-3. Epub 2022 May 26.

ReferenceCitation: Le Cesne A, Marec-Berard P, Blay JY, Gaspar N, Bertucci F, Penel N, Bompas E, Cousin S, Toulmonde M, Bessede A, Fridman WH, Sautes-Fridman C, Kind M, Le Loarer F, Pulido M, Italiano A. Programmed cell death 1 (PD-1) targeting in patients with advanced osteosarcomas: results from the PEMBROSARC study. Eur J Cancer. 2019 Sep;119:151-157. doi: 10.1016/j.ejca.2019.07.018. Epub 2019 Aug 21.

ReferenceCitation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. Review.

ReferenceCitation: Toulmonde M, Penel N, Adam J, Chevreau C, Blay JY, Le Cesne A, Bompas E, Piperno-Neumann S, Cousin S, Grellety T, Ryckewaert T, Bessede A, Ghiringhelli F, Pulido M, Italiano A. Use of PD-1 Targeting, Macrophage Infiltration, and IDO Pathway Activation in Sarcomas: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Jan 1;4(1):93-97. doi: 10.1001/jamaoncol.2017.1617.

lead_sponsor: Institut Bergonié

location_facility:
Institut Bergonié
Institut Paoli Calmettes
Institut de Cancérologie de l'Ouest
Centre Léon Bérard
Centre Oscar Lambret
Institut Gustave Roussy
Institut Claudius Regaud
Institut Curie


title: Prevention of Atrial Fibrillation by the Prescription of Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter

acronym: PREFACE

summary:
Atrial Flutter [AFL] is a relatively frequent arrhythmia, considered as benign, but associated with both invalidating symptoms and thromboembolic risk. The objective of the treatment consists to on the one hand the sinus rhythm [SR] restoration and on the other hand the prevention of the long-term recurrence. In this clinical setting, AFL radiofrequency ablation [RFA] became the first line therapy due to its both high effectiveness and safety. The effectiveness of AFL RFA is attenuated by the subsequent risk of atrial fibrillation [AFib] close to 25% at 1 year. This risk of subsequent AFib is related to the common substrate between both arrhythmias.

When AFib occurs, the interest to maintain the SR is still required, even if recent studies did not show a significant difference in term of total mortality between rate or rhythm control strategies [AFFIRM, RACE and PIAF studies]. The studies published underlined the anti-arrhythmic drugs limits in patients with both arrhythmias [AFib and AFL]. After years centered on the mechanisms and the electric treatments of AFib, researchers are nowadays focusing on the study's evaluation of the atrial tissue substrate.

Accordingly, the renin-angiotensin system role was investigated in many works. Indeed, angiotensin II plays a role in the modification of atrial pressure and in the fibers stretching ["stretch"], conditions required for the development of AFib. Angiotensin II is also a factor implied in the tissue fibrosis leading to tissue proliferation and collagen alteration. These mechanisms lead to atria cells conduction disorders and refractory periods modification. Moreover, the enzyme of conversion expression and the angiotensin II receptors deterioration were observed in patients with AFib.

This brings to the concept of AFib treatment while interfering on tissue remodeling by the way of renin-angiotensin system. Drugs such as the angiotensin converting enzyme inhibition [ACEI] may reduce AFib in patients with heart failure. No randomized study so far has compared the ACEI drugs against placebo among high-risk patients of AFib in post AFL RFA area. On the basis of experimental and clinical study, the investigators seek to evaluate the ACEI use in the prevention of AFib in an AFL post RFA ablation.

ReferenceCitation: Da Costa A, Thévenin J, Roche F, Romeyer-Bouchard C, Abdellaoui L, Messier M, Denis L, Faure E, Gonthier R, Kruszynski G, Pages JM, Bonijoly S, Lamaison D, Defaye P, Barthélemy JC, Gouttard T, Isaaz K; Loire-Ardèche-Drôme-Isère-Puy-de-Dôme Trial of Atrial Flutter Investigators. Results from the Loire-Ardèche-Drôme-Isère-Puy-de-Dôme (LADIP) trial on atrial flutter, a multicentric prospective randomized study comparing amiodarone and radiofrequency ablation after the first episode of symptomatic atrial flutter. Circulation. 2006 Oct 17;114(16):1676-81. Epub 2006 Oct 9.

ReferenceCitation: Da Costa A, Romeyer-Bouchard C, Zarqane-Sliman N, Messier M, Samuel B, Kihel A, Faure E, Isaaz K. Impact of first line radiofrequency ablation in patients with lone atrial flutter on the long term risk of subsequent atrial fibrillation. Heart. 2005 Jan;91(1):97-8.

ReferenceCitation: Madrid AH, Peng J, Zamora J, Marín I, Bernal E, Escobar C, Muños-Tinoco C, Rebollo JM, Moro C. The role of angiotensin receptor blockers and/or angiotensin converting enzyme inhibitors in the prevention of atrial fibrillation in patients with cardiovascular diseases: meta-analysis of randomized controlled clinical trials. Pacing Clin Electrophysiol. 2004 Oct;27(10):1405-10.

ReferenceCitation: Heart Outcomes Prevention Evaluation Study Investigators, Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000 Jan 20;342(3):145-53. Erratum in: 2000 May 4;342(18):1376. N Engl J Med 2000 Mar 9;342(10):748.

location_facility:
CHU de Rouen
CHU de Grenoble
CHU de Clermont-Ferrand
CHU de Brest
CHU de Saint-Etienne
Polyclinique des Fleurs
CHU de Montpellier
CHU de Rennes


title: Stool Biobanking and Impact of Antimicrobials on the Gut Microbiota in Patients With Bone and Joint Infection

acronym: GUMIBONE

summary:
Bone and joint infections (BJI) is a public health issue in industrialized countries.

Implant-associated BJI, are complex hospital-acquired infections and eradication of the pathogen is challenging in such patients.

A prolonged antimicrobial therapy is usually required from 6 weeks to 3 months, but some patients are eligible to several years of treatment and most of patients report gastrointestinal troubles, such as nausea and mild to severe diarrhea (but very few developed C. difficile diarrhea).

Moreover, the host gut microbiota is probably largely affected in abundance, richness and diversity. Indeed, it is known, that few days of antibiotics are sufficient to induce significant alterations of the gut microbiota, also called dysbiosis.

Severe dysbiosis, which is potentially irreversible and associated with a definitive shift in the gut microbiota metabolism and host homeostasis, may lead to and/or promote a large panel of severe diseases such as Clostridium difficile infection, diabetes mellitus, obesity, inflammatory bowel disease (IBD), cirrhosis, neurological disorders and cancer. It may also be associated with BJI recurrence and then impact global health costs.

The main objective of this study is to constitute biobanking of stools and perform DNA sequencing of the gut microbiota in patients with acute or sub-acute implant-related Bone and Joint Infection (BJI), caused by Staphylococcus aureus.

primary_purpose: Basic Science

lead_sponsor: Hospices Civils de Lyon

location_facility: Centre Hospitalier Lyon Sud-Service des maladies infectieuses

location_facility: Hôpital de la Croix Rousse-Service de chirurgie orthopédique

location_facility: Hôpital de la Croix Rousse-Service des Maladies Infectieuses et Tropicales

location_facility: Centre Hospitalier Lyon Sud-Service de Chirurgie Orthopédique


title: A Prospective Epidemiological Multicenter Cohort Study on Patients Clinically Suspected of Deep Vein Thrombosis or Pulmonary Embolism

acronym: OPTIMEV

summary:
The purpose of this study is to determine different risk factors of thromboembolic disease. Different points will be studied

do different types of thromboembolic disease (distal Deep Vein Thrombosis (DVT), proximal DVT, Pulmonary Embolism (PE) and DVT, PE without DVT) have the same clinical significance (risk factors and prognosis) ?
Is it necessary to obtain a detailed history of thromboembolic disease ?
Do older patients have particular risk factors ?
Do preventive treatments modify the level of risk factors and the clinical signs of thromboembolic disease ?
Do predictive clinical scores have the same performance for both in and outpatients ?
Can patients with a potential high level of thromboembolic risk (surgery, pregnancy) but no clinical thromboembolic symptoms, develop a low risk ?
The evolution of the disease in patients with negative or positive Venous ThromboEmbolism (VTE) exploratory tests.

ReferenceCitation: Bosson JL, Labarere J, Sevestre MA, Belmin J, Beyssier L, Elias A, Franco A, Le Roux P. Deep vein thrombosis in elderly patients hospitalized in subacute care facilities: a multicenter cross-sectional study of risk factors, prophylaxis, and prevalence. Arch Intern Med. 2003 Nov 24;163(21):2613-8.

ReferenceCitation: Samama MM. An epidemiologic study of risk factors for deep vein thrombosis in medical outpatients: the Sirius study. Arch Intern Med. 2000 Dec 11-25;160(22):3415-20.

ReferenceCitation: Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet. 1999 Apr 24;353(9162):1386-9.

ReferenceCitation: Stein PD, Hull RD, Ghali WA, Patel KC, Olson RE, Meyers FA, Kalra NK. Tracking the uptake of evidence: two decades of hospital practice trends for diagnosing deep vein thrombosis and pulmonary embolism. Arch Intern Med. 2003 May 26;163(10):1213-9.

ReferenceCitation: Sevestre MA, Labarere J, Brin S, Carpentier P, Constans J, Degeilh M, Deslandes B, Elgrishi I, Lanoye P, Laroche JP, Le Roux P, Pichot O, Quéré I, Bosson JL; OPTIMEV study. [Optimizing history taking for evaluating the risk of venous thromboembolism: the OPTIMEV study]. J Mal Vasc. 2005 Sep;30(4 Pt 1):217-27. French.

ReferenceCitation: Galanaud JP, Arnoult AC, Sevestre MA, Genty C, Bonaldi M, Guyard A, Giordana P, Pichot O, Colonna M, Quéré I, Bosson JL; OPTIMEV-SFMV Investigators. Impact of anatomical location of lower limb venous thrombus on the risk of subsequent cancer. Thromb Haemost. 2014 Dec;112(6):1129-36. doi: 10.1160/TH14-04-0351. Epub 2014 Aug 7.

ReferenceCitation: Le Moigne E, Genty C, Meunier J, Arnoult AC, Righini M, Bressollette L, Bosson JL, Le Gal G; OPTIMEV Investigators. Validation of the LEFt score, a newly proposed diagnostic tool for deep vein thrombosis in pregnant women. Thromb Res. 2014 Sep;134(3):664-7. doi: 10.1016/j.thromres.2014.07.009. Epub 2014 Jul 17.

ReferenceCitation: Galanaud JP, Bosson JL, Genty C, Presles E, Cucherat M, Sevestre MA, Quere I, Decousus H, Leizorovicz A. Superficial vein thrombosis and recurrent venous thromboembolism: a pooled analysis of two observational studies. J Thromb Haemost. 2012 Jun;10(6):1004-11. doi: 10.1111/j.1538-7836.2012.04704.x.

ReferenceCitation: Galanaud JP, Sevestre MA, Genty C, Laroche JP, Zizka V, Quéré I, Bosson JL; OPTIMEV SFMV investigators. Comparison of the clinical history of symptomatic isolated muscular calf vein thrombosis versus deep calf vein thrombosis. J Vasc Surg. 2010 Oct;52(4):932-8, 938.e1-2. doi: 10.1016/j.jvs.2010.05.019. Epub 2010 Jul 13.

lead_sponsor: University Hospital, Grenoble

location_country: France Guadeloupe Belgium

location_facility: University Hospital ND des Bruyeres Liege

location_facility: Office-based Specialist in vascular medecine


title: Multi-Center, Open-Label, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)

lead_sponsor: Kyowa Kirin, Inc.

location_country:
Brazil
United Kingdom
Peru
France
United States
Belgium

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Washington University School of Medicine

location_facility: University of Miami / Sylvester Comprehensive Cancer Center

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

location_facility: Hospital Universitario Professor Edgard Santos- UFBA

summary: The purpose of this study is to estimate the overall response rate of subjects with relapsed or refractory Adult T-cell Leukemia-Lymphoma (ATL).


type: Other Grant/Funding Number

title: Risk of Infertility Related to Adjuvant Chemotherapy for Early Breast Cancer: Oocyte/Embryo Cryopreservation (CHACRY-1501)

summary: The aim of the study is to perform a French multicenter prospective interventional study in order to assess the feasibility and safety of ovarian hyperstimulation for oocyte / embryo cryopreservation in young women with breast cancer. The oncologic and reproductive benefit / risk ratio will be investigated in the oncology and reproductive area.

lead_sponsor: Centre Oscar Lambret

location_facility: Centre Aliénor d'Aquitaine, Hôpital Pellegrin


title: Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors

acronym: AGADIR

summary: Basket trial concept to independently and simultaneously assess the effects of the association of atezolizumab + BDB001 + radiotherapy in multiple solid tumors.

location_facility:
Institut Bergonié
Centre Georges François Leclerc
IUCT Oncopôle
Hôpital La Timone
Institut Paoli Calmettes
CHU Poitiers
Centre Eugène Marquis
Centre Oscar Lambret
Chu Brest
Institut Curie
Centre François Baclesse


title: Screening for Occult Malignancy Using 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT) in Patients With Unprovoked Venous Thromboembolism

summary:
Venous thromboembolism (VTE) can be the earliest sign of cancer. Identifying occult cancers at the time of VTE diagnosis may lead to significant improvement of patients' care. This is also an upmost issue for patients who want to know if an underlying cancer might have triggered the VTE.

An individual patient-level data meta-analysis (IPDMA) supports extensive screening strategies for occult cancer especially based on FDG PET/CT, and suggests that the best target population for cancer screening would be patients with unprovoked VTE older than 50 years of age (6.7% in patients aged 50 years or more vs. 1.0% in patients of less than 50 years (OR: 7.1, 95% CI: 3.1 to 16%).

primary_purpose: Screening

ReferenceCitation: Robin P, Le Roux PY, Planquette B, Accassat S, Roy PM, Couturaud F, Ghazzar N, Prevot-Bitot N, Couturier O, Delluc A, Sanchez O, Tardy B, Le Gal G, Salaun PY; MVTEP study group. Limited screening with versus without (18)F-fluorodeoxyglucose PET/CT for occult malignancy in unprovoked venous thromboembolism: an open-label randomised controlled trial. Lancet Oncol. 2016 Feb;17(2):193-199. doi: 10.1016/S1470-2045(15)00480-5. Epub 2015 Dec 8.

ReferenceCitation: Carrier M, Lazo-Langner A, Shivakumar S, Tagalakis V, Zarychanski R, Solymoss S, Routhier N, Douketis J, Danovitch K, Lee AY, Le Gal G, Wells PS, Corsi DJ, Ramsay T, Coyle D, Chagnon I, Kassam Z, Tao H, Rodger MA; SOME Investigators. Screening for Occult Cancer in Unprovoked Venous Thromboembolism. N Engl J Med. 2015 Aug 20;373(8):697-704. doi: 10.1056/NEJMoa1506623. Epub 2015 Jun 22.

ReferenceCitation: van Es N, Le Gal G, Otten HM, Robin P, Piccioli A, Lecumberri R, Jara-Palomares L, Religa P, Rieu V, Rondina M, Beckers MM, Prandoni P, Salaun PY, Di Nisio M, Bossuyt PM, Büller HR, Carrier M. Screening for Occult Cancer in Patients With Unprovoked Venous Thromboembolism: A Systematic Review and Meta-analysis of Individual Patient Data. Ann Intern Med. 2017 Sep 19;167(6):410-417. doi: 10.7326/M17-0868. Epub 2017 Aug 22. Review.

ipd_sharing: Yes

ipd_sharing_description: All collected data that underlie results in a publication

lead_sponsor: University Hospital, Brest

location_country: Canada France

location_facility:
Hôpital Saint Musse - CH Toulon
University of Manitoba
CH Agen
Hôpital Européen Georges Pompidou
CHU Saint-Etienne
Sunnybrook Research Institute
CHU Angers
Brest University Hospital
CHU de Clermont-Ferrand
University of Calgary
CHU de Dijon
Hopital Montfort
Jewish General Hospital
Ottawa Hospital Research Institute
McGill University Health Centre
McMaster University
CHU de Limoges
London Health Sciences Centre
University Health Network
CH des Pays de Morlaix

intervention_type: Diagnostic Test


title: A Phase I/II, Open-Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Tor Kinase Inhibitor AZD8055 Administered Orally to Patients With Advanced Solid Tumours.

summary: The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD8055 and determine the maximum tolerated dose to take into phase II trials.

lead_sponsor: AstraZeneca

location_country:
United States
United Kingdom
France


title: A Double-blind, Randomized, Multicenter, Parallel Group Study to Evaluate the Efficacy, Tolerability, and Safety of Treatment With the Combination of Valsartan/Amlodipine 160/5 mg Compared to Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Controlled With Amlodipine 5 mg Alone

summary: This study was designed to compare the efficacy, tolerability, and safety of the combination valsartan/amlodipine 160/5 mg versus amlodipine 10 mg in patients with essential hypertension not adequately controlled (defined as mean sitting systolic blood pressure [msSBP] ≥ 130 mmHg and ≤ 160 mmHg) on amlodipine 5 mg alone. The study evaluated both the efficacy and tolerability of the treatments by providing data that assessed blood pressure and the proportion of patients developing peripheral edema.

ReferenceCitation: Schrader J, Salvetti A, Calvo C, Akpinar E, Keeling L, Weisskopf M, Brunel P. The combination of amlodipine/valsartan 5/160 mg produces less peripheral oedema than amlodipine 10 mg in hypertensive patients not adequately controlled with amlodipine 5 mg. Int J Clin Pract. 2009 Feb;63(2):217-25. doi: 10.1111/j.1742-1241.2008.01977.x.

location_country: Spain Italy Finland Argentina Ecuador Switzerland Sweden France Chile Turkey Norway Germany

location_facility:
sites in Chile
sites in Sweden
sites in Argentina
sites in France
sites in Turkey
sites in Spain
sites in Norway
sites in Germany
sites in Italy
sites in Finland
sites in Ecuador
sites in Switzerland


title: Cardiac Rehabilitation and Low Frequency Electrical MyoStimulation in Chronic Heart Failure

acronym: CREMS-HF

summary: The purpose of this study is to determine if addition of low frequency electro-myo-stimulation to cardiac rehabilitation is effective to improve exercise capacity and/or muscular strength in chronic heart failure patients.

primary_purpose: Supportive Care

lead_sponsor: French Cardiology Society

location_facility: Centre de réadaptation cardiaque Leopold Bellan

location_facility: Hôpital Intercommunal Sud Léman Valserine

location_facility: Hôpital de jour de soins de suite et de réadaptation Léopold Bellan

location_facility: Centre de réadaptation spécialisé Saint Luc


title: Cancer of the Upper Aero-digestive Tract and Socio-professional Future

acronym: CARDEL

summary: The aim of this study is to explore the main factors associated with the return to work of patients presenting an upper aero-digestive tract cancer.

location_facility:
CHU de Caen
Hôpital de la Timone
CHU de Rouen
Centre Antoine Lacassagne
Hôpital privé de l'Estuaire
Centre Oscar Lambret
CHRU de Lille
Centre François Baclesse

intervention_type: Behavioral


title: Comparison of Colonoscopy With Virtual Chromoendoscopy Using 3rd Generation NBI System to Chromoendoscopy With Indigo Carmine in Lynch Patients.

acronym: LYNCH-CHROMO

summary: This study compares two colonoscopy techniques (with Narrow Band Imaging versus with indigo carmine chromoendoscopy) in patients having Lynch Syndrome

primary_purpose: Diagnostic

ReferenceCitation: Cellier C, Perrod G, Colas C, Dhooge M, Saurin JC, Lecomte T, Coron E, Rahmi G, Savale C, Chaussade S, Bellanger J, Dray X, Benech N, Le Rhun M, Barbieux JP, Pereira H, Chatellier G, Samaha E. Back-to-Back Comparison of Colonoscopy With Virtual Chromoendoscopy Using a Third-Generation Narrow-Band Imaging System to Chromoendoscopy With Indigo Carmine in Patients With Lynch Syndrome. Am J Gastroenterol. 2019 Oct;114(10):1665-1670. doi: 10.14309/ajg.0000000000000386.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: AP-HP - Hôpital Européen Georges-Pompidou


title: Efficacy of the V0034CR01B Emollient on Xerosis in Children With Atopic Dermatitis. Randomised, Vehicle-controlled, Parallel-groups, Double-blind Study With an Open Label Extension.

lead_sponsor: Pierre Fabre Medicament

location_country: Poland Estonia Lithuania France Romania

location_facility: Poland Estonia Lithuania France Romania

summary:
Atopic dermatitis is a frequent, chronic inflammatory disease influenced by local, immunological, genetic and environmental factors. Important symptoms of atopic dermatitis are dry skin, intense pruritus and impaired epidermal barrier function. Atopic dermatitis is associated with skin barrier dysfunction that facilitates an easier allergen penetration into the skin with an increased irritation and subsequent cutaneous inflammation. A lack of important stratum corneum intercellular lipids and an inadequate ratio between compounds enhance trans-epidermal water loss leading to xerosis. Skin hydration by emollient therapy usually twice daily improves dryness and subsequently pruritus during the treatment of atopic dermatitis and especially improves the barrier function. Emollients make part of basic therapy (grade 1) for treatment of atopic dermatitis (European Academy of Dermatology and Venereology Task Force 2009 Position Paper). Improvement of cutaneous barrier alteration, measured by skin hydration, is a key element for evaluation of emollient treatment efficacy.

The primary objective of this study is to demonstrate the efficacy of the tested product (V0034CR01B) cream on xerosis in children with atopic dermatitis compared to the excipient formula during 28 days.


title: Evaluation of Biomarkers of Atopic Dermatitis in Pediatric Patients Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable

summary:
Primary Objective:

To explore associations between biomarkers of atopic dermatitis (AD) and:

Disease state and time course of AD,
Disease state and evolution of selected atopic comorbid conditions,
Effectiveness of specific AD treatments.

lead_sponsor: Sanofi

location_country:
Brazil
Spain
Australia
Mexico
Argentina
Canada
United States
France
Colombia
Netherlands

location_facility:
investigational site Colombia
Investigational site Australia
Investigational site Mexico
Investigational site Spain
Investigational Site United States
Investigational site Canada
Investigational site Brazil
Investigational site Argentina
investigational site Netherlands
investigational site France


title: Prospective, Observational, Longitudinal Study in Pediatric Patients With Moderate to Severe Atopic Dermatitis Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable

acronym: PEDISTAD

summary:
Primary Objectives:

To describe the characteristics of pediatric patients with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable.
To evaluate the time-course of AD and selected atopic comorbidities.

Secondary Objectives:

To characterize disease burden and unmet need.
To describe real-world treatment patterns (eg, dosing regimens, treatment duration, and reasons for discontinuation and/or switching).
To document the real-world effectiveness and safety of treatments.

ReferenceCitation: Paller AS, Guttman-Yassky E, Irvine AD, Baselga E, de Bruin-Weller M, Jayawardena S, Zhang A, Mina-Osorio P, Rizova E, Ozturk ZE. Protocol for a prospective, observational, longitudinal study in paediatric patients with moderate-to-severe atopic dermatitis (PEDISTAD): study objectives, design and methodology. BMJ Open. 2020 Mar 24;10(3):e033507. doi: 10.1136/bmjopen-2019-033507.

location_country:
Spain
Italy
United States
Belgium
Japan
Portugal
Russian Federation
Australia
Argentina
Israel
Mexico
Norway
Brazil
Canada
China
Denmark
Greece
Korea, Republic of
France
Colombia
Netherlands

location_facility:
Investigational site USA
Investigational site Canada
investigational site China
investigational site Argentina
Investigational site Belgium
investigational site Norway
Investigational site RUSSIA
investigational site Brazil
Investigational site Portugal
Investigational site Mexico
investigational site Italy
Investigational site Republic of Korea
investigational site France
investigational site Colombia
investigational site Japan
investigational site Denmark
investigational site AUSTRALIA
Investigational site Greece
investigational site Spain
investigational site Israel
Investigational site Netherlands


title: A Multicenter, Randomized, Double-blind, Parallel-group, Evaluation of 12 Weeks of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children 6 to 17 Years of Age With Hypertension

location_country:
Poland
Italy
Sweden
Hungary
United States
France
India
Turkey
Belgium
Germany
Slovakia

location_facility:
Sites in Belgium
Sites in France
Sites in Turkey
Sites in Hungary
Sites in India
Sites in Sweden
Sites in Italy
Sites in Germany
Sites in Slovakia
Sites in Poland
Sites in USA

summary: The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with hypertension (SSBP ≥ 95th percentile for age gender and height).