type: Registry Identifier

title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-4482 for the Prevention of COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection With Symptoms) in Adults Residing With a Person With COVID-19

acronym: MOVe-AHEAD

summary: The purpose of the study is to assess if the study medication (molnupiravir, MK-4482) will prevent symptomatic coronavirus disease 2019 (COVID-19) in adults who live with someone with confirmed COVID-19 infection. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study; half of the study participants will receive molnupiravir twice daily by mouth and the other half will receive a placebo. The primary objectives of the study are to determine if molnupiravir prevents symptomatic COVID-19 disease and to evaluate its safety and tolerability. All participants who develop COVID-19 during the study are still eligible for any COVID-19 treatment recommended by their doctor.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Argentina
Japan
Brazil
Thailand
Turkey
France
Colombia
Hungary
United States
Kenya
Dominican Republic
Ukraine
Romania
Malaysia
Peru
Philippines
Egypt
Guatemala
Mexico
Spain
South Africa
Bulgaria
Russian Federation

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 1101)

location_facility: Preferred Clinical Research ( Site 2470)

location_facility: Medical Clinical Investigational Center of Medical Center Health Clinic ( Site 2210)

location_facility: Clinical Research Trials of Florida ( Site 2402)

location_facility: Faculdade de Medicina da Universidade Federal de Mato Grosso do Sul - UFMS ( Site 0305)

location_facility: Cherokee Nation WW Hastings Indian Hospital/Cherokee Nation Health Services ( Site 2459)

location_facility: Medical Research Institute LLC. ( Site 1814)

location_facility: Asian Hospital and Medical Center ( Site 1503)

location_facility: Oaxaca Site Management Organization S.C. ( Site 1304)

location_facility: National Center for allergies and chest ( Site 2940)

location_facility: Non profit municipal enterprise City hospital student of Kharkiv city council ( Site 2229)

location_facility: Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 1301)

location_facility: Limited liability company "Scientific research center Eco-safety" ( Site 1809)

location_facility: Obudai Egeszsegugyi Centrum - Zalaegerszeg ( Site 0819)

location_facility: Future Innovative Treatments, LLC ( Site 2471)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 2010)

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0312)

location_facility: Crossroads Clinical Research LLC ( Site 2451)

location_facility: Centro Cientifico Asistencial Jose Luis Accini ( Site 0412)

location_facility: Fundacion Centro de Investigaciones Clinicas CARDIOMET ( Site 0409)

location_facility: Unidad de Diagnostico Cardiologico ( Site 0701)

location_facility: Hospital Nossa Senhora das Gracas ( Site 0310)

location_facility: St.Petersburg Outpatient Clinic No. 109 ( Site 1818)

location_facility: National Research Institute ( Site 2452)

location_facility: Private Clinic - Dr. Hugo Pezzarossi ( Site 0704)

location_facility: MNPE Consultative-Diagnostic Centre of Desnyanskyi District of Kyiv ( Site 2205)

location_facility: Velocity Clinical Research-Providence ( Site 2432)

location_facility: Ankara Universitesi Ibni Sina Hastanesi ( Site 2101)

location_facility: PCNE Kharkiv City polyclinic 9 of the Kharkiv City Council ( Site 2201)

location_facility: Limpopo Clinical Research Initiative ( Site 1901)

location_facility: CHRISTUS - LATAM HUB CENTER OF EXCELLENCE AND INNOVATION S.C. ( Site 1315)

location_facility: Policlínico Especializado en Neurología - Unid. Inv. Neurológica ( Site 1403)

location_facility: Regional Phthisiopulmonological Center ( Site 2203)

location_facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2107)

location_facility: The Lindner Center for Research and Education at The Christ Hospital ( Site 2517)

location_facility: Infectious Clinical Hospital # 1 ( Site 1834)

location_facility: Instituto Neumologico del Oriente S.A. ( Site 0408)

location_facility: Medical Center Hera Kyustendi EOOD ( Site 3003)

location_facility: University of Missouri Hospital ( Site 2486)

location_facility: DTHF Masiphumelele Clinical Research Site ( Site 1919)

location_facility: Centro Médico Universitario ( Site 1316)

location_facility: Clinical Site Partners, LLC d/b/a CSP Miami ( Site 2425)

location_facility: Caja de Compensacion Familiar CAFAM ( Site 0403)

location_facility: DRC Gyogyszervizsgalo Kozpont Kft. ( Site 0801)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 1308)

location_facility: Chiba Aoba Municipal Hospital ( Site 1100)

location_facility: Centro de Referência e Treinamento DST/AIDS ( Site 0301)

location_facility: The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2484)

location_facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0402)

location_facility: Jadestone Clinical Research, LLC ( Site 2530)

location_facility: Balanced Life Healthcare Solutions/SKYCRNG ( Site 2539)

location_facility: KEMRI-CMR-RCTP- Kenya Medical Research Institute Kisumu ( Site 1925)

location_facility: Masri - CRC - Ain Shams University ( Site 2900)

location_facility: LLC -Clinic of modern medicine of Doctor Bogorodskaya ( Site 1828)

location_facility: SPb SBHI. City outpatient clinic No.44 ( Site 1830)

location_facility: Michigan Center of Medical Research ( Site 2445)

location_facility: University of Nebraska Medical Center ( Site 2430)

location_facility: Limited Liability Company Medical center Healthy Happy ( Site 2225)

location_facility: Southern Clinical Research Associates ( Site 2542)

location_facility: Social Medical Corporation Yuuaikai Yuuai Medical Center ( Site 1108)

location_facility: Hospital Italiano de Buenos Aires ( Site 0102)

location_facility: Smolensk State Medical Academy ( Site 1803)

location_facility: Advanced Research For Health Improvement LLC ( Site 2436)

location_facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0105)

location_facility: Hospital Universitario La Paz ( Site 2024)

location_facility: ICARO Investigaciones en Medicina ( Site 1313)

location_facility: Voronezh Regional Clinical Hospital #1 ( Site 1823)

location_facility: Mzansi Ethical Research Centre ( Site 1918)

location_facility: Obudai Egeszsegugyi Centrum - OEC ( Site 0821)

location_facility: University of California Davis ( Site 2497)

location_facility: Instituto de Investigacion Nutricional - Anexo Huascar ( Site 1404)

location_facility: SPb SBHI City outpatient clinic 112 ( Site 1829)

location_facility: Excel Clinical Research, LLC ( Site 2404)

location_facility: Smorodintsev Research Institute of Influenza ( Site 1833)

location_facility: Center for Clinical Research (CCR) KEMRI ( Site 1929)

location_facility: LLC -Medical Center . Capital-Polis ( Site 1825)

location_facility: NPME -Central Clinical Hospital of Ivano-Frankivsk City Council ( Site 2204)

location_facility: Unidad de Aislamiento del Centro de Obstetricia y Ginecologia ( Site 2650)

location_facility: Tribe Clinical Research, LLC ( Site 2409)

location_facility: Asociacion Civil por la Salud ( Site 1411)

location_facility: Hospital Raja Perempuan Zainab II ( Site 2851)

location_facility: Partners in Health Research and Development PHRD ( Site 1928)

location_facility: Centro de Referencia Professor Helio Fraga - FIOCRUZ/RJ ( Site 0314)

location_facility: Healthy Medical Center S.A.S ( Site 0413)

location_facility: Quirino Memorial Medical Center ( Site 1501)

location_facility: Kyiv railway clinical hospital 2 of Branch Health center ( Site 2207)

location_facility: The Institute for Liver Health DBA Arizona Clinical Trials ( Site 2448)

location_facility: Accel Research Sites-DeLand Clinical Research Unit ( Site 2535)

location_facility: CHU de la Reunion - Groupe Hospitalier Sud ( Site 0508)

location_facility: Health Index Multi-Specialty and Lying -in Clinic ( Site 1504)

location_facility: Maison de Sante Universitaire La Providence ( Site 0506)

location_facility: Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 0702)

location_facility: Hospital General de Acapulco ( Site 1319)

location_facility: Hôpital Pitié - Salpêtrière ( Site 0501)

location_facility: Centro de Investigacion Medica Aguascalientes ( Site 1305)

location_facility: FSBI Central Hospital with Policlinics ( Site 1807)

location_facility: Morales Vargas Centro de Investigacion, S.C. ( Site 1318)

location_facility: Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1802)

location_facility: Velocity Clinical Research, Hallandale Beach ( Site 2485)

location_facility: Centrul Medical Unirea SRL Constanta ( Site 1703)

location_facility: Chicago Clinical Research Institute Inc ( Site 2454)

location_facility: Municipal Noncommercial Enterprise Lviv 4th City Clinical Hospital ( Site 2200)

location_facility: Right To Care Research - Esizayo ( Site 1907)

location_facility: Fundaçao de Medicina Tropical Doutor Heitor Vieira Dourado ( Site 0303)

location_facility: Enhancing Care Foundation-DICRS ( Site 1922)

location_facility: Hospital Universitario Infanta Leonor ( Site 2002)

location_facility: The Golden Jubilee Medical Center ( Site 2800)

location_facility: Basaksehir Cam ve Sakura City Hospital ( Site 2112)

location_facility: Hacettepe Universitesi Tip Fakultesi ( Site 2102)

location_facility: Investigaciones Medicas en Salud - INMENSA ( Site 1401)

location_facility: Medical Center Hera EOOD - Montana branch ( Site 3002)

location_facility: Sancaktepe Prof Dr Ilhan Varank EAH-Prof Dr Feriha Oz Hastanesi ( Site 2113)

location_facility: Global Clinical Trial Centre ( Site 1904)

location_facility: Klinik Kesihatan Masjid Tanah ( Site 2850)

location_facility: Centrul Medical Unirea SRL Bucuresti ( Site 1706)

location_facility: Prime Health and Wellness/SKYCRNG ( Site 2538)

location_facility: SC Policlinica CCBR SRL. Bucuresti ( Site 1704)

location_facility: Michigan Center of Medical Research ( Site 2525)

location_facility: Allina Health Infectious Diseases Research Clinic ( Site 2507)

location_facility: Instituto Medico de la Fundacion Estudios Clinicos ( Site 0106)

location_facility: Hospital Universitario Clinica San Rafael ( Site 0410)

location_facility: Private Practice - Dr. Neyaseelan Gounden ( Site 1911)

location_facility: Emerson Clinical Research Institute ( Site 2457)

location_facility: Valley Clinical Trials Inc. ( Site 2406)

location_facility: National Hepatology and Tropical Medicine Research Institute ( Site 2930)

location_facility: Köhler & Milstein Research S.A. de C.V. ( Site 1300)

location_facility: Mautalen Salud e Investigacion ( Site 0103)

location_facility: Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 2232)

location_facility: MNCE -Odesa regional clinical hospital of Odesa regional council ( Site 2226)

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi ( Site 2110)

location_facility: C.S. Vallcarca-Sant Gervasi ( Site 2000)

location_facility: HIV-NAT AIDS Research Centre ( Site 2804)

location_facility: Masri - CRC - Ain Shams University ( Site 2910)

location_facility: Centrul Medical Unirea SRL IASI ( Site 1701)

location_facility: Centro de Investigaciones Pediatricas ( Site 0703)

location_facility: Instituto Jalisciense de Metabolismo SC ( Site 1314)

location_facility: Covid-19 Clinical Research Center (CCRC) ( Site 2421)

location_facility: Grupo Oroño Centro medico San Nicolas ( Site 0109)

location_facility: Mercury Street Medical Group PLLC ( Site 2476)

location_facility: National Hospital Organization Okinawa National Hospital ( Site 1109)

location_facility: Gazi Universitesi Tip Fakultesi Hastanesi ( Site 2106)

location_facility: Debreceni Egyetem Klinikai Kozpont- Infektologiai Klinika ( Site 0824)

location_facility: Odesa Regional Center of Socially Significant Diseases ( Site 2230)

location_facility: Sanatorio de la Trinidad Mitre ( Site 0108)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2105)

location_facility: Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 2227)

location_facility: Clinical Site Partners, LLC d/b/a CSP Miami ( Site 2508)

location_facility: Oncosite-Centro de Pesquisa Clinica em Oncologia ( Site 0300)

location_facility: Rush University Medical Center ( Site 2510)

location_facility: Asociacion Civil IMPACTA Salud y Educacion - Sede San Miguel ( Site 1410)

location_facility: SPb SBHI City outpatient clinic 4 ( Site 1831)

location_facility: CDC Research Institute, LLC ( Site 2540)

location_facility: Institute of Human Virology ( Site 2504)

location_facility: Air Force Specialized Hospital Clinical Research Center ( Site 2920)

location_facility: Medipol Universite Hastanesi ( Site 2108)

location_facility: Wits Health Consortium. Clinical HIV Research Unit ( Site 1923)

location_facility: Indago Research and Health Center Inc ( Site 2412)

location_facility: Amici Clinical Research LLC ( Site 2426)

location_facility: Maison de santé du Pays Neufchatelois ( Site 0507)


type: Other Identifier

title: One-year Follow-up of Iron in Basal Ganglia - R2*: a Biomarker of Parkinson's Disease Progression?

summary: The study of non-invasive and reliable biomarkers to track progression of Parkinson's disease (PD) is essential while disease-modifying treatments are being developed. Many clinical biological or imaging biomarkers have been tested but no "gold standard" has been found as of yet. Among these, Magnetic Resonance Imaging (MRI) relaxometry using R2* measurement (R2* = 1/T2*), which is a validated marker for estimating brain iron concentration, appears to be an attractive technique because its safety, rapidly measured in clinical conditions and its ease to ensure individual longitudinal follow-up. Current data of cross sectional studies of R2*, which have shown an iron increase in Substantia Nigra (SN), led to suppose that it could be a biomarker of disease vulnerability. Recently, the investigators have conducted the first longitudinal follow-up of R2* (1.5 T MRI), which showed a rapid R2* increase in both parts of the SN and in the caudal putamen. We propose, here, a multicenter prospective study of one-year cohort follow-up of R2* variations (ΔR2*) in three regions of interest (ROIs) (the SN, the Ventral Tegmental Area (VTA) and the Putamen) of 160 patients with PD, using a 3 Tesla MRI, to evaluate the potential interest of R2* as a biomarker of disease progression. The variation of R2* (ΔR2*) will be correlated with clinical markers of disease progress, non-motor symptoms. 80 healthy controls subjects will also be included to assess the effect of aging on cerebral physiological iron levels.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Diagnostic

enrollment_type: Anticipated

lead_sponsor: University Hospital, Clermont-Ferrand

sponsor_collaborators:
University Hospital, Clermont-Ferrand
France Parkinson Association
Federation for Brain Research
NS-PARK Network

location_facility:
Chu Grenoble
Hôpital Henri Mondor
Chu Lille
Chu Poitiers
Chu Toulouse
Chu Montpellier
Chu Reims
CHU Pitié Salpétrière
CHU Clermont-Ferrand
Chu Nancy
Chu Pellegrin
Hôpital neurologique Pierre Wertheimer
Chu Dupuytren

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown

appel_a_projets: PHRCI

region: Auvergne-Rhône-Alpes

nom_etablissement: CHU DE CLERMONT-FERRAND

type_etablissement: CH

titre: Evolution à un an de la teneur en fer dans les ganglions de la base  R2* : un biomarqueur de la progression de la Maladie de Parkinson.

discipline_principale: hors cancer

nom_porteur: MARQUES

prenom_porteur: Ana


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.

status: Completed

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Lederman MM, Valdez H. Immune restoration with antiretroviral therapies: implications for clinical management. JAMA. 2000 Jul 12;284(2):223-8. doi: 10.1001/jama.284.2.223.

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. doi: 10.1001/jama.283.3.381.

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. doi: 10.1016/s0140-6736(00)02504-6.

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. doi: 10.1086/342603. 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. doi: 10.1097/00002030-200002180-00006.

ReferenceType: derived

ReferenceCitation: Borges AH, 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.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

ReferenceCitation: Castillo-Mancilla JR, Phillips AN, Neaton JD, Neuhaus J, Collins S, Mannheimer S, Pett S, Touzeau-Romer 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.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: PubMed Central - Europe PMC

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

repositories:
PubMed Central
Pure (Denmark)
UCL Discovery

repositories_concat: PubMed Central;Pure (Denmark);UCL Discovery

repositories_institution: University College London - UCL Discovery

unpaywall_oa_status: gold

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.

oa_host_type: repository

version: acceptedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: SAGE Publications

ReferenceCitation: Nordell AD, McKenna M, Borges AH, 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.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

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. doi: 10.1371/journal.pone.0040245. 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-Moller 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. doi: 10.1097/qai.0b013e3181d32158.

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. doi: 10.7326/0003-4819-149-5-200809020-00003.

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. doi: 10.1177/135965350801300215.

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. doi: 10.1097/QAD.0b013e3282f20a77.

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. doi: 10.1097/QAI.0b013e31815acaa4.

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, Fatkenheuer 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. doi: 10.1056/NEJMoa062360.

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

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

location_facility: Servizio Regionale di Immunologia Clinica e Tipizz

location_facility: Centro de Referencia e Treinamento DST/AIDS

location_facility: Center for Prevention and Treatment of Infections

location_facility: AIDS Research Consortium of Atlanta (ARCA) Central

location_facility: T1 Coleridge Unit, North Middlesex Hospital

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

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

location_facility: AID Atlanta/Morehouse Med School Ryan White Cl

location_facility: McGuire VA / Division of Infectious Diseases

location_facility: Klein and Slotten Associates / AIDS Research Alliance

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

location_facility: Centro de Pesquisa Clinical do Hospital Guilherme

location_facility: Hospital Universitario Professor Edgard Santos

location_facility: Hospital Interzonall de San Juan de Dios

location_facility: Community Research Initiatives of New England

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

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

location_facility: Michigan State University Infectious Diseases Clinic

location_facility: Washington Reg AIDS Prog / Dept of Infect Dis

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

location_facility: Cassiano Antonio de Moraes University Hospital

location_facility: HIV Services Clinic/Family Practice Medical Center

location_facility: Infectious Disease Associates of Virginia

location_facility: HIV Care Program, Windsor Regional Hospital

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

location_facility: Johann Wolfgang Goethe University Hospital

location_facility: Treasure Coast Infectious Disease Consultants

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

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

location_facility: Providence Hosp- Newland Med Assoc. Inc.

location_facility: Ambulatorio de Imunodeficiencias Secundarias/Der30

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

location_facility: Los Angeles Gay and Lesbian Community Service Ctr

location_facility: SOCDU Malattie Infettive Ospedale Civile Asti

location_facility: Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

location_facility: Montreal Chest Institute/Royal Victoria Hospital

location_facility: Recherche Clinique Centre Medical Halles de Saint-

location_facility: Southern Illinois University (SIU) School of Medicine

location_facility: Cooper Hospital Early Intervention Program

location_facility: Klinik fur Dermatologie, Venerologie, Allergologie

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

location_facility: Centre Hospitalier Universitaire Sart-Tilman

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Universidade Federal De Sao Paulo-Hospital Sao Paulo

location_facility: Dekalb County Health Dept Infectious Disease

location_facility: Cobb-Douglas County Infectious Disease Clinic

location_facility: University of Vienna Medical School, AKH

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Homerton University Hospital NHS Foundation Trust

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

location_facility: Universita degli Studi di Modena e Reggio Emilia

location_facility: Hawthorn House, Birmingham Heartlands NHS Trust

location_facility: Christiana Care Health Services HIV Program George

location_facility: KU Medical School-Wichita, Midtown Clinic

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

location_facility: Consorcio Hospital General Universitario de Valencia

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

location_facility: Kaiser Permanente-Fremont/Hayward Medical Centers

location_facility: Watford Sexual Health Center;Watford General Hosp

location_facility: National Centre in HIV Epidemiology and Clinical Research

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

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: New Jersey Community Research Initiative

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

location_facility: University of Mississippi Medical Center

location_facility: Hospital Universitario Principe de Asturias

location_facility: Cross Over Clinic / Div of Infectious Diseases

location_facility: Instituto de Malattie Infettive e Tropicali

location_facility: The Caldecot Centre, Kings College Hospital NHS Tr

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

location_facility: AIDS Medical Center, International Medical Center


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.

lead_sponsor: University Hospital, Brest

sponsor_collaborators:
University Hospital, Brest
Fondation de France
Fondation Motrice
Fondation Apicil

location_facility: Centre de Rééducation fonctionnelle de Kerpape


intervention_type: Drug

acronym: CAROLINA

lead_sponsor: Boehringer Ingelheim

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.

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.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

repository_institution: Erasmus University Rotterdam - EUR Research Repository

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

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.

oa_host_type: publisher

repositories_concat: closed

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.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repositories_concat: PubMed Central;pure.eur.nl;repub.eur.nl

publisher_dissemination: Springer-Nature

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.

evidence: open (via free pdf)

publisher_dissemination: American Medical Association

ReferenceCitation: Janssen J, van den Berg E, Zinman B, Espeland MA, Geijselaers SLC, Mattheus M, Johansen OE, Biessels GJ. HbA1c, Insulin Resistance, and beta-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. No abstract available.

license: unspecified-oa

license_normalized: unspecified-oa

ReferenceCitation: Biessels GJ, Janssen J, van den Berg E, Zinman B, Espeland MA, Mattheus M, Johansen OE; CAROLINA(R) investigators. Rationale and design of the CAROLINA(R) - 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(R)). 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.

sponsor_collaborators:
Boehringer Ingelheim
Eli Lilly and Company

location_facility: Internal & Diabetology Ambulance Dr. Vrkoc, Ostrava

location_facility: Global Hospital- Superspeciality & Transplant Centre

location_facility: National Institute of Endocrinology, Tbilisi

location_facility: National Health Insurance Service Ilsan Hospital

location_facility: CIIGMA Institute of Medical Sciences Pvt Ltd

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

location_facility: General Hospital Subotica, Internal Medicine

location_facility: Forusakutten - Kolibri Medical, Avd. Stavanger

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Castlerock Clinical Research Consultants, LLC

location_facility: Internal & Diabetology Ambulance, Jablonec nad Nisou

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: Fundacion del Caribe de Investigacion Biomedica

location_facility: Instituto Delgado de Investigacion Medica

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

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

location_facility: Internal & Diabetology Ambulance, Prostejov

location_facility: Vinnitsia Regional Endocrinology Dispensary

location_facility: University General Hospital of Thessaloniki AHEPA

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

location_facility: Sunil's Diabetes care and Research Centre

location_facility: Southgate Medical Group/ Southgate Medical Park

location_facility: Daishinkai Medical Corporation Ookuma Hospital

location_facility: Saitama Medical Cooperative Association Hanyu General Hospital

location_facility: Zhordania Institute of Human Reproduction, Tbilisi

location_facility: Instituto de Investigaciones Clínicas de Bahía Blanca

location_facility: Northeast Clinical Research of San Antonio, LLC

location_facility: Instituto de Molestias Cardiovasculares - IMC

location_facility: National Center for Diabetes Research Ltd., Tbilisi

location_facility: Detweiler Family Medicine & Associates, PC

location_facility: MMU City Outpatient Clinic no. 20, Saratov

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

location_facility: Hospital de Servicios Médicos Godoy Ltda

location_facility: Centro de Investigaciones Médicas METABOLICARE SAC

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

location_facility: Unidad de Investigacion Clinica Cardiometabolica de Occident

location_facility: Keimyung University Dongsan Medical Center

location_facility: General Hopsital of Thessaloniki "Ippokrateio"

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

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

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

location_facility: Pusan National University Yangsan Hospital

location_facility: New England Center for Clinical Research, Inc

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

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: UNIENDO Unidad Integral de Endocrinologia

location_facility: Lausmed Kft. Outpatient Unit of Internal Medicine

location_facility: Policlinico Universitario Mater Domini, Universita di Catanzaro

location_facility: Clinical Medical Center Zvezdara, Belgrade

location_facility: Yalamanchi Hospitals & Research Centres Pvt Ltd.

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

location_facility: Multiprofile Hospital for Active Treatment "Zaritza Johanna"

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

location_facility: LLC Clinic of new technologies of medicine

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

location_facility: Centro Cientifico Asistencial Jose Luis Accini

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

location_facility: centro de Diagnostico Cardiologico para la Investigacion Bio

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

location_facility: Donetsk Regional Clinical Hosp, Therapy Department

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

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

location_facility: The University of North Carolina at Chapel Hill

location_facility: University of Texas Southwestern Medical Center

location_facility: State Healthcare Institution, Regional hospital #2

location_facility: Consultorios Asociados de Endocrinología e Invest Clínica

location_facility: Chemotherapy & Immunotherapy Clinic 'Medulla', Tbilisi

location_facility: Kovai Diabetes Speciality Centre & Hospital

location_facility: Hospital Universitário João de Barros Barreto

location_facility: Instituto de Investigaciones Clinicas de Rosario

location_facility: M V Hospital For Diabetes and Diabetes Research Centre

location_facility: Centro de Estudos em Diabetes e Hipertensão

location_facility: Edinger Medical Group and Research Center

location_facility: Centro de Investigacion Cardiometabolica de Aguascalientes

location_facility: Limited Liability Company "CENTER DIABET", Samara

location_facility: Grant Medical Foundation, Ruby Hall Clinic

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

location_facility: San Diego Sports Medicine and Family Health Center

location_facility: Grof Esterhazy Hospital and Outpatient Clinic

location_facility: Noordwest Ziekenhuisgroep, location Den Helder

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Albany Medical Center / Albany Medical College

location_facility: Ivano-Frankivsk City Central Clinical Hospital

location_facility: Fundación Centro de Investigaciones Biomédicas Riescard

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

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

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

location_facility: Instituto Estadual de Diabetes e Endocrinologia

location_facility: Tristan Medical Enterprises, PC dba Regeneris

location_facility: Quality of Life Medical & Research Center

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

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

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

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

location_facility: Royal Brisbane & Women's Hospital-Endocrinology

location_facility: Diamed Clinical Research Services Pvt. Ltd.

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Consulta Privada Maria Loreto Aguirre Coveña

location_facility: PFÜTZNER Science & Health Institute GmbH

location_facility: Pharmacotherapy Research Associates, Inc

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Hospital Strakonice, Internal Department

location_facility: Diabetes and Endocrine Center of Orlando

location_facility: Emergency County Clinical Hospital, Sibiu

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

location_facility: Multiprofile Hospital for Active Treatment

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Klinische Forschung Management & Services GmbH

location_facility: Seoul National University Bundang Hospital

location_facility: Taipei Medical University-Shuang Ho Hospital

location_facility: IFG Institut für Gesundheitsförderung GmbH

location_facility: Japan Community Health care Organization Nihonmatsu Hospital

location_facility: South Carolina Nephrology and Hypertension Center, Inc

location_facility: Institut für Stoffwechselforschung, Frankfurt

location_facility: Edith Wolfson Medical Center, Diabetic Unit, Holon

location_facility: Centro de Investigaciones Clínicas del Litoral

location_facility: The Chaim Sheba Medical Center Tel Hashomer

location_facility: University Diabetes and Endocrine Consultants

location_facility: Shree Krishna Hospital and Heart Care Centre, Ahmedabad

location_facility: Instituto Cardiovascular de Corrientes Juana Francisca Cabra

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.

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


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.

study_completion_date_type: Actual

primary_purpose: Treatment

enrollment_type: Actual

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. doi: 10.1016/s0029-7844(01)01702-1.

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. doi: 10.1067/mob.2003.345.

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. doi: 10.2214/ajr.183.6.01831713. 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. doi: 10.1016/j.burns.2005.04.019. Epub 2005 Jun 20. No abstract available.

ReferenceCitation: Fennessy FM, Tempany CM. MRI-guided focused ultrasound surgery of uterine leiomyomas. Acad Radiol. 2005 Sep;12(9):1158-66. doi: 10.1016/j.acra.2005.05.018.

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. doi: 10.1016/j.fertnstert.2005.04.072. 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. doi: 10.1148/radiol.2433060267. 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. doi: 10.1016/j.ejogrb.2005.10.008. Epub 2005 Nov 15.

lead_sponsor: Philips Healthcare

sponsor_collaborators:
Philips Healthcare
Philips Medical Systems

location_country:
Germany
Korea, Republic of
Netherlands
France

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

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


acronym: PERASTUN

lead_sponsor: University Hospital, Tours

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.

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

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

location_facility: Service de gynécologie-obstétrique, CHR Le Mans

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

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

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

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

location_facility: Service de gynécologie-obstétrique, Polyclinique du PARC

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

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-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, Maison de la Femme de la Mère et de l'Enfant, CHU de Fort de France

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

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

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

primary_purpose: Prevention

type: EudraCT Number

source: euctr

design_allocation: Randomized

location_country: Martinique France


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, Mahe I, Wilts IT, Twint DC, Porreca E, Arrieta O, Stepanian A, Smit K, De Tursi M, Bleker SM, Bossuyt PM, Nieuwland R, Kamphuisen PW, Buller 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.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repositories_concat: PubMed Central;pure.rug.nl

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

lead_sponsor: Harry R. Buller

collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

collaborators: Università degli Studi 'G. d'Annunzio' Chieti e Pescara

collaborators: Instituto Nacional de Cancerologia de Mexico

location_country: Italy Netherlands Mexico France

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

location_facility: Royal Hallamshire Hospital, Pulmonary Vascular Medicine

location_facility: University of Tennessee Health Science Center

location_facility: Virginia Commonwealth University Medical Center

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

location_facility: Columbia University Medical Center; Pediatric Cardiology

location_facility: Royal Free Hospital, Rheumatology Department

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

location_facility: University of Colorado Health Sciences Center

location_facility: Harper University Hospital/Wayne State University

location_facility: Boston Medical Center/Boston University School of Medicine

location_facility: Duke University Medical Center; Duke University Health Systems

location_facility: Amsterdam Medical Center, Department of Hematology

location_facility: Henry Ford Hospital; Dept. of Pulmonology


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


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

collaborators: Hospital Universitario Reina Sofia de Cordoba

collaborators: Hospitales Universitarios Virgen del Rocío

collaborators: Institut Universitaire du Cancer - Oncopole. Toulose. France

location_country: Spain France

location_facility: Hospital Universitario Virgen de las Nieves

status_simplified: Ongoing


acronym: REVRI

lead_sponsor: Institut Curie

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.

ReferenceType: result

ReferenceCitation: Ghesquieres H, Chevrier M, Laadhari M, Chinot O, Choquet S, Molucon-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)dagger. Ann Oncol. 2019 Apr 1;30(4):621-628. doi: 10.1093/annonc/mdz032.

oa_host_type: closed

sponsor_collaborators: Centre Hospitalier Universitaire, Amiens

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

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


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:
United States
Italy
Croatia
France

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

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

location_facility: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

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

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: Kidney Transplant Department, Saint-Louis 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
Hungary
Norway
Romania
Sweden
Netherlands
Belgium
Latvia
Serbia
Bulgaria
Ukraine
Czech Republic
France

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


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.

lead_sponsor: ApoPharma

location_country: Italy Spain Belgium France

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.

repository_institution: University of Liège - Open Repository and Bibliography

ReferenceCitation: Martin-Loeches I, Povoa P, Rodriguez 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: Colombia Portugal Ecuador Argentina Brazil Bolivia Spain France

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

sponsor_collaborators:
Genzyme, a Sanofi Company
Worldwide Clinical Trials

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
Spain
Luxembourg
France

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


title: A Multicentric Randomized Double-Blind Phase 3 Trial Evaluating the Efficacy of an Adapted Antibiotherapy in Hurley Stage 2 Active Hidradenitis Suppurativa Patients Versus Tetracycline Derivative

summary: The study evaluates the efficacy of an adapted antibiotherapy in Hurley stage 2 active Hidradenitis Suppurativa patients versus tetracycline derivative

status: Not yet recruiting

ReferenceCitation: Guet-Revillet H, Jais JP, Ungeheuer MN, Coignard-Biehler H, Duchatelet S, Delage M, Lam T, Hovnanian A, Lortholary O, Nassif X, Nassif A, Join-Lambert O. The Microbiological Landscape of Anaerobic Infections in Hidradenitis Suppurativa: A Prospective Metagenomic Study. Clin Infect Dis. 2017 Jul 15;65(2):282-291. doi: 10.1093/cid/cix285.

ReferenceCitation: Guet-Revillet H, Coignard-Biehler H, Jais JP, Quesne G, Frapy E, Poiree S, Le Guern AS, Le Fleche-Mateos A, Hovnanian A, Consigny PH, Lortholary O, Nassif X, Nassif A, Join-Lambert O. Bacterial pathogens associated with hidradenitis suppurativa, France. Emerg Infect Dis. 2014 Dec;20(12):1990-8. doi: 10.3201/eid2012.140064.

ReferenceCitation: Join-Lambert O, Coignard H, Jais JP, Guet-Revillet H, Poiree S, Fraitag S, Jullien V, Ribadeau-Dumas F, Theze J, Le Guern AS, Behillil S, Lefleche A, Berche P, Consigny PH, Lortholary O, Nassif X, Nassif A. Efficacy of rifampin-moxifloxacin-metronidazole combination therapy in hidradenitis suppurativa. Dermatology. 2011 Feb;222(1):49-58. doi: 10.1159/000321716. Epub 2010 Nov 25.

ipd_sharing: Yes

ipd_sharing_description: All IPD that underlie results in a publication

lead_sponsor: Institut Pasteur

collaborators: Centre Hospitalier Universitaire de Caen

collaborators: Assistance Publique Hopitaux De Marseille

location_facility:
Centre Médical de l'Institut Pasteur
Hopital St Joseph
Hôpital Edouard Herriot
Hôpital de la Timone
CHU de Rouen


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

sponsor_collaborators:
Delafontaine Hospital
Saint-Louis Hospital, Paris, France
Jacques Cartier Institute
Unity Health Toronto
Institut Pasteur

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


lead_sponsor: Santen SAS

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.

location_facility: New Delhi, National Capitol Territory, IN

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

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


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.

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

repository_normalized: HAL

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

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

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

repositories:
HAL
PubMed Central
univOAK

repositories_concat: HAL;PubMed Central;univOAK

publisher_dissemination: Informa

lead_sponsor: Jennerex Biotherapeutics

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

location_facility: Pusan National University Yangsan Hospital

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital Civil

location_facility: University Hospitals Case Medical Center

location_facility: The Methodist Hospital Department of Surgery

location_facility: Severance Hospital,Yonsei University Health System

location_facility: Hôpital Saint Antoine, CPP Ile de France V

location_facility: Centre Hospitalier Universitaire Hôpital Saint André

location_facility: Moores University of California San Diego Cancer Center

location_facility: Klinikum Rechts der Isar der Technischen Universität München


lead_sponsor: Novartis Pharmaceuticals

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.

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

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.

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


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. Prevention du Risque d'Embolie Pulmonaire par Interruption Cave Study Group. N Engl J Med. 1998 Feb 12;338(7):409-15. doi: 10.1056/NEJM199802123380701.

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. doi: 10.1161/CIRCULATIONAHA.104.512834. 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

collaborators:
Ministry of Health, France
Fondation de France
Fondation de l'Avenir
ALN Implants Company

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

location_facility: Service de Pneumologie, Hôpital Antoine Beclere

location_facility: Service de Médecine Vasculaire, CH Toulon

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

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

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

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

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

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

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

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

location_facility: Service de Médecine Vasculaire, CHU Amiens

location_facility: Unité de Médecine Vasculaire, CHU de Grenoble


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.

lead_sponsor: University Hospital, Bordeaux

sponsor_collaborators:
University Hospital, Bordeaux
National Cancer Institute, France
Fondation ARC
Novartis

location_facility: Centre Oscar Lambret - Oncologie pédiatrie

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

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

location_facility: Institut Curie - Centre D'Oncologie SIREDO

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

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


acronym: MOVIE

lead_sponsor: UNICANCER

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.

sponsor_collaborators:
UNICANCER
National Cancer Institute, France
AstraZeneca
Pierre Fabre Laboratories

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

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

status: Active, not recruiting

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