- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01400971
Een observationele studie om de uitdagingen te begrijpen die verband houden met de progressie van insulinetherapie bij diabetes type 2 (MOSAIc)
25 februari 2020 bijgewerkt door: Eli Lilly and Company
Een multinationaal observationeel onderzoek ter beoordeling van het insulinegebruik: inzicht in de uitdagingen die samenhangen met de progressie van de therapie - de MOSAIc Type 2 Diabetes Study
Het doel van deze studie is om specifieke patiënt-, arts- en gezondheidssysteemgerelateerde factoren te identificeren die verband houden met de progressie naar een intensiever regime van initiële insulinetherapie voor patiënten met diabetes type 2.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Observationeel
Inschrijving (Werkelijk)
4299
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Buenos Aires, Argentinië, CBA 1419
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Corrientes, Argentinië, 3400
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Mendoza, Argentinië, 5500
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Parana, Argentinië, 3100
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Rosario, Argentinië, S2000DSZ
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San Juan, Argentinië, 5400
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Campina Grande Do Sul, Brazilië, 83430-000
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Caxias Do Sul, Brazilië, 95070560
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Fortaleza, Brazilië, 60430-370
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Santa Maria, Brazilië, 97015-530
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Setor Oeste/Goiania, Brazilië, 74100-120
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São Paulo, Brazilië, 04020-041
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Tatui, Brazilië, 18270-170
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Alberta
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Edmonton, Alberta, Canada, T5A 4L8
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Spruce Grove, Alberta, Canada, T7X 2V2
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Manitoba
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Winnipeg, Manitoba, Canada, R3C 0N2
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Newfoundland and Labrador
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St. John'S, Newfoundland and Labrador, Canada, A1A3R5
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Ontario
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Burlington, Ontario, Canada, L7M 4Y1
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London, Ontario, Canada, N6A 5G6
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Smiths Falls, Ontario, Canada, K7A 4W8
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Quebec
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Gatineau, Quebec, Canada, J8V 2P5
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Montreal, Quebec, Canada, H3N 1S4
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Sherbrooke, Quebec, Canada, J1G 1B8
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Beijing, China, 100101
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Changchun City, China, 130041
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Chongqing, China
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Guang Zhou, China, 510080
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Shijiazhuang, China, 50000
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Xi'An, China, 710061
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Bosenheim, Duitsland, 55545
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Dresden, Duitsland, 01307
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Essen, Duitsland, 45359
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Hamburg, Duitsland, 22415
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Hohenmölsen, Duitsland, 06679
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Kamp-Lintfort, Duitsland, 47475
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Köln, Duitsland, 51069
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Lambrecht, Duitsland, 67466
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Schramberg, Duitsland, 78713
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Speyer, Duitsland, 67346
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Ahmedabad, Indië, 380007
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Ahmedabad, Gujarat, Indië, 380009
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Bangalore, Indië, 560054
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Belgaum, Indië, 590001
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Hyderabaad, Indië, 500033
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Jaipur, Indië, 302020
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Kormangala, Indië, 560034
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Mangalore, Indië, 575001
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Mumbai, Indië, 400053
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Mysore, Indië, 570023
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Nagpur, Indië, 440025
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New Delhi, Indië, 110070
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Pune, Indië, 411035
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Beer Sheva, Israël, 84350
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Beer Yaakov, Israël, 70300
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Dimona, Israël, 68000
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Givataim, Israël, 53488
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Netanya, Israël, 42470
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Petach Tikwa, Israël, 49582
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Rishon Le Zion, Israël, 75650
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Safed, Israël, 13110
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Acquaviva Delle Fonti, Italië, 70021
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Ancona, Italië, 60110
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Foggia, Italië, 71100
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Lucca, Italië, 55100
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Napoli, Italië, 80131
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Parma, Italië, 43100
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Pavia, Italië, 27100
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Rome, Italië, 00168
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San Giovanni Rotondo, Italië, 71013
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Siena, Italië, 53100
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Kanagawa, Japan, 242-0004
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Kanagawa-Ken, Japan, 232-0071
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Ankara, Kalkoen, 6560
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Canakkale, Kalkoen, 06310
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Diyarbakir, Kalkoen, 21280
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Gaziantep, Kalkoen, 27310
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Istanbul, Kalkoen, 34865
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Izmir, Kalkoen
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Kahramanmaras, Kalkoen, 46050
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Kirikkale, Kalkoen, 71450
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Daegu, Korea, republiek van, 705-717
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Daejeon, Korea, republiek van, 301-721
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Gangwon-Do, Korea, republiek van, 200-722
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Goyang-Si, Korea, republiek van, 412-270
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Jeju Special Self-Governing Pr, Korea, republiek van, 690-767
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Sungnam-Si, Korea, republiek van, 463-712
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Aguascalientes, Mexico, 20217
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Durango, Mexico, 34080
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Guadalajara, Mexico, 44680
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Huixquilucan, Mexico, 52763
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mexico City, Mexico, 11850
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Zapopan, Mexico, 45200
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bayamon, Puerto Rico, 00956
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Carolina, Puerto Rico, 00983
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Loiza, Puerto Rico, 772
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rio Grande, Puerto Rico, 00745
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rio Piedras, Puerto Rico, 00921
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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San Juan, Puerto Rico, 00920
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Toa Baja, Puerto Rico, 00949
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Villa Fontana, Puerto Rico, 00983
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Moscow, Russische Federatie, 117997
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nizhniy Novgorod, Russische Federatie, 603126
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rostov-On-Don, Russische Federatie, 344022
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Saint Petersburg, Russische Federatie, 194358
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Tomsk, Russische Federatie, 634050
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Vsevolozhsk, Russische Federatie, 188640
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Yaroslavl, Russische Federatie, 150010
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Dammam, Saoedi-Arabië, 31412
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Makkah, Saoedi-Arabië, 21955
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Riyadh, Saoedi-Arabië, 245
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taif, Saoedi-Arabië, 21944
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Barcelona, Spanje, 8025
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Gerena, Spanje
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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La Roca Del Valles, Spanje, 8430
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Madrid, Spanje, 28034
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Sevilla, Spanje, 41009
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Vic, Spanje, 08500
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Cardiff, Verenigd Koninkrijk, CF5 4AD
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Chesterfield, Verenigd Koninkrijk, S40 4TF
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Avon
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Bath, Avon, Verenigd Koninkrijk, BA2 3HT
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cornwall
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Torpoint, Cornwall, Verenigd Koninkrijk, PL11 2JW
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Greater Manchester
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Manchester, Greater Manchester, Verenigd Koninkrijk, M20 2RN
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lancashire
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Bolton, Lancashire, Verenigd Koninkrijk, BL3 6TL
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Yorkshire
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Doncaster, South Yorkshire, Verenigd Koninkrijk, DN9 1EP
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Warwickshire
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Atherstone, Warwickshire, Verenigd Koninkrijk, CV9 1EU
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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West Glamorgan
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Swansea, West Glamorgan, Verenigd Koninkrijk, SA2 8QA
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wiltshire
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Bradford On Avon, Wiltshire, Verenigd Koninkrijk, BA15 1DQ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Abu Dhabi, Verenigde Arabische Emiraten
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Al Ain, Verenigde Arabische Emiraten
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Dubai, Verenigde Arabische Emiraten, 9115
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Sharjah, Verenigde Arabische Emiraten
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arkansas
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Little Rock, Arkansas, Verenigde Staten, 72204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Florida
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Orlando, Florida, Verenigde Staten, 32806
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wellington, Florida, Verenigde Staten, 33414
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Georgia
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Canton, Georgia, Verenigde Staten, 30114
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Illinois
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Crystal Lake, Illinois, Verenigde Staten, 60012
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nebraska
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North Platte, Nebraska, Verenigde Staten, 69101
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nevada
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Reno, Nevada, Verenigde Staten, 89511
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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North Carolina
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Burlington, North Carolina, Verenigde Staten, 27215
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Greensboro, North Carolina, Verenigde Staten, 27408
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Morganton, North Carolina, Verenigde Staten, 28655
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tabor City, North Carolina, Verenigde Staten, 28463
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pennsylvania
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Johnstown, Pennsylvania, Verenigde Staten, 15905
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Levittown, Pennsylvania, Verenigde Staten, 19056
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Carolina
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Charleston, South Carolina, Verenigde Staten, 29412
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tennessee
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Kingsport, Tennessee, Verenigde Staten, 37660
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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Dallas, Texas, Verenigde Staten, 75235
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fort Worth, Texas, Verenigde Staten, 76104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Georgetown, Texas, Verenigde Staten, 78626
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Houston, Texas, Verenigde Staten, 77074
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Plano, Texas, Verenigde Staten, 75023
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Virginia
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Alexandria, Virginia, Verenigde Staten, 22304
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Richmond, Virginia, Verenigde Staten, 23219
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Patiënten met type 2-diabetes die naar eerstelijnszorg en gespecialiseerde diabetesklinieken gaan.
Beschrijving
Inclusiecriteria:
- Er is diabetes type 2 vastgesteld
- Zijn gepresenteerd binnen de normale loop van de zorg
- ≥3 maanden op hun initiële insulinetherapie zijn geweest (met of zonder een combinatie van goedgekeurde niet-insuline antidiabetica)
- niet tegelijkertijd deelnemen aan een studie die een onderzoeksgeneesmiddel of procedure bevat bij deelname aan de studie
- Volledig geïnformeerd zijn en schriftelijke toestemming hebben gegeven voor het gebruik van hun gegevens
- Voldoende kennis hebben van de primaire taal van het land, zodat ze de vragenlijsten kunnen invullen
- U bent niet begonnen met basale bolustherapie (drie maaltijdinsuline-injecties)
Uitsluitingscriteria:
- Geen
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Ander
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
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MOSAIC-deelnemers
Deelnemers die deelnamen aan de Multinational Observational Study Assessing Insulin use (MOSAIc) en die over volledige behandelingsgegevens beschikten tijdens de studie.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Aantal deelnemers met insulinegerelateerde behandelingsverandering ten opzichte van initiële insulinetherapie
Tijdsspanne: Basislijn tot 24 maanden
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Het multivariabele logistische regressiemodel onderzocht baseline deelnemers-, arts- en gezondheidszorggerelateerde factoren die verband houden met het optreden van enige verandering in de insulinetherapie.
Discriminatiedomein van de Interpersonal Processes of Care Survey [IPC] varieert van 1-5 waarbij hogere scores meer discriminatie aangeven en Diabetes Distress Scale varieert van 1-6 waarbij hogere scores meer leed aangeven.
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Basislijn tot 24 maanden
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Aantal episoden van hypoglykemie en ernstige hypoglykemie
Tijdsspanne: Basislijn tot 24 maanden
|
Hypoglykemie en ernstige hypoglykemie-episodes worden door alle deelnemers zelf gerapporteerd met volledige behandelingsgegevens van één maand voorafgaand aan het basisbezoek tot het laatste bezoek (24 maanden).
Patiënten werd bij elk bezoek gevraagd om zelf eventuele hypoglykemie sinds hun laatste bezoek te melden.
Bij het basisbezoek werden de deelnemers gevraagd naar hun hypoglykemie-informatie voor de maand voorafgaand aan het basisbezoek.
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Basislijn tot 24 maanden
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Aantal deelnemers dat zich aan de voorgeschreven insulinetherapie hield tijdens het onderzoek (onderzoeksvolgend)
Tijdsspanne: Basislijn tot 24 maanden
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MOSAIC-deelnemers beantwoordden de vraag: "Hoe vaak heb je je insuline-injecties gemist in de afgelopen 7 dagen?".
Bij elk bezoek werden de deelnemers gedefinieerd als een bezoekaanhanger als de deelnemer antwoordde "Ik heb geen enkele opname gemist" of "Ik heb een aantal van mijn opnames gemist".
Ze werden gedefinieerd als niet-aanhankelijk als hij/zij een van de volgende antwoorden gaf: "Ik heb ongeveer de helft van mijn injecties gemist", "Ik heb de meeste van mijn injecties gemist" of "Ik heb al mijn injecties gemist".
Een deelnemer wordt als studievolger beschouwd als ten minste: 4 van de 5 therapietrouw is.
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Basislijn tot 24 maanden
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Aantal deelnemers dat hun gepersonaliseerde HbA1c-streefwaarde aan het einde van het onderzoek heeft bereikt
Tijdsspanne: Basislijn tot 24 maanden
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Aangezien diabetesbeheerpraktijken variëren in de landen die in MOSAIC vertegenwoordigd zijn, is een meer geschikte maatstaf voor het bereiken van het doel het gepersonaliseerde doel dat aan het begin van het onderzoek voor elke patiënt werd vastgesteld.
|
Basislijn tot 24 maanden
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Matsuba I, Kawata T, Ajima M, Umezawa S, Kaneshiro M, Asakura T, Machimura H, Sawa T, Tanaka K, Takeda H, Imaoka T, Kanamori A. Multinational Observational Study to Understand Insulin Treatment Intensification: Japanese Subgroup Analysis of the MOSAIc Study. Diabetes Ther. 2022 Feb;13(2):265-274. doi: 10.1007/s13300-021-01195-8. Epub 2022 Jan 6.
- Caballero AE, Nordstrom BL, Liao B, Fan L, Zhang N, Fraeman KH, Perez-Nieves M. Individualized HbA1c target selection and achievement in the Multinational Observational Study Assessing Insulin Use (MOSA1c) type 2 diabetes study. J Diabetes Complications. 2021 Nov;35(11):108011. doi: 10.1016/j.jdiacomp.2021.108011. Epub 2021 Jul 30.
- Linetzky B, Curtis B, Frechtel G, Montenegro R Jr, Escalante Pulido M, Stempa O, de Lana JM, Gagliardino JJ. Challenges associated with insulin therapy progression among patients with type 2 diabetes: Latin American MOSAIc study baseline data. Diabetol Metab Syndr. 2016 Jul 22;8:41. doi: 10.1186/s13098-016-0157-1. eCollection 2016.
- Matsuba I, Sawa T, Kawata T, Kanamori A, Jiang D, Machimura H, Takeda H, Han JH, Wang K, Tanaka K, Shen L, Ajima M, Kaneshiro M, Kim SW, Umezawa S, Asakura T, Suzuki S, Kim SC. Cross-National Variation in Glycemic Control and Diabetes-Related Distress Among East Asian Patients Using Insulin: Results from the MOSAIc Study. Diabetes Ther. 2016 Jun;7(2):349-60. doi: 10.1007/s13300-016-0178-7. Epub 2016 Jun 2.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juli 2011
Primaire voltooiing (Werkelijk)
1 september 2015
Studie voltooiing (Werkelijk)
1 september 2015
Studieregistratiedata
Eerst ingediend
21 juli 2011
Eerst ingediend dat voldeed aan de QC-criteria
21 juli 2011
Eerst geplaatst (Schatting)
25 juli 2011
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 maart 2020
Laatste update ingediend die voldeed aan QC-criteria
25 februari 2020
Laatst geverifieerd
1 februari 2020
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 14056
- F3Z-MC-B010 (Andere identificatie: Eli Lilly and Company)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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