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221por Teramoto, Tamio, Kondo, Akira, Kiyosue, Arihiro, Harada-Shiba, Mariko, Ishigaki, Yasushi, Tobita, Kimimasa, Kawabata, Yumiko, Ozaki, Asuka, Baccara-Dinet, Marie T., Sata, Masataka“…METHODS: The randomized, double-blind, placebo-controlled, parallel-group, phase 3 ODYSSEY NIPPON study will explore alirocumab 150 mg every 4 weeks (Q4W) in 163 Japanese patients with hypercholesterolemia who are on the lowest-strength dose of atorvastatin (5 mg/day) or are receiving a non-statin lipid-lowering therapy (LLT) (fenofibrate, bezafibrate, ezetimibe, or diet therapy alone). …”
Publicado 2017
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222por Ray, Kausik K., Leiter, Lawrence A., Müller‐Wieland, Dirk, Cariou, Bertrand, Colhoun, Helen M., Henry, Robert R., Tinahones, Francisco J., Bujas‐Bobanovic, Maja, Domenger, Catherine, Letierce, Alexia, Samuel, Rita, Del Prato, Stefano“…AIM: To compare alirocumab, a proprotein convertase subtilisin‐kexin type 9 inhibitor, with usual care (UC) in individuals with type 2 diabetes (T2DM) and mixed dyslipidaemia not optimally managed by maximally tolerated statins in the ODYSSEY DM‐DYSLIPIDEMIA trial (NCT02642159). MATERIALS AND METHODS: The UC options (no additional lipid‐lowering therapy; fenofibrate; ezetimibe; omega‐3 fatty acid; nicotinic acid) were selected prior to stratified randomization to open‐label alirocumab 75 mg every 2 weeks (with increase to 150 mg every 2 weeks at week 12 if week 8 non‐HDL cholesterol concentration was ≥2.59 mmol/L [100 mg/dL]) or UC for 24 weeks. …”
Publicado 2018
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223por Vallejo‐Vaz, Antonio J., Ginsberg, Henry N., Davidson, Michael H., Eckel, Robert H., Cannon, Christopher P., Lee, L. Veronica, Bessac, Laurence, Pordy, Robert, Letierce, Alexia, Ray, Kausik K.“…METHODS AND RESULTS: Data pooled from 10 phase 3 ODYSSEY randomized trials (n=4983) comparing alirocumab with control (placebo/ezetimibe) were assessed for association between 39 mg/dL lower on‐treatment LDL‐C and percentage LDL‐C change from baseline, and MACE risk by sex, using multivariable Cox regression. …”
Publicado 2018
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224por Visvikis-Siest, Sophie, Gorenjak, Vesna, Stathopoulou, Maria G., Petrelis, Alexandros M., Weryha, Georges, Masson, Christine, Hiegel, Brigitte, Kumar, Satish, Barouki, Robert, Boerwinkle, Eric, Dagher, Georges, Deloukas, Panagiotis, Innocenti, Federico, Lamont, John, Marschler, Michael, Meyer, Heiko, Meyer, Urs A., Nofziger, Charity, Paulmichl, Markus, Vacher, Cora, Webster, Lynn“…The 9th traditional biannual conference on Systems Medicine, Personalised Health & Therapy—“The Odyssey from Hope to Practice”, inspired by the Greek mythology, was a call to search for practical solutions in cardio-metabolic diseases and cancer, to resolve and overcome the obstacles in modern medicine by creating more interactions among disciplines, as well as between academic and industrial research, directed towards an effective ‘roadmap’ for personalised health and therapy. …”
Publicado 2018
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225por Balogun, Folusho Mubowale, Malele-Kolisa, Yolanda, Nieuwoudt, Sara Jewett, Jepngetich, Hellen, Kiplagat, Jepchirchir, Morakinyo, Oyewale Mayowa, Dawa, Jeanette, Chandiwana, Nomathemba, Chikandiwa, Admire, Akinyemi, Oluwaseun, Olusanya, Bolutife Ayokunnu, Afolabi, Esther Kikelomo, Dube, Nkosiyazi, Obembe, Taiwo, Karumi, Esther, Ndikumana, Celestin, Bukenya, Justine Nnakate, Chikalipo, Maria, Ayamolowo, Sunday Joseph, Shema, Emmanuel, Kapanda, Lester, Maniragaba, Fred, Khuluza, Felix, Zakumumpa, Henry, Mbada, Kikelomo, Sang, Hillary, Kaindoa, Emmanuel“…CONCLUSION: The CARTA model which builds the research capacity of doctoral fellows through robust support, including intermittent strategic Joint Advanced Seminars has had effective and transformative impacts on our doctoral odyssey. However, there is a need to maintain the momentum through continuous communication between CARTA and the fellows all through this journey.…”
Publicado 2021
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228por Barlow‐Mosha, Linda Namutebi, Ahimbisibwe, Grace Miriam, Chappell, Elizabeth, Amuge, Pauline Mary, Nanduudu, Annet, Kaudha, Elizabeth, Amukele, Timothy, Balamusani, David, Kafufu, Bosco, Nimwesiga, Audrey, Kataike, Hajira, Namwanje, Rosemary, Kasangaki, Gladys, Mulindwa, Alice, Muzorah, Gerald Agaba, Bbuye, Dickson, Musiime, Victor, Mujyambere, Emmanuel, Ssenyonga, Mark, Mulima, Disan, Kyambadde, Raymonds Crespo, Namusanje, Josephine, Isabirye, Richard, Nabalamba, Mariam, Nakirya, Barbara Musoke, Kityo, Cissy, Kekitiinwa, Adeodata R., Giaquinto, Carlo, Copp, Andrew, Gibb, Diana M., Ford, Deborah, Musoke, Philippa, Turkova, Anna“…RBC mean corpuscular volume (MCV) was measured 24‐weekly in all ODYSSEY participants. Samples analysed in the sub‐study were collected between September 2016 and October 2020. …”
Publicado 2023
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230por Bays, Harold E., Leiter, Lawrence A., Colhoun, Helen M., Thompson, Desmond, Bessac, Laurence, Pordy, Robert, Toth, Peter P.“…Data were derived from 4983 patients enrolled in 10 randomized, placebo‐ or ezetimibe‐controlled Phase 3 ODYSSEY trials. Primary end point for this pooled analysis was percent reduction in non‐HDL‐C and apoB at Week 24; secondary end points included the percentage of patients achieving guideline‐directed treatment goals (National Lipid Association guidelines: non‐HDL‐C <100 or <130 mg/dL for patients at very high and high cardiovascular risk, respectively; European Society of Cardiology/European Atherosclerosis Society guidelines: apoB <80 mg/dL for patients at very‐high cardiovascular risk). …”
Publicado 2017
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231por Waalewijn, Hylke, Chan, Man K, Bollen, Pauline D J, Mujuru, Hilda A, Makumbi, Shafic, Kekitiinwa, Adeodata R, Kaudha, Elizabeth, Sarfati, Tatiana, Musoro, Godfrey, Nanduudu, Annet, Lugemwa, Abbas, Amuge, Pauline, Moore, Cecilia L, Rojo, Pablo, Giaquinto, Carlo, Colbers, Angela, Gibb, Diana M, Ford, Deborah, Turkova, Anna, Burger, David M“…We therefore aimed to evaluate dolutegravir dosing and safety in children weighing 3 kg to less than 20 kg by assessing pharmacokinetic parameters and safety data in children taking dolutegravir within the ODYSSEY trial. METHODS: We did pharmacokinetic substudies nested within the open-label, multicentre, randomised, non-inferiority ODYSSEY trial. …”
Publicado 2022
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232por Turkova, Anna, Waalewijn, Hylke, Chan, Man K, Bollen, Pauline D J, Bwakura-Dangarembizi, Mutsa F, Kekitiinwa, Adeodata R, Cotton, Mark F, Lugemwa, Abbas, Variava, Ebrahim, Ahimbisibwe, Grace Miriam, Srirompotong, Ussanee, Mumbiro, Vivian, Amuge, Pauline, Zuidewind, Peter, Ali, Shabinah, Kityo, Cissy M, Archary, Moherndran, Ferrand, Rashida A, Violari, Avy, Gibb, Diana M, Burger, David M, Ford, Deborah, Colbers, Angela“…METHODS: We nested a two-period, fixed-order pharmacokinetic substudy within the open-label, multicentre, randomised, controlled, non-inferiority ODYSSEY trial at research centres in South Africa, Uganda, and Zimbabwe. …”
Publicado 2022
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233por Schwartz, Gregory G, Szarek, Michael, Bhatt, Deepak L, Bittner, Vera A, Bujas-Bobanovic, Maja, Diaz, Rafael, Fazio, Sergio, Fras, Zlatko, Goodman, Shaun G, Harrington, Robert A, Jukema, J Wouter, Manvelian, Garen, Pordy, Robert, Ray, Kausik K, Scemama, Michel, White, Harvey D, Steg, Ph Gabriel“…METHODS AND RESULTS: In 18 924 patients with recent acute coronary syndrome, the ODYSSEY OUTCOMES trial compared the PCSK9 inhibitor alirocumab with placebo, each added to high-intensity or maximum-tolerated statin therapy. …”
Publicado 2023
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234por Schwartz, Gregory G., Steg, Philippe Gabriel, Szarek, Michael, Bittner, Vera A., Diaz, Rafael, Goodman, Shaun G., Kim, Yong-Un, Jukema, J. Wouter, Pordy, Robert, Roe, Matthew T., White, Harvey D., Bhatt, Deepak L.“…METHODS: This was a prespecified analysis of the ODYSSEY OUTCOMES randomized clinical trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome), which was conducted in 18 924 patients with recent acute coronary syndrome on intensive or maximum-tolerated statin treatment who were randomized to the PCSK9 inhibitor alirocumab or placebo. …”
Publicado 2020
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236por Tuñón, José, Steg, Philippe Gabriel, Bhatt, Deepak L, Bittner, Vera A, Díaz, Rafael, Goodman, Shaun G, Jukema, J Wouter, Kim, Yong-Un, Li, Qian H, Mueller, Christian, Parkhomenko, Alexander, Pordy, Robert, Sritara, Piyamitr, Szarek, Michael, White, Harvey D, Zeiher, Andreas M, Schwartz, Gregory G“…METHODS AND RESULTS: ODYSSEY OUTCOMES compared alirocumab with placebo in patients with recent ACS and dyslipidaemia despite intensive statin treatment. …”
Publicado 2020
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237por Schwartz, Gregory G., Gabriel Steg, Philippe, Bhatt, Deepak L., Bittner, Vera A., Diaz, Rafael, Goodman, Shaun G., Jukema, J. Wouter, Kim, Yong-Un, Li, Qian H., Manvelian, Garen, Pordy, Robert, Sourdille, Timothée, White, Harvey D., Szarek, Michael“…To overcome these limitations, we performed a propensity score–matching analysis of the ODYSSEY OUTCOMES trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) which compared alirocumab with placebo in 18 924 patients with recent acute coronary syndrome receiving intensive or maximum-tolerated statin treatment. …”
Publicado 2021
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238por Amuge, Pauline, Lugemwa, Abbas, Wynne, Ben, Mujuru, Hilda A, Violari, Avy, Kityo, Cissy M, Archary, Moherndran, Variava, Ebrahim, White, Ellen, Turner, Rebecca M, Shakeshaft, Clare, Ali, Shabinah, Nathoo, Kusum J, Atwine, Lorna, Liberty, Afaaf, Bbuye, Dickson, Kaudha, Elizabeth, Mngqibisa, Rosie, Mosala, Modehei, Mumbiro, Vivian, Nanduudu, Annet, Ankunda, Rogers, Maseko, Lindiwe, Kekitiinwa, Adeodata R, Giaquinto, Carlo, Rojo, Pablo, Gibb, Diana M, Turkova, Anna, Ford, Deborah“…Safety analyses are presented for all randomly assigned children in this study (<14 kg cohort). ODYSSEY is registered with ClinicalTrials.gov, NCT02259127. …”
Publicado 2022
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239por Robinson, Jennifer G., Colhoun, Helen M., Bays, Harold E., Jones, Peter H., Du, Yunling, Hanotin, Corinne, Donahue, Stephen“…The phase 3 ODYSSEY OPTIONS studies (OPTIONS I, NCT01730040; OPTIONS II, NCT01730053) are multicenter, multinational, randomized, double‐blind, active‐comparator, 24‐week studies evaluating the efficacy and safety of alirocumab, a fully human monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9, as add‐on therapy in ∼ 650 high‐cardiovascular (CV)‐risk patients whose low‐density lipoprotein cholesterol (LDL‐C) levels are ≥100 mg/dL or ≥70 mg/dL according to the CV‐risk category, high and very high CV risk, respectively, with atorvastatin (20–40 mg/d) or rosuvastatin (10–20 mg/d). …”
Publicado 2014
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240por Visvikis-Siest, Sophie, Stathopoulou, Maria G., Sunder-Plassmann, Raute, Alizadeh, Behrooz Z., Barouki, Robert, Chatzaki, Ekaterina, Dagher, Georges, Dedoussis, George, Deloukas, Panagiotis, Haliassos, Alexander, Hiegel, Brigitte Boisson, Manolopoulos, Vangelis, Masson, Christine, Paré, Guillaume, Paulmichl, Markus, Petrelis, Alexandros M., Sipeky, Csilla, Süsleyici, Belgin, Weryha, Georges, Chenchik, Alex, Diehl, Paul, Everts, Robin E., Haushofer, Alexander, Lamont, John, Mercado, Ruth, Meyer, Heiko, Munoz-Galeano, Herna, Murray, Helena, Nhat, Ferrier, Nofziger, Charity, Schnitzel, Wolfgang, Kanoni, StavroulaEnlace del recurso
Publicado 2023
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