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2. A European, multicentre, observational, post-authorisation safety study of oral sulphate solution: compliance and safety

Author

Jaroslaw Regula, Manon C.W. Spaander MD, Stepan Suchanek, Anne Kornowski, Valerie Perrot, and Wolfgang Fischbach

Subjects
Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Background and study aims Oral sulphate solution (OSS) is a sulphate-based, low-volume bowel cleansing preparation taken in two doses of 500 mL, each followed by 1000mL of water or clear liquid. The primary objective of this observational study was to document compliance with the recommended hydration guidelines in a representative sample of the European population. Patients and methods Prospective, non-interventional, multicentre study (NCT02630680, EUPAS9361) in patients prescribed OSS for colonoscopy preparation in routine clinical practice in Europe. Patients were included according to pre-agreed consecutive enrolment rules. Patients recorded the volume of OSS and water or clear liquid intake, and occurrence of adverse events (AEs). Compliance with hydration was calculated as a ratio of actual volume of water/clear liquid taken versus prescribed 2,000 mL, and non-compliance defined as

Published
2020
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3. Pooled sample-based GWAS: a cost-effective alternative for identifying colorectal and prostate cancer risk variants in the Polish population.

Author

Pawel Gaj, Natalia Maryan, Ewa E Hennig, Joanna K Ledwon, Agnieszka Paziewska, Aneta Majewska, Jakub Karczmarski, Monika Nesteruk, Jan Wolski, Artur A Antoniewicz, Krzysztof Przytulski, Andrzej Rutkowski, Alexander Teumer, Georg Homuth, Teresa Starzyńska, Jaroslaw Regula, and Jerzy Ostrowski

Subjects
Medicine, Science
Abstract

BackgroundProstate cancer (PCa) and colorectal cancer (CRC) are the most commonly diagnosed cancers and cancer-related causes of death in Poland. To date, numerous single nucleotide polymorphisms (SNPs) associated with susceptibility to both cancer types have been identified, but their effect on disease risk may differ among populations.MethodsTo identify new SNPs associated with PCa and CRC in the Polish population, a genome-wide association study (GWAS) was performed using DNA sample pools on Affymetrix Genome-Wide Human SNP 6.0 arrays. A total of 135 PCa patients and 270 healthy men (PCa sub-study) and 525 patients with adenoma (AD), 630 patients with CRC and 690 controls (AD/CRC sub-study) were included in the analysis. Allele frequency distributions were compared with t-tests and χ(2)-tests. Only those significantly associated SNPs with a proxy SNP (p0.7) were selected. GWAS marker selection was conducted using PLINK. The study was replicated using extended cohorts of patients and controls. The association with previously reported PCa and CRC susceptibility variants was also examined. Individual patients were genotyped using TaqMan SNP Genotyping Assays.ResultsThe GWAS selected six and 24 new candidate SNPs associated with PCa and CRC susceptibility, respectively. In the replication study, 17 of these associations were confirmed as significant in additive model of inheritance. Seven of them remained significant after correction for multiple hypothesis testing. Additionally, 17 previously reported risk variants have been identified, five of which remained significant after correction.ConclusionPooled-DNA GWAS enabled the identification of new susceptibility loci for CRC in the Polish population. Previously reported CRC and PCa predisposition variants were also identified, validating the global nature of their associations. Further independent replication studies are required to confirm significance of the newly uncovered candidate susceptibility loci.

Published
2012
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5. Etrolizumab versus adalimumab or placebo as induction therapy for moderately to severely active ulcerative colitis (HIBISCUS): two phase 3 randomised, controlled trials

Author

Rustem, Abdulkhakov, Norasiah, Abu Bakar, Humberto, Aguilar, Diego, Aizenberg, Hale, Akpinar, Evangelos, Akriviadis, Olga, Alexeeva, Bagdadi, Alikhanov, Andres, Alvarisqueta, Ashwin, Ananthakrishnan, Jane, Andrews, Tomasz, Arlukowicz, Nathan, Atkinson, Ozlen, Atug, Mauro, Bafutto, Jozef, Balaz, George, Bamias, Marko, Banic, Andrey, Baranovsky, Guerino, Barbalaco Neto, Metin, Basaranoglu, Curtis, Baum, Stefan, Baydanov, William, Bennetts, Fatih, Besisik, Sudhir, Bhaskar, Andrzej, Bielasik, Leonid, Bilianskyi, Bahri, Bilir, Pavol, Blaha, Verle, Bohman, Julia, Borissova, Vladimir, Borzan, Francisco, Bosques-Padilla, Yoram, Bouhnik, James, Brooker, Tetiana, Budko, Igor, Budzak, Ivan, Bunganic, Jonathon, Chapman, Azlida, Che' Aun, Tatiana, Chernykh, Michael, Chiorean, Ivan, Chopey, Dimitrios, Christodoulou, Pui Shan, Chu, Galina, Chumakova, Andrew, Cummins, Robert, Cunliffe, Mirjana, Cvetkovic, Ulku, Dagli, Wit Cezary, Danilkiewicz, Olena, Datsenko, Carlos Fernando, de Magalhães Francesconi, Henry, Debinski, Elena, Deminova, Jelena, Derova, John Nik, Ding, Julia, Dmitrieva, Oleg, Dolgikh, Tomas, Douda, Piotr, Drobinski, Gerald, Dryden, Pedro, Duarte Gaburri, George Aaron, DuVall, Mikhail, Dvorkin, Craig, Ennis, Yusuf, Erzin, Galyna, Fadieienko, Oleksandr, Fediv, Olga, Fedorishina, Miroslav, Fedurco, Roland, Fejes, Jorge, Fernandez, Monica Lorena, Fernandez, Lucky, Flores, Bradley, Freilich, Keith, Friedenberg, Sergio, Fuster, Beata, Gawdis-Wojnarska, Fabio Leonel, Gil Parada, Edgardo Daniel, Gimenez, Nataliia, Golovchenko, Oleksandr, Golovchenko, Maciej, Gonciarz, Can, Gonen, Glenn, Gordon, Milos, Gregus, Vladimir, Grinevich, Rogelio, Guajardo Rodriguez, Stephen, Hall, John, Hanson, Marek, Hartleb, Xavier, Hebuterne, Peter, Hendy, Robert, Herring, David, Hetzel, Peter, Higgins, Raouf, Hilal, Ida Normiha, Hilmi, Tibor, Hlavaty, Richard, Holman, Gerald, Holtmann, John, Hong, Frantisek, Horvath, Ihor, Hospodarskyy, Irena, Hrstic, Sadettin, Hulagu, Luis Alberto, Ibarra Verdugo, Ikechukwu, Ibegbu, Stephen, Inns, Vladimir, Ivashkin, James, Izanec, Rajesh, Jain, Zofia, Jamrozik-Kruk, Victor, Kamburov, John, Karagiannis, Tarkan, Karakan, Marek, Karczewski, Irina, Kasherininova, Seymour, Katz, Barry, Kaufman, Edita, Kazenaite, Irina, Kholina, Sunil, Khurana, Jaroslaw, Kierkus, Anzela, Kiselevska, Dariusz, Kleczkowski, Volodymyr, Klymenko, Slavko, Knezevic, Malgorzata, Kondusz-Szklarz, Natalya, Korablina, Bartosz, Korczowski, Lyubomir, Kosturkov, Iskren, Kotzev, Georgios, Kouklakis, Ioannis, Koutroubakis, Richard, Krause, Ian, Kronborg, Miodrag, Krstic, Zeljko, Krznaric, Mikolaj, Krzyzanowski, Grazyna, Kulig, Karin, Kull, Limas, Kupcinskas, Mark, Lamet, Tatjana, Latinovic Radakovic, Rupert, Leong, Wai Keung, Leung, Henry, Levine, Michael Kin Kong, Li, Lúcia, Libanez Bessa Campelo Braga, Maria, Livzan, Tetiana, Lohdanidi, Maria Helena, Louzada Pereira, John, Lowe, Kresimir, Luetic, Milan, Lukas, Yurii, Lymar, Finlay, Macrae, Anu, Mäelt, Igor, Maev, Arkadiusz, Mamos, Gerasimos, Mantzaris, Benno, Margus, Ivanka, Marinova, Inna, Markevych, Mario, Markov, Srdjan, Markovic, Juan Ricardo, Marquez Velasquez, Felipe, Mazzoleni, Konstantinos, Mimidis, Brent, Mitchell, Gregory, Moore, Luis Alonso, Morales Garza, Salvatore, Moscatello, Yuriy, Mostovoy, Reme, Mountifield, Aleksandar, Nagorni, Viacheslav, Neshta, Andrey, Obrezan, Oleksandr, Oliinyk, Genoile, Oliveira Santana Silva, Maria, Orzeszko, Vladimir, Pavlenko, Dimitar, Pavlov, Mariana, Penkova, Sasa, Peric, Plamen, Petkov, Asen, Petrov, Plamen, Petrov, Michaela, Petrova, Raymond, Phillips, Sergio, Pintor Chacon, Igor, Polianskyi, Ludmyla, Prystupa, Mykhailo, Pugach, Ana Teresa, Pugas Carvalho, Aldis, Pukitis, Jiri, Pumprla, Volodymyr, Pyrogovskyy, Istvan, Racz, Graham, Radford-Smith, Raja Affendi, Raja Ali, Daniel, Ramos Castañeda, Odery, Ramos Júnior, David, Rausher, Andrey, Rebrov, Jaroslaw, Regula, Amir, Rezk, Viktoriia, Reznikova, Iaroslava, Rishko, Xavier, Roblin, Grigory, Rodoman, Carlos Arturo, Rojas Rodriguez, Jerzy, Rozciecha, David, Rubin, Maciej, Rupinski, Jacek, Rzucidlo, Oleg, Sablin, Halil, Sahin, Rosemi, Salleh, Douglas, Samuel, Antonio, Scafuto Scotton, Robert, Schnabel, Michael, Schulman, Michael, Schultz, John, Scott, Shahriar, Sedghi, Ahmad, Shaban, Marina, Shapina, Natalia, Shaposhnikova, Oksana, Shchukina, Alex, Sherman, Irina, Shumikhina, Vladimir, Simanenkov, Vladislav, Simonov, Giedrius, Simulionis, Igor, Skrypnyk, Zbigniew, Sliwowski, Jan, Smid, Mahmood, Solaiman, Najm, Soofi, Konstantinos, Soufleris, Zoia, Spassova, Mykola, Stanislavchuk, Krystyna, Stec-Michalska, Jonathas, Stifft, Simeon, Stoinov, Girgina, Stoyanova, Keith, Sultan, Lindsey, Surace, Dimitar, Takov, Jaak, Tälli, Ludmila, Tankova, Hugo, Tanno, Dino, Tarabar, Elias, Tarakji, Konstantin, Tchernev, Hoi Poh, Tee, Lena, Thin, Carlton, Thomas, Irina, Tishaeva, Tsveta, Todorova, Oleksandr, Tokarenko, Ivars, Tolmanis, Ratko, Tomasevic, Vasiliy, Trofimov, Zsolt, Tulassay, Belkis, Unsal, Alma, Uzunova-Genova, John, Valentine, Ekaterina, Valuyskikh, Eduardo, Vasconcellos, Galina, Vasileva, Sergiy, Vasylyuk, Byron, Vaughn, Francisco, Velazquez, Vadym, Vizir, Borislav, Vladimirov, Miroslava, Volfova, Petr, Vyhnalek, Ian, Wallace, Marek, Waluga, William, Watkins, John, Weber, Anna, Wiechowska-Kozlowska, Nathaniel, Winstead, Pawel, Wojtkiewicz, Barbara, Wozniak-Stolarska, Bruce, Yacyshyn, Alexey, Yakovlev, Ziad, Younes, Lígia, Yukie Sassaki, Ilhami, Yuksel, Jan, Zachar, Cyrla, Zaltman, Natasa, Zdravkovic Petrovic, Vyacheslav, Zhdan, Maryna, Zinchenko, Maciej, Zymla, Rubin, David T, Dotan, Iris, DuVall, Aaron, Bouhnik, Yoram, Radford-Smith, Graham, Higgins, Peter D R, Mishkin, Daniel S, Arrisi, Pablo, Scalori, Astrid, Oh, Young S, Tole, Swati, Chai, Akiko, Chamberlain-James, Kirsten, Lacey, Stuart, McBride, Jacqueline, and Panés, Julian

Published
2022
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6. Challenges of correlating pH change with relief of clinical symptoms in gastro esophageal reflux disease: a phase III, randomized study of Zegerid versus Losec.

Author

Dave Walker, Richard Ng Kwet Shing, Deborah Jones, Hans-Jurgen Gruss, and Jarosław Reguła

Subjects
Medicine, Science
Abstract

BACKGROUND:Zegerid (on demand immediate-release omeprazole and sodium bicarbonate combination therapy) has demonstrated earlier absorption and more rapid pH change compared with Losec (standard enteric coated omeprazole), suggesting more rapid clinical relief of heartburn. This Phase III, multicenter, double-blind, double-dummy, randomized study assessed the clinical superiority of Zegerid versus Losec for rapid relief of heartburn associated with gastro-esophageal reflux disease (GERD). METHODS:Patients with a history of frequent (2 3 days/week) uncomplicated GERD, were randomized to receive Zegerid (20 mg) or Losec (20 mg) with corresponding placebo. Study medication was self-administered on the first episode of heartburn, and could be taken for up to 3 days within a 14 day study period. Heartburn severity was self assessed up to 180 minutes post dose (9 point Likert scale). Primary endpoint was median time to sustained response (≥3 point reduction in heartburn severity for ≥45 minutes). RESULTS:Of patients randomized to Zegerid (N=122) or Losec (N=117), 228/239 had recorded ≥1 evaluable heartburn episodes and were included in the modified intent-to-treat population. No significant between-group differences were observed for median time to sustained response (60.0 vs. 52.2 minutes, Zegerid [N=117] and Losec [N=111], respectively), sustained partial response (both, 37.5 minutes) and sustained total relief (both, 105 minutes). Significantly more patients treated with Zegerid reached sustained total relief within 0-30 minutes post dose in all analysis sets (p

Published
2015
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