title: Oncological Treatment During Pregnancy: Pharmacokinetics of Chemotherapy and Long Term Follow up of the Offspring

summary: The researchers aim to investigate the outcome (overall survival) of mothers who are diagnosed and/or treated for cancer during pregnancy. Furthermore they want to test the hypothesis that children who were exposed to cancer or cancer treatment (cytotoxic drugs, radiation therapy, targeted therapy,...) develop normally (neurologic and cardiologic examination).

status: Recruiting

ReferenceCitation: Caluwaerts S, VAN Calsteren K, Mertens L, Lagae L, Moerman P, Hanssens M, Wuyts K, Vergote I, Amant F. Neoadjuvant chemotherapy followed by radical hysterectomy for invasive cervical cancer diagnosed during pregnancy: report of a case and review of the literature. Int J Gynecol Cancer. 2006 Mar-Apr;16(2):905-8.

ReferenceCitation: Van Calsteren K, Berteloot P, Hanssens M, Vergote I, Amant F, Ganame J, Claus P, Mertens L, Lagae L, Delforge M, Paridaens R, Noens L, Humblet Y, Vandermeersch B, De Muylder X. In utero exposure to chemotherapy: effect on cardiac and neurologic outcome. J Clin Oncol. 2006 Apr 20;24(12):e16-7.

ReferenceCitation: Lishner M, Avivi I, Apperley JF, Dierickx D, Evens AM, Fumagalli M, Nulman I, Oduncu FS, Peccatori FA, Robinson S, Van Calsteren K, Vandenbroucke T, Van den Heuvel F, Amant F. Hematologic Malignancies in Pregnancy: Management Guidelines From an International Consensus Meeting. J Clin Oncol. 2016 Feb 10;34(5):501-8. doi: 10.1200/JCO.2015.62.4445. Epub 2015 Nov 30.

ReferenceCitation: Amant F, Verheecke M, Wlodarska I, Dehaspe L, Brady P, Brison N, Van Den Bogaert K, Dierickx D, Vandecaveye V, Tousseyn T, Moerman P, Vanderstichele A, Vergote I, Neven P, Berteloot P, Putseys K, Danneels L, Vandenberghe P, Legius E, Vermeesch JR. Presymptomatic Identification of Cancers in Pregnant Women During Noninvasive Prenatal Testing. JAMA Oncol. 2015 Sep;1(6):814-9. doi: 10.1001/jamaoncol.2015.1883.

ReferenceCitation: de Haan J, Verheecke M, Amant F. Management of ovarian cysts and cancer in pregnancy. Facts Views Vis Obgyn. 2015;7(1):25-31. Review.

ReferenceCitation: Amant F, Han SN, Gziri MM, Vandenbroucke T, Verheecke M, Van Calsteren K. Management of cancer in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2015 Jul;29(5):741-53. doi: 10.1016/j.bpobgyn.2015.02.006. Epub 2015 Mar 4. Review.

ReferenceCitation: van Dam L, Han SN, Dierickx D, Amant F. Optimal staging of lymphoma during pregnancy is crucial. Womens Health (Lond). 2015 Mar;11(2):101-2. doi: 10.2217/whe.14.77.

ReferenceCitation: Han SN, Van Peer S, Peccatori F, Gziri MM, Amant F; International Network on Cancer, Infertility and Pregnancy. Contraception is as important as fertility preservation in young women with cancer. Lancet. 2015 Feb 7;385(9967):508. doi: 10.1016/S0140-6736(15)60201-X.

ReferenceCitation: Han SN, Verheecke M, Vandenbroucke T, Gziri MM, Van Calsteren K, Amant F. Management of gynecological cancers during pregnancy. Curr Oncol Rep. 2014 Dec;16(12):415. doi: 10.1007/s11912-014-0415-z. Review.

ReferenceCitation: Van Calsteren K, Amant F. Cancer during pregnancy. Acta Obstet Gynecol Scand. 2014 May;93(5):443-6. doi: 10.1111/aogs.12380.

ReferenceCitation: Amant F, Halaska MJ, Fumagalli M, Dahl Steffensen K, Lok C, Van Calsteren K, Han SN, Mir O, Fruscio R, Uzan C, Maxwell C, Dekrem J, Strauven G, Mhallem Gziri M, Kesic V, Berveiller P, van den Heuvel F, Ottevanger PB, Vergote I, Lishner M, Morice P, Nulman I; ESGO task force 'Cancer in Pregnancy'. Gynecologic cancers in pregnancy: guidelines of a second international consensus meeting. Int J Gynecol Cancer. 2014 Mar;24(3):394-403. doi: 10.1097/IGC.0000000000000062. Review. Erratum in: Int J Gynecol Cancer. 2014 May;24(4):819.

ReferenceCitation: Vandenbriele C, Dierickx D, Amant F, Delforge M. The treatment of hematologic malignancies in pregnancy. Facts Views Vis Obgyn. 2010;2(2):74-87. Review.

ReferenceCitation: Deckers S, Amant F. Breast cancer in pregnancy: a literature review. Facts Views Vis Obgyn. 2009;1(2):130-41. Review.

ReferenceCitation: Gziri MM, Goffin F, Debieve F, Amant F. [Cancer diagnosis during pregnancy: importance of a national and European registration]. Rev Med Liege. 2013 Oct;68(10):527-30. French.

ReferenceCitation: Han SN, Kesic VI, Van Calsteren K, Petkovic S, Amant F; ESGO 'Cancer in Pregnancy' Task Force. Cancer in pregnancy: a survey of current clinical practice. Eur J Obstet Gynecol Reprod Biol. 2013 Mar;167(1):18-23. doi: 10.1016/j.ejogrb.2012.10.026. Epub 2012 Nov 19.

ReferenceCitation: Han SN, Gziri MM, Van Calsteren K, Amant F. Is chemotherapy during the first trimester of pregnancy really safe? Int J Cancer. 2013 Apr 1;132(7):1728. doi: 10.1002/ijc.27815. Epub 2012 Sep 28.

ReferenceCitation: Han SN, Lotgerink A, Gziri MM, Van Calsteren K, Hanssens M, Amant F. Physiologic variations of serum tumor markers in gynecological malignancies during pregnancy: a systematic review. BMC Med. 2012 Aug 8;10:86. doi: 10.1186/1741-7015-10-86.

ReferenceCitation: Loibl S, Han SN, Amant F. Being Pregnant and Diagnosed with Breast Cancer. Breast Care (Basel). 2012 Jun;7(3):204-209. Epub 2012 Jun 27.

ReferenceCitation: Amant F. Safety of chemotherapy in pregnancy. Clin Adv Hematol Oncol. 2012 Apr;10(4):258-9.

ReferenceCitation: Verheecke M, Hermans E, Tuyaerts S, Souche E, Van Bree R, Verbist G, Everaert T, Cortès-Calabuig A, Van Houdt J, Van Calsteren K, Amant F. Acute Drug Effects on the Human Placental Tissue: The Development of a Placental Murine Xenograft Model. Reprod Sci. 2018 Dec;25(12):1637-1648. doi: 10.1177/1933719118756771. Epub 2018 Feb 13.

ReferenceCitation: Boere I, Lok C, Vandenbroucke T, Amant F. Cancer in pregnancy: safety and efficacy of systemic therapies. Curr Opin Oncol. 2017 Sep;29(5):328-334. doi: 10.1097/CCO.0000000000000386. Review.

ReferenceCitation: Fruscio R, de Haan J, Van Calsteren K, Verheecke M, Mhallem M, Amant F. Ovarian cancer in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2017 May;41:108-117. doi: 10.1016/j.bpobgyn.2016.09.013. Epub 2016 Oct 1. Review.

ReferenceCitation: Vercruysse DC, Deprez S, Sunaert S, Van Calsteren K, Amant F. Effects of prenatal exposure to cancer treatment on neurocognitive development, a review. Neurotoxicology. 2016 May;54:11-21. doi: 10.1016/j.neuro.2016.02.013. Epub 2016 Mar 4. Review.

ReferenceCitation: de Haan J, Vandecaveye V, Han SN, Van de Vijver KK, Amant F. Difficulties with diagnosis of malignancies in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2016 May;33:19-32. doi: 10.1016/j.bpobgyn.2015.10.005. Epub 2015 Oct 19. Review.

ReferenceCitation: Han SN, Mhallem Gziri M, Van Calsteren K, Amant F. Cervical cancer in pregnant women: treat, wait or interrupt? Assessment of current clinical guidelines, innovations and controversies. Ther Adv Med Oncol. 2013 Jul;5(4):211-9. doi: 10.1177/1758834013494988.

ReferenceCitation: Amant F, Han SN, Gziri MM, Dekrem J, Van Calsteren K. Chemotherapy during pregnancy. Curr Opin Oncol. 2012 Sep;24(5):580-6. doi: 10.1097/CCO.0b013e328354e754. Review.

ReferenceCitation: Amant F, Loibl S, Neven P, Van Calsteren K. Breast cancer in pregnancy. Lancet. 2012 Feb 11;379(9815):570-9. doi: 10.1016/S0140-6736(11)61092-1. Review.

ReferenceCitation: Han SN, Van Calsteren K, Amant F. Use of chemotherapy during pregnancy in the treatment of ovarian malignancies. Eur J Obstet Gynecol Reprod Biol. 2011 Jun;156(2):237. doi: 10.1016/j.ejogrb.2011.02.004. Epub 2011 Mar 25.

ReferenceCitation: Amant F, Deckers S, Van Calsteren K, Loibl S, Halaska M, Brepoels L, Beijnen J, Cardoso F, Gentilini O, Lagae L, Mir O, Neven P, Ottevanger N, Pans S, Peccatori F, Rouzier R, Senn HJ, Struikmans H, Christiaens MR, Cameron D, Du Bois A. Breast cancer in pregnancy: recommendations of an international consensus meeting. Eur J Cancer. 2010 Dec;46(18):3158-68. doi: 10.1016/j.ejca.2010.09.010.

ReferenceCitation: Amant F, Brepoels L, Halaska MJ, Gziri MM, Calsteren KV. Gynaecologic cancer complicating pregnancy: an overview. Best Pract Res Clin Obstet Gynaecol. 2010 Feb;24(1):61-79. doi: 10.1016/j.bpobgyn.2009.08.001. Epub 2009 Sep 8. Review.

ReferenceCitation: Van Calsteren K, Hartmann D, Van Aerschot L, Verbesselt R, Van Bree R, D'Hooge R, Amant F. Vinblastine and doxorubicin administration to pregnant mice affects brain development and behaviour in the offspring. Neurotoxicology. 2009 Jul;30(4):647-57. doi: 10.1016/j.neuro.2009.04.009. Epub 2009 May 5.

ReferenceCitation: Amant F, Van Calsteren K, Halaska MJ, Beijnen J, Lagae L, Hanssens M, Heyns L, Lannoo L, Ottevanger NP, Vanden Bogaert W, Ungar L, Vergote I, du Bois A. Gynecologic cancers in pregnancy: guidelines of an international consensus meeting. Int J Gynecol Cancer. 2009 May;19 Suppl 1:S1-12. doi: 10.1111/IGC.0b013e3181a1d0ec.

ReferenceCitation: Van Calsteren K, Devlieger R, De Catte L, D'Hooghe T, Chai DC, Mwenda JM, Vergote I, Amant F. Feasibility of ultrasound-guided percutaneous samplings in the pregnant baboon: a model for studies on transplacental transport. Reprod Sci. 2009 Mar;16(3):280-5. doi: 10.1177/1933719108324890. Epub 2008 Dec 15.

ReferenceCitation: Amant F, Van Calsteren K, Vergote I, Ottevanger N. Gynecologic oncology in pregnancy. Crit Rev Oncol Hematol. 2008 Sep;67(3):187-95. doi: 10.1016/j.critrevonc.2008.01.006. Epub 2008 Mar 4. Review.

ReferenceCitation: Van Calsteren K, Heyns L, De Smet F, Van Eycken L, Gziri MM, Van Gemert W, Halaska M, Vergote I, Ottevanger N, Amant F. Cancer during pregnancy: an analysis of 215 patients emphasizing the obstetrical and the neonatal outcomes. J Clin Oncol. 2010 Feb 1;28(4):683-9. doi: 10.1200/JCO.2009.23.2801. Epub 2009 Oct 19.

ReferenceCitation: Amant F, Van Calsteren K, Halaska MJ, Gziri MM, Hui W, Lagae L, Willemsen MA, Kapusta L, Van Calster B, Wouters H, Heyns L, Han SN, Tomek V, Mertens L, Ottevanger PB. Long-term cognitive and cardiac outcomes after prenatal exposure to chemotherapy in children aged 18 months or older: an observational study. Lancet Oncol. 2012 Mar;13(3):256-64. doi: 10.1016/S1470-2045(11)70363-1. Epub 2012 Feb 10.

ReferenceCitation: Gziri MM, Debiève F, DE Catte L, Mertens L, Barrea C, VAN Calsteren K, Han SN, Heyns L, Amant F. Chemotherapy during pregnancy: effect of anthracyclines on fetal and maternal cardiac function. Acta Obstet Gynecol Scand. 2012 Dec;91(12):1465-8. doi: 10.1111/j.1600-0412.2012.01524.x. Epub 2012 Nov 1.

ReferenceCitation: Loibl S, Han SN, von Minckwitz G, Bontenbal M, Ring A, Giermek J, Fehm T, Van Calsteren K, Linn SC, Schlehe B, Gziri MM, Westenend PJ, Müller V, Heyns L, Rack B, Van Calster B, Harbeck N, Lenhard M, Halaska MJ, Kaufmann M, Nekljudova V, Amant F. Treatment of breast cancer during pregnancy: an observational study. Lancet Oncol. 2012 Sep;13(9):887-96. doi: 10.1016/S1470-2045(12)70261-9. Epub 2012 Aug 16.

ReferenceCitation: Gziri MM, Amant F, Debiève F, Van Calsteren K, De Catte L, Mertens L. Effects of chemotherapy during pregnancy on the maternal and fetal heart. Prenat Diagn. 2012 Jul;32(7):614-9. doi: 10.1002/pd.3847. Epub 2012 Apr 17. Review.

ReferenceCitation: Mhallem Gziri M, Han SN, Van Calsteren K, Heyns L, Delaere P, Nuyts S, Van den Heuvel F, Cheron AC, Fossion E, Van den Weyngaert D, Lok C, Amant F. Tongue cancers during pregnancy: Case reports and review of literature. Head Neck. 2013 Apr;35(4):E102-8. doi: 10.1002/hed.21924. Epub 2011 Oct 19. Review.

ReferenceCitation: Gziri MM, Hui W, Amant F, Van Calsteren K, Ottevanger N, Kapusta L, Mertens L. Myocardial function in children after fetal chemotherapy exposure. A tissue Doppler and myocardial deformation imaging study. Eur J Pediatr. 2013 Feb;172(2):163-70. doi: 10.1007/s00431-012-1849-7. Epub 2012 Oct 5.

ReferenceCitation: Boussios S, Han SN, Fruscio R, Halaska MJ, Ottevanger PB, Peccatori FA, Koubková L, Pavlidis N, Amant F. Lung cancer in pregnancy: report of nine cases from an international collaborative study. Lung Cancer. 2013 Dec;82(3):499-505. doi: 10.1016/j.lungcan.2013.09.002. Epub 2013 Sep 12.

ReferenceCitation: Amant F, von Minckwitz G, Han SN, Bontenbal M, Ring AE, Giermek J, Wildiers H, Fehm T, Linn SC, Schlehe B, Neven P, Westenend PJ, Müller V, Van Calsteren K, Rack B, Nekljudova V, Harbeck N, Untch M, Witteveen PO, Schwedler K, Thomssen C, Van Calster B, Loibl S. Prognosis of women with primary breast cancer diagnosed during pregnancy: results from an international collaborative study. J Clin Oncol. 2013 Jul 10;31(20):2532-9. doi: 10.1200/JCO.2012.45.6335. Epub 2013 Apr 22.

ReferenceCitation: Verheecke M, Halaska MJ, Lok CA, Ottevanger PB, Fruscio R, Dahl-Steffensen K, Kolawa W, Gziri MM, Han SN, Van Calsteren K, Van den Heuvel F, De Vleeschouwer S, Clement PM, Menten J, Amant F; ESGO Task Force 'Cancer in Pregnancy'. Primary brain tumours, meningiomas and brain metastases in pregnancy: report on 27 cases and review of literature. Eur J Cancer. 2014 May;50(8):1462-71. doi: 10.1016/j.ejca.2014.02.018. Epub 2014 Mar 14. Review.

ReferenceCitation: Vandenbroucke T, Van Calsteren K, Amant F. Pediatric Outcome after Maternal Cancer Diagnosed during Pregnancy. N Engl J Med. 2016 Feb 18;374(7):693. doi: 10.1056/NEJMc1515462.

ReferenceCitation: Amant F, Vandenbroucke T, Verheecke M, Fumagalli M, Halaska MJ, Boere I, Han S, Gziri MM, Peccatori F, Rob L, Lok C, Witteveen P, Voigt JU, Naulaers G, Vallaeys L, Van den Heuvel F, Lagae L, Mertens L, Claes L, Van Calsteren K; International Network on Cancer, Infertility, and Pregnancy (INCIP). Pediatric Outcome after Maternal Cancer Diagnosed during Pregnancy. N Engl J Med. 2015 Nov 5;373(19):1824-34. doi: 10.1056/NEJMoa1508913. Epub 2015 Sep 28.

ReferenceCitation: Loibl S, Schmidt A, Gentilini O, Kaufman B, Kuhl C, Denkert C, von Minckwitz G, Parokonnaya A, Stensheim H, Thomssen C, van Calsteren K, Poortmans P, Berveiller P, Markert UR, Amant F. Breast Cancer Diagnosed During Pregnancy: Adapting Recent Advances in Breast Cancer Care for Pregnant Patients. JAMA Oncol. 2015 Nov;1(8):1145-53. doi: 10.1001/jamaoncol.2015.2413. Erratum in: JAMA Oncol. 2015 Nov;1(8):1172.

ReferenceCitation: Vandenbroucke T, Amant F. Development of children born to mothers with cancer during pregnancy: comparing in utero chemotherapy-exposed children with nonexposed controls. Am J Obstet Gynecol. 2015 Jun;212(6):830-1. doi: 10.1016/j.ajog.2015.01.035. Epub 2015 Jan 28.

ReferenceCitation: Vandenbroucke T, Verheecke M, Van Calsteren K, Han S, Claes L, Amant F. Fetal outcome after prenatal exposure to chemotherapy and mechanisms of teratogenicity compared to alcohol and smoking. Expert Opin Drug Saf. 2014 Dec;13(12):1653-65. doi: 10.1517/14740338.2014.965677. Epub 2014 Nov 10. Review.

ReferenceCitation: van Hasselt JGC, van Calsteren K, Heyns L, Han S, Mhallem Gziri M, Schellens JHM, Beijnen JH, Huitema ADR, Amant F. Optimizing anticancer drug treatment in pregnant cancer patients: pharmacokinetic analysis of gestation-induced changes for doxorubicin, epirubicin, docetaxel and paclitaxel. Ann Oncol. 2014 Oct;25(10):2059-2065. doi: 10.1093/annonc/mdu140. Epub 2014 Apr 8.

ReferenceCitation: Dekrem J, Van Calsteren K, Amant F. Effects of fetal exposure to maternal chemotherapy. Paediatr Drugs. 2013 Oct;15(5):329-34. doi: 10.1007/s40272-013-0040-6. Review.

ReferenceCitation: Gziri MM, Pokreisz P, De Vos R, Verbeken E, Debiève F, Mertens L, Janssens SP, Amant F. Fetal rat hearts do not display acute cardiotoxicity in response to maternal Doxorubicin treatment. J Pharmacol Exp Ther. 2013 Sep;346(3):362-9. doi: 10.1124/jpet.113.205419. Epub 2013 Jun 21.

ReferenceCitation: de Haan J, Verheecke M, Van Calsteren K, Van Calster B, Shmakov RG, Mhallem Gziri M, Halaska MJ, Fruscio R, Lok CAR, Boere IA, Zola P, Ottevanger PB, de Groot CJM, Peccatori FA, Dahl Steffensen K, Cardonick EH, Polushkina E, Rob L, Ceppi L, Sukhikh GT, Han SN, Amant F; International Network on Cancer and Infertility Pregnancy (INCIP). Oncological management and obstetric and neonatal outcomes for women diagnosed with cancer during pregnancy: a 20-year international cohort study of 1170 patients. Lancet Oncol. 2018 Mar;19(3):337-346. doi: 10.1016/S1470-2045(18)30059-7. Epub 2018 Jan 26. Erratum in: Lancet Oncol. 2021 Sep;22(9):e389.

ReferenceCitation: de Haan J, van Thienen JV, Casaer M, Hannivoort RA, Van Calsteren K, van Tuyl M, van Gerwen MM, Debeer A, Amant F, Painter RC. Severe Adverse Reaction to Vemurafenib in a Pregnant Woman with Metastatic Melanoma. Case Rep Oncol. 2018 Feb 15;11(1):119-124. doi: 10.1159/000487128. eCollection 2018 Jan-Apr.

ReferenceCitation: Boucek J, de Haan J, Halaska MJ, Plzak J, Van Calsteren K, de Groot CJM, Dahl Steffensen K, Fruscio R, Massolt ET, Klaritsch P, Zola P, Amant F; International Network on Cancer, Infertility, and Pregnancy. Maternal and obstetrical outcome in 35 cases of well-differentiated thyroid carcinoma during pregnancy. Laryngoscope. 2018 Jun;128(6):1493-1500. doi: 10.1002/lary.26936. Epub 2017 Oct 8.

ReferenceCitation: de Haan J, Lok CA, de Groot CJ, Crijns MB, Van Calsteren K, Dahl Steffensen K, Halaska MJ, Altintas S, Boere IA, Fruscio R, Kolawa W, Witteveen PO, Amant F; International Network on Cancer, Infertility and Pregnancy (INCIP). Melanoma during pregnancy: a report of 60 pregnancies complicated by melanoma. Melanoma Res. 2017 Jun;27(3):218-223. doi: 10.1097/CMR.0000000000000327.

ReferenceCitation: Verheecke M, Cortès Calabuig A, Finalet Ferreiro J, Brys V, Van Bree R, Verbist G, Everaert T, Leemans L, Gziri MM, Boere I, Halaska MJ, Vanhoudt J, Amant F, Van Calsteren K. Genetic and microscopic assessment of the human chemotherapy-exposed placenta reveals possible pathways contributive to fetal growth restriction. Placenta. 2018 Apr;64:61-70. doi: 10.1016/j.placenta.2018.03.002. Epub 2018 Mar 9. Erratum in: Placenta. 2018 Sep;69:117.

ReferenceCitation: Vandenbroucke T, Verheecke M, Fumagalli M, Lok C, Amant F. Effects of cancer treatment during pregnancy on fetal and child development. Lancet Child Adolesc Health. 2017 Dec;1(4):302-310. doi: 10.1016/S2352-4642(17)30091-3. Epub 2017 Sep 29. Review.

ReferenceCitation: Gziri MM, Brunée L, Cayphas C, Prigogine T, Van Raemdonck D, Amant F, Hubinont C. Low-grade bronchial mucoepidermoid carcinoma during pregnancy successfully treated by lobectomy. J Obstet Gynaecol. 2017 Nov;37(8):1082-1084. doi: 10.1080/01443615.2017.1308325. Epub 2017 Jun 1.

ReferenceCitation: de Haan J, Van Calsteren K, Lok CAR, de Groot CJM, Amant F. Comment on "Maternal and perinatal outcomes in pregnancy-associated melanoma. Report of two cases and a systematic literature review". Eur J Obstet Gynecol Reprod Biol. 2017 Sep;216:261-262. doi: 10.1016/j.ejogrb.2017.07.025. Epub 2017 Jul 23.

ReferenceCitation: Vandenbroucke T, Han SN, Van Calsteren K, Wilderjans TF, Van den Bergh BRH, Claes L, Amant F. Psychological distress and cognitive coping in pregnant women diagnosed with cancer and their partners. Psychooncology. 2017 Aug;26(8):1215-1221. doi: 10.1002/pon.4301. Epub 2016 Nov 21. Erratum in: Psychooncology. 2018 Oct;27(10):2521.

ReferenceCitation: Gziri MM, Han SN, Amant F. Use of general anesthesia and sentinel node procedure during pregnancy. J Surg Oncol. 2012 Dec;106(8):1008. doi: 10.1002/jso.23164. Epub 2012 Jun 4.

ReferenceCitation: Lambrechts S, Van Calsteren K, Capoen A, Op De Beeck K, Joniau S, Timmerman D, Amant F. Polypoid endometriosis of the bladder during pregnancy mimicking urachal carcinoma. Ultrasound Obstet Gynecol. 2011 Oct;38(4):475-8. doi: 10.1002/uog.8985. Epub 2011 Sep 6.

ReferenceCitation: Van Calsteren K, Verbesselt R, Van Bree R, Heyns L, de Bruijn E, de Hoon J, Amant F. Substantial variation in transplacental transfer of chemotherapeutic agents in a mouse model. Reprod Sci. 2011 Jan;18(1):57-63. doi: 10.1177/1933719110379650. Epub 2010 Sep 8.

ReferenceCitation: Van Calsteren K, Verbesselt R, Beijnen J, Devlieger R, De Catte L, Chai DC, Van Bree R, Heyns L, de Hoon J, Amant F. Transplacental transfer of anthracyclines, vinblastine, and 4-hydroxy-cyclophosphamide in a baboon model. Gynecol Oncol. 2010 Dec;119(3):594-600. doi: 10.1016/j.ygyno.2010.08.019. Epub 2010 Sep 17.

ReferenceCitation: Calsteren KV, Verbesselt R, Devlieger R, De Catte L, Chai DC, Van Bree R, Heyns L, Beijnen J, Demarsin S, de Bruijn E, de Hoon J, Amant F. Transplacental transfer of paclitaxel, docetaxel, carboplatin, and trastuzumab in a baboon model. Int J Gynecol Cancer. 2010 Dec;20(9):1456-64. doi: 10.1111/IGC.0b013e3181fb18c8.

ReferenceCitation: Van Calsteren K, Verbesselt R, Ottevanger N, Halaska M, Heyns L, Van Bree R, de Bruijn E, Chai D, Delforge M, Noens L, Renard V, Witteveen E, Rob L, de Hoon J, Amant F. Pharmacokinetics of chemotherapeutic agents in pregnancy: a preclinical and clinical study. Acta Obstet Gynecol Scand. 2010 Oct;89(10):1338-45. doi: 10.3109/00016349.2010.512070.

ReferenceCitation: Van Calsteren K, Hanssens M, Moerman P, Orye G, Bielen D, Vergote I, Amant F. Successful conservative treatment of endocervical adenocarcinoma stage Ib1 diagnosed early in pregnancy. Acta Obstet Gynecol Scand. 2008;87(2):250-3. doi: 10.1080/00016340701870794.

ReferenceCitation: Van Calsteren K, Van Mensel K, Joniau S, Oyen R, Hanssens M, Amant F, Van Poppel H. Urachal carcinoma during pregnancy. Urology. 2006 Jun;67(6):1290.e19-21.

ReferenceCitation: Vandenbroucke T, Verheecke M, van Gerwen M, Van Calsteren K, Halaska MJ, Fumagalli M, Fruscio R, Gandhi A, Veening M, Lagae L, Ottevanger PB, Voigt JU, de Haan J, Gziri MM, Maggen C, Mertens L, Naulaers G, Claes L, Amant F; International Network on Cancer, Infertility and Pregnancy (INCIP). Child development at 6 years after maternal cancer diagnosis and treatment during pregnancy. Eur J Cancer. 2020 Oct;138:57-67. doi: 10.1016/j.ejca.2020.07.004. Epub 2020 Aug 25.

lead_sponsor: University Hospital, Gasthuisberg

location_country:
Denmark
Poland
Portugal
Greece
Austria
Italy
Mexico
Argentina
Netherlands
Russian Federation
Tunisia
Sweden
Ukraine
United States
France
Turkey
Belgium
Norway
Germany
Czechia

location_facility: Regional Hospital of High Specialty of Ixtapaluca (2018-ongoing)

location_facility: Almazov National Medical Research Center (2018-ongoing)

location_facility: University Hospital Ostrava (2018-ongoing)

location_facility: Haukeland University Hospital (2017-ongoing)

location_facility: Research Center for Obstetrics, Gynecology and Perinatology (2014-ongoing)

location_facility: Ioannina University Hospital (retrosepctive 2015-2018)

location_facility: UZ Gasthuisberg, Katholieke Universiteit Leuven (2004-ongoing)

location_facility: Hellenic Anticancer-Oncological Hospital of Athens (retrospective 2015-2018)

location_facility: Trakya University Faculty of Medicine (retrospective 2015-2018)

location_facility: Grigoriev Institute for medical Radiology (retrospective until 2018)

location_facility: Hippokration Hospital (retrospective 2015-2018)

location_facility: Universitätsklinik Freiburg (retrospective until 2018)

location_facility: Pozanan University of Medical Sciences (2017-ongoing)

location_facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore (2012-ongoing)

location_facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano (2017-ongoing)

location_facility: University Hospital Krakow (2018-ongoing)

location_facility: CIttà della Salute e della Scienza di Torino (2015-ongoing)

location_facility: Medyczne Macierzynstwo (retrospective 2010-2018)

location_facility: Hospital de Vila Franca de Xira (2017-ongoing)

location_facility: Karolinska University Hospital (2017-ongoing)

location_facility: N.N.Blokchin National Medical Research Center of Oncology (2013-2018 retrospective; 2018-ongoing prospective)

location_facility: European Institute of Oncology (2010-ongoing)

location_facility: 3rd medical faculty of Charles University (2010-ongoing)

location_facility: Hopital Bichat-Claude-Bernard (retrospective until 2018)

location_facility: Cooper University Hospital (2015-ongoing)

location_facility: Copenhagen University Hospital (2015-ongoing)

location_facility: Universitätsklinik für Frauenheilkunde und Geburtshilfe (retrospective 2016-2018)

location_facility: F.Hached University Teaching Hospital (retrospective 2016-2018)

lead_sponsor_type: academique

status_simplified: Ongoing


title: A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension

summary:
This study was an international, multicenter, randomized (2:1 active:placebo), double-blind, placebo-controlled study in subjects with PAH who were NOT currently receiving approved therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and Week 12.

Patients who completed all assessments for 12 weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Jing ZC, Parikh K, Pulido T, Jerjes-Sanchez C, White RJ, Allen R, Torbicki A, Xu KF, Yehle D, Laliberte K, Arneson C, Rubin LJ. Efficacy and safety of oral treprostinil monotherapy for the treatment of pulmonary arterial hypertension: a randomized, controlled trial. Circulation. 2013 Feb 5;127(5):624-33. doi: 10.1161/CIRCULATIONAHA.112.124388. Epub 2013 Jan 10.

lead_sponsor: United Therapeutics

location_country:
Poland
Italy
Austria
Mexico
Canada
Puerto Rico
United States
France
China
India
Belgium
Israel
Netherlands

location_facility: Krakowski Szpital Specjalistyczny im. (Kraków Specialist Hospital)

location_facility: University of Maryland School of Medicine

location_facility: Asian Heart Institute and Research Centre

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Unidad de Investigacion Clinica en Medicina (UDICEM)

location_facility: National Tuberculosis and Lung Disease Research Institute

location_facility: Narayana Hrudayalaya Institute of Medical Sciences

location_facility: University of Colorado Health Science Center

location_facility: Mary M Parkes Center for Asthma, Allergy and Pulmonary Care - University of Rochester

location_facility: Lifecare Institute of Medical Sciences & Research

location_facility: University of California, San Francisco-Fresno

location_facility: Baylor College of Medicine, Pulmonary & Critical Care

location_facility: Wojewódzki Szpital Specjalistyczny we Wroclawiu (Provincial Specialist Hospital in Wrocław)

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


title: Open-label, Non Comparative, Multi-center Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Oral Miglustat as a Maintenance Therapy After a Switch From Enzyme Replacement Therapy in Adult Patients With Stable Type 1 Gaucher Disease

summary: Although miglustat has been approved as a treatment for mild to moderate type 1 Gaucher disease in patients who are unsuitable for enzyme replacement therapy (ERT), more data are required to establish the long term efficacy, safety and tolerability of miglustat in maintaining diseases stability after a switch from ERT.

ReferenceType: result

ReferenceCitation: Cox TM, Amato D, Hollak CE, Luzy C, Silkey M, Giorgino R, Steiner RD; Miglustat Maintenance Study Group. Evaluation of miglustat as maintenance therapy after enzyme therapy in adults with stable type 1 Gaucher disease: a prospective, open-label non-inferiority study. Orphanet J Rare Dis. 2012 Dec 27;7:102. doi: 10.1186/1750-1172-7-102.

lead_sponsor: Actelion

location_country:
Taiwan
Brazil
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Hungary
United States
France
Germany
Czechia

location_facility: Doembecher Children's Hospital, Oregon Health and Sciences University

location_facility: Klinika detskeho a dorostoveho lekarstvi

intervention_type: Drug


title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Tracleer (Bosentan) on Oxygen Saturation and Cardiac Hemodynamics in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology

summary: This study evaluates the effects of bosentan on oxygen saturation, hemodynamics and exercise capacity in patients with pulmonary arterial hypertension related to Eisenmenger physiology. Patients receive bosentan or placebo for 16 weeks.

location_country:
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
United States
France
Belgium
Germany

location_facility: Royal Prince Alfred Hospital - Central Clinical School

location_facility: Scottish Vascular Unit - Western Infirmary

location_facility: Unidad Medico Quirurgica de Cardiologia - Edificio General

location_facility: Universitatsklinikum fur Innere Medizin II


type: Other Identifier

type: EudraCT Number

title: A Randomized, Double-blind, Triple-dummy, Dose-ranging Study, Including an Active Control of Unfractionated Heparin and Eptifibatide, to Evaluate the Clinical Efficacy and Safety of Otamixaban, in Patients With Non-ST Elevation Acute Coronary Syndrome and Planned Early Invasive Strategy

summary:
Primary objective: To demonstrate the clinical efficacy of otamixaban (dose effect via 5 intravenous [IV] regimens) in patients with moderate-to-high-risk non-ST elevation acute coronary syndromes (ACS) and planned early invasive strategy.

Secondary objectives: To evaluate safety and assess pharmacokinetics (PK) and pharmacodynamics (PD).

ReferenceCitation: Sabatine MS, Antman EM, Widimsky P, Ebrahim IO, Kiss RG, Saaiman A, Polasek R, Contant CF, McCabe CH, Braunwald E. Otamixaban for the treatment of patients with non-ST-elevation acute coronary syndromes (SEPIA-ACS1 TIMI 42): a randomised, double-blind, active-controlled, phase 2 trial. Lancet. 2009 Sep 5;374(9692):787-95. doi: 10.1016/S0140-6736(09)61454-9. Epub 2009 Aug 28. Erratum in: Lancet. 2009 Oct 31;374(9700):1502.

lead_sponsor: Sanofi

location_country:
Croatia
Spain
Italy
United States
Romania
South Africa
Poland
Portugal
Austria
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Malaysia
Singapore
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Estonia
Finland
Czech Republic
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands


title: A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide Versus Doxorubicin and Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment of Operable Breast Cancer HER2neu Negative Patients With Positive Axillary Lymph Nodes

summary:
Primary objective :

To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive axillary lymph nodes.

Secondary objectives :

To compare toxicity and quality of life between the 2 above-mentioned arms.
To evaluate pathologic and molecular markers for predicting efficacy.

ReferenceCitation: Press MF, Sauter G, Buyse M, Fourmanoir H, Quinaux E, Tsao-Wei DD, Eiermann W, Robert N, Pienkowski T, Crown J, Martin M, Valero V, Mackey JR, Bee V, Ma Y, Villalobos I, Campeau A, Mirlacher M, Lindsay MA, Slamon DJ. HER2 Gene Amplification Testing by Fluorescent In Situ Hybridization (FISH): Comparison of the ASCO-College of American Pathologists Guidelines With FISH Scores Used for Enrollment in Breast Cancer International Research Group Clinical Trials. J Clin Oncol. 2016 Oct 10;34(29):3518-3528. doi: 10.1200/JCO.2016.66.6693.

ReferenceCitation: Mackey JR, Pieńkowski T, Crown J, Sadeghi S, Martin M, Chan A, Saleh M, Sehdev S, Provencher L, Semiglazov V, Press MF, Sauter G, Lindsay M, Houé V, Buyse M, Drevot P, Hitier S, Bensfia S, Eiermann W. Long-term outcomes after adjuvant treatment of sequential versus combination docetaxel with doxorubicin and cyclophosphamide in node-positive breast cancer: BCIRG-005 randomized trial. Ann Oncol. 2016 Jun;27(6):1041-1047. doi: 10.1093/annonc/mdw098. Epub 2016 Mar 2.

location_country:
Croatia
Saudi Arabia
Spain
Venezuela
United States
Belgium
Romania
South Africa
Poland
Hong Kong
Portugal
Slovenia
Russian Federation
Australia
Argentina
Uruguay
Israel
Mexico
Cyprus
Egypt
Bosnia and Herzegovina
Brazil
Lebanon
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Greece
Ireland
Estonia
New Zealand
Czech Republic
Korea, Republic of
France
Colombia

location_facility: Sanofi-aventis Sanofi-Aventis


summary: The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.

ReferenceCitation: Cuervo J, Castejón N, Khalaf KM, Waweru C, Globe D, Patrick DL. Development of the Incontinence Utility Index: estimating population-based utilities associated with urinary problems from the Incontinence Quality of Life Questionnaire and Neurogenic Module. Health Qual Life Outcomes. 2014 Oct 8;12:147. doi: 10.1186/s12955-014-0147-7.

ReferenceCitation: Chancellor MB, Patel V, Leng WW, Shenot PJ, Lam W, Globe DR, Loeb AL, Chapple CR. OnabotulinumtoxinA improves quality of life in patients with neurogenic detrusor overactivity. Neurology. 2013 Aug 27;81(9):841-8. doi: 10.1212/WNL.0b013e3182a2ca4d. Epub 2013 Jul 26.

ReferenceCitation: Ginsberg D, Gousse A, Keppenne V, Sievert KD, Thompson C, Lam W, Brin MF, Jenkins B, Haag-Molkenteller C. Phase 3 efficacy and tolerability study of onabotulinumtoxinA for urinary incontinence from neurogenic detrusor overactivity. J Urol. 2012 Jun;187(6):2131-9. doi: 10.1016/j.juro.2012.01.125. Epub 2012 Apr 12.

lead_sponsor: Allergan

location_country:
Poland
United Kingdom
Austria
Australia
New Zealand
Canada
Czech Republic
Russian Federation
Ukraine
United States
France
Belgium
Germany
Slovakia

intervention_type: Biological


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of CNTO 1275 in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis.

summary: The primary objective of this study is to evaluate the efficacy and safety of ustekinumab (CNTO 1275) in the treatment of patients with moderate to severe plaque psoriasis.

ReferenceCitation: Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum in: Drug Saf. 2019 Apr 22;:.

ReferenceCitation: Papp KA, Langley RG, Lebwohl M, Krueger GG, Szapary P, Yeilding N, Guzzo C, Hsu MC, Wang Y, Li S, Dooley LT, Reich K; PHOENIX 2 study investigators. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet. 2008 May 17;371(9625):1675-84. doi: 10.1016/S0140-6736(08)60726-6.

lead_sponsor: Centocor Research & Development, Inc.

location_country:
United Kingdom
Austria
Canada
Switzerland
United States
France
Germany


title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung Cancer or Esophageal Cancer

summary: Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer.

status: Terminated

lead_sponsor: Bayer

location_country:
Denmark
Spain
United Kingdom
Austria
Australia
Canada
United States
France
Belgium
Germany

status_simplified: Unknown


title: A Randomized Trial of a Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer

summary: This trial is designed to determine whether an 8-week course of escalated dose conformal radiation can be compressed safely, and with similar efficacy into a 4-week course.

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Martin J, Frantzis J, Chung P, Langah I, Crain M, Cornes D, Plank A, Finch T, Jones M, Khoo E, Catton C. Prostate radiotherapy clinical trial quality assurance: how real should real time review be? (A TROG-OCOG Intergroup Project). Radiother Oncol. 2013 Jun;107(3):333-8. doi: 10.1016/j.radonc.2013.05.015. Epub 2013 Jun 8.

lead_sponsor: Ontario Clinical Oncology Group (OCOG)

location_country: Australia Canada France

location_facility: Stronach Regional Cancer Centre, Southlake Regional Health Centre

location_facility: The Credit Valley Hospital - Carlo Fidani Peel Regional Cancer Centre

location_facility: Ballarat Austin Radiation Oncology Centre (BAROC)

location_facility: Liverpool Hospital & Campbelltown Hospital

location_facility: Northern Sydney Cancer Centre, Royal North Shore Hospital

location_facility: Wollongong Hospital / Illawarra Cancer Care Centre

location_facility: R.S. McLaughlin Durham Regional Cancer Centre

intervention_type: Procedure


title: Phase 2 Study of HKI-272 In Subjects With Advanced Breast Cancer

lead_sponsor: Puma Biotechnology, Inc.

source: euctr

study_start_date_type: Actual

location_country:
Russian Federation
Mexico
India
United States
France
China
Belgium

location_facility: Norris Cotton Cancer Center Dartmouth Hitchcock Medical Center

location_facility: Chinese People's Liberation Army General Hospital

location_facility: Breast Tumor Department, N.N. Petrov Research Institute of Oncology

location_facility: N.N. Blokhin Russian Cancer Research Center of RAMS

location_facility: No. 81 Hospital of Chinese People's Liberation Army

location_facility: Institut Jules Bordet Unite du Chimiotherapie

location_facility: Medical Radiological Research Center of RAMS, Department of Radiation and Surgical Methods

location_facility: The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army

location_facility: City Hospital N 31 Oncology Haematology Dept. For Adults

location_facility: St-Augustinus Ziekenhuis Oncology Department

location_facility: Hospital Regional Lic. Adolfo Lopez Mateos Oncología Médica

location_facility: Cancer Hospital Peking Union Medical College

location_facility: Institut Gustave ROUSSY Service de Pathologie Mammaire

location_facility: The Cleveland Clinic Taussig Cancer Center

summary: The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer.


title: An Open-label, Fixed-dose, Multicenter, Phase II Study of MDX-060 in Patients With Relapsed or Refractory Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma

summary: This study is an open-label, fixed-dose, multicenter study of MDX-060 in patients with ALCL who have relapsed or refractory disease. There will be 3 phases of this study: Induction, Maintenance, and Follow-up. Patients will be required to attend all protocol-required visits in the 4-week Induction Phase, in which administration of MDX-060 will occur, as well as other testing. Patients who complete the Induction Phase may be eligible for additional MDX-060 treatment ever 2 months for 1 year in the Maintenance Phase. Patients who complete the Maintenance Phase with a response of stable disease or better will be followed every 2 months for 1 year or until disease progression. The purpose of this study is to determine objective response rate at Day 50 in patients with relapsed or refractory classic systemic ALCL or primary cutaneous ALCL treated with MDX-060. Other objectives will be evaluated.

status: Withdrawn

design_allocation: Non-Randomized

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
France

location_facility: Centre Hospitalier Regional Unv. de Lille, Hopital Claude Huriez

location_facility: The Cancer Institute of New Jersey - Robert Wood Johnson Unv. Hosp.

location_facility: California Oncology of the Central Valley


title: A Phase 2, Double-Blind, Multi-center, Randomized Study Comparing Tenofovir Disoproxil Fumarate, Emtricitabine Plus Tenofovir Disoproxil Fumarate, and Entecavir in the Treatment of Chronic Hepatitis B Subjects With Decompensated Liver Disease and in the Prevention of Hepatitis B Recurrence Post-Transplantation

summary:
This study was designed to evaluate and compare the safety and tolerability of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC)/TDF, and entecavir (ETV) in the treatment of hepatitis B patients with decompensated liver disease. Safety was assessed by evaluating adverse events (AEs) and laboratory abnormalities. Efficacy was assessed by evaluating reductions in Child-Pugh-Turcotte (CPT) and Model for End Stage Liver Disease (MELD) scores, reductions in hepatitis B virus (HBV) deoxyribonucleic acid (DNA), changes in liver enzymes, development of drug-resistant mutations, and generation of antibody to virus.

A maximum randomized treatment duration of 168 weeks was planned. Since subjects with decompensated liver disease were enrolled into this study, it was necessary to provide early intervention strategies if profound viral suppression was not expeditiously achieved. For this reason, subjects with a decrease in plasma HBV DNA from baseline of < 2 log_10 copies/mL and plasma HBV DNA > 10,000 copies/mL (or plasma HBV DNA > 1,000 copies/mL for subjects who entered the study with HBV DNA < 10,000 copies/mL) at Week 8 had the option to start open-label FTC/TDF and continue in the study. Subjects with a virologic breakthrough or who had plasma HBV DNA levels remaining > 400 copies/mL (confirmed) at or after 24 weeks of treatment could have been unblinded at the investigator's discretion for selection of alternative anti-HBV therapy that may have included open-label FTC/TDF. If study drug was permanently discontinued, immediate initiation of another anti-HBV regimen was strongly recommended.

ReferenceCitation: Liaw YF, Sheen IS, Lee CM, Akarca US, Papatheodoridis GV, Suet-Hing Wong F, Chang TT, Horban A, Wang C, Kwan P, Buti M, Prieto M, Berg T, Kitrinos K, Peschell K, Mondou E, Frederick D, Rousseau F, Schiff ER. Tenofovir disoproxil fumarate (TDF), emtricitabine/TDF, and entecavir in patients with decompensated chronic hepatitis B liver disease. Hepatology. 2011 Jan;53(1):62-72. doi: 10.1002/hep.23952. Epub 2010 Oct 27.

lead_sponsor: Gilead Sciences

location_country:
Poland
Taiwan
Spain
Greece
Italy
Canada
United States
France
Singapore
Turkey
Germany

location_facility: Mt. Sinai School of Medicine/ Mt. Sinai Medical Center

location_facility: Hospital General Universitari Vall d'Hebron

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Rush Presbyterian - St. Luke's Medical Center

location_facility: University of Miami, Center for Liver Diseases

location_facility: National University Hospital Dept. of Gastroenterology & Hepatology

location_facility: Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie

location_facility: Hospital Universitario y Politecnico la Fe

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Clinic i Provincial de Barcelona (HCPB)

location_facility: Wojewodzki Szpital Specjalistyczny im Dluskeigo

location_facility: California Pacific Medical Center Research Institute


title: An Analysis of Mortality in Subjects Who Participated in Three Studies of Galantamine in Mild Cognitive Impairment

summary: The purpose of the study is to collect data of patients who were randomized (assignment of study medication by chance) and treated in 3 previous studies of galantamine (CR003145, CR002014 and CR005947) for the treatment of mild cognitive impairment (isolated memory impairment). This data were not recorded during the course of these 3 previous studies.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
Poland
Spain
United Kingdom
Austria
Australia
Netherlands
Argentina
Canada
Czech Republic
Finland
Sweden
United States
France
Israel
Belgium
Germany


title: A 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of Fingolimod 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis

acronym: FREEDOMS

summary: This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)

ReferenceCitation: Nowak CP, Mütze T, Konietschke F. Group sequential methods for the Mann-Whitney parameter. Stat Methods Med Res. 2022 Oct;31(10):2004-2020. doi: 10.1177/09622802221107103. Epub 2022 Jun 13.

ReferenceCitation: Fox RJ, Chan A, Zhang A, Xiao J, Levison D, Lewin JB, Edwards MR, Marantz JL. Comparative effectiveness using a matching-adjusted indirect comparison between delayed-release dimethyl fumarate and fingolimod for the treatment of multiple sclerosis. Curr Med Res Opin. 2017 Feb;33(2):175-183. doi: 10.1080/03007995.2016.1248380. Epub 2016 Nov 10.

ReferenceCitation: Derfuss T, Bergvall NK, Sfikas N, Tomic DL. Efficacy of fingolimod in patients with highly active relapsing-remitting multiple sclerosis. Curr Med Res Opin. 2015;31(9):1687-91. doi: 10.1185/03007995.2015.1067191. Epub 2015 Aug 20.

ReferenceCitation: Kremenchutzky M, O'Connor P, Hohlfeld R, Zhang-Auberson L, von Rosenstiel P, Meng X, Grinspan A, Hashmonay R, Kappos L. Impact of prior treatment status and reasons for discontinuation on the efficacy and safety of fingolimod: Subgroup analyses of the Fingolimod Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis (FREEDOMS) study. Mult Scler Relat Disord. 2014 May;3(3):341-9. doi: 10.1016/j.msard.2013.10.006. Epub 2013 Nov 5.

ReferenceCitation: Chinea Martinez AR, Correale J, Coyle PK, Meng X, Tenenbaum N. Efficacy and safety of fingolimod in Hispanic patients with multiple sclerosis: pooled clinical trial analyses. Adv Ther. 2014 Oct;31(10):1072-81. doi: 10.1007/s12325-014-0154-4. Epub 2014 Sep 23.

ReferenceCitation: Zarbin MA, Jampol LM, Jager RD, Reder AT, Francis G, Collins W, Tang D, Zhang X. Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. Ophthalmology. 2013 Jul;120(7):1432-9. doi: 10.1016/j.ophtha.2012.12.040. Epub 2013 Mar 24.

ReferenceCitation: Radue EW, O'Connor P, Polman CH, Hohlfeld R, Calabresi P, Selmaj K, Mueller-Lenke N, Agoropoulou C, Holdbrook F, de Vera A, Zhang-Auberson L, Francis G, Burtin P, Kappos L; FTY720 Research Evaluating Effects of Daily Oral Therapy in Multiple Sclerosis (FREEDOMS) Study Group. Impact of fingolimod therapy on magnetic resonance imaging outcomes in patients with multiple sclerosis. Arch Neurol. 2012 Oct;69(10):1259-69.

ReferenceCitation: Devonshire V, Havrdova E, Radue EW, O'Connor P, Zhang-Auberson L, Agoropoulou C, Häring DA, Francis G, Kappos L; FREEDOMS study group. Relapse and disability outcomes in patients with multiple sclerosis treated with fingolimod: subgroup analyses of the double-blind, randomised, placebo-controlled FREEDOMS study. Lancet Neurol. 2012 May;11(5):420-8. doi: 10.1016/S1474-4422(12)70056-X. Epub 2012 Apr 10. Erratum in: Lancet Neurol. 2012 Aug;11(8):658.

ReferenceCitation: Kappos L, Radue EW, O'Connor P, Polman C, Hohlfeld R, Calabresi P, Selmaj K, Agoropoulou C, Leyk M, Zhang-Auberson L, Burtin P; FREEDOMS Study Group. A placebo-controlled trial of oral fingolimod in relapsing multiple sclerosis. N Engl J Med. 2010 Feb 4;362(5):387-401. doi: 10.1056/NEJMoa0909494. Epub 2010 Jan 20.

lead_sponsor: Novartis

location_country:
Poland
United Kingdom
Greece
Russian Federation
Australia
Netherlands
Finland
Canada
Czech Republic
Lithuania
Sweden
Switzerland
France
Israel
South Africa
Turkey
Belgium
Germany
Slovakia

location_facility: Univ. Med. Sci. Poznan, Katedra i Klinika Neurologii,

location_facility: T.C. Saglik Bakanligi Goztepe Egitim ve Arastirma Hastanesi

location_facility: National Multiple Sclerose Centrum v.z.w

location_facility: Helsinki Headache Center Postitalon Lääkäriasema

location_facility: Athens Naval Hospital, Neurology Department

location_facility: Neurologické oddelenie, Nemocnica s poliklinikou Žilina

location_facility: King's College Hospital, Trials office Academie Neuroscience Center

location_facility: UniversitätsSpital Zürich, Neurologische Klinik

location_facility: St. George's Hospital, Neurology Dept. Atkinson Morley Wing

location_facility: Jadwiga Kruszewska-Ozimska, Instytut Psychiatrii i Neurologii

location_facility: Mersin Universitesi Tip Fakultesi Hastanesi

location_facility: Neurologická klinika, Martinská fakultná nemocnica

location_facility: Dokuz University Medical Faculty, Neurology Department

location_facility: Algemeen Ziekenhuis St. Jan, Department of Neurology

location_facility: Karolinska University Hospital, Department of Medicine

location_facility: GUZ "Central Medical Sanitary Department #122 of Federal Medical-Biological agency", Neurology department

location_facility: I. Neurologická klinika, Fakultná nemocnica s poliklinikou Bratislava pracovisko Staré mesto

location_facility: Centralny Szpital Kliniczny, Klinika Neurologii

location_facility: Turku University Hospital, Neurology Department 799

location_facility: II. Neurologická klinika Fakultná nemocnica s poliklinikou Bratislava pracovisko Kramáre

location_facility: Private Neurologist (Morningside Medi-Clinic), Suite C, Block C, Rochester Place

location_facility: St Vincent's Hospital Melbourne, Department of Clinical Neurosciences

location_facility: University General Hospital of Thessaloniki "AHEPA", B' University Department of Neurology

location_facility: Centre Hospitalier, Universitaire Vaudois Policlinique de Neurologie

location_facility: Interregional Clinical Diagnistic Center, Neurology Department

location_facility: Suomen Terveystalo/ Päänsärkykeskus, Tampere

location_facility: Katedra i Klinika Neurologii Slaskiej Akademii Medycznej

location_facility: Moscow Regional Research Clinical Institue

location_facility: Katedra i Klinika Neurologii Centralny Szpital Kliniczny AM w Warszawie

location_facility: Frenchay Hospital, Department of Neurology

location_facility: Central Clinical Hospital of Medical Center of Administration of President of Russian Federation

location_facility: Istanbul University, Cerrahpasa School of Medicine

location_facility: Niezalezny Zespol Opieki Zdrowotnej Kendron

location_facility: Division of Neurology, Groote Schuur Hospital

location_facility: Military Medical Academy, Neurology Department

location_facility: Kaunas University Hospital Department of Neurology

location_facility: Istanbul University, Istanbul Faculty of Medicine

location_facility: Neurologicka klinika, Fakultni nemocnice

location_facility: Hopital Maisonneuve-Rosemont, Recherche Clinique de Neurologie

location_facility: Bakirkoy Ruh ve Sinir Hastaliklari Hastanesi

location_facility: Neurology Department Athens General Hospital, G. Gennimatas

location_facility: Facultní Nemocnice Spoliklinikou Ostrava, Neurology Department


title: Treatment Protocol of the Third International Study For Langerhans Cell Histiocytosis

summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of Langerhans cell histiocytosis, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may be an effective treatment for Langerhans cell histiocytosis.

PURPOSE: This randomized clinical trial is studying combination chemotherapy to see how well it works in treating young patients with Langerhans cell histiocytosis.

ReferenceCitation: Gadner H, Minkov M, Grois N, Pötschger U, Thiem E, Aricò M, Astigarraga I, Braier J, Donadieu J, Henter JI, Janka-Schaub G, McClain KL, Weitzman S, Windebank K, Ladisch S; Histiocyte Society. Therapy prolongation improves outcome in multisystem Langerhans cell histiocytosis. Blood. 2013 Jun 20;121(25):5006-14. doi: 10.1182/blood-2012-09-455774. Epub 2013 Apr 15.

lead_sponsor: Histiocyte Society

location_country:
United Kingdom
Ireland
Austria
Italy
Argentina
Canada
Sweden
United States
France
Germany

location_facility: Our Lady's Hospital for Sick Children Crumlin

location_facility: Great Ormond Street Hospital for Children

location_facility: Royal Liverpool Children's Hospital, Alder Hey

location_facility: Institute of Child Health at University of Bristol

location_facility: Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Masonic Cancer Center at University of Minnesota

location_facility: Fondazione I.R.C.C.S. Policlinico San Matteo

location_facility: University Medical Center Hamburg - Eppendorf

location_facility: Leeds Cancer Centre at St. James's University Hospital

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Sir James Spence Institute of Child Health at Royal Victoria Infirmary


title: A Phase 2 Study of HKI-272 In Subjects With Advanced Non-Small Cell Lung Cancer

summary: The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.

location_country:
Poland
Spain
Hungary
United States
France

location_facility: Dolnośląskie Centrum Chorób Płuc we Wrocławiu

location_facility: Wielkopolskie Centrum Chorób Płuc i Gruźlicy

location_facility: Massachusetts General Hospital, Yawkey Center for Outpatient Care

location_facility: Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy

location_facility: Országos Korányi TBC és Pulmonológiai Intézet


title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalpha MonoclonalAntibody, Administered Subcutaneously, in Subjects With Active Ankylosing Spondylitis

summary: The purpose of this study is to evaluate the safety and efficacy of subcutaneous injections (under the skin) of golimumab for the treatment of active ankylosing spondylitis [AS(arthritis of the spine)]. Efficacy will be measured by reduction in the signs and symptoms of active AS, including effects on back pain and stiffness, physical function, range of motion in the spine, quality of life, and rate of spine damage or fusion on x-ray.

ReferenceCitation: Leu JH, Adedokun OJ, Gargano C, Hsia EC, Xu Z, Shankar G. Immunogenicity of golimumab and its clinical relevance in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Rheumatology (Oxford). 2019 Mar 1;58(3):441-446. doi: 10.1093/rheumatology/key309.

ReferenceCitation: Inman RD, Baraliakos X, Hermann KA, Braun J, Deodhar A, van der Heijde D, Xu S, Hsu B. Serum biomarkers and changes in clinical/MRI evidence of golimumab-treated patients with ankylosing spondylitis: results of the randomized, placebo-controlled GO-RAISE study. Arthritis Res Ther. 2016 Dec 28;18(1):304. doi: 10.1186/s13075-016-1200-1.

ReferenceCitation: Kay J, Fleischmann R, Keystone E, Hsia EC, Hsu B, Zhou Y, Goldstein N, Braun J. Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis. J Rheumatol. 2016 Dec;43(12):2120-2130. Epub 2016 Nov 1.

ReferenceCitation: Braun J, Baraliakos X, Hermann KG, Xu S, Hsu B. Serum C-reactive Protein Levels Demonstrate Predictive Value for Radiographic and Magnetic Resonance Imaging Outcomes in Patients with Active Ankylosing Spondylitis Treated with Golimumab. J Rheumatol. 2016 Sep;43(9):1704-12. doi: 10.3899/jrheum.160003. Epub 2016 Jul 15.

ReferenceCitation: Braun J, Baraliakos X, Hermann KG, Xu S, Hsu B. Serum Vascular Endothelial Growth Factor Levels Lack Predictive Value in Patients with Active Ankylosing Spondylitis Treated with Golimumab. J Rheumatol. 2016 May;43(5):901-6. doi: 10.3899/jrheum.150897. Epub 2016 Mar 1.

ReferenceCitation: Deodhar A, Braun J, Inman RD, van der Heijde D, Zhou Y, Xu S, Han C, Hsu B. Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 5-year results of the GO-RAISE study. Ann Rheum Dis. 2015 Apr;74(4):757-61. doi: 10.1136/annrheumdis-2014-205862. Epub 2014 Nov 11.

ReferenceCitation: van der Heijde D, Braun J, Deodhar A, Inman RD, Xu S, Mack ME, Hsu B. Comparison of three enthesitis indices in a multicentre, randomized, placebo-controlled trial of golimumab in ankylosing spondylitis (GO-RAISE). Rheumatology (Oxford). 2013 Feb;52(2):321-5. doi: 10.1093/rheumatology/kes251. Epub 2012 Sep 28.

ReferenceCitation: van der Heijde D, Deodhar A, Inman RD, Braun J, Hsu B, Mack M. Comparison of three methods for calculating the Bath Ankylosing Spondylitis Metrology Index in a randomized placebo-controlled study. Arthritis Care Res (Hoboken). 2012 Dec;64(12):1919-22. doi: 10.1002/acr.21771.

ReferenceCitation: Deodhar A, Braun J, Inman RD, Mack M, Parasuraman S, Buchanan J, Hsu B, Gathany T, van der Heijde D. Golimumab reduces sleep disturbance in patients with active ankylosing spondylitis: results from a randomized, placebo-controlled trial. Arthritis Care Res (Hoboken). 2010 Sep;62(9):1266-71. doi: 10.1002/acr.20233.

lead_sponsor: Centocor, Inc.

location_country:
Taiwan
Netherlands
Finland
Canada
Korea, Republic of
United States
France
Belgium
Germany


title: Randomized, Multinational, Multicenter, Double-blind, Placebo-controlled, Two-arm Parallel Group Trial of Rimonabant 20 mg OD for Reducing the Risk of Major Cardiovascular Events in Abdominally Obese Patients With Clustering Risk Factors

acronym: CRESCENDO

summary:
The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI), stroke, or death from an MI or stroke in patients with abdominal obesity with other cardiovascular (CV) risk factors.

The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV death, or CV hospitalization in these patients.

ReferenceCitation: Topol EJ, Bousser MG, Fox KA, Creager MA, Despres JP, Easton JD, Hamm CW, Montalescot G, Steg PG, Pearson TA, Cohen E, Gaudin C, Job B, Murphy JH, Bhatt DL; CRESCENDO Investigators. Rimonabant for prevention of cardiovascular events (CRESCENDO): a randomised, multicentre, placebo-controlled trial. Lancet. 2010 Aug 14;376(9740):517-23. doi: 10.1016/S0140-6736(10)60935-X.

ReferenceCitation: Bhatia G, Bansal V, Harismendy O, Schork NJ, Topol EJ, Frazer K, Bafna V. A covering method for detecting genetic associations between rare variants and common phenotypes. PLoS Comput Biol. 2010 Oct 14;6(10):e1000954. doi: 10.1371/journal.pcbi.1000954.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Philippines
Romania
South Africa
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Tunisia
India
Israel
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Greece
Ireland
Finland
Czech Republic
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: sanofi-aventis Australia & New Zealand administrative office


title: REcurrent VEnous Thromboembolism Risk Stratification Evaluation A Study to Develop a Clinical Prediction Rule to Predict Low Recurrence Risk in Patients With Idiopathic Venous Thromboembolism.

summary: The purpose of this study is to develop a way to predict which patients diagnosed with idiopathic blood clots can safely stop warfarin therapy after six months. We will use patient characteristics, blood test results and imaging test results to identify those patients who have the lowest risk of developing a new blood clot after warfarin is stopped.

status: Unknown status

study_completion_date_type: Anticipated

time_perspective: Prospective

ReferenceCitation: Wan T, Rodger M, Zeng W, Robin P, Righini M, Kovacs MJ, Tan M, Carrier M, Kahn SR, Wells PS, Anderson DR, Chagnon I, Solymoss S, Crowther M, White RH, Vickars L, Bazarjani S, Le Gal G. Residual pulmonary embolism as a predictor for recurrence after a first unprovoked episode: Results from the REVERSE cohort study. Thromb Res. 2018 Feb;162:104-109. doi: 10.1016/j.thromres.2017.11.020. Epub 2017 Dec 8.

ReferenceCitation: Rodger MA, Scarvelis D, Kahn SR, Wells PS, Anderson DA, Chagnon I, Le Gal G, Gandara E, Solymoss S, Sabri E, Kovacs J, Kovacs MJ. Long-term risk of venous thrombosis after stopping anticoagulants for a first unprovoked event: A multi-national cohort. Thromb Res. 2016 Jul;143:152-8. doi: 10.1016/j.thromres.2016.03.028. Epub 2016 Mar 29.

ReferenceCitation: Galanaud JP, Holcroft CA, Rodger MA, Kovacs MJ, Betancourt MT, Wells PS, Anderson DR, Chagnon I, Le Gal G, Solymoss S, Crowther MA, Perrier A, White RH, Vickars LM, Ramsay T, Kahn SR. Predictors of post-thrombotic syndrome in a population with a first deep vein thrombosis and no primary venous insufficiency. J Thromb Haemost. 2013 Mar;11(3):474-80. doi: 10.1111/jth.12106.

ReferenceCitation: Galanaud JP, Holcroft CA, Rodger MA, Kovacs MJ, Betancourt MT, Wells PS, Anderson DR, Chagnon I, Le Gal G, Solymoss S, Crowther MA, Perrier A, White RH, Vickars LM, Ramsay T, Kahn SR. Comparison of the Villalta post-thrombotic syndrome score in the ipsilateral vs. contralateral leg after a first unprovoked deep vein thrombosis. J Thromb Haemost. 2012 Jun;10(6):1036-42. doi: 10.1111/j.1538-7836.2012.04713.x.

ReferenceCitation: Kovacs MJ, Kahn SR, Wells PS, Anderson DA, Chagnon I, LE Gal G, Solymoss S, Crowther M, Perrier A, Ramsay T, Betancourt MT, White RH, Vickars L, Rodger MA. Patients with a first symptomatic unprovoked deep vein thrombosis are at higher risk of recurrent venous thromboembolism than patients with a first unprovoked pulmonary embolism. J Thromb Haemost. 2010 Sep;8(9):1926-32. doi: 10.1111/j.1538-7836.2010.03958.x.

ReferenceCitation: Le Gal G, Kovacs MJ, Carrier M, Do K, Kahn SR, Wells PS, Anderson DA, Chagnon I, Solymoss S, Crowther M, Righini M, Perrier A, White RH, Vickars L, Rodger M. Validation of a diagnostic approach to exclude recurrent venous thromboembolism. J Thromb Haemost. 2009 May;7(5):752-9. doi: 10.1111/j.1538-7836.2009.03324.x. Epub 2009 Feb 18.

ReferenceCitation: Rodger MA, Kahn SR, Wells PS, Anderson DA, Chagnon I, Le Gal G, Solymoss S, Crowther M, Perrier A, White R, Vickars L, Ramsay T, Betancourt MT, Kovacs MJ. Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy. CMAJ. 2008 Aug 26;179(5):417-26. doi: 10.1503/cmaj.080493.

lead_sponsor: Ottawa Hospital Research Institute

location_country: Canada France

location_facility:
Hopital du Sacre Coeur
Montreal Jewish General Hospital
CHU de le Cavale Blanche
The Ottawa Hospital
QE II Health Sciences Centre
London Health Sciences Centre
Montreal General Hospital


title: Measuring the Glycaemic Index of Foods: Interlaboratory Study #2

summary: The purpose of this study is to assess the extent of and sources of variation in the glycaemic index values of foods measured by different laboratories around the world.

ReferenceCitation: Wolever TM, Brand-Miller JC, Abernethy J, Astrup A, Atkinson F, Axelsen M, Björck I, Brighenti F, Brown R, Brynes A, Casiraghi MC, Cazaubiel M, Dahlqvist L, Delport E, Denyer GS, Erba D, Frost G, Granfeldt Y, Hampton S, Hart VA, Hätönen KA, Henry CJ, Hertzler S, Hull S, Jerling J, Johnston KL, Lightowler H, Mann N, Morgan L, Panlasigui LN, Pelkman C, Perry T, Pfeiffer AF, Pieters M, Ramdath DD, Ramsingh RT, Robert SD, Robinson C, Sarkkinen E, Scazzina F, Sison DC, Sloth B, Staniforth J, Tapola N, Valsta LM, Verkooijen I, Weickert MO, Weseler AR, Wilkie P, Zhang J. Measuring the glycemic index of foods: interlaboratory study. Am J Clin Nutr. 2008 Jan;87(1):247S-257S.

lead_sponsor: Glycaemic Index Testing, Inc.

location_country:
Denmark
United Kingdom
Italy
Australia
Netherlands
Canada
Finland
New Zealand
Trinidad and Tobago
Sweden
United States
France
China
Malaysia
South Africa
Philippines
Germany

location_facility: Institute of Nutrition and Food Safety, Chinese Centre for Disease Control and Prevention

location_facility: The Royal Veterinary & Agricultural University


title: Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: a 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study

acronym: GEMS

summary: The purpose of the study is to assess efficacy and safety of eplivanserin in the population of patients complaining of sleep maintenance insomnia. The patients suffering from that condition frequently wake up during the night, their sleep is nonrestorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.

location_country:
Spain
United Kingdom
Australia
Netherlands
Argentina
Canada
Czech Republic
United States
Chile
France
Mexico
Germany


title: Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia: a 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study Followed by an Open Treatment Phase Extension With Eplivanserin for a 40-week Period

acronym: EPLILONG

location_country:
Spain
United Kingdom
Austria
Australia
Netherlands
Argentina
Canada
Czech Republic
Finland
United States
Chile
France
Mexico
Germany


title: Predictors of Response to Cardiac Re-Synchronization Therapy

summary: Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. Using a medical device like a pacemaker or a defibrillator can help the heart to pump in regular beats. However, not all patients do better with a device. Currently, there is not a way to identify which patients will benefit from the device. The purpose of this study is to determine if using medical tests, Echocardiogram, can help in predicting which patients will improve. The types of patients needed for this study are those who have been diagnosed with moderate or severe heart failure.

ReferenceCitation: Hsing JM, Selzman KA, Leclercq C, Pires LA, McLaughlin MG, McRae SE, Peterson BJ, Zimetbaum PJ. Paced left ventricular QRS width and ECG parameters predict outcomes after cardiac resynchronization therapy: PROSPECT-ECG substudy. Circ Arrhythm Electrophysiol. 2011 Dec;4(6):851-7. doi: 10.1161/CIRCEP.111.962605. Epub 2011 Sep 28.

ReferenceCitation: Chan PS, Khumri T, Chung ES, Ghio S, Reid KJ, Gerritse B, Nallamothu BK, Spertus JA. Echocardiographic dyssynchrony and health status outcomes from cardiac resynchronization therapy: insights from the PROSPECT trial. JACC Cardiovasc Imaging. 2010 May;3(5):451-60. doi: 10.1016/j.jcmg.2009.08.012.

ReferenceCitation: Chung ES, Leon AR, Tavazzi L, Sun JP, Nihoyannopoulos P, Merlino J, Abraham WT, Ghio S, Leclercq C, Bax JJ, Yu CM, Gorcsan J 3rd, St John Sutton M, De Sutter J, Murillo J. Results of the Predictors of Response to CRT (PROSPECT) trial. Circulation. 2008 May 20;117(20):2608-16. doi: 10.1161/CIRCULATIONAHA.107.743120. Epub 2008 May 5.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Denmark
Hong Kong
Spain
Italy
Austria
Netherlands
United Kingdom
Finland
United States
France
Belgium
Norway
Germany


title: A Parallel Randomized Controlled Evaluation of Clopidogrel Plus Aspirin, With Factorial Evaluation of Irbesartan, for the Prevention of Vascular Events, in Patients With Atrial Fibrillation

summary: The purpose of this study is to determine if the combination of clopidogrel 75mg once daily (od) plus aspirin 100mg daily (recommended dose) is better than aspirin alone (100mg daily recommended dose) for preventing vascular events such as stroke and heart attack during approximately three years of follow-up in patients with atrial fibrillation associated with at least one major risk factor of vascular event such as elderly, blood pressure increase, history of stroke or transient ischemic attack or left ventricular dysfunction etc. The study will also accept patients with atrial fibrillation and unwilling to take oral anticoagulant therapy.

primary_purpose: Prevention

ReferenceCitation: ACTIVE Investigators, Connolly SJ, Pogue J, Hart RG, Hohnloser SH, Pfeffer M, Chrolavicius S, Yusuf S. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med. 2009 May 14;360(20):2066-78. doi: 10.1056/NEJMoa0901301. Epub 2009 Mar 31.

ReferenceCitation: Paré G, Mehta SR, Yusuf S, Anand SS, Connolly SJ, Hirsh J, Simonsen K, Bhatt DL, Fox KA, Eikelboom JW. Effects of CYP2C19 genotype on outcomes of clopidogrel treatment. N Engl J Med. 2010 Oct 28;363(18):1704-14. doi: 10.1056/NEJMoa1008410. Epub 2010 Aug 29.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
South Africa
Poland
Hong Kong
Portugal
Austria
Australia
Argentina
Mexico
Norway
Malaysia
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Greece
Finland
Czech Republic
France
Chile
Netherlands

location_facility:
Sanofi-aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis


acronym: ACTIVE I

summary: The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular events.

ReferenceCitation: ACTIVE I Investigators, Yusuf S, Healey JS, Pogue J, Chrolavicius S, Flather M, Hart RG, Hohnloser SH, Joyner CD, Pfeffer MA, Connolly SJ. Irbesartan in patients with atrial fibrillation. N Engl J Med. 2011 Mar 10;364(10):928-38. doi: 10.1056/NEJMoa1008816.


title: A Dose-ranging Safety and Pharmacokinetics Study of Candesartan Cilexetil in Hypertensive Pediatric Subjects 1 to Less That 6 Years of Age: A 4-week, Multicenter, Randomized, Double-blind Study With a 1-year, Open-label, Follow-up Period.

summary: This is a dose ranging study of candesartan cilexetil in hypertensive pediatric subjects ages 1 to less than 6 years of age. It employs a double blind, randomized, dose ranging design intended for conduct as a multicenter trial. There are 3 study 'periods': a 1-week placebo run-in, a 4-week double blind treatment, and a 52-week open-label, long-term treatment period. Subjects undergo a screening evaluation, then a 1-week single-blind, placebo run-in, after which eligible subjects are allocated to receive 1 of 3 dose levels of candesartan cilexetil (0.05 mg/kg, or 0.20 mg /kg or 0.40 mg /kg), liquid formulation, in a 1:1:1 ratio for 4-weeks. At the end of randomized dose allocation (Day 28), blood pressure assessment will be performed and subjects may begin the 52-week, open-label treatment period of the study.

ReferenceCitation: Schaefer F, van de Walle J, Zurowska A, Gimpel C, van Hoeck K, Drozdz D, Montini G, Bagdasorova IV, Sorof J, Sugg J, Teng R, Hainer JW; Candesartan in Children with Hypertension Investigators. Efficacy, safety and pharmacokinetics of candesartan cilexetil in hypertensive children from 1 to less than 6 years of age. J Hypertens. 2010 May;28(5):1083-90. doi: 10.1097/HJH.0b013e328336b86b.

lead_sponsor: AstraZeneca

location_country:
Denmark
Poland
United Kingdom
Italy
Ukraine
Puerto Rico
United States
France
Belgium
Germany


summary: The purpose of this study is to determine if the combination of Clopidogrel 75mg once daily (od) plus aspirin at 100mg daily (recommended dose) is as effective as oral anticoagulation therapy with a lower risk of bleeding in patients with atrial fibrillation associated with at least one major cardiovascular risk factor.Primary objectives :The combination of clopidogrel plus aspirin compared to adjusted dose (INR between 2.0 and 3.3) oral anticoagulation (a vitamin K antagonist) will result in the same risk of the composite outcome of stroke, non-CNS systemic embolism, myocardial infarction or vascular death in patients with atrial fibrillation.The secondary objective is to establish whether or not aspirin plus clopidogrel has a lower risk of hemorrhage than standard anticoagulation therapy.

ReferenceCitation: ACTIVE Writing Group of the ACTIVE Investigators, Connolly S, Pogue J, Hart R, Pfeffer M, Hohnloser S, Chrolavicius S, Pfeffer M, Hohnloser S, Yusuf S. Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial. Lancet. 2006 Jun 10;367(9526):1903-12.

ReferenceCitation: Flaker GC, Pogue J, Yusuf S, Pfeffer MA, Goldhaber SZ, Granger CB, Anand IS, Hart R, Connolly SJ; Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE) Investigators. Cognitive function and anticoagulation control in patients with atrial fibrillation. Circ Cardiovasc Qual Outcomes. 2010 May;3(3):277-83. doi: 10.1161/CIRCOUTCOMES.109.884171. Epub 2010 Mar 16.

ReferenceCitation: Cairns JA, Wittes J, Wyse DG, Pogue J, Gent M, Hirsh J, Marler J, Pritchett EL. Monitoring the ACTIVE-W trial: some issues in monitoring a noninferiority trial. Am Heart J. 2008 Jan;155(1):33-41. Epub 2007 Nov 26. Review.

ReferenceCitation: Hohnloser SH, Pajitnev D, Pogue J, Healey JS, Pfeffer MA, Yusuf S, Connolly SJ; ACTIVE W Investigators. Incidence of stroke in paroxysmal versus sustained atrial fibrillation in patients taking oral anticoagulation or combined antiplatelet therapy: an ACTIVE W Substudy. J Am Coll Cardiol. 2007 Nov 27;50(22):2156-61. Epub 2007 Nov 13.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
South Africa
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Israel
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Greece
Finland
Czech Republic
France
Chile
Netherlands


title: A Prospective, Multicenter, Open-Label Study of Aripiprazole in the Management of Patients With Schizophrenia in General Psychiatric Practices (Broad Effectiveness Trial With Aripiprazole- BETA)

summary: The purpose of this clinical research study is to evaluate if Aripiprazole will prove to be effective, safe and well tolerated in the treatment of patients with schizophrenia who are treated in a general psychiatric setting.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country: Portugal Spain France Belgium Netherlands


title: Placebo Controlled Double Blind Dose Ranging Study of the Efficacy and Safety of SSR149744C 50, 100, 200, or 300 mg OD, With Amiodarone as Calibrator for the Maintenance of Sinus Rhythm in Patients With Recent Atrial Fibrillation/Flutter

acronym: MAIA

summary: Double blind study to evaluate the efficacy and tolerability of SSR149744C and select a dose to be further investigated in the maintenance of sinus rhythm after electrical, pharmacological or spontaneous conversion of AF/AFL.

ReferenceCitation: Khitri AR, Aliot EM, Capucci A, Connolly SJ, Crijns H, Hohnloser SH, Kulakowski P, Roy D, Radzik D, Kowey PR. Celivarone for maintenance of sinus rhythm and conversion of atrial fibrillation/flutter. J Cardiovasc Electrophysiol. 2012 May;23(5):462-72. doi: 10.1111/j.1540-8167.2011.02234.x. Epub 2011 Dec 15.

lead_sponsor: Sanofi

location_country:
Denmark
Poland
Spain
Italy
Russian Federation
Australia
Netherlands
Argentina
Canada
Switzerland
Sweden
Hungary
United States
Chile
France
Japan
Germany


title: A Phase II, Multicenter, Randomized, Open-Label, Dose-Ranging, Parallel Group Study to Compare the Anti-Viral Effects, Pharmacokinetics and Safety of HepeX-Bä, a Mixture of Two Monoclonal Antibodies, as Compared to Hepatitis B Immune Globulin in Patients Who Have Received Hepatic Allografts for Treatment of End-Stage Liver Disease Due to Hepatitis B Virus Infection

summary: The purpose of this study is to compare the use of HepeX-B versus HBIg, two anti-viral drugs, in patients who have received liver transplants due to liver failure caused by Hepatitis B infection. Patients will be evaluated over a 6 month to 1.5 year period to evaluate whether or not the drugs prevent the Hepatitis B virus from infecting the new liver.

lead_sponsor: Cubist Pharmaceuticals LLC

location_country:
Spain
United Kingdom
New Zealand
United States
Israel
France
Germany

location_facility: Virginia Commonwealth University Health System

location_facility: University of Pennsylvania Health System

location_facility: Metropolitan Liver Diseases/Gastroenterology Center

location_facility: Centre Hepato-Biliaire Hospital Paul Brousse

location_facility: Humbolt University Virchow Clinic Dept. Viceral and Transplant Surgery

location_facility: Hospital La Fe Servicio de Medicina Degestiva


title: A Phase 2 Multi-Center, Open Label Long-Term Extension Trial To Assess The Safety Of Oral Uk-390,957 Administered As Required In Adult Men With Premature Ejaculation

summary: To determine whether UK-390,957 is a safe treatment for premature ejaculation.

lead_sponsor: Pfizer

location_country:
Poland
United Kingdom
Italy
Austria
Australia
Canada
Czech Republic
Sweden
United States
France
Israel
Turkey
Norway
Germany


title: A Phase III Multi-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis

summary: An open ended study in which patients who completed the double-blind study CDP870-027 [NCT00152386] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of Rheumatoid Arthritis (RA).

ReferenceCitation: Paul S, Marotte H, Kavanaugh A, Goupille P, Kvien TK, de Longueville M, Mulleman D, Sandborn WJ, Vande Casteele N. Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis. Clin Transl Sci. 2020 Jul;13(4):743-751. doi: 10.1111/cts.12760. Epub 2020 Apr 1.

ReferenceCitation: Keystone EC, Combe B, Smolen J, Strand V, Goel N, van Vollenhoven R, Mease P, Landewé R, Fleischmann R, Luijtens K, van der Heijde D. Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial. Rheumatology (Oxford). 2012 Sep;51(9):1628-38. doi: 10.1093/rheumatology/kes082. Epub 2012 May 16.

ReferenceCitation: van der Heijde D, Keystone EC, Curtis JR, Landewé RB, Schiff MH, Khanna D, Kvien TK, Ionescu L, Gervitz LM, Davies OR, Luijtens K, Furst DE. Timing and magnitude of initial change in disease activity score 28 predicts the likelihood of achieving low disease activity at 1 year in rheumatoid arthritis patients treated with certolizumab pegol: a post-hoc analysis of the RAPID 1 trial. J Rheumatol. 2012 Jul;39(7):1326-33. doi: 10.3899/jrheum.111171. Epub 2012 May 15.

ReferenceCitation: Curtis JR, Chen L, Luijtens K, Navarro-Millan I, Goel N, Gervitz L, Weinblatt M. Dose escalation of certolizumab pegol from 200 mg to 400 mg every other week provides no additional efficacy in rheumatoid arthritis: an analysis of individual patient-level data. Arthritis Rheum. 2011 Aug;63(8):2203-8. doi: 10.1002/art.30387.

ReferenceCitation: Curtis JR, Winthrop K, O'Brien C, Ndlovu MN, de Longueville M, Haraoui B. Use of a baseline risk score to identify the risk of serious infectious events in patients with rheumatoid arthritis during certolizumab pegol treatment. Arthritis Res Ther. 2017 Dec 15;19(1):276. doi: 10.1186/s13075-017-1466-y.

ReferenceCitation: Smolen J, Landewé RB, Mease P, Brzezicki J, Mason D, Luijtens K, van Vollenhoven RF, Kavanaugh A, Schiff M, Burmester GR, Strand V, Vencovsky J, van der Heijde D. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis. 2009 Jun;68(6):797-804. doi: 10.1136/ard.2008.101659. Epub 2008 Nov 17.

lead_sponsor: UCB Pharma

location_country:
Croatia
Serbia
Lithuania
Ukraine
United States
Belgium
Czechia
Russian Federation
Australia
Argentina
Israel
Mexico
Slovakia
Canada
Hungary
Bulgaria
Latvia
Estonia
New Zealand
Finland
France
Chile


type: Registry Identifier

title: PROspective PioglitAzone Clinical Trial In MacroVascular Events: A Macrovascular Outcome Study in Type 2 Diabetic Patients Comparing Pioglitazone With Placebo in Addition to Existing Therapy

acronym: PROactive

summary: The purpose of this study is to determine whether pioglitazone, once daily (QD), can delay the time to death, heart attack, acute coronary syndrome, heart bypass surgery, stroke, leg bypass surgery or amputation in patients with type 2 diabetes.

ReferenceCitation: Bottomley JM, Palmer AJ, Williams R, Dormandy JA, Massi-Benedetti M. PROactive 03: Pioglitazone, type 2 diabetes and reducing macrovascular events - economic implications?. Br J Diabetes Vasc Dis 2006;6(Pt 2):64-69

ReferenceCitation: Kirby,M, Heart Disease Prevention - What Place for the Glitazones. Br J Cardiol 2006;13:(1):66-70.

ReferenceCitation: Brändle M, Goodall G, Erny-Albrecht KM, Erdmann E, Valentine WJ. Cost-effectiveness of pioglitazone in patients with type 2 diabetes and a history of macrovascular disease in a Swiss setting. Swiss Med Wkly. 2009 Mar 21;139(11-12):173-84. doi: smw-12381.

ReferenceCitation: Betteridge DJ, DeFronzo RA, Chilton RJ. PROactive: time for a critical appraisal. Eur Heart J. 2008 Apr;29(8):969-83. doi: 10.1093/eurheartj/ehn114. Epub 2008 Mar 28. Review.

ReferenceCitation: Scherbaum WA, Goodall G, Erny-Albrecht KM, Massi-Benedetti M, Erdmann E, Valentine WJ. Cost-effectiveness of pioglitazone in type 2 diabetes patients with a history of macrovascular disease: a German perspective. Cost Eff Resour Alloc. 2009 May 5;7:9. doi: 10.1186/1478-7547-7-9.

ReferenceCitation: van Troostenburg de Bruyn AR, Dormandy J. Risk of thiazolidinedione-associated fracture should be appropriately assessed. Arch Intern Med. 2010 Jan 25;170(2):209-10. doi: 10.1001/archinternmed.2009.487.

ReferenceCitation: Dormandy JA, Charbonnel B, Eckland DJ, Erdmann E, Massi-Benedetti M, Moules IK, Skene AM, Tan MH, Lefèbvre PJ, Murray GD, Standl E, Wilcox RG, Wilhelmsen L, Betteridge J, Birkeland K, Golay A, Heine RJ, Korányi L, Laakso M, Mokán M, Norkus A, Pirags V, Podar T, Scheen A, Scherbaum W, Schernthaner G, Schmitz O, Skrha J, Smith U, Taton J; PROactive Investigators. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet. 2005 Oct 8;366(9493):1279-89.

ReferenceCitation: Schneider CA, Ferrannini E, Defronzo R, Schernthaner G, Yates J, Erdmann E. Effect of pioglitazone on cardiovascular outcome in diabetes and chronic kidney disease. J Am Soc Nephrol. 2008 Jan;19(1):182-7. Epub 2007 Dec 5. Erratum in: J Am Soc Nephrol. 2016 Sep;27(9):2918.

ReferenceCitation: Rydén L, Thráinsdóttir I, Swedberg K. Adjudication of serious heart failure in patients from PROactive. Lancet. 2007 Jan 20;369(9557):189-90.

ReferenceCitation: Erdmann E, Dormandy J, Wilcox R, Massi-Benedetti M, Charbonnel B. PROactive 07: pioglitazone in the treatment of type 2 diabetes: results of the PROactive study. Vasc Health Risk Manag. 2007;3(4):355-70. Review.

ReferenceCitation: Erdmann E, Dormandy JA. The Effect of Pioglitazone on Recurrent Myocardial Infarction in 2445 Patients with Type 2 Diabetes and Preexisting Myocardial Infarction - Data from the PROactive Study. Circulation 2005;112:(21):3364-3364

ReferenceCitation: Erdmann E, Dormandy JA, Charbonnel B, Massi-Benedetti M, Moules IK, Skene AM; PROactive Investigators. The effect of pioglitazone on recurrent myocardial infarction in 2,445 patients with type 2 diabetes and previous myocardial infarction: results from the PROactive (PROactive 05) Study. J Am Coll Cardiol. 2007 May 1;49(17):1772-80. Epub 2007 Apr 16.

ReferenceCitation: Valentine WJ, Bottomley JM, Palmer AJ, Brändle M, Foos V, Williams R, Dormandy JA, Yates J, Tan MH, Massi-Benedetti M; PROactive Study Group. PROactive 06: cost-effectiveness of pioglitazone in Type 2 diabetes in the UK. Diabet Med. 2007 Sep;24(9):982-1002. Epub 2007 Jun 25.

ReferenceCitation: Wilcox R, Bousser MG, Betteridge DJ, Schernthaner G, Pirags V, Kupfer S, Dormandy J; PROactive Investigators. Effects of pioglitazone in patients with type 2 diabetes with or without previous stroke: results from PROactive (PROspective pioglitAzone Clinical Trial In macroVascular Events 04). Stroke. 2007 Mar;38(3):865-73. Epub 2007 Feb 8.

ReferenceCitation: Erdmann E, Charbonnel B, Wilcox RG, Skene AM, Massi-Benedetti M, Yates J, Tan M, Spanheimer R, Standl E, Dormandy JA; PROactive Investigators. Pioglitazone use and heart failure in patients with type 2 diabetes and preexisting cardiovascular disease: data from the PROactive study (PROactive 08). Diabetes Care. 2007 Nov;30(11):2773-8. Epub 2007 Jul 31.

ReferenceCitation: Valentine WJ, Tucker D, Palmer AJ, Minshall ME, Foos V, Silberman C; PROactive Study Group. Long-term cost-effectiveness of pioglitazone versus placebo in addition to existing diabetes treatment: a US analysis based on PROactive. Value Health. 2009 Jan-Feb;12(1):1-9. doi: 10.1111/j.1524-4733.2008.00403.x. Epub 2008 Jul 24.

ReferenceCitation: Wilcox R, Kupfer S, Erdmann E; PROactive Study investigators. Effects of pioglitazone on major adverse cardiovascular events in high-risk patients with type 2 diabetes: results from PROspective pioglitAzone Clinical Trial In macro Vascular Events (PROactive 10). Am Heart J. 2008 Apr;155(4):712-7. doi: 10.1016/j.ahj.2007.11.029. Epub 2008 Feb 21. Erratum in: Am Heart J. 2008 Aug;156(2):255.

ReferenceCitation: Charbonnel B, Dormandy J, Erdmann E, Massi-Benedetti M, Skene A; PROactive Study Group. The prospective pioglitazone clinical trial in macrovascular events (PROactive): can pioglitazone reduce cardiovascular events in diabetes? Study design and baseline characteristics of 5238 patients. Diabetes Care. 2004 Jul;27(7):1647-53.

ReferenceCitation: Spanheimer R, Betteridge DJ, Tan MH, Ferrannini E, Charbonnel B; PROactive Investigators. Long-term lipid effects of pioglitazone by baseline anti-hyperglycemia medication therapy and statin use from the PROactive experience (PROactive 14). Am J Cardiol. 2009 Jul 15;104(2):234-9. doi: 10.1016/j.amjcard.2009.03.023. Epub 2009 Jun 3.

ReferenceCitation: Scheen AJ, Tan MH, Betteridge DJ, Birkeland K, Schmitz O, Charbonnel B; PROactive investigators. Long-term glycaemic control with metformin-sulphonylurea-pioglitazone triple therapy in PROactive (PROactive 17). Diabet Med. 2009 Oct;26(10):1033-9. doi: 10.1111/j.1464-5491.2009.02816.x.

ReferenceCitation: Scheen AJ, Tan MH, Betteridge DJ, Birkeland K, Schmitz O, Charbonnel B; PROactive investigators. Long-term glycaemic effects of pioglitazone compared with placebo as add-on treatment to metformin or sulphonylurea monotherapy in PROactive (PROactive 18). Diabet Med. 2009 Dec;26(12):1242-9. doi: 10.1111/j.1464-5491.2009.02857.x.

ReferenceCitation: Dormandy JA, Betteridge DJ, Schernthaner G, Pirags V, Norgren L; PROactive investigators. Impact of peripheral arterial disease in patients with diabetes--results from PROactive (PROactive 11). Atherosclerosis. 2009 Jan;202(1):272-81. doi: 10.1016/j.atherosclerosis.2008.03.002. Epub 2008 Mar 18.

ReferenceCitation: Spanheimer,RG, Ferrannini,E, Long term effects of pioglitazone on diabetic dyslipidemia independent of baseline statin use and antihyperglycemic medication: a review from PROactive. Asia Pac J Cardiol 2009;1:(1):75-81.

ReferenceCitation: Dormandy J, Bhattacharya M, van Troostenburg de Bruyn AR; PROactive investigators. Safety and tolerability of pioglitazone in high-risk patients with type 2 diabetes: an overview of data from PROactive. Drug Saf. 2009;32(3):187-202. doi: 10.2165/00002018-200932030-00002. Review.

ReferenceCitation: Betteridge DJ. CHICAGO, PERISCOPE and PROactive: CV risk modification in diabetes with pioglitazone. Fundam Clin Pharmacol. 2009 Dec;23(6):675-9. doi: 10.1111/j.1472-8206.2009.00741.x. Epub 2009 Sep 10. Review.

ReferenceCitation: Erdmann E, Spanheimer R, Charbonnel B; PROactive Study Investigators. Pioglitazone and the risk of cardiovascular events in patients with Type 2 diabetes receiving concomitant treatment with nitrates, renin-angiotensin system blockers, or insulin: results from the PROactive study (PROactive 20). J Diabetes. 2010 Sep;2(3):212-20. doi: 10.1111/j.1753-0407.2010.00082.x.

ReferenceCitation: Ferrannini E, Betteridge DJ, Dormandy JA, Charbonnel B, Wilcox RG, Spanheimer R, Erdmann E, Defronzo RA, Laakso M. High-density lipoprotein-cholesterol and not HbA1c was directly related to cardiovascular outcome in PROactive. Diabetes Obes Metab. 2011 Aug;13(8):759-64. doi: 10.1111/j.1463-1326.2011.01404.x.

ReferenceCitation: Doehner W, Erdmann E, Cairns R, Clark AL, Dormandy JA, Ferrannini E, Anker SD. Inverse relation of body weight and weight change with mortality and morbidity in patients with type 2 diabetes and cardiovascular co-morbidity: an analysis of the PROactive study population. Int J Cardiol. 2012 Dec 15;162(1):20-6. doi: 10.1016/j.ijcard.2011.09.039. Epub 2011 Oct 29.

ReferenceCitation: Pfister R, Cairns R, Erdmann E, Schneider CA; PROactive investigators. Prognostic impact of electrocardiographic signs in patients with Type 2 diabetes and cardiovascular disease: results from the PROactive study. Diabet Med. 2011 Oct;28(10):1206-12. doi: 10.1111/j.1464-5491.2011.03281.x.

ReferenceCitation: Charbonnel B, DeFronzo R, Davidson J, Schmitz O, Birkeland K, Pirags V, Scheen A; PROactive investigators. Pioglitazone use in combination with insulin in the prospective pioglitazone clinical trial in macrovascular events study (PROactive19). J Clin Endocrinol Metab. 2010 May;95(5):2163-71. doi: 10.1210/jc.2009-1974. Epub 2010 Mar 17.

lead_sponsor: Takeda

location_country:
Denmark
Poland
United Kingdom
Italy
Austria
Estonia
Latvia
Finland
Czech Republic
Lithuania
Netherlands
Sweden
Hungary
Switzerland
France
Belgium
Norway
Germany
Slovakia


title: A Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140.

summary: Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate in patients with pulmonary arterial hypertension

ReferenceCitation: Wirostko BM, Tressler C, Hwang LJ, Burgess G, Laties AM. Ocular safety of sildenafil citrate when administered chronically for pulmonary arterial hypertension: results from phase III, randomised, double masked, placebo controlled trial and open label extension. BMJ. 2012 Feb 21;344:e554. doi: 10.1136/bmj.e554.

ReferenceCitation: Rubin LJ, Badesch DB, Fleming TR, Galiè N, Simonneau G, Ghofrani HA, Oakes M, Layton G, Serdarevic-Pehar M, McLaughlin VV, Barst RJ; SUPER-2 Study Group. Long-term treatment with sildenafil citrate in pulmonary arterial hypertension: the SUPER-2 study. Chest. 2011 Nov;140(5):1274-1283. doi: 10.1378/chest.10-0969. Epub 2011 May 5.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
South Africa
Czechia
Poland
Hong Kong
Australia
Israel
Mexico
Sweden
Malaysia
Singapore
Brazil
Hungary
Germany
Denmark
Korea, Republic of
France
Netherlands


title: Evaluation of Pharmacokinetics, Safety, Efficacy and Immunogenicity of rAHF-PFM in Previously Treated Hemophilia A Patients - A Continuation Study

summary: The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A subjects. The study consists of 2 parts: Part 1 is a pharmacokinetic and safety study, and Part 2 is an evaluation of efficacy and safety. The study is open to patients who completed Baxter Study 069901.

ReferenceCitation: Shapiro A, Gruppo R, Pabinger I, Collins PW, Hay CR, Schroth P, Casey K, Patrone L, Ehrlich H, Ewenstein BM. Integrated analysis of safety and efficacy of a plasma- and albumin-free recombinant factor VIII (rAHF-PFM) from six clinical studies in patients with hemophilia A. Expert Opin Biol Ther. 2009 Mar;9(3):273-83. doi: 10.1517/14712590902729392 .

lead_sponsor: Baxalta now part of Shire

location_country:
United Kingdom
Italy
Austria
Canada
Sweden
United States
France
Belgium
Germany

location_facility: Mountain States Regional Hemophilia and Thrombosis Center

location_facility: Hemophilia Center of Western Pennsylvania

location_facility: University of Medicine & Dentistry of New Jersey

location_facility: Klinikum Innenstadt der Universität München

location_facility: Childrens Healthcare of Atlanta Blood Bank

location_facility: Children's Hospital Medical Center Pharmacy


title: TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension

acronym: TRIUMPH

summary: This is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. The primary outcome is the change in 6-minute walk distance from baseline to week 12.

ReferenceCitation: McLaughlin VV, Benza RL, Rubin LJ, Channick RN, Voswinckel R, Tapson VF, Robbins IM, Olschewski H, Rubenfire M, Seeger W. Addition of inhaled treprostinil to oral therapy for pulmonary arterial hypertension: a randomized controlled clinical trial. J Am Coll Cardiol. 2010 May 4;55(18):1915-22. doi: 10.1016/j.jacc.2010.01.027.

lead_sponsor: United Therapeutics

location_country:
Spain
Ireland
Austria
Italy
United Kingdom
United States
France
Israel
Belgium
Germany

location_facility: Instituto Malattie dell'Apparato Vascolare

location_facility: Univesitatsklinikum Giessen und Marburg GmbH


title: An Open Label Trial of Telbivudine (LdT) in Adults With Chronic Hepatitis B Previously Treated in Idenix-Sponsored Telbivudine Studies

summary: This trial is being conducted as an open-label, extended-term study for patients with chronic hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.

ReferenceCitation: Hsu CW, Chao YC, Lee CM, Chang TT, Chen YC. Efficacy of telbivudine in Taiwanese chronic hepatitis B patients compared with GLOBE extension study and predicting treatment outcome by HBV DNA kinetics at week 24. BMC Gastroenterol. 2012 Dec 13;12:178. doi: 10.1186/1471-230X-12-178.

ipd_sharing: Undecided

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
United States
Czechia
Poland
Hong Kong
Australia
Puerto Rico
India
Israel
Turkey
Singapore
Canada
China
Germany
Taiwan
New Zealand
Thailand
Korea, Republic of
France


title: A Study to Determine the Tolerability and Pharmacokinetics for Ropinirole in Paediatric / Adolescent Patients With RLS (Type 2)

summary: This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole titration regimen for this age group. Patients will receive two single doses unless poor tolerability is observed following the first dose.

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
United States
France
Belgium


title: Phase 3 Multi-Center, Double-Blind, Randomized, Parallel Group, Carotid B-mode Ultrasound Evaluation of the Anti-Atherosclerotic Efficacy, Safety, and Tolerability of Fixed Combination CP-529,414/Atorvastatin, Administered Orally, Once Daily (QD) for 24 Months, Compared With Atorvastatin Alone, in Subjects With Mixed Hyperlipidemia

acronym: RADIANCE 2

summary:
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To look at ultrasound images taken in the carotid arteries and to look at various lipids in the blood of people with mixed hyperlipidemia

ReferenceCitation: Tajik P, Meijer R, Duivenvoorden R, Peters SA, Kastelein JJ, Visseren FJ, Crouse JR 3rd, Palmer MK, Raichlen JS, Grobbee DE, Bots ML. Asymmetrical distribution of atherosclerosis in the carotid artery: identical patterns across age, race, and gender. Eur J Prev Cardiol. 2012 Aug;19(4):687-97. doi: 10.1177/1741826711410821. Epub 2011 May 25.

ReferenceCitation: Vergeer M, Bots ML, van Leuven SI, Basart DC, Sijbrands EJ, Evans GW, Grobbee DE, Visseren FL, Stalenhoef AF, Stroes ES, Kastelein JJ. Cholesteryl ester transfer protein inhibitor torcetrapib and off-target toxicity: a pooled analysis of the rating atherosclerotic disease change by imaging with a new CETP inhibitor (RADIANCE) trials. Circulation. 2008 Dec 9;118(24):2515-22. doi: 10.1161/CIRCULATIONAHA.108.772665. Epub 2008 Nov 24. Erratum in: Circulation. 2009 Feb 10;119(5):e197.

ReferenceCitation: Bots ML, Visseren FL, Evans GW, Riley WA, Revkin JH, Tegeler CH, Shear CL, Duggan WT, Vicari RM, Grobbee DE, Kastelein JJ; RADIANCE 2 Investigators. Torcetrapib and carotid intima-media thickness in mixed dyslipidaemia (RADIANCE 2 study): a randomised, double-blind trial. Lancet. 2007 Jul 14;370(9582):153-160. doi: 10.1016/S0140-6736(07)61088-5.

ReferenceCitation: Kastelein JJ, van Leuven SI, Evans GW, Riley WA, Revkin JH, Shear CL, Bots ML; RADIANCE 1 and 2 Study Investigators. Designs of RADIANCE 1 and 2: carotid ultrasound studies comparing the effects of torcetrapib/atorvastatin with atorvastatin alone on atherosclerosis. Curr Med Res Opin. 2007 Apr;23(4):885-94.

location_country:
Finland
Czech Republic
Canada
United States
France
Netherlands