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

study_completion_date_type: Anticipated

time_perspective: Prospective

enrollment_type: Anticipated

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.

name: From the Department of Obstetrics & Gynecology, University Hospital Gasthuisberg, Katholieke Universiteit, Leuven; National Alliance of Christian Sickness Funds; Belgian Cancer Registry, Brussels; Obstetrics and Gynecology, Université Catholique de Louvain, Louvain-la-Neuve, Belgium; Department of Medical Oncology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands; Department of Obstetrics and Gynecology, Charles University, Prague, Czech Republic.

family: Van Calsteren

full_name: Kristel Van Calsteren

given: Kristel

family: Heyns

full_name: Liesbeth Heyns

given: Liesbeth

family: De Smet

full_name: Frank De Smet

given: Frank

family: Van Eycken

full_name: Liesbet Van Eycken

given: Liesbet

family: Gziri

full_name: Mina Mhallem Gziri

given: Mina Mhallem

family: Van Gemert

full_name: Willemijn Van Gemert

given: Willemijn

family: Halaska

full_name: Michael Halaska

given: Michael

family: Vergote

full_name: Ignace Vergote

given: Ignace

family: Ottevanger

full_name: Nelleke Ottevanger

given: Nelleke

family: Amant

full_name: Frédéric Amant

given: Frédéric

journal_name: Journal of Clinical Oncology

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

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

repositories_institution: The Pennsylvania State University - CiteSeer X

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Cancer During Pregnancy: An Analysis of 215 Patients Emphasizing the Obstetrical and the Neonatal Outcomes

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.

title: Long-term cognitive and cardiac outcomes after prenatal exposure to chemotherapy in children aged 18 months or older: an observational study

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.

journal_name: Acta Obstetricia et Gynecologica Scandinavica

title: Chemotherapy during pregnancy: effect of anthracyclines on fetal and maternal cardiac function

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.

title: Treatment of breast cancer during pregnancy: an observational study

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.

name: Department of Obstetrics and Gynaecology; University Hospitals Leuven; Leuven; Belgium

name: Department of Obstetrics and Gynaecology, Hopital Saint-Luc; Université Catholique de Louvain; Woluwe; Belgium

title: Effects of chemotherapy during pregnancy on the maternal and fetal heart

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.

title: Tongue cancers during pregnancy: Case reports and review of literature

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.

title: Myocardial function in children after fetal chemotherapy exposure. A tissue Doppler and myocardial deformation imaging study

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.

title: Lung cancer in pregnancy: Report of nine cases from an international collaborative study

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.

name: Frédéric Amant, Sileny N. Han, Hans Wildiers, Patrick Neven, Kristel Van Calsteren, and Ben Van Calster, University Hospitals Leuven and Katholieke Universiteit Leuven, Leuven, Belgium; Gunter von Minckwitz, Valentina Nekljudova, and Sibylle Loibl, German Breast Group, Neu-Isenburg; Tanja Fehm, University Women's Hospital Tübingen, Tübingen; Bettina Schlehe, University Women's Hospital Heidelberg, Heidelberg; Volkmar Müller, University Medical Center Hamburg-Eppendorf, Hamburg; Brigitte Rack, Ludwigs...

title: Prognosis of Women With Primary Breast Cancer Diagnosed During Pregnancy: Results From an International Collaborative Study

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.

title: Primary brain tumours, meningiomas and brain metastases in pregnancy: Report on 27 cases and review of literature

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.

repository_institution: Utrecht University - Utrecht University Repository

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repositories_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_institution: Utrecht University - Utrecht University Repository

title: Pediatric Outcome after Maternal Cancer Diagnosed during Pregnancy

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.

name: German Breast Group, Neu-Isenburg, Germany2Sana Klinimum, Offenbach, Germany

name: European Institute of Oncology, Milano, Italy

name: Chaim Sheba Medical Center, Ramat Gan, Israel

name: German Breast Group, Neu-Isenburg, Germany

name: Blochin Cancer Research Center, Moscow, Russia

name: Department of Oncology, Oslo University Hospital, Oslo, Norway

name: University Hospital Halle (Saale), Halle (Saale), Germany

name: University Hospital Gasthuisberg, Leuven, Belgium

name: Radboud University Medical Center, Nijmegen, the Netherlands

name: Leuven Cancer Institute, Leuven, Belgium

title: Breast Cancer Diagnosed During Pregnancy

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.

journal_name: American Journal of Obstetrics and Gynecology

title: Development of children born to mothers with cancer during pregnancy: comparing in utero chemotherapy-exposed children with nonexposed controls

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.

title: Fetal outcome after prenatal exposure to chemotherapy and mechanisms of teratogenicity compared to alcohol and smoking

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.

title: Optimizing anticancer drug treatment in pregnant cancer patients: pharmacokinetic analysis of gestation-induced changes for doxorubicin, epirubicin, docetaxel and paclitaxel

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.

title: Effects of Fetal Exposure to Maternal Chemotherapy

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.

journal_name: Journal of Pharmacology and Experimental Therapeutics

publisher: American Society for Pharmacology & Experimental Therapeutics (ASPET)

publisher_dissemination: American Society for Pharmacology & Experimental Therapeutics

publisher_group: American Society for Pharmacology & Experimental Therapeutics

publisher_normalized: American Society for Pharmacology & Experimental Therapeutics

title: Fetal Rat Hearts Do Not Display Acute Cardiotoxicity in Response to Maternal Doxorubicin Treatment

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.

title: Oncological management and obstetric and neonatal outcomes for women diagnosed with cancer during pregnancy: a 20-year international cohort study of 1170 patients

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.

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

title: Severe Adverse Reaction to Vemurafenib in a Pregnant Woman with Metastatic Melanoma

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.

name: Department of Otorhinolaryngology, Head and Neck SurgeryCharles University in Prague, University Hospital MotolPrague Czech Republic

name: Department of OncologyUniversity of LeuvenLeuven Belgium

name: Department of Obstetrics and GynecologyVU University Medical CenterAmsterdam the Netherlands

name: Department of Obstetrics and Gynecology3rd Medical Faculty, Charles University and Faculty Hospital Kralovske VinohradyPrague Czech Republic

name: Department of Obstetrics and GynecologyUniversity Hospitals LeuvenLeuven Belgium

name: Department of Reproduction and RegenerationUniversity of LeuvenLeuven Belgium

name: Department of Clinical OncologyVejle HospitalVejle Denmark

name: Institute of Regional Health ResearchUniversity of Southern DenmarkOdense Denmark

name: Clinic of Obstetrics and GynecologyUniversity of Milan‐Bicocca, San Gerardo HospitalMonza Italy

name: Department of EndocrinologyRotterdam Thyroid Center, Erasmus Medical CenterRotterdam the Netherlands

name: Division of Obstetrics and Maternal Fetal Medicine, Department of Obstetrics and GynecologyMedical University of GrazGraz Austria

name: Department of Surgical SciencesUniversity of TurinTurin Italy

name: Division of Gynecologic OncologyUniversity Hospitals LeuvenLeuven Belgium

name: Center for Gynecologic Oncology AmsterdamAntoni van Leeuwenhoek–Netherlands Cancer InstituteAmsterdam the Netherlands

name: on behalf of the International Network on Cancer, Infertility, and Pregnancy

title: Maternal and obstetrical outcome in 35 cases of well‐differentiated thyroid carcinoma during pregnancy

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.

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repositories_institution: University of Antwerp - Institutional Repository University of Antwerp

title: Melanoma during pregnancy: a report of 60 pregnancies complicated by melanoma

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.

title: Genetic and microscopic assessment of the human chemotherapy-exposed placenta reveals possible pathways contributive to fetal growth restriction

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.

title: Effects of cancer treatment during pregnancy on fetal and child development

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.

name: Department of Obstetrics, Cliniques Universitaires Saint-Luc, Brussels, Belgium;

name: Department of Obstetrics, Clinique Edith Cavell, Brussels, Belgium;

name: Department of Pneumology, Clinique Edith Cavell, Brussels, Belgium;

name: Department of Thoracic Surgery, University Hospitals Leuven, Leuven, Belgium;

name: Department of Gynecology Oncology, University Hospitals Leuven, Leuven, Belgium

title: Low-grade bronchial mucoepidermoid carcinoma during pregnancy successfully treated by lobectomy

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.

journal_name: European Journal of Obstetrics & Gynecology and Reproductive Biology

title: Comment on “Maternal and perinatal outcomes in pregnancy-associated melanoma. Report of two cases and a systematic literature review”

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.

name: Department of Oncology; KU Leuven-University of Leuven; Leuven Belgium

name: Gynecological Oncology, Department of Obstetrics and Gynecology; University Hospitals Leuven; Leuven Belgium

name: Department of Development and Regeneration; KU Leuven-University of Leuven; Leuven Belgium

name: Department of Obstetrics and Gynecology; University Hospitals Leuven; Leuven Belgium

name: Methodology and Statistics Research Unit, Institute of Psychology, Faculty of Social and Behavioral Sciences; Leiden University; Leiden The Netherlands

name: Faculty of Psychology and Educational Sciences; KU Leuven-University of Leuven; Leuven Belgium

name: Tilburg School of Social and Behavioral Sciences; Tilburg University; Tilburg The Netherlands

name: Faculty of Medicine and Mental Health (CAPRI); University of Antwerp; Antwerp Belgium

name: Antoni van Leeuwenhoek, Netherlands Cancer Institute; Amsterdam The Netherlands

title: Psychological distress and cognitive coping in pregnant women diagnosed with cancer and their partners

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.

title: Use of general anesthesia and sentinel node procedure during pregnancy

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.

title: Polypoid endometriosis of the bladder during pregnancy mimicking urachal carcinoma

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.

name: Department of Obstetrics and Gynecology, Division Gynecologic Oncology and Experimental Laboratory of Gynecology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Belgium

name: Center for Clinical Pharmacology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Belgium

name: Department of Obstetrics and Gynecology, Experimental Laboratory of Gynecology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Belgium

name: Laboratory of Medical Oncology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Belgium

name: Department of Obstetrics and Gynecology, Division Gynecologic Oncology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Belgium

title: Substantial Variation in Transplacental Transfer of Chemotherapeutic Agents in a Mouse Model

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.

title: Transplacental transfer of anthracyclines, vinblastine, and 4-hydroxy-cyclophosphamide in a baboon model

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.

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_institution: Ghent University - Ghent University Academic Bibliography

title: Pharmacokinetics of chemotherapeutic agents in pregnancy: a preclinical and clinical study

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.

title: Successful conservative treatment of endocervical adenocarcinoma stage Ib1 diagnosed early in pregnancy

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.

repositories:
LIRIAS (KU Leuven)
PubMed Central
air.unimi.it

title: Child development at 6 years after maternal cancer diagnosis and treatment during pregnancy

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

location_facility: Ioannina University Hospital (retrosepctive 2015-2018)

location_facility: University Hospital Ostrava (2018-ongoing)

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

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

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

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

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

location_facility: Cooper University Hospital (2015-ongoing)

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

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

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

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

location_facility: Medyczne Macierzynstwo (retrospective 2010-2018)

location_facility: Hippokration Hospital (retrospective 2015-2018)

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

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

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

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

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

location_facility: University Hospital Krakow (2018-ongoing)

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

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

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

location_facility: Universitätsklinik Freiburg (retrospective until 2018)

location_facility: Haukeland University Hospital (2017-ongoing)

location_facility: Karolinska University Hospital (2017-ongoing)

location_facility: Copenhagen University Hospital (2015-ongoing)

location_facility: European Institute of Oncology (2010-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.

name: From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China (Z.-C.J.); Care Institute of Medical Science, Ahmedabad, India (K.P.); Instituto Nacional de Cardiologia, Mexico City, Mexico (T.P.); Unidad de Investigacion Clinica en Medicina, Monterrey, Mexico (C.J.-S.); University of Rochester Medical Center, Rochester, NY (R.J.W.); UC Davis Medical Center, Sacramento, CA (R.A.); Medical Center of Postgraduate Education, ECZ – Otwock, Poland (A.T.); Peking Union Medical...

family: Jing

full_name: Zhi-Cheng Jing

given: Zhi-Cheng

sequence: first

family: Parikh

full_name: Keyur Parikh

given: Keyur

sequence: additional

family: Pulido

full_name: Tomas Pulido

given: Tomas

family: Jerjes-Sanchez

full_name: Carlos Jerjes-Sanchez

given: Carlos

family: White

full_name: R. James White

given: R. James

family: Allen

full_name: Roblee Allen

given: Roblee

family: Torbicki

full_name: Adam Torbicki

given: Adam

family: Xu

full_name: Kai-Feng Xu

given: Kai-Feng

family: Yehle

full_name: David Yehle

given: David

family: Laliberte

full_name: Kevin Laliberte

given: Kevin

family: Arneson

full_name: Carl Arneson

given: Carl

family: Rubin

full_name: Lewis J. Rubin

given: Lewis J.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Circulation

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Efficacy and Safety of Oral Treprostinil Monotherapy for the Treatment of Pulmonary Arterial Hypertension

lead_sponsor: United Therapeutics

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

location_facility: University of Texas Health Science Center at San Antonio

location_facility: University of Colorado Health Science Center

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

location_facility: National Tuberculosis and Lung Disease Research Institute

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

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: Asian Heart Institute and Research Centre

location_facility: Narayana Hrudayalaya Institute of Medical Sciences

location_facility: Baylor College of Medicine, Pulmonary & Critical Care

location_facility: University of Maryland School of Medicine

location_facility: University of California, San Francisco-Fresno

location_facility: Unidad de Investigacion Clinica en Medicina (UDICEM)

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.

family: Cox

full_name: Timothy M Cox

given: Timothy M

family: Amato

full_name: Dominick Amato

given: Dominick

family: Hollak

full_name: Carla EM Hollak

given: Carla EM

family: Luzy

full_name: Cecile Luzy

given: Cecile

family: Silkey

full_name: Mariabeth Silkey

given: Mariabeth

family: Giorgino

full_name: Ruben Giorgino

given: Ruben

family: Steiner

full_name: Robert D Steiner

given: Robert D

name: for the Miglustat Maintenance Study Group

currency_apc_doaj: GBP

journal_name: Orphanet Journal of Rare Diseases

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: University of Toronto - TSpace

repository_normalized: localhost

evidence: oa repository (via pmcid lookup)

repositories:
PubMed Central
localhost

repositories_institution:
PubMed Central - Europe PMC
University of Toronto - TSpace

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Actelion

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

location_facility: Klinika detskeho a dorostoveho lekarstvi

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

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

location_facility: Royal Prince Alfred Hospital - Central Clinical School

location_facility: Universitatsklinikum fur Innere Medizin II

location_facility: Scottish Vascular Unit - Western Infirmary

location_facility: Unidad Medico Quirurgica de Cardiologia - Edificio General


title: ESSAI RANDOMISE MULTICENTRIQUE DE PHASE III COMPARANT L’IMMUNOGENICITE ET LA TOLERANCE DE TROIS SCHEMAS DE VACCINATION CONTRE LE VIRUS DE L’HEPATITE B CHEZ DES PATIENTS INFECTES PAR LE VIH AYANT DES LYMPHOCYTES T CD4 SUPERIEURS A 200/mm3

acronym: VIHVAC-B

source: euctr

lead_sponsor: ANRS

status: Ongoing

lead_sponsor_type: academique

status_simplified: Ongoing


title: Analyse en Morpho-TEP au FDG de l'évolutivité des anévrismes abdominaux aortiques non chirurgicaux

lead_sponsor: CHU de Nancy


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.

family: Sabatine

full_name: Marc S Sabatine

given: Marc S

family: Antman

full_name: Elliott M Antman

given: Elliott M

family: Widimsky

full_name: Petr Widimsky

given: Petr

family: Ebrahim

full_name: Iftikhar O Ebrahim

given: Iftikhar O

family: Kiss

full_name: Robert G Kiss

given: Robert G

family: Saaiman

full_name: André Saaiman

given: André

family: Polasek

full_name: Rostislav Polasek

given: Rostislav

family: Contant

full_name: Charles F Contant

given: Charles F

family: McCabe

full_name: Carolyn H McCabe

given: Carolyn H

family: Braunwald

full_name: Eugene Braunwald

given: Eugene

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Sanofi

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


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.

name: Michael F. Press, Denice D. Tsao-Wei, Yanling Ma, Ivonne Villalobos, and Anaamika Campeau, University of Southern California Norris Comprehensive Cancer Center; Dennis J. Slamon, Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA; Nicholas Robert, Virginia Cancer Specialists/US Oncology Research Network, Fairfax, VA; Vicente Valero, The University of Texas MD Anderson Cancer Center, Houston, TX; Guido Sauter and Martina Mirlacher, University of Hamburg, Hamburg;...

family: Press

full_name: Michael F. Press

given: Michael F.

family: Sauter

full_name: Guido Sauter

given: Guido

family: Buyse

full_name: Marc Buyse

given: Marc

family: Fourmanoir

full_name: Hélène Fourmanoir

given: Hélène

family: Quinaux

full_name: Emmanuel Quinaux

given: Emmanuel

family: Tsao-Wei

full_name: Denice D. Tsao-Wei

given: Denice D.

family: Eiermann

full_name: Wolfgang Eiermann

given: Wolfgang

family: Robert

full_name: Nicholas Robert

given: Nicholas

family: Pienkowski

full_name: Tadeusz Pienkowski

given: Tadeusz

family: Crown

full_name: John Crown

given: John

family: Martin

full_name: Miguel Martin

given: Miguel

family: Valero

full_name: Vicente Valero

given: Vicente

family: Mackey

full_name: John R. Mackey

given: John R.

family: Bee

full_name: Valerie Bee

given: Valerie

family: Ma

full_name: Yanling Ma

given: Yanling

family: Villalobos

full_name: Ivonne Villalobos

given: Ivonne

family: Campeau

full_name: Anaamika Campeau

given: Anaamika

family: Mirlacher

full_name: Martina Mirlacher

given: Martina

family: Lindsay

full_name: Mary-Ann Lindsay

given: Mary-Ann

family: Slamon

full_name: Dennis J. Slamon

given: Dennis J.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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


title: Safety and efficacy of subcutaneous (SC) administration of Clinimix N9G15E in elderly patients at risk for malnutrition, at a dose of 1 liter infused over 12 hours for 7 to 10 consecutive days. A prospective, multicentre, randomized, open-label, non-inferiority, controlled phase III B trial carried out in parallel groups: subcutaneous versus peripheral intravenous administration.

lead_sponsor: Baxter R and D Europe SCRL


title: La reviviscence dans l'état de stress post-traumatique : une pathologie du rappel émotionnel ? Application thérapeutique

acronym: VIVITRAU

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)


title: Réversibilité sous Tiotropium (SPIRIVA®) chez les patients BPCO : paramètres EFR, dyspnée et TDM

acronym: REVERSPIR

lead_sponsor: Centre Hospitalier Régional et Universitaire de Lille


title: Etude randomisée, en double aveugle, contre placebo, de l’Efficacité de l’ Escitalopram dans le traitement de la détresse émotionnelle des sujets atteints de cancer ORL en cours de traitement

acronym: TADDOR

lead_sponsor: Institut Gustave Roussy


title: Essai pilote multicentrique évaluant la capacité d’une stratégie de traitement antirétroviral intermittent à maintenir une stabilité immunologique chez des patients infectés par le VIH-1, jamais traités et ayant un nombre de lymphocytes CD4 > ou = 500 par mm3.

acronym: TIPI

lead_sponsor: Agence nationale de recherches sur le sida et les hépatites virales. ANRS.


title: PC Pharma CVA : PostConditionnement pharmacologique au cours de la Chirurgie Valvulaire Aortique

acronym: PC Pharma CVA

lead_sponsor: Hospices Civils de Lyon


title: Mannitol vs serum salé hypertonique en cas d'HTIC après traumatisme crânien grave: comparaison des effets sur la PtiO2 et le profil métabolique focal obtenu par microdialyse.

acronym: Mannitol vs SSH et microdialyse cérébrale

lead_sponsor: service de santé des armées


title: Essai multicentrique randomisé de phase II comparant le Taxotère® en monothérapie à l’association Taxotère® plus curcumine en première ou deuxième ligne de traitement des cancers du sein inopérables, en rechute ou métastatiques, Her2 négatifs

acronym: CURRYTAX

lead_sponsor: CENTRE JEAN PERRIN

status: Prematurely Ended

status_simplified: Unknown


title: Protocole Clinique de Phase II multicentrique non randomisé évaluant l’efficacité, la tolérance et la toxicité d’un conditionnement à intensité réduite combinant Clofarabine (Evoltra) + Busulfan IV (Busilvex) + ATG (Thymoglobuline) (CBT) chez des patients nécessitant une allogreffe pour une  MDS, LAM ou une LAL à haut risque

acronym: CLORIC

lead_sponsor: CHU de Nantes


title: Diagnostic et traitement de l'asthme chez le sportif : la frontière entre la pathologie et le dopage

acronym: SALBEXO

lead_sponsor: Centre Hospitalier de Toulouse


title: Comparaison des effets du nébivolol et de l'aténolol sur la fonction endothéliale vasomotrice des artères de conductance lors de l'hypertension artérielle essentielle

acronym: Etude CANOE

lead_sponsor: Laboratoires NEGMA


title: Traitement par la toxine botulinique de la dystonie en griffe des orteils chez les patients parkinsoniens :  Comparaison de l’efficacité d’injections effectuées dans la musculature extrinsèque (le long fléchisseur des orteils) et dans la musculature intrinsèque (la chair carrée/le court fléchisseur plantaire).

acronym: MPI-BOT TOX

lead_sponsor: CHU Clermont-Ferrand


title: ESSAI EN DEUX ETAPES DE L’EVALUATION DE LA LENALIDOMIDE  (REVLIMID®) DANS LE CANCER DE L’OVAIRE EN RECHUTE TARDIVE (> 6 MOIS): - EN MONOTHERAPIE CHEZ DES PATIENTES ASYMPTOMATIQUES AVEC UNE ELEVATION DU TAUX DE CA125 (PHASE II) ; - PUIS EN ASSOCIATION AVEC DU CARBOPLATINE ET DE LA DOXORUBICINE LIPOSOMALE PEGYLEE (PHASE I).

acronym: REV

lead_sponsor: ARCAGY


title: Essai randomisé en double insu comparant l’efficacité et la tolérance du tartrate de varénicline versus placebo dans l’aide à l’arrêt de la consommation de tabac chez les patients infectes infectés par le VIH.

acronym: Inter-ACTIV


title: Etude multicentrique en ouvert sur l'efficacité et la tolérance d'un traitement local avec polygynax au cours des vaginites mycosiques et/ou bactériennes

lead_sponsor: Innotech international


title: ESSAI RANDOMISE, EN DOUBLE AVEUGLE CONTRE PLACEBO EVALUANT L’EFFICACITE DU RISEDRONATE ORAL 35 MG PAR SEMAINE DANS LA PREVENTION DE LA PERTE OSSEUSE CHEZ LA FEMME ATTEINTE D’UN CANCER DU SEIN TRAITE PAR INHIBITEURS DE L’AROMATASE

acronym: RISAROS


title: A Phase III randomized trial investigating the duration of adjuvant therapy with the modified FOLFOX 6 regimen (3 versus 6 months) for patients with stage III colon cancer.

acronym: IDEA

lead_sponsor: GERCOR


title: Transporteur de la Dopamine (DAT) dans les traitements pharmacologiques de la dépendance à la cocaïne

acronym: CAIMAN STUDY


title: ACTION OF THE AMANTADINE ON POST STROKE APHASIC PATIENTS LANGUAGE AND COMMUNICATION

lead_sponsor: Centre hospitalier universitaire de nice


title: Evaluation de l’effet anesthésique de la dexmédétomidine dans une population d’opérés recevant une anesthésie totale intraveineuse en « boucle » guidée par l’index bispectral (Etude monocentrique, prospective, randomisée)

acronym: Boucle-Dexmet

lead_sponsor: Hopital Foch


title: Etude de phase II non contrôlée: traitement de première ligne par sunitinib plus folfiri pour les patients ayant un cancer du rectum avec des métastases synchrones résécables (SUREMETS)

lead_sponsor: Fédération Francophone de Cancérologie Digestive


title: Efficacité clinique de VALDOXAN dans les conditions de pratique quotidienne (efficience) chez des patients déprimés, en switch ou naïfs de traitement  Etude clinique interventionelle de phase IV, multicentrique,  ouverte. Etude VALDOXAN D-CHANGE.

lead_sponsor: EUTHERAPIE pour le compte du promoteur Les Laboratoires Servier


title: Analgésie post-césarienne par infusion continue de ropivacaïne et de diclofenac dans la plaie opératoire versus morphine par voie intrathécale : Comparaison de la qualité de l’analgésie, des effets secondaires, et de l’incidence des douleurs cicatricielles résiduelles

lead_sponsor: CHU de Nîmes


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.

family: Liaw

full_name: Yun-Fan Liaw

given: Yun-Fan

family: Sheen

full_name: I-Shyan Sheen

given: I-Shyan

family: Lee

full_name: Chuan-Mo Lee

given: Chuan-Mo

family: Akarca

full_name: Ulus Salih Akarca

given: Ulus Salih

family: Papatheodoridis

full_name: George V. Papatheodoridis

given: George V.

family: Suet-Hing Wong

full_name: Florence Suet-Hing Wong

given: Florence

family: Chang

full_name: Ting-Tsung Chang

given: Ting-Tsung

family: Horban

full_name: Andrzej Horban

given: Andrzej

family: Wang

full_name: Chia Wang

given: Chia

family: Kwan

full_name: Peter Kwan

given: Peter

family: Buti

full_name: Maria Buti

given: Maria

family: Prieto

full_name: Martin Prieto

given: Martin

family: Berg

full_name: Thomas Berg

given: Thomas

family: Kitrinos

full_name: Kathryn Kitrinos

given: Kathryn

family: Peschell

full_name: Ken Peschell

given: Ken

family: Mondou

full_name: Elsa Mondou

given: Elsa

family: Frederick

full_name: David Frederick

given: David

family: Rousseau

full_name: Franck Rousseau

given: Franck

family: Schiff

full_name: Eugene R. Schiff

given: Eugene R.

journal_name: Hepatology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Gilead Sciences

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

location_facility: Hospital Clinic i Provincial de Barcelona (HCPB)

location_facility: University of Miami, Center for Liver Diseases

location_facility: Wojewodzki Szpital Specjalistyczny im Dluskeigo

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

location_facility: Hospital Universitario y Politecnico la Fe

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

location_facility: National University Hospital Dept. of Gastroenterology & Hepatology

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie

location_facility: Hospital General Universitari Vall d'Hebron

location_facility: Chang Gung Memorial Hospital - Kaohsiung

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


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: 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.

name: Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, OH, USA;

family: Fox

full_name: Robert J. Fox

given: Robert J.

name: Department of Neurology, University Hospital Bern and University of Bern, Bern, Switzerland;

family: Chan

full_name: Andrew Chan

given: Andrew

family: Zhang

full_name: Annie Zhang

given: Annie

family: Xiao

full_name: James Xiao

given: James

family: Levison

full_name: Dane Levison

given: Dane

family: Lewin

full_name: James B. Lewin

given: James B.

family: Edwards

full_name: Michael R. Edwards

given: Michael R.

family: Marantz

full_name: Jing L. Marantz

given: Jing L.

journal_name: Current Medical Research and Opinion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

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.

name: aDepartment of Biomedicine, University Hospital Basel, Basel, Switzerland

family: Derfuss

full_name: T. Derfuss

given: T.

family: Bergvall

full_name: N.K. Bergvall

family: Sfikas

full_name: N. Sfikas

given: N.

family: Tomic

full_name: D.L. Tomic

publisher: Informa Healthcare

title: Efficacy of fingolimod in patients with highly active relapsing–remitting multiple sclerosis

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.

family: Kremenchutzky

full_name: Marcelo Kremenchutzky

given: Marcelo

family: O’Connor

full_name: Paul O’Connor

given: Paul

family: Hohlfeld

full_name: Reinhard Hohlfeld

given: Reinhard

family: Zhang-Auberson

full_name: Lixin Zhang-Auberson

given: Lixin

family: von Rosenstiel

full_name: Philipp von Rosenstiel

given: Philipp

family: Meng

full_name: Xiangyi Meng

given: Xiangyi

family: Grinspan

full_name: Augusto Grinspan

journal_name: Multiple Sclerosis and Related Disorders

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.

title: Efficacy and Safety of Fingolimod in Hispanic Patients with Multiple Sclerosis: Pooled Clinical Trial Analyses

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.

title: Ophthalmic Evaluations in Clinical Studies of Fingolimod (FTY720) in Multiple Sclerosis

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.

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

title: A Placebo-Controlled Trial of Oral Fingolimod in Relapsing Multiple Sclerosis

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

location_facility: Katedra i Klinika Neurologii Slaskiej Akademii Medycznej

location_facility: Centre Hospitalier, Universitaire Vaudois Policlinique de Neurologie

location_facility: Centralny Szpital Kliniczny, Klinika Neurologii

location_facility: Bakirkoy Ruh ve Sinir Hastaliklari Hastanesi

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

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

location_facility: Karolinska University Hospital, Department of Medicine

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

location_facility: Jadwiga Kruszewska-Ozimska, Instytut Psychiatrii i Neurologii

location_facility: Frenchay Hospital, Department of Neurology

location_facility: Helsinki Headache Center Postitalon Lääkäriasema

location_facility: Mersin Universitesi Tip Fakultesi Hastanesi

location_facility: Kaunas University Hospital Department of Neurology

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

location_facility: Istanbul University, Cerrahpasa School of Medicine

location_facility: Turku University Hospital, Neurology Department 799

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

location_facility: Algemeen Ziekenhuis St. Jan, Department of Neurology

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

location_facility: Dokuz University Medical Faculty, Neurology Department

location_facility: Hopital Maisonneuve-Rosemont, Recherche Clinique de Neurologie

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

location_facility: Athens Naval Hospital, Neurology Department

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

location_facility: Moscow Regional Research Clinical Institue

location_facility: Niezalezny Zespol Opieki Zdrowotnej Kendron

location_facility: Neurologicka klinika, Fakultni nemocnice

location_facility: Interregional Clinical Diagnistic Center, Neurology Department

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

location_facility: Neurologické oddelenie, Nemocnica s poliklinikou Žilina

location_facility: Neurologická klinika, Martinská fakultná nemocnica

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

location_facility: Istanbul University, Istanbul Faculty of Medicine

location_facility: Military Medical Academy, Neurology Department

location_facility: Neurology Department Athens General Hospital, G. Gennimatas

location_facility: Division of Neurology, Groote Schuur Hospital

location_facility: Suomen Terveystalo/ Päänsärkykeskus, Tampere

location_facility: Facultní Nemocnice Spoliklinikou Ostrava, Neurology Department

location_facility: National Multiple Sclerose Centrum v.z.w

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

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

location_facility: UniversitätsSpital Zürich, Neurologische Klinik


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.

name: Children’s Cancer Research Institute and St. Anna Children’s Hospital, Vienna, Austria;

family: Gadner

full_name: Helmut Gadner

given: Helmut

family: Minkov

full_name: Milen Minkov

given: Milen

family: Grois

full_name: Nicole Grois

given: Nicole

family: Pötschger

full_name: Ulrike Pötschger

given: Ulrike

family: Thiem

full_name: Elfriede Thiem

given: Elfriede

name: Department of Hematology-Oncology, University Children’s Hospital, Florence, Italy;

family: Aricò

full_name: Maurizio Aricò

given: Maurizio

name: Hospital Universitario Cruces, Bilbao, Spain;

family: Astigarraga

full_name: Itziar Astigarraga

given: Itziar

name: Hospital Nacional de Pediatria J. Garrahan, Buenos Aires, Argentina;

family: Braier

full_name: Jorge Braier

given: Jorge

family: Donadieu

full_name: Jean Donadieu

given: Jean

name: Childhood Cancer Research Unit, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden;

family: Henter

full_name: Jan-Inge Henter

given: Jan-Inge

name: Department of Hematology and Oncology, University Medical Center, Hamburg, Germany;

family: Janka-Schaub

full_name: Gritta Janka-Schaub

given: Gritta

name: Texas Children’s Cancer and Hematology Centers, Houston, TX;

family: McClain

full_name: Kenneth L. McClain

given: Kenneth L.

name: Hospital for Sick Children, Division of Hematology/Oncology, Toronto, Ontario, Canada;

family: Weitzman

full_name: Sheila Weitzman

given: Sheila

name: Newcastle University, Newcastle, United Kingdom; and

family: Windebank

full_name: Kevin Windebank

given: Kevin

name: Children’s Research Institute, Children’s National Medical Center, Washington DC

family: Ladisch

full_name: Stephan Ladisch

given: Stephan

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

lead_sponsor: Histiocyte Society

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

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

location_facility: Masonic Cancer Center at University of Minnesota

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

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

location_facility: Royal Liverpool Children's Hospital, Alder Hey

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

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: University Medical Center Hamburg - Eppendorf

location_facility: Institute of Child Health at University of Bristol

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Great Ormond Street Hospital for Children

location_facility: Our Lady's Hospital for Sick Children Crumlin


title:
PHASE II  STUDY EVALUATION OF EFFICACITY AND TOLERANCE OF REGORAFENIB FOR 70 YEARS OLD AND MORE PATIENTS WITH A METASTATIC COLORECTAL ADENOCARCIMA

 ETUDE DE PHASE II EVALUANT L’EFFICACITE ET LA TOLERANCE DU REGORAFENIB CHEZ LES PATIENTS DE 70 ANS ET PLUS ATTEINTS D’UN ADENOCARCINOME COLORECTAL METASTATIQUE

acronym:
REGOLD

 REGOLD

lead_sponsor: FEDERATION FRANCOPHONE DE CANCEROLOGIE DIGESTIVE


title:
Analgésie postopératoire par infiltration locale peropératoire versus blocs fémoral et cutané latéral de la cuisse dans la chirurgie de prothèse totale de hanche

 Analgésie postopératoire par infiltration locale peropératoire versus blocs fémoral et cutané latéral de la cuisse dans la chirurgie de prothèse totale de hanche

acronym:
ALRIAL

 ALRIAL

lead_sponsor: Hospices Civils de Lyon


title:
.

 IMPACT DE L’INHALATION D’UN MELANGE EQUIMOLAIRE OXYGENE – PROTOXYDE D’AZOTE (MEOPA) SUR LA DOULEUR ET L’ANXIETE DURANT UNE PONCTION LOMBAIRE : ETUDE CONTROLEE, RANDOMISEE, EN DOUBLE AVEUGLE

acronym: PL-MEOPA

lead_sponsor: CHU de Clermont-Ferrand


title:
A multicenter, two arms, randomized, open label clinical Phase IV study investigating the proportion of CMV seropositive kidney transplant recipients who will develop a CMV infection within the first 6 months post-transplantation when treated with an immunosuppressive regimen including everolimus (Certican®) and reduced dose of cyclosporine A (Néoral®) versus an immunosuppressive regimen with mycophenolic acid (Myfortic®) and standard dose of cyclosporine A (Néoral®).

 Essai clinique de phase IV ouvert multicentrique randomisé prospectif comparant chez les patients transplantés rénaux séropositifs pour le cytomégalovirus, l’incidence de l’infection à cytomégalovirus entre deux STRATEGIES IMMUNOSUPPRESSIVES : Everolimus (Certican®) - doses réduites de cyclosporine A (Neoral®) versus acide mycophénolique (Myfortic®) - doses standard de cyclosporine (Neoral®).

acronym:
EVERCMV

 EVERCMV

lead_sponsor: CHU de Bordeaux


title: Efficacy of Aflibercept (Eylea®) on Type 3 choroidal neovascularization.

acronym: ATTRACT

lead_sponsor: CHU DE POITIERS


title:
The role of dexchlorpheniramine (Polaramine®) to prevent hemodynamic instability after separation from cardiopulmonary bypass during cardiac surgery.

 Intérêt de la dexchlorphéniramine (Polaramine®) en prévention de l’instabilité́ hémodynamique en péri-opératoire de chirurgie cardiaque sous circulation extra-corporelle.

acronym:
HIPPIE

 HIPPIE


title: Effets d’un soluté hypertonique et du Ringer Lactate sur la fonction ventriculaire droite après chirurgie cardiaque

acronym: SUCCESS

lead_sponsor: Centre Hospitalier Universitaire de Grenoble


title: EVALUATION D'UN GEL DE MORPHINE ORAL DANS LES MUCITES CHIMIOINDUITES DE L'ENFANT ET DU JEUNE ADULTE

acronym: MorphinOGel

lead_sponsor: Hôpitaux Universitaires de Strasbourg


title: Targeting Microenvironment and Cellular Immunity in Sarcomas Weekly trabectedin combined with Metronomic Cyclophosphamide in Patients with Advanced Pretreated Soft-tissue Sarcomas. A Phase I/II study from the French Sarcoma Group.

acronym: Protocol TARMIC

lead_sponsor: INSTITUT BERGONIE


title:
Effets de l'administration intranasale répétée d'ocytocine chez des patients adultes présentant un syndrome de Prader-Willi.

 Effets de l'administration intranasale répétée d'ocytocine chez des patients adultes présentant un syndrome de Prader-Willi.

acronym: PRADOTIM

lead_sponsor: Centre Hospitalier de Toulouse


title:
Cardiovascular effects of esmolol alone and in combination with levosimendan during septic shock

 Effets cardiovasculaires associés à l'administration d'esmolol seul et en association au lévosimendan chez le patient en choc septique

lead_sponsor: DIRECTION CENTRALE DU SERVICE DE SANTE DES ARMEES


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

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.

family: Wan

full_name: Tony Wan

given: Tony

family: Rodger

full_name: Marc Rodger

given: Marc

family: Zeng

full_name: Wanzhen Zeng

given: Wanzhen

family: Robin

full_name: Philippe Robin

given: Philippe

family: Righini

full_name: Marc Righini

family: Kovacs

full_name: Michael J. Kovacs

given: Michael J.

family: Tan

full_name: Melanie Tan

given: Melanie

family: Carrier

full_name: Marc Carrier

family: Kahn

full_name: Susan R. Kahn

given: Susan R.

family: Wells

full_name: Philip S. Wells

given: Philip S.

family: Anderson

full_name: David R. Anderson

given: David R.

family: Chagnon

full_name: Isabelle Chagnon

given: Isabelle

family: Solymoss

full_name: Susan Solymoss

given: Susan

family: Crowther

full_name: Mark Crowther

given: Mark

family: White

full_name: Richard H. White

given: Richard H.

family: Vickars

full_name: Linda Vickars

given: Linda

family: Bazarjani

full_name: Sadri Bazarjani

given: Sadri

family: Le Gal

full_name: Grégoire Le Gal

given: Grégoire

journal_name: Thrombosis Research

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.

full_name: Marc A. Rodger

given: Marc A.

family: Scarvelis

full_name: Dimitri Scarvelis

given: Dimitri

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.

name: Centre for Clinical Epidemiology; Jewish General Hospital; Montreal Quebec Canada

name: Thrombosis Program; Division of Hematology; Department of Medicine; University of Ottawa; Ottawa Ontario Canada

name: Clinical Epidemiology Unit; Ottawa Hospital Research Institute; The Ottawa Hospital; Ottawa Canada

name: Division of Hematology; Department of Medicine; University of Western Ontario; London Canada

name: Department of Medicine; Dalhousie University; Halifax Nova Scotia Canada

name: Department of Medicine; Hôpital du Sacré-Coeur de Montréal; University of Montreal; Montreal Quebec Canada

name: Université de Brest; EA3878, Brest France

name: Department of Medicine; McGill University; Montreal Quebec Canada

name: Department of Medicine; Michael G. DeGroote School of Medicine; McMaster University; Hamilton Ontario Canada

name: Department of Internal Medicine; Geneva University Hospital; Geneva Switzerland

name: Department of Medicine; UC Davis School of Medicine; Sacramento California USA

name: Department of Medicine; St Paul's Hospital; University of British Columbia; Vancouver British Columbia Canada

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.

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


title:
Pilot study of the pharmacokinetic profile of paracetamol subcutaneously versus intravenously in patients receiving palliative care

 Etude pilote du profil pharmacocinétique du paracétamol par voie sous cutanée versus voie intraveineuse chez les patients en soins palliatifs

acronym:
ParaSCIVPallia

 ParaSCIVPallia

lead_sponsor: CHU CAEN


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.

design_allocation: Non-Randomized

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

location_facility: The Royal Veterinary & Agricultural University

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


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.

lead_sponsor: Sanofi

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


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


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.

name: From the Department of Medicine (J.M.H., M.G.M., P.J.Z.), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass; Department of Medicine (K.A.S.), George E. Wahlen VA Hospital, University of Utah, Salt Lake City; Department de Cardiologie (C.L.), Centre Cafrdio-pneumologique, Centre Hospitalier Universitaire Pontchaillou, Rennes, France; Department of Medicine (L.A.P.), St John Hospital and Medical Center, Detroit, MI; and Medtronic Inc (S.E.M., B.J.P.), Minneapolis, Minn.

family: Hsing

full_name: Jeff M. Hsing

given: Jeff M.

family: Selzman

full_name: Kimberly A. Selzman

given: Kimberly A.

family: Leclercq

full_name: Christophe Leclercq

given: Christophe

family: Pires

full_name: Luis A. Pires

given: Luis A.

family: McLaughlin

full_name: Michael G. McLaughlin

given: Michael G.

family: McRae

full_name: Scott E. McRae

given: Scott E.

family: Peterson

full_name: Brett J. Peterson

given: Brett J.

family: Zimetbaum

full_name: Peter J. Zimetbaum

given: Peter J.

journal_name: Circulation: Arrhythmia and Electrophysiology

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_normalized: HAL

title: Paced Left Ventricular QRS Width and ECG Parameters Predict Outcomes After Cardiac Resynchronization Therapy

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.

family: Chan

full_name: Paul S. Chan

given: Paul S.

family: Khumri

full_name: Taiyeb Khumri

given: Taiyeb

family: Chung

full_name: Eugene S. Chung

given: Eugene S.

family: Ghio

full_name: Stefano Ghio

given: Stefano

family: Reid

full_name: Kimberly J. Reid

given: Kimberly J.

family: Gerritse

full_name: Bart Gerritse

given: Bart

family: Nallamothu

full_name: Brahmajee K. Nallamothu

given: Brahmajee K.

family: Spertus

full_name: John A. Spertus

given: John A.

journal_name: JACC: Cardiovascular Imaging

evidence: open (via crossref license)

title: Echocardiographic Dyssynchrony and Health Status Outcomes From Cardiac Resynchronization Therapy

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.

name: From the Lindner Clinical Trial Center, The Ohio Heart and Vascular Center, and The Christ Hospital, Cincinnati, Ohio (E.S.C.); Emory University–Crawford Long Hospital, Atlanta, Ga (A.R.L., J.-P.S., J.M.); Ospedale Policlinico San Matteo, Pavia, Italy (L.T., S.G.); Imperial College London and Hammersmith Hospital, London, UK (P.N.); Ohio State University Heart Center, Columbus (W.T.A.); University Hospital, Rennes, France (C.L.); Leiden University Medical Center, Leiden, the Netherlands (J.J.B.);...

title: Results of the Predictors of Response to CRT (PROSPECT) Trial

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

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


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.

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Effect of Clopidogrel Added to Aspirin in Patients with Atrial Fibrillation

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.

family: Paré

full_name: Guillaume Paré

given: Guillaume

family: Mehta

full_name: Shamir R. Mehta

given: Shamir R.

family: Yusuf

full_name: Salim Yusuf

given: Salim

family: Anand

full_name: Sonia S. Anand

given: Sonia S.

family: Connolly

full_name: Stuart J. Connolly

given: Stuart J.

family: Hirsh

full_name: Jack Hirsh

given: Jack

family: Simonsen

full_name: Katy Simonsen

given: Katy

family: Bhatt

full_name: Deepak L. Bhatt

given: Deepak L.

family: Fox

full_name: Keith A.A. Fox

given: Keith A.A.

family: Eikelboom

full_name: John W. Eikelboom

given: John W.

oa_host_type: repository

repository_institution: University of Edinburgh - Edinburgh Research Explorer

version: submittedVersion

title: Effects ofCYP2C19Genotype on Outcomes of Clopidogrel Treatment

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

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


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: Irbesartan in Patients with Atrial Fibrillation


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.

family: Schaefer

full_name: Franz Schaefer

given: Franz

family: van de Walle

full_name: Johan van de Walle

given: Johan

family: Zurowska

full_name: Aleksandra Zurowska

given: Aleksandra

family: Gimpel

full_name: Charlotte Gimpel

given: Charlotte

family: van Hoeck

full_name: Koen van Hoeck

given: Koen

family: Drozdz

full_name: Dorota Drozdz

given: Dorota

family: Montini

full_name: Giovanni Montini

given: Giovanni

family: Bagdasorova

full_name: Ingretta V Bagdasorova

given: Ingretta V

family: Sorof

full_name: Jonathan Sorof

given: Jonathan

family: Sugg

full_name: Jennifer Sugg

given: Jennifer

family: Teng

full_name: Renli Teng

given: Renli

family: Hainer

full_name: James W Hainer

given: James W

journal_name: Journal of Hypertension

lead_sponsor: AstraZeneca

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