title: A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (VTE), Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication.

acronym: RE-COVER I

summary: The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.

ReferenceCitation: Goldhaber SZ, Eriksson H, Kakkar A, Schellong S, Feuring M, Fraessdorf M, Kreuzer J, Schueler E, Schulman S. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER(R), RE-COVER II, and RE-MEDY. Vasc Med. 2016 Dec;21(6):506-514. doi: 10.1177/1358863X16668588. Epub 2016 Nov 1.

publisher_dissemination: SAGE Publications

ReferenceCitation: Schulman S, Kakkar AK, Goldhaber SZ, Schellong S, Eriksson H, Mismetti P, Christiansen AV, Friedman J, Le Maulf F, Peter N, Kearon C; RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014 Feb 18;129(7):764-72. doi: 10.1161/CIRCULATIONAHA.113.004450. Epub 2013 Dec 16.

ReferenceCitation: Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.

ReferenceCitation: Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, Baanstra D, Schnee J, Goldhaber SZ; RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009 Dec 10;361(24):2342-52. doi: 10.1056/NEJMoa0906598.

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New Zealand
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France
Czech Republic
Portugal
Slovakia
Hungary
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United States
Ukraine
India
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Russian Federation
Israel

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type: Other Identifier

type: EudraCT Number

title: A Six Month, Open-label Outpatient, Parallel Group Trial Assessing The Impact Of Inhaled Insulin (Exubera(Registered)) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On Two Oral Anti-diabetic Agents

summary: To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Pfizer

location_country: Portugal Sweden Spain Greece Turkey Canada France

location_facility: General Hospital of Athens "Laikon", 1st Propedeutic University Internal Medicine Clinic

location_facility: Serviço de Endocrinologia - Hospital de Egas Moniz

location_facility: Centre de santé et de services sociaux de Chicoutimi, Centre de médecine genique communataire

location_facility: CHU Cote de Nacre, Service d'Endocrinologie

location_facility: Hacettepe University Medical School Department of Endocrinology

location_facility: Peripheral General Hospital of Nikaia "Ag. Panteleimon", Internal Medicine Department

location_facility: Hotel Dieu CHU, Clinique d´Endocrinologie, Maladie Metaboliques, Nutrition

location_facility: "Hygeia" Diagnostic and Therapeutic Center of Athens, Diabetes Clinic

location_facility: Hopital LA Cavale Blanche, Service de Diabetologie

location_facility: Hospital Clinico Universitario de Santiago

location_facility: "ATTIKON" University General Hospital, 2nd Propedeutic University Internal Medicine Clinic

location_facility: Hospital General Universitario de Alicante

location_facility: Groupe Hospitalier Sud/Service d'Endocrinologie

location_facility: Istanbul University Istanbul Medical School, Department of Endocrinology

location_facility: Associação Protectora dos Diabéticos de Portugal

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Douglas Tweel M.D. Professional Corporation

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hôpital Jeanne d'Arc - Dommartin les Toul

location_facility: Hospital General Universitario Valle de Hebron

location_facility: University General Hospital of Thessaloniki "A.H.E.P.A." 1st Propedeutic University Internal Medicin

location_facility: Dokuz Eylul University Medical School, Department of Endocrinology

location_facility: Complejo Hospitalario Carlos Haya Hospital Civil - Pabellon C

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients With Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus

summary: The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.

status: Completed

ReferenceType: result

ReferenceCitation: Viberti G, Kahn SE, Greene DA, Herman WH, Zinman B, Holman RR, Haffner SM, Levy D, Lachin JM, Berry RA, Heise MA, Jones NP, Freed MI. A diabetes outcome progression trial (ADOPT): an international multicenter study of the comparative efficacy of rosiglitazone, glyburide, and metformin in recently diagnosed type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1737-43. doi: 10.2337/diacare.25.10.1737.

ReferenceCitation: Viberti G, Lachin J, Holman R, Zinman B, Haffner S, Kravitz B, Heise MA, Jones NP, O'Neill MC, Freed MI, Kahn SE, Herman WH; ADOPT Study Group. A Diabetes Outcome Progression Trial (ADOPT): baseline characteristics of Type 2 diabetic patients in North America and Europe. Diabet Med. 2006 Dec;23(12):1289-94. doi: 10.1111/j.1464-5491.2006.02022.x.

ReferenceCitation: Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, Kravitz BG, Lachin JM, O'Neill MC, Zinman B, Viberti G; ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006 Dec 7;355(23):2427-43. doi: 10.1056/NEJMoa066224. Epub 2006 Dec 4. Erratum In: N Engl J Med. 2007 Mar 29;356(13):1387-8.

ReferenceCitation: Kahn SE, Zinman B, Haffner SM, O'Neill MC, Kravitz BG, Yu D, Freed MI, Herman WH, Holman RR, Jones NP, Lachin JM, Viberti GC; ADOPT Study Group. Obesity is a major determinant of the association of C-reactive protein levels and the metabolic syndrome in type 2 diabetes. Diabetes. 2006 Aug;55(8):2357-64. doi: 10.2337/db06-0116.

ReferenceCitation: Zinman B, Kahn SE, Haffner SM, O'Neill MC, Heise MA, Freed MI; ADOPT Study Group. Phenotypic characteristics of GAD antibody-positive recently diagnosed patients with type 2 diabetes in North America and Europe. Diabetes. 2004 Dec;53(12):3193-200. doi: 10.2337/diabetes.53.12.3193.

ReferenceType: derived

ReferenceCitation: Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

version: publishedVersion

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Lachin JM, Viberti G, Zinman B, Haffner SM, Aftring RP, Paul G, Kravitz BG, Herman WH, Holman RR, Kahn SE; ADOPT Study Group. Renal function in type 2 diabetes with rosiglitazone, metformin, and glyburide monotherapy. Clin J Am Soc Nephrol. 2011 May;6(5):1032-40. doi: 10.2215/CJN.09291010. Epub 2011 Mar 31.

ReferenceCitation: Kahn SE, Haffner SM, Viberti G, Herman WH, Lachin JM, Kravitz BG, Yu D, Paul G, Holman RR, Zinman B; Diabetes Outcome Progression Trial (ADOPT) Study Group. Rosiglitazone decreases C-reactive protein to a greater extent relative to glyburide and metformin over 4 years despite greater weight gain: observations from a Diabetes Outcome Progression Trial (ADOPT). Diabetes Care. 2010 Jan;33(1):177-83. doi: 10.2337/dc09-1661. Epub 2009 Oct 6.

ReferenceCitation: Kahn SE, Zinman B, Lachin JM, Haffner SM, Herman WH, Holman RR, Kravitz BG, Yu D, Heise MA, Aftring RP, Viberti G; Diabetes Outcome Progression Trial (ADOPT) Study Group. Rosiglitazone-associated fractures in type 2 diabetes: an Analysis from A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care. 2008 May;31(5):845-51. doi: 10.2337/dc07-2270. Epub 2008 Jan 25.

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
Finland
Germany
Ireland
Italy
Hungary
Norway
Denmark
United Kingdom
Sweden
Netherlands
Austria
Belgium
United States
Spain
Czechia
Canada
France

status_simplified: Completed


title: Medtronic CRDM Product Performance Report

acronym: PPR

summary: The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Medtronic

location_country:
Germany
Poland
Australia
Japan
Kuwait
Czechia
Canada
Serbia
France
Slovenia
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Iceland
Belgium
China
Malaysia
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Saudi Arabia
Spain
Greece
Israel

intervention_type: Device

status_simplified: Ongoing


title: A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Long-term Effects of Salmeterol/Fluticasone Propionate (Seretide tm) 50/500mcg BD, Salmeterol 50mcg BD and Fluticasone Propionate 500mcg BD, All Delivered Via the Diskus tm/Accuhaler tm Inhaler, on Mortality and Morbidity of Subjects With Chronic Obstructive Pulmonary Disease (COPD) Over 3 Years of Treatment

summary: The purpose of this study is to see if fluticasone 500mcg/salmeterol 50mcg can improve the survival of subjects with COPD and also assess the long term safety profile of this drug.

ReferenceType: background

ReferenceCitation: Briggs AH, Glick HA, Lozano-Ortega G, Spencer M, Calverley PM, Jones PW, Vestbo J; TOwards a Revolution in COPD Health (TORCH) investigators. Is treatment with ICS and LABA cost-effective for COPD? Multinational economic analysis of the TORCH study. Eur Respir J. 2010 Mar;35(3):532-9. doi: 10.1183/09031936.00153108. Epub 2009 Aug 28.

ReferenceCitation: Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Yates JC, Vestbo J; TORCH investigators. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007 Feb 22;356(8):775-89. doi: 10.1056/NEJMoa063070.

ReferenceCitation: Celli BR, Thomas NE, Anderson JA, Ferguson GT, Jenkins CR, Jones PW, Vestbo J, Knobil K, Yates JC, Calverley PM. Effect of pharmacotherapy on rate of decline of lung function in chronic obstructive pulmonary disease: results from the TORCH study. Am J Respir Crit Care Med. 2008 Aug 15;178(4):332-8. doi: 10.1164/rccm.200712-1869OC. Epub 2008 May 29.

ReferenceCitation: Jenkins CR, Jones PW, Calverley PM, Celli B, Anderson JA, Ferguson GT, Yates JC, Willits LR, Vestbo J. Efficacy of salmeterol/fluticasone propionate by GOLD stage of chronic obstructive pulmonary disease: analysis from the randomised, placebo-controlled TORCH study. Respir Res. 2009 Jun 30;10(1):59. doi: 10.1186/1465-9921-10-59.

ReferenceCitation: Crim C, Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Willits LR, Yates JC, Vestbo J. Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results. Eur Respir J. 2009 Sep;34(3):641-7. doi: 10.1183/09031936.00193908. Epub 2009 May 14.

ReferenceCitation: Ernst P, Suissa S. Pneumonia in elderly patients with chronic obstructive pulmonary disease. Curr Infect Dis Rep. 2008 May;10(3):223-8. doi: 10.1007/s11908-008-0037-4.

ReferenceCitation: Ferguson GT, Calverley PMA, Anderson JA, Jenkins CR, Jones PW, Willits LR, Yates JC, Vestbo J, Celli B. Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study. Chest. 2009 Dec;136(6):1456-1465. doi: 10.1378/chest.08-3016. Epub 2009 Jul 6.

ReferenceCitation: Hanania NA. The impact of inhaled corticosteroid and long-acting beta-agonist combination therapy on outcomes in COPD. Pulm Pharmacol Ther. 2008;21(3):540-50. doi: 10.1016/j.pupt.2007.12.004. Epub 2008 Jan 6.

ReferenceCitation: Houghton CM, Lawson N, Borrill ZL, Wixon CL, Yoxall S, Langley SJ, Woodcock A, Singh D. Comparison of the effects of salmeterol/fluticasone propionate with fluticasone propionate on airway physiology in adults with mild persistent asthma. Respir Res. 2007 Jul 14;8(1):52. doi: 10.1186/1465-9921-8-52.

ReferenceCitation: Johnson M, Agusti AG, Barnes NC. Reflections on TORCH: potential mechanisms for the survival benefit of salmeterol/fluticasone propionate in COPD patients. COPD. 2008 Dec;5(6):369-75. doi: 10.1080/15412550802522924.

ReferenceCitation: Keene ON, Vestbo J, Anderson JA, Calverley PM, Celli B, Ferguson GT, Jenkins C, Jones PW. Methods for therapeutic trials in COPD: lessons from the TORCH trial. Eur Respir J. 2009 Nov;34(5):1018-23. doi: 10.1183/09031936.00122608.

ReferenceCitation: Drummond MB, Wise RA, John M, Zvarich MT, McGarvey LP. Accuracy of death certificates in COPD: analysis from the TORCH trial. COPD. 2010 Jun;7(3):179-85. doi: 10.3109/15412555.2010.481695.

ReferenceCitation: Marchand E. Effect of pharmacotherapy on rate of decline of FEV(1) in the TORCH study. Am J Respir Crit Care Med. 2009 Mar 1;179(5):426; author reply 426-7. doi: 10.1164/ajrccm.179.5.426. No abstract available.

ReferenceCitation: McGarvey LP, John M, Anderson JA, Zvarich M, Wise RA; TORCH Clinical Endpoint Committee. Ascertainment of cause-specific mortality in COPD: operations of the TORCH Clinical Endpoint Committee. Thorax. 2007 May;62(5):411-5. doi: 10.1136/thx.2006.072348. Epub 2007 Feb 20.

ReferenceCitation: Middleton PG. Management of patients with COPD: a comparison of the INSPIRE and TORCH studies. Am J Respir Crit Care Med. 2008 Jul 1;178(1):106; author reply 106-7. doi: 10.1164/ajrccm.178.1.106. No abstract available.

ReferenceCitation: Miravitlles M, Anzueto A. Insights into interventions in managing COPD patients: lessons from the TORCH and UPLIFT studies. Int J Chron Obstruct Pulmon Dis. 2009;4:185-201. Epub 2009 May 7.

ReferenceCitation: Niewoehner DE. TORCH and UPLIFT: what has been learned from the COPD "mega-trials"? COPD. 2009 Feb;6(1):1-3. doi: 10.1080/15412550902723984.

ReferenceCitation: Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Crim C, Willits LR, Yates JC, Vestbo J; TORCH Investigators. Cardiovascular events in patients with COPD: TORCH study results. Thorax. 2010 Aug;65(8):719-25. doi: 10.1136/thx.2010.136077.

ReferenceCitation: Salmeterol plus fluticasone fails to reduce mortality in patients with COPD. Formulary 2007;42:245-6.

ReferenceCitation: Stockley RA. Progression of chronic obstructive pulmonary disease: impact of inflammation, comorbidities and therapeutic intervention. Curr Med Res Opin. 2009 May;25(5):1235-45. doi: 10.1185/03007990902868971.

ReferenceCitation: Suissa S, Ernst P, Vandemheen KL, Aaron SD. Methodological issues in therapeutic trials of COPD. Eur Respir J. 2008 May;31(5):927-33. doi: 10.1183/09031936.00098307. Epub 2008 Jan 23.

ReferenceCitation: Vestbo J; TORCH Study Group. The TORCH (towards a revolution in COPD health) survival study protocol. Eur Respir J. 2004 Aug;24(2):206-10. doi: 10.1183/09031936.04.00120603.

ReferenceCitation: Vestbo J, Anderson JA, Calverley PM, Celli B, Ferguson GT, Jenkins C, Knobil K, Willits LR, Yates JC, Jones PW. Adherence to inhaled therapy, mortality and hospital admission in COPD. Thorax. 2009 Nov;64(11):939-43. doi: 10.1136/thx.2009.113662. Epub 2009 Aug 23.

ReferenceCitation: Paly VF, Naya I, Gunsoy NB, Driessen MT, Risebrough N, Briggs A, Ismaila AS. Long-term cost and utility consequences of short-term clinically important deterioration in patients with chronic obstructive pulmonary disease: results from the TORCH study. Int J Chron Obstruct Pulmon Dis. 2019 May 3;14:939-951. doi: 10.2147/COPD.S188898. eCollection 2019.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: PubMed Central - Europe PMC

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

unpaywall_oa_status: gold

publisher_dissemination: Informa

ReferenceCitation: Naya IP, Tombs L, Muellerova H, Compton C, Jones PW. Long-term outcomes following first short-term clinically important deterioration in COPD. Respir Res. 2018 Nov 20;19(1):222. doi: 10.1186/s12931-018-0928-3.

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

publisher_dissemination: Springer-Nature

ReferenceCitation: Jenkins CR, Celli B, Anderson JA, Ferguson GT, Jones PW, Vestbo J, Yates JC, Calverley PM. Seasonality and determinants of moderate and severe COPD exacerbations in the TORCH study. Eur Respir J. 2012 Jan;39(1):38-45. doi: 10.1183/09031936.00194610. Epub 2011 Jul 7.

ReferenceCitation: Jones PW, Anderson JA, Calverley PM, Celli BR, Ferguson GT, Jenkins C, Yates JC, Vestbo J, Spencer MD; TORCH investigators. Health status in the TORCH study of COPD: treatment efficacy and other determinants of change. Respir Res. 2011 May 31;12(1):71. doi: 10.1186/1465-9921-12-71.

ReferenceCitation: Celli B, Vestbo J, Jenkins CR, Jones PW, Ferguson GT, Calverley PM, Yates JC, Anderson JA, Willits LR, Wise RA; Investigators of the TORCH Study. Sex differences in mortality and clinical expressions of patients with chronic obstructive pulmonary disease. The TORCH experience. Am J Respir Crit Care Med. 2011 Feb 1;183(3):317-22. doi: 10.1164/rccm.201004-0665OC. Epub 2010 Sep 2.

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Thailand
Croatia
Chile
Pakistan
Canada
France
Czech Republic
Lithuania
Slovakia
Hungary
Hong Kong
Denmark
United States
Latvia
Iceland
Ukraine
Romania
Belgium
China
Malaysia
Estonia
Puerto Rico
Philippines
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Sweden


title: Phase III Study of an Optimized Chemotherapy Followed by Maintenance With Bevacizumab Strategy With or Without Erlotinib in Unresectable Metastatic Colorectal Cancer. DREAM OPTIMOX 3. C04-2

acronym: DREAM

summary: PURPOSE: This randomized phase III trial is studying maintenance therapy with bevacizumab alone after an induction therapy combining bevacizumab+chemotherapy to see how well they work compared to maintenance therapy with bevacizumab+erlotinib alone after an induction therapy combining bevacizumab+chemotherapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

ReferenceCitation: Tournigand C, Chibaudel B, Samson B, Scheithauer W, Vernerey D, Mesange P, Lledo G, Viret F, Ramee JF, Tubiana-Mathieu N, Dauba J, Dupuis O, Rinaldi Y, Mabro M, Aucoin N, Latreille J, Bonnetain F, Louvet C, Larsen AK, Andre T, de Gramont A. Bevacizumab with or without erlotinib as maintenance therapy in patients with metastatic colorectal cancer (GERCOR DREAM; OPTIMOX3): a randomised, open-label, phase 3 trial. Lancet Oncol. 2015 Nov;16(15):1493-1505. doi: 10.1016/S1470-2045(15)00216-8. Epub 2015 Oct 22. Erratum In: Lancet Oncol. 2015 Dec;16(16):e589.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_country: Canada Austria France

location_facility: Centre Hospitalier Intercommunal Le Raincy - Montfermeil

location_facility: Centre Hospitalier Saint Joseph Saint Luc

location_facility: AKH Universitätsklinik für Innere Medizin I


title: A Comparative Study on Clinical Efficacy and Safety of Levocetirizine 5 mg Oral Capsules Once Daily in the Morning vs. Desloratadine 5 mg Oral Capsules Once Daily in the Morning in Patients Suffering From Chronic Idiopathic Urticaria (CIU)

summary: A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus severity score over the first week of treatment

lead_sponsor: UCB Pharma

location_country:
Germany
Italy
United Kingdom
Romania
Belgium
Spain
Malaysia
South Africa
France


title: A Randomized, Multicenter, Phase III Study of Erlotinib Versus Observation in Patients With no Evidence of Disease Progression After First Line, Platinum-Based Chemotherapy For High-Risk Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

summary:
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sometimes after treatment, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether erlotinib is more effective than observation after first-line chemotherapy in treating patients with ovarian cancer, peritoneal cancer, or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to observation in treating patients who have undergone first-line chemotherapy for ovarian cancer, peritoneal cancer, or fallopian tube cancer.

ReferenceCitation: Vergote IB, Jimeno A, Joly F, Katsaros D, Coens C, Despierre E, Marth C, Hall M, Steer CB, Colombo N, Lesoin A, Casado A, Reinthaller A, Green J, Buck M, Ray-Coquard I, Ferrero A, Favier L, Reed NS, Cure H, Pujade-Lauraine E. Randomized phase III study of erlotinib versus observation in patients with no evidence of disease progression after first-line platin-based chemotherapy for ovarian carcinoma: a European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group, and Gynecologic Cancer Intergroup study. J Clin Oncol. 2014 Feb 1;32(4):320-6. doi: 10.1200/JCO.2013.50.5669. Epub 2013 Dec 23.

oa_host_type: publisher

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Italy
Portugal
United Kingdom
Australia
Netherlands
Austria
Spain
France

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Sir Charles Gairdner Hospital - Nedlands

location_facility: Queen Elizabeth The Queen Mother Hospital

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Centre Hospitalier de L' Agglomeration Montargoise

location_facility: Murray Valley Private Hospital and Cancer Treatment Centre

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Mid Kent Oncology Centre at Maidstone Hospital

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Azienda Sanitaria Ospedaliera Ordine Mauriziano

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Velindre Cancer Center at Velindre Hospital

location_facility: Centre Hospitalier General de Mont de Marsan

location_facility: Centre Hospital General Robert Ballanger

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Centre Hospitalier General Andre Boulloche