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

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

ReferenceCitation: Wolever TM, Brand-Miller JC, Abernethy J, Astrup A, Atkinson F, Axelsen M, Bjorck 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, Hatonen 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. doi: 10.1093/ajcn/87.1.247S.

lead_sponsor: Glycaemic Index Testing, Inc.

collaborators: Sydney University Glycaemic Index Research Services

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

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

location_facility: The Royal Veterinary & Agricultural University


type: EudraCT Number

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.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Sanofi

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

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


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:
Finland
France
Germany
United Kingdom
Argentina
Australia
Netherlands
Austria
Mexico
United States
Spain
Chile
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.

study_type: Observational

time_perspective: Prospective

ReferenceType: derived

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

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

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

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

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


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

ReferenceType: result

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

ReferenceCitation: Pare 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.

sponsor_collaborators:
Sanofi
Bristol-Myers Squibb

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

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

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

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

lead_sponsor: AstraZeneca

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


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

status: Terminated

ReferenceCitation: ACTIVE Writing Group of the ACTIVE Investigators; Connolly S, Pogue J, Hart R, Pfeffer M, Hohnloser S, Chrolavicius S, Pfeffer M, Hohnloser S, Yusuf S. Clopidogrel plus aspirin versus oral anticoagulation for atrial fibrillation in the Atrial fibrillation Clopidogrel Trial with Irbesartan for prevention of Vascular Events (ACTIVE W): a randomised controlled trial. Lancet. 2006 Jun 10;367(9526):1903-12. doi: 10.1016/S0140-6736(06)68845-4.

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

ReferenceCitation: Cairns JA, Wittes J, Wyse DG, Pogue J, Gent M, Hirsh J, Marler J, Pritchett EL. Monitoring the ACTIVE-W trial: some issues in monitoring a noninferiority trial. Am Heart J. 2008 Jan;155(1):33-41. doi: 10.1016/j.ahj.2007.09.011. Epub 2007 Nov 26.

ReferenceCitation: Hohnloser SH, Pajitnev D, Pogue J, Healey JS, Pfeffer MA, Yusuf S, Connolly SJ; ACTIVE W Investigators. Incidence of stroke in paroxysmal versus sustained atrial fibrillation in patients taking oral anticoagulation or combined antiplatelet therapy: an ACTIVE W Substudy. J Am Coll Cardiol. 2007 Nov 27;50(22):2156-61. doi: 10.1016/j.jacc.2007.07.076. Epub 2007 Nov 13.

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

status_simplified: Unknown


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

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

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country: Portugal Netherlands Belgium Spain France


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

acronym: MAIA

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

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

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

location_facility: sanofi-aventis Australia & New Zealand administrative office


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

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

lead_sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

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

location_facility: Virginia Commonwealth University Health System

location_facility: Centre Hepato-Biliaire Hospital Paul Brousse

location_facility: University of Pennsylvania Health System

location_facility: Metropolitan Liver Diseases/Gastroenterology Center

location_facility: Hospital La Fe Servicio de Medicina Degestiva

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


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

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

design_allocation: Non-Randomized

lead_sponsor: Pfizer

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


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

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

ReferenceType: background

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

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

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Wiley

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

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

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

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

license: cc-by

license_normalized: cc-by

publisher_dissemination: Springer-Nature

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

lead_sponsor: UCB Pharma

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

intervention_type: Biological


type: Registry Identifier

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

acronym: PROactive

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

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

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

ReferenceCitation: Brandle M, Goodall G, Erny-Albrecht KM, Erdmann E, Valentine WJ. Cost-effectiveness of pioglitazone in patients with type 2 diabetes and a history of macrovascular disease in a Swiss setting. Swiss Med Wkly. 2009 Mar 21;139(11-12):173-84. doi: 10.4414/smw.2009.12381.

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

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

ReferenceCitation: van Troostenburg de Bruyn AR, Dormandy J. Risk of thiazolidinedione-associated fracture should be appropriately assessed. Arch Intern Med. 2010 Jan 25;170(2):209-10. doi: 10.1001/archinternmed.2009.487. No abstract available.

ReferenceCitation: Dormandy JA, Charbonnel B, Eckland DJ, Erdmann E, Massi-Benedetti M, Moules IK, Skene AM, Tan MH, Lefebvre PJ, Murray GD, Standl E, Wilcox RG, Wilhelmsen L, Betteridge J, Birkeland K, Golay A, Heine RJ, Koranyi L, Laakso M, Mokan M, Norkus A, Pirags V, Podar T, Scheen A, Scherbaum W, Schernthaner G, Schmitz O, Skrha J, Smith U, Taton J; PROactive Investigators. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet. 2005 Oct 8;366(9493):1279-89. doi: 10.1016/S0140-6736(05)67528-9.

ReferenceCitation: Schneider CA, Ferrannini E, Defronzo R, Schernthaner G, Yates J, Erdmann E. Effect of pioglitazone on cardiovascular outcome in diabetes and chronic kidney disease. J Am Soc Nephrol. 2008 Jan;19(1):182-7. doi: 10.1681/ASN.2007060678. Epub 2007 Dec 5. Erratum In: J Am Soc Nephrol. 2016 Sep;27(9):2918.

ReferenceCitation: Ryden L, Thrainsdottir I, Swedberg K. Adjudication of serious heart failure in patients from PROactive. Lancet. 2007 Jan 20;369(9557):189-90. doi: 10.1016/S0140-6736(07)60106-8. No abstract available.

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

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

ReferenceCitation: Erdmann E, Dormandy JA, Charbonnel B, Massi-Benedetti M, Moules IK, Skene AM; PROactive Investigators. The effect of pioglitazone on recurrent myocardial infarction in 2,445 patients with type 2 diabetes and previous myocardial infarction: results from the PROactive (PROactive 05) Study. J Am Coll Cardiol. 2007 May 1;49(17):1772-80. doi: 10.1016/j.jacc.2006.12.048. Epub 2007 Apr 16.

ReferenceCitation: Valentine WJ, Bottomley JM, Palmer AJ, Brandle M, Foos V, Williams R, Dormandy JA, Yates J, Tan MH, Massi-Benedetti M; PROactive Study Group. PROactive 06: cost-effectiveness of pioglitazone in Type 2 diabetes in the UK. Diabet Med. 2007 Sep;24(9):982-1002. doi: 10.1111/j.1464-5491.2007.02188.x. Epub 2007 Jun 25.

ReferenceCitation: Wilcox R, Bousser MG, Betteridge DJ, Schernthaner G, Pirags V, Kupfer S, Dormandy J; PROactive Investigators. Effects of pioglitazone in patients with type 2 diabetes with or without previous stroke: results from PROactive (PROspective pioglitAzone Clinical Trial In macroVascular Events 04). Stroke. 2007 Mar;38(3):865-73. doi: 10.1161/01.STR.0000257974.06317.49. Epub 2007 Feb 8.

ReferenceCitation: Erdmann E, Charbonnel B, Wilcox RG, Skene AM, Massi-Benedetti M, Yates J, Tan M, Spanheimer R, Standl E, Dormandy JA; PROactive Investigators. Pioglitazone use and heart failure in patients with type 2 diabetes and preexisting cardiovascular disease: data from the PROactive study (PROactive 08). Diabetes Care. 2007 Nov;30(11):2773-8. doi: 10.2337/dc07-0717. Epub 2007 Jul 31.

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

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

ReferenceCitation: Charbonnel B, Dormandy J, Erdmann E, Massi-Benedetti M, Skene A; PROactive Study Group. The prospective pioglitazone clinical trial in macrovascular events (PROactive): can pioglitazone reduce cardiovascular events in diabetes? Study design and baseline characteristics of 5238 patients. Diabetes Care. 2004 Jul;27(7):1647-53. doi: 10.2337/diacare.27.7.1647.

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

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

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

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

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

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

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

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

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

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

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

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

lead_sponsor: Takeda

sponsor_collaborators:
Takeda
Eli Lilly and Company

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


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

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

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

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

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

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


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

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

study_start_date_type: Actual

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

lead_sponsor: Baxalta now part of Shire

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

location_facility: University of Medicine & Dentistry of New Jersey

location_facility: Hemophilia Center of Western Pennsylvania

location_facility: Klinikum Innenstadt der Universität München

location_facility: Mountain States Regional Hemophilia and Thrombosis Center

location_facility: Children's Hospital Medical Center Pharmacy

location_facility: Childrens Healthcare of Atlanta Blood Bank


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

acronym: TRIUMPH

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

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

lead_sponsor: United Therapeutics

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

location_facility: Instituto Malattie dell'Apparato Vascolare

location_facility: Univesitatsklinikum Giessen und Marburg GmbH


type: Other Identifier

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

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

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

ipd_sharing: Undecided

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

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

lead_sponsor: Novartis Pharmaceuticals

sponsor_collaborators:
Novartis Pharmaceuticals
Merck Sharp & Dohme LLC

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


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

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

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
United States
Belgium
France


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

acronym: RADIANCE 2

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

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

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

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

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

ReferenceCitation: Kastelein JJ, van Leuven SI, Evans GW, Riley WA, Revkin JH, Shear CL, Bots ML; RADIANCE 1 and 2 Study Investigators. Designs of RADIANCE 1 and 2: carotid ultrasound studies comparing the effects of torcetrapib/atorvastatin with atorvastatin alone on atherosclerosis. Curr Med Res Opin. 2007 Apr;23(4):885-94. doi: 10.1185/030079907x182121.

location_country:
Finland
Netherlands
United States
Canada
Czech Republic
France


title: A Randomized Trial of Switching Antiviral Therapy From Lamivudine to Telbivudine (LdT) vs. Continued Lamivudine Treatment in Adults With Chronic Hepatitis B

summary: This study is being conducted to compare the safety and effectiveness of switching treatment from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from patients who were taking lamivudine and then switched to telbivudine will be compared with the results from patients who continued on lamivudine alone.

lead_sponsor: Novartis

sponsor_collaborators:
Novartis
Novartis Pharmaceuticals

location_country:
New Zealand
Israel
Singapore
United Kingdom
Australia
United States
China
Thailand
Taiwan
Canada
France


title: A Phase II/III Extension Study to Evaluate the Safety and Tolerability of Atrasentan

summary: The primary purpose of the study is to evaluate long-term safety and tolerability of atrasentan 10 mg in men with hormone refractory prostate cancer.

lead_sponsor: Abbott

location_country:
United Kingdom
Netherlands
United States
Canada
France

location_facility: University Hospital Rotterdam, Department of Urology

location_facility: University of Pittsburgh Department of Urology

location_facility: Leighton Hospital Urology Research Dept., Michael Heal Outpatients Dept.

location_facility: CroMedia Prime/Prime Trials Vancouver Hospital

location_facility: McGill University Health Center Royal VIctoria Hosptial

location_facility: ViaHealth Rochester General Hospital Center for Urology

location_facility: Oregon Urology Specialist, Division of Clinical Research

location_facility: Beth Isreal Medical Center, Phillips Ambulatory Care Ceneter


title: Open Label Extension Study of Eculizumab in Patients With Transfusion Dependent PNH

summary: The purpose of this study is to evaluate the long-term safety of eculizumab in patients with transfusion dependent hemolytic PNH.

ReferenceCitation: Hillmen P, Muus P, Duhrsen U, Risitano AM, Schubert J, Luzzatto L, Schrezenmeier H, Szer J, Brodsky RA, Hill A, Socie G, Bessler M, Rollins SA, Bell L, Rother RP, Young NS. Effect of the complement inhibitor eculizumab on thromboembolism in patients with paroxysmal nocturnal hemoglobinuria. Blood. 2007 Dec 1;110(12):4123-8. doi: 10.1182/blood-2007-06-095646. Epub 2007 Aug 16.

ipd_sharing: No

lead_sponsor: Alexion Pharmaceuticals, Inc.

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

location_facility: Hartford Hospital, Cancer Clinical Research Office

location_facility: Stockholm South Hospital, Division of Hematology

location_facility: St. James's Hospital, Cancer Clinical Trial Office

location_facility: Royal North Shore Hospital, Haematology Department

location_facility: Universitatskliniken des Saarlandes, Innere Medizin 1

location_facility: Stanford University Medical Center, Division of Hematology

location_facility: Institut fur Klinische Transfusionmedizin und Immunogenetik, Abtlg. Transfusionmedizin des Univ. Ulm

location_facility: Hospital De La Paz, Servicio de Hematologia

location_facility: UMC St. Radboud, Department of Hematology

location_facility: Cleveland Clinic Florida, Department of Clinical Research

location_facility: Princess Alexandra Hospital, Oncology Haematology Radiation Department

location_facility: London Regional Cancer Centre, Clinical Research Unit Room C3080

location_facility: Royal Melbourne Hospital, Department of Clinical Haematology & Medical Oncology

location_facility: Ospedale Maggiore di Milano, Divisione di Ematologia

location_facility: National Heart, Lung, and Blood Institute, National Institutes of Health

location_facility: St. George's Hospital, Department of Haematology

location_facility: The Royal Perth Hospital, Department of Haematology/Level 2

location_facility: The Queen Elizabeth Hospital, Haematology/Oncology Department

location_facility: Washington University, Department of Internal Medicine/Division of Hematology

location_facility: University of Alberta, Cross Cancer Institute

location_facility: Hopital Saint Louis, Centre d'investigation Clinique

location_facility: Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thombosis Program

location_facility: Hospital Clinic i Provincial, Servicio de Hematologia

location_facility: Azienda Ospedaliera Universitaria Careggi, Dipartimento di area critica medico-chirurgica

location_facility: Ospedale San Martino, Department of Hematology

location_facility: Ospedale San Bortolo, Divisione di Ematologia

location_facility: Medizinische Hochschule Hannover, Abt. Hamatologie/Onkologie, Zentrum fur Innere Medizin

location_facility: Leeds General Infirmary, D Floor Brotherton Wing

location_facility: Duke University Medical Center, Division Cell Therapy, Heme Malignancies Program

location_facility: Hospital Universitario Germans Trias I Pujol, Servicio de Hematologia

location_facility: Universitatsklinikum Essen, Zentrum fur Innere Medizin

location_facility: Universita degli Studi di Napoli, Divisione di Ematologia, Azienda Universitar Policlinico


title: Safety in Hemolytic PNH Patients Treated With Eculizumab: a Multi-Center Open-Label Research Design Study

summary: The primary objective is to evaluate the safety of eculizumab in patients with transfusion-dependent hemolytic PNH

location_country:
Germany
Ireland
Italy
United Kingdom
Australia
Sweden
Netherlands
Switzerland
Belgium
United States
Spain
Canada
France

location_facility: Hartford Hospital, Cancer Clinical Research Office

location_facility: Washington University Medical Center, Department of Internal Medicine/Division of Hematology

location_facility: Royal Melbourne Hospital, Dept. of Clinical Haematology & Medical Oncology

location_facility: Stockholm South Hospital, Division of Hematology

location_facility: Royal North Shore Hospital, Haematology Department

location_facility: St. James Hospital, Haematology Dept., Cancer Clinical Trial Office

location_facility: Ospedale San Martino, Dept. of Hematology

location_facility: Universitatskliniken des Saarlandes, Innere Medizin 1

location_facility: Stanford University Medical Center, Division of Hematology

location_facility: Hospital De La Paz, Servicio de Hematologia

location_facility: Kantonsspital Basel, Abteilung fuer Haematologie

location_facility: Institut fur Klinische Transfusionmedizin und Immungenetik, Abtlg. Transfusionmedizin des Univer. Ulm

location_facility: University Hospital, Dept. of Haematology

location_facility: UMC St. Radboud, Department of Hematology

location_facility: Princess Alexandra Hospital, Oncology Haematology Radiation Department

location_facility: London Regional Cancer Centre, Clinical Research Unit Room C3080

location_facility: Cooper University Hospital, Cooper Cancer Institute

location_facility: Ospedale Maggiore di Milano, Divisione di Ematologia

location_facility: OHSU Center for Hematologic Malignancies

location_facility: National Heart, Lung, and Blood Institute, National Institutes of Health

location_facility: Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thrombosis Program

location_facility: Hopital Saint-Louis, Centre d'investigation Clinique

location_facility: St. Georges Hospital, Department of Haematology

location_facility: Cleveland Clinic Florida, Dept. of Clinical Research

location_facility: University of Utah, Hematology-BMT Department

location_facility: The Royal Perth Hospital, Dept. of Haematology/Level 2


title: A Phase III Randomized Trial of Docetaxel Based Induction Chemotherapy in Patients With N2/N3 Locally Advanced Head and Neck Cancer

acronym: DeCIDE

summary: The combined use of chemotherapeutic drugs with radiation has proven to be effective in improving overall survival and local control among patients with locally advanced head and neck cancer. Induction chemotherapy given before receiving local treatment has been shown to reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from growing or dividing, although it has yet to be determined which agent, or specific combination of agents, is most effective in treating head and neck cancer. Docetaxel is a drug which has been reported to show promising activity in Phase II head and neck cancer studies. Therefore, the purpose of this trial is to compare the effectiveness of induction chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in patients with locally advanced head and neck cancer.

lead_sponsor: University of Chicago

location_country:
United States
Spain
Croatia
Russian Federation
France

location_facility: UM Sylvester Comprehensive Cancer Center

location_facility: NN Blokhin Russian Cancer Research Centre RAMS

location_facility: USC University of Southern California Keck School of Medicine

location_facility: Clinic of Oncology, University Hospital Center Zagreb

location_facility: University of Tennessee Cancer Institute

location_facility: Fort Wayne Medical Oncology/Hematology Inc.

lead_sponsor_type: academique


title: A Randomized, Open-Label Trial of Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

summary: This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking adefovir dipivoxil.

ReferenceCitation: Chan HL, Heathcote EJ, Marcellin P, Lai CL, Cho M, Moon YM, Chao YC, Myers RP, Minuk GY, Jeffers L, Sievert W, Bzowej N, Harb G, Kaiser R, Qiao XJ, Brown NA; 018 Study Group. Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial. Ann Intern Med. 2007 Dec 4;147(11):745-54. doi: 10.7326/0003-4819-147-11-200712040-00183. Epub 2007 Oct 1.

location_country:
Singapore
Australia
United States
China
Korea, Republic of
Thailand
Taiwan
Canada
France


title: A Multicenter, Multinational Study to Assess the Safety and Efficacy of Antithrombin Alfa in Hereditary Antithrombin (AT) Deficient Patients in High-Risk Situations for Thrombosis

summary: Patients with hereditary antithrombin deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial focused on patients with confirmed hereditary antithrombin deficiency who were undergoing a surgical procedure or induced/spontaneous labor and delivery, and/or caesarean section. The study assessed the incidence of thromboembolic events following prophylactic intravenous administration of recombinant human antithrombin (rhAT) to patients with hereditary antithrombin (AT) deficiency in situations usually associated with a high risk for thromboembolic events.

ReferenceCitation: DeJongh J, Frieling J, Lowry S, Drenth HJ. Pharmacokinetics of recombinant human antithrombin in delivery and surgery patients with hereditary antithrombin deficiency. Clin Appl Thromb Hemost. 2014 May;20(4):355-64. doi: 10.1177/1076029613516188. Epub 2013 Dec 11.

oa_host_type: publisher

evidence: open (via page says license)

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: SAGE Publications

lead_sponsor: rEVO Biologics

location_country:
Germany
Italy
United Kingdom
Australia
Austria
United States
Canada
France


title: A Single Agent Phase II Study of Depsipeptide (FK228) in the Treatment of Cutaneous T-cell Lymphoma

summary: GPI-04-0001 was a Phase II, non-randomized, open label, single arm study that was conducted at approximately 30 sites, primarily in the United States, Europe and Russia. It assessed the efficacy, safety, and tolerability of romidepsin as a treatment for cutaneous T-cell lymphoma (CTCL). Study patients (pts) received romidepsin in a dose of 14 mg/m^2 intravenously over 4 hours on Days 1, 8 and 15 of each 28-day cycle. The duration of study treatment was 6 cycles although pts who showed an objective response or stable disease could continue to receive therapy, at the discretion of the investigator, until disease progression or another withdrawal criterion was met.

ReferenceCitation: Duvic M, Bates SE, Piekarz R, Eisch R, Kim YH, Lerner A, Robak T, Samtsov A, Becker JC, McCulloch W, Waksman J, Whittaker S. Responses to romidepsin in patients with cutaneous T-cell lymphoma and prior treatment with systemic chemotherapy. Leuk Lymphoma. 2018 Apr;59(4):880-887. doi: 10.1080/10428194.2017.1361022. Epub 2017 Aug 30.

ReferenceCitation: Foss F, Duvic M, Lerner A, Waksman J, Whittaker S. Clinical Efficacy of Romidepsin in Tumor Stage and Folliculotropic Mycosis Fungoides. Clin Lymphoma Myeloma Leuk. 2016 Nov;16(11):637-643. doi: 10.1016/j.clml.2016.08.009. Epub 2016 Aug 10.

ReferenceCitation: Foss F, Coiffier B, Horwitz S, Pro B, Prince HM, Sokol L, Greenwood M, Lerner A, Caballero D, Baran E, Kim E, Nichols J, Balser B, Wolfson J, Whittaker S. Tolerability to romidepsin in patients with relapsed/refractory T-cell lymphoma. Biomark Res. 2014 Sep 8;2:16. doi: 10.1186/2050-7771-2-16. eCollection 2014.

repositories_concat: PubMed Central;University of Melbourne - Minerva Access

publisher_dissemination: Springer

ReferenceCitation: Demierre M, et al. Pooled analyses of two international, multicenter clinical studies of romidepsin in 167 patients with cutaneous T-cell lymphoma (CTCL). Presented at 2009 ASCO Annual Meeting, May 29-June 2, 2009, Orlando, FL. Abstract No: 8546. J Clin Oncol 27:15s, 2009 (suppl)

ReferenceCitation: Cabell C, et al. Systematic Assessment of Potential Cardiac Effects of the Novel Histone Deacetylase (HDAC) Inhibitor Romidepsin. Presented at 2009 ASCO Annual Meeting, May 29-June 2, 2009, Orlando, FL. Abstract No: e19533. C J Clin Oncol 2009;27(suppl)

ReferenceCitation: Kim YH, et al. Clinically Significant Responses Achieved with Romidepsin in 37 Patient with Cutaneous T-Cell Lymphoma (CTCL) with Blood Involvement. Presented at American Society of Hematology 2009, New Orleans, LA. Abstract No. 2683.

ReferenceCitation: Whittaker SJ, Demierre MF, Kim EJ, Rook AH, Lerner A, Duvic M, Scarisbrick J, Reddy S, Robak T, Becker JC, Samtsov A, McCulloch W, Kim YH. Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma. J Clin Oncol. 2010 Oct 10;28(29):4485-91. doi: 10.1200/JCO.2010.28.9066. Epub 2010 Aug 9.

lead_sponsor: Celgene

sponsor_collaborators:
Celgene
Celgene Corporation

location_country:
Germany
Poland
United Kingdom
United States
Russian Federation
France

location_facility: University of Pennsylvania Abrahamson Cancer Center


title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab

summary: The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.

ReferenceCitation: Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Colombel JF, Panaccione R, D'Haens G, Li J, Rosenfeld MR, Kent JD, Pollack PF. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med. 2007 Jun 19;146(12):829-38. doi: 10.7326/0003-4819-146-12-200706190-00159. Epub 2007 Apr 30.

location_country:
United States
Canada
Belgium
France

location_facility: Mount Sinai School of Medicine IBD Research Center

location_facility: Liver and Intestinal Disease Research Center

location_facility: Long Island Clinical Research Assoc. LLP

location_facility: The Oregon Clinic, PC Gastroenterology Division

location_facility: Capitol Gastroenterology Consultants Medical Group, Inc.

location_facility: Atlantic Gastroenterology Associates, LLC

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Heritage Medical Research Clinic Health Sciences Centre University of Calgary

location_facility: University of Kentucky Medical Center Division of Digestive Diseases

location_facility: Outpatient Clinical Research Facility University of Indianapolis

location_facility: Gastroenterology Center of the Mid South

location_facility: Gastrointestinal and Liver Disease Consultants

location_facility: Regional Gastroenterologist Associates of Lancaster

location_facility: Gastroenterology Associates of Cleveland


title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 18-Month Study of the Efficacy of Xaliproden in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

summary: The purpose of this study is to assess xaliproden's potential capacity of slowing the deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's disease. The patients participating in this study will take orally once daily xaliproden or placebo (inactive substance pill).

lead_sponsor: Sanofi

location_country:
Italy
Hong Kong
Singapore
Australia
Netherlands
United States
Spain
South Africa
Taiwan
France

location_facility: Alzheimer's Research & Clinical Programs

location_facility: University Medical Center, Dept. of Psychiatry Clinical Trials

location_facility: Neurological Physicians of Arizona, Inc.

location_facility: Eastern Virginia Medical School - The Glennan Center For Geriatrics "Gerontology"

location_facility: sanofi-aventis Australia & New Zealand administrative office


title: A Phase III Multicenter, 52-Week, Randomized, Double-Blind, Placebo-Controlled Study of the Clinical Efficacy and Safety of ICA-17043 With or Without HU Therapy in Patients With Sickle Cell Disease Who Have Had =>2 Acute Sickle-Related Painful Crises Within the Preceding 12 Months

acronym: ASSERT

summary: The purpose of this study is to compare the effects of ICA-17043 to placebo with or without hydroxyurea (an oral drug used for treatment of sickle cell disease) in patients with sickle cell disease who have had 2 or more acute sickle-related painful crises requiring a visit to a medical facility within the past 12 months.

ReferenceCitation: Stocker JW, De Franceschi L, McNaughton-Smith GA, Corrocher R, Beuzard Y, Brugnara C. ICA-17043, a novel Gardos channel blocker, prevents sickled red blood cell dehydration in vitro and in vivo in SAD mice. Blood. 2003 Mar 15;101(6):2412-8. doi: 10.1182/blood-2002-05-1433. Epub 2002 Nov 14.

lead_sponsor: Icagen

collaborators: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

location_country:
Jamaica
Trinidad and Tobago
United Kingdom
Brazil
United States
France


title: A Multinational, Randomized, Double-blind, Placebo-controlled, Forced-titration, 2 x 2 Factorial Design Study of the Efficacy and Safety of Long-term Administration of Nateglinide and Valsartan in the Prevention of Diabetes and Cardiovascular Outcomes in Subjects With Impaired Glucose Tolerance (IGT)

acronym: Navigator

summary: This study is a test of the safety and effectiveness of two drugs, one for diabetes and one for hypertension, in keeping patients with high lab values of glucose from progressing to frank diabetes and developing cardiovascular complications. People in this study cannot have frank diabetes but are considered "borderline" based on blood tests. People in the study take none, one or both of the drugs and do not know which one(s) they are taking.

ReferenceCitation: Harumi Higuchi Dos Santos M, Sharma A, Sun JL, Pieper K, McMurray JJ, Holman RR, Lopes RD. International Variation in Outcomes Among People with Cardiovascular Disease or Cardiovascular Risk Factors and Impaired Glucose Tolerance: Insights from the NAVIGATOR Trial. J Am Heart Assoc. 2017 Jan 13;6(1):e003892. doi: 10.1161/JAHA.116.003892.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: Australian Catholic University - Research Bank

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

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

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Preiss D, Thomas LE, Wojdyla DM, Haffner SM, Gill JM, Yates T, Davies MJ, Holman RR, McMurray JJ, Califf RM, Kraus WE; NAVIGATOR Investigators. Prospective relationships between body weight and physical activity: an observational analysis from the NAVIGATOR study. BMJ Open. 2015 Aug 14;5(8):e007901. doi: 10.1136/bmjopen-2015-007901.

publisher_dissemination: British Medical Journal

ReferenceCitation: Katz M, Califf RM, Sun JL, McMurray JJ, Thomas L, Lopes RD. Venous thromboembolism and cardiovascular risk: results from the NAVIGATOR trial. Am J Med. 2015 Mar;128(3):297-302. doi: 10.1016/j.amjmed.2014.08.022. Epub 2014 Nov 20.

oa_host_type: closed

publisher_dissemination: Elsevier

ReferenceCitation: Preiss D, Haffner SM, Thomas LE, Sun JL, Sattar N, Yates T, J Davies M, McMurray JJ, Holman RR, Califf RM, Kraus WE. Change in levels of physical activity after diagnosis of type 2 diabetes: an observational analysis from the NAVIGATOR study. Diabetes Obes Metab. 2014 Dec;16(12):1265-8. doi: 10.1111/dom.12320. Epub 2014 Jun 19.

ReferenceCitation: Huffman KM, Sun JL, Thomas L, Bales CW, Califf RM, Yates T, Davies MJ, Holman RR, McMurray JJ, Bethel MA, Tuomilehto J, Haffner SM, Kraus WE. Impact of baseline physical activity and diet behavior on metabolic syndrome in a pharmaceutical trial: results from NAVIGATOR. Metabolism. 2014 Apr;63(4):554-61. doi: 10.1016/j.metabol.2014.01.002. Epub 2014 Jan 15.

oa_host_type: repository

ReferenceCitation: Yates T, Haffner SM, Schulte PJ, Thomas L, Huffman KM, Bales CW, Califf RM, Holman RR, McMurray JJ, Bethel MA, Tuomilehto J, Davies MJ, Kraus WE. Association between change in daily ambulatory activity and cardiovascular events in people with impaired glucose tolerance (NAVIGATOR trial): a cohort analysis. Lancet. 2014 Mar 22;383(9922):1059-66. doi: 10.1016/S0140-6736(13)62061-9. Epub 2013 Dec 20.

ReferenceCitation: Shen L, Shah BR, Reyes EM, Thomas L, Wojdyla D, Diem P, Leiter LA, Charbonnel B, Mareev V, Horton ES, Haffner SM, Soska V, Holman R, Bethel MA, Schaper F, Sun JL, McMurray JJ, Califf RM, Krum H. Role of diuretics, beta blockers, and statins in increasing the risk of diabetes in patients with impaired glucose tolerance: reanalysis of data from the NAVIGATOR study. BMJ. 2013 Dec 9;347:f6745. doi: 10.1136/bmj.f6745. Erratum In: BMJ. 2014;348:f1339.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: NAVIGATOR Study Group; McMurray JJ, Holman RR, Haffner SM, Bethel MA, Holzhauer B, Hua TA, Belenkov Y, Boolell M, Buse JB, Buckley BM, Chacra AR, Chiang FT, Charbonnel B, Chow CC, Davies MJ, Deedwania P, Diem P, Einhorn D, Fonseca V, Fulcher GR, Gaciong Z, Gaztambide S, Giles T, Horton E, Ilkova H, Jenssen T, Kahn SE, Krum H, Laakso M, Leiter LA, Levitt NS, Mareev V, Martinez F, Masson C, Mazzone T, Meaney E, Nesto R, Pan C, Prager R, Raptis SA, Rutten GE, Sandstroem H, Schaper F, Scheen A, Schmitz O, Sinay I, Soska V, Stender S, Tamas G, Tognoni G, Tuomilehto J, Villamil AS, Vozar J, Califf RM. Effect of valsartan on the incidence of diabetes and cardiovascular events. N Engl J Med. 2010 Apr 22;362(16):1477-90. doi: 10.1056/NEJMoa1001121. Epub 2010 Mar 14. Erratum In: N Engl J Med. 2010 May 6;362(18):1748.

ReferenceCitation: NAVIGATOR Study Group; Holman RR, Haffner SM, McMurray JJ, Bethel MA, Holzhauer B, Hua TA, Belenkov Y, Boolell M, Buse JB, Buckley BM, Chacra AR, Chiang FT, Charbonnel B, Chow CC, Davies MJ, Deedwania P, Diem P, Einhorn D, Fonseca V, Fulcher GR, Gaciong Z, Gaztambide S, Giles T, Horton E, Ilkova H, Jenssen T, Kahn SE, Krum H, Laakso M, Leiter LA, Levitt NS, Mareev V, Martinez F, Masson C, Mazzone T, Meaney E, Nesto R, Pan C, Prager R, Raptis SA, Rutten GE, Sandstroem H, Schaper F, Scheen A, Schmitz O, Sinay I, Soska V, Stender S, Tamas G, Tognoni G, Tuomilehto J, Villamil AS, Vozar J, Califf RM. Effect of nateglinide on the incidence of diabetes and cardiovascular events. N Engl J Med. 2010 Apr 22;362(16):1463-76. doi: 10.1056/NEJMoa1001122. Epub 2010 Mar 14. Erratum In: N Engl J Med. 2010 May 6;362(18):1748.

ReferenceCitation: Krum H, McMurray JJ, Horton E, Gerlock T, Holzhauer B, Zuurman L, Haffner SM, Bethel MA, Holman RR, Califf RM. Baseline characteristics of the Nateglinide and Valsartan Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) trial population: comparison with other diabetes prevention trials. Cardiovasc Ther. 2010 Apr;28(2):124-32. doi: 10.1111/j.1755-5922.2010.00146.x. Epub 2010 Feb 23.

ReferenceCitation: Bethel MA, Deedwania P, Levitt NS, Schmitz O, Huntsman-Labed A, Califf RM, Haffner SM, Diem P; NAVIGATOR Study Group. Metabolic syndrome and alanine aminotransferase: a global perspective from the NAVIGATOR screening population. Diabet Med. 2009 Dec;26(12):1204-11. doi: 10.1111/j.1464-5491.2009.02864.x.

ReferenceCitation: Bethel MA, Holman R, Haffner SM, Califf RM, Huntsman-Labed A, Hua TA, McMurray J. Determining the most appropriate components for a composite clinical trial outcome. Am Heart J. 2008 Oct;156(4):633-40. doi: 10.1016/j.ahj.2008.05.018. Epub 2008 Jul 31.

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Turkey
Chile
Czechia
Canada
France
Colombia
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Belgium
China
Malaysia
Peru
Italy
Guatemala
Ecuador
Norway
Singapore
United Kingdom
Netherlands
Austria
Mexico
Uruguay
Spain
Greece
South Africa
Taiwan
Russian Federation
Sweden


title: A 24 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Donepezil Hydrochloride (E2020) in Patients With Severe Alzheimer's Disease Followed by a 12 Week Open-Label Extension Period

summary:
Donepezil hydrochloride (Aricept) has been approved to treat symptoms associated with mild to moderate Alzheimer's disease (AD). Aricept has been shown to improve the memory and thinking abilities, activities of daily living and global function in patients. The purpose of the study is to further investigate the effectiveness and safety of donepezil in patients with severe Alzheimer's disease.

Donepezil is thought to work in the brain by increasing the levels of an important brain chemical called acetylcholine. This chemical helps a person's memory to work better.

lead_sponsor: Eisai Inc.

sponsor_collaborators:
Eisai Inc.
Pfizer

location_country:
Ireland
United Kingdom
Australia
United States
Canada
France


title: An Open-label, Non-comparative, Multi-centre Study to Assess the Efficacy and Safety of Bicalutamide When Used in Combination With Anastrozole for the Treatment of Gonadotropin-independent Precocious Puberty in Boys With Testotoxicosis

acronym: BATT

summary: The primary objective of this study is to investigate whether bicalutamide given in combination with anastrozole once daily for 12 months is effective in treating testotoxicosis in boys. Testotoxicosis is a condition that causes early puberty in boys including growth in height, and development of muscles and sexual organs .

lead_sponsor: AstraZeneca

location_country:
India
United Kingdom
United States
Canada
Russian Federation
France


title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Mildly Symptomatic Pulmonary Arterial Hypertension (PAH)

summary: The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients suffering from PAH Class II.

ReferenceCitation: Galie N, Rubin Lj, Hoeper M, Jansa P, Al-Hiti H, Meyer G, Chiossi E, Kusic-Pajic A, Simonneau G. Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. Lancet. 2008 Jun 21;371(9630):2093-100. doi: 10.1016/S0140-6736(08)60919-8.

lead_sponsor: Actelion

location_country:
France
Germany
Italy
United Kingdom
Australia
Netherlands
Austria
Belgium
Switzerland
United States
China
Spain
Canada
Czech Republic

location_facility: Centre de Pneumologie de L'Hospital Laval


title: Phase II Multi-Center, Open-Label, Non-Randomized Study of Intravenous RPR109881 Given Every 3 Weeks in Patients With Metastatic Breast Cancer Progressing After Therapy With Anthracyclines, Taxanes and Capecitabine

summary: The purpose of this clinical trial is to determine if the investigational drug is able to reduce/shrink advanced breast cancer tumors in patients who no longer benefit from anthracyclines, taxanes and capecitabine.

location_country:
Germany
Italy
Colombia
Argentina
Denmark
Netherlands
Switzerland
Belgium
United States
Korea, Republic of
Spain
South Africa
Turkey
Canada
France


title: A Phase III Randomized Trial to Evaluate the Efficacy and Safety of Second-Line Therapy With Fludarabine Plus Alemtuzumab vs. Fludarabine Alone in Patients With B-Cell Chronic Lymphocytic Leukemia

summary: This is a Phase 3, prospective, multicenter, open-label, randomized, controlled study to evaluate and compare the efficacy and safety of fludarabine plus alemtuzumab versus fludarabine alone as second-line therapy for patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL). Patients who meet all eligibility criteria and sign the informed consent document may be entered on the study.

ReferenceCitation: Engert A, et al. Overall Survival Advantage and Acceptable Safety Profile with Fludarabine in Combination with Alemtuzumab (FluCam) in Previously Treated Patients with Advanced Stage Chronic Lymphocytic Leukemia. Poster Presentation at American Society of Hematology 10 December 2010; Blood (ASH Annual Meeting Abstracts), Nov 2010;116:919. http://ash.confex.com/ash/2010/webprogram/Paper31687.html

ReferenceCitation: Engert A, et al. Improved Progression-free Survival (PFS) of Alemtuzumab (Campath®, MabCampath®) plus Fludarabine (Fludara®) versus Fludarabine Alone as Second-line Treatment of Patients with B-Cell Chronic Lymphocytic Leukemia: Preliminary Results from a Phase III Randomized Trial. 51st ASH Annual Meeting. Blood 2009;114. Abstract 537. http://ash.confex.com/ash/2009/webprogram/Paper21929.html

ReferenceCitation: Engert A, et al. Fludarabine (FLU) plus Alemtuzumab (FluCAM) Improves Progression Free Survival versus Fludarabine in Previously Treated Chronic Lymphocytic Leukemia and Demonstrates Activity in High Risk Patients. Poster Presentation at European Hematology Association 12 June 2010. Abstract 0768. http://www.eventure-online.com/eventure/publicAbstractView.do?id=136964&congressId=3446

ReferenceCitation: Elter T, Gercheva-Kyuchukova L, Pylylpenko H, Robak T, Jaksic B, Rekhtman G, Kyrcz-Krzemien S, Vatutin M, Wu J, Sirard C, Hallek M, Engert A. Fludarabine plus alemtuzumab versus fludarabine alone in patients with previously treated chronic lymphocytic leukaemia: a randomised phase 3 trial. Lancet Oncol. 2011 Dec;12(13):1204-13. doi: 10.1016/S1470-2045(11)70242-X. Epub 2011 Oct 10.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Germany
Italy
Poland
Portugal
Romania
Sweden
Austria
United States
Greece
Croatia
Ukraine
Bulgaria
Canada
Russian Federation
France

location_facility: Istituto di Ematologia Dipartmento di Biotechnologie Celluari ed Ematologia, Universita di Roma "La Sapienza"

location_facility: GOUVPO "Saint-Petersburg State Medical University named after acad I.P.Pavlov of Roszdrav", Bone Marrow Transplantology Clinic

location_facility: State Healthcare Department "Sverdlovsk Regional Clinical Hospital #1",

location_facility: Institutol Clinic Fundeni, Clinica Heamtologie

location_facility: Charite Universitatsklinikum der Humboldt-Universitat zu Berlin

location_facility: Khmelnitskiy Regional Hospital, Hematology Department

location_facility: Clinical Hospital Center Rijeka, Department of Haematology

location_facility: University Hospital, Dept. of Hematology

location_facility: Katedra i Klinika Hamatologii, Onkologii I Chorob Wewnetrznych AM

location_facility: National Center for Heamtology and Transfusiology

location_facility: Scientific Centre for Radiation Medicine AMS of Ukraine, Dept of Hematology and Transplantology

location_facility: Charite-Universitatsmedizin Berlin Campus Benjamin-Franklin

location_facility: Multiprofile Hospital for Active Treatment "Alexandrovska"

location_facility: Unita Operativa di Medicina Generale Reumatologia e Oncoematologia

location_facility: University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski

location_facility: Hospital de Sao Teotonio, Servico de Hematologia/Hosptial de Dia Oncologico

location_facility: City Clinical Hospital #4, Regional Hematology Center

location_facility: Orebro University Hospital, Dep. of Medicine

location_facility: Klinika Hematologii Pomorskiej Akademii Medycznej w Szczecinie

location_facility: Lviv National Medical University named Danilo Galytcky

location_facility: Hospital de Santa Maria Servico de Hematologia Clinica/Hospital de dia de Hematologia

location_facility: "Laikon" General Hospital, University of Athens

location_facility: U.O. Oncologia Medica Azienda Ospedaliera "Pugliese-Ciaccio"

location_facility: Saint-Petersburg GUZ "City Hospital #31" 3, Dynamo Prospect

location_facility: Kharkov Regional Clinical Oncology Center, Department of Hematology

location_facility: Institute of Hematology and Transfusiology AMS of Ukraine, City Clinical Hospital #9

location_facility: Klinika Hematologii i Transplantacji Szpiku

location_facility: Multiprofile Hospital for Active Treatment, St. Marina

location_facility: Klinika Hematologii, Nowotworow Krwii 1 Transplantacji Szpiku

location_facility: GU "Main Military Clinical Hospital named after acad. N.N.Burdenko of MO of Russia", Haematology Centre 3

location_facility: Klinikum der Universitat zu Koln, Klinik 1 fur Innere Medizin


title: Randomized Phase II Trial of Docetaxel (Taxotere) and Oblimersen (Antisense Oligonucleotide Directed to BCL-2) Versus Taxotere Alone in Patients With Hormone-Refractory Prostate Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of docetaxel by making tumor cells more sensitive to the drug.

PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with oblimersen works compared to docetaxel alone in treating patients with hormone-refractory adenocarcinoma (cancer) of the prostate.

ReferenceCitation: Sternberg CN, Dumez H, Van Poppel H, Skoneczna I, Sella A, Daugaard G, Gil T, Graham J, Carpentier P, Calabro F, Collette L, Lacombe D; EORTC Genitourinary Tract Cancer Group. Docetaxel plus oblimersen sodium (Bcl-2 antisense oligonucleotide): an EORTC multicenter, randomized phase II study in patients with castration-resistant prostate cancer. Ann Oncol. 2009 Jul;20(7):1264-9. doi: 10.1093/annonc/mdn784. Epub 2009 Mar 17.

ReferenceCitation: Sternberg CN, Dumez H, Van Poppel H, et al.: Multicenter randomized EORTC trial 30021 of docetaxel + oblimersen and docetaxel in patients (pts) with hormone refractory prostate cancer (HRPC). [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-144, 2007.

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

location_country:
France
Italy
Poland
Portugal
United Kingdom
Denmark
Netherlands
Austria
Belgium
Spain
Israel

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Hospital General Universitari Vall d'Hebron

location_facility: Academisch Medisch Centrum at University of Amsterdam


title: Double-blind, Partially Randomized, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis Having Completed the Phase III Oral Ibandronate Trial BM16549

summary: This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Poland
Hungary
Norway
Denmark
United Kingdom
Brazil
Mexico
Belgium
United States
Spain
Czechia
France


title: Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)

summary:
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with Waldenstrom's macroglobulinemia.

status: Withdrawn

lead_sponsor: Jonsson Comprehensive Cancer Center

sponsor_collaborators:
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)

location_country:
United Kingdom
Australia
United States
Canada
France

location_facility: Jonsson Comprehensive Cancer Center at UCLA

location_facility: Rocky Mountain Cancer Centers - Denver Midtown

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University

location_facility: Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

location_facility: Herbert Irving Comprehensive Cancer Center at Columbia University

location_facility: Greenebaum Cancer Center at University of Maryland Medical Center

location_facility: McMaster Children's Hospital at Hamilton Health Sciences


title: A Randomized, Double-Blind, Double-Dummy , Parallel Group, Multinational, Clinical Study to Evaluate the Efficacy and Safety of Enoxaparin Versus Unfractionated Heparin in Patients With Acute ST-Segment Elevation Myocardial Infarction Receiving Fibrinolytic Therapy

summary: The primary objective of the study is to determine whether enoxaparin compared to unfractionated heparin will reduce the composite endpoint of all-cause mortality and non-fatal myocardial re-infarction within 30 days after randomization in patients with acute ST-segment elevation myocardial infarction who are eligible to receive fibrinolytic therapy

ReferenceCitation: Antman EM, Morrow DA, McCabe CH, Murphy SA, Ruda M, Sadowski Z, Budaj A, Lopez-Sendon JL, Guneri S, Jiang F, White HD, Fox KA, Braunwald E; ExTRACT-TIMI 25 Investigators. Enoxaparin versus unfractionated heparin with fibrinolysis for ST-elevation myocardial infarction. N Engl J Med. 2006 Apr 6;354(14):1477-88. doi: 10.1056/NEJMoa060898. Epub 2006 Mar 14.

ReferenceCitation: Morrow DA, Antman EM, Fox KA, White HD, Giugliano R, Murphy SA, McCabe CH, Braunwald E; ExTRACT-TIMI 25 Investigators. One-year outcomes after a strategy using enoxaparin vs. unfractionated heparin in patients undergoing fibrinolysis for ST-segment elevation myocardial infarction: 1-year results of the ExTRACT-TIMI 25 trial. Eur Heart J. 2010 Sep;31(17):2097-102. doi: 10.1093/eurheartj/ehq098. Epub 2010 Apr 17.

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Thailand
Turkey
Croatia
Chile
Canada
France
Belarus
Lithuania
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Latvia
Ukraine
India
Romania
Lebanon
Belgium
China
Malaysia
Estonia
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Uruguay
Greece
South Africa
Jordan
Bulgaria
Russian Federation
Israel

location_facility: sanofi-aventis Australia & New Zealand administrative office


title: A Double-Blind, Placebo-Controlled, Parallel, Multicenter Study on Extended VTE Prophylaxis in Acutely Ill Medical Patients With Prolonged Immobilization

summary:
Primary objective:

To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd for 28 ± 4 days, compared to placebo, both following 10 ± 4 days of initial treatment with enoxaparin 40mg sc qd

Secondary objectives:

To assess the reduction in mortality rate at the end of the double-blind treatment period, at 3 (90 ± 10 days) and at 6 (180 ± 10 days) months from the time of entry to the study, in patients on extended prophylaxis
To assess the incidence of VTE at 3 months (90 ± 10 days) from the time of randomization to the study

To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical patients with prolonged immobilization. Safety evaluation includes:

Major and minor hemorrhage
Heparin induced thrombocytopenia
Serious adverse events
To assess differences in levels of health-care utilization and cost between patients receiving extended VTE prophylaxis versus those receiving placebo.

ReferenceCitation: Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Turpie AG, Hull RD, Schellong SM, Tapson VF, Monreal M, Samama MM, Chen M, Yusen RD; EXCLAIM Investigators. Venous thromboembolism risk in ischemic stroke patients receiving extended-duration enoxaparin prophylaxis: results from the EXCLAIM study. Stroke. 2013 Jan;44(1):249-51. doi: 10.1161/STROKEAHA.112.659797. Epub 2012 Nov 1.

evidence: open (via free pdf)

unpaywall_oa_status: bronze

ReferenceCitation: Sharma A, Chatterjee S, Lichstein E, Mukherjee D. Extended thromboprophylaxis for medically ill patients with decreased mobility: does it improve outcomes? J Thromb Haemost. 2012 Oct;10(10):2053-60. doi: 10.1111/j.1538-7836.2012.04874.x.

ReferenceCitation: Hull RD, Schellong SM, Tapson VF, Monreal M, Samama MM, Nicol P, Vicaut E, Turpie AG, Yusen RD; EXCLAIM (Extended Prophylaxis for Venous ThromboEmbolism in Acutely Ill Medical Patients With Prolonged Immobilization) study. Extended-duration venous thromboembolism prophylaxis in acutely ill medical patients with recently reduced mobility: a randomized trial. Ann Intern Med. 2010 Jul 6;153(1):8-18. doi: 10.7326/0003-4819-153-1-201007060-00004.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Canada
France
Colombia
United States
India
Tunisia
Belgium
Italy
United Kingdom
Austria
Mexico
Spain
South Africa
Russian Federation
Israel


title: Randomized, Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis

summary: This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine.

ReferenceCitation: E.J. Gane, H.L. Chan, G. Choudhuri, D.J. Suh4, A. Chutaputti, R. Safadi, T. Tanwandee, S. Thongsawat, N. Assy, S.K. Sarin, W. Bao, A. Trylesinski, C. Avila. TREATMENT OF DECOMPENSATED HBV-CIRRHOSIS: RESULTS FROM 2-YEARS RANDOMIZED TRIAL WITH TELBIVUDINE OR LAMIVUDINE. Journal of Hepatology 52, Supplement 1, Page S4. April 2010

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Poland
New Zealand
Australia
Thailand
Vietnam
Turkey
Canada
France
United States
Latvia
India
China
Malaysia
United Kingdom
Singapore
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


title: Phase 2 Study of AG 013736 as Second-Line Treatment in Patients With Metastatic Renal Cell Cancer

summary: The primary purpose of this protocol is to determine the activity of AG 013736 in patients with metastatic renal cell cancer who have received 1 prior cytokine-based therapy.

ReferenceCitation: Rixe O, Bukowski RM, Michaelson MD, Wilding G, Hudes GR, Bolte O, Motzer RJ, Bycott P, Liau KF, Freddo J, Trask PC, Kim S, Rini BI. Axitinib treatment in patients with cytokine-refractory metastatic renal-cell cancer: a phase II study. Lancet Oncol. 2007 Nov;8(11):975-84. doi: 10.1016/S1470-2045(07)70285-1. Epub 2007 Oct 23.

lead_sponsor: Pfizer

location_country:
United States
Germany
France


title: A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node

summary:
RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection.

PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases.

ReferenceCitation: Galimberti V, Cole BF, Viale G, Veronesi P, Vicini E, Intra M, Mazzarol G, Massarut S, Zgajnar J, Taffurelli M, Littlejohn D, Knauer M, Tondini C, Di Leo A, Colleoni M, Regan MM, Coates AS, Gelber RD, Goldhirsch A; International Breast Cancer Study Group Trial 23-01. Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel-node micrometastases (IBCSG 23-01): 10-year follow-up of a randomised, controlled phase 3 trial. Lancet Oncol. 2018 Oct;19(10):1385-1393. doi: 10.1016/S1470-2045(18)30380-2. Epub 2018 Sep 5.

ReferenceCitation: Galimberti V, Cole BF, Zurrida S, Viale G, Luini A, Veronesi P, Baratella P, Chifu C, Sargenti M, Intra M, Gentilini O, Mastropasqua MG, Mazzarol G, Massarut S, Garbay JR, Zgajnar J, Galatius H, Recalcati A, Littlejohn D, Bamert M, Colleoni M, Price KN, Regan MM, Goldhirsch A, Coates AS, Gelber RD, Veronesi U; International Breast Cancer Study Group Trial 23-01 investigators. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol. 2013 Apr;14(4):297-305. doi: 10.1016/S1470-2045(13)70035-4. Epub 2013 Mar 11. Erratum In: Lancet Oncol. 2013 Jun;14(7):e254.

unpaywall_oa_status: green

lead_sponsor: ETOP IBCSG Partners Foundation

location_country:
Slovenia
Italy
New Zealand
Denmark
Australia
Brazil
Switzerland
Belgium
Peru
France

location_facility: Oncology Institute of Southern Switzerland

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Sydney Cancer Centre at Royal Prince Alfred Hospital

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Westmead Institute for Cancer Research at Westmead Hospital

intervention_type: Procedure