title: A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)

acronym: ORIGIN

summary:
The primary objectives of the ORIGIN study were:

To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes;
To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes.

The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce:

total mortality (all causes);
the risk of diabetic microvascular outcomes;
the rate of progression of IGT or IFG to type 2 diabetes.

ReferenceCitation: Origin Trial Investigators; Gerstein H, Yusuf S, Riddle MC, Ryden L, Bosch J. Rationale, design, and baseline characteristics for a large international trial of cardiovascular disease prevention in people with dysglycemia: the ORIGIN Trial (Outcome Reduction with an Initial Glargine Intervention). Am Heart J. 2008 Jan;155(1):26-32, 32.e1-6. doi: 10.1016/j.ahj.2007.09.009. Epub 2007 Nov 26.

ReferenceCitation: Hanefeld M, Koehler C, Hoffmann C, Wilhelm K, Kamke W, Gerstein H. Effect of targeting normal fasting glucose levels with basal insulin glargine on glycaemic variability and risk of hypoglycaemia: a randomized, controlled study in patients with early Type 2 diabetes. Diabet Med. 2010 Feb;27(2):175-80. doi: 10.1111/j.1464-5491.2009.02915.x.

ReferenceCitation: Badings EA, Dyal L, Schoterman L, Lok DJ, Stoel I, Gerding MN, Gerstein HC, Tijssen JG. Strategies to detect abnormal glucose metabolism in people at high risk of cardiovascular disease from the ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial population. J Diabetes. 2011 Sep;3(3):232-7. doi: 10.1111/j.1753-0407.2011.00124.x.

ReferenceCitation: Ramachandran A, Riddle MC, Kabali C, Gerstein HC; ORIGIN Investigators. Relationship between A1C and fasting plasma glucose in dysglycemia or type 2 diabetes: an analysis of baseline data from the ORIGIN trial. Diabetes Care. 2012 Apr;35(4):749-53. doi: 10.2337/dc11-1918. Epub 2012 Feb 8.

ReferenceCitation: ORIGIN Trial Investigators; Gerstein HC, Bosch J, Dagenais GR, Diaz R, Jung H, Maggioni AP, Pogue J, Probstfield J, Ramachandran A, Riddle MC, Ryden LE, Yusuf S. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med. 2012 Jul 26;367(4):319-28. doi: 10.1056/NEJMoa1203858. Epub 2012 Jun 11.

ReferenceCitation: ORIGIN Trial Investigators; Bosch J, Gerstein HC, Dagenais GR, Diaz R, Dyal L, Jung H, Maggiono AP, Probstfield J, Ramachandran A, Riddle MC, Ryden LE, Yusuf S. n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia. N Engl J Med. 2012 Jul 26;367(4):309-18. doi: 10.1056/NEJMoa1203859. Epub 2012 Jun 11.

ReferenceCitation: Cukierman-Yaffe T, Lee SF, Pare G, McQueen M, Hess S, Gerstein HC. Biomarkers of Prevalent and Incident Cognitive Dysfunction in People with Dysglycemia: Data from the ORIGIN Trial. J Alzheimers Dis. 2022;87(3):1143-1150. doi: 10.3233/JAD-215195.

publisher_dissemination: IOS Press

ReferenceCitation: Shao H, Kianmehr H, Guo J, Li P, Fonseca V, Shi L. Efficacy of iGlarLixi on 5-year risk of diabetes-related complications: A simulation study. J Diabetes Complications. 2022 Mar;36(3):108132. doi: 10.1016/j.jdiacomp.2022.108132. Epub 2022 Jan 25.

ReferenceCitation: Pigeyre M, Hess S, Gomez MF, Asplund O, Groop L, Pare G, Gerstein H. Validation of the classification for type 2 diabetes into five subgroups: a report from the ORIGIN trial. Diabetologia. 2022 Jan;65(1):206-215. doi: 10.1007/s00125-021-05567-4. Epub 2021 Oct 21.

ReferenceCitation: Wang A, Gerstein HC, Lee SF, Hess S, Pare G, Ryden L, Mellbin LG. Testosterone and sex hormone-binding globulin in dysglycemic women at high cardiovascular risk: A report from the Outcome Reduction with an Initial Glargine Intervention trial. Diab Vasc Dis Res. 2021 Mar-Apr;18(2):14791641211002475. doi: 10.1177/14791641211002475.

ReferenceCitation: Pigeyre M, Sjaarda J, Chong M, Hess S, Bosch J, Yusuf S, Gerstein H, Pare G. ACE and Type 2 Diabetes Risk: A Mendelian Randomization Study. Diabetes Care. 2020 Apr;43(4):835-842. doi: 10.2337/dc19-1973. Epub 2020 Feb 4.

publisher_dissemination: American Diabetes Association

ReferenceCitation: Theriault S, Sjaarda J, Chong M, Hess S, Gerstein H, Pare G. Identification of Circulating Proteins Associated With Blood Pressure Using Mendelian Randomization. Circ Genom Precis Med. 2020 Feb;13(1):e002605. doi: 10.1161/CIRCGEN.119.002605. Epub 2020 Jan 12.

ReferenceCitation: Gerstein HC, Pare G, McQueen MJ, Lee SF, Bangdiwala SI, Kannt A, Hess S; ORIGIN Trial Investigators. Novel Biomarkers for Change in Renal Function in People With Dysglycemia. Diabetes Care. 2020 Feb;43(2):433-439. doi: 10.2337/dc19-1604. Epub 2019 Nov 14.

ReferenceCitation: Pigeyre M, Sjaarda J, Mao S, Chong M, Hess S, Yusuf S, Gerstein H, Pare G. Identification of Novel Causal Blood Biomarkers Linking Metabolically Favorable Adiposity With Type 2 Diabetes Risk. Diabetes Care. 2019 Sep;42(9):1800-1808. doi: 10.2337/dc18-2444. Epub 2019 Jun 24.

ReferenceCitation: Cukierman-Yaffe T, Bosch J, Jung H, Punthakee Z, Gerstein HC. Hypoglycemia and Incident Cognitive Dysfunction: A Post Hoc Analysis From the ORIGIN Trial. Diabetes Care. 2019 Jan;42(1):142-147. doi: 10.2337/dc18-0690. Epub 2018 Nov 13.

ReferenceCitation: Mohammadi-Shemirani P, Sjaarda J, Gerstein HC, Treleaven DJ, Walsh M, Mann JF, McQueen MJ, Hess S, Pare G. A Mendelian Randomization-Based Approach to Identify Early and Sensitive Diagnostic Biomarkers of Disease. Clin Chem. 2019 Mar;65(3):427-436. doi: 10.1373/clinchem.2018.291104. Epub 2018 Oct 18.

ReferenceCitation: Morieri ML, Gao H, Pigeyre M, Shah HS, Sjaarda J, Mendonca C, Hastings T, Buranasupkajorn P, Motsinger-Reif AA, Rotroff DM, Sigal RJ, Marcovina SM, Kraft P, Buse JB, Wagner MJ, Gerstein HC, Mychaleckyj JC, Pare G, Doria A. Genetic Tools for Coronary Risk Assessment in Type 2 Diabetes: A Cohort Study From the ACCORD Clinical Trial. Diabetes Care. 2018 Nov;41(11):2404-2413. doi: 10.2337/dc18-0709. Epub 2018 Sep 27.

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

ReferenceCitation: Birkeland KI, Grill V, Wium C, McQueen MJ, Lopez-Jaramillo P, Lee SF, Gerstein HC. The association of basal insulin treatment versus standard care with outcomes in anti-GAD positive and negative subjects: A post-hoc analysis of the ORIGIN trial. Diabetes Obes Metab. 2019 Feb;21(2):429-433. doi: 10.1111/dom.13528. Epub 2018 Oct 3.

repository_institution: University of Oslo - Duo Research Archive

ReferenceCitation: Sjaarda J, Gerstein H, Chong M, Yusuf S, Meyre D, Anand SS, Hess S, Pare G. Blood CSF1 and CXCL12 as Causal Mediators of Coronary Artery Disease. J Am Coll Cardiol. 2018 Jul 17;72(3):300-310. doi: 10.1016/j.jacc.2018.04.067. Epub 2018 Jul 9.

ReferenceCitation: Gerstein HC, Ferrannini E, Riddle MC, Yusuf S; ORIGIN Trial Investigators. Insulin resistance and cardiovascular outcomes in the ORIGIN trial. Diabetes Obes Metab. 2018 Mar;20(3):564-570. doi: 10.1111/dom.13112. Epub 2017 Oct 8.

ReferenceCitation: Papademetriou V, Nylen ES, Doumas M, Probstfield J, Mann JFE, Gilbert RE, Gerstein HC. Chronic Kidney Disease, Basal Insulin Glargine, and Health Outcomes in People with Dysglycemia: The ORIGIN Study. Am J Med. 2017 Dec;130(12):1465.e27-1465.e39. doi: 10.1016/j.amjmed.2017.05.047. Epub 2017 Aug 31.

ReferenceCitation: Yates T, Davies MJ, Jung H, Bosch J, Spinas GA, Sreenan S, Commerford P, Gerstein HC; ORGIN investigators. Effect of insulin glargine on recreational physical activity and TV viewing: Analysis of the randomised ORIGIN trial. Diabetes Res Clin Pract. 2017 Oct;132:137-143. doi: 10.1016/j.diabres.2017.07.035. Epub 2017 Jul 31.

repository_institution: University of Illinois at Chicago - INDIGO

repository_institution: University of Leicester - Leicester Research Archive

ReferenceCitation: Rautio A, Boman K, Gerstein HC, Hernestal-Boman J, Lee SF, Olofsson M, Mellbin LG. The effect of basal insulin glargine on the fibrinolytic system and von Willebrand factor in people with dysglycaemia and high risk for cardiovascular events: Swedish substudy of the Outcome Reduction with an Initial Glargine Intervention trial. Diab Vasc Dis Res. 2017 Jul;14(4):345-352. doi: 10.1177/1479164117703034. Epub 2017 Apr 12.

ReferenceCitation: Gerstein HC, Pare G, McQueen MJ, Lee SF, Hess S; ORIGIN Trial Investigators. Validation of the ORIGIN Cardiovascular Biomarker Panel and the Value of Adding Troponin I in Dysglycemic People. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2251-2257. doi: 10.1210/jc.2017-00273.

ReferenceCitation: Gerstein HC, Pare G, Hess S, Ford RJ, Sjaarda J, Raman K, McQueen M, Lee S, Haenel H, Steinberg GR; ORIGIN Investigators. Growth Differentiation Factor 15 as a Novel Biomarker for Metformin. Diabetes Care. 2017 Feb;40(2):280-283. doi: 10.2337/dc16-1682. Epub 2016 Dec 14.

ReferenceCitation: ORIGIN Trial Investigators. Cardiovascular and Other Outcomes Postintervention With Insulin Glargine and Omega-3 Fatty Acids (ORIGINALE). Diabetes Care. 2016 May;39(5):709-16. doi: 10.2337/dc15-1676. Epub 2015 Dec 17.

repository_institution: Monash University - Monash University Research Portal

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

ReferenceCitation: Gerstein HC, Pare G, McQueen MJ, Haenel H, Lee SF, Pogue J, Maggioni AP, Yusuf S, Hess S; Outcome Reduction With Initial Glargine Intervention Trial Investigators. Identifying Novel Biomarkers for Cardiovascular Events or Death in People With Dysglycemia. Circulation. 2015 Dec 15;132(24):2297-304. doi: 10.1161/CIRCULATIONAHA.115.015744. Epub 2015 Oct 30.

ReferenceCitation: Cukierman-Yaffe T, Bosch J, Diaz R, Dyal L, Hancu N, Hildebrandt P, Lanas F, Lewis BS, Marre M, Yale JF, Yusuf S, Gerstein HC; ORIGIN Investigators. Effects of basal insulin glargine and omega-3 fatty acid on cognitive decline and probable cognitive impairment in people with dysglycaemia: a substudy of the ORIGIN trial. Lancet Diabetes Endocrinol. 2014 Jul;2(7):562-72. doi: 10.1016/S2213-8587(14)70062-2. Epub 2014 Jun 2.

ReferenceCitation: ORIGIN trial investigators; Gilbert RE, Mann JF, Hanefeld M, Spinas G, Bosch J, Yusuf S, Gerstein HC. Basal insulin glargine and microvascular outcomes in dysglycaemic individuals: results of the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial. Diabetologia. 2014 Jul;57(7):1325-31. doi: 10.1007/s00125-014-3238-4. Epub 2014 Apr 26.

ReferenceCitation: Lopez-Jaramillo P, Cohen DD, Gomez-Arbelaez D, Bosch J, Dyal L, Yusuf S, Gerstein HC; ORIGIN Trial Investigators. Association of handgrip strength to cardiovascular mortality in pre-diabetic and diabetic patients: a subanalysis of the ORIGIN trial. Int J Cardiol. 2014 Jun 15;174(2):458-61. doi: 10.1016/j.ijcard.2014.04.013. Epub 2014 Apr 13. No abstract available.

ReferenceCitation: Lamy A, Tong W, Jung H, Gafni A, Singh K, Tyrwhitt J, Yusuf S, Gerstein HC; ORIGIN Investigators. Cost implications of the use of basal insulin glargine in people with early dysglycemia: the ORIGIN trial. J Diabetes Complications. 2014 Jul-Aug;28(4):553-8. doi: 10.1016/j.jdiacomp.2014.02.012. Epub 2014 Mar 2.

ReferenceCitation: Bordeleau L, Yakubovich N, Dagenais GR, Rosenstock J, Probstfield J, Chang Yu P, Ryden LE, Pirags V, Spinas GA, Birkeland KI, Ratner RE, Marin-Neto JA, Keltai M, Riddle MC, Bosch J, Yusuf S, Gerstein HC; ORIGIN Trial Investigators. The association of basal insulin glargine and/or n-3 fatty acids with incident cancers in patients with dysglycemia. Diabetes Care. 2014;37(5):1360-6. doi: 10.2337/dc13-1468. Epub 2014 Feb 26.

ReferenceCitation: ORIGIN Trial Investigators; Mellbin LG, Ryden L, Riddle MC, Probstfield J, Rosenstock J, Diaz R, Yusuf S, Gerstein HC. Does hypoglycaemia increase the risk of cardiovascular events? A report from the ORIGIN trial. Eur Heart J. 2013 Oct;34(40):3137-44. doi: 10.1093/eurheartj/eht332. Epub 2013 Sep 2.

ReferenceCitation: ORIGIN Trial Investigators. Characteristics associated with maintenance of mean A1C<6.5% in people with dysglycemia in the ORIGIN trial. Diabetes Care. 2013 Oct;36(10):2915-22. doi: 10.2337/dc12-2238. Epub 2013 May 8.

ReferenceCitation: Lonn EM, Bosch J, Diaz R, Lopez-Jaramillo P, Ramachandran A, Hancu N, Hanefeld M, Krum H, Ryden L, Smith S, McQueen MJ, Dyal L, Yusuf S, Gerstein HC; GRACE and ORIGIN Investigators. Effect of insulin glargine and n-3FA on carotid intima-media thickness in people with dysglycemia at high risk for cardiovascular events: the glucose reduction and atherosclerosis continuing evaluation study (ORIGIN-GRACE). Diabetes Care. 2013 Sep;36(9):2466-74. doi: 10.2337/dc12-2129. Epub 2013 Apr 5.

sponsor_collaborators:
Sanofi
Population Health Research Institute

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Turkey
Croatia
Chile
Canada
France
Belarus
Lithuania
Colombia
Slovakia
Hungary
Denmark
Switzerland
United States
Latvia
India
Romania
China
Estonia
Philippines
Italy
Norway
United Kingdom
Venezuela
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Bermuda
Russian Federation
Israel

location_facility:
Sanofi-Aventis Administrative Office
Makati City
Sanofi-Aventis Aministrative Office


title: Phase I/II Randomized, Double Blind, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Subcutaneous Bay 50-4798 Administration in Patients With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to Patients on HAART Alone.

summary: The purpose of this study is to evaluate the safety of the experimental drug Bay 50-4798 in HIV positive patients receiving HAART and to test the drug's effect on the CD4+ T-cell count.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Bayer

location_country:
United States
United Kingdom
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: European Study Group For Pancreatic Cancer - Trial 3

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective, or whether chemotherapy is more effective than observation, in treating pancreatic cancer after surgery.

PURPOSE: Phase III trial to compare the effectiveness of two chemotherapy regimens with no further therapy in treating patients who have completely resected pancreatic cancer.

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: Neoptolemos JP, Moore MJ, Cox TF, Valle JW, Palmer DH, McDonald AC, Carter R, Tebbutt NC, Dervenis C, Smith D, Glimelius B, Charnley RM, Lacaine F, Scarfe AG, Middleton MR, Anthoney A, Ghaneh P, Halloran CM, Lerch MM, Olah A, Rawcliffe CL, Verbeke CS, Campbell F, Buchler MW; European Study Group for Pancreatic Cancer. Effect of adjuvant chemotherapy with fluorouracil plus folinic acid or gemcitabine vs observation on survival in patients with resected periampullary adenocarcinoma: the ESPAC-3 periampullary cancer randomized trial. JAMA. 2012 Jul 11;308(2):147-56. doi: 10.1001/jama.2012.7352. Erratum In: JAMA. 2012 Nov 14;308(18):1861.

ReferenceCitation: Neoptolemos JP, Stocken DD, Bassi C, Ghaneh P, Cunningham D, Goldstein D, Padbury R, Moore MJ, Gallinger S, Mariette C, Wente MN, Izbicki JR, Friess H, Lerch MM, Dervenis C, Olah A, Butturini G, Doi R, Lind PA, Smith D, Valle JW, Palmer DH, Buckels JA, Thompson J, McKay CJ, Rawcliffe CL, Buchler MW; European Study Group for Pancreatic Cancer. Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial. JAMA. 2010 Sep 8;304(10):1073-81. doi: 10.1001/jama.2010.1275.

ReferenceType: derived

ReferenceCitation: Jones RP, Psarelli EE, Jackson R, Ghaneh P, Halloran CM, Palmer DH, Campbell F, Valle JW, Faluyi O, O'Reilly DA, Cunningham D, Wadsley J, Darby S, Meyer T, Gillmore R, Anthoney A, Lind P, Glimelius B, Falk S, Izbicki JR, Middleton GW, Cummins S, Ross PJ, Wasan H, McDonald A, Crosby T, Ting Y, Patel K, Sherriff D, Soomal R, Borg D, Sothi S, Hammel P, Lerch MM, Mayerle J, Tjaden C, Strobel O, Hackert T, Buchler MW, Neoptolemos JP; European Study Group for Pancreatic Cancer. Patterns of Recurrence After Resection of Pancreatic Ductal Adenocarcinoma: A Secondary Analysis of the ESPAC-4 Randomized Adjuvant Chemotherapy Trial. JAMA Surg. 2019 Nov 1;154(11):1038-1048. doi: 10.1001/jamasurg.2019.3337.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

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

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

version: submittedVersion

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

ReferenceCitation: Ghaneh P, Kleeff J, Halloran CM, Raraty M, Jackson R, Melling J, Jones O, Palmer DH, Cox TF, Smith CJ, O'Reilly DA, Izbicki JR, Scarfe AG, Valle JW, McDonald AC, Carter R, Tebbutt NC, Goldstein D, Padbury R, Shannon J, Dervenis C, Glimelius B, Deakin M, Anthoney A, Lerch MM, Mayerle J, Olah A, Rawcliffe CL, Campbell F, Strobel O, Buchler MW, Neoptolemos JP; European Study Group for Pancreatic Cancer. The Impact of Positive Resection Margins on Survival and Recurrence Following Resection and Adjuvant Chemotherapy for Pancreatic Ductal Adenocarcinoma. Ann Surg. 2019 Mar;269(3):520-529. doi: 10.1097/SLA.0000000000002557.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Royal Liverpool University Hospital

collaborators: Australasian Gastro-Intestinal Trials Group

location_country:
Finland
Germany
Italy
Hungary
United Kingdom
Australia
Japan
Sweden
Switzerland
Greece
Canada
Czech Republic
France

location_facility: British Columbia Cancer Agency - Centre for the Southern Interior

location_facility: Institute for Clinical and Experimental Medicine

location_facility: Ottawa Hospital Regional Cancer Centre - General Campus

location_facility: Cross Cancer Institute at University of Alberta

location_facility: Institute of Oncology at Prince of Wales Hospital

location_facility: Edmond Odette Cancer Centre at Sunnybrook

location_facility: British Columbia Cancer Agency - Vancouver Island Centre

location_facility: McGill Cancer Centre at McGill University

location_facility: Cancer Research Institute at Queen's University

location_facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital

location_facility: London Regional Cancer Program at London Health Sciences Centre

lead_sponsor_type: academique


title: A Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Plus BCG Versus Placebo Plus BCG as a Post-Surgical Treatment for Stage IV Melanoma

summary: This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.

status: Unknown status

ReferenceCitation: Faries MB, Mozzillo N, Kashani-Sabet M, Thompson JF, Kelley MC, DeConti RC, Lee JE, Huth JF, Wagner J, Dalgleish A, Pertschuk D, Nardo C, Stern S, Elashoff R, Gammon G, Morton DL; MMAIT-IV Clinical Trial Group. Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases. Ann Surg Oncol. 2017 Dec;24(13):3991-4000. doi: 10.1245/s10434-017-6072-3. Epub 2017 Oct 10.

publisher_dissemination: Springer-Nature

ReferenceCitation: Hoshimoto S, Faries MB, Morton DL, Shingai T, Kuo C, Wang HJ, Elashoff R, Mozzillo N, Kelley MC, Thompson JF, Lee JE, Hoon DS. Assessment of prognostic circulating tumor cells in a phase III trial of adjuvant immunotherapy after complete resection of stage IV melanoma. Ann Surg. 2012 Feb;255(2):357-62. doi: 10.1097/SLA.0b013e3182380f56.

lead_sponsor: CancerVax Corporation

location_country:
Germany
Ireland
Italy
New Zealand
Israel
United Kingdom
Australia
Brazil
Netherlands
Switzerland
United States
Canada
France

location_facility: Lineberger Comprehensive Cancer Center, UNC

location_facility: St. Louis University Health Sciences Center

location_facility: Arthur G. James Cancer Hospital - Ohio State University

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: UCSF Cancer Center and Cancer Research Institute

location_facility: The Cancer Institute at Good Samaritan Medical Center

location_facility: Central Arkansas Veterans Healthcare System

location_facility: University of Texas - MD Anderson Cancer Center

location_facility: University of Pennsylvania Cancer Center

location_facility: University of Arkansas for Medical Sciences

location_facility: Cedars Sinai Comprehensive Cancer Center

location_facility: Sidney Kimmel Comprehensive Cancer Center

location_facility: The Cancer Cener at Hackensack University Medical Center

location_facility: Intermountain Health Care- Mckay-Dee Hospital

intervention_type: Biological

status_simplified: Unknown


title: Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With BCG Plus a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Versus BCG Plus a Placebo as a Post-Surgical Treatment for Stage III Melanoma

summary: This is a Phase 3 study in patients with melanoma that has spread to the lymph nodes (stage III), and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.

location_facility: Winship Cancer Institute at Emory University


title: A Phase III, Multicenter, Multinational, Randomized, Parallel Group, Double-blind Trial of Clopidogrel Versus Placebo in High-risk Patients Aged 45 Years and Older, at Risk of Atherothrombotic Events, and Who Are Receiving Background Therapy Including Low-dose ASA.

summary:
RATIONALE:

Atherothrombosis is a progressive and generalized vascular disease resulting in events leading to myocardial infarction (heart attack), stroke, and vascular death.
In patients at risk for this disease, it is characterized by an unpredictable, sudden disruption of atherosclerotic plaques, which may lead to total occlusion of artery due to formation of a clot. The use of aspirin (blood thinner agent) for reducing those major ischemic events is either indicated, or recommended by international guidelines. However, aspirin fails to prevent a high percentage of such life-threatening events. Therefore, more effective blood thinning therapy may provide additional clinical benefit to such patients.
The results of the CURE trial in patients with unstable angina demonstrate the additional benefit of long-term treatment (up to one year) with clopidogrel, (a blood thinner agent), when administered in combination with standard therapy including aspirin. The purpose of CHARISMA is to investigate whether a similar clinical benefit of clopidogrel may apply to a broad population of high-risk patients receiving low-dose aspirin therapy. Such population includes patients with previous cardiovascular, neurovascular or peripheral arterial manifestations of atherothrombosis and patients with combinations of recognized risk factors for atherosclerosis.

OBJECTIVES:

To assess the efficacy of clopidogrel 75 mg once-daily by comparison with a placebo, in preventing cardiovascular morbidity/mortality. The study will compare the efficacy of the two regimens in preventing the occurrence of major cardiovascular complications (stroke, heart attack, cardiovascular death) in high-risk patients who are otherwise receiving low-dose aspirin therapy (75-162 mg daily).
To evaluate the safety of clopidogrel in this population, and more specifically the incidence of fatal or severe bleeding (as per GUSTO definition), in order to estimate the global benefit of clopidogrel in this patient population.

ReferenceCitation: Bhatt DL, Fox KA, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Flather MD, Haffner SM, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Brennan DM, Fabry-Ribaudo L, Booth J, Topol EJ; CHARISMA Investigators. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006 Apr 20;354(16):1706-17. doi: 10.1056/NEJMoa060989. Epub 2006 Mar 12.

ReferenceCitation: Bhatt DL, Pare G, Eikelboom JW, Simonsen KL, Emison ES, Fox KA, Steg PG, Montalescot G, Bhakta N, Hacke W, Flather MD, Mak KH, Cacoub P, Creager MA, Berger PB, Steinhubl SR, Murugesan G, Mehta SR, Kottke-Marchant K, Lincoff AM, Topol EJ; CHARISMA Investigators. The relationship between CYP2C19 polymorphisms and ischaemic and bleeding outcomes in stable outpatients: the CHARISMA genetics study. Eur Heart J. 2012 Sep;33(17):2143-50. doi: 10.1093/eurheartj/ehs059. Epub 2012 Mar 26.

ReferenceCitation: Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

oa_host_type: repository

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

repository_institution: The University of Sydney - The Sydney eScholarship Repository

repositories_concat: PubMed Central;ses.library.usyd.edu.au

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Bangalore S, Bhatt DL, Steg PG, Weber MA, Boden WE, Hamm CW, Montalescot G, Hsu A, Fox KA, Lincoff AM. beta-blockers and cardiovascular events in patients with and without myocardial infarction: post hoc analysis from the CHARISMA trial. Circ Cardiovasc Qual Outcomes. 2014 Nov;7(6):872-81. doi: 10.1161/CIRCOUTCOMES.114.001073. Epub 2014 Sep 30.

ReferenceCitation: Berger PB, Bhatt DL, Fuster V, Steg PG, Fox KA, Shao M, Brennan DM, Hacke W, Montalescot G, Steinhubl SR, Topol EJ; CHARISMA Investigators. Bleeding complications with dual antiplatelet therapy among patients with stable vascular disease or risk factors for vascular disease: results from the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) trial. Circulation. 2010 Jun 15;121(23):2575-83. doi: 10.1161/CIRCULATIONAHA.109.895342. Epub 2010 Jun 1.

ReferenceCitation: Steinhubl SR, Bhatt DL, Brennan DM, Montalescot G, Hankey GJ, Eikelboom JW, Berger PB, Topol EJ; CHARISMA Investigators. Aspirin to prevent cardiovascular disease: the association of aspirin dose and clopidogrel with thrombosis and bleeding. Ann Intern Med. 2009 Mar 17;150(6):379-86. doi: 10.7326/0003-4819-150-6-200903170-00006.

ReferenceCitation: Mak KH, Bhatt DL, Shao M, Haffner SM, Hamm CW, Hankey GJ, Johnston SC, Montalescot G, Steg PG, Steinhubl SR, Fox KA, Topol EJ. The influence of body mass index on mortality and bleeding among patients with or at high-risk of atherothrombotic disease. Eur Heart J. 2009 Apr;30(7):857-65. doi: 10.1093/eurheartj/ehp037. Epub 2009 Feb 20.

ReferenceCitation: Eikelboom JW, Hankey GJ, Thom J, Bhatt DL, Steg PG, Montalescot G, Johnston SC, Steinhubl SR, Mak KH, Easton JD, Hamm C, Hu T, Fox KA, Topol EJ; Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA) Investigators. Incomplete inhibition of thromboxane biosynthesis by acetylsalicylic acid: determinants and effect on cardiovascular risk. Circulation. 2008 Oct 21;118(17):1705-12. doi: 10.1161/CIRCULATIONAHA.108.768283. Epub 2008 Oct 6.

ReferenceCitation: Bhatt DL, Flather MD, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Fabry-Ribaudo L, Hu T, Topol EJ, Fox KA; CHARISMA Investigators. Patients with prior myocardial infarction, stroke, or symptomatic peripheral arterial disease in the CHARISMA trial. J Am Coll Cardiol. 2007 May 15;49(19):1982-8. doi: 10.1016/j.jacc.2007.03.025. Epub 2007 Apr 11.

lead_sponsor: Sanofi

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Turkey
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
Russian Federation
Sweden

location_facility:
The Cleveland Clinic Foundation
Sanofi-aventis Administrative Office


summary: The purpose of this study is to determine the optimal dosage of YM598 for slowing down disease progression in patients with rising PSA after initial therapy for localized prostate cancer.

status: Terminated

lead_sponsor: Astellas Pharma Inc

sponsor_collaborators:
Astellas Pharma Inc
Astellas Pharma US, Inc.

location_country:
Germany
Poland
United Kingdom
Belgium
Spain
Czech Republic
France

location_facility: Fundacion Hospital Alcorcón, Servicio Urología

location_facility: Department of Urology, Bristol Royal Infirmary

location_facility: Department of Urology, Gartnavel Hospital

location_facility: Department of Urology, Norfolk & Norwich Hospital

location_facility: Department of Urology, Taunton & Somerset Hospital

location_facility: Hospital Universitario Principe de Asturias, Servicio de Urología, Ctra.

location_facility: Regional Hospital, Department of Urology

location_facility: Klinik und Poliklinik für Urologie, Universitätsklinikum Carl-Gustav-Carus

location_facility: Complejo Hospitaliaro Juan Canalejo, Servicio de Urología

location_facility: Bielanski Hospital, Department of Urology

location_facility: Klinik u. Poliklinik für Urologie, Philipps Universität, Baldingerstraße

location_facility: Oncology Center, Department of Urinary Tract Cancer


title: A Randomized, Open-label Study Comparing the Effects of Low-dose Cyclosporine vs Cyclosporine Withdrawal on Renal Function in Kidney Transplant Patients Treated With CellCept and Daclizumab

summary: This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, and the target sample size is 500+ individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Poland
Norway
United Kingdom
Australia
Sweden
Mexico
Belgium
United States
Spain
Canada
France


title: A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging, Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Patients With Moderate to Severe Pulmonary Arterial Hypertension

summary: The purpose of this study is to determine if treating patients suffering from moderate to severe pulmonary arterial hypertension with BSF 208075 will improve the patients' ability to exercise.

lead_sponsor: Gilead Sciences

location_country:
Germany
Italy
Australia
Belgium
United States
France

location_facility: University of California San Diego Medical Center

location_facility: University of California - San Francisco

location_facility: University of Bologna - Institute of Cardiology

location_facility: University of Colorado Health Sciences Center

location_facility: Los Angeles County Harbor-UCLA Medical Center


title: An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-naive Subjects (1-24 Months of Age)

summary: This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.

design_allocation: Non-Randomized

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:
Italy
Lithuania
Portugal
Slovakia
Hungary
Argentina
Australia
Netherlands
Lebanon
United States
Latvia
Turkey
Estonia
Puerto Rico
France


title: A Double-Blind, Placebo-Controlled, Add-On Clinical Trial of the Safety, Pharmacokinetics and Efficacy of Lamictal in Pediatric Age Subjects (1-24 Months)

summary: This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to the current therapy of pediatric patients age 1-24 months old with partial seizures. The medication used in this study has been approved by FDA for the adjunctive treatment of partial seizures in patients 2 years and older.

location_country:
Italy
Lithuania
Portugal
Slovakia
Hungary
Australia
Netherlands
Lebanon
United States
Latvia
Spain
Turkey
Estonia
France


type: Other Identifier

title: An International Field Study Of The Reliability And Validity Of The EORTC QLQ-C30 And A Disease-Specific Questionnaire Module (QLQ-PR25) For Assessing Quality Of Life Of Patients With Prostate Cancer

summary:
RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may help determine the intermediate and long-term effects of the treatment on these patients.

PURPOSE: Clinical trial to study the effectiveness of two questionnaires in assessing quality of life of patients who have prostate cancer.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Arraras JI, Villafranca E, Arias de la Vega F, Romero P, Rico M, Vila M, Asin G, Chicata V, Dominguez MA, Lainez N, Manterola A, Martinez E, Martinez M. The EORTC Quality of Life Questionnaire for patients with prostate cancer: EORTC QLQ-PR25. Validation study for Spanish patients. Clin Transl Oncol. 2009 Mar;11(3):160-4. doi: 10.1007/s12094-009-0332-z.

ReferenceCitation: Arraras Urdaniz JI, Villafranca Iturre E, Arias de la Vega F, Dominguez Dominguez MA, Lainez Milagro N, Manterola Burgaleta A, Martinez Lopez E, Romero Rojano P, Martinez Aguillo M. The eortc quality of life questionnaire QLQ-C30 (version 3.0). Validation study for Spanish prostate cancer patients. Arch Esp Urol. 2008 Oct;61(8):949-54. doi: 10.4321/s0004-06142008000800017.

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

location_country:
Germany
Italy
Norway
United Kingdom
Denmark
Australia
Romania
Netherlands
Belgium
Turkey
France

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Azienda Ospedaliera Maggiore Della Carita

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

location_facility: Velindre Cancer Center at Velinde Hospital

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: Dokuz Eylul University School of Medicine

intervention_type: Other


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Safety and Efficacy Trial of LJP 394 in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease

summary: The purpose of this study is to determine whether LJP 394 (abetimus sodium) is safe and effective in delaying and reducing renal flares in patients with lupus nephritis.

ReferenceCitation: Cardiel MH, Tumlin JA, Furie RA, Wallace DJ, Joh T, Linnik MD; LJP 394-90-09 Investigator Consortium. Abetimus sodium for renal flare in systemic lupus erythematosus: results of a randomized, controlled phase III trial. Arthritis Rheum. 2008 Aug;58(8):2470-80. doi: 10.1002/art.23673.

lead_sponsor: La Jolla Pharmaceutical Company

location_country:
Germany
Italy
United Kingdom
Sweden
Austria
Mexico
United States
Spain
Canada
France

location_facility: Insituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran, Depto. de Immunology y Rheumatology

location_facility: Department for Internal Medicine and Institute of Immunology and Rheumatology

location_facility: Rheumatology Associates of North Alabama

location_facility: Arthritis Center of Excellence, Toronto Western Hospital, University Health Network

location_facility: Saint Louis University Health Sciences Center

location_facility: Thomas Jefferson University, Division of Rheumatology

location_facility: Texas Tech University Health Sciences Center, Department of Internal Medicine

location_facility: University of Louisville, Dept of Medicine/Division of Rheumatology

location_facility: Hospital General Valle de Hebron Servicio Medicina Interna. Edificio

location_facility: Ambulatory Clinical Research Center, Hospital for Joint Diseases Orthopaedic Institute, NYU

location_facility: University of Pittsburgh, Div. of Rheumatology and Clinical Immun.

location_facility: Lupus Research Unit St. Thomas Hospital, The Rayne Institute

location_facility: LSU Health Sciences Center, Department of Rheumatology

location_facility: Hospital Universitario La Paz Servico de Medicina

location_facility: San Antonio Kidney Disease Center, Research Center

location_facility: Hospital for Joint Diseases, Department of Rheumatology

location_facility: Metrohealth Medical Center, Division of Rheumatology

location_facility: University of Connecticut Health Center, Division of Rheumatology

location_facility: Hospital Clinic y Provinical de Barcelona, Unitat de Malalties Autoimmunes

location_facility: Department of Rheumatology, University Hospital of Lund

location_facility: Presbyterian Hospital of Dallas, Arthritis Consultation Center

location_facility: Division of Rheumatology, Department of Internal Medicine

location_facility: Harbor-UCLA Research & Education Institute, Medicine/Rheumatology Division

location_facility: Service De Rhumatologie Hopital de Hautepierre

location_facility: University of Michigan Health System, Internal Medicine-Rheumatology

location_facility: Wayne State University, Rheumatology Division

location_facility: U.O di Reumatologia, Dipartimento di Medicina Interna, Universita di Pisa

location_facility: Emory University School of Medicine, Renal Division

location_facility: Universitatklinikum Charite, Medizinische Universitatsklinik

location_facility: Department of Rheumatology, Karolinska Hospital

location_facility: Hospital for Joint Diseases, NYU Medical Center

location_facility: Wake Forest University School of Medicine


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing Effect and Safety in Obese Patients With Type 2 Diabetes

acronym: RIO-Diabetes

summary: To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with Type 2 Diabetes

ReferenceCitation: Scheen AJ, Finer N, Hollander P, Jensen MD, Van Gaal LF; RIO-Diabetes Study Group. Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study. Lancet. 2006 Nov 11;368(9548):1660-72. doi: 10.1016/S0140-6736(06)69571-8. Erratum In: Lancet. 2006 Nov 11;368(9548):1650.

location_country:
Finland
France
Germany
Poland
United Kingdom
Argentina
Netherlands
Belgium
United States
Canada
Czech Republic

location_facility: Center for Nutrition and Preventive Medicine

location_facility: Endocrinology and Diabetes Consultants, PC

location_facility: Southern California Prevention and Research Center Inc. (SPARC)

location_facility: Medical University of South Carolina, Division of Clinical Pharmacology

location_facility: Jacksonville Center for Clinical Research

location_facility: University of Oklahoma Health Sciences Center

location_facility: Salem Veterans Affairs Medical Center (151)


title: Multicenter Phase III Randomized Trial Comparing Doxorubicin and Cyclophosphamide Followed By Docetaxel (AC-T) With Doxorubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab (Herceptin)(AC-TH) and With Docetaxel, Carboplatin and Trastuzumab (TCH) In The Adjuvant Treatment Of Node Positive and High Risk Node Negative Patients With Operable Breast Cancer Containing The HER2 Alteration

summary:
Primary objective:

Compare disease-free survival in women with human epidermal growth factor receptor 2 (HER2)-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin, cyclophosphamide, and docetaxel with or without trastuzumab (Herceptin) vs trastuzumab, docetaxel, and carboplatin.

Secondary objective:

Compare overall survival of participants treated with these regimens.
Compare the toxic effects (including cardiac) of these regimens in these participants.
Compare quality of life of participants treated with these regimens.
Compare pathologic and molecular markers for predicting efficacy of these regimens in these participants.
For substudy: Compare peripheral levels of shed HER2-neu extracellular domain with fluorescence in situ hybridization in predicting outcome in participants treated with these regimens.

ReferenceType: background

ReferenceCitation: Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, Mackey J, Glaspy J, Chan A, Pawlicki M, Pinter T, Valero V, Liu MC, Sauter G, von Minckwitz G, Visco F, Bee V, Buyse M, Bendahmane B, Tabah-Fisch I, Lindsay MA, Riva A, Crown J; Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011 Oct 6;365(14):1273-83. doi: 10.1056/NEJMoa0910383.

ReferenceCitation: Au HJ, Eiermann W, Robert NJ, Pienkowski T, Crown J, Martin M, Pawlicki M, Chan A, Mackey J, Glaspy J, Pinter T, Liu MC, Fornander T, Sehdev S, Ferrero JM, Bee V, Santana MJ, Miller DP, Lalla D, Slamon DJ; Translational Research in Oncology BCIRG 006 Trial Investigators. Health-related quality of life with adjuvant docetaxel- and trastuzumab-based regimens in patients with node-positive and high-risk node-negative, HER2-positive early breast cancer: results from the BCIRG 006 Study. Oncologist. 2013;18(7):812-8. doi: 10.1634/theoncologist.2013-0091. Epub 2013 Jun 28.

ReferenceCitation: Perez EA, Press MF, Dueck AC, Jenkins RB, Kim C, Chen B, Villalobos I, Paik S, Buyse M, Wiktor AE, Meyer R, Finnigan M, Zujewski J, Shing M, Stern HM, Lingle WL, Reinholz MM, Slamon DJ. Immunohistochemistry and fluorescence in situ hybridization assessment of HER2 in clinical trials of adjuvant therapy for breast cancer (NCCTG N9831, BCIRG 006, and BCIRG 005). Breast Cancer Res Treat. 2013 Feb;138(1):99-108. doi: 10.1007/s10549-013-2444-y. Epub 2013 Feb 19.

ReferenceCitation: Press MF, Sauter G, Buyse M, Bernstein L, Guzman R, Santiago A, Villalobos IE, Eiermann W, Pienkowski T, Martin M, Robert N, Crown J, Bee V, Taupin H, Flom KJ, Tabah-Fisch I, Pauletti G, Lindsay MA, Riva A, Slamon DJ. Alteration of topoisomerase II-alpha gene in human breast cancer: association with responsiveness to anthracycline-based chemotherapy. J Clin Oncol. 2011 Mar 1;29(7):859-67. doi: 10.1200/JCO.2009.27.5644. Epub 2010 Dec 28.

ReferenceCitation: Stern HM, Gardner H, Burzykowski T, Elatre W, O'Brien C, Lackner MR, Pestano GA, Santiago A, Villalobos I, Eiermann W, Pienkowski T, Martin M, Robert N, Crown J, Nuciforo P, Bee V, Mackey J, Slamon DJ, Press MF. PTEN Loss Is Associated with Worse Outcome in HER2-Amplified Breast Cancer Patients but Is Not Associated with Trastuzumab Resistance. Clin Cancer Res. 2015 May 1;21(9):2065-74. doi: 10.1158/1078-0432.CCR-14-2993. Epub 2015 Feb 3.

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

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: PubMed Central - Europe PMC

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

license: cc-by

license_normalized: cc-by

repository_normalized: dnet

evidence: oa repository (semantic scholar lookup)

repositories:
PubMed Central
dnet
pdfs.semanticscholar.org

repositories_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

unpaywall_oa_status: hybrid

publisher_dissemination: American Society of Clinical Oncology (ASCO)

collaborators: Cancer International Research Group (CIRG)

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Bosnia and Herzegovina
Turkey
Croatia
Canada
France
Czech Republic
Slovenia
Colombia
Slovakia
Hungary
Hong Kong
Switzerland
United States
India
Romania
Tunisia
Lebanon
Belgium
Estonia
Egypt
Italy
United Kingdom
Venezuela
Sweden
Austria
Mexico
Korea, Republic of
Spain
Uruguay
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: A Phase III Double-Blind, Randomized, Placebo-Controlled Study of Erythropoietin When Used as an Adjuvant to Radiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may help prevent or treat cancer-related anemia. It is not yet known whether radiation therapy is more effective with or without epoetin alfa in treating head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating patients who have head and neck cancer.

ReferenceCitation: Bourhis J, Lapeyre M, Tortochaux J, Rives M, Aghili M, Bourdin S, Lesaunier F, Benassi T, Lemanski C, Geoffrois L, Lusinchi A, Verrelle P, Bardet E, Julieron M, Wibault P, Luboinski M, Benhamou E. Phase III randomized trial of very accelerated radiation therapy compared with conventional radiation therapy in squamous cell head and neck cancer: a GORTEC trial. J Clin Oncol. 2006 Jun 20;24(18):2873-8. doi: 10.1200/JCO.2006.08.057.

collaborators: Groupe Oncologie Radiotherapie Tete et Cou

collaborators: Grup per l'Estudi dels Limfomes de Catalunya i Balears

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

location_country:
Germany
Hungary
Israel
United Kingdom
Australia
Netherlands
Switzerland
Belgium
Spain
France

location_facility:
Cliniques Universitaires Saint-Luc
Beatson Oncology Centre
Institut Jules Bordet
Universitaetsklinikum Charite
Radiotherapeutisch Instituut Limburg
Hospital de la Santa Cruz I Sant Pau
U.Z. Gasthuisberg
Ospedale San Giovanni
Rambam Medical Center
Newcastle Mater Misericordiae Hospital
Algemeen Ziekenhuis Middelheim
Institut Gustave Roussy
Clinique Sainte Elisabeth
Hopital de Jolimont
Radius Hungaricus Oncology Group


title: Prophylactic Cranial Irradiation In Extensive Disease Small Cell Lung Cancer

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy to the brain may be effective in preventing brain metastases. It is not yet known if radiation therapy is effective following chemotherapy in preventing brain metastases.

PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in preventing brain metastases in patients who have received chemotherapy for extensive-stage small cell lung cancer.

ReferenceCitation: Slotman BJ, Mauer ME, Bottomley A, Faivre-Finn C, Kramer GW, Rankin EM, Snee M, Hatton M, Postmus PE, Collette L, Senan S. Prophylactic cranial irradiation in extensive disease small-cell lung cancer: short-term health-related quality of life and patient reported symptoms: results of an international Phase III randomized controlled trial by the EORTC Radiation Oncology and Lung Cancer Groups. J Clin Oncol. 2009 Jan 1;27(1):78-84. doi: 10.1200/JCO.2008.17.0746. Epub 2008 Dec 1. Erratum In: J Clin Oncol. 2009 Feb 20;27(6):1002.

ReferenceCitation: Slotman B, Faivre-Finn C, Kramer G, et al.: A randomized trial of prophylactic cranial irradiation (PCI) versus no PCI in extensive disease small cell lung cancer after a response to chemotherapy (EORTC 08993-22993). [Abstract] J Clin Oncol 25 (Suppl 18): A-4, 2s, 2007.

ReferenceCitation: Slotman B, Faivre-Finn C, Kramer G, Rankin E, Snee M, Hatton M, Postmus P, Collette L, Musat E, Senan S; EORTC Radiation Oncology Group and Lung Cancer Group. Prophylactic cranial irradiation in extensive small-cell lung cancer. N Engl J Med. 2007 Aug 16;357(7):664-72. doi: 10.1056/NEJMoa071780.

ReferenceCitation: Slotman BJ, Faivre-Finn C, Kramer GWPM, et al.: Prophylactic cranial irradiation (PCI) in extensive stage small cell lung cancer (ES-SCLC) (EORTC 22993-08993). [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-7, S4, 2007.

ReferenceCitation: Bernhardt D, Adeberg S, Bozorgmehr F, Opfermann N, Hoerner-Rieber J, Repka MC, Kappes J, Thomas M, Bischoff H, Herth F, Heussel CP, Debus J, Steins M, Rieken S. Nine-year Experience: Prophylactic Cranial Irradiation in Extensive Disease Small-cell Lung Cancer. Clin Lung Cancer. 2017 Jul;18(4):e267-e271. doi: 10.1016/j.cllc.2016.11.012. Epub 2016 Dec 2.

publisher_dissemination: Elsevier

ReferenceCitation: Slotman BJ, Faivre-Finn C, Kramer GW, Rankin E, Snee M, Hatton M, Postmus PE, Collette L, Musat E, Senan S. [Prophylactic cranial irradiation in patients with extensive disease caused by small-cell lung cancer responsive to chemotherapy: fewer symptomatic brain metastases and improved survival]. Ned Tijdschr Geneeskd. 2008 Apr 26;152(17):1000-4. Dutch.

location_country:
Germany
Italy
Cyprus
Poland
Hungary
Israel
United Kingdom
Netherlands
Belgium
Turkey
Egypt
France

location_facility: Nijmegen Cancer Center at Radboud University Medical Center

location_facility: Edinburgh Cancer Centre at Western General Hospital

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: Cookridge Hospital at Leeds Teaching Hospital NHS Trust

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Velindre Cancer Center at Velindre Hospital

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Royal Marsden NHS Foundation Trust - Surrey

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Centre Hospitalier Regional de la Citadelle

intervention_type: Radiation


type: Registry Identifier

title: Autologous Peripheral Blood Stem Cell Mobilization and Transplantation for Myelofibrosis

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelofibrosis.

ReferenceCitation: Anderson JE, Tefferi A, Craig F, Holmberg L, Chauncey T, Appelbaum FR, Guardiola P, Callander N, Freytes C, Gazitt Y, Razvillas B, Deeg HJ. Myeloablation and autologous peripheral blood stem cell rescue results in hematologic and clinical responses in patients with myeloid metaplasia with myelofibrosis. Blood. 2001 Aug 1;98(3):586-93. doi: 10.1182/blood.v98.3.586.

lead_sponsor: Fred Hutchinson Cancer Center

sponsor_collaborators:
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: New York Presbyterian Hospital - Cornell Campus

location_facility: University of Illinois College of Medicine

location_facility: Washington University Siteman Cancer Center


title: Vancomycin Versus Placebo in Persistently Febrile Granulocytopenic Patients Given Piperacillin/Tazobactam

summary:
RATIONALE: Antibiotic therapy may prevent the development of infection in patients with hematologic cancer and the persistent fever caused by a low white blood cell count. It is not yet known which regimen of antibiotics is most effective in preventing infection in these patients.

PURPOSE: Randomized phase III trial to study the effectiveness of piperacillin-tazobactam with or without vancomycin in reducing fever in patients who have leukemia, lymphoma, or Hodgkin's disease.

primary_purpose: Supportive Care

location_country:
Finland
France
Germany
Slovakia
Israel
United Kingdom
Switzerland
Belgium
United States
Greece
Turkey
Canada
Czech Republic

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Marlene & Stewart Greenebaum Cancer Center, University of Maryland

location_facility: Athens University-Laikon General Hospital

location_facility: Ottawa Regional Cancer Center - General Division

location_facility: Hellenic Institute for Cancer-Saint Savas Hospital


title: RANDOMIZED TRIAL OF SURGERY VERSUS RADIOTHERAPY IN PATIENTS WITH STAGE IIIa NON-SMALL CELL LUNG CANCER AFTER A RESPONSE TO INDUCTION-CHEMOTHERAPY

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether chemotherapy followed by surgery with or without radiation therapy is more effective than chemotherapy followed by radiation therapy alone in treating non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy followed by surgery with or without radiation therapy to that of chemotherapy followed by radiation therapy alone in treating patients who have stage III non-small cell lung cancer.

ReferenceCitation: Van Meerbeeck JP, De Pauw R, Tournoy K. What is the optimal treatment of stage IIIA-N2 non-small-cell lung cancer after EORTC 08941? Expert Rev Anticancer Ther. 2008 Feb;8(2):199-206. doi: 10.1586/14737140.8.2.199.

ReferenceCitation: van Meerbeeck JP, Kramer GW, Van Schil PE, Legrand C, Smit EF, Schramel F, Tjan-Heijnen VC, Biesma B, Debruyne C, van Zandwijk N, Splinter TA, Giaccone G; European Organisation for Research and Treatment of Cancer-Lung Cancer Group. Randomized controlled trial of resection versus radiotherapy after induction chemotherapy in stage IIIA-N2 non-small-cell lung cancer. J Natl Cancer Inst. 2007 Mar 21;99(6):442-50. doi: 10.1093/jnci/djk093.

ReferenceCitation: Kramer GW, Legrand CL, van Schil P, Uitterhoeve L, Smit EF, Schramel F, Biesma B, Tjan-Heijnen V, van Zandwijk N, Splinter T, Giaccone G, van Meerbeeck JP; EORTC-Lung Cancer Group. Quality assurance of thoracic radiotherapy in EORTC 08941: a randomised trial of surgery versus thoracic radiotherapy in patients with stage IIIA non-small-cell lung cancer (NSCLC) after response to induction chemotherapy. Eur J Cancer. 2006 Jul;42(10):1391-8. doi: 10.1016/j.ejca.2006.01.052.

ReferenceCitation: Van Meerbeeck JP, Kramer GW, Legrand C, et al.: Does downstaging in patients (pts) with IIIA-N2 non-small cell lung cancer (NSCLC) and a response to induction chemotherapy (ICT) influence outcome with surgery (S) or radiotherapy (RT)? An exploratory analysis of EORTC 08941. [Abstract] J Clin Oncol 24 (Suppl 18): A-7047, 375s, 2006.

ReferenceCitation: Van Meerbeeck JP, Kramer G, Van Schil PE, et al.: A randomized trial of radical surgery (S) versus thoracic radiotherapy (TRT) in patients (pts) with stage IIIA-N2 non-small cell lung cancer (NSCLC) after response to induction chemotherapy (ICT) (EORTC 08941). [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA7015, 624s, 2005.

ReferenceCitation: Van Schil P, Van Meerbeeck J, Kramer G, Splinter T, Legrand C, Giaccone G, Manegold C, van Zandwijk N. Morbidity and mortality in the surgery arm of EORTC 08941 trial. Eur Respir J. 2005 Aug;26(2):192-7. doi: 10.1183/09031936.05.00127204.

ReferenceCitation: van Meerbeeck JP, Kramer GWPM, van Schil PEY, et al.: Induction chemotherapy (CT) in stage IIIA-N2 non-small cell lung cancer (NSCLC):an analysis of different regimens used in EORTC 08941. [Abstract] Lung Cancer 41 (Suppl 2): A-O-273, S79, 2003.

ReferenceCitation: van Schil PE, van Meerbeeck JP, Kramer G, et al.: Surgery after induction chemotherapy: morbidity and mortality in the first 100 patients of the surgery arm of EORTC 08941 trial. [Abstract] Lung Cancer 41 (Suppl 2): A-O-147, S45, 2003.

ReferenceCitation: Splinter TA, van Schil PE, Kramer GW, van Meerbeeck J, Gregor A, Rocmans P, Kirkpatrick A. Randomized trial of surgery versus radiotherapy in patients with stage IIIA (N2) non small-cell lung cancer after a response to induction chemotherapy. EORTC 08941. Clin Lung Cancer. 2000 Aug;2(1):69-72; discussion 73. doi: 10.3816/clc.2000.n.020.

location_country:
Italy
United Kingdom
Netherlands
Belgium
France

location_facility: Twee Steden Ziekenhuis Vestiging Tilburg

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: CHR - Clinique Saint Joseph - Hopital de Warqueguies

location_facility: University Hospital - Rotterdam Dijkzigt


title: A RANDOMISED TRIAL OF CHEMOTHERAPY WITH OR WITHOUT GRANULOCYTE COLONY-STIMULATING FACTOR IN OPERABLE OSTEOSARCOMA

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether chemotherapy and surgery plus G-CSF is more effective than chemotherapy and surgery alone in treating patients with osteosarcoma.

PURPOSE: Randomized phase III trial to compare the effectiveness combination chemotherapy and surgery with or without G-CSF in treating patients who have newly diagnosed osteosarcoma.

ReferenceCitation: Lewis IJ, Nooij MA, Whelan J, Sydes MR, Grimer R, Hogendoorn PC, Memon MA, Weeden S, Uscinska BM, van Glabbeke M, Kirkpatrick A, Hauben EI, Craft AW, Taminiau AH; MRC BO06 and EORTC 80931 collaborators; European Osteosarcoma Intergroup. Improvement in histologic response but not survival in osteosarcoma patients treated with intensified chemotherapy: a randomized phase III trial of the European Osteosarcoma Intergroup. J Natl Cancer Inst. 2007 Jan 17;99(2):112-28. doi: 10.1093/jnci/djk015.

ReferenceCitation: Lewis IJ, Nooij M: Chemotherapy at standard or increased dose intensity in patients with operable osteosarcoma of the extremity: a randomised controlled trial conducted by the European Osteo Sarcoma Intergroup (ISRCTN 86294690). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-3281, 816, 2003.

location_country:
Slovenia
Portugal
United Kingdom
Denmark
Netherlands
Belgium
Saudi Arabia
France

location_facility: King Faisal Specialist Hospital and Research Centre

location_facility: Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa


title: A Randomized, Double-Blind Trial of Valacyclovir Hydrochloride (BW 256U87) Prophylaxis for Opportunistic Cytomegalovirus End-Organ Disease in Patients With Advanced HIV Infection (< 100 CD4+ Lymphocytes)

summary:
PRIMARY: To evaluate the efficacy of valacyclovir hydrochloride (BW 256U87) in the prevention of cytomegalovirus (CMV) end-organ disease in HIV/CMV co-infected patients with CD4+ lymphocytes < 100 cells/mm3. To assess the impact of BW 256U87, high-dose oral acyclovir and low-dose oral acyclovir on survival.

SECONDARY: To evaluate the effect of BW 256U87 on quality of life, the safety of the drug administered concurrently with standard antiretroviral agents and other essential therapies for the treatment and prevention of opportunistic diseases, and the efficacy of BW 256U87 in suppressing activation of other herpesviruses. To evaluate serologic and virologic risk factors for the development of CMV disease, including assessment of HIV activation, and the risk of developing drug-resistant CMV, HSV, and VZV.

Gastrointestinal absorption of acyclovir is not high enough to prevent CMV disease in patients with advanced HIV disease, although there is evidence that high doses of the drug may extend survival. Valacyclovir, a prodrug that is rapidly converted to acyclovir after oral administration, has a higher absorption rate and may therefore provide inhibitory activity against CMV.

ReferenceCitation: Feinberg JE, Hurwitz S, Cooper D, Sattler FR, MacGregor RR, Powderly W, Holland GN, Griffiths PD, Pollard RB, Youle M, Gill MJ, Holland FJ, Power ME, Owens S, Coakley D, Fry J, Jacobson MA. A randomized, double-blind trial of valaciclovir prophylaxis for cytomegalovirus disease in patients with advanced human immunodeficiency virus infection. AIDS Clinical Trials Group Protocol 204/Glaxo Wellcome 123-014 International CMV Prophylaxis Study Group. J Infect Dis. 1998 Jan;177(1):48-56. doi: 10.1086/513804.

ReferenceCitation: Fry J, Coakley D, Power M, Feinberg J. International collaborative clinical trials: the ACTG 204 experience. Int Conf AIDS. 1996 Jul 7-12;11(2):276 (abstract no ThB4146)

ReferenceCitation: Griffiths PD, Feinberg J. Detection of cytomegalovirus in samples from patients enrolled in ACTG 204 / Glaxo Wellcome 123-014. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:54

ReferenceCitation: Brosgart C, Fisher E, Pulling C, Chaloner K, Cohn D, Elsadr W, Verheggen R, Schmetter B, Alston B. Prevalence of asymptomatic CMV retinitis (CMVR) in AIDS patients. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:152 (abstract no 453)

ReferenceCitation: Fisher E, Brosgart C, Cohn D, Chaloner K, Pulling C, Alston B, Schmetter B, El-Sadr W. Placebo (PLC)-controlled, multicenter trial of adefovir dipivoxil (ADV) in patients (pt) with HIV disease. . Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:160 (abstract no 491)

ReferenceCitation: Feinberg JE, Bell WR, Chulay JD. A thrombotic microangiopathy (TMA)-like syndrome in patients with advanced HIV disease in a cytomegalovirus (CMV) prophylaxis trial (ACTG 204). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:196 (abstract no 715)

ReferenceCitation: Sprenger HG, Law G, Pastoor G, Postma S, Schirm J, Weits J, The TH. Cytomegalovirus antigenemia (CMVAg) compared with other CMV tests during phase III study of valaciclovir (VACV) for CMV prophylaxis in advanced HIV disease (ACTG 204 study). Int Conf AIDS. 1996 Jul 7-12;11(2):285 (abstract no ThB4200)

ReferenceCitation: Bell WR, Chulay JD, Feinberg JE. Manifestations resembling thrombotic microangiopathy in patients with advanced human immunodeficiency virus (HIV) disease in a cytomegalovirus prophylaxis trial (ACTG 204). Medicine (Baltimore). 1997 Sep;76(5):369-80. doi: 10.1097/00005792-199709000-00004. No abstract available.

ReferenceCitation: Emery V, Sabin C, Feinberg J, Grywacz M, Knight S, Griffiths P. Quantitative effects of valaciclovir on the replication of cytomegalovirus in patients with advanced HIV disease. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:153 (abstract no 459)

ReferenceCitation: Weinberg A, Schneider SA, Clark JC. Acyclovir (ACV) and valacyclovir (VAL) prophylaxis of AIDS patients does not alter cytomegalovirus (CMV) susceptibility to ganciclovir (GCV) or foscarnet (FOS). Program Abstr Intersci Conf Antimicrob Agents Chemother. 1996 Sep 15-18:202 (abstract no I87)

ReferenceCitation: Nokta MA, Holland F, De Gruttola V, Emery VC, Jacobson MA, Griffiths P, Pollard RB, Feinberg JE; AIDS Clinical Trials Group, Protocol 204/GlaxoWellcome 123-014, International CMV Prophylaxis Study Group. Cytomegalovirus (CMV) polymerase chain reaction profiles in individuals with advanced human immunodeficiency virus infection: relationship to CMV disease. J Infect Dis. 2002 Jun 15;185(12):1717-22. doi: 10.1086/340651. Epub 2002 May 31.

lead_sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

location_country:
Germany
Italy
United Kingdom
Denmark
Australia
Sweden
Switzerland
United States
Canada
France

location_facility: Southern Alberta HIV Clinic / Foothills Hosp

location_facility: North Central Bronx Hosp / Bronx Municipal Hosp

location_facility: Univ of California / San Diego Treatment Ctr

location_facility: Univ of North Carolina School of Medicine

location_facility: Birmingham Veterans Administration Med Ctr

location_facility: Highland Gen Hosp / San Francisco Gen Hosp


title: A Randomized, Double-Blind Study of 566C80 Versus Septra (Trimethoprim/Sulfamethoxazole) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients

summary:
To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and SMX/TMP in AIDS patients with an acute episode of PCP.

Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.

ReferenceCitation: Hughes W, et al. Comparison of 566C80 & trimethoprim-sulfamethoxazole (TMP-SMZ) for the treatment of P. carinii pneumonitis (PCP). An International Multicenter, CCTG & ACTG Collaboration. Int Conf AIDS. 1992 Jul 19-24;8(1):We48 (abstract no WeB 1019)

ReferenceCitation: Hughes W, Leoung G, Kramer F, Bozzette SA, Safrin S, Frame P, Clumeck N, Masur H, Lancaster D, Chan C, et al. Comparison of atovaquone (566C80) with trimethoprim-sulfamethoxazole to treat Pneumocystis carinii pneumonia in patients with AIDS. N Engl J Med. 1993 May 27;328(21):1521-7. doi: 10.1056/NEJM199305273282103.

sponsor_collaborators: National Institute of Allergy and Infectious Diseases (NIAID)

location_country:
Germany
United Kingdom
Netherlands
Belgium
United States
Canada
Puerto Rico
France

location_facility: Universitat Munchen / Medizinische Poliklinik

location_facility: Beth Israel Med Ctr / Peter Krueger Clinic

location_facility: August-Viktoria-Krankenhaus Chefarst derII Inneren Abteilung

location_facility: Natl Inst of Allergy & Infect Dis / Cln Ctr

location_facility: San Juan Veterans Administration Med Ctr

location_facility: Harlem AIDS Treatment Group / Harlem Hosp Ctr


title: A PHASE II DOUBLE-BLIND VEHICLE-CONTROLLED CROSSOVER SINGLE DOSE (400 µG) V0147 GEL EFFECT AND TOLERANCE STUDY IN SPINAL CORD INJURED PATIENTS WITH ERECTILE DYSFUNCTION

source: euctr

lead_sponsor: PIERRE FABRE MEDICAMENT

status: Prematurely Ended


title: Efficacy of Testosterone gel to restore normal serum values of testosterone during the acute phase of critical illness in adult ICU patients. An open-label parallel randomized controlled pilot study

lead_sponsor: CHU  de Clermont-ferrand

status: Ongoing

status_simplified: Ongoing


title:
Effect of early use of levosimendan versus placebo on top of a conventional strategy of inotrope use on a combined morbidity-mortality endpoint in patients with cardiogenic shock. LevoHeartShock Study.

 Effet de l’utilisation précoce du levosimendan versus placebo en plus d’une stratégie conventionnelle d’utilisation des inotropes sur un critère composite de morbidité-mortalité dans le choc cardiogénique. Protocole LEVOHEARTSHOCK.

acronym:
LevoHearShock

 LevoHeartShock

lead_sponsor: CHRU de Nancy


title: Lean body mass normalization of oxaliplatin based chemotherapy for stage III colon cancer patients treated in adjuvant satting: Impact on Oxaliplatin induced sensitive neurotoxicity. A multicenter phase II randomized trial

acronym: LEANOX

lead_sponsor: Institut régional du Cancer de Montpellier


title:
Tamsulosin to prevent the failures of early bladder catheter removal after acute urinary retention in elderly women hospitalized for an acute medical problem

 Tamsulosine pour prévenir les échecs de retrait de sonde vésicale précoce après rétention aiguë d’urines chez la femme âgée hospitalisée pour un problème médical aigu

acronym: TAMSU

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


title:
A Phase 2 Open-Label Study to Evaluate the Efficacy and Safety of Ustekinumab, a Human Monoclonal Anti-IL-12/IL-23 Antibody, in patients with Behçet disease : STELABEC

 STELABEC : Etude ouverte de phase 2 évaluant l'efficacité et la tolérance de l'ustekinumab, anticorps monoclonal humain anti-IL-12/IL-23, chez les patients atteints de maladie de Behçet.

acronym: STELABEC


title:
L-carnitine as an adjunct treatment for septic shock patients with acute kidney injury: a multicentre, randomized, 2-parallel group, superiority trial

 L-carnitine comme traitement complémentaire pour les patients en choc septique avec insuffisance rénale aigüe : une étude de supériorité, multicentrique, randomisée, à deux groupes parallèles

acronym:
CARNISAVE

 CARNISAVE

lead_sponsor: CHU de Nîmes


title:
RETINO 2018 : Ocular conservative treatment for retinoblastoma: efficacy of the new management strategies and visual outcome.

 RETINO 2018 :Traitements conservateurs du rétinoblastome: efficacité des nouvelles stratégies et devenir visuel.

acronym:
RETINO 2018

 RETINO 2018

lead_sponsor: Institut Curie


title:
NA

 Etude de la réponse clinique et biologique à l’administration répétée d’interleukine-2 à faible dose chez des patients présentant un diabète de type 1 ayant gardé une sécrétion résiduelle d’insuline

acronym:
DFIL2-REP

 DFIL2-REP


title:
IMPACT OF 5% LIDOCAINE MEDICATED PLASTER ON ALLODYNIC SYMPTOMS OF LOCALIZED NEUROPATHIC PAIN AFTER KNEE SURGERY. A prospective, randomized, placebo controlled study in parallel groups.

 Impact de l’utilisation de patch de Lidocaïne 5% sur les douleurs neuropathiques à type d’allodynie après chirurgie du genou
 Étude prospective, randomisée, en double aveugle, contrôlée versus placebo

lead_sponsor: CHU Clermont-Ferrand


title:
Multicentric non-randomized phase II of pembrolizumab in combination with etoposide-cisplatin-based chemotherapy in first-line advanced small cell ovarian carcinoma of hypercalcemic type

 Etude de phase II, multicentrique, évaluant le pembrolizumab en combinaison à une chimiothérapie à base d’étoposide-cisplatine (PAVEP) en première intention chez des patientes atteintes d’un carcinome à petites cellules avancé de l’ovaire (stades II-IV) de type hypercalcémique.

acronym: PembroSCCOHT

lead_sponsor: ARCAGY-GINECO


title:
A multicentric randomized phase II/III evaluating TSR-042 (anti-PD-1 mAb) in combination with Niraparib (parpi) versus Niraparib alone compared to chemotherapy in the treatment of metastatic or recurrent endometrial or ovarian carcinosarcoma after at least one line of chemotherapy

 Etude de phase II/III, randomisée, multicentrique évaluant le TSR-042 (anti-PD-1 mAb) associé au Niraparib versus le Niraparib seul comparé à la chimiothérapie chez des patientes atteintes d’un carcinosarcome métastasique ou en récidive de l’ovaire ou de l’endomètre après une chimiothérapie de première intention

acronym: ROCSAN


title: Altération de la Réponse dopaminergique à l'Administration de Psychostimulants par Inhibition de la Dopamine beta-hydroxylase. Exploration par TEP du mécanisme d'action d'une nouvelle stratégie thérapeutique chez les cocaïnomanes. (Acronyme : RAPID)

acronym: RAPID


title: A phase II randomized trial comparing alpelisib and fulvestrant versus chemotherapy as maintenance therapy in patients with PIK3CA mutated advanced breast cancer

acronym: SAFIR PI3K

lead_sponsor: UNICANCER


title: Adjuvant  immunotherapy after salvage surgery in head and neck squamous cell carcinoma : phase 2 trial evaluating the efficacy and the toxicity of nivolumab alone, and of the combination nivolumab and ipilimumab

lead_sponsor: Gustave Roussy


title:
Evaluation of the efficacy, safety and tolerability of alisporivir for the treatment of hospitalised patients with infections due to SARS-CoV-2 (COVID-19).
 A randomised, open-label, proof of concept, Phase 2 study.

 Evaluation de l’efficacité, la sécurité et la tolérance de l'alisporivir chez des patients hospitalisés pour une infection par le SARS- CoV-2 (COVID-19).
 Étude de faisabilité de phase 2, randomisée, en ouvert.

acronym: CYCLOVID

lead_sponsor: Assistance Publique - Hôpitaux Paris


title:
Evaluation of the 64Cu-ATSM PET-CT as a predictor of the response to neo-adjuvant treatment in locally advanced rectal cancers

 Evaluation de la TEP-TDM au 64Cu-ATSM comme facteur prédictif de la réponse au traitement néo-adjuvant dans les cancers localement avancés du rectum

acronym:
TEP-64Cu-ATSM-Rectum

 TEP-64Cu-ATSM-Rectum

lead_sponsor: INSTITUT DE CANCEROLOGIE DE L'OUEST


title:
A phase III randomized trial evaluating chemotherapy followed by pelvic reirradiation versus chemotherapy alone as pre-operative treatment for  locally recurrent rectal cancer
 (GRECCAR – PRODIGE – FRENCH)

 Etude randomisée de phase III comparant chimiothérapie suivie d’une ré-irradiation pelvienne versus chimiothérapie seule en traitement préopératoire des récidives locorégionales des cancers du rectum
 (GRECCAR-PRODIGE-FRENCH)

acronym:
GRECCAR 15

 GRECCAR 15

lead_sponsor: CHU DE BORDEAUX


title:
Influence des dermocorticoïdes sur la densité minérale osseuse chez les patients atteints de pemphigoïde bulleuse

 Influence des dermocorticoïdes sur la densité minérale osseuse chez les patients atteints de pemphigoïde bulleuse

acronym: DERMOS

lead_sponsor: CHU Amiens Picardie


title:
Efficacy of a personalized caplacizumab regimen based on ADAMTS-13 activity monitoring in adult acquired thrombotic thrombocytopenic purpura: A phase II, multicenter non-inferiority single-arm study

 Efficacité d'un schéma posologique personnalisé de caplacizumab basé sur la surveillance de l'activité ADAMTS13 chez l'adulte atteint de purpura thrombopénique thrombotique acquis (PTTa): étude de non-infériorité de phase II, multicentrique à un seul bras

acronym:
CAPLAVIE

 CAPLAVIE

lead_sponsor: CHU de Rouen


title:
Non-inferiority of intranasal fentanyl versus oral morphine sulfate in the treatment of pain in pediatric trauma : a controled randomized , single blind study

 Etude randomisée contrôlée en simple aveugle évaluant la non infériorité du Fentanyl intranasal versus sulfate de morphine per os dans le traitement de la douleur en traumatologie pédiatrique

acronym:
FINDOL

 FINDOL

lead_sponsor: University Hospital of Montpellier


title: Efficiency of an antibioprophylaxy (levofloxacin) in patient treated by azacitidine

acronym: AZABAC

lead_sponsor: Centre Henri Becquerel


title:
Dosage optimization of piperacillin/tazobactam in ICU patients based on therapeutic drug monitoring of amikacin - OPTIMA

 Optimisation du dosage de pipéracilline tazobactam en fonction du monitoring thérapeutique de l’amikacine chez les patients de réanimation - OPTIMA

acronym: OPTIMA

lead_sponsor: Hospices Civils de Lyon


title:
Assesment of Propofol sedation during intra tracheal surfactant administration by the LISA method (Less Invasive Surfactant Administration)

 Evaluation de la sédation au Propofol lors de l’administration intra-trachéale d’un surfactant par la méthode LISA (administration moins invasive de surfactants)

acronym: PROLISA

lead_sponsor: CHU Grenoble-Alpes


title: Phase I-II study of nivolumab in combination with temozolomide and radiotherapy in children and adolescents with newly diagnosed high-grade glioma

acronym: NIVOGLIO


title: A Phase II, multi-centre study, to evaluate the efficacy and safety of osimertinib treatment for patients with EGFR-mutated  non-small cell lung cancer (NSCLC)  with Brain or Leptomeningeal metastases

lead_sponsor: IFCT


title:
Effect of impact of PCSK9 inhibitor on coronary microvascular dysfunction in patients with atherosclerotic cardiovascular disease proved by myocardial ischemia and needing coronarography.

  Évaluation de l’impact des anticorps monoclonaux anti--proprotéine convertase subtilisine/kexine de type 9 (PCSK9), sur le dysfonctionnement microvasculaire coronarien chez les patients atteints d’une maladie cardiovasculaire athérosclérotique, prouvée par une ischémie myocardique nécessitant une coronarographie.

acronym:
MICROPROTECT

 MICROPROTECT

lead_sponsor: University Hospital Grenoble


title:
Prospective randomized versus placebo study evaluating the feasibility of plasma therapy in septic shock induced coagulopathy

 Étude prospective randomisée versus placebo évaluant la faisabilité d'une plasmathérapie dans la coagulopathie induite par le choc septique

acronym:
PLASMA-faisa

 PLASMA-faisa

lead_sponsor: Hôpitaux Universitaires de Strasbourg


title:
Antibioprophylaxis for excision-graft surgery in burn patient: a multicenter randomized double-blind study

 Antibioprophylaxie pour la chirurgie d'excision-greffe chez le patient brûlé : Etude multicentrique, randomisée et en double aveugle

lead_sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (APHP)


title: Peri-operative association of immunotherapy (pre-operative association of nivolumab and ipilimumab, post-operative nivolumab alone) in localized microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) oeso-gastric adenocarcinoma: An open-label GERCOR phase II study

acronym: NEONIPIGA D18-02

lead_sponsor: GERCOR


title:
Safety of Intraperitoneal (IP) OXAliplatin (OXA) in Association With Systemic FOLFIRI Bevacizumab Chemotherapy in Patients With Peritoneal Carcinosis ( IPOXA )

 IPOXA, Essai de Phase I/II en escalade de dose visant à évaluer la tolérance de l’administration Intra-péritonéale (IP) d’OXAliplatine (OXA) en association avec une chimiothérapie systémique de type FOLFIRI Bevacizumab chez des patients atteints de carcinose péritonéale d’origine colorectale de résécabilité incertaine

acronym:
IPOXA

 IPOXA


title: Evaluation of the effect of Atomoxetine on impulsive state of High impulsive Tourette’s patients.

acronym: ATO-TS

lead_sponsor: CHU DE POITIERS


title:
A Prospective study evaluating the effect of ocrelizumab on brain innate immune Microglial cells Activation in Multiple Sclerosis using PET-MRI with 18F-DPA714

 Une étude prospective évaluant l'effet de l'ocrélizumab sur l'activation des cellules microgliales du système immunitaire inné dans le cerveau des patients atteints de sclérose en plaques

acronym: INN-MS

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


title: ETUDE TRANSCRIPTOMIQUE DE LA REPONSE AU MINOXIDIL CHEZ L'HOMME ALOPECIQUE

lead_sponsor: L'OREAL


title: Effets du moclobémide sur le profil d'activation cérébrale de patients dépressifs âgés lors de tâches cognitives et émotionnelles, en référence à des sujets témoins. Etude ouverte, multicentrique, chez le patient âgé présentant un épisode dépressif majeur et traité par moclobémide pendant 6 semaines

lead_sponsor: BIOCODEX


title: Essai en ouvert, randomisé et multicentrique évaluant l’efficacité et la tolérance de l’association de l’Enfuvirtide en cure d’induction de 3 mois à un traitement optimisé (TO) comprenant au moins 2 molécules pleinement actives, versus TO seul, chez des patients VIH-1 en échec virologique et naïfs d’Enfuvirtide, avec réintensification possible du traitement optimisé par « séquences » de 3 mois d’Enfuvirtide en cas de nouvel échec virologique

acronym: INNOVE

lead_sponsor: Roche


title: Labetalol versus MgSO4 for the Prevention of Eclampsia Trial

acronym: LAMPET


title: Etude pharmacocinétique, prospective, ouverte, de la diffusion de l’Ertapénème dans le muscle par microdialyse chez des patients de réanimation sous ventilation mécanique, recevant ou non des vasopresseurs

lead_sponsor: Assistance Publique Hopitaux de marseille


title: Essai thérapeutique de phase IIA évaluant l'efficacité du Bortezomib (velcade) chez les patients atteints de la maladie de Waldenstrom en phase avancée


title: AMBIZYGO. Etude de phase II de l'efficacité d'une posologie initiale élevée d'amphotéricine B liposomale (AmBisome) (10mg/kg/j) dans le traitement des zygomycoses

acronym: AMBIZYGO


title: "Etude d'évaluation du profil d'efficacité/tolérance de 2 doses de dropéridol intraveineux dans la prévention des nausées et des vomissements post-opératoires (NVPO) liés à la chirurgie de la thyroïde"

acronym: DIPAVO

lead_sponsor: CHU de Bordeaux


title: Effets du méthylphénidate dans le Trouble Déficitaire d’Attention avec Hyperactivité : Etude longitudinale en imagerie par résonance magnétique chez l’enfant

lead_sponsor: CHU d'Amiens


title: Etude de l'effet de la pioglitazone dans l'ataxie de Friedreich : étude "preuve de concept"

acronym: ACTFRIE


title: Etude de pharmacocinétique de population du linézolide chez des patients de réanimation présentant une infection sévère à Staphylocoque doré méticillino-résistant

lead_sponsor: CHU de Toulouse


title: Essai de phase II évaluant l'association de FOLFOX et CETUXIMAB avec radiothérapie concomitante en traitement des cancers de l'oesophage de stade III

acronym: ERAFOX


title: Lavage Bronchiolo-Alvéolaire sous ventilation non Invasive et sédation intra veineuse en objectif de concentration au Propofol chez le malade en insuffisance Respiratoire Aiguë. Etude Randomisée Contrôlée

acronym: SEDA-FIBRO


title: Etude de phase 3 comparant une chimiothérapie d'induction séquentielle systématique à une chimiothérapie d'induction séquentielle conditionnelle chez des patients atteints d'une Leucémie Aigüe Myéloïde du groupe CBF


title: Efficacité de l'infiltration tissulaire peropératoire par la ropivacaïne (Naropeine®) dans la chirurgie thyroïdienne : étude randomisée, en double aveugle versus placebo

acronym: MORFREE


title: ASSESMENT OG EFFICACY AND TOLERABILITY OF INHABLED TOBRAMYCIN VS PLACEBO IN CYSTIC FIBROSIS PATIENTS REVEIVING ANTIBIOTHERAPY FOR 28 DAYS FOR PSEUDOMONAS AERUGINOSA PRIMO COLONISATION.

acronym: NEBCINAL 01-07

lead_sponsor: Laboratoire Erempharma


title: Pilot study of Lapatinib (Tyverb®) in néoadjuvant treatment for patients with locally bladder carcinoma before cystectomy

acronym: LAPAINBLAD


title: Traitement par Sandostatine LP remplaçant le traitement par Sandostatine SC chez les enfants présentant un hyperinsulinisme congénital résistant au diazoxide.

acronym: HI_SANDO LP


title: Etude prospective ouverte de l'efficacité du leflunomide dans le traitement de la pemphigoïde bulleuse en association aux dermocorticoïdes.

acronym: ARABUL

lead_sponsor: CHU de Limoges


title: DETECTION OF ACUTE RENAL FAILURE IN CRITICALLY ILL PATIENTS: A prospective evaluation of cystatin C diagnostic performance

lead_sponsor: CHU Saint-Etienne


title: Pharmacocinétique de l’association pipéracilline-tazobactam chez les patients septiques, en insuffisance rénale oligo-anurique, traités par hémodiafiltration veino-veineuse continue

lead_sponsor: CHU de TOULOUSE


title: ETUDE DE PHASE II DU THALIDOMIDE DANS LES MASTOCYTOSES

lead_sponsor: CHU Amiens


title: Evaluation de l'action neuroréparatrice fonctionnelle et morphologique du traitement antidepresseur au cours de la rémission clinique dans la dépression recurrente.

acronym: RESILIENCE


title: Etude chez le sujet volontaire sain de l’effet de carbolevure versus placebo sur la fermentation intestinale induite par l’ingestion de lactulose.

lead_sponsor: Pierre Fabre Médicament


title: Etude randomisée, en double aveugle, comparant l’efficacité et la tolérance de la méthylprednisolone administrée à forte dose par voie orale ou par voie intraveineuse dans le traitement des poussées de sclérose en plaques

acronym: COPOUSEP

lead_sponsor: CHU Rennes


title: EVALUATION DE LA REPONSE IMMUNITAIRE CONTRE LA SOUCHE  DE NEISSERIA MENINGITIDIS B:14,P1.7,16  CHEZ LES SUJETS VACCINES PAR MenBVac

acronym: Immunogénicité MenBVac

lead_sponsor: CHU - Hôpitaux de Rouen


title: Etude contrôlée comparative en double aveugle de l'effet d'un traitement par le fénofibrate sur l'expression des génes de l'homéostasie du cholestérol, de l'inflammation et de la prolifération cellulaire dans les plaques artéroscléreuses carotidiennes asymptomatiques.

acronym: FENOGEN

lead_sponsor: Centre Hospitalier Régional et Universitaire


title: A phase IIIb, open label, randomized, exploratory clinical study exploring efficacy, safety and patients’ satisfaction with Certolizumab pegol treatment in moderate to severe Crohn’s disease when treatment is administered in two different settings : either at hospital or at home

acronym: PERFECT

lead_sponsor: UCB PHARMA S.A.


title: omparaison randomisée en double aveugle du délai d’action de la Ropivacaïne 0,75% contre un mélange [Ropivacaïne 0,75% + Mépivacaïne 1,5%] pour le bloc du nerf sciatique par voie subglutéale

acronym: loc Sciatique, anesthésique local unique ou mélange d’anesthésiques locaux ?


title: Confirmation clinique d'une interaction pharmacodynamique entre tropisétron et paracétamol

lead_sponsor: CHU de Clermont-Ferrand


title: Evaluation de l'apport de l'échoendoscopie de contraste dans le diagnostic des lésions solides du pancréas

acronym: Protocole SONOVUE


title: A prospective, multicenter, open-label, uncontrolled, two-parallel group, phase 1/2 study to evaluate safety and efficacy of masitinib at 9 mg/kg/day in monotherapy and in combination with dacarbazine in the treatment of patients with non-resectable or metastatic stage 3 or stage 4 melanoma not carrying a mutation in the juxta membrane domain of c-kit

lead_sponsor: AB SCIENCE


title: Etude ouverte de phase 2 de 52 semaines visant à établir l'efficacité et la tolérance du Belimumab (HGS1006, LymphoStat-B), un anticorps monoclonal humanisé anti-BLys (BAFF), chez des patients atteints de syndrome de Sjögren primitif

acronym: BELISS

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


title: étude cas-témoins comparant l'efficacité d’une combinaison thérapeutique contenant l'inhibiteur de l'intégrase raltégravir (400 mg x 2) ou une combinaison thérapeutique ne contenant pas le raltégravir sur la diminution de l'ADN proviral chez des sujets prétraités présentant une infection par le VIH-1 avec une charge virale détectable

acronym: IN-DEEP

lead_sponsor: STOP SIDA


title: Profil des populations leucocytaires chez les patients atteints de psoriasis répondeurs et non répondeurs au traitement par efaluzimab (anti-CD11A) : étude systémique et cutanée

acronym: REPSORA

lead_sponsor: CHU de Bordeaux


title: Effet de la stimulation dopaminergique continue par pompe à apomorphine sur les fluctuations cognitives et psychiques des patients parkinsoniens: étude clinique et métabolique cérébrale par TEP au 18FDG

acronym: APO TEP

lead_sponsor: CHU de Rennes


title: A phase II study evaluating the efficacy and safety of Lenalidomide (Revlimid®) with or without Epoetin beta (NeoRecormon®) in transfusion-dependent ESA-resistant patients with IPSS low- and intermediate-1 risk myelodysplastic syndromes without chromosome 5 abnormality

lead_sponsor: Groupe Francophone des Myélodysplasies


title: INTERET DE LA CORTICOTHERAPIE EN PREMIERE INTENTION, EN INJECTIONS INTRAVITREENES LORS  DES ENDOPHTALMIES POST-OPERATOIRES

lead_sponsor: CHU DIJON


title: Etude prospective, multicentrique contrôlée vs. placebo, randomisée, en double Insu, évaluant les bénéfices et risques d'un traitement précoce par faibles doses de corticoïdes, des pneumonies graves dues à la grippe A/H1N1v 2009, associé à un traitement anti-viral.

acronym: CORTIFLU


title: Protocole IFM 2008 :  Primo-traitement des patients de moins de 65 ans atteints de myélome


title: A double-blind, escalating dose, randomized, placebo-controlled study to assess the pharmacokinetics, safety and tolerability of single subcutaneous injections of GSK2402968 in non-ambulant subjects with Duchenne muscular dystrophy

lead_sponsor: GlaxoSmithKline Research and Development LTD


title: Determination De La Dose Efficace De L-Bupivacaine Pour Rachianesthésie En Chirurgie Proctologique : Étude Comparative Prospective Randomisée En Double Aveugle.

acronym: CHIRO

lead_sponsor: Hospices Civils de Lyon


title: Etude de phase 3 randomisée multicentrique étudiant l’effet de l’addition de l’anticorps monoclonal Gemtuzumab Ozogamicin (Mylotarg) utilisé en doses fractionnées au traitement d’induction et de consolidation par Daunorubicine et Aracytine chez les patients atteints de Leucémie Aigue Myéloide (LAM) et âgés de 50 à 70 ans.

acronym: Mylofrance 3

lead_sponsor: CH-Versailles


title: AN  INVESTIGATOR BLIND PARALLEL GROUP  VEHICLE  CONTROL STUDY COMPARING THE EFFICACY AND SAFETY OF CD 5024  1%  CREAM  WITH  METRONIDAZOLE 0.75% CREAM IN SUBJECTS WITH PAPULOPUSTULAR ROSACEA OVER 16 WEEKS TREATMENT

lead_sponsor: GALDERMA R&D SNC


title: Etude de phase II d’évaluation de la toxicité et de l’efficacité d’un traitement par Tacrolimus (Prograf®) chez des patients atteints d’un lymphome diffus à grandes cellules B ou T.

acronym: LY-PROGRAPH

lead_sponsor: INSTITUT CURIE


title: Etude de phase II multicentrique étudiant l’efficacité de la doxorubicine associée à de la trabectedine (Yondelis)  en première ligne dans le traitement des patients présentant un léiomyosarcome métastatique (utérin ou des tissus mous) et/ou en rechute inopérable

lead_sponsor: Institut Gustave Roussy


title: Etude des effets des immunoglobulines intraveineuses sur l'excitabilité nerveuse dans les neuropathies démyélinisantes dysimmunes chroniques

acronym: IVIG


title: Evaluation de la tolérance et de l’acceptabilité de la Rasagiline dans le traitement de la maladie de Parkinson au stade précoce

acronym: ACTOR

lead_sponsor: Qualissima


title: Effet d'un antagoniste du récepteur de l'endothéline 1 (Sitaxentan, Thelin) sur le remodelage bronchique au cours de l'asthme sévère avec obstruction bronchique persistante.

acronym: Entholéine et remodelage bronchique dans l'asthme sévère

lead_sponsor: INSERM


title: Etude des marqueurs biologiques, histologiques et d’imagerie dans le traitement de 1ère ligne du carcinome à cellules claires du rein en situation métastatique par Sunitinib avant et après néphrectomie.

acronym: PREINSUT


title: Etude de phase I associant la rapamycine et l’irinotecan dans toutes tumeurs solides réfractaires de l’enfant

acronym: RAPIRI

lead_sponsor: Hôpitaux Universitaires de Strasbourg


title: Efficacy and safety of sodium cromolyn eye drops compared with placebo eye drops in patients with a history of allergic conjunctivitis using the Conjunctival Allergen Challenge model.

lead_sponsor: Laboratoires Théa


title: Injections intradétrusoriennes de toxine botulique A chez l'enfant présentant un syndrome d'hyperactivité vésicale neurogène : essai thérapeutique contrôlé multicentrique de non infériorité entre deux doses rapportées au poids.

acronym: TBIDE

lead_sponsor: Centre Hospitalier Universitaire de Reims


title: Evaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien

acronym: DOULOX

lead_sponsor: CHU de Toulouse


title: Evaluation of the impact of physical reconditioning associated with specific nutritional supplementation in obese patients suffering of metabolic syndrome.

acronym: OBEFITT

lead_sponsor: CHU-HOPITAUX DE ROUEN


title: Etude ouverte, randomisée, comparant l'efficacité du retraitement par etanercept ou par rituximab, après insuffisance d'efficacité du rituximab, chez les patients atteints de polyarthrite rhumatoïde active

lead_sponsor: CHRU Montpellier- Direction de la Recherche, Partenariats et Réseaux, Relations avec l'Université


title: Etude nationale, multicentrique, prospective, évaluant la correction et le maintien du taux d’hémoglobine avec une administration sous-cutanée mensuelle de Mircera® chez des patients transplantés rénaux depuis plus de 6 mois présentant une anémie symptomatique traitée ou non par ASE

acronym: TRAMWAY

lead_sponsor: CHU AMIENS


title:
ICLL01 BOMP Study

 Phase II salvage treatment with Bendamustine, Ofatumumab and MethylPrednisolone (BOMP) in relapsed B-cell chronic lymphocytic leukemia (B-CLL).

acronym: ICLL 01 BOMP study

lead_sponsor: Groupe Est Ouest des Leucémies et Autres Maladies du Sang


title: Etude multicentrique, randomisée de non infériorité de deux stratégies thérapeutiques chez des enfants atteints de toxoplasmose congénitale

acronym: TOSCANE

lead_sponsor: CHU DIJON


title: Evaluation de la tolérance d'une administration intra-nasale d'ocytocine chez des nourrissons présentant un syndrome de Prader-Willi et de son effet sur la succion et la prise alimentaire.

acronym: OTBB

lead_sponsor: Centre Hospitalier de Toulouse


title: Essai comparatif, multicentrique, prospectif, randomisé, en double insu, d’efficacité et de tolérance de Météoxane® versus placebo dans la poussée douloureuse du syndrome de l'intestin irritable

lead_sponsor: Laboratoires IPRAD


title: Etude ARCTIC Comparaison randomisée 1/ d'un traitement antiplaquettaire ajusté par monitoring à un traitement standard à dose fixe pour stenting coronaire avec DES, et 2/ d'un arrêt versus poursuite d'un traitement antiplaquettaire double un an après stenting

acronym: ARCTIC

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


title: A phase I/II study of the efficacy and safety of an intensified schedule of Azacitidine (Vidaza®) in intermediate-2 and high risk MDS patients

acronym: GFM-Aza intensif

lead_sponsor: Groupe Francophone des Myélodysplasies


title: Evaluation de l’arrêt du traitement immunosuppresseur d’entretien après 2 ans dans les glomérulonéphrites lupiques prolifératives

acronym: etude WIN LUPUS

lead_sponsor: ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE


title: Etude de l'efficacité et de la tolérance de la mexiletine dans les myotonies non dystrophiques

acronym: MYOMEX


title: Etude pilote, prospective, multicentrique, randomisée, en ouvert, comparant deux protocoles d’immunosuppression utilisant en traitement d’induction : soit un anticorps monoclonal antirécepteur de l’Interleukine 2 (Simulect®), soit des globulines antilymphocytaires (ATG® Frésénius), associés à une trithérapie Prograf®, Myfortic® et corticoïdes, pour la prévention du rejet chez les adultes transplantés rénaux immunisés de novo.

acronym: SATIR

lead_sponsor: CHU Toulouse


title: Essai de phase II évaluant l’effet curatif de la pravastatine chez des patients présentant une fibrose cutanée et sous-cutanée radio-induite établie

acronym: PravaCUR

lead_sponsor: Institut Gustave Roussy


title: Etude randomisée, contrôlée, en double insu, prospective, comparant différentes doses de neostigmine lors de la décurarisation avancée; NEODEC

acronym: NEODEC

lead_sponsor: Centre Hospitalier Départemental Vendée


title: Efficacité et Tolérance de la Plitidepsine chez les patients souffrant d’un liposarcome dédifférencié (DLPS) avancé, non opérable ou métastatique, en rechute/réfractaire : Une étude exploratoire multicentrique de phase II.

lead_sponsor: Pharma Mar, S.A.


title: Evaluation de l’entretien de l’anesthésie générale sous Xénon comparé au Desflurane au cours de l’endartérectomie carotidienne, étude prospective, randomisée et comparative.

lead_sponsor: CHU de Poitiers


title: Efficacy and safety of cholecalciferol on rheumatoid arthritis activity in patients with vitamin D deficiency

acronym: SCORPION

lead_sponsor: CHU de Clermont-Ferrand


title: Effets de l’administration orale d'arginine sur le métabolisme protéique intestinal chez des patients porteurs d’une iléo-jéjunostomie après résection intestinale étendue.

acronym: Argiléo

lead_sponsor: CHU - Hôpitaux de Rouen


title: SUPPLEMENTATION EN VITAMINE D CHEZ LES FEMMES MENOPAUSEES OSTEOPOROTIQUES: EVALUATION D’UN SCHEMA THERAPEUTIQUE DE NORMALISATION BIOLOGIQUE DU TAUX SERIQUE DE 25OHVITAMINE D

acronym: VITAD

lead_sponsor: CHU Caen


title: ETUDE PILOTE SUR L’EFFICACITE ET LA TOLERANCE DES INJECTIONS INTRA-VITREENNES DE LUCENTIS (RANIBIZUMABÒ) A LA PHASE INITIALE DES OCCLUSIONS DE LA VEINE CENTRALE DE LA RETINE

lead_sponsor: Centre Hospitalier Intercommunal de Créteil


title: Etude de l’efficacité et de la toxicité d’une stratégie d’allogreffe de cellules souches hématopoïétiques à conditionnement atténué dans le lymphome folliculaire en rechute chimiosensible.

acronym: RITALLO

lead_sponsor: CHU de Bordeaux


title: Etude multicentrique randomisée évaluant l’intérêt du Rituximab pour le traitement des glomérulonéphrites extra membraneuses idiopathiques

acronym: GEMRITUX


title: Traitement des récidives de glioblastomes par le SUTENT (SU11248) : essai de phase 2 avec étude translationnelle biologique et en imagerie

acronym: GLIRES


title:
Phase II pilot study assessing efficacy of a Cisplatine – Métronomic
 Cyclophosphamide treatment in Patients with Stade IV Triple Negative
 breast Cancer Secondary Resistant to Anthracyclines and Taxanes

 Etude Pilote de Phase II évaluant l’Efficacité d’un Traitement par Cisplatine – Cyclophosphamide Métronomique Oral chez des Patientes atteintes d’un Cancer du Sein de Stade IV de type Triple Négatif présentant une Résistance Secondaire aux Anthracyclines et Taxanes

acronym:
META2

 META2

lead_sponsor: CENTRE JEAN PERRIN


title: Imagerie moléculaire de l’activation microgliale dans l’infarctus cérébral: validation d’un nouveau radiopharmaceutique le [18F]-DPA-714.

lead_sponsor: CHRU de Tours


title: Etude prospective, randomisée, en ouvert évaluant le bénéfice clinique sur les hypoglycémies après 6 mois de l’addition de la vildagliptine versus celle d’un autre antidiabétique oral, chez des patients âgés diabétiques de type 2, insuffisamment contrôlés par la metformine en monothérapie.

acronym: GLYCEMIA

lead_sponsor: Novartis Pharma S.A.S