title: A Prospective, Randomised, Double-blind, Placebo-controlled, International, Multicentre, Parallel-group Comparison Trial Evaluating the Efficacy and Safety of Tenecteplase During Cardiopulmonary Resuscitation as Compared With Standard Treatment in Patients Suffering From Out-of-hospital Cardiac Arrest of Presumed Cardiac Origin Thrombolysis in Cardiac Arrest (TROICA) Trial

summary: The general aim of this study is to compare the efficacy and safety of tenecteplase to standard treatment during cardiopulmonary resuscitation in patients suffering from out-of-hospital cardiac arrest.

ReferenceCitation: Bottiger BW, Arntz HR, Chamberlain DA, Bluhmki E, Belmans A, Danays T, Carli PA, Adgey JA, Bode C, Wenzel V; TROICA Trial Investigators; European Resuscitation Council Study Group. Thrombolysis during resuscitation for out-of-hospital cardiac arrest. N Engl J Med. 2008 Dec 18;359(25):2651-62. doi: 10.1056/NEJMoa070570.

location_country: Germany Italy Norway Sweden Switzerland Austria Belgium Spain France

location_facility: Univ.-Klinik f. Anaesthesie u. Intensivmedizin

location_facility: Hjärt/Kärlforskn.enheten, Sahlgrenska Univ.sjh. Göteborg

location_facility: Hospital Clínico Universitario Vírgen de la Victoria / ICU

location_facility: Hospital Clínico Provincial de BCN / Cardiology Service

location_facility: Algemeen Ziekenhuis Antwerpen / Campus Stuivenberg

location_facility: Centre interdisciplinaire des urgences (CIU), CHUV BH 06-429

location_facility: Pre Hospital Klinikk, Sykehuset i Vestfold Tønsberg

location_facility: Hospital Universitario Reina Sofía / ICU

location_facility: Hospital Clínico San Carlos / Hemodynamics

location_facility: Complejo Hospitalario Universitario de Vigo / Cardiology

location_facility: Boehringer Ingelheim Investigational Site

location_facility: Akuttklinikken / NLA, Sentralsjukehuset i Rogaland

location_facility: Vírgen de las Nieves. Critical Care-Emergency Room


title: A Prospective, Randomised, Double-blind, Double-dummy, Forced-titration, Multicentre, Parallel Group, One Year Treatment Trial to Investigate the Efficacy of Telmisartan 80 mg Versus Valsartan 160 mg in Hypertensive Type 2 Diabetic Patients With Overt Nephropathy VIVALDI-Study

summary:
The general aim of this study is to compare telmisartan 80 mg with valsartan 160 mg in hypertensive patients with type 2 diabetes and overt nephropathy with adjusted blood pressure beyond the target of 130/80 mmHg after one year of treatment.

The primary objective of this study is to show that telmisartan 80 mg is at least as effective (i.e., not inferior) and possibly superior to valsartan 160 mg in reducing 24 hour proteinuria after one year of treatment.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Italy
Portugal
Slovakia
Denmark
Korea, Republic of
Spain
Malaysia
Taiwan
Ukraine
Czech Republic
Russian Federation
France

location_facility: Russian Academy for Advanced Medical Studies

location_facility: Associac?o Protectora dos Diabeticos de Portugal

location_facility: Institute of Diabetic pathology problems

location_facility: V.P. Komisarenko Institute of Endocrinology and Metabolism

location_facility: Keimyung University Dongsan Medical Center

location_facility: Azienda Ospedaliera Policlinico S. Orsola Malpighi

location_facility: Azienda Ospedaliera S. Maria degli Angeli

location_facility: National Endocrinology Research Center of Russia

location_facility: Regional Clinical Scientific Research Institute

location_facility: Hospital Clinico y Provincial de Barcelona

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: An 8-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Study Of Pregabalin (300-600 Mg/Day) And Venlafaxine XR (75-225 Mg/Day) For The Acute Treatment Of DSM-IV Generalized Anxiety Disorder In Outpatients

summary: The purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the treatment of generalized anxiety disorder.

study_completion_date_type: Actual

ReferenceType: derived

ReferenceCitation: Kasper S, Herman B, Nivoli G, Van Ameringen M, Petralia A, Mandel FS, Baldinetti F, Bandelow B. Efficacy of pregabalin and venlafaxine-XR in generalized anxiety disorder: results of a double-blind, placebo-controlled 8-week trial. Int Clin Psychopharmacol. 2009 Mar;24(2):87-96. doi: 10.1097/yic.0b013e32831d7980.

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

location_country: Ireland Italy Sweden Netherlands Belgium Spain Canada France


title: A Randomized Two-Arm, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects With Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

summary: This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Chu SC, Tang JL, Li CC. Dasatinib in chronic myelogenous leukemia. N Engl J Med. 2006 Sep 7;355(10):1062-3; author reply 1063-4. No abstract available.

ReferenceCitation: Lilly MB, Ottmann OG, Shah NP, Larson RA, Reiffers JJ, Ehninger G, Muller MC, Charbonnier A, Bullorsky E, Dombret H, Brigid Bradley-Garelik M, Zhu C, Martinelli G. Dasatinib 140 mg once daily versus 70 mg twice daily in patients with Ph-positive acute lymphoblastic leukemia who failed imatinib: Results from a phase 3 study. Am J Hematol. 2010 Mar;85(3):164-70. doi: 10.1002/ajh.21615.

ReferenceCitation: Kantarjian H, Cortes J, Kim DW, Dorlhiac-Llacer P, Pasquini R, DiPersio J, Muller MC, Radich JP, Khoury HJ, Khoroshko N, Bradley-Garelik MB, Zhu C, Tallman MS. Phase 3 study of dasatinib 140 mg once daily versus 70 mg twice daily in patients with chronic myeloid leukemia in accelerated phase resistant or intolerant to imatinib: 15-month median follow-up. Blood. 2009 Jun 18;113(25):6322-9. doi: 10.1182/blood-2008-11-186817. Epub 2009 Apr 15.

lead_sponsor: Bristol-Myers Squibb

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Thailand
Canada
France
Czech Republic
Hungary
Denmark
Switzerland
United States
Belgium
Peru
Philippines
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel

location_facility: Washington Cancer Institute At Washington Hospital Center

location_facility: The University Of Texas Md Anderson Cancer Center

location_facility: The Cancer Center At Hackensack University Medical Center

location_facility: Washington University School Of Medicine

location_facility: The University Of North Carolina At Chapel Hill


title: A Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

summary: This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).

ReferenceType: background

ReferenceCitation: Porkka K, Khoury HJ, Paquette RL, Matloub Y, Sinha R, Cortes JE. Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion. Cancer. 2010 Jan 15;116(2):377-86. doi: 10.1002/cncr.24734.

ReferenceCitation: Muller MC, Cortes JE, Kim DW, Druker BJ, Erben P, Pasquini R, Branford S, Hughes TP, Radich JP, Ploughman L, Mukhopadhyay J, Hochhaus A. Dasatinib treatment of chronic-phase chronic myeloid leukemia: analysis of responses according to preexisting BCR-ABL mutations. Blood. 2009 Dec 3;114(24):4944-53. doi: 10.1182/blood-2009-04-214221. Epub 2009 Sep 24.

ReferenceCitation: Shah NP, Kantarjian HM, Kim DW, Rea D, Dorlhiac-Llacer PE, Milone JH, Vela-Ojeda J, Silver RT, Khoury HJ, Charbonnier A, Khoroshko N, Paquette RL, Deininger M, Collins RH, Otero I, Hughes T, Bleickardt E, Strauss L, Francis S, Hochhaus A. Intermittent target inhibition with dasatinib 100 mg once daily preserves efficacy and improves tolerability in imatinib-resistant and -intolerant chronic-phase chronic myeloid leukemia. J Clin Oncol. 2008 Jul 1;26(19):3204-12. doi: 10.1200/JCO.2007.14.9260. Epub 2008 Jun 9.

ReferenceCitation: Shah NP, Rousselot P, Schiffer C, Rea D, Cortes JE, Milone J, Mohamed H, Healey D, Kantarjian H, Hochhaus A, Saglio G. Dasatinib in imatinib-resistant or -intolerant chronic-phase, chronic myeloid leukemia patients: 7-year follow-up of study CA180-034. Am J Hematol. 2016 Sep;91(9):869-74. doi: 10.1002/ajh.24423. Epub 2016 Jun 20.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_institution: University of California - eScholarship University of California

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: California Digital Library - eScholarship;PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Wiley

ReferenceCitation: Shah NP, Guilhot F, Cortes JE, Schiffer CA, le Coutre P, Brummendorf TH, Kantarjian HM, Hochhaus A, Rousselot P, Mohamed H, Healey D, Cunningham M, Saglio G. Long-term outcome with dasatinib after imatinib failure in chronic-phase chronic myeloid leukemia: follow-up of a phase 3 study. Blood. 2014 Apr 10;123(15):2317-24. doi: 10.1182/blood-2013-10-532341. Epub 2014 Feb 25.

oa_colors: green other

evidence: open (via free pdf)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Canada
France
Czech Republic
Hungary
Denmark
Switzerland
United States
Belgium
Peru
Philippines
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel

location_facility: Oncology Hematology Associates Of Central Illinois, Pc

location_facility: Central Hematology Oncology Medical Group Inc.

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: University Of North Carolina At Chapel Hill


type: Other Identifier

title: A Randomized, Double-Blind, Multicenter Study Comparing MDX-010 Monotherapy, MDX-010 in Combination With a Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A2*0201-Positive Patients With Previously Treated Unresectable Stage III or IV Melanoma

summary: The purpose of this study is to determine the safety and efficacy of MDX-010 (ipilimumab, BMS-734016) (anti-CTLA4) in combination with MDX-1379 (gp100, BMS-734019) in patients with previously treated, unresectable Stage III or IV melanoma. Survival time will be evaluated, as well as patient responses and time to disease progression. Eligible patients are those who in response to a single regimen containing interleukin-2 (IL-2), dacarbazine, and/or temozolomide, have 1) relapsed following an objective response (partial response/complete response [PR/CR]); 2) failed to demonstrate an objective response (PR/CR); or 3) could not tolerate such a regimen due to unacceptable toxicity. Patients will be randomized into one of three groups, and will receive one of the following treatments: MDX-010 alone, MDX-1379 alone, or MDX-010 in combination with MDX-1379.

ReferenceCitation: Larkin J, Hatswell AJ, Nathan P, Lebmeier M, Lee D. The Predicted Impact of Ipilimumab Usage on Survival in Previously Treated Advanced or Metastatic Melanoma in the UK. PLoS One. 2015 Dec 23;10(12):e0145524. doi: 10.1371/journal.pone.0145524. eCollection 2015.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

unpaywall_oa_status: gold

publisher_dissemination: Public Library of Science

ReferenceCitation: Koguchi Y, Hoen HM, Bambina SA, Rynning MD, Fuerstenberg RK, Curti BD, Urba WJ, Milburn C, Bahjat FR, Korman AJ, Bahjat KS. Serum Immunoregulatory Proteins as Predictors of Overall Survival of Metastatic Melanoma Patients Treated with Ipilimumab. Cancer Res. 2015 Dec 1;75(23):5084-92. doi: 10.1158/0008-5472.CAN-15-2303.

oa_host_type: repository

evidence: oa repository (via page says license)

unpaywall_oa_status: green

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Johnson DB, Friedman DL, Berry E, Decker I, Ye F, Zhao S, Morgans AK, Puzanov I, Sosman JA, Lovly CM. Survivorship in Immune Therapy: Assessing Chronic Immune Toxicities, Health Outcomes, and Functional Status among Long-term Ipilimumab Survivors at a Single Referral Center. Cancer Immunol Res. 2015 May;3(5):464-9. doi: 10.1158/2326-6066.CIR-14-0217. Epub 2015 Feb 3.

version: acceptedVersion

ReferenceCitation: Hatswell AJ, Pennington B, Pericleous L, Rowen D, Lebmeier M, Lee D. Patient-reported utilities in advanced or metastatic melanoma, including analysis of utilities by time to death. Health Qual Life Outcomes. 2014 Sep 10;12:140. doi: 10.1186/s12955-014-0140-1.

repository_institution: University College London - UCL Discovery

repositories:
PubMed Central
UCL Discovery
eprints.whiterose.ac.uk

repositories_institution: University College London - UCL Discovery

ReferenceCitation: McDermott D, Haanen J, Chen TT, Lorigan P, O'Day S; MDX010-20 investigators. Efficacy and safety of ipilimumab in metastatic melanoma patients surviving more than 2 years following treatment in a phase III trial (MDX010-20). Ann Oncol. 2013 Oct;24(10):2694-2698. doi: 10.1093/annonc/mdt291. Epub 2013 Aug 13.

ReferenceCitation: Robert C, Schadendorf D, Messina M, Hodi FS, O'Day S; MDX010-20 investigators. Efficacy and safety of retreatment with ipilimumab in patients with pretreated advanced melanoma who progressed after initially achieving disease control. Clin Cancer Res. 2013 Apr 15;19(8):2232-9. doi: 10.1158/1078-0432.CCR-12-3080. Epub 2013 Feb 26.

ReferenceCitation: Weber JS, Dummer R, de Pril V, Lebbe C, Hodi FS; MDX010-20 Investigators. Patterns of onset and resolution of immune-related adverse events of special interest with ipilimumab: detailed safety analysis from a phase 3 trial in patients with advanced melanoma. Cancer. 2013 May 1;119(9):1675-82. doi: 10.1002/cncr.27969. Epub 2013 Feb 7.

ReferenceCitation: Revicki DA, van den Eertwegh AJ, Lorigan P, Lebbe C, Linette G, Ottensmeier CH, Safikhani S, Messina M, Hoos A, Wagner S, Kotapati S. Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment. Health Qual Life Outcomes. 2012 Jun 13;10:66. doi: 10.1186/1477-7525-10-66.

ReferenceCitation: Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, Gonzalez R, Robert C, Schadendorf D, Hassel JC, Akerley W, van den Eertwegh AJ, Lutzky J, Lorigan P, Vaubel JM, Linette GP, Hogg D, Ottensmeier CH, Lebbe C, Peschel C, Quirt I, Clark JI, Wolchok JD, Weber JS, Tian J, Yellin MJ, Nichol GM, Hoos A, Urba WJ. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010 Aug 19;363(8):711-23. doi: 10.1056/NEJMoa1003466. Epub 2010 Jun 5. Erratum In: N Engl J Med. 2010 Sep 23;363(13):1290.

location_country:
Germany
Hungary
Argentina
United Kingdom
Brazil
Netherlands
Switzerland
Belgium
United States
South Africa
Chile
Canada
France

location_facility: Dermatologische Klinik Universitatsspital Zurich

location_facility: La Jolla Hematology and Oncology Medical Group

location_facility: Yale University School of Medicine - Oncology Outpatient Clinic

location_facility: University of Debrecen, Medical and Health Sciences Center

location_facility: Emory University Hospital-Winship Cancer Institute

location_facility: Mount Sinai Comprehensive Cancer Center at Aventura

location_facility: Henry Ford Medical Center- West Bloomfield

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: University of Pittsburgh Cancer Institute

location_facility: Erasme Hospital, Free Universtiy of Brussels

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: St. Luke's Cancer Center, The Royal Surrey County Hospital

location_facility: Hospital General de Agudos Carlos G. Durand

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: Center for Oncology Research and Treatment

location_facility: North County Oncology Medical Clinical, Inc.

location_facility: Hospital Municipal de Oncoligia Maria Curie

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Klinik fur und Poliklinik fur Dermatologie, Venerologie und Allergologie

location_facility: Fundacao Central Sul-Americana para o Desenvolvimento de Drogas Anticancer-SOAD

location_facility: Centre Hospitalier Universitaire Vaudois - CHUV

location_facility: University of Szeged, Albert Szent-Gyorgyi Medical and Pharmaceutical Center

location_facility: University of Colorado Health Sciences Center

location_facility: Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Centre-Hospitalier Universitaire de Saint-Etienne

location_facility: University of North Carolina at Chapel Hill

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Columbia University Medical Center, Irving Center for Clinical Research

location_facility: Hospital Araujo Jorge da Associacoa de Combate ao Cancer em Goias

location_facility: Klinikum der Friedrich-Schiller-Universitaet Jena

location_facility: Hematology-Oncology Associates of Northern NJ, PA

location_facility: Indiana Oncology Hematology Consultants North

location_facility: Hospital Privado Centro Medico de Cordoba S.A.

location_facility: Hospital Municipal de Oncologia Maria Curie

location_facility: New Mexico Oncology Hematology Consultants, Ltd.

location_facility: University of Florida/Jacksonville Faculty Clinic

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: The Angeles Clinic and Research Institute

location_facility: Sociedade Beneficante de Sennores - Hospital Sino Libante

location_facility: Sir Mortimer B. Davis - Jewish General Hospital

location_facility: Cardinal Bernardin Cancer Center, Loyola Unv. Med. Ctr.

location_facility: St. Mary's Medical Center - Northern California Melanoma Center

location_facility: The Ottawa Hospital Regional Cancer Centre

location_facility: The Cancer Center at Hackensack University Medical Center

location_facility: Cancer Centre of Southeastern Ontario at KGH

location_facility: Hospital de Cancer de Barretos - Fundacao Pio XII

location_facility: Indiana Oncology Hematology Consutants of Noblesville

location_facility: Center for Cancer Care at Goshen Health System

location_facility: Santo Andre Diagnosticos e Tratamentos Ltda.

location_facility: Biocor - Hosp. de Doencas Cardiovasculares Ltda.

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: Washington Unv. School of Med./ Siteman Cancer Center


title: A Randomized, Open-Label, Parallel Group, International, Multicenter, Phase III Study of Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Locally Advanced or Metastatic Recurrent Non-Small Cell Lung Cancer Who Have Previously Received Platinum-Based Chemotherapy

summary: The purpose of this study is to compare the effects of ZD1839 or docetaxel in patients with advanced non-small cell lung cancer (NSCLC) that has recurred or progressed after receiving prior treatment with platinum-based chemotherapy.

ReferenceCitation: Lombard A, Mistry H, Aarons L, Ogungbenro K. Dose individualisation in oncology using chemotherapy-induced neutropenia: Example of docetaxel in non-small cell lung cancer patients. Br J Clin Pharmacol. 2021 Apr;87(4):2053-2063. doi: 10.1111/bcp.14614. Epub 2020 Dec 19.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

ReferenceCitation: Douillard JY, Shepherd FA, Hirsh V, Mok T, Socinski MA, Gervais R, Liao ML, Bischoff H, Reck M, Sellers MV, Watkins CL, Speake G, Armour AA, Kim ES. Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-cell lung cancer: data from the randomized phase III INTEREST trial. J Clin Oncol. 2010 Feb 10;28(5):744-52. doi: 10.1200/JCO.2009.24.3030. Epub 2009 Dec 28.

ReferenceCitation: Kim ES, Hirsh V, Mok T, Socinski MA, Gervais R, Wu YL, Li LY, Watkins CL, Sellers MV, Lowe ES, Sun Y, Liao ML, Osterlind K, Reck M, Armour AA, Shepherd FA, Lippman SM, Douillard JY. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet. 2008 Nov 22;372(9652):1809-18. doi: 10.1016/S0140-6736(08)61758-4.

lead_sponsor: AstraZeneca

location_country:
Germany
Argentina
Brazil
Thailand
Turkey
Croatia
Canada
France
Slovenia
Hong Kong
Denmark
Switzerland
United States
Latvia
Indonesia
Belgium
China
Malaysia
Estonia
Philippines
Italy
Singapore
Mexico
Spain
Sweden

location_facility:
Research site
Research Site


title: A Phase III, Randomized Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer

summary: This study is being done to evaluate the safety and efficacy of atrasentan in men with non-metastatic hormone-refractory prostate cancer.

lead_sponsor: Abbott

location_country:
Germany
Ireland
Italy
Poland
New Zealand
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
United States
Spain
Greece
South Africa
Canada
France

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Mississippi Center For Clinical Research, LLC

location_facility: University Of Natal - Nelson R Mandela School of Medicine

location_facility: Northeastern Ontario Regional Cancer Centre

location_facility: Clinica Urologica - Università Di Milano

location_facility: Clinical Research Centre - St Georges Hospital

location_facility: Clinica Urologica I - Università di Bari

location_facility: University Of Washington School Of Medicine

location_facility: Istituto Nazionale per la Ricerca sul Cancro -IST

location_facility: Albany Medical Center South Clinical Campus

location_facility: Urologische Klinik Und Poliklinik Grosshadern

location_facility: South Orange County Medical Research Center

location_facility: Katedra i Klinika Urologii - Akademia Medyczna w Gdansku

location_facility: The Institute Of Cancer Research - Royal Marsden Hospital

location_facility: The University Of TX SW Medical Center At Dallas

location_facility: Klinik fur Urologie der Universitat Wien

location_facility: Dept of Veteran's Affairs North Texas Healthcare System

location_facility: Hillcrest Urological Medical Group, Inc.

location_facility: Vancouver Hospital & Health Sciences Centre

location_facility: Drs. Werner, Murdock, & Francis, Pa Urology Assoc.

location_facility: Klinik Und Poliklinik für Urologie und Kinder

location_facility: The University Of North Carolina At Chapel Hill


title: PHASE III RANDOMISED TRIAL INVESTIGATING THE ROLE OF INTERNAL MAMMARY AND MEDIAL SUPRACLAVICULAR (IM-MS) LYMPH NODE CHAIN IRRADIATION IN STAGE I-III BREAST CANCER

summary:
RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no further therapy in treating women with stage I, stage II, or stage III breast cancer that has been surgically removed.

status: Unknown status

enrollment_type: Anticipated

ReferenceCitation: Matzinger O, Heimsoth I, Poortmans P, Collette L, Struikmans H, Van Den Bogaert W, Fourquet A, Bartelink H, Ataman F, Gulyban A, Pierart M, Van Tienhoven G; EORTC Radiation Oncology & Breast Cancer Groups. Toxicity at three years with and without irradiation of the internal mammary and medial supraclavicular lymph node chain in stage I to III breast cancer (EORTC trial 22922/10925). Acta Oncol. 2010;49(1):24-34. doi: 10.3109/02841860903352959.

ReferenceCitation: Musat E, Poortmans P, Van den Bogaert W, Struikmans H, Fourquet A, Bartelink H, Kirkove C, Budach V, Pierart M, Collette L. Quality assurance in breast cancer: EORTC experiences in the phase III trial on irradiation of the internal mammary nodes. Eur J Cancer. 2007 Mar;43(4):718-24. doi: 10.1016/j.ejca.2006.11.015. Epub 2007 Jan 19.

ReferenceCitation: Poortmans P, Kouloulias V, van Tienhoven G, Collette L, Struikmans H, Venselaar JL, Van den Bogaert W, Davis JB, Lambin P; EORTC Radiation Oncology and Breast Cancer Groups. Quality assurance in the EORTC randomized trial 22922/10925 investigating the role of irradiation of the internal mammary and medial supraclavicular lymph node chain works. Strahlenther Onkol. 2006 Oct;182(10):576-82. doi: 10.1007/s00066-006-1629-2.

ReferenceCitation: Poortmans P, Kouloulias VE, Venselaar JL, Struikmans H, Davis JB, Huyskens D, van Tienhoven G, Hurkmans C, Mijnheer B, Van den Bogaert W. Quality assurance of EORTC trial 22922/10925 investigating the role of internal mammary--medial supraclavicular irradiation in stage I-III breast cancer: the individual case review. Eur J Cancer. 2003 Sep;39(14):2035-42. doi: 10.1016/s0959-8049(03)00455-6.

ReferenceCitation: Poortmans PM, Venselaar JL, Struikmans H, Hurkmans CW, Davis JB, Huyskens D, van Tienhoven G, Vlaun V, Lagendijk JJ, Mijnheer BJ, De Winter KA, Van der Hulst MH, Van den Bogaert WF. The potential impact of treatment variations on the results of radiotherapy of the internal mammary lymph node chain: a quality-assurance report on the dummy run of EORTC Phase III randomized trial 22922/10925 in Stage I--III breast cancer(1). Int J Radiat Oncol Biol Phys. 2001 Apr 1;49(5):1399-408. doi: 10.1016/s0360-3016(00)01549-2.

ReferenceCitation: Poortmans P, Van Den Bogaert W, Venselaar J, et al.: Quality assurance in EORTC trial 22922/10925 concerning internal mammary chain (IMC) irradiation: the dummy run. Radiother Oncol 48(suppl 1): A735, s186, 1998.

ReferenceCitation: Poortmans P, Van Den Bogaert W, Venselaar J, et al.: EORTC randomized phase III trials 22922/10925 investigating the role of internal mammary chain (IMC) irradiation in stage I-II breast cancer: a quality assurance report on the dummy run. Eur J Cancer 34(suppl 5): A257, s58, 1998.

ReferenceCitation: Kaidar-Person O, Fortpied C, Hol S, Weltens C, Kirkove C, Budach V, Peignaux-Casasnovas K, van der Leij F, Vonk E, Valli M, Weidner N, Guckenberger M, Koiter E, Fourquet A, Bartelink H, Struikmans H, Poortmans P; EORTC Radiation Oncology and Breast Cancer Groups. The association of internal mammary and medial supraclavicular lymph node radiation technique with clinical outcomes: Results from the EORTC 22922/10925 randomised trial. Radiother Oncol. 2022 Jul;172:99-110. doi: 10.1016/j.radonc.2022.05.006. Epub 2022 May 12.

oa_host_type: closed

publisher_dissemination: Elsevier

ReferenceCitation: Poortmans PM, Struikmans H, De Brouwer P, Weltens C, Fortpied C, Kirkove C, Budach V, Peignaux-Casasnovas K, van der Leij F, Vonk E, Valli M, vanTienhoven G, Weidner N, Noel G, Guckenberger M, Koiter E, vanLimbergen E, Engelen A, Fourquet A, Bartelink H; EORTC Radiation Oncology and Breast Cancer Groups. Side Effects 15 Years After Lymph Node Irradiation in Breast Cancer: Randomized EORTC Trial 22922/10925. J Natl Cancer Inst. 2021 Oct 1;113(10):1360-1368. doi: 10.1093/jnci/djab113.

publisher_dissemination: Oxford University Press

ReferenceCitation: Poortmans PM, Weltens C, Fortpied C, Kirkove C, Peignaux-Casasnovas K, Budach V, van der Leij F, Vonk E, Weidner N, Rivera S, van Tienhoven G, Fourquet A, Noel G, Valli M, Guckenberger M, Koiter E, Racadot S, Abdah-Bortnyak R, Van Limbergen EF, Engelen A, De Brouwer P, Struikmans H, Bartelink H; European Organisation for Research and Treatment of Cancer Radiation Oncology and Breast Cancer Groups. Internal mammary and medial supraclavicular lymph node chain irradiation in stage I-III breast cancer (EORTC 22922/10925): 15-year results of a randomised, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1602-1610. doi: 10.1016/S1470-2045(20)30472-1. Epub 2020 Nov 2. Erratum In: Lancet Oncol. 2021 Jan;22(1):e5.

ReferenceCitation: Poortmans PM, Collette S, Kirkove C, Van Limbergen E, Budach V, Struikmans H, Collette L, Fourquet A, Maingon P, Valli M, De Winter K, Marnitz S, Barillot I, Scandolaro L, Vonk E, Rodenhuis C, Marsiglia H, Weidner N, van Tienhoven G, Glanzmann C, Kuten A, Arriagada R, Bartelink H, Van den Bogaert W; EORTC Radiation Oncology and Breast Cancer Groups. Internal Mammary and Medial Supraclavicular Irradiation in Breast Cancer. N Engl J Med. 2015 Jul 23;373(4):317-27. doi: 10.1056/NEJMoa1415369.

repository_institution: Radboud University - Radboud Repository

repository_institution: University of Zurich - Zurich Open Repository and Archive

publisher_dissemination: Massachusetts Medical Society

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

location_country:
Germany
Italy
Poland
Portugal
Israel
United Kingdom
Netherlands
Switzerland
Belgium
Bosnia and Herzegovina
Spain
Turkey
Chile
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Service Cancerologie Polyclinique Clairval

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Institute of Oncology - Clinical Center University of Sarajevo

location_facility: Hopital Cantonal Universitaire de Geneve

location_facility: Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Istanbul University-Institute of Oncology

location_facility: Instituto Portugues de Oncologia Centro do Porto, SA

intervention_type: Procedure

status_simplified: Unknown


title: A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension

acronym: BaxHTN

summary: This is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of 1 or 2 mg baxdrostat versus placebo, administered once daily (QD) orally, on the reduction of systolic blood pressure in approximately 720 participants aged ≥ 18 years with hypertension, despite a stable regimen of 2 antihypertensive agents at baseline, one of which is a diuretic (uncontrolled hypertension); or ≥ 3 antihypertensive agents at baseline, one of which is a diuretic (treatment-resistant hypertension).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

location_country:
Germany
Poland
Argentina
Australia
Japan
Thailand
Vietnam
Turkey
Czechia
Canada
France
Slovakia
Hungary
Denmark
United States
India
Belgium
Malaysia
Italy
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Israel

status_simplified: Ongoing


title: A Phase 3b, Multi-center, Randomized, Parallel-group, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Oral Dolutegravir/Lamivudine Once-daily as a First-line Regimen Compared to Oral Bictegravir/Emtricitabine/Tenofovir Alafenamide Once Daily for Virologic Suppression and Maintenance in Antiretroviral Therapy Naive Adults Living With HIV

acronym: VOGUE

summary: This study will compare safety, efficacy, participant reported outcomes and implementation outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus lamivudine (3TC) and a three-drug regimen FDC of bictegravir (BIC), emtricitabine (FTC) and tenofovir alafenamide (TAF) in HIV-1 infected adult participants who have not previously received antiretroviral therapy.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing_description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

lead_sponsor: ViiV Healthcare

location_country:
Germany
Ireland
Italy
Poland
Portugal
Israel
Argentina
Denmark
Japan
Sweden
Switzerland
Mexico
Belgium
United Kingdom
Spain
Greece
France


title: A Multicenter, Randomized, Parallel-group, Double-blind,Two-arm Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared With Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive With Systemic Sclerosis

acronym: DAISY

summary: The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The target population for this study includes patients who meet the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification for systemic sclerosis, either limited or diffuse cutaneous subsets, with a disease duration of less than 6 years from first non-Raynaud's phenomenon symptom.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AstraZeneca disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AstraZeneca group of companies sponsored clinical trials are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Germany
Poland
Japan
Turkey
Canada
France
Hungary
United States
Romania
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Israel


type: Registry Identifier

title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome

acronym: LIBREXIA-ACS

summary: The purpose of this study is to evaluate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the composite of cardiovascular [CV] death, myocardial infarction [MI], and ischemic stroke).

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

sponsor_collaborators:
Janssen Research & Development, LLC
Bristol-Myers Squibb

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Lithuania
Portugal
Slovakia
Hungary
Denmark
United States
India
Romania
Belgium
China
Malaysia
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria

location_facility: Multiprofile Hospital for Active Treatment Heart and Brain, Pleven

location_facility: Tianjin Medical University General Hospital

location_facility: Midwest Cardiovascular Research Foundation

location_facility: Hyogo Prefectural Harima-Himeji General Medical Center

location_facility: University Clinical Hospital Center Dr Dragisa Misovic- Dedi

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: GFO Kliniken Bonn, Betriebsstaette St. Marien

location_facility: FGM Clínica Paulista de Doenças Cardiovasculares Ltda.

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS

location_facility: Mission Cardiovascular Research Institute

location_facility: Methodist Physicians Clinic Heart Consultants

location_facility: Santa Casa de Misericórdia de Votuporanga

location_facility: The Second Affiliatted Hospital of Soochow University

location_facility: Asanokawa, Kanazawa Cardiovascular Hospital

location_facility: NZOZ PRO CORDIS Sopockie Centrum Badan Kardiologicznych

location_facility: C.E.C.-Centro Especializado em Cardiologia Ltda.- Loema Medicina e Bem Estar

location_facility: Corporacion Medica de Gral. San Martin S.A.

location_facility: Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei

location_facility: University Multiprofile Hospital for Active Treatment - Tsaritsa Yoanna - ISUL, EAD

location_facility: Kutahya Health Science University Evliya Celebi Research and Training Hospital

location_facility: Public Central Hospital of Matto Ishikawa

location_facility: Prairie Cardiovascular Consultants, Ltd.

location_facility: Nuvance Health Medical Practices Cardiology Danbury

location_facility: Centro de Cardiologia Clinica e Pesquisa Doutora Juliana Souza Ltda. - CECAP Centro de Cardiologia Clinica

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Texas Tech University Health Sciences Center-El Paso

location_facility: The First Affiliated Hospital of Chongqing Medical University

location_facility: Bezmi Alem Vakif University Medical Faculty Hospital

location_facility: Centro de Investigaciones Medicas Mar Del Plata

location_facility: Azienda USL di Bologna - Ospedale Maggiore

location_facility: National Cerebral and Cardiovascular Center

location_facility: Hubei Zhongshan Hospital The Third People's Hospital of Hubei Province

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria

location_facility: Amarillo Heart Clinical Research Institute

location_facility: Afyon Kocatepe University Medical Faculty

location_facility: Azienda Ospedaliera Ospedale Treviglio-Caravaggio di Treviglio

location_facility: Eastern Maine Medical Center Northeast Cardiology Associates

location_facility: KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre (MRC)

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Instytut Kardiologii im Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego

location_facility: Katholisches Krankenhaus St. Josef gGmbH - Abtlg. für Gynäkologie

location_facility: Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'

location_facility: National Hospital Organization Saitama National Hospital

location_facility: Japanese Red Cross Nagoya Daiichi Hospital

location_facility: Katholisches Klinikum Mainz; Innere Medizin I- Kardiologie

location_facility: Institut Universitaire De Cardiologie Et De Pneumologie De Québec

location_facility: Vilnius University Hospital Santariskiu Clinic, Public Institution

location_facility: Wojewodzki Szpital im. Sw. Ojcia Pio w Przemyslu

location_facility: Irmandade Da Santa Casa De Misericordia De Sao Paulo

location_facility: Multiprofile Hospital for Active Treatment - Haskovo

location_facility: Kardiologicka ambulancia CARDIO D&R s.r.o.

location_facility: Basingstoke And North Hampshire Hospital

location_facility: Cardiology Associates of Fairfield County, P.C.

location_facility: National Hospital Organization Ureshino Medical Center

location_facility: Dayanand Medical College & Hospital, Tagore Nagar, Civil Lines

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Hudson Valley Cardiovascular Practice, PC

location_facility: Centro de Estudios Clínicos V Región Ltda

location_facility: Spitalul Clinic Judetean de Urgenta Brasov

location_facility: University Hospital Bristol and Weston NHS trust

location_facility: National Hospital Organization Kyoto Medical Center

location_facility: The Curators of the University of Missouri on behalf of University of Missouri Health Care

location_facility: Specjalistyczna Poradnia Kardiologiczna i Nadcisnienia Tetniczego

location_facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center

location_facility: Batra Hospital And Medical Research Centre

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Spitalul Clinic Judetean de Urgenta Craiova

location_facility: St. Francis Physician Services, Inc, DBA Upstate Cardiology Research

location_facility: Shands Jacksonville Medical Center Inc dba UF Health Jacksonville

location_facility: Tokyobay Urayasu Ichikawa Medical Center

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Uniao Brasileira de Educaçao e Assistencia-Hospital Sao Lucas da PUCRS

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: The First Affiliated Hospital of Nanyang Medical College

location_facility: Instituto de Pesquisa Clinica de Campinas

location_facility: Centro Medico Dra. Laura Maffei - Investigacion Clinica Aplicada

location_facility: Multiprofile Hospital for Active Treatment Dr. Tota Venkova

location_facility: Ankara Numune Research and Training Hospital

location_facility: Central India Cardiology Hospital and Research Institute

location_facility: The Third Affiliated Hospital of Xinxiang Medical University

location_facility: Klaipeda Seamen's Hospital, Public Institution

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Centro de Estudios Cardiologicos y de Medicina Interna

location_facility: Affiliated Hospital Of Guangdong Medical University

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: Stredoslovensky ustav srdcovych a cievnych chorob a.s

location_facility: Instituto de Cardiologia de Santa Catarina

location_facility: Krankenhaus Dresden-Friedrichstadt - Städtisches Klinikum

location_facility: Cardiology Partners Clinical Research Institute

location_facility: National Hospital Organization Fukuoka Higashi Medical Center

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP

location_facility: Ascension Medical Group - St. John Clinic Infectious Disease


title: An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

acronym: ELAINEIII

summary:
The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation.

The main question the study aims to answer is:

• To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.

ipd_sharing: No

lead_sponsor: Sermonix Pharmaceuticals Inc.

location_country:
Germany
Italy
Poland
Hungary
Israel
Romania
Australia
United Kingdom
Belgium
United States
Korea, Republic of
Spain
Turkey
Taiwan
Czechia
Canada
France

location_facility: Institut de cancerologie Strasbourg Europe (ICANS)

location_facility: Severance Hospital, Yonsei University Health System

location_facility: The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: KO - MED Centra Kliniczne Sp. z o.o., Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej

location_facility: Lady Davis Institute for Medical Research Jewish General Hospital

location_facility: David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

location_facility: Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu, Oddzial Chemioterapii

location_facility: CHU UCL Namur - Site De Sainte-Elisabeth

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach, I Klinika Radioterapii i Chemioterapii

location_facility: Linkou Chang Gung Memorial Hospital (CGMHLK)

location_facility: Oklahoma University Health Sciences Center

location_facility: Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Klinika Onkologii Klinicznej

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie - Oddzial Onkologii Klinicznej z Pododdzialem Dziennym

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: Instytut Centrum Zdrowia Matki Polki - Klinika Onkologii

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Service d'Oncologie Medicale - CHRU Besancon

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

location_facility: Allina Health System DBA Virginia Piper Cancer Institute

location_facility: Suat Seren Training and Research Hospital

location_facility: Hospital Regional Universitario de Malaga

location_facility: Providence Medical Foundation - Santa Rosa, CA

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Ankara University Medical Faculty Medical Oncology Department

location_facility: Fakultni nemocnice Olomouc - Oncology clinic

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

location_facility: Washington University School of Medicine

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie, Oddzial Onkologii Klinicznej

location_facility: Wielkopolskie Centrum Onkologii (WCO) / The Greater Poland Cancer Center

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

location_facility: Azienda Ospedaliero-Universitaria di Modena

location_facility: CHU Poitiers - Pole Regional de Cancerologie de Poitiers (PRC)

location_facility: Clinica Universidad de Navarra - Pamplona

location_facility: IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l.

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital

location_facility: Sunnybrook Health Sciences Centre -Bayview Campus


type: EudraCT Number

title: A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)

acronym: AMETHYST

summary: The primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B].

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

lead_sponsor: Biogen

location_country:
Germany
Poland
Argentina
Japan
Brazil
Chile
Canada
Serbia
France
Portugal
Slovakia
Hungary
Switzerland
United States
Puerto Rico
Philippines
Italy
United Kingdom
Mexico
Korea, Republic of
Saudi Arabia
Spain
Taiwan
Bulgaria
Sweden

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Centro de Investigacion Clínica GRAMEL S.C

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: University of New Mexico School of Medicine

location_facility: Hospital of the University of Occupational and Environmental Health

location_facility: Laster Rejuvenation Clinics Edmonton D.T. Inc.

location_facility: Consultorio Privado Dr. Miguel Cortes Hernandez

location_facility: University of Utah Health Sciences Center

location_facility: Kliniczny Szpital Wojewodzki nr 1 im.F.Chopina

location_facility: Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Centro de Investigaciones Medicas Tucuman

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: The Regents of the University of California

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: University Hospitals Cleveland Medical Center

location_facility: Centro Hospitalar e Universitário de Coimbra, E.P.E (HUC)

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: L2IP - Instituto de Pesquisas Clínicas Ltda.

location_facility: Azienda Ospedaliera Universitaria Policlinico 'Federico II'

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Unidade Local de Saúde do Alto Minho, E.P.E.

location_facility: Niigata University Medical & Dental Hospital

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Centro Hospitalar Universitártio do Porto, E.P.E.

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: UAB Center for Women's Reproductive Health

location_facility: Centro de Investigaciones Medicas Mar del Plata

location_facility: Investigacion y Biomedicina de Chihuahua, S.C.

location_facility: CIEC - Centro Internacional de Estudios Clínicos

location_facility: Clinica Mayo de Urgencias Medicas Cruz Blanca SRL

location_facility: University of North Carolina at Chapel Hill

location_facility: University of Cincinnati Department of Dermatology

location_facility: HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University of Miami Miller School of Medicine

location_facility: CER San Juan Centro Polivalente de Asistencia e Inv. Clinica

location_facility: Penn State University Milton S. Hershey Medical Center

location_facility: CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

location_facility: Inland Rheumatology Clinical Trials, Inc.

location_facility: Ilocos Training and Regional Medical Center

location_facility: Centro Privado de Medicina Familiar - Mind Out Research

location_facility: CINME - Centro De Investigaciones Metabolicas

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

location_facility: Shiga University of Medical Science Hospital

location_facility: Far Eastern University - Dr. Nicanor Reyes Medical Foundation

location_facility: Karolinska Universitetssjukhuset - Solna

location_facility: North Texas Center for Clinical Research

location_facility: Dermoklinika Centrum Medyczne SC M Kierstan J Narbutt A Lesiak

location_facility: Precision Comprehensive Clinical Research Solutions

location_facility: Nucleo de Pesquisa Clinica do Rio Grande do Sul

location_facility: CHU de Caen - Hopital de la Cote de Nacre

location_facility: Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski

location_facility: Centro de investigacion medica y reumatologia

location_facility: Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A

location_facility: Changhua Christian Medical Foundation Changhua Christian Hospital

location_facility: Centre for Rheumatology, Immunology and Arthritis

location_facility: AA MRC LLC Ahmed Arif Medical Research Center

location_facility: IDERJ - Instituto de Dermatologia e Estética do Brasil Ltda

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel


title: A Non-interventional Study to Assess the Long-term Safety and Efficacy of Osilodrostat in Patients With Endogenous Cushing's Syndrome

summary: This is a non-interventional, multinational, multi-centre study with primary data collection, to further document the safety and efficacy of osilodrostat administered in routine clinical practice in patients treated with osilodrostat for endogenous Cushing's Syndrome

study_type: Observational

time_perspective: Prospective

lead_sponsor: RECORDATI GROUP

location_country:
United States
Germany
France

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

location_facility: University of Pennsylvania Medical Center

location_facility: Memorial Sloan-Kettering Cancer Center (MSKCC) - New York

location_facility: Washington University School of Medicine


title: CYCLONE 3: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abemaciclib in Combination With Abiraterone Plus Prednisone in Men With High-Risk Metastatic Hormone-Sensitive Prostate Cancer

acronym: CYCLONE 3

summary: The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
France
Hungary
United States
Romania
Belgium
China
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Israel

location_facility: Wannan Medical College Yijishan Hospital

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Baylor Scott & White Medical Center - Temple

location_facility: Instituto de Investigaciones Clínicas Mar del Plata

location_facility: Centro Avançado de Tratamento Oncológico- CENANTRON

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Icesp - Instituto Do Câncer Do Estado de São Paulo

location_facility: Xiangya Hospital Central South University

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: The University of Vermont Medical Center Inc.

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: Associated Medical Professionals - Urology

location_facility: The Center for Cancer and Blood Disorders

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Investigaciones Clinicas Moleculares (ICM)

location_facility: Southern Medical University Nanfang Hospital

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: Kobe City Medical Center General Hospital

location_facility: Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

location_facility: The University of Louisville, James Graham Brown Cancer Center

location_facility: University of Massachusetts Medical School

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Torrance Memorial Physician Network / Cancer Care

location_facility: Instituto do Cancer Arnaldo Vieira de Carvalho

location_facility: Universitätsklinikum Münster - Albert Schweitzer Campus

location_facility: İnönü Üniversitesi Turgut Özal Tıp Merkezi

location_facility: MemorialCare Health System - Long Beach Medical Center

location_facility: Instituto de Educação, Pesquisa e Gestão em Saúde

location_facility: TRIO-US (Translational Research in Oncology-US)

location_facility: Perlmutter Cancer Center at NYU Langone Hospital - Long Island

location_facility: Fundación Instituto Valenciano de Oncología

location_facility: Second Affiliated hospital of Anhui Medical University

location_facility: Fundación Cenit Para La Investigación En Neurociencias

location_facility: Huadong Hospital Affiliated to Fudan University

location_facility: Universitätsmedizin Johannes Gutenberg Universität Mainz

location_facility: Health Pharma Professional Research S.A. de C.V:

location_facility: Asociación de Beneficencia Hospital Sirio Libanés

location_facility: Centro Integrado de Oncologia de Curitiba

location_facility: Afflilated Hospital of Bengbu Medical College

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: The Second Hospital of Tianjin Medical University

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Harbin Medical University Cancer Hospital

location_facility: St. Antonius Ziekenhuis, locatie Utrecht

location_facility: Urologicum Duisburg Fachärztesozietät - Walsum

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi

location_facility: Centro de Pesquisa Clínica do Instituto do Câncer do Ceará

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Actualidad Basada en la Investigación del Cáncer

location_facility: Tongji Hospital Tongji Medical,Science & Technology

location_facility: The University of Arizona Cancer Center - North Campus

location_facility: Laura and Isaac Perlmutter Cancer Center

location_facility: University General Hospital of Heraklion

location_facility: Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego

location_facility: Centro Para El Desarrollo de La Medicina Y de Asistencia Medica Especializada S.C.

location_facility: University of Miami Hospital and Clinics, Sylvester Cancer Center

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: West China Hospital of Sichuan University

location_facility: InVO Institut für Versorgungsforschung in der Onkologie

location_facility: Chang Gung Medical Foundation-Linkou Branch


title: A Multicenter, Single-Arm, Open-Label, Extension, Rollover Study To Evaluate The Long-Term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis

acronym: OLERO

summary: This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.

status: Active, not recruiting

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Turkey
Croatia
Czechia
Canada
Serbia
France
Belarus
Lithuania
Portugal
Slovakia
Hungary
Switzerland
United States
Latvia
Ukraine
Romania
Tunisia
Belgium
Estonia
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Bulgaria
Russian Federation
Israel

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: SBIH of Nizhniy Novgorod region "City Clinical Hospital # 3"

location_facility: Tel Aviv Sourasky Medical Center; Department of Neurology

location_facility: Walton Centre For Neurology and Neurosurgery

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution

location_facility: Azienda Socio Sanitaria Territoriale della Valle Olona (pres

location_facility: Michigan Institute for Neurological Disorders

location_facility: SBEI HPE "Samara State Medical University" of the MoH of the RF

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: SBIH City Polyclinic 2 of the Department of Health of the City of Moscow

location_facility: Spitalul Universitar de Urgenta Elias; Oncologie Medicala

location_facility: FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Centro de Estudios Clinicos y Especialidades Medicas S C

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: Centre Hospitalier Intercommunal de Poissy

location_facility: CE I.I.Mechnykov Dnipropetrovsk RC Hosp Dept of Neurology DSMU

location_facility: Nottingham University Hospitals Queen's Medical Centre

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Neurología

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria

location_facility: Montreal Neurological Institute and Hospital; Pharmacy Department

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Hospital Garcia de Orta; Servico de Neurologia

location_facility: University of Vermont Medical Center; Neurology

location_facility: IMV Pesquisa Neurologica Sociedade Simples Ltda

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: Wojewodzki Specjalistyczny Szpital w Olsztynie

location_facility: St Michael Hospital; Hematology and Oncology

location_facility: Zuyderland Medisch Centrum - Sittard-Geleen'

location_facility: Medical Center of Limited Liability Company Medical Center Saliutem

location_facility: Rutgers New Jersey Medical School Department of Neurology

location_facility: Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie

location_facility: NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH

location_facility: Acibadem City Clinic Tokuda Hospital Ead

location_facility: Rabin Medical Center Beilinson Campus; Gaucher Clinic Genetics Institute

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: Hospital de Basurto Servicio de Neurologia

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology

location_facility: University of Alberta; Northern Alberta Trials & Research Centre

location_facility: SAIH "Kemerovo Regional Clinical Hospital"

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Clinica Neurológica e Neurocirúrgica de Joinville

location_facility: SAHI "Interregional Clinical and Diagnostic Center"

location_facility: Universitaetsklinikum Giessen und Marburg GmbH; Zytostatikaabteilung

location_facility: Hospital Universitario Gaffree e Guinle; Neurologia

location_facility: Hopital Roger Salengro Service de Neurologie

location_facility: HUCFF-UFRJ - Hospital Universitário Clementino Fraga Filho Universidade Federal do Rio de Janeiro

location_facility: Univerzitna nemocnica Bratislava Nemocnica Ruzinov

location_facility: Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

location_facility: Hospital Regional Universitario de Malaga

location_facility: SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery

location_facility: Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien

location_facility: Kirov RSBIH "Kirov City Clinical Hospital # 1"

location_facility: Jahn Ferenc Del-Pesti Korhaz es Rendelointezet

location_facility: Medizinische Einrichtungen des Bezirks Oberpfalz GmbH

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: University First MHAT-Sofia St. Joan Krastitel EAD

location_facility: Hopital Universitaire Fattouma Bourguiba

location_facility: CMPI Chernihiv Regional Hospital; Reg.Cen.for Inflam.&demyelin.dis.of the CNS

location_facility: FSBIH Siberian Clinical Center of FMBA of Novosibirsk

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: AKH - Medizinische Universität Wien; Neurology

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: Hospital Universitario de la Princesa; Servicio de Neurologia

location_facility: University of Minnesota; Clin. Neuro Research Unit

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: Krajska zdravotni a.s. - Nemocnice Teplice o.z.

location_facility: Institute of Neurology Psychiatry and Narcology of NAMS of Ukraine

location_facility: University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)

location_facility: State Institution Minsk Research and Practice Center of Surgery Transplantation and Hematology

location_facility: Medical Center of Limited Liability Company Medbud-Clinic

location_facility: MHAT Avis Medica OOD Department of Neurology

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Klaipeda University Hospital Public Institution

location_facility: Uni of Texas Health Science Center At Houston

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Military Medical Academy MHAT Sofia Department of Rheumatology; Department of Rheumatology

location_facility: SBIH of Republic Mordoviya "Republican Clinical Hospital # 4"

location_facility: Maritime Medicine Centre of Latvia Hospital of Vecmilgravis Department of Neurology

location_facility: UBC Multiple Sclerosis & Neuromyelitis Optica NMO Clinical Trials

location_facility: RSBIH "Smolensk Regional Clinical Hospital"

location_facility: Specjal. Praktyka Lekarska; Prof. Grzegorz Opala

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. Aguascalientes

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Collaborative Neuroscience Research, LLC

location_facility: Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz

location_facility: MUDr. Beata Dupejova Neurologicka ambulancia s.r.o

location_facility: Chaim Sheba Medical Center; Neurology Department

location_facility: CHU Nantes Hopital Nord Laënnec; Pharmacy

location_facility: CNE Odesa Regional Clinical Hospital of Odesa Regional Council

location_facility: Vero Beach Neurology and Research Institute

location_facility: CNE of Lviv Reg Clin Hospital Dept of Neurology D.Halytskyi Lviv NMU

location_facility: Klinikum Bayreuth Standort Hohe Warte Klinik fur Neurologie; Klinik für Neurologie

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Charité Universitaetsmedizin Berlin - Campus Ch

location_facility: SBIH of Stavropol territory " City Hospital # 2" of Pyatigorsk; Neurology Department

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia

location_facility: HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

location_facility: CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council

location_facility: Vilnius University Hospital Santaros Klinikos


title: A 52-week, Randomized, Double-blind, Double-dummy, Parallel-group, Multi-centre, Non-inferiority Study to Investigate the Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA) Receiving Standard of Care (SoC) Therapy

acronym: OCEAN

summary: This study aims to investigate the efficacy and safety of depemokimab compared with mepolizumab in adults with relapsing or refractory EGPA receiving SoC therapy.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Czechia
Canada
France
Portugal
Hungary
United States
Belgium
China
Italy
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Israel


title: A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON-2)

summary: Study RIN-PF-303 is a multinational study designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52.

lead_sponsor: United Therapeutics

location_country:
Italy
New Zealand
Israel
Argentina
Denmark
Australia
Netherlands
Mexico
Belgium
Korea, Republic of
Spain
Chile
Taiwan
Peru
France

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Institute for Respiratory Health - Midland

location_facility: Gentofte Hospital - Lungemedicinsk forskning

location_facility: Unidad de Investigación Clínica en Medicina, S.C.

location_facility: Kaohsiung Medical University - Chung-Ho Memorial Hospital

location_facility: Azienda Ospedaliero Universitaria Policlinico "G.Rodolico-San Marco"

location_facility: Fondazione Policlinico Universitario A Gemelli-Rome

location_facility: Service de Pneumologie, Hôpital Européen Georges Pompídou (HEGP)

location_facility: Royal Prince Alfred Hospital, Missenden Road

location_facility: Westmead Hospital, Corner of Hawkesbury and Darcy Road

location_facility: Centro Integral de Medicina Respiratoria

location_facility: Ziekenhuis Netwerk Antwerpen (ZNA) Middelheim

location_facility: CINME S.A. - Centro de Investigaciones Metabolicas

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Hospital Universitario "Dr. José Eleuterio González"

location_facility: Odense University Hospital - Department of Respiratory Medicine J.

location_facility: CHU Amiens Picardie Site Sud - Service de Pneumologie

location_facility: Instituto Ave Pulmo - Fundación enfisema

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Universitario Central de Asturias

location_facility: Aarhus University Hospital - Department of Respiratory Diseases and Allergy, Research Unit

location_facility: Instituto Nacional De Enfermedades Respiratorias Ismael Cosio Villegas

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Institute for Respiratory Health - Nedlands

location_facility: The Catholic University of Korea - Eunpyeong St. Mary's Hospital

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Azienda Ospedaliero-Universitaria delle Marche

location_facility: Investigaciones en Patologías Respiratorias

location_facility: Groupement Hospitalier EST, Service de Pneumologie


title: A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)

summary: The purpose of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL. Participants may or may not have already had treatment for their cancer. Participation could last up to six years.

lead_sponsor: Loxo Oncology, Inc.

sponsor_collaborators:
Loxo Oncology, Inc.
Eli Lilly and Company

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Hungary
United States
Belgium
China
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Taiwan
Israel

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Tianjin Medical University General Hospital

location_facility: Koo Foundation Sun Yan-Sen Cancer Center

location_facility: Clínica de Nefrología, Urología y Enfermedades Cardiovasculares

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Centro de Pesquisas Clínicas do Hospital das Clínicas da UFMG - Ebserh

location_facility: Centro de Hematologia e Hemoterapia - Hemocentro de Campinas - UNICAMP

location_facility: Hospital Beneficência Portuguesa de São Paulo

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Dokuz Eylul University Faculty of Medicine

location_facility: Blood Institute of the Chinese Academy of Medical science

location_facility: First Affiliated Hosp of College of Med, Zhejiang University

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Stanford School of Medicine-Cancer Clinical Trials Office

location_facility: American Oncology Partners of Maryland, PA

location_facility: The 2nd Xiangya Hospital of Central South University

location_facility: GEFOS (Gesellschaft für onkologische Studien) Dortmund mbH

location_facility: Southern Medical University Nanfang Hospital

location_facility: Institut Català d'Oncologia de Girona (ICO Girona)

location_facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

location_facility: Novant Health, Oncology Research Institute

location_facility: TidalHealth Richard A. Henson Cancer Institute

location_facility: Centro Ricerche Cliniche di Verona s.r.l.

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Gemeinschaftspraxis Haematologie und Onkologie

location_facility: California Cancer Associates for Research and Excellence

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu Klinika Hematologii

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST

location_facility: Hospital Privado Centro Medico de Cordoba SA

location_facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyKlinika Hematologii

location_facility: Houston Methodist Hospital Cancer Center

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP

location_facility: Hospital Uopeccan - Centro de Pesquisa Clinica

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Fondazione del Piemonte per l'Oncologia IRCCS Candiolo

location_facility: CIONC-Centro Integrado de Oncologia de Curitiba

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP

location_facility: Guangxi Medical University Affiliated Tumor Hospital

location_facility: Centro Integrado de Oncologia de Curitiba

location_facility: Centro de Investigaciones Clínicas Viña del Mar (CIC)

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

location_facility: Cancer Specialists of North Florida -St Augustine

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Centre Hospitalier Universitaire (Limoges) (CHU DUPUYTREN 1)

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital

location_facility: Klinika Hematoonkologii i Transplantacji Szpiku

location_facility: Eastern Connecticut Hematology/Oncology Assoc.

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

location_facility: The Fourth Affiliated Hospital Zhejiang University School of Medicine

location_facility: Sociedad de Investigaciones Médicas Limitada

location_facility: Tulane Cancer Center Office of Clinical Research

location_facility: The Catholic University of Korea-Seoul St. Mary's Hospital

location_facility: Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo

location_facility: Gemeinschaftspraxis für Hämatologie and Onkologie

location_facility: Azienda Unita Sanitaria Locale di Reggio Emilia

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

location_facility: Instituto do Câncer - Hospital São Vicente de Paulo

location_facility: The Second Hospital of Anhui Medical University

location_facility: City Hospital, Nottingham University Hospitals

location_facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

location_facility: The Affiliated Cancer Hospital of Xinjiang Medical university

location_facility: Tokai University Hospital- Isehara Campus


title: Impact of CardiolRx on Myocardial Recovery in Acute Myocarditis. A Double-blind, Placebo-controlled Trial

acronym: ARCHER

summary:
Multi-center, double-blind, placebo-controlled, parallel group design. Patients with myocarditis will be screened and, if eligible, randomized within 10 days of the diagnostic CMR to CardiolRx or placebo.

CardiolRx is pharmaceutically produced Cannabidiol and is free of tetrahydrocannabinol (THC<5 ppm). The treatment period is 12 weeks; a last follow-up visit is scheduled one week after the last treatment, 13 weeks after randomization. Study assessments include Cardiac Magnetic Resonance imaging (CMR), ECG monitoring, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Columbia-Suicide Severity Rating Scale (C-SSRS) as well as physical exams and laboratory tests.

The primary and secondary outcome parameters are measured by CMR. Additional outcomes include clinical endpoints and changes in inflammatory and biomarkers.

ReferenceCitation: Lee WS, Erdelyi K, Matyas C, Mukhopadhyay P, Varga ZV, Liaudet L, Hasku G, Cihakova D, Mechoulam R, Pacher P. Cannabidiol Limits T Cell-Mediated Chronic Autoimmune Myocarditis: Implications to Autoimmune Disorders and Organ Transplantation. Mol Med. 2016 Sep;22:136-146. doi: 10.2119/molmed.2016.00007. Epub 2016 Jan 8.

lead_sponsor: Cardiol Therapeutics Inc.

location_country:
France
Brazil
United States
Canada
Israel

location_facility: Irmandade da Santa Casa de Misericórdia de São Paulo

location_facility: Hôpital Lariboisière - Département de Cardiologie

location_facility: Hopital Louis Pradel Hospices Civils de Lyon

location_facility: Beilinson Hospital, Rabin medical Center

location_facility: Tel Aviv Sourasky Medical Center (Ichilov)

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Hospital de Clínicas de Porto Alegre (HCPA)

location_facility: Hospital Felicio Rocho - Fundação Felice Rosso

location_facility: Institut de Cardiologie hopital Pitié Salpêtrière

location_facility: Centre Hospitalier Universitaire de Poitiers


title: A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

acronym: VALIANT

summary: This is a Phase 3 study to assess the efficacy and safety of twice-weekly subcutaneous (SC) doses of pegcetacoplan compared to placebo in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN) on the basis of a reduction in proteinuria.

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Czechia
Canada
France
Switzerland
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Israel

location_facility: Institute for Clinical and Experimental Medicine

location_facility: Renal and Transplant Associates of New England, PC

location_facility: Hospital Edouard Herriot, Hospices Civils de Lyon

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Rangueil Hospital-University Hospital Center (CHU) of Toulouse

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Great Ormond Street Hospital Foundation Trust

location_facility: Canberra Hospital - Renal Clinical Trials & Research Unit

location_facility: Hospital Universitario 12 de Octubre, Nephrology Department

location_facility: Real Hospital Portuguas de Beneficancia em Pernambuco

location_facility: Hospital Universitario Materno-Infantil Vall d' Hebron, Nefrologia Pediatrica

location_facility: Medizinische Hochschule Hannover, Studienzentrum fur Nieren und Hochdruckerkrankungen

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Keimyung University Dongsan Medical Center

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: Lille Regional University Hospital Center, Claude Huriez Hospital, Department of Nephrology

location_facility: Instituto da Crianca-Hospital das Clinicas University of Sao Paulo

location_facility: The Ohio State University Medical Center

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Yonsei University College of Medicine, Sinchon Severance Hospital

location_facility: Hospital Privado-Universitario de Cordoba

location_facility: Instituti Clinici Scientifici Maugeri SPA-IRCCS

location_facility: SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

location_facility: Keck School of Medicine, University of Southern California

location_facility: Aichi Children's Health and Medical Center

location_facility: Hospital das Clinicas de Ribeirao Preto, Division of Nephrology

location_facility: Hospital Materno Infantil Sant Joan de Deu

location_facility: Istituto di Ricerche Farmacologiche Mario Negri IRCCS

location_facility: HCFMUSP-Hospital Clinicas da Faculdade Medicina da Universidade de São Paulo

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi


title: A Multicenter, Open-Label, Phase I/II Study of EOS884448 (EOS-448) in Combination With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors

summary: This is a multicenter, open-label, phase I/II basket study, evaluating the safety, tolerability, RP2D, pharmacokinetics, pharmacodynamics and antitumor activity of EOS-448 (also known as GSK4428859A or belrestotug) combined with standard of care and/or with investigational therapies in participants with advanced solid tumors.

design_allocation: Non-Randomized

lead_sponsor: iTeos Belgium SA

collaborators:
GlaxoSmithKline
iTeos Therapeutics

sponsor_collaborators:
iTeos Belgium SA
GlaxoSmithKline
iTeos Therapeutics

location_country:
Italy
United Kingdom
Belgium
United States
Spain
France

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS (Meldola)

location_facility: The Gabrail Pharmacology Phase 1 Research Center LLC

location_facility: Consorcio Hospitalario Provincial de Castello

location_facility: Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo

location_facility: Hospital Universitario de Navarra (Pamplona)

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: University of Kentucky, Markey Cancer Center

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

location_facility: Innovative Clinical Research Institute, LLC


title: A Randomized, Multi-center, Open-label, Active-controlled Phase 3 Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) Versus Octreotide LAR or Lanreotide ATG in Patients With GEP-NET

acronym: SORENTO

summary: The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.

lead_sponsor: Camurus AB

location_country:
Germany
Italy
Hungary
Israel
Romania
Australia
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: White Plains Hospital - Center for Cancer Care

location_facility: Rocky Mountain Cancer Centers - Denver - Midtown

location_facility: University of Kentucky (UK) - Markey Cancer Center

location_facility: Parc Taulí Sabadell Hospital Universitari

location_facility: Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut d'Oncologia (VHIO)

location_facility: IRCCS - Istituto Nazionale dei Tumori di Napoli Fondazione G. Pascale - Oncologia Addominale

location_facility: CHRU Brest - Hopital Morvan - Institut de Cancerologie et d'Hematologie

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Hadassah Medical Center (HMC) - Hadassah University Hospital (HUH) - Ein Kerem

location_facility: Universita Degli Studi di Genova - Center of Excellence for Biomedical Research (CEBR)

location_facility: Szegedi Tudományegyetem; I.Belgyógyászati Klinika

location_facility: Universitaetsklinikum Erlangen - Hautklinik

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg

location_facility: Groupe Hospitalier de l'Institut Catholique de Lille - Hopital Saint Vincent de Paul

location_facility: Charite - UB - CVK - Medizinische Klinik

location_facility: Azienda Ospedaliero - Universitaria di Modena Policlinico

location_facility: Centre Hospitalier de l'Universite de Montreal - Notre-Dame Hospital

location_facility: Centre Hospitalier Chretien (CHC) - Clinique Notre-Dame - Hermalle

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST IRCCS

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Mayo Clinic Cancer Center (MCCC) - Phoenix

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: CHU de Lyon - Groupement Hospitalier Edouard Herriot

location_facility: Hospital Universitario Central de Asturias

location_facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis

location_facility: Facultad de Medicina - Hospital Universitario Fundacion Jimenez Diaz (UAM-FJD) (Clinica de la Concepcion)

location_facility: Hospital Universitario Marques de Valdecilla (HUMV)

location_facility: Medizinischen Fakultät Mannheim der Universität Heidelberg

location_facility: Azienda Ospedaliero - Universitaria di Bologna Policlinico S. Orsola - Malpighi

location_facility: Universita degli Studi di Bari - Aldo Moro

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque

location_facility: Universita degli Studi di Firenze - Azienda Ospedaliero - Universitaria Careggi - SC di Oncologia Medical

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuţă" Cluj Napoca

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: Niagara Health System - St. Catharines General Site

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - L'Hopital General


title: EPIK-B5: A Phase III, Randomized, Double-blind, Placebo-controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With HR-positive, HER2-negative Advanced Breast Cancer With a PIK3CA Mutation, Who Progressed on or After Aromatase Inhibitor and a CDK4/6 Inhibitor

summary: The purpose of this study is to complement Study CBYL719C2301 (SOLAR-1) and obtain more comprehensive data on the efficacy and safety of alpelisib (BYL719) in combination with fulvestrant compared with placebo plus fulvestrant in men or postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation who progressed or relapsed on or after treatment with an AI plus a CDK4/6 inhibitor.

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country: Finland Germany Ireland Italy Poland Portugal Slovakia Hungary Denmark Romania Belgium Spain Greece Czechia Bulgaria Canada France