summary:
The Mucopolysaccharidosis I (MPS I) Registry is an ongoing, observational database that tracks the outcomes of patients with MPS I. The data collected by the MPS I Registry will provide information to better characterize the natural history and progression of MPS I as well as the clinical responses of patients receiving enzyme replacement therapy, such as Aldurazyme (Recombinant Human Alpha-L-Iduronidase), or other treatment modalities.

The objectives of the Registry are:

To evaluate the long-term effectiveness and safety of Aldurazyme® (laronidase)
To characterize and describe the MPS I population as a whole, including the variability, progression, and natural history of MPS I
To help the MPS I medical community with the development of recommendations for monitoring patients and reports on patient outcomes to optimize patient care

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Other

enrollment_type: Anticipated

ReferenceCitation: Viskochil D, Muenzer J, Guffon N, Garin C, Munoz-Rojas MV, Moy KA, Hutchinson DT. Carpal tunnel syndrome in mucopolysaccharidosis I: a registry-based cohort study. Dev Med Child Neurol. 2017 Dec;59(12):1269-1275. doi: 10.1111/dmcn.13545. Epub 2017 Sep 11.

ReferenceCitation: Arn P, Bruce IA, Wraith JE, Travers H, Fallet S. Airway-related symptoms and surgeries in patients with mucopolysaccharidosis I. Ann Otol Rhinol Laryngol. 2015 Mar;124(3):198-205. doi: 10.1177/0003489414550154. Epub 2014 Sep 11.

ReferenceCitation: Beck M, Arn P, Giugliani R, Muenzer J, Okuyama T, Taylor J, Fallet S. The natural history of MPS I: global perspectives from the MPS I Registry. Genet Med. 2014 Oct;16(10):759-65. doi: 10.1038/gim.2014.25. Epub 2014 Mar 27.

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Kuwait
Thailand
Vietnam
Croatia
Chile
Pakistan
Czechia
Canada
France
Colombia
Portugal
Slovakia
Hungary
Denmark
United States
Indonesia
India
Romania
Lebanon
Belgium
Malaysia
Egypt
Philippines
Italy
United Kingdom
Singapore
Netherlands
United Arab Emirates
Korea, Republic of
Saudi Arabia
Taiwan
Russian Federation
Sweden

location_facility: University of California at San Diego-Site Number:840007

location_facility: University of Louisville- Genetics-Site Number:840030

location_facility: Children's Hospital of Michigan-Site Number:840066

location_facility: Children's Hospital IMD Clinic-Site Number:840069

location_facility: Children's Hospital of Philadelphia HUP Medical Genetics-Site Number:840089

location_facility: Atlantic Health System-Site Number:840099

location_facility: USC Health Sciences Center Dept of Genetics-Site Number:840082

location_facility: Joseph M. Sanzari Children's Hospital-Site Number:840101

location_facility: University of Minnesota Medical Center Pediatrics-Site Number:840076

location_facility: LSD Data Registry Site LLC-Site Number:840094

location_facility: Cincinnati Children's Hospital-Genetics-Site Number:840041

location_facility: Children's Hospital of the Kings Daughters-Site Number:840072

location_facility: University of Virginia School of Medicine-Pediatrics-Site Number:840078

location_facility: Boston Children's Hospital-Site Number:840093

location_facility: Southern California Permanente Medical Group-Site Number:840108

location_facility: Nationwide Children's Hospital-Site Number:840091

location_facility: Ochsner Medical Center-Site Number:840120

location_facility: St. Peter's University Hospital-Site Number:840016

location_facility: Washington University of St. Louis-Site Number:840100

location_facility: Children's Hospital Oakland-Site Number:840029

location_facility: Baylor Research Center-Site Number:840058

location_facility: Ann and Robert Lurie Children's Hospital-Site Number:840011

location_facility: Massachusetts General Hospital-Genetics-Site Number:840062

location_facility: Indianapolis University School of Medicine-Site Number:840027

location_facility: University of Florida Pediatrics Genetics-Site Number:840121

location_facility: Loma Linda University Children's Hospital-Site Number:840117

location_facility: Arkansas Childrens Hospital-Site Number:840109

location_facility: Children's National Medical Center-Site Number:840067

location_facility: Pediatric Endocrine Associates-Site Number:840017

location_facility: University Of Washington Medical Center-Site Number:840059

location_facility: Rhode Island Hospital Genetics-Site Number:840053

location_facility: State University of New York-Site Number:840052

location_facility: St. Joseph's Children's Hospital-Site Number:840057

location_facility: Children's Hospital of Philadelphia-Site Number:840034

location_facility: University of Nebraska Medical Center- Pediatrics-Site Number:840084

location_facility: Metropolitan Hospital Center-Site Number:840110

location_facility: Seattle Children's Hospital-Site Number:840028

location_facility: Children's Hospital of Orange County-Site Number:840074

location_facility: University of Utah Medical Center-Site Number:840092

location_facility: Phoenix Children's Hospital-Site Number:840003

location_facility: Stanford Unviersity MC Dept of Genetics-Site Number:840022

location_facility: Duke University Medical Center Genetics Dept-Site Number:840037

location_facility: Oregon Health & Science University-Site Number:840080

location_facility: University of Colorado at Denver Genetics-Site Number:840068

location_facility: University of Pittsburgh-Site Number:840023

location_facility: Children's Hospital of Wisconsin-Pediatrics-Site Number:840054

location_facility: University Of Miami SOM-Site Number:840006

location_facility: University of Rochester Medical Center SOM-Site Number:840105

location_facility: University of California at San Francisco-Site Number:840051

location_facility: Emory University School of Medicine- Human Genetics-Site Number:840060

location_facility: Multicare Health System ¿ Mary Bridge Childrens Hospital-Site Number:840115

location_facility: UC Davis MIND Institute-Site Number:840010

location_facility: New York University School Of Medicine-Site Number:840040

location_facility: Children's Specialty Center of Nevada-Site Number:840008

location_facility: University of Michigan Pediatrics-Site Number:840107

location_facility: University of Florida Dept of Genetics-Site Number:840083

location_facility: Children's Health Care-Site Number:840114

location_facility: Rush University Medical Center Genetics-Site Number:840079

status_simplified: Ongoing


title: Pregabalin Open-Label, Multicenter Add-On Trial Following a 4-Day Double-Blind Transition Period to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures.

summary: To evaluate long-term safety and efficacy of pregabalin in patients with partial seizures.

status: Completed

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

lead_sponsor: Pfizer

location_country:
Finland
Germany
Italy
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
South Africa
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase IV, Open-Label, Randomized, Multicenter Trial Assessing a Reyataz-Based Substitution Approach in the Management of Lipodystrophy Syndrome. Research Into Atazanavir in Lipodystrophy (The REAL Study)

summary: The purpose of this clinical research study is to learn if human immunodeficiency virus (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral treatment (HAART) regimen have better changes in fat distribution after switching to atazanavir-ritonavir than those remaining on their current protease inhibitor boosted HAART regimen.

study_completion_date_type: Actual

design_allocation: Randomized

enrollment_type: Actual

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
Poland
United Kingdom
Mexico
United States
Spain
Canada
France


title: An Open-Label, Randomized, Phase 3 Trial Of Intravenous Temsirolimus (CCI-779) At Two Dose Levels Compared To Investigator's Choice Therapy In Relapsed, Refractory Subjects With Mantle Cell Lymphoma (MCL)

acronym: OPTIMAL

summary: This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL).

ReferenceType: derived

ReferenceCitation: Hess G, Coiffier B, Crump M, Gisselbrecht C, Offner F, Romaguera J, Kang L, Moran PJ. Effect of prognostic classification on temsirolimus efficacy and safety in patients with relapsed or refractory mantle cell lymphoma: a retrospective analysis. Exp Hematol Oncol. 2015 Apr 11;4:11. doi: 10.1186/s40164-015-0006-1. eCollection 2015.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Toronto - TSpace

repository_normalized: localhost

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
PubMed Central
archive.ugent.be
localhost

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Australia
Brazil
Netherlands
Austria
Belgium
Sweden
United States
China
Spain
Switzerland
Chile
Canada
France


type: Other Identifier

title: A Randomized, Controlled, Open-label Trial to Compare the Efficacy, Safety and Tolerability of TMC114/RTV Versus LPV/RTV in Treatment-Experienced HIV-1 Infected Patients

summary: Study TMC114-C214 is a randomized, controlled, open-label trial to compare the efficacy, safety and tolerability of TMC114 boosted with low dose ritonavir (RTV) versus Kaletra (LPV)/RTV in lopinavir-naïve treatment-experienced HIV-1 infected patients.

ReferenceType: result

ReferenceCitation: Madruga JV, Berger D, McMurchie M, Suter F, Banhegyi D, Ruxrungtham K, Norris D, Lefebvre E, de Bethune MP, Tomaka F, De Pauw M, Vangeneugden T, Spinosa-Guzman S; TITAN study group. Efficacy and safety of darunavir-ritonavir compared with that of lopinavir-ritonavir at 48 weeks in treatment-experienced, HIV-infected patients in TITAN: a randomised controlled phase III trial. Lancet. 2007 Jul 7;370(9581):49-58. doi: 10.1016/S0140-6736(07)61049-6.

ReferenceCitation: Banhegyi D, Katlama C, da Cunha CA, Schneider S, Rachlis A, Workman C, De Meyer S, Vandevoorde A, Van De Casteele T, Tomaka F. Week 96 efficacy, virology and safety of darunavir/r versus lopinavir/r in treatment-experienced patients in TITAN. Curr HIV Res. 2012 Mar;10(2):171-81. doi: 10.2174/157016212799937218.

lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
Germany
Argentina
Australia
Brazil
Thailand
Chile
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
Malaysia
Puerto Rico
Guatemala
United Kingdom
Netherlands
Austria
Mexico
Spain
Greece
Panama
South Africa
Russian Federation


title: A Phase II Study to Evaluate the Efficacy, Safety and Pharmacodynamics of Lapatinib in Patients With Relapsed or Refractory Inflammatory Breast Cancer

summary: This study was designed to determine how effective and safe a new investigational drug, lapatinib, is in treating patients with treatment refractory or relapsed inflammatory breast cancer. Tumor tissue collected pre-treatment and at Day 28 will be examined for biologic activity by IHC (immunohistochemistry). Treatment will consist of daily oral therapy with lapatinib. A patient may continue treatment as long as they are receiving benefit. Blood samples for hematology and chemistry panels, MUGA/ECHO (multigated acquisition/echocardiogram) exams and physical exams will be performed throughout the study to monitor safety.

ReferenceCitation: Kaufman B, Trudeau M, Awada A, Blackwell K, Bachelot T, Salazar V, DeSilvio M, Westlund R, Zaks T, Spector N, Johnston S. Lapatinib monotherapy in patients with HER2-overexpressing relapsed or refractory inflammatory breast cancer: final results and survival of the expanded HER2+ cohort in EGF103009, a phase II study. Lancet Oncol. 2009 Jun;10(6):581-8. doi: 10.1016/S1470-2045(09)70087-7. Epub 2009 Apr 24.

ReferenceCitation: Kaufman B, Wu Y, Amonkar MM, Sherrill B, Bachelot T, Salazar V, Viens P, Johnston S. Impact of lapatinib monotherapy on QOL and pain symptoms in patients with HER2+ relapsed or refractory inflammatory breast cancer. Curr Med Res Opin. 2010 May;26(5):1065-73. doi: 10.1185/03007991003680323.

lead_sponsor: GlaxoSmithKline

location_country:
France
United Kingdom
Tunisia
Belgium
United States
Spain
Canada
Israel


title: A Randomized, Open-Label, Comparative Evaluation of Conversion From Calcineurin Inhibitor Treatment to Sirolimus Treatment Versus Continued Calcineurin Inhibitor Treatment in Liver Allograft Recipients Undergoing Maintenance Therapy

summary: The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.

status: Terminated

lead_sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

location_country:
Germany
Italy
Portugal
United Kingdom
Netherlands
Switzerland
Belgium
United States
Spain
Canada
Czech Republic
France

status_simplified: Unknown


title: A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma

summary: The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).

ReferenceCitation: Rini BI, Hutson TE, Figlin RA, Lechuga MJ, Valota O, Serfass L, Rosbrook B, Motzer RJ. Sunitinib in Patients With Metastatic Renal Cell Carcinoma: Clinical Outcome According to International Metastatic Renal Cell Carcinoma Database Consortium Risk Group. Clin Genitourin Cancer. 2018 Aug;16(4):298-304. doi: 10.1016/j.clgc.2018.04.005. Epub 2018 May 4.

oa_host_type: repository

version: acceptedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

ReferenceCitation: Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.

ReferenceCitation: Cella D, Michaelson MD, Bushmakin AG, Cappelleri JC, Charbonneau C, Kim ST, Li JZ, Motzer RJ. Health-related quality of life in patients with metastatic renal cell carcinoma treated with sunitinib vs interferon-alpha in a phase III trial: final results and geographical analysis. Br J Cancer. 2010 Feb 16;102(4):658-64. doi: 10.1038/sj.bjc.6605552. Epub 2010 Jan 26.

ReferenceCitation: Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Rixe O, Oudard S, Negrier S, Szczylik C, Kim ST, Chen I, Bycott PW, Baum CM, Figlin RA. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):115-24. doi: 10.1056/NEJMoa065044.

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Brazil
United States
Spain
Canada
Russian Federation
France


title: A Randomized, Controlled, Open-label, Multi-center, Parallel-group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Intravenously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis.

summary: This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

ReferenceCitation: Canaud B, Mingardi G, Braun J, Aljama P, Kerr PG, Locatelli F, Villa G, Van Vlem B, McMahon AW, Kerloeguen C, Beyer U; STRIATA Study Investigators. Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Nephrol Dial Transplant. 2008 Nov;23(11):3654-61. doi: 10.1093/ndt/gfn320. Epub 2008 Jun 27.

lead_sponsor: Hoffmann-La Roche

location_country: Finland Germany Italy Denmark Australia Sweden Switzerland Austria Belgium Spain Canada France


title: Multiple-dose, Open-label, Randomized, Safety and Pharmacokinetic Study of Tipranavir in Combination With Low-dose Ritonavir in HIV-infected Pediatric Patients

summary:
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide information concerning the pharmacokinetic characteristics of tipranavir and ritonavir in this age group, and to determine the relative bioavailability of the TPV liquid formulation and TPV capsule formulation in adolescents switching from liquid to capsule.

The secondary objective of this study is the determination of the dose of topranavir and ritonavir (TPV/r) in children and adolescents between 2 and 18 years of age required for an adult equivalent systemic exposure of TPV/r 500 mg / 200 mg.

ReferenceCitation: Salazar JC, Cahn P, Della Negra M, De Aquino MZ, Robinson PA, Jelaska A, Mikl J. Efficacy and safety of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents: 5 years of experience. Pediatr Infect Dis J. 2014 Apr;33(4):396-400. doi: 10.1097/INF.0000000000000038.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Salazar JC, Cahn P, Yogev R, Negra MD, Castelli-Gattinara G, Fortuny C, Flynn PM, Giaquinto C, Ruan PK, Smith ME, Mikl J, Jelaska A; PACTG 1051/BI Study Team. Efficacy, safety and tolerability of tipranavir coadministered with ritonavir in HIV-1-infected children and adolescents. AIDS. 2008 Sep 12;22(14):1789-98. doi: 10.1097/QAD.0b013e32830c481b.

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Italy
Argentina
Brazil
Mexico
United States
Spain
Canada
Puerto Rico
France

location_facility: 1182.14.00005 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.00008 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.00006 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.00010 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.11001 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.33001 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.33005 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.39003 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.34001 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.00004 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.00002 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.52001 CLINDI (Clínica de Inmunodeficiencias)

location_facility: 1182.14.39001 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.33004 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.33006 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.00003 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.33002 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.00001 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.49004 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.49002 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.11002 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.00007 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.00009 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.49001 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.34002 Boehringer Ingelheim Investigational Site

location_facility: 1182.14.33003 Boehringer Ingelheim Investigational Site


title: A Randomised, Blinded, Phase 2 Study of Letrozole Plus the Farnesyl Transferase Inhibitor ZARNESTRA TM (R115777) and Letrozole Plus Placebo in the Treatment of Advanced Breast Cancer After Antiestrogen Therapy.

summary: The purpose of this study is to determine if the addition of tipifarnib to standard letrozole therapy leads to a better response to treatment for your cancer in comparison to letrozole plus a placebo. Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors (FTI). It blocks proteins that make cancer cells grow.

ReferenceCitation: Johnston SR, Semiglazov VF, Manikhas GM, Spaeth D, Romieu G, Dodwell DJ, Wardley AM, Neven P, Bessems A, Park YC, De Porre PM, Perez Ruixo JJ, Howes AJ. A phase II, randomized, blinded study of the farnesyltransferase inhibitor tipifarnib combined with letrozole in the treatment of advanced breast cancer after antiestrogen therapy. Breast Cancer Res Treat. 2008 Jul;110(2):327-35. doi: 10.1007/s10549-007-9726-1. Epub 2007 Sep 13.

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
United Kingdom
Netherlands
Belgium
United States
Russian Federation
France


type: U.S. NIH Grant/Contract

summary: The purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure (CHF).

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Whellan DJ, O'Connor CM, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Houston-Miller N, Fleg JL, Schulman KA, Pina IL; HF-ACTION Trial Investigators. Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. Am Heart J. 2007 Feb;153(2):201-11. doi: 10.1016/j.ahj.2006.11.007.

ReferenceCitation: Hejjaji V, Tang Y, Coles T, Jones PG, Reeve BB, Mentz RJ, Spatz ES, Dunlay SM, Caldwell B, Saha A, Tarver ME, Tran A, Patel KK, Henke D, Pina IL, Spertus JA. Psychometric Evaluation of the Kansas City Cardiomyopathy Questionnaire in Men and Women With Heart Failure. Circ Heart Fail. 2021 Sep;14(9):e008284. doi: 10.1161/CIRCHEARTFAILURE.120.008284. Epub 2021 Sep 1.

oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

ReferenceCitation: Truby LK, Regan JA, Giamberardino SN, Ilkayeva O, Bain J, Newgard CB, O'Connor CM, Felker GM, Kraus WE, McGarrah RW, Shah SH. Circulating long chain acylcarnitines and outcomes in diabetic heart failure: an HF-ACTION clinical trial substudy. Cardiovasc Diabetol. 2021 Aug 3;20(1):161. doi: 10.1186/s12933-021-01353-z.

ReferenceCitation: Feng KY, O'Connor CM, Clare R, Alhanti B, Pina IL, Kraus WE, Whellan DJ, Mentz RJ. Greater Pain Severity Is Associated with Worse Outcomes in Patients with Heart Failure. J Cardiovasc Transl Res. 2021 Oct;14(5):984-991. doi: 10.1007/s12265-021-10104-0. Epub 2021 Feb 9.

ReferenceCitation: Regan JA, Kitzman DW, Leifer ES, Kraus WE, Fleg JL, Forman DE, Whellan DJ, Wojdyla D, Parikh K, O'Connor CM, Mentz RJ. Impact of Age on Comorbidities and Outcomes in Heart Failure With Reduced Ejection Fraction. JACC Heart Fail. 2019 Dec;7(12):1056-1065. doi: 10.1016/j.jchf.2019.09.004.

oa_colors: green hybrid

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

unpaywall_oa_status: hybrid

ReferenceCitation: Mediano MFF, Leifer ES, Cooper LS, Keteyian SJ, Kraus WE, Mentz RJ, Fleg JL. Influence of Baseline Physical Activity Level on Exercise Training Response and Clinical Outcomes in Heart Failure: The HF-ACTION Trial. JACC Heart Fail. 2018 Dec;6(12):1011-1019. doi: 10.1016/j.jchf.2018.09.012.

ReferenceCitation: Luo N, O'Connor CM, Cooper LB, Sun JL, Coles A, Reed SD, Whellan DJ, Pina IL, Kraus WE, Mentz RJ. Relationship between changing patient-reported outcomes and subsequent clinical events in patients with chronic heart failure: insights from HF-ACTION. Eur J Heart Fail. 2019 Jan;21(1):63-70. doi: 10.1002/ejhf.1299. Epub 2018 Aug 31.

evidence: open (via free article)

ReferenceCitation: Warraich HJ, O'Connor C, Wu A, Coles A, Kraus WE, Pina IL, Whellan DJ, Mentz RJ. Differences Between Patients Enrolled Early and Late During Clinical Trial Recruitment: Insights From the HF-ACTION Trial. Circ Cardiovasc Qual Outcomes. 2018 Jul;11(7):e004643. doi: 10.1161/CIRCOUTCOMES.117.004643. No abstract available.

ReferenceCitation: Ambrosy AP, Bhatt AS, Stebbins AL, Wruck LM, Fudim M, Greene SJ, Kraus WE, O'Connor CM, Pina IL, Whellan DJ, Mentz RJ. Prevalent digoxin use and subsequent risk of death or hospitalization in ambulatory heart failure patients with a reduced ejection fraction-Findings from the Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) randomized controlled trial. Am Heart J. 2018 May;199:97-104. doi: 10.1016/j.ahj.2018.02.004. Epub 2018 Feb 11.

ReferenceCitation: Pokharel Y, Khariton Y, Tang Y, Nassif ME, Chan PS, Arnold SV, Jones PG, Spertus JA. Association of Serial Kansas City Cardiomyopathy Questionnaire Assessments With Death and Hospitalization in Patients With Heart Failure With Preserved and Reduced Ejection Fraction: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Cardiol. 2017 Dec 1;2(12):1315-1321. doi: 10.1001/jamacardio.2017.3983. Erratum In: JAMA Cardiol. 2018 Feb 1;3(2):181.

ReferenceCitation: Sharma A, Stevens SR, Lucas J, Fiuzat M, Adams KF, Whellan DJ, Donahue MP, Kitzman DW, Pina IL, Zannad F, Kraus WE, O'Connor CM, Felker GM. Utility of Growth Differentiation Factor-15, A Marker of Oxidative Stress and Inflammation, in Chronic Heart Failure: Insights From the HF-ACTION Study. JACC Heart Fail. 2017 Oct;5(10):724-734. doi: 10.1016/j.jchf.2017.07.013.

ReferenceCitation: Ambrosy AP, Cerbin LP, DeVore AD, Greene SJ, Kraus WE, O'Connor CM, Pina IL, Whellan DJ, Wojdyla D, Wu A, Mentz RJ. Aerobic exercise training and general health status in ambulatory heart failure patients with a reduced ejection fraction-Findings from the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)trial. Am Heart J. 2017 Apr;186:130-138. doi: 10.1016/j.ahj.2016.12.017. Epub 2017 Jan 19.

ReferenceCitation: Luo N, Merrill P, Parikh KS, Whellan DJ, Pina IL, Fiuzat M, Kraus WE, Kitzman DW, Keteyian SJ, O'Connor CM, Mentz RJ. Exercise Training in Patients With Chronic Heart Failure and Atrial Fibrillation. J Am Coll Cardiol. 2017 Apr 4;69(13):1683-1691. doi: 10.1016/j.jacc.2017.01.032.

ReferenceCitation: Kelly JP, Dunning A, Schulte PJ, Fiuzat M, Leifer ES, Fleg JL, Cooper LS, Keteyian SJ, Kitzman DW, Pina IL, Kraus WE, Whellan DJ, O'Connor CM, Mentz RJ. Statins and Exercise Training Response in Heart Failure Patients: Insights From HF-ACTION. JACC Heart Fail. 2016 Aug;4(8):617-24. doi: 10.1016/j.jchf.2016.05.006. Epub 2016 Jul 6.

ReferenceCitation: Keteyian SJ, Patel M, Kraus WE, Brawner CA, McConnell TR, Pina IL, Leifer ES, Fleg JL, Blackburn G, Fonarow GC, Chase PJ, Piner L, Vest M, O'Connor CM, Ehrman JK, Walsh MN, Ewald G, Bensimhon D, Russell SD; HF-ACTION Investigators. Variables Measured During Cardiopulmonary Exercise Testing as Predictors of Mortality in Chronic Systolic Heart Failure. J Am Coll Cardiol. 2016 Feb 23;67(7):780-9. doi: 10.1016/j.jacc.2015.11.050. Erratum In: J Am Coll Cardiol. 2016 Apr 26;67(16):1979-80.

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

repository_institution: California Digital Library - eScholarship

repositories_institution: California Digital Library - eScholarship

ReferenceCitation: Ahmad T, Kelly JP, McGarrah RW, Hellkamp AS, Fiuzat M, Testani JM, Wang TS, Verma A, Samsky MD, Donahue MP, Ilkayeva OR, Bowles DE, Patel CB, Milano CA, Rogers JG, Felker GM, O'Connor CM, Shah SH, Kraus WE. Prognostic Implications of Long-Chain Acylcarnitines in Heart Failure and Reversibility With Mechanical Circulatory Support. J Am Coll Cardiol. 2016 Jan 26;67(3):291-9. doi: 10.1016/j.jacc.2015.10.079.

ReferenceCitation: Cooper LB, Mentz RJ, Sun JL, Schulte PJ, Fleg JL, Cooper LS, Pina IL, Leifer ES, Kraus WE, Whellan DJ, Keteyian SJ, O'Connor CM. Psychosocial Factors, Exercise Adherence, and Outcomes in Heart Failure Patients: Insights From Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION). Circ Heart Fail. 2015 Nov;8(6):1044-51. doi: 10.1161/CIRCHEARTFAILURE.115.002327. Erratum In: Circ Heart Fail. 2016 Mar;9(3):e000014.

ReferenceCitation: Fiuzat M, Wojdyla D, Pina I, Adams K, Whellan D, O'Connor CM. Heart Rate or Beta-Blocker Dose? Association With Outcomes in Ambulatory Heart Failure Patients With Systolic Dysfunction: Results From the HF-ACTION Trial. JACC Heart Fail. 2016 Feb;4(2):109-115. doi: 10.1016/j.jchf.2015.09.002. Epub 2015 Oct 28.

ReferenceCitation: Ahmad T, O'Brien EC, Schulte PJ, Stevens SR, Fiuzat M, Kitzman DW, Adams KF, Kraus WE, Pina IL, Donahue MP, Zannad F, Whellan DJ, O'Connor CM, Felker GM. Evaluation of the Incremental Prognostic Utility of Increasingly Complex Testing in Chronic Heart Failure. Circ Heart Fail. 2015 Jul;8(4):709-16. doi: 10.1161/CIRCHEARTFAILURE.114.001996. Epub 2015 Jun 1.

ReferenceCitation: Dardas T, Li Y, Reed SD, O'Connor CM, Whellan DJ, Ellis SJ, Schulman KA, Kraus WE, Forman DE, Levy WC. Incremental and independent value of cardiopulmonary exercise test measures and the Seattle Heart Failure Model for prediction of risk in patients with heart failure. J Heart Lung Transplant. 2015 Aug;34(8):1017-23. doi: 10.1016/j.healun.2015.03.017. Epub 2015 Mar 26.

ReferenceCitation: Mentz RJ, Babyak MA, Bittner V, Fleg JL, Keteyian SJ, Swank AM, Pina IL, Kraus WE, Whellan DJ, O'Connor CM, Blumenthal JA; HF-ACTION Investigators. Prognostic significance of depression in blacks with heart failure: insights from Heart Failure: a Controlled Trial Investigating Outcomes of Exercise Training. Circ Heart Fail. 2015 May;8(3):497-503. doi: 10.1161/CIRCHEARTFAILURE.114.001995. Epub 2015 Apr 21.

ReferenceCitation: Ahmad T, Pencina MJ, Schulte PJ, O'Brien E, Whellan DJ, Pina IL, Kitzman DW, Lee KL, O'Connor CM, Felker GM. Clinical implications of chronic heart failure phenotypes defined by cluster analysis. J Am Coll Cardiol. 2014 Oct 28;64(17):1765-74. doi: 10.1016/j.jacc.2014.07.979. Epub 2014 Oct 21.

ReferenceCitation: Jones LW, Douglas PS, Khouri MG, Mackey JR, Wojdyla D, Kraus WE, Whellan DJ, O'Connor CM. Safety and efficacy of aerobic training in patients with cancer who have heart failure: an analysis of the HF-ACTION randomized trial. J Clin Oncol. 2014 Aug 10;32(23):2496-502. doi: 10.1200/JCO.2013.53.5724. Epub 2014 Jul 7.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Felker GM, Fiuzat M, Thompson V, Shaw LK, Neely ML, Adams KF, Whellan DJ, Donahue MP, Ahmad T, Kitzman DW, Pina IL, Zannad F, Kraus WE, O'Connor CM. Soluble ST2 in ambulatory patients with heart failure: Association with functional capacity and long-term outcomes. Circ Heart Fail. 2013 Nov;6(6):1172-9. doi: 10.1161/CIRCHEARTFAILURE.113.000207. Epub 2013 Oct 8.

ReferenceCitation: Piccini JP, Hellkamp AS, Whellan DJ, Ellis SJ, Keteyian SJ, Kraus WE, Hernandez AF, Daubert JP, Pina lL, O'Connor CM; HF-ACTION Investigators. Exercise training and implantable cardioverter-defibrillator shocks in patients with heart failure: results from HF-ACTION (Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing). JACC Heart Fail. 2013 Apr;1(2):142-8. doi: 10.1016/j.jchf.2013.01.005.

ReferenceCitation: McCullough PA, Barnard D, Clare R, Ellis SJ, Fleg JL, Fonarow GC, Franklin BA, Kilpatrick RD, Kitzman DW, O'Connor CM, Pina IL, Thadani U, Thohan V, Whellan DJ; HF-ACTION Investigators. Anemia and associated clinical outcomes in patients with heart failure due to reduced left ventricular systolic function. Clin Cardiol. 2013 Oct;36(10):611-20. doi: 10.1002/clc.22181. Epub 2013 Aug 8.

ReferenceCitation: Li Y, Neilson MP, Whellan DJ, Schulman KA, Levy WC, Reed SD. Associations between Seattle Heart Failure Model scores and health utilities: findings from HF-ACTION. J Card Fail. 2013 May;19(5):311-6. doi: 10.1016/j.cardfail.2013.03.008.

ReferenceCitation: Keteyian SJ, Leifer ES, Houston-Miller N, Kraus WE, Brawner CA, O'Connor CM, Whellan DJ, Cooper LS, Fleg JL, Kitzman DW, Cohen-Solal A, Blumenthal JA, Rendall DS, Pina IL; HF-ACTION Investigators. Relation between volume of exercise and clinical outcomes in patients with heart failure. J Am Coll Cardiol. 2012 Nov 6;60(19):1899-905. doi: 10.1016/j.jacc.2012.08.958. Epub 2012 Oct 10.

ReferenceCitation: Reed SD, Li Y, Ellis SJ, Isitt JJ, Cheng S, Schulman KA, Whellan DJ. Associations between hemoglobin level, resource use, and medical costs in patients with heart failure: findings from HF-ACTION. J Card Fail. 2012 Oct;18(10):784-91. doi: 10.1016/j.cardfail.2012.08.359.

ReferenceCitation: Blumenthal JA, Babyak MA, O'Connor C, Keteyian S, Landzberg J, Howlett J, Kraus W, Gottlieb S, Blackburn G, Swank A, Whellan DJ. Effects of exercise training on depressive symptoms in patients with chronic heart failure: the HF-ACTION randomized trial. JAMA. 2012 Aug 1;308(5):465-74. doi: 10.1001/jama.2012.8720. Erratum In: JAMA. 2012 Nov 7;308(17):1742.

ReferenceCitation: Swank AM, Horton J, Fleg JL, Fonarow GC, Keteyian S, Goldberg L, Wolfel G, Handberg EM, Bensimhon D, Illiou MC, Vest M, Ewald G, Blackburn G, Leifer E, Cooper L, Kraus WE; HF-ACTION Investigators. Modest increase in peak VO2 is related to better clinical outcomes in chronic heart failure patients: results from heart failure and a controlled trial to investigate outcomes of exercise training. Circ Heart Fail. 2012 Sep 1;5(5):579-85. doi: 10.1161/CIRCHEARTFAILURE.111.965186. Epub 2012 Jul 6.

ReferenceCitation: Fiuzat M, Wojdyla D, Kitzman D, Fleg J, Keteyian SJ, Kraus WE, Pina IL, Whellan D, O'Connor CM. Relationship of beta-blocker dose with outcomes in ambulatory heart failure patients with systolic dysfunction: results from the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) trial. J Am Coll Cardiol. 2012 Jul 17;60(3):208-15. doi: 10.1016/j.jacc.2012.03.023. Epub 2012 May 2.

ReferenceCitation: Whellan DJ, Nigam A, Arnold M, Starr AZ, Hill J, Fletcher G, Ellis SJ, Cooper L, Onwuanyi A, Chandler B, Keteyian SJ, Ewald G, Kao A, Gheorghiade M. Benefit of exercise therapy for systolic heart failure in relation to disease severity and etiology-findings from the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise Training study. Am Heart J. 2011 Dec;162(6):1003-10. doi: 10.1016/j.ahj.2011.09.017.

ReferenceCitation: O'Connor CM, Whellan DJ, Wojdyla D, Leifer E, Clare RM, Ellis SJ, Fine LJ, Fleg JL, Zannad F, Keteyian SJ, Kitzman DW, Kraus WE, Rendall D, Pina IL, Cooper LS, Fiuzat M, Lee KL. Factors related to morbidity and mortality in patients with chronic heart failure with systolic dysfunction: the HF-ACTION predictive risk score model. Circ Heart Fail. 2012 Jan;5(1):63-71. doi: 10.1161/CIRCHEARTFAILURE.111.963462. Epub 2011 Nov 23.

ReferenceCitation: Felker GM, Fiuzat M, Shaw LK, Clare R, Whellan DJ, Bettari L, Shirolkar SC, Donahue M, Kitzman DW, Zannad F, Pina IL, O'Connor CM. Galectin-3 in ambulatory patients with heart failure: results from the HF-ACTION study. Circ Heart Fail. 2012 Jan;5(1):72-8. doi: 10.1161/CIRCHEARTFAILURE.111.963637. Epub 2011 Oct 20.

ReferenceCitation: Atchley AE, Iskandrian AE, Bensimhon D, Ellis SJ, Kitzman DW, Shaw LK, Pagnanelli RA, Whellan DJ, Gardin JM, Kao A, Abdul-Nour K, Ewald G, Walsh MN, Kraus WE, O'Connor CM, Borges-Neto S; HF-ACTION Trial Nuclear Ancillary Study Investigators. Relationship of technetium-99m tetrofosmin-gated rest single-photon emission computed tomography myocardial perfusion imaging to death and hospitalization in heart failure patients: results from the nuclear ancillary study of the HF-ACTION trial. Am Heart J. 2011 Jun;161(6):1038-45. doi: 10.1016/j.ahj.2011.02.007. Epub 2011 Apr 6.

ReferenceCitation: Reed SD, Whellan DJ, Li Y, Friedman JY, Ellis SJ, Pina IL, Settles SJ, Davidson-Ray L, Johnson JL, Cooper LS, O'Connor CM, Schulman KA; HF-ACTION Investigators. Economic evaluation of the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) randomized controlled trial: an exercise training study of patients with chronic heart failure. Circ Cardiovasc Qual Outcomes. 2010 Jul;3(4):374-81. doi: 10.1161/CIRCOUTCOMES.109.907287. Epub 2010 Jun 15.

ReferenceCitation: Keteyian SJ, Isaac D, Thadani U, Roy BA, Bensimhon DR, McKelvie R, Russell SD, Hellkamp AS, Kraus WE; HF-ACTION Investigators. Safety of symptom-limited cardiopulmonary exercise testing in patients with chronic heart failure due to severe left ventricular systolic dysfunction. Am Heart J. 2009 Oct;158(4 Suppl):S72-7. doi: 10.1016/j.ahj.2009.07.014.

ReferenceCitation: Flynn KE, Lin L, Ellis SJ, Russell SD, Spertus JA, Whellan DJ, Pina IL, Fine LJ, Schulman KA, Weinfurt KP; HF-ACTION Investigators. Outcomes, health policy, and managed care: relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure. Am Heart J. 2009 Oct;158(4 Suppl):S64-71. doi: 10.1016/j.ahj.2009.07.010.

ReferenceCitation: Atchley AE, Kitzman DW, Whellan DJ, Iskandrian AE, Ellis SJ, Pagnanelli RA, Kao A, Abdul-Nour K, O'Connor CM, Ewald G, Kraus WE, Borges-Neto S; HF-ACTION Investigators. Myocardial perfusion, function, and dyssynchrony in patients with heart failure: baseline results from the single-photon emission computed tomography imaging ancillary study of the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION) Trial. Am Heart J. 2009 Oct;158(4 Suppl):S53-63. doi: 10.1016/j.ahj.2009.07.009.

ReferenceCitation: Felker GM, Whellan D, Kraus WE, Clare R, Zannad F, Donahue M, Adams K, McKelvie R, Pina IL, O'Connor CM; HF-ACTION Investigators. N-terminal pro-brain natriuretic peptide and exercise capacity in chronic heart failure: data from the Heart Failure and a Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) study. Am Heart J. 2009 Oct;158(4 Suppl):S37-44. doi: 10.1016/j.ahj.2009.07.011.

ReferenceCitation: Horwich TB, Leifer ES, Brawner CA, Fitz-Gerald MB, Fonarow GC; HF-ACTION Investigators. The relationship between body mass index and cardiopulmonary exercise testing in chronic systolic heart failure. Am Heart J. 2009 Oct;158(4 Suppl):S31-6. doi: 10.1016/j.ahj.2009.07.016.

ReferenceCitation: Russell SD, Saval MA, Robbins JL, Ellestad MH, Gottlieb SS, Handberg EM, Zhou Y, Chandler B; HF-ACTION Investigators. New York Heart Association functional class predicts exercise parameters in the current era. Am Heart J. 2009 Oct;158(4 Suppl):S24-30. doi: 10.1016/j.ahj.2009.07.017.

ReferenceCitation: Pina IL, Kokkinos P, Kao A, Bittner V, Saval M, Clare B, Goldberg L, Johnson M, Swank A, Ventura H, Moe G, Fitz-Gerald M, Ellis SJ, Vest M, Cooper L, Whellan D; HF-ACTION Investigators. Baseline differences in the HF-ACTION trial by sex. Am Heart J. 2009 Oct;158(4 Suppl):S16-23. doi: 10.1016/j.ahj.2009.07.012.

ReferenceCitation: Whellan DJ, Ellis SJ, Kraus WE, Hawthorne K, Pina IL, Keteyian SJ, Kitzman DW, Cooper L, Lee K, O'Connor CM. Method for establishing authorship in a multicenter clinical trial. Ann Intern Med. 2009 Sep 15;151(6):414-20. doi: 10.7326/0003-4819-151-6-200909150-00006.

ReferenceCitation: Flynn KE, Pina IL, Whellan DJ, Lin L, Blumenthal JA, Ellis SJ, Fine LJ, Howlett JG, Keteyian SJ, Kitzman DW, Kraus WE, Miller NH, Schulman KA, Spertus JA, O'Connor CM, Weinfurt KP; HF-ACTION Investigators. Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1451-9. doi: 10.1001/jama.2009.457. Erratum In: JAMA. 2009 Dec 2;302(21):2322.

ReferenceCitation: O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Pina IL; HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50. doi: 10.1001/jama.2009.454.

collaborators: National Heart, Lung, and Blood Institute (NHLBI)

location_facility: Mid America Heart Institute-Saint Luke's Hospital

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: University of Medicine & Dentistry of New Jersey

location_facility: Ahmanson-University of California Los Angeles

location_facility: University of Colorado Health Sciences Center

location_facility: University of Oklahoma Health Sciences Center

location_facility: University of North Carolina School of Medicine

location_facility: University of California, Davis Medical Center

location_facility: Washington University School of Medicine

location_facility: University of California at San Diego Medical Center

location_facility: Heart and Vascular Clinic of Northern Colorado

location_facility: University of Manitoba Health Sciences Center

location_facility: Wake Forest University School of Medicine


title: A Randomized, Open-Label Study of 800 Mg Lopinavir/200 Mg Ritonavir QD in Combination With Tenofovir and Emtricitabine Vs. 400 Mg Lopinavir /100 Mg Ritonavir BID in Combination With Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects

summary: The purpose of this study is to compare the safety, tolerability and antiviral activity between once-daily (QD) and twice-daily (BID) dosing of lopinavir/ritonavir and to further characterize the pharmacokinetics of once-daily dosing of lopinavir/ritonavir.

ReferenceCitation: Podsadecki TJ, Vrijens BC, Tousset EP, Rode RA, Hanna GJ. Decreased adherence to antiretroviral therapy observed prior to transient human immunodeficiency virus type 1 viremia. J Infect Dis. 2007 Dec 15;196(12):1773-8. doi: 10.1086/523704.

lead_sponsor: Abbott

location_country:
Germany
United Kingdom
Singapore
Australia
United States
Spain
France

location_facility: Associates in Medical and Mental Health, P.C.

location_facility: Ground Zero Medical Centre / AIDS Research Initiative

location_facility: AIDS Research Consortium of Atlanta Inc.

location_facility: Infectious Disease Research Institute, Inc.

location_facility: St. Stephen's Centre Chelsea & Westminster Hospital

location_facility: Orange County Center for Special Immunology

location_facility: Treasure Coast Infectious Disease Consultants

location_facility: AIDS Healthcare Foundation Research Center

location_facility: Morris, Sklaver, Mestre & Denney, M.D., PA

location_facility: Klinik I fur Innere Medizin der Universitat zu Koln

location_facility: The Caldecot Centre King's Healthcare NHS Trust


title: An Open Label, Phase II Study of Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART

summary: The purpose of this study is to study amprenavir/ritonavir, saquinavir/ritonavir or efavirenz in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first protease inhibitor based HAART.

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Brazil
United States
Spain
Canada
Puerto Rico
France

location_facility: State University of New York at Stony Brook

location_facility: AIDS Research Consortium of Atlanta, Inc.

location_facility: Montreal Chest Institute/Royal Victoria Hospital

location_facility: Groupe Hospitalier Cochin -Saint-Vincent-de-Paul La Roche-Guyon

location_facility: 20th Avenue Medical Center Kaiser Permanente

location_facility: Tower Infectious Diseases Medical Associates

location_facility: University of Colorado Health Sciences Center

location_facility: C.H.U. Brabois - Tour Drouet, Rue du Morvan

location_facility: AIDS Health Care Foundation - Research Center

location_facility: Institut fur Immunologie Pathologie und Molekularbiologie

location_facility: Toronto General Hospital Division of The University Health Network


title: An Open Label, Phase II Study of Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra (Lopinavir/Ritonavir) as Their Second Protease Inhibitor.

summary: The purpose of this study is to study the safety and efficacy of Amprenavir/ritonavir or saquinavir/ritonavir in HIV infected patients that have failed Kaletra as their second protease inhibitor based HAART.

location_country:
Italy
Poland
United Kingdom
Argentina
Brazil
United States
Spain
Canada
Puerto Rico
France

location_facility: Infectious Disease Research Institute, Inc.

location_facility: Hospital do Servidor Publico Estadual de Sao Paulo

location_facility: III Infectious Diseases Division IRCCS "L. Spallanzani"

location_facility: Service du C.I.S.I.H. - C.H.U. de Grenoble


title: Temozolomide Versus Temozolomide + Whole Brain Radiation In Stage IV Melanoma Patients With Asymptomatic Brain Metastases

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if chemotherapy is more effective with or without radiation therapy in treating brain metastases.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy to the brain in treating patients who have stage IV melanoma with asymptomatic brain metastases.

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

location_country:
Germany
Italy
Portugal
Norway
United Kingdom
Netherlands
Austria
Belgium
Switzerland
Czech Republic
France

location_facility: Clatterbridge Centre for Oncology NHS Trust

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

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Federal Armed Forces Hospital of Ulm - Department of Dermatology

location_facility: Centre Hospital Regional Universitaire de Limoges


title: Phase I and Pharmacokinetics Study to Determine the Safety of CHS 828 in Patients With a Solid Tumor on a Single Oral Dose Repeated Every 3 Weeks

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of CHS 828 in treating patients who have solid tumors.

status: Withdrawn

ReferenceCitation: Ravaud A, Cerny T, Terret C, Wanders J, Bui BN, Hess D, Droz JP, Fumoleau P, Twelves C. Phase I study and pharmacokinetic of CHS-828, a guanidino-containing compound, administered orally as a single dose every 3 weeks in solid tumours: an ECSG/EORTC study. Eur J Cancer. 2005 Mar;41(5):702-7. doi: 10.1016/j.ejca.2004.12.023.

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

location_country:
Germany
Norway
United Kingdom
Denmark
Netherlands
Austria
Belgium
Switzerland
France

location_facility: Universitaetsklinik und Strahlenklinik - Essen

location_facility: Herlev Hospital - University Hospital of Copenhagen


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined With Ruxolitinib in Janus-associated Kinase Inhibitor (JAKi) Treatment-Naïve Myelofibrosis (MF) Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib

summary: This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib.

study_start_date_type: Actual

lead_sponsor: Telios Pharma, Inc.

location_country:
Germany
Italy
Poland
United States
Spain
France

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia


acronym: ALKALINE

summary:
This study includes patients diagnosed with a metastatic non small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) translocation. The standard treatment for patients with metastatic non small cell lung cancer with ALK translocation is represented by personalized treatment with drugs called ALK inhibitors. During the treatment with an ALK inhibitor, the tumour can start to grow again, because the tumour adapts to the drug and develops escape mechanisms, becoming resistant. At the tumour cells level, the mechanisms underlying resistance can include the development of other alterations, mainly mutations, including in the ALK gene. The alterations that developed depend on the drug the tumour has been exposed to.

The alterations can be identified by analysing tumour tissue obtained through a biopsy, however, repeating a tumour biopsy is difficult and risky and might not be able to provide sufficient tissue for the test. Therefore in the last years, new tests have been developed to identify the mutations in the blood.

Lorlatinib is a drug that inhibits ALK and has already been identified to be able to control the tumour growth when ALK mutations are identified and is already approved as standard treatment after progression to a previous treatment with ALK inhibitors.

The purpose of this study is to identify which patient populations may benefit most from treatment with lorlatinib, based on the alterations found in their genes.

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol

location_facility: CHU-UCL Namur - CHU Mont Godinne - UCL Namur

location_facility: Institut Jules Bordet-Hopital Universitaire ULB

location_facility: Assistance Publique Hopitaux Paris - Hopital Avicenne

location_facility: Clinica Universidad de Navarra - Clinica Universitaria De Navarra

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centre Hopitalier Intercommunal De Creteil

location_facility: Oslo University Hospital - Radiumhospitalet

status: Active, not recruiting

title: Activity of Lorlatinib Based on ALK Resistance Mutations on Blood in ALK Positive NSCLC Patients Previously Treated With 2nd Generation ALK Inhibitor

type: EudraCT Number

source: euctr

location_country:
Norway
United Kingdom
Netherlands
Belgium
Spain
Jordan
France

ipd_sharing: No


title: A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer

summary: This is a study consisting of four cohorts in this setting. In Cohort 1, the safety and efficacy of ipatasertib (ipat) in combination with atezolizumab (atezo) and paclitaxel (pac) or nab-paclitaxel will be evaluated for participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not previously received chemotherapy. In Cohort 2, ipatasertib and atezolizumab (with no chemotherapy), will be administered to participants with locally advanced or metastatic TNBC. In Cohort 3, the safety and efficacy of neoadjuvant ipatasertib, atezolizumab, doxorubicin and cyclophosphamide (AC) (Ipat + Atezo + AC) followed by Ipat + Atezo + Pac will be evaluated in participants with locally advanced Type 2-4 (T2-4) TNBC. In Cohort 4, the safety and efficacy of Ipat + Atezo + Pac will be evaluated in participants with PD-L1 (Programmed Death-Ligand-1) positive locally advanced or metastatic TNBC that is not amenable to resection and who have not previously received chemotherapy in the advanced setting.

location_country:
United Kingdom
Australia
United States
Spain
France

location_facility: Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: St Vincents Hospital; Cardiopulmonary transplant Ambulatory Care Dept


title: Randomised, Double-blind, Placebo-controlled (Within Dose Groups) and Active Controlled (Eplerenone Group) Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Oral Doses of BI 690517 Over 28 Days in Female and Male Patients With Diabetic Nephropathy

summary:
The primary objective of this current trial is to investigate the safety and tolerability of 3 oral doses of BI 690517 over 28 days in female and male patients with diabetic nephropathy as add-on-therapy to Angiotensin Converting Enzyme inhibitor [ACEi] or Angiotensin-receptor blockers [ARB].

Secondary objective is to evaluate the change from baseline in Urine Albumin-to-Creatinine Ratio [UACR].

location_country:
Germany
Portugal
Slovakia
United Kingdom
Denmark
Sweden
Spain
Greece
Russian Federation
France

location_facility: Copenhagen University Hospital, Rigshospitalet

location_facility: APDP - Associação Protectora dos Diabéticos de Portugal

location_facility: Profil Institut für Stoffwechselforschung GmbH

location_facility: Nonstate Private Healthcare Institution "Scientific Clinical Center of LLC Russian Railways"

location_facility: City Clinical Hospital named after V.P. Demikhova Department of Health of Moscow

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Iatriko of Athens Group/ Iatriko of P. Faliro

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: University General Hospital of Thessaloniki AHEPA

location_facility: Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António


title: A Multicentre, Double Blind, Randomised, Placebo-controlled, Phase II Trial to Evaluate Resminostat for Maintenance Treatment of Patients With Advanced Stage (Stage IIB-IVB) Mycosis Fungoides (MF) or Sézary Syndrome (SS) That Have Achieved Disease Control With Systemic Therapy - the RESMAIN Study

acronym: RESMAIN

summary: The purpose of this study is to determine whether resminostat will be able to delay or prevent worsening of disease in patients with advanced stage mycosis fungoides or Sézary Syndrome that have recently achieved disease control with previous systemic therapy.

ReferenceCitation: Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

publisher_dissemination: Wiley

lead_sponsor: 4SC AG

location_country:
Germany
Italy
Poland
United Kingdom
Japan
Netherlands
Austria
Belgium
Switzerland
Spain
Greece
France

location_facility: Niigata University Medical and Dental Hospital

location_facility: Klinikum der Stadt Ludwigshafen am Rhein

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Uni. Nuestra Senora de Candelaria

location_facility: Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital

location_facility: ATTIKON Hospital and Cutaneous Lymphoma Clinic

location_facility: St John's Institute Of Dermatology - Guy's & St Thomas' Nhs Foundation Trust

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Saint-André

location_facility: Uniwersytecki Szpital Kliniczny im. WAM - CSW

location_facility: Universitaetsklinikum Schleswig-Holstein (UKSH), Campus Kiel

location_facility: Centre hospitalier universitaire vaudois (CHUV)

location_facility: Universitaetsklinikum Bochum - St. Josef-Hospital

location_facility: Leids Universitair Medisch Centrum (LUMC)


title: Historical Case Record Survey of Visual Acuity Data From Patients With Leber's Hereditary Optic Neuropathy (LHON)

summary: The purpose of this survey is to collect visual acuity data from patients with LHON in order to establish the clinical course (natural history) and visual acuity outcomes in patients with a genetically confirmed diagnosis of LHON. In addition, this survey will generate data that will serve as comparator for the open-label study SNT-IV-006.

time_perspective: Retrospective

lead_sponsor: Santhera Pharmaceuticals

location_country:
Germany
Italy
Norway
United Kingdom
Netherlands
Belgium
France

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Fondation Ophtalmologique Adolphe de Rothschild


title: A Phase 1 Trial to Investigate the Safety, Pharmacokinetic Profiles and the Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Relapsed/Refractory Hematologic Malignancies

summary: This study evaluates the efficacy, safety and pharmacokinetics of tinostamustine (EDO-S101) in patients with relapsed/refractory hematologic malignancies. All patients will receive tinostamustine.

ipd_sharing: Yes

ipd_sharing_description: relevant patient listing data of de-identified patients may be reviewed

lead_sponsor: Mundipharma Research Limited

location_country:
Germany
Italy
Netherlands
Switzerland
United States
Spain
France

location_facility: University Hospitals Cleveland Seidman Cancer Center

location_facility: Institut Català d'Oncologia de Barcelona

location_facility: Institute of Hematology "L. A. Seràgnoli", University of Bologna

location_facility: National Cancer Institute, Fondazione 'G. Pascale'

location_facility: University Hospital of Ulm, Department of Internal Medicine III

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: CHU ESTAING Service de thérapie Cellulaire et hématologique Clinique


lead_sponsor: Novartis Pharmaceuticals

summary: Estimate the maximum tolerated dose and/or recommended phase II dose and efficacy of FGF401 as single agent and in combination with PDR001 in patients with hepatocellular carcinoma and as single agent in patients with other solid malignancies based on RECIST 1.1.

ReferenceCitation: Chan SL, Schuler M, Kang YK, Yen CJ, Edeline J, Choo SP, Lin CC, Okusaka T, Weiss KH, Macarulla T, Cattan S, Blanc JF, Lee KH, Maur M, Pant S, Kudo M, Assenat E, Zhu AX, Yau T, Lim HY, Bruix J, Geier A, Guillen-Ponce C, Fasolo A, Finn RS, Fan J, Vogel A, Qin S, Riester M, Katsanou V, Chaudhari M, Kakizume T, Gu Y, Porta DG, Myers A, Delord JP. A first-in-human phase 1/2 study of FGF401 and combination of FGF401 with spartalizumab in patients with hepatocellular carcinoma or biomarker-selected solid tumors. J Exp Clin Cancer Res. 2022 Jun 2;41(1):189. doi: 10.1186/s13046-022-02383-5.

ReferenceCitation: Castanon Alvarez E, Giallombardo M, Gil-Bazo I, Papadimitriou K, Pauwels P, Peeters M, Rolfo C. Looking into the "Garden of the Hesperides": new drugs for hepatocellular carcinoma. Minerva Chir. 2015 Apr;70(2):119-29. Epub 2015 Jan 23.

location_facility: Massachusetts General Hospital Oncology Dept

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University of California at Los Angeles Santa Monica Location

title: A Phase I/II, Multicenter, Open-label Study of Oral FGF401 in Adult Patients With Hepatocellular Carcinoma or Solid Malignancies Characterized by Positive FGFR4 and KLB Expression

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

location_country:
Germany
Italy
Hong Kong
Singapore
Japan
United States
China
Korea, Republic of
Spain
Taiwan
France


title: A Cross-sectional Study of Patients With Immune Thrombocytopenic Purpura and Caregivers to Estimate the Proportion Who Administer Romiplostim Correctly After Receipt of Home Administration Training Materials

summary: Cross-sectional study, observation made by healthcare professionals of subjects or caregivers, administering romiplostim at their first standard-of-care visit 4 weeks after training with the home administration training pack. Further observations can also be recorded in the study if made within 16 weeks of enrolment. Data will be collected from the subjects' dose diary at their first standard of care visit to ensure there were no problems with administration while not at the clinic.

time_perspective: Prospective

lead_sponsor: Amgen

location_country:
Germany
United Kingdom
Netherlands
Austria
Belgium
Spain
Greece
France


title: A Sequential Two Phase Multicenter, Randomized Study to Optimize Dose Selection and Evaluate Safety After Treatment With the Holaira™ Lung Denervation System in Patients With Moderate to Severe COPD.

acronym: AIRFLOW

summary: The purpose of this study is to evaluate safety of Targeted Lung Denervation (or TLD) in patients suffering from moderate to severe COPD. It is hypothesized that TLD will have a similar safety profile and improved physiological and functional outcomes to a sham-control.

ReferenceCitation: Valipour A, Shah PL, Herth FJ, Pison C, Schumann C, Hubner RH, Bonta PI, Kessler R, Gesierich W, Darwiche K, Lamprecht B, Perez T, Skowasch D, Deslee G, Marceau A, Sciurba FC, Gosens R, Hartman JE, Conway F, Duller M, Mayse M, Norman HS, Slebos DJ; AIRFLOW-2 Trial Study Group. Two-Year Outcomes for the Double-Blind, Randomized, Sham-Controlled Study of Targeted Lung Denervation in Patients with Moderate to Severe COPD: AIRFLOW-2. Int J Chron Obstruct Pulmon Dis. 2020 Nov 5;15:2807-2816. doi: 10.2147/COPD.S267409. eCollection 2020.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repositories_concat: PubMed Central;pure.rug.nl

publisher_dissemination: Informa

ReferenceCitation: Slebos DJ, Shah PL, Herth FJF, Pison C, Schumann C, Hubner RH, Bonta PI, Kessler R, Gesierich W, Darwiche K, Lamprecht B, Perez T, Skowasch D, Deslee G, Marceau A, Sciurba FC, Gosens R, Hartman JE, Srikanthan K, Duller M, Valipour A; AIRFLOW-2 Study Group. Safety and Adverse Events after Targeted Lung Denervation for Symptomatic Moderate to Severe Chronic Obstructive Pulmonary Disease (AIRFLOW). A Multicenter Randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2019 Dec 15;200(12):1477-1486. doi: 10.1164/rccm.201903-0624OC.

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: 4 institutions : Université de Strasbourg, Université de Haute Alsace, INSA Strasbourg, Bibliothèque Nationale et Universitaire de Strasbourg - univOAK

repository_normalized: univOAK

repositories:
PubMed Central
pure.rug.nl
univOAK

repositories_concat: PubMed Central;pure.rug.nl;univOAK

publisher_dissemination: American Thoracic Society

lead_sponsor: Nuvaira, Inc.

location_country:
Germany
United Kingdom
Netherlands
Austria
Belgium
France

location_facility: AKH Allgemeines Krankenhaus der Stadt Linz GmbH

location_facility: CHU de Paris - Hopital Bichat Claude Bernard

location_facility: Ruhrlandklinik - West German Lung Center

intervention_type: Device


title: Randomized, Controlled, Open Label, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of CetuGEX™ Plus CT in Comparison to Cetuximab Plus CT in Patients With Stage III/IV Recurrent and/or Metastatic SCCHN

acronym: RESGEX

summary: The aim of the study is to evaluate the efficacy of CetuGEX™ for the treatment of patients with stage III/IV recurrent and/or metastatic SCCHN as compared to cetuximab (both in combination with platinum-based chemotherapy) in terms of progression-free survival (PFS).

lead_sponsor: Glycotope GmbH

location_country: Germany Italy Poland Romania Belgium Spain France

location_facility:
Glycotope-contracted Research Facility
Gycotope-contracted Research Facility
Glycotope-contracted Research Facillity
Glycotope-contracteed Research Facility


title: IntErnational Non-randomized, Single-arm, Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN

acronym: EnligHTN-II

summary: The purpose of this post market clinical investigation is to further evaluate the safety and performance of the EnligHTN™ Renal Denervation System in the treatment of patients with uncontrolled hypertension.

lead_sponsor: Abbott Medical Devices

location_country:
Germany
Italy
New Zealand
Norway
United Kingdom
Australia
Sweden
Netherlands
Spain
Greece
France

location_facility: Hopital Civil - Universitaires de Strasbourg

location_facility: University of Athens, Ippocration Hospital

location_facility: Uni-Klinik Leipzig, Intervent. Angiologie

location_facility: Institute Cardio. Paris-Sud-Institut Jacques Cartier

location_facility: Sahlgrenska University Hospital Gothenburg

location_facility: Universitats-Herzzentrum Freiburg - Bad Krozingen

location_facility: Fondazione Toscana Gabriele Monasterio CNR

location_facility: NIHR Barts Cardiovascular Biomedical Research Unit


summary: This was a multicenter, open label, randomized phase II study to evaluate the efficacy and safety of BEZ235 as compared to everolimus in patients with advanced, low to intermediate grade pancreatic neuroendocrine tumor (pNET).

ReferenceCitation: Salazar R, Garcia-Carbonero R, Libutti SK, Hendifar AE, Custodio A, Guimbaud R, Lombard-Bohas C, Ricci S, Klumpen HJ, Capdevila J, Reed N, Walenkamp A, Grande E, Safina S, Meyer T, Kong O, Salomon H, Tavorath R, Yao JC. Phase II Study of BEZ235 versus Everolimus in Patients with Mammalian Target of Rapamycin Inhibitor-Naive Advanced Pancreatic Neuroendocrine Tumors. Oncologist. 2018 Jul;23(7):766-e90. doi: 10.1634/theoncologist.2017-0144. Epub 2017 Dec 14.

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

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

repository_normalized: dnet

repositories:
PubMed Central
UCL Discovery
dnet
escholarship.org

publisher_dissemination: Oxford University Press

location_facility:
Cedars Sinai Medical Center SC-3
University of Colorado Univ Colorado
Montefiore Medical Center SC
Novartis Investigative Site
University of Kentucky Univ Kebtucky

title: Randomized Phase II Study of BEZ235 or Everolimus in Advanced Pancreatic Neuroendocrine Tumors

location_country:
Italy
United Kingdom
Netherlands
Switzerland
United States
Spain
Russian Federation
France


title: REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance

summary: The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

ReferenceCitation: Meredith IT, Walters DL, Dumonteil N, Worthley SG, Tchetche D, Manoharan G, Blackman DJ, Rioufol G, Hildick-Smith D, Whitbourn RJ, Lefevre T, Lange R, Muller R, Redwood S, Feldman TE, Allocco DJ, Dawkins KD. 1-Year Outcomes With the Fully Repositionable and Retrievable Lotus Transcatheter Aortic Replacement Valve in 120 High-Risk Surgical Patients With Severe Aortic Stenosis: Results of the REPRISE II Study. JACC Cardiovasc Interv. 2016 Feb 22;9(4):376-384. doi: 10.1016/j.jcin.2015.10.024.

repository_institution: Monash University - Monash University Research Portal

ReferenceCitation: Meredith Am IT, Walters DL, Dumonteil N, Worthley SG, Tchetche D, Manoharan G, Blackman DJ, Rioufol G, Hildick-Smith D, Whitbourn RJ, Lefevre T, Lange R, Muller R, Redwood S, Allocco DJ, Dawkins KD. Transcatheter aortic valve replacement for severe symptomatic aortic stenosis using a repositionable valve system: 30-day primary endpoint results from the REPRISE II study. J Am Coll Cardiol. 2014 Sep 30;64(13):1339-48. doi: 10.1016/j.jacc.2014.05.067.

oa_host_type: publisher

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Italy
United Kingdom
Australia
Sweden
Netherlands
Switzerland
Spain
France

location_facility: Guys and St. Thomas NHS Foundation Trust


title: A Phase-II, Double-blind, Placebo-controlled, Randomised, Parallel-group,Multi-centre Study to Assess the Efficacy and Safety of Two Staggered Dose Levels of Inhaled Once Daily AZD5423 or Twice Daily Budesonide for 12 Weeks in COPD Patients on a Background Therapy of Formoterol.

summary: The purpose of the study is to assess the efficacy and safety of two staggered dose levels of inhaled once daily AZD5423 or twice daily budesonide for 12 weeks in COPD patients on a background therapy of formoterol.

lead_sponsor: AstraZeneca

location_country:
Italy
Poland
Slovakia
Hungary
Bulgaria
Ukraine
Russian Federation
France


type: Registry Identifier

title: A Randomized, Double Blind, Placebo Controlled Phase II Trial to Evaluate the Safety and Efficacy of recMAGE-A3 + AS15 ASCI in Patients With MAGE-A3 Positive Muscle Invasive Bladder Cancer After Cystectomy

acronym: MAGNOLIA

summary: The purpose of this clinical trial was to demonstrate the benefit of the immunotherapeutic product recMAGE-A3 + AS-15 given to patients with bladder cancer after removal of the bladder. A course of 13 injections was administered over 27 months.

ReferenceCitation: Colombel M, Heidenreich A, Martinez-Pineiro L, Babjuk M, Korneyev I, Surcel C, Yakovlev P, Colombo R, Radziszewski P, Witjes F, Schipper R, Mulders P, Witjes WP. Perioperative chemotherapy in muscle-invasive bladder cancer: overview and the unmet clinical need for alternative adjuvant therapy as studied in the MAGNOLIA trial. Eur Urol. 2014 Mar;65(3):509-11. doi: 10.1016/j.eururo.2013.10.056. Epub 2013 Nov 11.

lead_sponsor: European Association of Urology Research Foundation

location_country:
Germany
Italy
Poland
Romania
Netherlands
Spain
Czechia
Ukraine
Russian Federation
France

location_facility: Universitaria Policlinico Consorziale di Bari

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Clinical County Emergency Hospital Craiova

location_facility: Federal State Institution "Moscow Research Oncology Institute named after P.A. Gertsen" of the Ministry of Healthcare and Social Development of the Russian Federation

location_facility: Municipal Budget Institution of Health Care "Clinical Diagnostic Center "Zdorovie" of Rostov-on-Don city"

location_facility: Universitätsklinikum C.-G. Carus Dresden

location_facility: Federal State Budget Institution "Scientific Research Institute of Urology" of the Ministry of Healthcare and Social Development of the Russian Federation

location_facility: Institution of the Russian Academy of Medical Science Russian Oncology Research Center named after N.N. Blokhin of RAMS

location_facility: Oddzial Urologii Miedzyleski Szpital Specjalistyczny w Warszawie

location_facility: Hospital 12 de Octubre, Fundación de Investigación Biomédica

location_facility: Kliniczny Dzial Urologii Swietokrzyskiego Centrum Onkologii

location_facility: Hospital Universitario Principe de Asturias

location_facility: Hospital Universitario Central de Asturias

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

location_facility: Saint Petersburg State Institution of Health Care "City Multi-Field Hospital #2"

intervention_type: Biological


title: ALternate Site Cardiac ReSYNChronization Study

acronym: ALSYNC

summary:
The ALternate site cardiac reSYNChronization (ALSYNC) study, a non-comparative, prospective, non-randomized, multi-national clinical investigation.

The purpose of this clinical investigation is to evaluate the safety and performance of the investigational atrial transseptal endocardial LV lead delivery system and the implant procedure for delivering the SelectSecure® Model 3830 lead into the Left Ventricle via a superior approach, and to evaluate the performance of the SelectSecure® Model 3830 lead in the Left Ventricle.

ReferenceCitation: Biffi M, Defaye P, Jais P, Ruffa F, Leclercq C, Gras D, Yang Z, Gerritse B, Ziacchi M, Morgan JM; ALSYNC Investigators. Benefits of left ventricular endocardial pacing comparing failed implants and prior non-responders to conventional cardiac resynchronization therapy: A subanalysis from the ALSYNC study. Int J Cardiol. 2018 May 15;259:88-93. doi: 10.1016/j.ijcard.2018.01.030.

ReferenceCitation: Morgan JM, Biffi M, Geller L, Leclercq C, Ruffa F, Tung S, Defaye P, Yang Z, Gerritse B, van Ginneken M, Yee R, Jais P; ALSYNC Investigators. ALternate Site Cardiac ResYNChronization (ALSYNC): a prospective and multicentre study of left ventricular endocardial pacing for cardiac resynchronization therapy. Eur Heart J. 2016 Jul 14;37(27):2118-27. doi: 10.1093/eurheartj/ehv723. Epub 2016 Jan 18.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Italy
Hungary
United Kingdom
Netherlands
Belgium
Canada
France

location_facility: London Health Sciences Centre - University Campus

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant' Orsola - Malpighi

location_facility: Azienda Complesso Ospedaliero San Filippo Neri Ospedale San Filippo Neri

location_facility: University College London Hospitals NHS Foundation Trust - The Heart Hospital


summary: This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).

ReferenceCitation: Ceklic L, Wolf-Schnurrbusch U, Gekkieva M, Wolf S. Visual acuity outcome in RADIANCE study patients with dome-shaped macular features. Ophthalmology. 2014 Nov;121(11):2288-9. doi: 10.1016/j.ophtha.2014.06.012. Epub 2014 Aug 8. No abstract available.

ReferenceCitation: Wolf S, Balciuniene VJ, Laganovska G, Menchini U, Ohno-Matsui K, Sharma T, Wong TY, Silva R, Pilz S, Gekkieva M; RADIANCE Study Group. RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia. Ophthalmology. 2014 Mar;121(3):682-92.e2. doi: 10.1016/j.ophtha.2013.10.023. Epub 2013 Dec 8.

title: A 12 Month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Different Dosing Regimens of 0.5 mg Ranibizumab vs. Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

location_country:
Germany
Poland
Japan
Turkey
Canada
France
Lithuania
Portugal
Slovakia
Hungary
Hong Kong
Switzerland
Latvia
India
Italy
United Kingdom
Singapore
Austria
Korea, Republic of
Spain


title: A Multicener, Randomised, Double-blind, Placebo-controlled Study, to Assess the Long Term Safety of 52 Weeks Treatment With QVA149 (110 ug Indacaterol/50ug Glycopyrrolate) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

acronym: ENLIGHTEN

summary: The study is designed to provide long-term safety data for QVA149 in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

ReferenceCitation: Buhl R, Gessner C, Schuermann W, Foerster K, Sieder C, Hiltl S, Korn S. Efficacy and safety of once-daily QVA149 compared with the free combination of once-daily tiotropium plus twice-daily formoterol in patients with moderate-to-severe COPD (QUANTIFY): a randomised, non-inferiority study. Thorax. 2015 Apr;70(4):311-9. doi: 10.1136/thoraxjnl-2014-206345. Epub 2015 Feb 12.

publisher_dissemination: British Medical Journal

ReferenceCitation: Dahl R, Chapman KR, Rudolf M, Mehta R, Kho P, Alagappan VK, Chen H, Banerji D. Safety and efficacy of dual bronchodilation with QVA149 in COPD patients: the ENLIGHTEN study. Respir Med. 2013 Oct;107(10):1558-67. doi: 10.1016/j.rmed.2013.05.016. Epub 2013 Jul 16.

location_country:
Lithuania
India
Hungary
United Kingdom
Romania
Korea, Republic of
Latvia
South Africa
Canada
France


acronym: LEIDA

lead_sponsor: MEDA Pharma GmbH & Co. KG

summary: This clinical trial serves the purpose to compare the long-term effects of a treatment of actinic keratosis - your skin disorder - using Aldara® 5% cream or Solaraze® 3% gel on the face or the scalp. In particular, it should be found out whether the healing effect of these two medications on the skin lesions (i.e. the damaged skin parts) can be maintained for a prolonged period.

location_facility: Clinic and Medical Faculty of Johann Wolfgang Goethe-University, Center for Dermatology and Venereology

location_facility: Medical Department of Otto-von-Guericke-University Magdeburg, University Clinic for Dermatology and Venereology

location_facility: Department of Dermatology J. Gutenberg-University Mainz, Clinical Research Center

location_facility: University Clinic Düsseldorf, Clinic for Dermatology

location_facility: University Clinic Schleswig-Holstein, Campus Kiel, Clinic for Dermatology, Venereology and Allergology

location_facility: University Clinic Münster, Clinic and Polyclinic for Skin Diseases

location_facility: Medical University Innsbruck, University Clinic for Dermatology and Venereology

location_facility: Medical University Vienna, Department for General Dermatology

location_facility: CHU St Jacques, Department for Dermatology

location_facility: Hospital Sainte Marguerite, Department for Dermatology and Venereology, Pavilion 3, First Floor

location_facility: CHU Nice - Hospital Archet 2, Department for Dermatology

location_facility: Hospital Center Lyon South, Department for Dermatology and Immuno-Allergology

location_facility: Clinic University Regensburg, Clinic and Polyclinic for Dermatology

location_facility: Hospital Saint-Louis, Derpartment for Dermatology

location_facility: Charite - Medicine University Berlin, Dermatoma Center, Clinic for Dermatology, Allergology and Venereology

location_facility: Hospital Feldkirch, Department for Dermatology and Venereology

location_facility: Medical University Graz, University Clinic for Dermatology and Venereology

location_facility: Science, Onco & Beauty GbR, Practice for Dermatology and Medical Cosmetics

location_facility: Medical practice for Dermatology and Venerology

title: Long-term Effects of Aldara® 5% Cream and Solaraze® 3% Gel in the Treatment of Actinic Keratoses on the Face or Scalp (LEIDA)

location_country: Germany Austria France


title: Phase IIIb/IV Randomized, Controlled Study Evaluating an Intensification Treatment Strategy of Adding Enfuvirtide (ENF) to an Oral Highly Active AntiRetroviral Therapy (HAART) in Treatment Experienced Patients

acronym: INTENSE

summary: To assess the efficacy of enfuvirtide (Fuzeon) added to HAART compared to treatment with HAART alone in achieving and maintaining viral load suppression.

ReferenceCitation: Clotet B, Capetti A, Soto-Ramirez LE, Gatell JM, Rowell L, Salgo M, Schapiro JM. A randomized, controlled study evaluating an induction treatment strategy in which enfuvirtide was added to an oral, highly active antiretroviral therapy regimen in treatment-experienced patients: the INTENSE study. J Antimicrob Chemother. 2008 Dec;62(6):1374-8. doi: 10.1093/jac/dkn377. Epub 2008 Sep 8.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
France
Italy
Netherlands
Mexico
Switzerland
United States
Spain
Canada
Israel


title: An Open-label, Randomized, Controlled Phase-II Trial Evaluating the Efficacy and Safety of EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients

summary: The purpose of this study is to assess the efficacy, safety and tolerability of a therapy with EndoTAG-1 + paclitaxel in combination and EndoTAG-1 alone as a rescue therapy for patients with relapsed or metastatic triple receptor negative breast cancer (a special subgroup of breast cancer).

ReferenceCitation: Awada A, Bondarenko IN, Bonneterre J, Nowara E, Ferrero JM, Bakshi AV, Wilke C, Piccart M; CT4002 study group. A randomized controlled phase II trial of a novel composition of paclitaxel embedded into neutral and cationic lipids targeting tumor endothelial cells in advanced triple-negative breast cancer (TNBC). Ann Oncol. 2014 Apr;25(4):824-831. doi: 10.1093/annonc/mdu025.

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: MediGene

location_country: Poland India Romania Belgium Ukraine France

location_facility: Regional Clinical Oncological Dispensary

location_facility: Institute of Oncology "Prof. Dr. Al. Trestioreanu"

location_facility: Institute of Medical Radiology of Acedamy of Medical Sciences

location_facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

location_facility: Institute of Oncology "Prof. Dr. I. Chiricuta"

location_facility: Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles


title: A Randomized, Double-blind, Placebo Controlled, Phase IIA Study to Assess the Effect on Gastroesophageal Reflux Disease (GERD) Symptoms, Pharmacokinetics, Safety and Tolerability of 4 Weeks Treatment With AZD3355 65 mg Bid as add-on Treatment to a Proton Pump Inhibitor (PPI) in Patients With an Incomplete Response to PPI.

summary: The purpose of this study is to estimate the effect of AZD3355 as an add-on treatment to a Proton Pump Inhibitor (PPI) on Gastroesophageal reflux disease (GERD) symptoms in patients with an incomplete response to PPI treatment.

ReferenceCitation: Boeckxstaens GE, Beaumont H, Hatlebakk JG, Silberg DG, Bjorck K, Karlsson M, Denison H. A novel reflux inhibitor lesogaberan (AZD3355) as add-on treatment in patients with GORD with persistent reflux symptoms despite proton pump inhibitor therapy: a randomised placebo-controlled trial. Gut. 2011 Sep;60(9):1182-8. doi: 10.1136/gut.2010.235630. Epub 2011 Mar 14.

location_country: Germany Hungary Norway Romania Australia Netherlands Belgium France


title: A Randomized Phase 2 Study of Ompenaclid Versus Placebo in Combination With FOLFIRI Plus Bevacizumab in Patients With Previously Treated RAS Mutant Advanced or Metastatic Colorectal Cancer

summary: The purpose of this study is to measure tumor response to treatment with ompenaclid (RGX-202) in patients with previously treated RAS mutant advanced or metastatic CRC. All patients will receive treatment with FOLFIRI and bevacizumab. In addition, patients will be randomized to receive either ompenaclid 3000 mg BID or matching placebo (herein referred to as Study Drug). Each treatment cycle is 28 days in duration.

ipd_sharing: Undecided

lead_sponsor: Inspirna, Inc.

location_country: Spain Belgium France

location_facility: Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc

location_facility: Hospital Clinico Universitario De Valencia

location_facility: CHU de Liège University hospital in Liège

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Groupe Hospitalier Paris Saint Joseph - Oncologie


title: A Phase 3b Open-label Study Evaluating Physical Activity and Joint Health in Previously Treated Patients ≥12 Years With Severe Haemophilia A Treated With Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (Efanesoctocog Alfa) for 24 Months

acronym: FREEDOM

summary:
FREEDOM is a multicentre, open-label, single-arm, phase 3b study in Europe that aims to enrol approximately 90 previously treated severe haemophilia A patients aged ≥12 years, currently on prophylaxis. After a run-in period of 30-45 days, patients will receive efanesoctocog alfa prophylaxis, 50 IU/kg once-weekly for 24 months (additional preventive dose not permitted). An activity tracker and an electronic patient diary will be used to collect data on physical activity, bleeds, factor dosing, pain, and injuries from screening throughout the study.

The primary objective is to describe changes in physical activities over 24 months on efanesoctocog alfa prophylaxis, with a primary endpoint of change from baseline in International Physical Activity Questionnaire (IPAQ) at month 24.

Secondary objectives include relationship between physical activity and other variables (bleeds, joint status, pain, injuries, and quality of life); changes in joint status as assessed by HEAD-US, HJHS and MRI; occurrence of bleeds, injuries, pain. Safety and tolerability of efanesoctocog alfa will also be evaluated.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sobi's data sharing criteria and process for requesting access can be found at: https://www.sobi.com/en/policies

lead_sponsor: Swedish Orphan Biovitrum

sponsor_collaborators:
Swedish Orphan Biovitrum
Syneos Health

location_country:
Germany
Ireland
Italy
Slovenia
Norway
United Kingdom
Sweden
Netherlands
Austria
Belgium
Spain
Greece
Croatia
Czechia
France


title: A Multicenter, Single-Dose, Uncontrolled, Open-label, One Group Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Patients With Bacterial Infections

summary: The main aim of the study is to investigate the plasma pharmacokinetics (PK) and safety of intravenous (IV) administration of a single dose of 400 milligrams (mg) or 600 mg RO7223280 in critically ill participants with bacterial infections.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/innovation/process/clinical -trials/data-sharing/).

location_country:
France
United States
Korea, Republic of
Moldova, Republic of
Israel

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: The Chaim Sheba Medical Center; Multiple Sclerosis Center

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: East Carolina University (ECU) Physicians - Infectious Disease Clinic - Greenville

location_facility: ARENSIA Phase 1 Unit- Spitalul Clinic Republican Location

location_facility: Hôpitaux Universitaires de strasbourg - hôpital civil

location_facility: Centre Hospitalier Régional Universitaire de Lille


title: An Open-Label, Randomised, Phase 4 Study of Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge in Participants With Chronic Kidney Disease Treated for Hyperkalaemia

acronym: CONTINUITY

summary:
This is an open-label, randomised study in participants with chronic kidney disease (CKD) treated for hyperkalaemia (HK) whilst in hospital. The study will compare SZC to standard of care (SoC) with the goal of determining:

If continued use of SZC maintains normokalaemia (NK) better than SoC after participant discharge from the hospital.
If continued use of SZC after discharge will reduce HK related healthcare resource utilisation compared to SoC.

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 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 shared.

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
Spain
France


title: An Open-label Phase 1b/2 Study Assessing the Safety and Efficacy of Mitazalimab in Combination With Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

summary: Phase 1b/2 study to assess the safety and efficacy of mitazalimab in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma.

lead_sponsor: Alligator Bioscience AB

collaborators:
Theradex
4Pharma Ltd.

sponsor_collaborators:
Alligator Bioscience AB
Theradex
4Pharma Ltd.

location_facility: Hospital Universitario Miguel Servet, Zaragoza, Spain

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut-Lévêque,

location_facility: Hospital Universitario Ramon y Cajal, Madrid, Spain

location_facility: Hospital Universitario Virgen del Rocio, Sevilla, Spain

location_facility: Hospital Universitario Vall d'Hebron, Barcelona, Spain

location_facility: Hospital Universitario La Paz, Madrid, Spain


title: Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation (RESOLVE-MR) (Tendyne™ PMCF Study)

acronym: RESOLVE-MR

summary: To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.

location_country:
Germany
Italy
Israel
Norway
United Kingdom
Netherlands
Austria
Belgium
Switzerland
Saudi Arabia
Spain
Czechia
France

location_facility: Ludwig-Maximilians-Universität (LMU) München / Campus Großhadern

location_facility: Lancisi Cardiovascular Center - Politechnic University of Marcher

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: University Hospital Basel, Clinic for Cardiac Surgery

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel


title: A Prospective, Multinational, Multicentre, Open-label, Randomised, Non-inferiority Trial to Compare Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series vs. Contemporary Valves (Edwards's Sapien THV Series and Medtronic's Evolut THV Series) in Patients With Severe Symptomatic Native Aortic Valve Stenosis

acronym: LANDMARK

summary:
The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis.

This study will be done in total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves)

The randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series)

ReferenceCitation: Kawashima H, Soliman O, Wang R, Ono M, Hara H, Gao C, Zeller E, Thakkar A, Tamburino C, Bedogni F, Neumann FJ, Thiele H, Abdel-Wahab M, Morice MC, Webster M, Rosseel L, Mylotte D, Onuma Y, Wijns W, Baumbach A, Serruys PW. Rationale and design of a randomized clinical trial comparing safety and efficacy of myval transcatheter heart valve versus contemporary transcatheter heart valves in patients with severe symptomatic aortic valve stenosis: The LANDMARK trial. Am Heart J. 2021 Feb;232:23-38. doi: 10.1016/j.ahj.2020.11.001. Epub 2020 Nov 6.

ReferenceCitation: Kawashima H, Wang R, Mylotte D, Jagielak D, De Marco F, Ielasi A, Onuma Y, den Heijer P, Terkelsen CJ, Wijns W, Serruys PW, Soliman O. Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves. Glob Heart. 2021 Mar 19;16(1):20. doi: 10.5334/gh.959.

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

publisher_dissemination: Ubiquity Press

lead_sponsor: Meril Life Sciences Pvt. Ltd.

location_country:
Germany
Belarus
Italy
Poland
Portugal
New Zealand
Slovakia
Hungary
Slovenia
Brazil
Netherlands
Sweden
Spain
Greece
Croatia
Estonia
France

location_facility: University Herzentrum Division of Cardiology and Angiology II,University Heart Center Freiburg, Südring 15

location_facility: Republican Scientific-Practical Centre "Cardiology"

location_facility: Hospital Universitario de Gran Canaria Dr Negrin

location_facility: Centro Hospitalar Lisboa Ocidental EPE- Hospital Santa Cruz, Av. Prof. Dr. Reinaldo dos Santos

location_facility: University of Bologna Policlinico S. Orsola-Malpigh

location_facility: Hospital de Santa Maria, Av. Prof. Egas Moniz MB

location_facility: Centro Hospital Lisboa Central E.P.E. - Santa Marta

location_facility: University hospital Banska Bystrica Námestie Ludvíka Svobodu 1

location_facility: Hospital Universitari Son Espases Carretera de Valldemossa

location_facility: University Hospital Città della Salute e della Scienza Turin Bramante

location_facility: Technology University Dresden Fetscherstraße 76

location_facility: Uniwersytecki Szpital Kliniczny (USK) Curie-Skłodowskiej 58

location_facility: Asklepios Kliniken Hamburg Gmbh Lohmuehlenstrasse 5

location_facility: Centre Hospitalier Universitaire De Rennes

location_facility: University Hospital Dubrava Avenija Gojka Šuška 6

location_facility: Klinik für Herz-, Thorax- und herznahe Gefäßchirurgie, Universitätsklinikum Regensburg

location_facility: Hospital Cliinico Univertistario de Valladolid


title: A Phase 1/2, Multicenter, Open-Label, Single Arm, Dose Escalation and Expansion Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

summary:
The purpose of the phase 1 portion (dose escalation) of the study will be to establish an optimally safe and biologically active recommended phase 2 dose (RP2D) and/or to determine maximum tolerated dose (MTD) for gilteritinib in sequential combination with fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG). The purpose of the phase 2 portion (dose expansion) is to determine complete remission (CR) rates and composite complete remission (CRc) rates after two cycles of therapy. The study will also assess safety, tolerability and toxicities of gilteritinib in combination with FLAG, evaluate FLT3 inhibition, assess pharmacokinetics (PK), perform serial measurements of minimal residual disease, obtain preliminary estimates of 1-year event free survival (EFS) and overall survival (OS) rate and assess the acceptability as well as palatability of the formulation.

One cycle is defined as 28 days of treatment. A participant completing 1 or 2 treatment cycles in phase 1 or 2 will have the option to participate in long term treatment (LTT) with gilteritinib (for up to 2 years).

ReferenceCitation: Abematsu T, Nishikawa T, Shiba N, Iijima-Yamashita Y, Inaba Y, Takahashi Y, Nakagawa S, Kodama Y, Okamoto Y, Kawano Y. Pediatric acute myeloid leukemia co-expressing FLT3/ITD and NUP98/NSD1 treated with gilteritinib plus allogenic peripheral blood stem cell transplantation: A case report. Pediatr Blood Cancer. 2021 Nov;68(11):e29216. doi: 10.1002/pbc.29216. Epub 2021 Jul 10. No abstract available.

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Germany
Italy
United Kingdom
United States
Spain
Canada
France

location_facility: The Children's Hospital of Philadelphia (CHOP)

location_facility: Cincinnati Children's Hospital Medical Center