title: HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial

acronym: HIP ATTACK

summary: HIP ATTACK is an international randomized controlled trial of 3000 patients with a hip fracture that requires a surgical intervention. This trial will determine the effect of accelerated medical clearance and accelerated surgery compared to standard care on the 90-day risk of mortality and major perioperative complication (i.e., a composite of mortality, nonfatal myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal sepsis, nonfatal stroke, and nonfatal life-threatening and major bleeding).

ReferenceCitation: HIP ATTACK Investigators. Accelerated surgery versus standard care in hip fracture (HIP ATTACK): an international, randomised, controlled trial. Lancet. 2020 Feb 29;395(10225):698-708. doi: 10.1016/S0140-6736(20)30058-1. Epub 2020 Feb 9. Erratum In: Lancet. 2021 Nov 27;398(10315):1964. Lancet. 2023 Apr 1;401(10382):1078.

repository_institution: University of Nottingham - Repository@Nottingham

ReferenceCitation: Borges FK, Devereaux PJ, Cuerden M, Bhandari M, Guerra-Farfan E, Patel A, Sigamani A, Umer M, Neary J, Tiboni M, Tandon V, Ramokgopa MT, Sancheti P, John B, Lawendy A, Balaguer-Castro M, Jenkinson R, Sleczka P, Nabi Nur A, Wood GCA, Feibel R, McMahon JS, Sigamani A, Biccard BM, Landoni G, Szczeklik W, Wang CY, Tomas-Hernandez J, Abraham V, Vincent J, Harvey V, Pettit S, Sontrop J, Garg AX; HIP ATTACK investigators. Effects of accelerated versus standard care surgery on the risk of acute kidney injury in patients with a hip fracture: a substudy protocol of the hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) international randomised controlled trial. BMJ Open. 2019 Sep 24;9(9):e033150. doi: 10.1136/bmjopen-2019-033150.

repository_institution: Academy of Humanities and Economics in Lodz - Homo Politicus

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

ReferenceCitation: Borges FK, Bhandari M, Patel A, Avram V, Guerra-Farfan E, Sigamani A, Umer M, Tiboni M, Adili A, Neary J, Tandon V, Sancheti PK, Lawendy A, Jenkinson R, Ramokgopa M, Biccard BM, Szczeklik W, Wang CY, Landoni G, Forget P, Popova E, Wood G, Nabi Nur A, John B, Sleczka P, Feibel RJ, Balaguer-Castro M, Deheshi B, Winemaker M, de Beer J, Kolesar R, Teixidor-Serra J, Tomas-Hernandez J, McGillion M, Shanthanna H, Moppett I, Vincent J, Pettit S, Harvey V, Gauthier L, Alvarado K, Devereaux PJ. Rationale and design of the HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial: a protocol for an international randomised controlled trial evaluating early surgery for hip fracture patients. BMJ Open. 2019 May 1;9(4):e028537. doi: 10.1136/bmjopen-2018-028537.

repository_institution: Aberdeen University - Aberdeen University Research Archive

lead_sponsor: McMaster University

sponsor_collaborators:
McMaster University
Population Health Research Institute
Hamilton Health Sciences Corporation

location_country:
Italy
Poland
Colombia
India
United Kingdom
Hong Kong
Netherlands
Belgium
United States
China
Spain
Thailand
Malaysia
Pakistan
South Africa
Canada
France

location_facility: Sancheti Institute for Orthopaedics and Rehabilitation

location_facility: Hospital Clinico Universitario de Vallad

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej W Myślenicach

location_facility: SPZOZ Szpital Powiatowy w Bochni im M. Wieckiej

location_facility: Hamilton Health Sciences - Juravinski Hospital

location_facility: University Hospital & Educational Center of Medical University in Lodz

location_facility: Hospital Sant Camil (Consorci Sanitari Garraf)

location_facility: Victoria Hospital, London Health Sciences

location_facility: Thunder Bay Regional Health Sciences Centre

lead_sponsor_type: academique


title: MPACT Extension Study: Multicenter, Survival Data Collection in Subjects Previously Enrolled in Protocol CA046

summary: A study to collect survival data on patients previously enrolled in Abraxane pancreatic cancer study CA046.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Ramanathan RK, Goldstein D, Korn RL, Arena F, Moore M, Siena S, Teixeira L, Tabernero J, Van Laethem JL, Liu H, McGovern D, Lu B, Von Hoff DD. Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas. Ann Oncol. 2016 Apr;27(4):648-53. doi: 10.1093/annonc/mdw020. Epub 2016 Jan 22.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Chiorean EG, Von Hoff DD, Reni M, Arena FP, Infante JR, Bathini VG, Wood TE, Mainwaring PN, Muldoon RT, Clingan PR, Kunzmann V, Ramanathan RK, Tabernero J, Goldstein D, McGovern D, Lu B, Ko A. CA19-9 decrease at 8 weeks as a predictor of overall survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Ann Oncol. 2016 Apr;27(4):654-60. doi: 10.1093/annonc/mdw006. Epub 2016 Jan 22.

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

repository_institution: American Medical Association - The Journal of the American Medical Association (JAMA) Network

repository_institution: Würzburg University - Online Publication Service of Würzburg University

ReferenceCitation: Goldstein D, Von Hoff DD, Moore M, Greeno E, Tortora G, Ramanathan RK, Macarulla T, Liu H, Pilot R, Ferrara S, Lu B. Development of peripheral neuropathy and its association with survival during treatment with nab-paclitaxel plus gemcitabine for patients with metastatic adenocarcinoma of the pancreas: A subset analysis from a randomised phase III trial (MPACT). Eur J Cancer. 2016 Jan;52:85-91. doi: 10.1016/j.ejca.2015.10.017. Epub 2015 Dec 1.

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: closed

ReferenceCitation: Portal A, Pernot S, Tougeron D, Arbaud C, Bidault AT, de la Fouchardiere C, Hammel P, Lecomte T, Dreanic J, Coriat R, Bachet JB, Dubreuil O, Marthey L, Dahan L, Tchoundjeu B, Locher C, Lepere C, Bonnetain F, Taieb J. Nab-paclitaxel plus gemcitabine for metastatic pancreatic adenocarcinoma after Folfirinox failure: an AGEO prospective multicentre cohort. Br J Cancer. 2015 Sep 29;113(7):989-95. doi: 10.1038/bjc.2015.328. Epub 2015 Sep 15.

evidence: open (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

ReferenceCitation: Goldstein D, El-Maraghi RH, Hammel P, Heinemann V, Kunzmann V, Sastre J, Scheithauer W, Siena S, Tabernero J, Teixeira L, Tortora G, Van Laethem JL, Young R, Penenberg DN, Lu B, Romano A, Von Hoff DD. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: long-term survival from a phase III trial. J Natl Cancer Inst. 2015 Jan 31;107(2):dju413. doi: 10.1093/jnci/dju413. Print 2015 Feb.

ReferenceCitation: Vogel A, Pelzer U, Salah-Eddin AB, Koster W. First-line nab-paclitaxel and gemcitabine in patients with metastatic pancreatic cancer from routine clinical practice. In Vivo. 2014 Nov-Dec;28(6):1135-40.

ReferenceCitation: Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.

ReferenceCitation: Al-Hajeili M, Azmi AS, Choi M. Nab-paclitaxel: potential for the treatment of advanced pancreatic cancer. Onco Targets Ther. 2014 Feb 4;7:187-92. doi: 10.2147/OTT.S40705. eCollection 2014.

ReferenceCitation: Tabernero J, Chiorean EG, Infante JR, Hingorani SR, Ganju V, Weekes C, Scheithauer W, Ramanathan RK, Goldstein D, Penenberg DN, Romano A, Ferrara S, Von Hoff DD. Prognostic factors of survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic pancreatic cancer. Oncologist. 2015 Feb;20(2):143-50. doi: 10.1634/theoncologist.2014-0394. Epub 2015 Jan 12.

ReferenceCitation: Chiorean EG, Von Hoff DD, Tabernero J, El-Maraghi R, Ma WW, Reni M, Harris M, Whorf R, Liu H, Li JS, Manax V, Romano A, Lu B, Goldstein D. Second-line therapy after nab-paclitaxel plus gemcitabine or after gemcitabine for patients with metastatic pancreatic cancer. Br J Cancer. 2016 Jul 12;115(2):188-94. doi: 10.1038/bjc.2016.185. Epub 2016 Jun 28. Erratum In: Br J Cancer. 2016 Oct 25;115(9):e13.

ReferenceCitation: Tehfe M, Dowden S, Kennecke H, El-Maraghi R, Lesperance B, Couture F, Letourneau R, Liu H, Romano A. nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine in Patients with Metastatic Pancreatic Adenocarcinoma: Canadian Subgroup Analysis of the Phase 3 MPACT Trial. Adv Ther. 2016 May;33(5):747-59. doi: 10.1007/s12325-016-0327-4. Epub 2016 Apr 16. Erratum In: Adv Ther. 2016 Nov 24;:

ReferenceCitation: Scheithauer W, Ramanathan RK, Moore M, Macarulla T, Goldstein D, Hammel P, Kunzmann V, Liu H, McGovern D, Romano A, Von Hoff DD. Dose modification and efficacy of nab-paclitaxel plus gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer: phase III MPACT trial. J Gastrointest Oncol. 2016 Jun;7(3):469-78. doi: 10.21037/jgo.2016.01.03.

ReferenceCitation: Vogel A, Rommler-Zehrer J, Li JS, McGovern D, Romano A, Stahl M. Efficacy and safety profile of nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic cancer treated to disease progression: a subanalysis from a phase 3 trial (MPACT). BMC Cancer. 2016 Oct 21;16(1):817. doi: 10.1186/s12885-016-2798-8.

ReferenceCitation: Tabernero J, Kunzmann V, Scheithauer W, Reni M, Shiansong Li J, Ferrara S, Djazouli K. nab-Paclitaxel plus gemcitabine for metastatic pancreatic cancer: a subgroup analysis of the Western European cohort of the MPACT trial. Onco Targets Ther. 2017 Feb 2;10:591-596. doi: 10.2147/OTT.S124097. eCollection 2017.

ReferenceCitation: Kunzmann V, Ramanathan RK, Goldstein D, Liu H, Ferrara S, Lu B, Renschler MF, Von Hoff DD. Tumor Reduction in Primary and Metastatic Pancreatic Cancer Lesions With nab-Paclitaxel and Gemcitabine: An Exploratory Analysis From a Phase 3 Study. Pancreas. 2017 Feb;46(2):203-208. doi: 10.1097/MPA.0000000000000742.

location_country:
Germany
Italy
Australia
Austria
United States
Spain
Canada
Ukraine
France

location_facility: Azienda Ospedaliera Universitaria Integrata Di Verona

location_facility: Ospedale Casa Sollievo Della Sofferenza IRCCS

location_facility: HOCA - the Wesley Clinic for Heamatology and Oncology

location_facility: Municipal institution Multifield City Clinical Hospital #4 of Dnipropetrovsk Regional Council

location_facility: University of Massachusetts Memorial Medical Center

location_facility: South Texas Oncology and Hematology (STOH)

location_facility: Centre Hospsitalier Universitaire de Montreal - Notre Dame


type: EudraCT Number

title: A Randomized, Parallel Group, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Darbepoetin Alfa) in the Maintenance Treatment of Anemia in Pre-dialysis Subjects With Chronic Kidney Disease on Darbepoetin Treatment in Europe and Asia Pacific

acronym: DIALOGUE 2

summary:
Anaemia is a condition in which blood has a lower than normal number of red blood cells. It can also occur if red blood cells do not contain enough haemoglobin, an oxygen carrying part of blood. Anaemia is common in patients with chronic kidney disease. Healthy kidneys produce a hormone called erythropoietin, which stimulates the bone marrow to produce the proper number of red blood cells needed to carry oxygen to vital organs. Chronic kidney disease is a general term that means that the kidneys are not functioning to their full potential. The study drug, BAY85-3934, is being evaluated as a drug to increase the body's ability to produce erythropoietin.

The purpose of this study is to find out if the study drug, a tablet taken orally, is safe and effective for the treatment of anaemia associated with chronic kidney disease.

The study will enroll 120 patients at multiple locations in Europe, Asia and Australia. Participation will involve a screening visit and between 12 and 15 study visits scheduled over a period of approximately 5 to 7 months. The estimated total duration of study treatment will be 16 weeks. During these scheduled visits patients will undergo a number of procedures to confirm efficacy and safety of the study drug, including measurement of heart rate and blood pressure, physical examination, Electrocardiogram and blood/urine sample collection for laboratory tests.

The study will be conducted at 3 hospitals in the UK. Bayer HealthCare AG is funding this research.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

oa_host_type: repository

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

lead_sponsor: Bayer

location_country:
Germany
Italy
Poland
Hungary
Israel
Romania
Australia
Japan
United Kingdom
Korea, Republic of
Spain
Turkey
Bulgaria
France

location_facility:
Baskent University Medical Faculty
Ankara Univ. Medical Faculty
Sifa University Medical Faculty

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Double-blind, Multicenter Study to Demonstrate Equivalent Efficacy and to Compare Safety and Immunogenicity of a Biosimilar Adalimumab (GP2017) and Humira® in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

acronym: ADACCESS

summary: The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.

ReferenceCitation: Blauvelt A, Leonardi CL, Gaylis N, Jauch-Lembach J, Balfour A, Lemke L, Hachaichi S, Brueckmann I, Festini T, Wiland P. Treatment with SDZ-ADL, an Adalimumab Biosimilar, in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis: Results of Patient-Reported Outcome Measures from Two Phase III Studies (ADMYRA and ADACCESS). BioDrugs. 2021 Mar;35(2):229-238. doi: 10.1007/s40259-021-00470-1. Epub 2021 Mar 2.

publisher_dissemination: Springer-Nature

ipd_sharing: Undecided

lead_sponsor: Sandoz

sponsor_collaborators:
Sandoz
Hexal AG

location_country:
United States
Bulgaria
Slovakia
France

location_facility: Pedi-Derma s.r.o., Dermatovenerologicka ambulancia

location_facility: Kozne oddelenie,Nemocnica Kosice-Saca a.s.,1. sukromna nemoc

location_facility: Bakersfield Dermatology and Skin Cancer Medical Group

location_facility: California Dermatology & Clinical Research Institute

location_facility: Center for Skin and Venereal Diseases EOOD Sofia

location_facility: SANARE s.r.o. Dermatovenerologická ambulancia

location_facility: Diagnostic-consulting center 3-Varna EOOD

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Psoriasis Treatment Center of South Florida

location_facility: Southern California Permanente Medical Group

location_facility: University of Pittsburgh Medical Center Health System

location_facility: Ohio State University Clinical Trials Management Office


type: Other Identifier

title: A MULTICENTER, INTERNATIONAL, PHASE 3, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826) 20 MG OR 80 MG IN COMPARISON TO PLACEBO IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (TTR-CM)

acronym: ATTR-ACT

summary: This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.

ReferenceCitation: Tess DA, Maurer TS, Li Z, Bulawa C, Fleming J, Moody AT. Relationship of binding-site occupancy, transthyretin stabilisation and disease modification in patients with tafamidis-treated transthyretin amyloid cardiomyopathy. Amyloid. 2023 Jun;30(2):208-219. doi: 10.1080/13506129.2022.2145876. Epub 2022 Nov 18.

publisher_dissemination: Informa

ReferenceCitation: Rozenbaum MH, Tran D, Bhambri R, Nativi-Nicolau J. Annual Cardiovascular-Related Hospitalization Days Avoided with Tafamidis in Patients with Transthyretin Amyloid Cardiomyopathy. Am J Cardiovasc Drugs. 2022 Jul;22(4):445-450. doi: 10.1007/s40256-022-00526-9. Epub 2022 Mar 30.

ReferenceCitation: Nativi-Nicolau J, Judge DP, Hoffman JE, Gundapaneni B, Keohane D, Sultan MB, Grogan M. How did transthyretin amyloid cardiomyopathy progress in patients who took placebo in the study ATTR-ACT? A plain language summary. Future Cardiol. 2022 Mar 17. doi: 10.2217/fca-2021-0150. Online ahead of print.

publisher_dissemination: Future Science Ltd

ReferenceCitation: Elliott P, Drachman BM, Gottlieb SS, Hoffman JE, Hummel SL, Lenihan DJ, Ebede B, Gundapaneni B, Li B, Sultan MB, Shah SJ. Long-Term Survival With Tafamidis in Patients With Transthyretin Amyloid Cardiomyopathy. Circ Heart Fail. 2022 Jan;15(1):e008193. doi: 10.1161/CIRCHEARTFAILURE.120.008193. Epub 2021 Dec 20.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Hanna M, Damy T, Grogan M, Stewart M, Gundapaneni B, Sultan MB, Maurer MS. Tafamidis and quality of life in people with transthyretin amyloid cardiomyopathy in the study ATTR-ACT: A plain language summary. Future Cardiol. 2022 Mar;18(3):165-172. doi: 10.2217/fca-2021-0095. Epub 2021 Nov 15.

ReferenceCitation: Rozenbaum MH, Garcia A, Grima D, Tran D, Bhambri R, Stewart M, Li B, Heeg B, Postma M, Masri A. Health impact of tafamidis in transthyretin amyloid cardiomyopathy patients: an analysis from the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) and the open-label long-term extension studies. Eur Heart J Qual Care Clin Outcomes. 2022 Aug 17;8(5):529-538. doi: 10.1093/ehjqcco/qcab031.

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

ReferenceCitation: Vong C, Boucher M, Riley S, Harnisch LO. Modeling of Survival and Frequency of Cardiovascular-Related Hospitalization in Patients with Transthyretin Amyloid Cardiomyopathy Treated with Tafamidis. Am J Cardiovasc Drugs. 2021 Sep;21(5):535-543. doi: 10.1007/s40256-021-00464-y. Epub 2021 Mar 26.

repository_institution: University of Illinois at Chicago - INDIGO

ReferenceCitation: Miller AB, Januzzi JL, O'Neill BJ, Gundapaneni B, Patterson TA, Sultan MB, Lopez-Sendon J. Causes of Cardiovascular Hospitalization and Death in Patients With Transthyretin Amyloid Cardiomyopathy (from the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial [ATTR-ACT]). Am J Cardiol. 2021 Jun 1;148:146-150. doi: 10.1016/j.amjcard.2021.02.035. Epub 2021 Mar 3.

ReferenceCitation: Rapezzi C, Elliott P, Damy T, Nativi-Nicolau J, Berk JL, Velazquez EJ, Boman K, Gundapaneni B, Patterson TA, Schwartz JH, Sultan MB, Maurer MS. Efficacy of Tafamidis in Patients With Hereditary and Wild-Type Transthyretin Amyloid Cardiomyopathy: Further Analyses From ATTR-ACT. JACC Heart Fail. 2021 Feb;9(2):115-123. doi: 10.1016/j.jchf.2020.09.011. Epub 2020 Dec 9.

repository_institution: University of Ferrara - Institutional Research Information System University of Ferrara

repository_institution: Umeå University - DiVA at Umeå University

ReferenceCitation: Hanna M, Damy T, Grogan M, Stewart M, Gundapaneni B, Patterson TA, Schwartz JH, Sultan MB, Maurer MS. Impact of Tafamidis on Health-Related Quality of Life in Patients With Transthyretin Amyloid Cardiomyopathy (from the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial). Am J Cardiol. 2021 Feb 15;141:98-105. doi: 10.1016/j.amjcard.2020.10.066. Epub 2020 Nov 19.

ReferenceCitation: Damy T, Garcia-Pavia P, Hanna M, Judge DP, Merlini G, Gundapaneni B, Patterson TA, Riley S, Schwartz JH, Sultan MB, Witteles R. Efficacy and safety of tafamidis doses in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) and long-term extension study. Eur J Heart Fail. 2021 Feb;23(2):277-285. doi: 10.1002/ejhf.2027. Epub 2020 Nov 12.

repository_institution: Francisco de Vitoria University - Deposito Digital UFV

ReferenceCitation: Li B, Alvir J, Stewart M. Extrapolation of Survival Benefits in Patients with Transthyretin Amyloid Cardiomyopathy Receiving Tafamidis: Analysis of the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial. Cardiol Ther. 2020 Dec;9(2):535-540. doi: 10.1007/s40119-020-00179-2. Epub 2020 Jun 10.

ReferenceCitation: Maurer MS, Schwartz JH, Gundapaneni B, Elliott PM, Merlini G, Waddington-Cruz M, Kristen AV, Grogan M, Witteles R, Damy T, Drachman BM, Shah SJ, Hanna M, Judge DP, Barsdorf AI, Huber P, Patterson TA, Riley S, Schumacher J, Stewart M, Sultan MB, Rapezzi C; ATTR-ACT Study Investigators. Tafamidis Treatment for Patients with Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2018 Sep 13;379(11):1007-1016. doi: 10.1056/NEJMoa1805689. Epub 2018 Aug 27.

repository_institution: St George's University of London - St George's Online Research Archive

ReferenceCitation: Maurer MS, Elliott P, Merlini G, Shah SJ, Cruz MW, Flynn A, Gundapaneni B, Hahn C, Riley S, Schwartz J, Sultan MB, Rapezzi C; ATTR-ACT Study Investigators. Design and Rationale of the Phase 3 ATTR-ACT Clinical Trial (Tafamidis in Transthyretin Cardiomyopathy Clinical Trial). Circ Heart Fail. 2017 Jun;10(6):e003815. doi: 10.1161/CIRCHEARTFAILURE.116.003815.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Germany
Italy
United Kingdom
Japan
Brazil
Netherlands
Sweden
Belgium
United States
Spain
Czechia
Canada
France

location_facility: Cedars-Sinai Medical Center, Investigational Drug Pharmacy Services

location_facility: University of Utah,Health Sciences Center

location_facility: Columbia University Medical Center/Clinical Cardiovascular Research Laboratory for the Elderly

location_facility: St. George's Hospital (St George's Healthcare NHS Trust)

location_facility: St Bartholomew's Hospital-Barts Health NHS Trust

location_facility: VCU Medical Center - Ambulatory Care Clinic

location_facility: Stanford University Hospital and Clinics

location_facility: Unidade de Pesquisa Clinica / Hospital Universitario Clementino Fraga Filho / UFRJ

location_facility: University of Calgary/Foothills Medical Centre

location_facility: The Mount Sinai Hospital Department of Pharmacy

location_facility: Michigan Medicine,University of Michigan

location_facility: Boston University Medical Center General Clinical Research Unit

location_facility: Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital

location_facility: Boston Medical Center Investigational Pharmacy Services

location_facility: Boston Medical Center - Cardiovascular Center, Outpatient Clinic

location_facility: Altman Clinical Translational Research Institute

location_facility: UCSD Clinical and Translational Research Institute, Investigational Drug Service

location_facility: Altman Clinical Translational Research institute

location_facility: Vseobecna fakultni nemocnice v Praze, Nemocnicni lekarna

location_facility: Oregon Health and Science University (OHSU)

location_facility: Mayo Clinic Arizona - Mayo Clinic Speciality Building

location_facility: Centro per lo Studio e la Cura Delle Amiloidosi Sistemiche - Fondazione IRCCS Policlinico S. Matteo

location_facility: Mayo Clinic Arizona - Mayo Clinic Building

location_facility: University Hospital, University of Alabama at Birmingham

location_facility: Columbia University Medical Center Research Pharmacy

location_facility: Fakultni nemocnice u sv. Anny, Nemocnicni lekarna

location_facility: S.O.D. Cardiologia Generale 1 - D.A.I. del Cuore e dei Vasi

location_facility: UCSF Cardiovascular Care and Prevention Center

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: University of Maryland, School of Medicine

location_facility: Hospital Universitario Puerta De Hierro - Majadahonda


title: A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia

summary:
The primary objective of this study is to evaluate the effects of idelalisib with obinutuzumab versus the combination of chlorambucil and obinutuzumab on progression-free survival (PFS) in participants with previously untreated chronic lymphocytic leukemia (CLL).

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.

status: Terminated

ipd_sharing: Yes

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

lead_sponsor: Gilead Sciences

location_country:
Poland
United Kingdom
Australia
Belgium
United States
Spain
Canada
France

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: Royal Victoria Regional Health Centre - Simcoe Musk

location_facility: Wojewodzki Szpital Specjalistyczny, im. M. Kopernika Klinika Hematologii Uniwersytetu Medycznego

location_facility: Szpital Specjalistyczny w Brzozowie, Oddzial Hematologii Onkologicznej

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim Centrum Onkologii w Olsztynie Oddzial Hematologii

location_facility: Wojewódzki Szpital Specjalistyczny w Legnicy

location_facility: UCLA Jonsson Comprehensive Cancer Center

status_simplified: Unknown


title: A Randomised, Double-Blind Study to Assess the Efficacy of Selumetinib (AZD6244: ARRY-142886) (Hyd-Sulfate) in Combination With Dacarbazine Compared With Placebo in Combination With Dacarbazine as First Systemic Therapy in Patients With Metastatic Uveal Melanoma (SUMIT)

acronym: SUMIT

summary: Selumetinib therapy in patients with metastatic uveal melanoma.

ReferenceCitation: Carvajal RD, Piperno-Neumann S, Kapiteijn E, Chapman PB, Frank S, Joshua AM, Piulats JM, Wolter P, Cocquyt V, Chmielowski B, Evans TRJ, Gastaud L, Linette G, Berking C, Schachter J, Rodrigues MJ, Shoushtari AN, Clemett D, Ghiorghiu D, Mariani G, Spratt S, Lovick S, Barker P, Kilgour E, Lai Z, Schwartz GK, Nathan P. Selumetinib in Combination With Dacarbazine in Patients With Metastatic Uveal Melanoma: A Phase III, Multicenter, Randomized Trial (SUMIT). J Clin Oncol. 2018 Apr 20;36(12):1232-1239. doi: 10.1200/JCO.2017.74.1090. Epub 2018 Mar 12. Erratum In: J Clin Oncol. 2018 Dec 10;36(35):3528.

oa_colors: green other

evidence: open (via free pdf)

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Carvajal RD, Schwartz GK, Mann H, Smith I, Nathan PD. Study design and rationale for a randomised, placebo-controlled, double-blind study to assess the efficacy of selumetinib (AZD6244; ARRY-142886) in combination with dacarbazine in patients with metastatic uveal melanoma (SUMIT). BMC Cancer. 2015 Jun 10;15:467. doi: 10.1186/s12885-015-1470-z.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

unpaywall_oa_status: gold

lead_sponsor: AstraZeneca

location_country:
Finland
France
Germany
Israel
United Kingdom
Netherlands
Belgium
United States
Spain
Canada
Czech Republic


lead_sponsor: UCB BIOSCIENCES, Inc.

summary: The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.

sponsor_collaborators:
UCB BIOSCIENCES, Inc.
UCB Biopharma SRL

title: A Multicenter, Open-label, Long-term Extension Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Pediatric Subjects With Epilepsy With Partial-Onset Seizures

source: euctr

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

location_country:
Poland
Argentina
Australia
Brazil
Thailand
Croatia
Czechia
Serbia
France
Slovenia
Lithuania
Colombia
Portugal
Montenegro
Hungary
Slovakia
United States
Latvia
Ukraine
Romania
Belgium
China
Moldova, Republic of
Estonia
Philippines
Italy
United Kingdom
Mexico
Korea, Republic of
Greece
Taiwan
Bulgaria
Georgia
Russian Federation
Israel


type: Registry Identifier

title: Diagnostic Performance of Prostate HistoScanningTM (PHS) in Men at Risk of Prostate Cancer Scheduled for an Initial Prostate Biopsy

summary:
The primary objective of the PHSTT-01 trial is to determine if prostate HistoScanning (HS) analysis can be used to improve the detection of clinically significant prostate cancer (PCa), and potentially reduce the burden and number of biopsies in routine clinical practice. Prostate HS is an ultrasound-based tissue characterization technology specifically developed to detect, visualize, and locate tissue suspected of harboring PCa. These suspicious tissues are displayed as red areas on an imaging monitor. Recently a new biopsy guidance tool has been developed that uses the results of the prostate HS analysis.

The subjects that will participate in this study are all scheduled for a first biopsy of the prostate. They will initially be imaged using transrectal ultrasound (TRUS) to obtain data for prostate HS analysis. The results of HS analysis will be used later in the procedure. Subjects will then undergo a routine systematic 10- to 12-core biopsy procedure using TRUS. This will be followed by a TRUS-guided biopsy that uses the result of prostate HS analysis and new biopsy guidance tool.

primary_purpose: Diagnostic

lead_sponsor: Advanced Medical Diagnostics s.a.

location_country:
France
Germany
Italy
Lithuania
Hungary
United Kingdom
Denmark
Netherlands
Austria
Belgium
Switzerland
Latvia
Spain
Turkey
Bulgaria
Estonia
Russian Federation
Czech Republic

location_facility: • University Medical Center Urinary Tract Surgery - Urology Dpt - Odense Universitetshospital Svendborg Sygehus

location_facility: Medical Center Med.Landeskrankenhaus Vöcklabruck

location_facility: Medical Center URO-TIP Urological Diagnosis Center

location_facility: University Medical Center Moscow State University of Medicine and Dentistry named after A.I.Evdokimov

location_facility: Medical Center Blackpool Victoria Hospital

location_facility: University Medical Center Vall d'Hebron University Hospital - Autonoma Universitat Barcelona

location_facility: University Medical Center St. Marina University Hospital

location_facility: Medical Center Cancer Center - Prostatazentrum

location_facility: Medical Center Institut Mutualiste Montouris

location_facility: • University Medical Center Cliniques Universitaires Saint Luc

location_facility: Medical Center Onze Lieve Vrouw Ziekenhuis OLVZ

location_facility: University Medical Center University Vita-Salute, Scientific Institute H. San Raffaele

location_facility: Medical Center Acıbadem Kozyatağı Hospital

location_facility: Medical Center Spire Washington Hospital

location_facility: University Medical Center Vilniaus Universiteto Onkologijos Institutas - Santariškiu Clinics

location_facility: Medical Center Antoni Van Leeuwenhoek Ziekenhuis - Nederlands Kanker Instituut

location_facility: University Medical Center Nuffield Health - University Hospitals Bristol (UHB) - Bristol Royal Infirmary and Southmead Hospitals

location_facility: Medical Center Klinikum Wolfsburg Urologie

location_facility: Medical Center Urologická klinika - Fakultní nemocnice

location_facility: Medical Center Martini Klinik - Prostate Cancer Center

location_facility: University Medical Center Všeobecná fakultní nemocnice v Praze (VFN) a 1. -General University Hospital and First Faculty of Medicine Charles University

location_facility: Medical Center St. Elisabeth Krankenhaus

location_facility: University Medical Center CHU Saint Etienne

location_facility: Medical Center North-Estonian Medical Center Foundation

intervention_type: Device


title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Negative, Chronic Hepatitis B

summary: The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection.

ReferenceCitation: Cathcart AL, Chan HL, Bhardwaj N, Liu Y, Marcellin P, Pan CQ, Shalimar, Buti M, Cox S, Parhy B, Zhou E, Martin R, Chang S, Lin L, Flaherty JF, Kitrinos KM, Gaggar A, Izumi N, Lim YS. No Resistance to Tenofovir Alafenamide Detected through 96 Weeks of Treatment in Patients with Chronic Hepatitis B Infection. Antimicrob Agents Chemother. 2018 Sep 24;62(10):e01064-18. doi: 10.1128/AAC.01064-18. Print 2018 Oct.

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Seto WK, Asahina Y, Brown TT, Peng CY, Stanciu C, Abdurakhmanov D, Tabak F, Nguyen TT, Chuang WL, Inokuma T, Ikeda F, Santantonio TA, Habersetzer F, Ramji A, Lau AH, Suri V, Flaherty JF, Wang H, Gaggar A, Subramanian GM, Mukewar S, Brunetto MR, Fung S, Chan HL. Improved Bone Safety of Tenofovir Alafenamide Compared to Tenofovir Disoproxil Fumarate Over 2 Years in Patients With Chronic HBV Infection. Clin Gastroenterol Hepatol. 2018 Jun 20:S1542-3565(18)30633-5. doi: 10.1016/j.cgh.2018.06.023. Online ahead of print.

oa_host_type: closed

ReferenceCitation: Agarwal K, Brunetto M, Seto WK, Lim YS, Fung S, Marcellin P, Ahn SH, Izumi N, Chuang WL, Bae H, Sharma M, Janssen HLA, Pan CQ, Celen MK, Furusyo N, Shalimar D, Yoon KT, Trinh H, Flaherty JF, Gaggar A, Lau AH, Cathcart AL, Lin L, Bhardwaj N, Suri V, Mani Subramanian G, Gane EJ, Buti M, Chan HLY; GS-US-320-0110; GS-US-320-0108 Investigators. 96 weeks treatment of tenofovir alafenamide vs. tenofovir disoproxil fumarate for hepatitis B virus infection. J Hepatol. 2018 Apr;68(4):672-681. doi: 10.1016/j.jhep.2017.11.039. Epub 2018 Jan 17.

ReferenceCitation: Buti M, Gane E, Seto WK, Chan HL, Chuang WL, Stepanova T, Hui AJ, Lim YS, Mehta R, Janssen HL, Acharya SK, Flaherty JF, Massetto B, Cathcart AL, Kim K, Gaggar A, Subramanian GM, McHutchison JG, Pan CQ, Brunetto M, Izumi N, Marcellin P; GS-US-320-0108 Investigators. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016 Nov;1(3):196-206. doi: 10.1016/S2468-1253(16)30107-8. Epub 2016 Sep 22. Erratum In: Lancet Gastroenterol Hepatol. 2016 Nov;1(3):e2.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy/

location_country:
Italy
Poland
India
New Zealand
United Kingdom
Hong Kong
Romania
Australia
Japan
United States
Korea, Republic of
Spain
Turkey
Taiwan
Canada
Russian Federation
France

location_facility: Gordon and Leslie Diamond Health Care Centre

location_facility: University California San Francisco (UCSF)

location_facility: State Novosibirsk Regional Clinical Hospital

location_facility: Scientific Research Institute of Clinical Immunology

location_facility: Szpital Specjalistyczny w Chorzowie Oddział

location_facility: Institute of Post Graduate Medical Education And Research

location_facility: Medical Hospital of Tokyo Medical and Dental University

location_facility: Gastrointestinal Research Institute (GIRI)

location_facility: Istanbul Universitesi Cerrahpassa Tip Fakultesi Hastanesi

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Azienda Ospedaliera S. Orsola - Malpighi

location_facility: Hopital Civil de Strasbourg- CHU Service

location_facility: SPZOZ, Wojewódzki Specjalistyczny Szpital

location_facility: Kobe City Medical Center General Hospital

location_facility: Vancouver Infectious Disease Research and Care Centre

location_facility: Keimyung University Dongsan Medical Center

location_facility: Centrul Medical de Diagnostic si Tratament "Dr. Victor Babes"

location_facility: Global Hospital Super Specialty & Transplant Centre

location_facility: Azienda Ospedaliero- Universitaria Pisana

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Barts and The London NHS Trust Royal London Hospital

location_facility: Spitatul Clinic de Boli Infectioase Constanta

location_facility: Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"

location_facility: Postgraduate Institute of Medical Education and Research

location_facility: Seth GS Medical College and KEM Hospital

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Pusan National University Yangsan Hospital

location_facility: S. R Kalla Memorial Gastro & General Hospital

location_facility: Infection Center LLC Building 20, MSH #163 Territory Koltsovo

location_facility: 1st Moscow State Medical University University Clinical Hospital #3

location_facility: Zeidler Ledcor Centre Division of Gastroenterology

location_facility: Centrum Badan Klinicznych - Przychodnia Badan

location_facility: Limited Liability Company "Modern Medicine Clinic"

location_facility: Uludag Üniversitesi Tıp Fakültesi Gastroenteroloji

location_facility: Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci

location_facility: Infectious Clinical Hospital #1 of Moscow Healthcare Department

location_facility: Institutul National de Boli Infectioase Prof.Dr. Matei Bals

location_facility: Clinical Infectious Hospital named after S.P.Botkin

location_facility: Centre for Liver Research & Diagnostic, Deccan College of Medical Sciences and Allied Hospitals

location_facility: Azienda Ospedaliero Universitaria Ospedali

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika

location_facility: Nottingham University Hospitals NHS Trust

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Dicle University Medical Faculty Department of Infectious Diseases


title: A Dose-Blinded, 2-Dose Level, Parallel-Group, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Efficacy, and Immunogenicity of BIIB023 in Subjects With Lupus Nephritis

summary: The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB023 in participants with lupus nephritis (LN).

lead_sponsor: Biogen

location_country:
Poland
Argentina
Australia
Brazil
Thailand
France
Colombia
Hungary
Hong Kong
United States
Belgium
Malaysia
Peru
Philippines
Italy
Mexico
Korea, Republic of
Spain
Russian Federation


title: Phase IIIB, Open-label, Multi-Center Study of the Efficacy and Safety of Rigosertib Administered as 72-hour Continuous Intravenous Infusions in Patients With Myelodysplastic Syndrome With Excess Blasts Progressing On or After Azacitidine or Decitabine

summary: This study will examine the effect intravenously administered rigosertib has on the relationship between bone marrow blasts response and overall survival in myelodysplastic syndromes (MDS) patients who have 5-30% bone marrow blasts and who progressed on or after treatment with azacitidine or decitabine.

ReferenceCitation: Olnes MJ, Shenoy A, Weinstein B, Pfannes L, Loeliger K, Tucker Z, Tian X, Kwak M, Wilhelm F, Yong AS, Maric I, Maniar M, Scheinberg P, Groopman J, Young NS, Sloand EM. Directed therapy for patients with myelodysplastic syndromes (MDS) by suppression of cyclin D1 with ON 01910.Na. Leuk Res. 2012 Aug;36(8):982-9. doi: 10.1016/j.leukres.2012.04.002. Epub 2012 Apr 21.

ReferenceCitation: Seetharam M, Fan AC, Tran M, Xu L, Renschler JP, Felsher DW, Sridhar K, Wilhelm F, Greenberg PL. Treatment of higher risk myelodysplastic syndrome patients unresponsive to hypomethylating agents with ON 01910.Na. Leuk Res. 2012 Jan;36(1):98-103. doi: 10.1016/j.leukres.2011.08.022. Epub 2011 Sep 14.

ReferenceCitation: Silverman LR, Greenberg P, Raza A, Olnes MJ, Holland JF, Reddy P, Maniar M, Wilhelm F. Clinical activity and safety of the dual pathway inhibitor rigosertib for higher risk myelodysplastic syndromes following DNA methyltransferase inhibitor therapy. Hematol Oncol. 2015 Jun;33(2):57-66. doi: 10.1002/hon.2137. Epub 2014 Apr 29.

ReferenceType: result

ReferenceCitation: Al-Kali A. Relationship of bone marrow blast (BMBL) response to overall survival (OS) in a multicenter study of rigosertib (Rigo) in patients (pts) with myelodysplastic syndrome (MDS) with excess blasts progressing on or after treatment with a hypomethylating agent (HMA). Journal of Clinical Oncology 2017 35:15_suppl, 7056-7056 ASCO 2017

ReferenceCitation: Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Blood Dec 2016, 128 (22) 2011; ASH 2016.

lead_sponsor: Onconova Therapeutics, Inc.

location_country:
Germany
Italy
Denmark
Australia
Sweden
United States
Spain
France

location_facility: New York Presbyterian Hospital-Weill Cornell Medical College

location_facility: Technische Universität München, III. Medizinische Klinik

location_facility: Greenbaum Cancer Center University of Maryland

location_facility: University of Kansas Cancer Center and Medical Pavilion

location_facility: Universitätsklinikum Frankfurt, Goethe Universität

location_facility: AOU Maggiore della Carità, SCUD Ematologia

location_facility: Hôpital Saint-Louis, Service d'Hématologie

location_facility: Karolinska University Hospital, Huddinge

location_facility: Universitätsklinikum Köln Klinik I für Innere Medizin

location_facility: Policlinico Umberto 1, Universita "Sapienza"

location_facility: Rigshospitalet, Department of Hematology

location_facility: University of Texas Southwestern Medical Center-Parkland Hospital


title: A Phase Ib, Open-label Study of Oral BGJ398 in Combination With Oral BYL719 in Adult Patients With Select Advanced Solid Tumors

summary: To study the safety and efficacy of the combination of BGJ398 with BYL719 in patients whose tumors express mutations to PIK3CA with or without alterations to FGFR 1-3.

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Singapore
Australia
Netherlands
Switzerland
Belgium
United States
Korea, Republic of
Spain
Canada
France

location_facility: Vanderbilt University Medical Center Dept of Onc

location_facility: Washington University School of Medicine Onc Dept

location_facility: Memorial Sloan Kettering Cancer Center Onc Dept

location_facility: University of Michigan Comprehensive Cancer Center SC

location_facility: H. Lee Moffitt Cancer Center & Research Institute Moffitt 4

location_facility: Cancer Therapy & Research Center / UT Health Science Center SC


acronym: CheckMate 069

lead_sponsor: Bristol-Myers Squibb

summary: The primary purpose of this study is to compare the objective response rate, as determined by investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in patients with untreated, unresectable, or metastatic melanoma

ReferenceCitation: Mantia CM, Werner L, Stwalley B, Ritchings C, Tarhini AA, Atkins MB, McDermott DF, Regan MM. Sensitivity of treatment-free survival to subgroup analyses in patients with advanced melanoma treated with immune checkpoint inhibitors. Melanoma Res. 2022 Feb 1;32(1):35-44. doi: 10.1097/CMR.0000000000000793.

ReferenceCitation: Hodi FS, Chesney J, Pavlick AC, Robert C, Grossmann KF, McDermott DF, Linette GP, Meyer N, Giguere JK, Agarwala SS, Shaheen M, Ernstoff MS, Minor DR, Salama AK, Taylor MH, Ott PA, Horak C, Gagnier P, Jiang J, Wolchok JD, Postow MA. Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial. Lancet Oncol. 2016 Nov;17(11):1558-1568. doi: 10.1016/S1470-2045(16)30366-7. Epub 2016 Sep 9.

ReferenceCitation: Postow MA, Chesney J, Pavlick AC, Robert C, Grossmann K, McDermott D, Linette GP, Meyer N, Giguere JK, Agarwala SS, Shaheen M, Ernstoff MS, Minor D, Salama AK, Taylor M, Ott PA, Rollin LM, Horak C, Gagnier P, Wolchok JD, Hodi FS. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med. 2015 May 21;372(21):2006-17. doi: 10.1056/NEJMoa1414428. Epub 2015 Apr 20. Erratum In: N Engl J Med. 2018 Nov 29;379(22):2185.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

location_facility: University Of Louisville Medical Center, Inc., Dba

location_facility: Washington University School Of Medicine

location_facility: University Of Wisconsin Paul P Carbone Comprehensive Ca Ctr

title: Phase 2, Randomized, Double Blinded, Study of Nivolumab (BMS-936558) in Combination With Ipilimumab vs Ipilimumab Alone in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

location_country:
United States
France


title: A Phase 3 Switchover Study of the Efficacy and Safety of BMN 701 (GILT-tagged Recombinant Human GAA) and Long-Term Study for Extended Treatment in rhGAA Exposed Subjects With Late-onset Pompe Disease

summary: Study 701-301 is a single-arm, open-label, switchover study in patients with late-onset Pompe disease who have been receiving treatment with recombinant human acid alpha-glucosidase (rhGAA) for 48 weeks or longer. Ambulatory patients who have mild to moderate respiratory impairment will switch directly to receive BMN 701 20 mg/kg by IV infusion every other week. All participants will receive active drug. No dose of existing therapy will be missed - experimental drug is started immediately.

lead_sponsor: BioMarin Pharmaceutical

location_country:
Germany
Italy
Portugal
United Kingdom
Netherlands
Belgium
United States
France

location_facility: Villa Metabolica, ZKJM MC University Mainz

location_facility: The Ohio State University - Wexner Medical Center

location_facility: Azienda Ospedaliera Universitaria Policlinico "G. Martino" - Messina

location_facility: National Hospital for Neurology and Neurosurgery

location_facility: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta


lead_sponsor: Sumitomo Pharma America, Inc.

summary: Efficacy and Safety study of Lurasidone in pediatric patients.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: CI Lviv Regional Clinical Psychiatric Hospital

location_facility: CI Kherson Regional Psychiatric Hospital of Kherson RC

location_facility: Instituto de Informacion de Investigacion en Salud Mental

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA

location_facility: Nizhny Novgorod Regional State Institution of Healthcare

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

location_facility: RPsH #3 Сhildren Dept SHEI Ivano-Frankivsk SMU

location_facility: Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara

location_facility: FSBSI "Scientific Research Institute of Mental Health"

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval

location_facility: Medical Research Group of Central Florida

location_facility: Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert

location_facility: M.I. Pyrogov VNMU Ch of Psych&Nar BO CI O.I. Yuschenko VRPsH

location_facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia

location_facility: Centro de Investigacion Clinica Psiquiatrica

location_facility: Regional Government Institution Kipetsk Regional Psychoneurology Hospital

location_facility: FSBI "Bekhterev Psychoneurological Research Institute SPb Russia"

location_facility: Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.

location_facility: Neuropsychiatric Research Center of Orange County

location_facility: Family Psychiatry of The Woodlands, P.A.

location_facility: SI Institute of Neurology, Psychiatry and Narcology of NAMSU

location_facility: Sverdlov regional Psychiatric Clinical Hospital

location_facility: SI Institute of Children and Adolescents Healthcare of NAMSU

location_facility: CI Odesa Regional Medical Center of Mental Health

location_facility: West Visayas State University Medical Center

location_facility: CITrials, Inc. - Riverside & San Bernardino County

location_facility: Alexian Brothers Health and Wellness Center

location_facility: California Pharmaceutical Research Institute, Inc

location_facility: TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions

location_facility: St. Petersburg State Healthcare Institution (SPSHI)

location_facility: SHI Regional Clinical Psychiatry Hospital of St. Sofia

location_facility: University Hospitals Case Medical Center

location_facility: Ternopil RCCPH Dept of Psychiatry #9 (adolescent)& #8 (pediatric) Ternopil I.Ya. Gorbachevskyi SMU

location_facility: O.F. Maltcev Poltava RCPsH Children Dept Ukrainian Medical Stomatological Academy

title: A 6-Week Randomized, Parallel, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study To Evaluate The Efficacy and Safety of Lurasidone in Adolescent Subjects With Schizophrenia

location_country:
Poland
Colombia
Russian Federation
Hungary
United Kingdom
Romania
Mexico
Belgium
United States
Korea, Republic of
Spain
Malaysia
Bulgaria
Ukraine
Puerto Rico
Philippines
France


acronym: Basalt 3

summary:
This is a multi-center, open-label Phase Ib dose escalation part followed by a randomized double-blinded placebo controlled Phase II part.

The Phase Ib part will determine the Maximum Tolerated Dose (MTD)/Recommended Phase II Dose (RP2D) of buparlisib in combination with docetaxel. Subsequently the MTD/RP2D will be investigated in a Phase II randomized trial in patients with advanced or metastatic squamous NSCLC.

location_facility: H. Lee Moffitt Cancer Center & Research Institute H Lee Moffitt

location_facility: Reliant Medical Group Reliant Medical Group

location_facility: Virginia Oncology Associates Virginia Oncology Assoc. (2)

title: A Phase Ib/II Study of Docetaxel With or Without Buparlisib as Second Line Therapy for Patients With Advanced or Metastatic Squamous Non-small Cell Lung Cancer

location_country:
Germany
Italy
Sweden
Belgium
United States
Korea, Republic of
Spain
France


title: A Randomized, Double-Blind, Multi-Centre Study to Evaluate the Efficacy and Safety of Adding Mirabegron to Solifenacin in Incontinent OAB Subjects Who Have Received Solifenacin for 4 Weeks and Warrant Additional Relief for Their OAB Symptoms

acronym: BESIDE

summary: The purpose of this study was to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be more effective in controlling incontinence than when using the antimuscarinic treatment alone.

ReferenceCitation: Gibson W, MacDiarmid S, Huang M, Siddiqui E, Stolzel M, Choudhury N, Drake MJ. Treating Overactive Bladder in Older Patients with a Combination of Mirabegron and Solifenacin: A Prespecified Analysis from the BESIDE Study. Eur Urol Focus. 2017 Dec;3(6):629-638. doi: 10.1016/j.euf.2017.08.008. Epub 2017 Sep 12.

ReferenceCitation: Drake MJ, Chapple C, Esen AA, Athanasiou S, Cambronero J, Mitcheson D, Herschorn S, Saleem T, Huang M, Siddiqui E, Stolzel M, Herholdt C, MacDiarmid S; BESIDE study investigators. Efficacy and Safety of Mirabegron Add-on Therapy to Solifenacin in Incontinent Overactive Bladder Patients with an Inadequate Response to Initial 4-Week Solifenacin Monotherapy: A Randomised Double-blind Multicentre Phase 3B Study (BESIDE). Eur Urol. 2016 Jul;70(1):136-145. doi: 10.1016/j.eururo.2016.02.030. Epub 2016 Mar 8.

repository_institution: University of Bristol - Bristol Research

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Europe Ltd.

location_country:
Finland
Germany
Ireland
Poland
Australia
Armenia
Turkey
Czechia
Canada
France
Slovenia
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Romania
Lebanon
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Georgia
Russian Federation
Israel

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: Associated Pharmaceutical Research Center, Inc.

location_facility: PMG Research of Raleigh, dba PMG Research of Cary


lead_sponsor: Neurim Pharmaceuticals Ltd.

summary: The purpose of this study is to establish the efficacy and safety of Circadin in children with neurodevelopmental disorders and to determine the dose, this randomized, placebo-controlled study is planned to evaluate the efficacy of a double-blind, 13 week treatment period with Circadin 2/5mg in improving maintenance of sleep, sleep latency and additional parameters in children with neurodevelopmental disabilities. The efficacy and safety of Circadin 2/5 mg will continue to be assessed during an open-label extension period of 13 weeks.

ReferenceCitation: Malow BA, Findling RL, Schroder CM, Maras A, Breddy J, Nir T, Zisapel N, Gringras P. Sleep, Growth, and Puberty After 2 Years of Prolonged-Release Melatonin in Children With Autism Spectrum Disorder. J Am Acad Child Adolesc Psychiatry. 2021 Feb;60(2):252-261.e3. doi: 10.1016/j.jaac.2019.12.007. Epub 2020 Jan 23.

ReferenceCitation: Gringras P, Nir T, Breddy J, Frydman-Marom A, Findling RL. Efficacy and Safety of Pediatric Prolonged-Release Melatonin for Insomnia in Children With Autism Spectrum Disorder. J Am Acad Child Adolesc Psychiatry. 2017 Nov;56(11):948-957.e4. doi: 10.1016/j.jaac.2017.09.414. Epub 2017 Sep 19.

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Clinical research center of New Jersey, LLC

location_facility: Guy's & St. Thomas's NHS Foundation Trust of St Thomas's Hospital

location_facility: Blackpool Victoria Teaching Hospitals NHS Foundation Trust

location_facility: Birmingham Childrens Hospital NHS FOUNDATION TRUST

location_facility: Strasbourg University Hospital Depatment of Child Psychiatry & Neurology

location_facility: Southwest Autism Research and Resource Center (SARRC)

location_facility: Attalla Consultants LLC, dba Institue for Behabiovral medicine

title: A Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of Circadin® to Alleviate Sleep Disturbances in Children With Neurodevelopmental Disabilities

location_country:
Finland
United Kingdom
Netherlands
United States
France


acronym: Chime

lead_sponsor: Eli Lilly and Company

summary: The primary purpose of this study is to evaluate the efficacy of the study drug known as LY2875358, administered alone or in combination with a second drug named Erlotinib, in participants affected by a defined type of lung cancer (MET biomarker diagnostic positive Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent treatment with Erlotinib.

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: University of California, Davis - Health Systems

location_facility: University of Colorado Health Sciences Center

location_facility: Georgetown University Medical Center IRB

title: A Randomized, Open-Label Phase 2 Study Evaluating LY2875358 Plus Erlotinib and LY2875358 Monotherapy in MET Diagnostic Positive NSCLC Patients With Acquired Resistance to Erlotinib

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

location_country:
Germany
France
Italy
United Kingdom
Netherlands
Belgium
United States
Korea, Republic of
Spain
Israel


title: A Randomized, Double-Masked and Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sarilumab Administered Subcutaneously Every 2 Weeks in Patients With Non-Infectious, Intermediate, Posterior or Pan-Uveitis (NIU)

acronym: SARILNIUSATURN

summary:
Primary Objective:

To evaluate the efficacy of sarilumab at Week 16 in participants with non-infectious uveitis (NIU).

Secondary Objectives:

To evaluate the change in best corrected visual acuity (BCVA). To evaluate the safety of subcutaneous sarilumab in participants with NIU. To evaluate the change in macular edema. To evaluate the change in other signs of ocular inflammation. To evaluate the effect on retinal vessel leakage. To evaluate the effect of sarilumab on reducing concomitant immunosuppressant therapy.

To evaluate the change in ocular inflammation in the anterior chamber. To evaluate the pharmacokinetics of sarilumab in NIU participants. To evaluate the immunogenicity with anti-drug antibodies (ADA).

lead_sponsor: Sanofi

location_country:
Italy
United States
Spain
Turkey
Czechia
France

location_facility:
Investigational Site Number 792004
Investigational Site Number 250002
Investigational Site Number 840009
Investigational Site Number 203001
Investigational Site Number 792005
Investigational Site Number 380003
Investigational Site Number 250001
Investigational Site Number 840007
Investigational Site Number 380001
Investigational Site Number 380004
Investigational Site Number 724001
Investigational Site Number 792001
Investigational Site Number 792003
Investigational Site Number 840006
Investigational Site Number 203002
Investigational Site Number 724003
Investigational Site Number 840008
Investigational Site Number 840005
Investigational Site Number 792006
Investigational Site Number 792002


title: An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study of the Pharmacokinetics, Safety and Tolerability of Olaparib Following a Single Oral 300 mg Dose to Patients With Advanced Solid Tumours and Normal Renal Function or Renal Impairment

summary: This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate renal impairment compared to patients with normal renal function; Part B will allow eligible study patients continued access to olaparib after the PK phase and will provide additional safety data.

ReferenceCitation: Rolfo C, de Vos-Geelen J, Isambert N, Molife LR, Schellens JHM, De Greve J, Dirix L, Grundtvig-Sorensen P, Jerusalem G, Leunen K, Mau-Sorensen M, Plummer R, Learoyd M, Bannister W, Fielding A, Ravaud A. Pharmacokinetics and Safety of Olaparib in Patients with Advanced Solid Tumours and Renal Impairment. Clin Pharmacokinet. 2019 Sep;58(9):1165-1174. doi: 10.1007/s40262-019-00754-4.

location_country:
United Kingdom
Denmark
Netherlands
Belgium
France


title: International (Pediatric) Peritoneal Biobank

summary:
Within few years the peritoneal membrane of adult peritoneal dialysis (PD) patients undergoes substantial morphological transformation, including progressive fibrosis, vasculopathy and neoangiogenesis. Ultrafiltration capacity steadily declines and ultimately results in PD failure. In children, peritoneal biopsies demonstrating PD associated alterations have not yet been obtained. They, however, should be particularly informative, since secondary tissue and vascular pathology related to ageing or diabetes is absent.

An international, prospective peritoneal membrane biopsy study in children on PD will therefore be performed. Biopsies will be obtained at time of PD catheter insertion, on occasion of intercurrent abdominal surgery (e.g. hernia repair, catheter exchange) and at time of renal transplantation. Quantitative histomorphometry and tissue protein expression analyses will be correlated with time integrated PD treatment modalities and functional characteristics as well as inflammatory and cardiovascular comorbidity surrogate parameter. Blood will be obtained during clinical routine sampling. Biopsies will be obtained during clinically indicated operations, without substantially increasing operation time and associated surgical risks. The detailed histomorphometry of the PD membrane will give additional information, potentially impacting on the individual PD regime.

3/2018: The analyses of the pediatric PD biopsy demonstrated early and major transformation of the peritoneal membrane with neutral pH low GDP fluids, and significant vasculopathy already in children with CKD stage 5, further progressing with PD. The underlying mechanisms are partly understood, only. In view of these major findings and the numerous open questions, collection of biosamples will be continued in children and also in adult PD patients. The following questions will be addressed: Molecular counterparts of peritoneal semi-permeability, solute and water transport (beyond AQP1), pathomechanisms and molecular and functional impact of peritoneal transformation with low and high GDP fluids, and the respective pathomechanisms and molecular and functional impact of vascular disease in CKD and with different PD fluids. The impact of renal transplantation following PD will be assessed in a subgroup of patients with tenckhoff catheter removal several weeks after transplantation and a functioning graft.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Catar RA, Bartosova M, Kawka E, Chen L, Marinovic I, Zhang C, Zhao H, Wu D, Zickler D, Stadnik H, Karczewski M, Kamhieh-Milz J, Jorres A, Moll G, Schmitt CP, Witowski J. Angiogenic Role of Mesothelium-Derived Chemokine CXCL1 During Unfavorable Peritoneal Tissue Remodeling in Patients Receiving Peritoneal Dialysis as Renal Replacement Therapy. Front Immunol. 2022 Feb 4;13:821681. doi: 10.3389/fimmu.2022.821681. eCollection 2022.

repository_institution: Universitätsbibliothek der Freien Universität Berlin - Refubium

repositories_concat: PubMed Central;refubium.fu-berlin.de

publisher_dissemination: Frontiers

ReferenceCitation: Bartosova M, Zhang C, Schaefer B, Herzog R, Ridinger D, Damgov I, Levai E, Marinovic I, Eckert C, Romero P, Sallay P, Ujszaszi A, Unterwurzacher M, Wagner A, Hildenbrand G, Warady BA, Schaefer F, Zarogiannis SG, Kratochwill K, Schmitt CP. Glucose Derivative Induced Vasculopathy in Children on Chronic Peritoneal Dialysis. Circ Res. 2021 Aug 20;129(5):e102-e118. doi: 10.1161/CIRCRESAHA.121.319310. Epub 2021 Jul 8.

repository_institution: Semmelweis University - Semmelweis University Repository

lead_sponsor: Heidelberg University

location_country:
Germany
Italy
Lithuania
Poland
Hungary
Sweden
Switzerland
Austria
Belgium
United States
Spain
Malaysia
Turkey
Czechia
France

location_facility: Department of Medicine I (Nephrology), University of Heidelberg

location_facility: Hospital Universitario Materno-Infantil Vall d' Hebron

location_facility: Paediatric CAPD unit, Kuala Lumpur Hospital

location_facility: Children's Hospital, Inselspital, Bern University Hospital and University of Bern

location_facility: KfH Pediatric Kidney Center, Department of Pediatric Nephrology, University of Marburg

location_facility: Krakow, Jagiellonian University Medical College

location_facility: Pediatric Nephrology, Dialysis and Transplant Unit

location_facility: Department of Pediatrics, Medical University Vienna

location_facility: Service de Néphrologie Pédiatrique, Hôpital Femme Mere Enfant

intervention_type: Procedure

status_simplified: Ongoing


title: Randomized, Double Blind, Placebo Controlled, Two Parallel Group Study to Evaluate the Efficacy and Safety of Piracetam, 12 g Intravenous (IV) Infusion Within 7 Hour (h) Post Stroke Onset, Followed by 12 g/d for 4 Weeks (IV Ampoules, Oral Solution) and 4.8 g/d for 8 Weeks (Tablets) in Adult Subjects With an Acute Ischemic Middle Cerebral Artery Stroke

summary: The aim of this study was to confirm the efficacy of piracetam after 12 weeks of treatment on the aphasic status of subjects suffering from aphasia after acute ischemic middle cerebral artery stroke and having received their medication within 7 h post-stroke onset.

lead_sponsor: UCB S.A. - Pharma Sector

location_country: Germany Italy Poland Hungary Argentina Norway Singapore Sweden Austria Belgium Spain Greece Turkey Taiwan France


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (Cp-690,550) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One Tnf Inhibitor

acronym: OPAL BEYOND

summary: To examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis who have previously had an inadequate response to at least one TNF inhibitor either due to lack of efficacy or an adverse event.

ReferenceCitation: de Vlam K, Mease PJ, Bushmakin AG, Fleischmann R, Ogdie A, Azevedo VF, Merola JF, Woolcott J, Cappelleri JC, Fallon L, Taylor PC. Identifying and Quantifying the Role of Inflammation in Pain Reduction for Patients With Psoriatic Arthritis Treated With Tofacitinib: A Mediation Analysis. Rheumatol Ther. 2022 Oct;9(5):1451-1464. doi: 10.1007/s40744-022-00482-5. Epub 2022 Sep 8.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

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

repositories_concat: LIRIAS (KU Leuven);PubMed Central;figshare.com;ora.ox.ac.uk

repositories_institution: La Trobe University - OPAL (Open@LaTrobe)

ReferenceCitation: Orbai AM, Mease PJ, Helliwell PS, FitzGerald O, Fleishaker DL, Mundayat R, Young P. Effect of tofacitinib on dactylitis and patient-reported outcomes in patients with active psoriatic arthritis: post-hoc analysis of phase III studies. BMC Rheumatol. 2022 Sep 1;6(1):68. doi: 10.1186/s41927-022-00298-4.

repositories_concat: PubMed Central;eprints.whiterose.ac.uk

ReferenceCitation: Taylor PC, Bushmakin AG, Cappelleri JC, Young P, Germino R, Merola JF, Yosipovitch G. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatolog Treat. 2022 Aug;33(5):2614-2620. doi: 10.1080/09546634.2022.2060924. Epub 2022 Apr 11.

repositories_institution: University of Illinois at Chicago - INDIGO

ReferenceCitation: Gladman DD, Coates LC, Wu J, Fallon L, Bacci ED, Cappelleri JC, Bushmakin AG, Helliwell PS. Time to response for clinical and patient-reported outcomes in patients with psoriatic arthritis treated with tofacitinib, adalimumab, or placebo. Arthritis Res Ther. 2022 Feb 9;24(1):40. doi: 10.1186/s13075-022-02721-0.

repository_institution: University of Toronto - TSpace

ReferenceCitation: Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17.

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

ReferenceCitation: Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

ReferenceCitation: Kivitz AJ, FitzGerald O, Nash P, Pang S, Azevedo VF, Wang C, Takiya L. Efficacy and safety of tofacitinib by background methotrexate dose in psoriatic arthritis: post hoc exploratory analysis from two phase III trials. Clin Rheumatol. 2022 Feb;41(2):499-511. doi: 10.1007/s10067-021-05894-2. Epub 2021 Sep 12.

ReferenceCitation: de Vlam K, Ogdie A, Bushmakin AG, Cappelleri JC, Fleischmann R, Taylor PC, Azevedo V, Fallon L, Woolcott J, Mease PJ. Median time to pain improvement and the impact of baseline pain severity on pain response in patients with psoriatic arthritis treated with tofacitinib. RMD Open. 2021 Jul;7(2):e001609. doi: 10.1136/rmdopen-2021-001609.

repositories:
LIRIAS (KU Leuven)
PubMed Central
ora.ox.ac.uk

repositories_concat: LIRIAS (KU Leuven);PubMed Central;ora.ox.ac.uk

ReferenceCitation: Coates LC, Bushmakin AG, FitzGerald O, Gladman DD, Fallon L, Cappelleri JC, Hsu MA, Helliwell PS. Relationships between psoriatic arthritis composite measures of disease activity with patient-reported outcomes in phase 3 studies of tofacitinib. Arthritis Res Ther. 2021 Mar 26;23(1):94. doi: 10.1186/s13075-021-02474-2.

repository_institution: Dr Steevens Hospital Library - Lenus, The Irish Health Repository

ReferenceCitation: Ritchlin CT, Giles JT, Ogdie A, Gomez-Reino JJ, Helliwell P, Young P, Wang C, Wu J, Romero AB, Woolcott J, Stockert L. Tofacitinib in Patients With Psoriatic Arthritis and Metabolic Syndrome: A Post hoc Analysis of Phase 3 Studies. ACR Open Rheumatol. 2020 Oct;2(10):543-554. doi: 10.1002/acr2.11166. Epub 2020 Sep 10.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:

repository_institution: Newcastle Univesity - Newcastle University ePrints

repositories_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Burmester GR, Curtis JR, Yun H, FitzGerald O, Winthrop KL, Azevedo VF, Rigby WFC, Kanik KS, Wang C, Biswas P, Jones T, Palmetto N, Hendrikx T, Menon S, Rojo R. An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis across Phase III and Long-Term Extension Studies with Comparison to Real-World Observational Data. Drug Saf. 2020 Apr;43(4):379-392. doi: 10.1007/s40264-020-00904-9.

ReferenceCitation: Gladman DD, Charles-Schoeman C, McInnes IB, Veale DJ, Thiers B, Nurmohamed M, Graham D, Wang C, Jones T, Wolk R, DeMasi R. Changes in Lipid Levels and Incidence of Cardiovascular Events Following Tofacitinib Treatment in Patients With Psoriatic Arthritis: A Pooled Analysis Across Phase III and Long-Term Extension Studies. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1387-1395. doi: 10.1002/acr.23930.

repositories_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 May 20;3(1):30. doi: 10.1186/s41687-019-0115-4.

ReferenceCitation: Strand V, de Vlam K, Covarrubias-Cobos JA, Mease PJ, Gladman DD, Chen L, Kudlacz E, Wu J, Cappelleri JC, Hendrikx T, Hsu MA. Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors in the phase III, randomised controlled trial: OPAL Beyond. RMD Open. 2019 Jan 11;5(1):e000808. doi: 10.1136/rmdopen-2018-000808. eCollection 2019.

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

ReferenceCitation: Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 Jan 24;3(1):5. doi: 10.1186/s41687-019-0094-5.

RetractionSource: J Patient Rep Outcomes. 2019 May 28;3(1):32

ReferenceCitation: Nash P, Coates LC, Fleischmann R, Papp KA, Gomez-Reino JJ, Kanik KS, Wang C, Wu J, Menon S, Hendrikx T, Ports WC. Efficacy of Tofacitinib for the Treatment of Psoriatic Arthritis: Pooled Analysis of Two Phase 3 Studies. Rheumatol Ther. 2018 Dec;5(2):567-582. doi: 10.1007/s40744-018-0131-5. Epub 2018 Nov 9.

ReferenceCitation: Helliwell P, Coates LC, FitzGerald O, Nash P, Soriano ER, Elaine Husni M, Hsu MA, Kanik KS, Hendrikx T, Wu J, Kudlacz E. Disease-specific composite measures for psoriatic arthritis are highly responsive to a Janus kinase inhibitor treatment that targets multiple domains of disease. Arthritis Res Ther. 2018 Oct 29;20(1):242. doi: 10.1186/s13075-018-1739-0.

ReferenceCitation: Gladman D, Rigby W, Azevedo VF, Behrens F, Blanco R, Kaszuba A, Kudlacz E, Wang C, Menon S, Hendrikx T, Kanik KS. Tofacitinib for Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors. N Engl J Med. 2017 Oct 19;377(16):1525-1536. doi: 10.1056/NEJMoa1615977.

location_country:
Germany
Poland
Slovakia
United Kingdom
Australia
Brazil
Mexico
Belgium
United States
Spain
Taiwan
Czechia
Russian Federation
France

location_facility: Drug Shipment/Storage: Investigational Drug Services

location_facility: Przychodnia Specjalistyczna Lekarskiej Spozielni Pracy "Medica" for X-Ray Only

location_facility: CIRI - Centrum für innovative Diagnostik und Therapie Rheumatologie/Immunologie (GmbH)

location_facility: Institute Medico Panamericano, S.A. de C.V. (For Emergencies Only)

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Sanatorio CEMSI Chapultepec (For Emergencies Only)

location_facility: Royal United Hospitals NHS Foundation Trust

location_facility: City Neurological Centre "SibNeyroMed", LLC

location_facility: Rheumatology Associates of North Alabama, PC

location_facility: Clinica Medica Bonfiglioli Ltda. / Clinica Bonfiglioli

location_facility: Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzez

location_facility: St. Luke's Intermountain Research Center

location_facility: Hospital de Clinicas de Porto Alegre (HCPA) / UFRGS

location_facility: Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba

location_facility: Charite Universitatsmedizin Berlin - Campus Charite Mitte

location_facility: State Institution of Healthcare of Yaroslavl Region

location_facility: State Autonomic Healthcare Institution City Clinical Hospital # 7

location_facility: Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"

location_facility: Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie

location_facility: NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela

location_facility: Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes

location_facility: York Hospital, York Teaching Hospital NHS Foundation Trust

location_facility: Bradford Teaching Hospitals NHS Foundation Trust

location_facility: Wojewodzki Szpital Zespolony Zaklad Radiologii

location_facility: Royal Prince Alfred Hospital, Rheumatology Department

location_facility: Integral Rheumatology & Immunology Specialists (IRIS)

location_facility: Universitaetsklinikum Erlangen, Medizinische Klinik 3

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Centro Multidisciplinario para el Desarrollo

location_facility: Barking Havering and Redbridge University Hospitals NHS Trust

location_facility: Radiologia Clínica de Campinas - RCC (Images only)

location_facility: Christus Muguerza del parque, S.A de C.V

location_facility: St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

location_facility: Hospital Erasme - Clinique Universitaire de Bruxelles

location_facility: Dartmouth-Hitchcock Medical Center (DHMC)

location_facility: Investigacion y Biomedicina de Chihuahua

location_facility: Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj

location_facility: Centro de Investigacion Clinica Pensiones

location_facility: Hospital General de Culiacan "Dr. Bernardo J. Gastelum"

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: SBIH of Moscow "City Clinical Hospital#1 n. a. N.I. Pirogov" of the Healthcare Department of Moscow

location_facility: The Center For Rheumatology And Bone Research

location_facility: Barking, Havering and Redbridge University Hospitals NHS Trust

location_facility: Centro Integral en Reumatologia SA de CV

location_facility: Rheumazentrum Prof. Dr. med Gunther Neeck

location_facility: Chang Gung Medical Foundation-Kaohsiung Branch

location_facility: University Hospital Leuven, Department of Rheumatology

location_facility: Medica Sur, S.A.B. de C.V. (For Emergencies Only)

location_facility: Star Medica S.A. de C.V. (For Emergencies Only)

location_facility: Hospital Universitaro Y Politecnico La Fe

location_facility: University Hospitals Case Medical Center

location_facility: Hospital Star Medica Merida (For Emergencies Only)

location_facility: Cincinnati Rheumatic Disease Study Group, Inc.

location_facility: CETAC - DIAGNOSTICO POR IMAGEM (image only)

location_facility: Adriana M. Pop-Moody, M.D., Clinic, P.A.

location_facility: Ronald Reagan UCLA Medical Center, Drug Information Center

location_facility: Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C

location_facility: Arizona Arthritis & Rheumatology Associates, P.C.

location_facility: Regional State Budgetary Healthcare Institution of Karelia Republic "Republic Hospital n.a.

location_facility: Rheumatology Associates of Central Florida, PA

location_facility: State Budget Educational Institution of Highest Professional Education

location_facility: MEDMAN s.r.o. - reumatologicka ambulancia


title: APRICOT: Anaesthesia PRactice In Children Observational Trial - European Prospective Multicenter Observational Study: Epidemiology of Severe Critical Events in Paediatric Anaesthesia

acronym: APRICOT

summary:
The aims of the APRICOT study are:

To establish the incidence of severe critical events in children undergoing anesthesia in Europe.
To describe the differences in paediatric anaesthesia practice throughout Europe.
To study the potential impact of this variability on the occurrence of severe critical events (Laryngospasm, Bronchospasm, Pulmonary aspiration, Drug error, Anaphylaxis, Cardiovascular instability, Neurological damage, Perianaesthetic cardiac arrest and postanaesthetic Stridor).

ReferenceCitation: Dahmani S, Laffargue A, Dadure C, Veyckemans F; French APRICOT trial group. Description of practices and complications in the French centres that participated to APRICOT: A secondary analysis. Anaesth Crit Care Pain Med. 2019 Dec;38(6):637-645. doi: 10.1016/j.accpm.2019.06.001. Epub 2019 Jun 11.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

repositories_concat: HAL

ReferenceCitation: Virag K, Sabourdin N, Thomas M, Veyckemans F, Habre W; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Epidemiology and incidence of severe respiratory critical events in ear, nose and throat surgery in children in Europe: A prospective multicentre observational study. Eur J Anaesthesiol. 2019 Mar;36(3):185-193. doi: 10.1097/EJA.0000000000000951.

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

ReferenceCitation: Engelhardt T, Virag K, Veyckemans F, Habre W; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Airway management in paediatric anaesthesia in Europe-insights from APRICOT (Anaesthesia Practice In Children Observational Trial): a prospective multicentre observational study in 261 hospitals in Europe. Br J Anaesth. 2018 Jul;121(1):66-75. doi: 10.1016/j.bja.2018.04.013. Epub 2018 May 18.

repository_institution: University of Geneva - Archive ouverte UNIGE

ReferenceCitation: Habre W, Disma N, Virag K, Becke K, Hansen TG, Johr M, Leva B, Morton NS, Vermeulen PM, Zielinska M, Boda K, Veyckemans F; APRICOT Group of the European Society of Anaesthesiology Clinical Trial Network. Incidence of severe critical events in paediatric anaesthesia (APRICOT): a prospective multicentre observational study in 261 hospitals in Europe. Lancet Respir Med. 2017 May;5(5):412-425. doi: 10.1016/S2213-2600(17)30116-9. Epub 2017 Mar 28. Erratum In: Lancet Respir Med. 2017 May;5(5):e19. Lancet Respir Med. 2017 Jun;5(6):e22.

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

lead_sponsor: European Society of Anaesthesiology

location_country:
Finland
Germany
Ireland
Poland
Malta
Turkey
Croatia
Gibraltar
Serbia
Kosovo
France
Czech Republic
Lithuania
Slovenia
Portugal
Slovakia
Denmark
Switzerland
Latvia
Ukraine
Romania
Belgium
Estonia
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Russian Federation
Israel

location_facility: Oslo University Hospital, Rikshospitalet

location_facility: Gibraltar Health Authority, St. Bernard´s Hospital

location_facility: Maastricht University Medical Center MUMC

location_facility: Anästhesie Kinderspital Klinik für Anästhesie, Intensivmedizin, Rettungsmedizin und Schmerztherapie (KLIFAIRS) Luzerner Kantonsspital Spitalstrasse

location_facility: Schneider Children's Medical center of Israel

location_facility: Queen Silvis Childrens Hospital Sahlgrens University Hospital

location_facility: Asklepios Klinik Sankt Augustin GmbH - Department of Paediatric Anaesthesia

location_facility: Centro Hospitalar Lisboa Norte - Hospital de Santa Maria

location_facility: Pirogov Russian National Research Medical University

location_facility: P.L.Shupyk National Medical Academy of Postgraduate Education, Municipal Children's Hospital #1

location_facility: Clinical University Hospital Department of Anaesthesiology and Intensive Care


title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures, With Optional Open-Label Extension

summary:
This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with an 8-week prospective baseline and an 18 week double-blind treatment period (including a 6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study drug taper period (for subjects leaving the study) or a 2-week blinded conversion period (for subjects who will participate in the open-label extension).

The primary objective of this study is to determine the effective dose range of YKP3089 as adjunctive therapy for the treatment of partial seizures.

The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy population.

ReferenceCitation: Klein P, Aboumatar S, Brandt C, Dong F, Krauss GL, Mizne S, Sanchez-Alvarez JC, Steinhoff BJ, Villanueva V. Long-Term Efficacy and Safety From an Open-Label Extension of Adjunctive Cenobamate in Patients With Uncontrolled Focal Seizures. Neurology. 2022 Jun 15;99(10):e989-98. doi: 10.1212/WNL.0000000000200792. Online ahead of print.

ReferenceCitation: Rosenfeld WE, Nisman A, Ferrari L. Efficacy of adjunctive cenobamate based on number of concomitant antiseizure medications, seizure frequency, and epilepsy duration at baseline: A post-hoc analysis of a randomized clinical study. Epilepsy Res. 2021 May;172:106592. doi: 10.1016/j.eplepsyres.2021.106592. Epub 2021 Feb 18.

ReferenceCitation: Krauss GL, Klein P, Brandt C, Lee SK, Milanov I, Milovanovic M, Steinhoff BJ, Kamin M. Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial. Lancet Neurol. 2020 Jan;19(1):38-48. doi: 10.1016/S1474-4422(19)30399-0. Epub 2019 Nov 14. Erratum In: Lancet Neurol. 2020 Mar;19(3):e3.

ReferenceCitation: Bialer M, Johannessen SI, Levy RH, Perucca E, Tomson T, White HS. Progress report on new antiepileptic drugs: A summary of the Twelfth Eilat Conference (EILAT XII). Epilepsy Res. 2015 Mar;111:85-141. doi: 10.1016/j.eplepsyres.2015.01.001. Epub 2015 Jan 19.

lead_sponsor: SK Life Science, Inc.

location_country:
Germany
Poland
Hungary
Israel
Romania
Australia
United States
Korea, Republic of
Spain
Thailand
Czechia
Bulgaria
Ukraine
Serbia
France

location_facility: Department of Neurology, Hadassah University Hospital Ein Kerem, Kiryat Hadassah

location_facility: Fakultni nemocnice v Motole, Neurologická klinika

location_facility: Instytut Psychaitrii I Neurologii, II Klinika Neurologiczna

location_facility: Hôpital Central - CHU de Nancy - Service de Neurologie

location_facility: Epilepsy Research Centre, Melbourne Brain Centre

location_facility: Fundacja Epileptologii profesora Jerzego Majkowskiego

location_facility: Neurology of Kharkiv Medical Academy of Postgraduate Education based on Department of Neurology #3 of State Treatment and Prevention Institution "Central Clinical Hospital of Ukrzaliznytsya"

location_facility: Kaiser Permanente, Department of Neurology

location_facility: Hospital Universitario San Cecilio - Servicio de Neurologia

location_facility: Hospital Clinico Universitario San Carlos, Serv. Neurologia

location_facility: MI "Odessa Regional Clinical Hospital," Neurological and Neurosurgical Center based on Neurosurgery Department

location_facility: University of Virginia Comprehensive Epilepsy Program

location_facility: University Multiprofile Hpspital for Active Treatment "Sveti Georgi" EAD, Clinic of Neurological Diseases

location_facility: St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics

location_facility: Hospital Ruber Internacional - Programa Epilepsia

location_facility: Epilepsiezentrum Berlin- Bradenburg, Epilepsieklinik "Tabor"

location_facility: Krankenhaus Mara gGmbH, Epilepsiezentrum Bethel

location_facility: Roceanu Adina Maria Neurology Individual Medical Center

location_facility: The Chaim Sheba Medical Center, Department of Neurology

location_facility: TDC "Epilepsy" based on Department #19 of Kiev Territorial Medical Association "Psychiatry"

location_facility: Clinical of Neurology, Clinical Center of Serbia

location_facility: Fundación Jiminez Diaz-Servicio de Neurologia

location_facility: Lviv Regional Antiepileptic Center based on Department of Neurology of Lviv Regional Clinical Hospital and Chair of Neurology of Lviv National Medical University n.a. Danylo Galytskyy

location_facility: Department #2 of Regional Clinical Center of Neurosurgery and Neurology

location_facility: Consultants in Epilepsy & Neurology, PLLC

location_facility: M.A. - LEK A.M. Maciejowscy S.C. Centrum Terapii SM

location_facility: Western Galilee Hospital, Department of Neurology

location_facility: Fakultní nemocnice Ostrava, Neurologická klinika

location_facility: Institute of Neurological Sciences, Prince of Wales Hospital

location_facility: Hospital Universitario y Politecnico La Fe - Servicio Neurologia

location_facility: The Comprehensive Epilepsy Care Center for Children and Adults

location_facility: West Los Angeles VA Medical Center, Clinical Research Center

location_facility: NOVO-MED Zielinski I Wspolnicy Spolka Jawna

location_facility: "First Multiprofile Hospital for Active Treatment - Sofia" EAD, Neurology Clinic

location_facility: Thomas Jefferson Comprehensive Epilepsy Center

location_facility: University of Multiprofile Hospital for Active Treatment "Aleksandrovska" EAD, Clinic of Neurological Diseases


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tadalafil for Duchenne Muscular Dystrophy

summary: The main purpose of this study is to determine if tadalafil can slow the decline in walking ability of boys who have Duchenne muscular dystrophy (DMD). The study will also assess the safety of tadalafil and any side effects that might be associated with it in boys who have DMD. Participants will receive study treatment (tadalafil or placebo) for the first 48 weeks of the study, and can then continue into an open label extension (OLE) that consists of two periods during which all participants will receive tadalafil. In OLE period 1, all participants will receive tadalafil for 48 weeks. Participants completing OLE period 1 will continue into OLE period 2 and will receive tadalafil for at least another 48 weeks.

ReferenceCitation: McDonald CM, Henricson EK, Han JJ, Abresch RT, Nicorici A, Elfring GL, Atkinson L, Reha A, Hirawat S, Miller LL. The 6-minute walk test as a new outcome measure in Duchenne muscular dystrophy. Muscle Nerve. 2010 Apr;41(4):500-10. doi: 10.1002/mus.21544.

ReferenceCitation: Victor RG, Sweeney HL, Finkel R, McDonald CM, Byrne B, Eagle M, Goemans N, Vandenborne K, Dubrovsky AL, Topaloglu H, Miceli MC, Furlong P, Landry J, Elashoff R, Cox D; Tadalafil DMD Study Group. A phase 3 randomized placebo-controlled trial of tadalafil for Duchenne muscular dystrophy. Neurology. 2017 Oct 24;89(17):1811-1820. doi: 10.1212/WNL.0000000000004570. Epub 2017 Sep 29.

repository_institution: hacettepe.edu.tr - Hacettepe University Institutional Repository

repository_institution: California Digital Library - eScholarship

repositories_concat: LIRIAS (KU Leuven);PubMed Central;eprint.ncl.ac.uk;escholarship.org;openaccess.hacettepe.edu.tr;ora.ox.ac.uk

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

location_country:
Germany
Italy
United Kingdom
Argentina
Japan
Netherlands
Belgium
United States
Korea, Republic of
Spain
Turkey
Taiwan
Canada
Puerto Rico
Russian Federation
France

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: Pennsylvania State University College of Medicine

location_facility: Univ of Texas Health Science Center at San Antonio

location_facility: Ann and Robert Lurie Children's Hospital of Chicago

location_facility: University of Puerto Rico, Medical Sciences Campus

location_facility: University of California, Davis - Health Systems

location_facility: University of Florida Health Science Center

location_facility: Seattle Children's Hospital Research Foundation


summary: This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).

title: A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF) Driven Choroidal Neovascularization.

location_country:
Germany
Poland
Australia
Turkey
Canada
Czech Republic
France
Lithuania
Portugal
Slovakia
Hungary
Denmark
Switzerland
Latvia
Peru
Italy
Singapore
Korea, Republic of
Spain
Greece
Russian Federation


title: A Cross-sectional Study of Renal Function in Treatment-naïve, Young Male Patients With Fabry Disease

summary:
No investigational drug will be administered in this study for the treatment of Fabry disease.

This will be a multicenter, multinational, non-treatment, cross-sectional study of young male patients with Fabry disease who have not yet initiated interventional treatment for this disease. The study will consist of a screening visit(s), a clinical investigation visit(s), and a follow-up phone contact.

The objectives of the study are:

To document renal function and other Fabry disease manifestations across age in treatment-naïve, young male patients with Fabry disease.
To provide a reference group for comparison with interventional clinical trials of Fabry disease.

The duration of each patient's participation in the study, inclusive of the screening visit and follow-up phone contact, will be approximately 12 weeks.

primary_purpose: Basic Science

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Finland
Poland
Hungary
Argentina
Norway
United Kingdom
Brazil
Austria
Belgium
United States
Spain
Taiwan
Canada
France

location_facility:
Investigational Site Number 348001
Investigational Site Number 124004
Investigational Site Number 250002
Investigational Site Number 724002
Investigational Site Number 840009
Investigational Site Number 840002
Investigational Site Number 826004
Investigational Site Number 616001
Investigational Site Number 250001
Investigational Site Number 040001
Investigational Site Number 124001
Investigational Site Number 840003
Investigational Site Number 826002
Investigational Site Number 724001
Investigational Site Number 840006
Investigational Site Number 578001
Investigational Site Number 032001
Investigational Site Number 840010
Investigational Site Number 158001
Investigational Site Number 076001
Investigational Site Number 246002
Investigational Site Number 056001


title: A Phase 2, Randomized, Double Blind Placebo Controlled Trial To Evaluate The Safety, Tolerability, Pharmacokinetics And Efficacy Of Pf-04360365 (Ponezumab) In Adult Subjects With Probable Cerebral Amyloid Angiopathy

summary: Cerebral Amyloid Angiopathy (CAA) is a condition caused by the build-up of a protein called amyloid, predominantly Aβ40, within the walls of brain blood vessels, especially those blood vessels in the occipital lobe of the brain. Probable CAA may be defined as two or more hemorrhages in the brain cortex in individuals 55 years of age or older. This study will examine the study drug (PF-04360365) vs. placebo (saline) at 10 mg/kg - Day 1 and the maintenance dose of the study drug (PF-04360365) vs. placebo (saline) at 7.5mg/kg on Days 30 and 60. Subjects will be followed for 6 months after receiving the last dose of study medication.

lead_sponsor: Pfizer

location_country:
United Kingdom
Netherlands
United States
Canada
France

location_facility: Anthinoula A. Martinos Center for Biomedical Imaging

location_facility: University of Calgary/Foothills Medical Centre

intervention_type: Other