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.

family: Borges

full_name: Flavia K Borges

given: Flavia K

family: Bhandari

full_name: Mohit Bhandari

given: Mohit

family: Guerra-Farfan

full_name: Ernesto Guerra-Farfan

given: Ernesto

family: Patel

full_name: Ameen Patel

given: Ameen

family: Sigamani

full_name: Alben Sigamani

given: Alben

family: Umer

full_name: Masood Umer

given: Masood

family: Tiboni

full_name: Maria E Tiboni

given: Maria E

family: Villar-Casares

full_name: Maria del Mar Villar-Casares

given: Maria del Mar

family: Tandon

full_name: Vikas Tandon

given: Vikas

family: Tomas-Hernandez

full_name: Jordi Tomas-Hernandez

given: Jordi

family: Teixidor-Serra

full_name: Jordi Teixidor-Serra

family: Avram

full_name: Victoria RA Avram

given: Victoria RA

family: Winemaker

full_name: Mitchell Winemaker

given: Mitchell

family: Ramokgopa

full_name: Mmampapatla T Ramokgopa

given: Mmampapatla T

family: Szczeklik

full_name: Wojciech Szczeklik

given: Wojciech

family: Landoni

full_name: Giovanni Landoni

given: Giovanni

family: Wang

full_name: Chew Yin Wang

given: Chew Yin

family: Begum

full_name: Dilshad Begum

given: Dilshad

family: Neary

full_name: John D Neary

given: John D

family: Adili

full_name: Anthony Adili

given: Anthony

family: Sancheti

full_name: Parag K Sancheti

given: Parag K

family: Lawendy

full_name: Abdel-Rahman Lawendy

given: Abdel-Rahman

family: Balaguer-Castro

full_name: Mariano Balaguer-Castro

given: Mariano

repository_institution: University of Nottingham - Repository@Nottingham

url: https://nottingham-repository.worktribe.com/3936426/1/hip attack paper submitted version

url_for_landing_page: https://nottingham-repository.worktribe.com/3936426/1/HIP ATTACK Paper Submitted Version

repository_institution: Western University - Scholarship@Western

ReferenceCitation: Borges FK, Devereaux PJ, Cuerden M, Bhandari M, Guerra-Farfán 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, Ślęczka 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: Jagiellonian University - Jagiellonian University Repository

ReferenceCitation: Borges FK, Bhandari M, Patel A, Avram V, Guerra-Farfán 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, Ślęczka 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

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

location_facility: Victoria Hospital, London Health Sciences

location_facility: Hamilton Health Sciences - Juravinski Hospital

location_facility: Hospital Clinico Universitario de Vallad

location_facility: Sancheti Institute for Orthopaedics and Rehabilitation

location_facility: Thunder Bay Regional Health Sciences Centre

location_facility: Hospital Sant Camil (Consorci Sanitari Garraf)

location_facility: SPZOZ Szpital Powiatowy w Bochni im M. Wieckiej

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

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej W Myślenicach


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.

family: Ramanathan

full_name: R.K. Ramanathan

sequence: first

family: Goldstein

full_name: D. Goldstein

given: D.

sequence: additional

family: Korn

full_name: R.L. Korn

family: Arena

full_name: F. Arena

given: F.

family: Moore

full_name: M. Moore

given: M.

family: Siena

full_name: S. Siena

given: S.

family: Teixeira

full_name: L. Teixeira

given: L.

family: Tabernero

full_name: J. Tabernero

given: J.

family: Van Laethem

full_name: J.-L. Van Laethem

family: Liu

full_name: H. Liu

given: H.

family: McGovern

full_name: D. McGovern

family: Lu

full_name: B. Lu

given: B.

family: Von Hoff

full_name: D.D. Von Hoff

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Oncology

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

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: 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.

family: Chiorean

full_name: E.G. Chiorean

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.

ReferenceCitation: Portal A, Pernot S, Tougeron D, Arbaud C, Bidault AT, de la Fouchardière C, Hammel P, Lecomte T, Dréanic J, Coriat R, Bachet JB, Dubreuil O, Marthey L, Dahan L, Tchoundjeu B, Locher C, Lepère 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.

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). pii: dju413. doi: 10.1093/jnci/dju413. Print 2015 Feb.

journal_name: JNCI Journal of the National Cancer Institute

title: nab-Paclitaxel Plus Gemcitabine for Metastatic Pancreatic Cancer: Long-Term Survival From a Phase III Trial

ReferenceCitation: Vogel A, Pelzer U, Salah-Eddin AB, Köster 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.

title: Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine

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. Review.

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, Römmler-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.

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:
Italy
Austria
United States
Germany
France
Australia
Spain
Canada
Ukraine

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

location_facility: HOCA - the Wesley Clinic for Heamatology and Oncology

location_facility: Ospedale Casa Sollievo Della Sofferenza IRCCS

location_facility: Azienda Ospedaliera Universitaria Integrata Di Verona

location_facility: Centre Hospsitalier Universitaire de Montreal - Notre Dame

location_facility: University of Massachusetts Memorial Medical Center

location_facility: South Texas Oncology and Hematology (STOH)


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

lead_sponsor: Bayer

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

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.

ReferenceType: derived

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.

family: Blauvelt

full_name: Andrew Blauvelt

given: Andrew

family: Leonardi

full_name: Craig L. Leonardi

given: Craig L.

family: Gaylis

full_name: Norman Gaylis

given: Norman

family: Jauch-Lembach

full_name: Julia Jauch-Lembach

given: Julia

family: Balfour

full_name: Alison Balfour

given: Alison

family: Lemke

full_name: Lena Lemke

given: Lena

family: Hachaichi

full_name: Sohaib Hachaichi

given: Sohaib

family: Brueckmann

full_name: Ines Brueckmann

given: Ines

family: Festini

full_name: Teodora Festini

given: Teodora

family: Wiland

full_name: Piotr Wiland

given: Piotr

journal_name: BioDrugs

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ipd_sharing: Undecided

lead_sponsor: Sandoz

location_country:
Slovakia
United States
France
Bulgaria

location_facility: Ohio State University Clinical Trials Management Office

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

location_facility: SANARE s.r.o. Dermatovenerologická ambulancia

location_facility: Diagnostic-consulting center 3-Varna EOOD

location_facility: Bakersfield Dermatology and Skin Cancer Medical Group

location_facility: Psoriasis Treatment Center of South Florida

location_facility: Southern California Permanente Medical Group

location_facility: California Dermatology & Clinical Research Institute

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

location_facility: University of Pittsburgh Medical Center Health System

location_facility: Center for Skin and Venereal Diseases EOOD Sofia

location_facility: Dawes Fretzin Clinical Research Group, LLC


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: 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. 2021 Nov 15. doi: 10.2217/fca-2021-0095. [Epub ahead of print]

name: Amyloidosis Center, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA

family: Hanna

full_name: Mazen Hanna

given: Mazen

name: GRC Amyloid Research Institute, Department of Cardiology, Henri-Mondor Hospital – APHP, Creteil, France

family: Damy

full_name: Thibaud Damy

given: Thibaud

name: Cardiac Amyloid Clinic, Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA

family: Grogan

full_name: Martha Grogan

given: Martha

family: Stewart

full_name: Michelle Stewart

given: Michelle

family: Gundapaneni

full_name: Balarama Gundapaneni

given: Balarama

family: Sultan

full_name: Marla B Sultan

given: Marla B

name: Columbia University Vagelos College of Physicians and Surgeons, New York, NY, USA

family: Maurer

full_name: Mathew S Maurer

given: Mathew S

journal_name: Future Cardiology

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

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.

family: Vong

full_name: Camille Vong

given: Camille

family: Boucher

full_name: Martin Boucher

given: Martin

family: Riley

full_name: Steve Riley

given: Steve

family: Harnisch

full_name: Lutz O. Harnisch

given: Lutz O.

journal_name: American Journal of Cardiovascular Drugs

ReferenceCitation: Miller AB, Januzzi JL, O'Neill BJ, Gundapaneni B, Patterson TA, Sultan MB, López-Sendón 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.

family: Miller

full_name: Alan B. Miller

given: Alan B.

family: Januzzi

full_name: James L. Januzzi

given: James L.

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: Umeå University - DiVA at Umeå University

repositories_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.

name: French Referral Center for Cardiac Amyloidosis, Amyloidosis Mondor Network, GRC Amyloid Research Institute and Department of Cardiology, all at APHP, CHU Henri Mondor; and INSERM U955, Clinical Investigation Center 006, and DHU ATVB  Créteil France

name: Hospital Universitario Puerta de Hierro Majadahonda, CIBERCV  Madrid Spain

name: Universidad Francisco de Vitoria, Pozuelo de Alarcon  Madrid Spain

name: Amyloidosis Centre Cleveland Clinic  Cleveland OH USA

name: Medical University of South Carolina  Charleston SC USA

name: Amyloidosis Center IRCCS Policlinico San Matteo and University of Pavia  Pavia Italy

name: Stanford University School of Medicine  Stanford CA USA

repository_institution: Francisco de Vitoria University - Deposito Digital UFV

title: Efficacy and safety of tafamidis doses in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial ( ATTR‐ACT ) and long‐term extension study

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.

name: From the Columbia University Vagelos College of Physicians and Surgeons (M.S.M.) and Pfizer (J.H.S., A.I.B., P.H., J.S., M.B.S.), New York; Syneos Health, Raleigh, NC (B.G.); University College London and St. Bartholomew’s Hospital, London (P.M.E.); the Amyloidosis Center, Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, and the University of Pavia, Pavia (G.M.), and the Department of Experimental, Diagnostic, and Specialty Medicine, University of Bologna, Bologna (C.R.) — both...

repository_institution: University of Florence - Florence Research

repository_institution: University College London - UCL Discovery

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

repositories_institution: University College London - UCL Discovery

repositories_institution: University of Florence - Florence Research

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). pii: e003815. doi: 10.1161/CIRCHEARTFAILURE.116.003815. Review.

name: From the Center for Advanced Cardiac Care, Columbia University College of Physicians and Surgeons, NY (M.S.M); Cardiovascular Medicine, University College London, United Kingdom (P.E.); IRCCS Policlinico San Matteo, University of Pavia, Italy (G.M.); Division of Cardiology, Northwestern University, Chicago, IL (S.J.S.); National Amyloidosis Referral Center, Centro de Estudos em Paramiloidose Antônio Rodrigues de Mello, Federal University of Rio de Janeiro, Brazil (M.W.C.); Pfizer, Inc, Collegeville,...

publisher: Ovid Technologies (Wolters Kluwer Health)

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

location_facility: University of Utah,Health Sciences Center

location_facility: Oregon Health and Science University (OHSU)

location_facility: Hospital Universitario Puerta De Hierro - Majadahonda

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

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

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

location_facility: Altman Clinical Translational Research institute

location_facility: Boston Medical Center Investigational Pharmacy Services

location_facility: University Hospital, University of Alabama at Birmingham

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

location_facility: VCU Medical Center - Ambulatory Care Clinic

location_facility: Mayo Clinic Arizona - Mayo Clinic Building

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

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

location_facility: Columbia University Medical Center Research Pharmacy

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

location_facility: UCSF Cardiovascular Care and Prevention Center

location_facility: University of Calgary/Foothills Medical Centre

location_facility: Michigan Medicine,University of Michigan

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

location_facility: Vseobecna fakultni nemocnice v Praze, Nemocnicni lekarna

location_facility: University of Maryland, School of Medicine

location_facility: Mayo Clinic Arizona - Mayo Clinic Speciality Building

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

location_facility: Boston University Medical Center General Clinical Research Unit

location_facility: Altman Clinical Translational Research Institute

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

location_facility: Boston Medical Center - Cardiovascular Center, Outpatient Clinic

location_facility: Fakultni nemocnice u sv. Anny, Nemocnicni lekarna

location_facility: Stanford University Hospital and Clinics

location_facility: The Mount Sinai Hospital Department of Pharmacy


title: A Randomized, Double-Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Two Dose Regimens (60 mg/kg and 120 mg/kg) of Weekly Intravenous Alpha1 Proteinase Inhibitor (Human) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency

acronym: SPARTA

summary: This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered weekly by IV infusion for 156 weeks. The study consists of an optional pre-screening phase, Screening Phase, a 156-week Treatment Phase, and an End of Study Visit at Week 160.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Sorrells S, Camprubi S, Griffin R, Chen J, Ayguasanosa J. SPARTA clinical trial design: exploring the efficacy and safety of two dose regimens of alpha1-proteinase inhibitor augmentation therapy in alpha1-antitrypsin deficiency. Respir Med. 2015 Apr;109(4):490-9. doi: 10.1016/j.rmed.2015.01.022. Epub 2015 Feb 13.

family: Sorrells

full_name: Susan Sorrells

given: Susan

family: Camprubi

full_name: Sandra Camprubi

given: Sandra

family: Griffin

full_name: Rhonda Griffin

given: Rhonda

family: Chen

full_name: Junliang Chen

given: Junliang

family: Ayguasanosa

full_name: Jaume Ayguasanosa

given: Jaume

journal_name: Respiratory Medicine

title: SPARTA clinical trial design: Exploring the efficacy and safety of two dose regimens of alpha1-proteinase inhibitor augmentation therapy in alpha1-antitrypsin deficiency

lead_sponsor: Grifols Therapeutics LLC

location_country:
Brazil
United States
Sweden
Spain
Germany
Finland
France
Poland
Romania
Argentina
Australia
New Zealand
Russian Federation
Estonia
Denmark
Canada

location_facility: Turku University Central Hospital, Department of Pulmonary Diseases

location_facility: New Zealand Respiratory and Sleep institute

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: University of Miami Miller School of Medicine

location_facility: Washington University School of Medicine

location_facility: SBEI HPE Altai State Medical University of MoH and SD

location_facility: Instytut Gruzlicy i Chorob Pluc w Warszawie

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque

location_facility: UNIFESP - Universidade Federal de São Paulo

location_facility: FSI Scientific Research Institute of Pulmonology

location_facility: Medical Research of Central Florida, LLC

location_facility: Hospital del Torax Dr. Antonio A. Cetrangolo

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Hospital Universitario Central de Asturias

location_facility: University of Texas Health Center at Tyler

location_facility: Penn State Univ. Milton S. Hershey Medical Center

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

location_facility: Spitalul Clinic de Boli Infectioase si Pneumoftiziologie

intervention_type: Other

status_simplified: Ongoing


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:
United States
France
Poland
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: Szpital Specjalistyczny w Brzozowie, Oddzial Hematologii Onkologicznej

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

location_facility: Wojewódzki Szpital Specjalistyczny w Legnicy

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

location_facility: Royal Victoria Regional Health Centre - Simcoe Musk

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.

name: Richard D. Carvajal and Gary K. Schwartz, Columbia University Medical Center; Paul B. Chapman and Alexander N. Shoushtari, Memorial Sloan Kettering Cancer Center, New York, NY; Sophie Piperno-Neumann and Manuel J. Rodrigues, Institut Curie, Paris; Lauris Gastaud, Centre Antoine-Lacassagne, Nice, France; Ellen Kapiteijn, Leiden University Medical Center, Leiden, the Netherlands; Stephen Frank, Hebrew University Hadassah Medical School – The Sharett Institute of Oncology, Jerusalem; Jacob Schachter, Sheba...

family: Carvajal

full_name: Richard D. Carvajal

given: Richard D.

family: Piperno-Neumann

full_name: Sophie Piperno-Neumann

given: Sophie

family: Kapiteijn

full_name: Ellen Kapiteijn

given: Ellen

family: Chapman

full_name: Paul B. Chapman

given: Paul B.

family: Frank

full_name: Stephen Frank

given: Stephen

family: Joshua

full_name: Anthony M. Joshua

given: Anthony M.

family: Piulats

full_name: Josep M. Piulats

given: Josep M.

family: Wolter

full_name: Pascal Wolter

given: Pascal

family: Cocquyt

full_name: Veronique Cocquyt

given: Veronique

family: Chmielowski

full_name: Bartosz Chmielowski

given: Bartosz

family: Evans

full_name: T.R. Jeffry Evans

given: T.R. Jeffry

family: Gastaud

full_name: Lauris Gastaud

given: Lauris

family: Linette

full_name: Gerald Linette

given: Gerald

family: Berking

full_name: Carola Berking

given: Carola

family: Schachter

full_name: Jacob Schachter

given: Jacob

family: Rodrigues

full_name: Manuel J. Rodrigues

given: Manuel J.

family: Shoushtari

full_name: Alexander N. Shoushtari

given: Alexander N.

family: Clemett

full_name: Delyth Clemett

given: Delyth

family: Ghiorghiu

full_name: Dana Ghiorghiu

given: Dana

family: Mariani

full_name: Gabriella Mariani

given: Gabriella

family: Spratt

full_name: Shirley Spratt

given: Shirley

family: Lovick

full_name: Susan Lovick

family: Barker

full_name: Peter Barker

given: Peter

repository_institution: The University of Glasgow - Enlighten: Publications

publisher: 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.

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


status: Active, not recruiting

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.

lead_sponsor: UCB BIOSCIENCES, Inc.

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

source: euctr

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

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


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

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

location_facility: Medical Center Spire Washington Hospital

location_facility: • University Medical Center Cliniques Universitaires Saint Luc

location_facility: Medical Center Martini Klinik - Prostate Cancer Center

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

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

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

location_facility: Medical Center Klinikum Wolfsburg Urologie

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

location_facility: University Medical Center CHU Saint Etienne

location_facility: Medical Center Med.Landeskrankenhaus Vöcklabruck

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

location_facility: Medical Center Blackpool Victoria Hospital

location_facility: Medical Center URO-TIP Urological Diagnosis Center

location_facility: Medical Center St. Elisabeth Krankenhaus

location_facility: Medical Center Cancer Center - Prostatazentrum

location_facility: Medical Center Acıbadem Kozyatağı Hospital

location_facility: Medical Center Urologická klinika - Fakultní nemocnice

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 North-Estonian Medical Center Foundation

location_facility: Medical Center Onze Lieve Vrouw Ziekenhuis OLVZ

location_facility: Medical Center Institut Mutualiste Montouris

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

location_facility: University Medical Center St. Marina University Hospital

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). pii: e01064-18. doi: 10.1128/AAC.01064-18. Print 2018 Oct.

name: Gilead Sciences, Foster City, California, USA

family: Cathcart

full_name: Andrea L. Cathcart

given: Andrea L.

name: Department of Medicine and Therapeutics, Institute of Digestive Disease and State Key Laboratory of Digestive Disease, The Chinese University of Hong Kong, Hong Kong

family: Chan

full_name: Henry Lik-Yuen Chan

given: Henry Lik-Yuen

family: Bhardwaj

full_name: Neeru Bhardwaj

given: Neeru

family: Liu

full_name: Yang Liu

given: Yang

name: Service d'Hépatologie, Hôpital Beaujon, Clichy, France

family: Marcellin

full_name: Patrick Marcellin

given: Patrick

name: Division of Gastroenterology and Hepatology, Department of Medicine, NYU Langone Medical Center, NYU School of Medicine, New York, New York, USA

family: Pan

full_name: Calvin Q. Pan

given: Calvin Q.

name: Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India

family: Shalimar

full_name: Shalimar

name: Hospital Universitari Vall d'Hebron, Barcelona, Spain

family: Buti

full_name: Maria Buti

given: Maria

family: Cox

full_name: Stephanie Cox

given: Stephanie

family: Parhy

full_name: Bandita Parhy

given: Bandita

family: Zhou

full_name: Eric Zhou

given: Eric

family: Martin

full_name: Ross Martin

given: Ross

family: Chang

full_name: Silvia Chang

given: Silvia

family: Lin

full_name: Lanjia Lin

given: Lanjia

family: Flaherty

full_name: John F. Flaherty

given: John F.

family: Kitrinos

full_name: Kathryn M. Kitrinos

given: Kathryn M.

family: Gaggar

full_name: Anuj Gaggar

given: Anuj

name: Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan

family: Izumi

full_name: Namiki Izumi

given: Namiki

name: Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea

family: Lim

full_name: Young-Suk Lim

given: Young-Suk

journal_name: Antimicrobial Agents and Chemotherapy

evidence: open (via free pdf)

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. pii: S1542-3565(18)30633-5. doi: 10.1016/j.cgh.2018.06.023. [Epub ahead of print]

journal_name: Clinical Gastroenterology and Hepatology

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, Çelen 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.

journal_name: The Lancet Gastroenterology & Hepatology

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

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku Klinika

location_facility: Uludag Üniversitesi Tıp Fakültesi Gastroenteroloji

location_facility: S. R Kalla Memorial Gastro & General Hospital

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

location_facility: Spitatul Clinic de Boli Infectioase Constanta

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

location_facility: Azienda Ospedaliero Universitaria Ospedali

location_facility: Pusan National University Yangsan Hospital

location_facility: State Novosibirsk Regional Clinical Hospital

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Istanbul Universitesi Cerrahpassa Tip Fakultesi Hastanesi

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

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

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

location_facility: Seth GS Medical College and KEM Hospital

location_facility: Azienda Ospedaliera S. Orsola - Malpighi

location_facility: Hopital Civil de Strasbourg- CHU Service

location_facility: Gordon and Leslie Diamond Health Care Centre

location_facility: Centrum Badan Klinicznych - Przychodnia Badan

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Dicle University Medical Faculty Department of Infectious Diseases

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Medical Hospital of Tokyo Medical and Dental University

location_facility: Vancouver Infectious Disease Research and Care Centre

location_facility: National Hospital Organization Nagasaki Medical Center

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

location_facility: Azienda Ospedaliero- Universitaria Pisana

location_facility: Postgraduate Institute of Medical Education and Research

location_facility: Infectious Clinical Hospital #1 of Moscow Healthcare Department

location_facility: Barts and The London NHS Trust Royal London Hospital

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

location_facility: Kobe City Medical Center General Hospital

location_facility: Limited Liability Company "Modern Medicine Clinic"

location_facility: Keimyung University Dongsan Medical Center

location_facility: Scientific Research Institute of Clinical Immunology

location_facility: Gastrointestinal Research Institute (GIRI)

location_facility: Institute of Post Graduate Medical Education And Research

location_facility: Ankara Üniversitesi Gastroenteroloji Bilim Dalı Cebeci

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Szpital Specjalistyczny w Chorzowie Oddział

location_facility: SPZOZ, Wojewódzki Specjalistyczny Szpital

location_facility: Zeidler Ledcor Centre Division of Gastroenterology

location_facility: Global Hospital Super Specialty & Transplant Centre

location_facility: University California San Francisco (UCSF)


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


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:
Italy
Sweden
Germany
France
Australia
Spain
Denmark
United States

location_facility: Karolinska University Hospital, Huddinge

location_facility: Universitätsklinikum Frankfurt, Goethe Universität

location_facility: Technische Universität München, III. Medizinische Klinik

location_facility: Hôpital Saint-Louis, Service d'Hématologie

location_facility: Greenbaum Cancer Center University of Maryland

location_facility: AOU Maggiore della Carità, SCUD Ematologia

location_facility: New York Presbyterian Hospital-Weill Cornell Medical College

location_facility: Universitätsklinikum Köln Klinik I für Innere Medizin

location_facility: University of Kansas Cancer Center and Medical Pavilion

location_facility: Rigshospitalet, Department of Hematology

location_facility: University of Texas Southwestern Medical Center-Parkland Hospital

location_facility: Policlinico Umberto 1, Universita "Sapienza"


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

location_facility: Memorial Sloan Kettering Cancer Center Onc Dept

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

location_facility: University of Michigan Comprehensive Cancer Center SC

location_facility: Washington University School of Medicine Onc Dept

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

location_facility: Vanderbilt University Medical Center Dept of Onc


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.

family: Hodi

full_name: F Stephen Hodi

given: F Stephen

family: Chesney

full_name: Jason Chesney

given: Jason

family: Pavlick

full_name: Anna C Pavlick

given: Anna C

family: Robert

full_name: Caroline Robert

given: Caroline

family: Grossmann

full_name: Kenneth F Grossmann

given: Kenneth F

family: McDermott

full_name: David F McDermott

given: David F

family: Linette

full_name: Gerald P Linette

given: Gerald P

family: Meyer

full_name: Nicolas Meyer

given: Nicolas

family: Giguere

full_name: Jeffrey K Giguere

given: Jeffrey K

family: Agarwala

full_name: Sanjiv S Agarwala

given: Sanjiv S

family: Shaheen

full_name: Montaser Shaheen

given: Montaser

family: Ernstoff

full_name: Marc S Ernstoff

given: Marc S

family: Minor

full_name: David R Minor

given: David R

family: Salama

full_name: April K Salama

given: April K

family: Taylor

full_name: Matthew H Taylor

given: Matthew H

family: Ott

full_name: Patrick A Ott

given: Patrick A

family: Horak

full_name: Christine Horak

given: Christine

family: Gagnier

full_name: Paul Gagnier

given: Paul

family: Jiang

full_name: Joel Jiang

given: Joel

family: Wolchok

full_name: Jedd D Wolchok

given: Jedd D

family: Postow

full_name: Michael A Postow

given: Michael A

journal_name: The Lancet Oncology

oa_host_type: repository

version: acceptedVersion

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.

name: From Memorial Sloan Kettering Cancer Center (M.A.P., J.D.W.), Weill Cornell Medical College (M.A.P., J.D.W.), and New York University, Perlmutter Cancer Center (A.C.P.) — all in New York; J. Graham Brown Cancer Center, University of Louisville, Louisville, KY (J.C.); Institute Gustave Roussy, Villejuif (C.R.), Paris-Sud University, Orsay (C.R.), and Institut Universitaire du Cancer, Toulouse (N.M.) — all in France; Huntsman Cancer Institute, Salt Lake City (K.G.); Beth Israel Deaconess Medical Center (D....

title: Nivolumab and Ipilimumab versus Ipilimumab in Untreated Melanoma

location_facility: University Of Wisconsin Paul P Carbone Comprehensive Ca Ctr

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

location_facility: Washington University School Of Medicine

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

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


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:
Italy
United States
Netherlands
France
Belgium
Portugal
Germany
United Kingdom

location_facility: The Ohio State University - Wexner Medical Center

location_facility: National Hospital for Neurology and Neurosurgery

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

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

location_facility: Villa Metabolica, ZKJM MC University Mainz


lead_sponsor: Sunovion

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

location_facility: Alexian Brothers Health and Wellness Center

location_facility: Centro de Investigacion Clinica Psiquiatrica

location_facility: Nizhny Novgorod Regional State Institution of Healthcare

location_facility: Sverdlov regional Psychiatric Clinical Hospital

location_facility: Instituto de Informacion de Investigacion en Salud Mental

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: FSBI "Bekhterev Psychoneurological Research Institute SPb Russia"

location_facility: FSBSI "Scientific Research Institute of Mental Health"

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

location_facility: Neuropsychiatric Research Center of Orange County

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

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

location_facility: CI Lviv Regional Clinical Psychiatric Hospital

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA

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

location_facility: Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert

location_facility: Hôpitaux Pédiatriques de Nice CHU-Lenval

location_facility: Medical Research Group of Central Florida

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

location_facility: University Hospitals Case Medical Center

location_facility: West Visayas State University Medical Center

location_facility: SHI Regional Clinical Psychiatry Hospital of St. Sofia

location_facility: CI Odesa Regional Medical Center of Mental Health

location_facility: CI Kherson Regional Psychiatric Hospital of Kherson RC

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

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

location_facility: Regional Government Institution Kipetsk Regional Psychoneurology Hospital

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

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

location_facility: St. Petersburg State Healthcare Institution (SPSHI)

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

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

location_facility: SI Institute of Children and Adolescents Healthcare of NAMSU

location_facility: California Pharmaceutical Research Institute, Inc

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

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

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


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

acronym: Basalt 3

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

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.


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, Stölzel 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.

family: Gibson

full_name: William Gibson

given: William

family: MacDiarmid

full_name: Scott MacDiarmid

given: Scott

family: Huang

full_name: Moses Huang

given: Moses

family: Siddiqui

full_name: Emad Siddiqui

given: Emad

family: Stölzel

full_name: Matthias Stölzel

given: Matthias

family: Choudhury

full_name: Nurul Choudhury

given: Nurul

family: Drake

full_name: Marcus J. Drake

given: Marcus J.

journal_name: European Urology Focus

ReferenceCitation: Drake MJ, Chapple C, Esen AA, Athanasiou S, Cambronero J, Mitcheson D, Herschorn S, Saleem T, Huang M, Siddiqui E, Stölzel 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.

family: Chapple

full_name: Christopher Chapple

given: Christopher

family: Esen

full_name: Ahmet A. Esen

given: Ahmet A.

family: Athanasiou

full_name: Stavros Athanasiou

given: Stavros

family: Cambronero

full_name: Javier Cambronero

given: Javier

family: Mitcheson

full_name: David Mitcheson

given: David

family: Herschorn

full_name: Sender Herschorn

given: Sender

family: Saleem

full_name: Tahir Saleem

given: Tahir

family: Herholdt

full_name: Claire Herholdt

given: Claire

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.

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

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


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.

family: Malow

full_name: Beth A. Malow

given: Beth A.

family: Findling

full_name: Robert L. Findling

given: Robert L.

family: Schroder

full_name: Carmen M. Schroder

given: Carmen M.

family: Maras

full_name: Athanasios Maras

given: Athanasios

family: Breddy

full_name: John Breddy

given: John

family: Nir

full_name: Tali Nir

given: Tali

family: Zisapel

full_name: Nava Zisapel

given: Nava

family: Gringras

full_name: Paul Gringras

given: Paul

journal_name: Journal of the American Academy of Child & Adolescent Psychiatry

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.

family: Frydman-Marom

full_name: Anat Frydman-Marom

given: Anat

lead_sponsor: Neurim Pharmaceuticals Ltd.

location_country:
Netherlands
Finland
France
United States
United Kingdom

location_facility: Blackpool Victoria Teaching Hospitals NHS Foundation Trust

location_facility: Attalla Consultants LLC, dba Institue for Behabiovral medicine

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

location_facility: Clinical research center of New Jersey, LLC

location_facility: Birmingham Childrens Hospital NHS FOUNDATION TRUST

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Southwest Autism Research and Resource Center (SARRC)

location_facility: Strasbourg University Hospital Depatment of Child Psychiatry & Neurology

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

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.


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

lead_sponsor: Eli Lilly and Company

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

acronym: Chime

location_facility: University of California, Davis - Health Systems

location_facility: University of Colorado Health Sciences Center

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: 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

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.


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
France
Czechia
Spain
Turkey
United States

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


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 Grève J, Dirix L, Grundtvig-Sørensen P, Jerusalem G, Leunen K, Mau-Sørensen 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.

family: Rolfo

full_name: Christian Rolfo

given: Christian

family: de Vos-Geelen

full_name: Judith de Vos-Geelen

given: Judith

family: Isambert

full_name: Nicolas Isambert

given: Nicolas

family: Molife

full_name: L. Rhoda Molife

given: L. Rhoda

family: Schellens

full_name: Jan H. M. Schellens

given: Jan H. M.

family: De Grève

full_name: Jacques De Grève

given: Jacques

family: Dirix

full_name: Luc Dirix

given: Luc

family: Grundtvig-Sørensen

full_name: Peter Grundtvig-Sørensen

given: Peter

family: Jerusalem

full_name: Guy Jerusalem

given: Guy

family: Leunen

full_name: Karin Leunen

given: Karin

family: Mau-Sørensen

full_name: Morten Mau-Sørensen

given: Morten

family: Plummer

full_name: Ruth Plummer

given: Ruth

family: Learoyd

full_name: Maria Learoyd

given: Maria

family: Bannister

full_name: Wendy Bannister

given: Wendy

family: Fielding

full_name: Anitra Fielding

given: Anitra

family: Ravaud

full_name: Alain Ravaud

given: Alain

journal_name: Clinical Pharmacokinetics

lead_sponsor: AstraZeneca

location_country:
Netherlands
France
Belgium
Denmark
United Kingdom


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.

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.

name: Center for Pediatric and Adolescent Medicine (M.B., C.Z., B.S., I.D., E.L., I.M., F.S., S.G.Z., C.P.S.), University of Heidelberg, Heidelberg, Germany.

family: Bartosova

full_name: Maria Bartosova

family: Zhang

full_name: Conghui Zhang

given: Conghui

family: Schaefer

full_name: Betti Schaefer

given: Betti

name: Christian Doppler Laboratory for Molecular Stress Research in Peritoneal Dialysis, Division of Pediatric Nephrology and Gastroenterology, Department of Pediatrics and Adolescent Medicine, Comprehensive Center for Pediatrics, Medical University of Vienna, Vienna, Austria (R.H., M.U., A.W., K.K.).

family: Herzog

full_name: Rebecca Herzog

given: Rebecca

name: Kirchhoff Institute for Physics (D.R., G.H.), University of Heidelberg, Heidelberg, Germany.

family: Ridinger

full_name: David Ridinger

given: David

family: Damgov

full_name: Ivan Damgov

given: Ivan

name: ELKH-SE, Pediatrics and Nephrology Research Group, Budapest, Hungary (E.L.).

name: 1st Department of Pediatrics, Semmelweis University, Budapest, Hungary (E.L., P.S.).

family: Levai

full_name: Eszter Levai

given: Eszter

family: Marinovic

full_name: Iva Marinovic

given: Iva

name: Institute of Pathology (C.E.), University of Heidelberg, Heidelberg, Germany.

family: Eckert

full_name: Christoph Eckert

given: Christoph

name: Division of Pediatric Surgery, Department of General, Visceral and Transplantation Surgery (P.R.), University of Heidelberg, Heidelberg, Germany.

family: Romero

full_name: Philipp Romero

given: Philipp

family: Sallay

full_name: Peter Sallay

name: Division of Nephrology, Heidelberg University Hospital, Heidelberg, Germany (A.U.).

family: Ujszaszi

full_name: Akos Ujszaszi

given: Akos

family: Unterwurzacher

full_name: Markus Unterwurzacher

given: Markus

family: Wagner

full_name: Anja Wagner

given: Anja

family: Hildenbrand

full_name: Georg Hildenbrand

given: Georg

name: Children’s Mercy Kansas City, Kansas City, MO (B.A.W.).

family: Warady

full_name: Bradley A. Warady

given: Bradley A.

full_name: Franz Schaefer

given: Franz

name: Department of Physiology, Faculty of Medicine, University of Thessaly, Larissa, Greece (S.G.Z.).

family: Zarogiannis

full_name: Sotirios G. Zarogiannis

given: Sotirios G.

family: Kratochwill

full_name: Klaus Kratochwill

given: Klaus

family: Schmitt

full_name: Claus Peter Schmitt

given: Claus Peter

journal_name: Circulation Research

repository_institution: Semmelweis University - Semmelweis University Repository

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

location_facility: Service de Néphrologie Pédiatrique, Hôpital Femme Mere Enfant

location_facility: Pediatric Nephrology, Dialysis and Transplant Unit

location_facility: Paediatric CAPD unit, Kuala Lumpur Hospital

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

location_facility: Krakow, Jagiellonian University Medical College

location_facility: Hospital Universitario Materno-Infantil Vall d' Hebron

location_facility: Department of Pediatrics, Medical University Vienna

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


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


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: 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. 2021 Sep 12. doi: 10.1007/s10067-021-05894-2. [Epub ahead of print]

family: Kivitz

full_name: Alan J. Kivitz

given: Alan J.

family: FitzGerald

full_name: Oliver FitzGerald

given: Oliver

family: Nash

full_name: Peter Nash

given: Peter

family: Pang

full_name: Shirley Pang

given: Shirley

family: Azevedo

full_name: Valderilio F. Azevedo

given: Valderilio F.

family: Wang

full_name: Cunshan Wang

given: Cunshan

family: Takiya

full_name: Liza Takiya

given: Liza

journal_name: Clinical Rheumatology

license: cc-by

license_normalized: cc-by

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

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). pii: e001609. doi: 10.1136/rmdopen-2021-001609.

family: de Vlam

full_name: Kurt de Vlam

given: Kurt

family: Ogdie

full_name: Alexis Ogdie

given: Alexis

family: Bushmakin

full_name: Andrew G Bushmakin

given: Andrew G

family: Cappelleri

full_name: Joseph C Cappelleri

given: Joseph C

family: Fleischmann

full_name: Roy Fleischmann

given: Roy

family: Taylor

full_name: Peter C Taylor

given: Peter C

full_name: Valderilio Azevedo

given: Valderilio

family: Fallon

full_name: Lara Fallon

given: Lara

family: Woolcott

full_name: John Woolcott

given: John

family: Mease

full_name: Philip J Mease

given: Philip J

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

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.

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.

name: University of Rochester Medical Center Rochester New York

name: Perelman School of Medicine at the University of Pennsylvania Philadelphia Pennsylvania

name: Hospital Clínico Universitario Santiago de Compostela Spain

name: Leeds Institute of Rheumatic and Musculoskeletal Medicine University of Leeds Leeds UK

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.

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

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.

name: University of Toronto and Toronto Western Hospital Toronto Ontario Canada

name: St. Vincent's University Hospital and University College Dublin Dublin Ireland

name: Medical University of South Carolina Charleston

name: Amsterdam Rheumatology and Immunology CenterVU University Medical Center, and Reade Amsterdam The Netherlands

repositories_institution: The University of Glasgow - Enlighten: Publications

title: 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

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. Corrected and republished in: J Patient Rep Outcomes. 2019 May 20;3(1):30. Retraction in: J Patient Rep Outcomes. 2019 May 28;3(1):32.

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

title: RETRACTED ARTICLE: Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis

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

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

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

location_facility: Barking Havering and Redbridge University Hospitals NHS Trust

location_facility: Drug Shipment/Storage: Investigational Drug Services

location_facility: Wojewodzki Szpital Zespolony Zaklad Radiologii

location_facility: University Hospital Leuven, Department of Rheumatology

location_facility: Hospital Universitario Marques de Valdecilla

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

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

location_facility: Integral Rheumatology & Immunology Specialists (IRIS)

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

location_facility: Charite Universitatsmedizin Berlin - Campus Charite Mitte

location_facility: Sanatorio CEMSI Chapultepec (For Emergencies Only)

location_facility: CETAC - DIAGNOSTICO POR IMAGEM (image only)

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

location_facility: Cincinnati Rheumatic Disease Study Group, Inc.

location_facility: Rheumazentrum Prof. Dr. med Gunther Neeck

location_facility: Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba

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

location_facility: Universitaetsklinikum Erlangen, Medizinische Klinik 3

location_facility: Clinica Medica Bonfiglioli Ltda. / Clinica Bonfiglioli

location_facility: Dartmouth-Hitchcock Medical Center (DHMC)

location_facility: Centro Multidisciplinario para el Desarrollo

location_facility: City Neurological Centre "SibNeyroMed", LLC

location_facility: St. Luke's Intermountain Research Center

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

location_facility: York Hospital, York Teaching Hospital NHS Foundation Trust

location_facility: Hospital Erasme - Clinique Universitaire de Bruxelles

location_facility: State Autonomic Healthcare Institution City Clinical Hospital # 7

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: University Hospitals Case Medical Center

location_facility: Investigacion y Biomedicina de Chihuahua

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

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

location_facility: Hospital Universitaro Y Politecnico La Fe

location_facility: Royal United Hospitals NHS Foundation Trust

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

location_facility: Centro Integral en Reumatologia SA de CV

location_facility: State Budget Educational Institution of Highest Professional Education

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

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

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

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

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

location_facility: Centro de Investigacion Clinica Pensiones

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: Bradford Teaching Hospitals NHS Foundation Trust

location_facility: Ronald Reagan UCLA Medical Center, Drug Information Center

location_facility: Chang Gung Medical Foundation-Kaohsiung Branch

location_facility: Hospital Star Medica Merida (For Emergencies Only)

location_facility: Barking, Havering and Redbridge University Hospitals NHS Trust

location_facility: Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie

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

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

location_facility: Rheumatology Associates of Central Florida, PA

location_facility: Royal Prince Alfred Hospital, Rheumatology Department

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

location_facility: The Center For Rheumatology And Bone Research

location_facility: State Institution of Healthcare of Yaroslavl Region

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

location_facility: Rheumatology Associates of North Alabama, PC

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