summary: A 6-month (24-week), randomized, open label evaluation of the safety, tolerability, and efficacy of a high and low dose ambrisentan (adjusted for body weight) treatment group in subjects aged 8 years up to 18 years with pulmonary arterial hypertension (PAH). An additional objective is to determine the ambrisentan population pharmacokinetics in the paediatric population. The study will include a screening/baseline period and a treatment period. The treatment period will be 24 weeks or until the subject's clinical condition deteriorates to the point that alternative/additional treatment is necessary. Patients who participate in the study and in whom continued treatment with ambrisentan is desired will be eligible to enrol into a long term follow-up study. The primary comparison will be the safety and tolerability of the two ambrisentan dose groups (Low vs. High) in the paediatric PAH population The secondary comparison will be the change from baseline for the efficacy parameters between the two treatment groups.

title: A Randomized, Open Label Study Comparing Safety and Efficacy Parameters for a High and a Low Dose of Ambrisentan (Adjusted for Body Weight) for the Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years


type: EudraCT Number

title: A Multicenter, Randomized, Blinded, Placebo-controlled Study To Evaluate The Safety Of Maraviroc In Combination With Other Antiretroviral Agents In Hiv-1-infected Subjects Co-infected With Hepatitis C And/or Hepatitis B Virus

summary: To describe liver enzyme elevations in patients who are coinfected with HIV and either Hepatitis C (HCV) and/or Hepatitis B (HBV) receiving maraviroc or placebo in combination with their current suppressive anti-HIV drug therapy.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Rockstroh JK, Plonski F, Bansal M, Fatkenheuer G, Small CB, Asmuth DM, Pialoux G, Zhang-Roper R, Wang R, Pineda JA, Heera J. Hepatic safety of maraviroc in patients with HIV-1 and hepatitis C and/or B virus: 144-week results from a randomized, placebo-controlled trial. Antivir Ther. 2017;22(3):263-269. doi: 10.3851/IMP3116. Epub 2016 Dec 7.

oa_host_type: repository

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

version: submittedVersion

unpaywall_oa_status: green

publisher_dissemination: SAGE Publications

ReferenceCitation: Rockstroh JK, Soriano V, Plonski F, Bansal M, Fatkenheuer G, Small CB, Asmuth DM, Pialoux G, Mukwaya G, Jagannatha S, Heera J, Pineda JA. Hepatic safety in subjects with HIV-1 and hepatitis C and/or B virus: a randomized, double-blind study of maraviroc versus placebo in combination with antiretroviral agents. HIV Clin Trials. 2015 Mar-Apr;16(2):72-80. doi: 10.1179/1528433614Z.0000000011. Erratum In: HIV Clin Trials. 2015 Nov;16(6):236-8.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

version: publishedVersion

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

repository_institution: University of California - eScholarship University of California

unpaywall_oa_status: hybrid

publisher_dissemination: Informa

lead_sponsor: ViiV Healthcare

sponsor_collaborators:
ViiV Healthcare
Pfizer

location_country:
Germany
Poland
Hungary
United Kingdom
United States
Spain
Czechia
Puerto Rico
France

location_facility: University of South Florida Health - HIV Clinical Research Unit

location_facility: EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej

location_facility: Universitaetsklinikum Bonn, Immunologische Ambulanz HIV

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Hopital Tenon, Service des Maladies Infectieuses

location_facility: The Office of Dr. Franco Antonio Felizarta, M.D.

location_facility: Southwest Infectious Disease Clinical Research Inc.

location_facility: Alameda Health System - Highland Hospital

location_facility: EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH

location_facility: Hospital Reina Sofia Hospital Provincial

location_facility: Egyesített Szent István és Szent László Kórház Rendelőintézet

location_facility: University of Iowa Hospitals and Clinics

location_facility: Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza w Bydgoszczy

location_facility: University of California, San Francisco - Hepatitis/HIV Clinical Trials Group (HHCTG)

location_facility: Harrison Wing Research Office, Guys and St. Thomas NHS Foundation Trust

location_facility: Kaiser Permanente Sunnybrook Medical Office

location_facility: University of Puerto Rico - School of Medicine

location_facility: Community AIDS Resource Inc dba Care Resource

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Centre Hospitalier Cochin Saint Vincent de Paul

location_facility: University of California, San Francisco - Mt. Zion Hospital

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase I Open-label Dose Escalation Study With Expansion to Assess the Safety and Tolerability of INC280 in Patients With c-MET Dependent Advanced Solid Tumors

summary: This study will assess the safety and efficacy of INC280 in patients with solid tumors that are refractory to current treatment or for which there is not a current standard of care and whose tumors have dysregulation of the c-MET pathway.

ReferenceCitation: Schuler M, Berardi R, Lim WT, de Jonge M, Bauer TM, Azaro A, Gottfried M, Han JY, Lee DH, Wollner M, Hong DS, Vogel A, Delmonte A, Akimov M, Ghebremariam S, Cui X, Nwana N, Giovannini M, Kim TM. Molecular correlates of response to capmatinib in advanced non-small-cell lung cancer: clinical and biomarker results from a phase I trial. Ann Oncol. 2020 Jun;31(6):789-797. doi: 10.1016/j.annonc.2020.03.293. Epub 2020 Mar 30.

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: Erasmus University, Rotterdam - RePub

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

version: acceptedVersion

publisher_dissemination: Elsevier

ReferenceCitation: Bang YJ, Su WC, Schuler M, Nam DH, Lim WT, Bauer TM, Azaro A, Poon RTP, Hong D, Lin CC, Akimov M, Ghebremariam S, Zhao S, Giovannini M, Ma B. Phase 1 study of capmatinib in MET-positive solid tumor patients: Dose escalation and expansion of selected cohorts. Cancer Sci. 2020 Feb;111(2):536-547. doi: 10.1111/cas.14254. Epub 2019 Dec 30.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: PubMed Central - Europe PMC

repository_institution: Seoul National University - Seoul National University Open Repository

unpaywall_oa_status: gold

publisher_dissemination: Wiley

ipd_sharing: No

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Israel
Hong Kong
Norway
Australia
Singapore
Netherlands
United States
Korea, Republic of
Spain
Thailand
Taiwan
Canada
France

location_facility: Sarah Cannon Research Institute Dept of Onc

location_facility: University of Texas/MD Anderson Cancer Center Dept of Onc

location_facility: Karmanos Cancer Institute Wayne St Karmanos


title: A Phase Ib, Open-label, Dose-finding Study of the JAK Inhibitor INC424 Tablets Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-polycythemia Veramyelofibrosis (PPV-MF) or Post-essentialthrombocythemia-myelofibrosis (PET-MF) and Baseline Platelet Counts ≥50 x109/L and <100 x109/L (EXPAND)

summary: This is a Phase IB, open-label, dose-finding study of the JAK 1 and 2 inhibitor ruxolitinib in patients with myelofibrosis (MF). The study consists of two periods: the core study period, comprising the dose escalation stage and the safety extension phase up to Week 24, then the extension study period beyond Week 24 and up to 3 years, to further characterize the safety and efficacy of ruxolitinib in this patient population. The dose escalation phase will enroll successive cohorts of patients who receive increasing doses of ruxolitinib until the maximum safe starting dose (MSSD) is determined. In the safety expansion phase, additional patients will be treated with ruxolitinib at the MSSD defined during dose escalation. The primary objective is to establish the MSSD of ruxolitinib in patients with MF and starting platelet counts < 100 x 10 ^9/L

ReferenceCitation: Guglielmelli P, Kiladjian JJ, Vannucchi AM, Duan M, Meng H, Pan L, He G, Verstovsek S, Boyer F, Barraco F, Niederwieser D, Pungolino E, Liberati AM, Harrison C, Roussou P, Wroclawska M, Karumanchi D, Sinclair K, Te Boekhorst PAW, Gisslinger H. Efficacy and safety of ruxolitinib in patients with myelofibrosis and low platelet count (50 x 109/L to <100 x 109/L) at baseline: the final analysis of EXPAND. Ther Adv Hematol. 2022 Sep 10;13:20406207221118429. doi: 10.1177/20406207221118429. eCollection 2022.

repositories_concat: PubMed Central;pure.eur.nl

repositories_institution: Erasmus University Rotterdam - EUR Research Repository

lead_sponsor: Incyte Corporation

sponsor_collaborators:
Incyte Corporation
Novartis

location_country:
Germany
Italy
United Kingdom
Netherlands
Austria
United States
China
France


title: A Randomized, Multicenter, Double-blind, Placebo and Active-controlled, Cross-over Study of the Efficacy and Safety of BMS-954561 in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

summary: The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared to placebo in the treatment of patients with diabetic peripheral neuropathic pain (DPNP).

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
France

location_facility: The Center For Pharmaceutical Research. Pc

location_facility: Comprehensive Clinical Development, Inc.


title: A Randomized, Open-label, Phase 3 Study of Carfilzomib vs Best Supportive Care in Subjects With Relapsed and Refractory Multiple Myeloma

acronym: FOCUS

summary: This is a Phase 3, randomized, open-label, multicenter study comparing two treatment regimens for subjects with multiple myeloma who have received all available approved treatment options and may therefore be considered candidates for palliative care.

ReferenceCitation: Hajek R, Masszi T, Petrucci MT, Palumbo A, Rosinol L, Nagler A, Yong KL, Oriol A, Minarik J, Pour L, Dimopoulos MA, Maisnar V, Rossi D, Kasparu H, Van Droogenbroeck J, Yehuda DB, Hardan I, Jenner M, Calbecka M, David M, de la Rubia J, Drach J, Gasztonyi Z, Gornik S, Leleu X, Munder M, Offidani M, Zojer N, Rajangam K, Chang YL, San-Miguel JF, Ludwig H. A randomized phase III study of carfilzomib vs low-dose corticosteroids with optional cyclophosphamide in relapsed and refractory multiple myeloma (FOCUS). Leukemia. 2017 Jan;31(1):107-114. doi: 10.1038/leu.2016.176. Epub 2016 Jun 24.

evidence: open (via page says license)

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery
ddd.uab.cat

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

publisher_dissemination: Springer-Nature

ReferenceCitation: Hajek R, Bryce R, Ro S, Klencke B, Ludwig H. Design and rationale of FOCUS (PX-171-011): a randomized, open-label, phase 3 study of carfilzomib versus best supportive care regimen in patients with relapsed and refractory multiple myeloma (R/R MM). BMC Cancer. 2012 Sep 19;12:415. doi: 10.1186/1471-2407-12-415.

lead_sponsor: Amgen

location_country:
Germany
Poland
New Zealand
Australia
Czechia
Serbia
France
Slovakia
Hungary
Belgium
Italy
United Kingdom
Sweden
Austria
Korea, Republic of
Spain
Greece
Russian Federation
Israel


title: Clinical Investigation of a DES (MiStent™ System) With Sirolimus and a Bioabsorbable Polymer for the Treatment of Patients With De Novo Lesions in Native Coronary Arteries.

acronym: DESSOLVE-II

summary: The DESSOLVE II clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent for the treatment for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions in the native coronary arteries.

ReferenceCitation: Rusinaru D, Vrolix M, Verheye S, Chowdhary S, Schoors D, Di Mario C, Desmet W, Donohoe DJ, Ormiston JA, Knape C, Bezerra H, Lansky A, Wijns W; DESSOLVE II Investigators. Bioabsorbable polymer-coated sirolimus-eluting stent implantation preserves coronary vasomotion: A DESSOLVE II trial sub-study. Catheter Cardiovasc Interv. 2015 Dec 1;86(7):1141-50. doi: 10.1002/ccd.25610. Epub 2015 Sep 22.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: Wijns W, Vrolix M, Verheye S, Schoors D, Slagboom T, Gosselink M, Benit E, Donohoe D, Knape C, Attizzani GF, Lansky AJ, Ormiston J; DESSOLVE II Investigators. Randomised study of a bioabsorbable polymer-coated sirolimus-eluting stent: results of the DESSOLVE II trial. EuroIntervention. 2015 Apr;10(12):1383-90. doi: 10.4244/EIJY14M05_03.

publisher_dissemination: Europa Digital & Publishing

lead_sponsor: Micell Technologies

location_country:
France
New Zealand
United Kingdom
Netherlands
Belgium
Sweden

location_facility:
Hospital Weezenlanden
OLV
St. Antonius Ziekenhuis
Christchurch Hospital
Mercy Angiography Unit
KUL Cardiology Gasthuisberg
Southampton UHT
University Hospital South Manchester
TweeSteden Ziekenhuis
Papworth Hospital
Norfolk/Norwich UHosp
Dunedin Hospital
Orebro University Hospital
UMC Utrecht
Jacques Cartier Hospital
Claude Galien Hospital
Clinique Pasteur
Guy's & St. Thomas'
Sahlgrenska University Hospital
Wellington Hospital
Royal Sussex Hosp
Antwerp Hospital, ZNA Middelheim
Royal Brompton
Brussels University Hospital
Ziekenhuis Oost-Limburg
Auckland City Hospital
Virga Jesse Ziekenhuis
Cardiovascular Center

intervention_type: Device


acronym: ASTERIA II

lead_sponsor: Genentech, Inc.

summary: The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dosed H1 antihistamine treatment.

ReferenceCitation: Ferrer M, Gimenez-Arnau A, Saldana D, Janssens N, Balp MM, Khalil S, Risson V. Predicting Chronic Spontaneous Urticaria Symptom Return After Omalizumab Treatment Discontinuation: Exploratory Analysis. J Allergy Clin Immunol Pract. 2018 Jul-Aug;6(4):1191-1197.e5. doi: 10.1016/j.jaip.2018.04.003. Epub 2018 Apr 12. Erratum In: J Allergy Clin Immunol Pract. 2018 Sep - Oct;6(5):1810.

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

repository_institution: University of Navarra - Deposito Adademico Digital Universidad De Navarra

ReferenceCitation: Goldstein S, Gabriel S, Kianifard F, Ortiz B, Skoner DP. Clinical features of adolescents with chronic idiopathic or spontaneous urticaria: Review of omalizumab clinical trials. Ann Allergy Asthma Immunol. 2017 Apr;118(4):500-504. doi: 10.1016/j.anai.2017.02.003.

oa_host_type: publisher

ReferenceCitation: Saini SS, Omachi TA, Trzaskoma B, Hulter HN, Rosen K, Sterba PM, Courneya JP, Lackey A, Chen H. Effect of Omalizumab on Blood Basophil Counts in Patients with Chronic Idiopathic/Spontaneous Urticaria. J Invest Dermatol. 2017 Apr;137(4):958-961. doi: 10.1016/j.jid.2016.11.025. Epub 2016 Dec 6. No abstract available. Erratum In: J Invest Dermatol. 2019 Feb;139(2):496-497.

ReferenceCitation: Gimenez-Arnau AM, Spector S, Antonova E, Trzaskoma B, Rosen K, Omachi TA, Stull D, Balp MM, Murphy T. Improvement of sleep in patients with chronic idiopathic/spontaneous urticaria treated with omalizumab: results of three randomized, double-blind, placebo-controlled studies. Clin Transl Allergy. 2016 Aug 18;6:32. doi: 10.1186/s13601-016-0120-0. eCollection 2016.

license: cc-by

license_normalized: cc-by

ReferenceCitation: Zazzali JL, Kaplan A, Maurer M, Raimundo K, Trzaskoma B, Solari PG, Antonova E, Mendelson M, Rosen KE. Angioedema in the omalizumab chronic idiopathic/spontaneous urticaria pivotal studies. Ann Allergy Asthma Immunol. 2016 Oct;117(4):370-377.e1. doi: 10.1016/j.anai.2016.06.024. Epub 2016 Jul 14.

ReferenceCitation: Casale TB, Bernstein JA, Maurer M, Saini SS, Trzaskoma B, Chen H, Grattan CE, Gimenez-Arnau A, Kaplan AP, Rosen K. Similar Efficacy with Omalizumab in Chronic Idiopathic/Spontaneous Urticaria Despite Different Background Therapy. J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):743-50.e1. doi: 10.1016/j.jaip.2015.04.015. Epub 2015 Jun 6.

ReferenceCitation: Maurer M, Rosen K, Hsieh HJ, Saini S, Grattan C, Gimenez-Arnau A, Agarwal S, Doyle R, Canvin J, Kaplan A, Casale T. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med. 2013 Mar 7;368(10):924-35. doi: 10.1056/NEJMoa1215372. Epub 2013 Feb 24. Erratum In: N Engl J Med. 2013 Jun 13;368(24):2340-1.

title: A Phase III, Multicenter, Randomized, Double-blind, Dose-ranging, Placebo-controlled Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria Who Remain Symptomatic Despite Antihistamine Treatment (H1)

location_country:
Germany
Italy
Poland
Denmark
United States
Spain
Turkey
France


type: Other Identifier

title: A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)

acronym: ANDANTE

summary: This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.

ReferenceCitation: Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25.

oa_colors: green other

evidence: open (via free article)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

ReferenceCitation: Danese S, Vermeire S, Hellstern P, Panaccione R, Rogler G, Fraser G, Kohn A, Desreumaux P, Leong RW, Comer GM, Cataldi F, Banerjee A, Maguire MK, Li C, Rath N, Beebe J, Schreiber S. Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II). Gut. 2019 Jan;68(1):40-48. doi: 10.1136/gutjnl-2017-314562. Epub 2017 Dec 15.

publisher_dissemination: British Medical Journal

lead_sponsor: Pfizer

location_country:
France
Germany
Ireland
Italy
New Zealand
Hungary
Israel
Denmark
Australia
Brazil
Romania
Switzerland
Belgium
United Kingdom
United States
Greece
Canada
Czech Republic

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak./I. Belgyogyaszati-Gasztroenterologiai

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Medical Research Center of Connecticut, LLC

location_facility: University of Louisville Research Foundation

location_facility: University of California - San Francisco

location_facility: Aarhus Universitetshospital, Aarhus Sygehus Aarhus University Hospital

location_facility: Klinicke centrum ISCARE I.V.F. - gastroenterologie

location_facility: Hospital Universitário Fraga Filho da UFRJ

location_facility: New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Hopital Saint-Antoine - Service De Gastroenterologie

location_facility: Heritage Medical Research Clinic - University of Calgary

location_facility: The Institute Of Gastroenterology & Liver Diseases

location_facility: Hull and East Yorkshire Hospitals NHS Trust

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: London Health Science Centre - University Hospital

location_facility: McGill University Health Centre - Royal Victoria Hospital

location_facility: Physicians Endoscopy Center (Colonoscopy)

location_facility: University of California San Francisco at Mount Zion

location_facility: Research Protocol Management Specialists

location_facility: Pioneer Research Solutions, Inc. (Admin. Office)

location_facility: Baylor College of Medicine - Baylor Medical Center

location_facility: Maryland Diagnostics & Therapeutic Endo Center

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: Royal Free Hospital (Royal Free London NHS Foundation Trust)

location_facility: Weill Cornell Medical College of Cornell University-Greenberg

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: The University of Texas Health Science Center at Houston

location_facility: Casa Sollievo della Sofferenza/Div.Gastroenterologia Endoscopia Digestiva

location_facility: International Clinical Research - US, LLC

location_facility: Newcross Hospital-The Royal Wolverhampton Hospitals NHS Trust

location_facility: Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar / I. sz. Belgyogyaszati Klinika

location_facility: Colonoscopy and X-rays: OU Physicians Building

location_facility: The University of Chicago Medical Center (Ucmc)

location_facility: General Hospital of Athens "Evangelismos",1st Gastroenterology Department

location_facility: Houston Hospital for Specialized Surgery (Endoscopy Only)

location_facility: The University of Texas Medical School at Houston

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

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda.

location_facility: Medicinsk Afdeling, Gastroenterologisk Sektion

location_facility: A. Gemelli University Hospital-Department of Medical Sciences - Division of Internal Medicine and

location_facility: VCU Medical Investigational Drug Service (IDS)

location_facility: Gastroenterology Associates of Western Michigan

location_facility: Weill Cornell Imaging at New York Presbyterian Hospital

location_facility: Addenbrooke's Hospital, Department of Gastroenterology

location_facility: Azienda Ospedaliera - Universita di Padova

location_facility: Institut klinicke a experimentalni mediciny

location_facility: An Spiessens H.-Hartziekenhuis Roeselare-Menen vzw

location_facility: Semmelweis Egyetem II. Sz. Belgyogyaszati Klinika

location_facility: Oklahoma Foundation for Digestive Research

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: University Of Louisville Healthcare Outpatient Center

location_facility: Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology

location_facility: Pathology, Haematology and Biochemistry Laboratories, St Vincent's Healthcare Group


acronym: ASTERIA I

summary: The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dose H1 antihistamine treatment.

repositories_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

repositories_institution: University of Navarra - Deposito Adademico Digital Universidad De Navarra

ReferenceCitation: Saini SS, Bindslev-Jensen C, Maurer M, Grob JJ, Bulbul Baskan E, Bradley MS, Canvin J, Rahmaoui A, Georgiou P, Alpan O, Spector S, Rosen K. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: a randomized, placebo-controlled study. J Invest Dermatol. 2015 Jan;135(1):67-75. doi: 10.1038/jid.2014.306. Epub 2014 Jul 21. Erratum In: J Invest Dermatol. 2015 Mar;135(3):925.

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

title: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Xolair® (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)


title: An Open-Label, Multi-Center Phase II Study of the BRAF Inhibitor Vemurafenib in Patients With Metastatic or Unresectable Papillary Thyroid Cancer (PTC) Positive for the BRAF V600 Mutation and Resistant to Radioactive Iodine

summary: This open-label, multi-center study will evaluate the safety and efficacy of Vemurafenib (RO5185426) in participants with metastatic or unresectable papillary thyroid cancer (PTC) positive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Participants will receive vemurafenib 960 milligrams (mg) orally twice daily until progressive disease or unacceptable toxicity occurs.

design_allocation: Non-Randomized

ReferenceCitation: Brose MS, Cabanillas ME, Cohen EE, Wirth LJ, Riehl T, Yue H, Sherman SI, Sherman EJ. Vemurafenib in patients with BRAF(V600E)-positive metastatic or unresectable papillary thyroid cancer refractory to radioactive iodine: a non-randomised, multicentre, open-label, phase 2 trial. Lancet Oncol. 2016 Sep;17(9):1272-82. doi: 10.1016/S1470-2045(16)30166-8. Epub 2016 Jul 23.

repositories_concat: PubMed Central;escholarship.org

repositories_institution: University of California - eScholarship University of California

lead_sponsor: Hoffmann-La Roche

location_country:
United States
Italy
Netherlands
France


title: A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma

summary: The primary objective of this study is to determine whether reslizumab is more effective than placebo in reducing the number of clinical asthma exacerbations (CAEs) in patients with eosinophilic asthma.

ReferenceCitation: Nair P, Bardin P, Humbert M, Murphy KR, Hickey L, Garin M, Vanlandingham R, Chanez P. Efficacy of Intravenous Reslizumab in Oral Corticosteroid-Dependent Asthma. J Allergy Clin Immunol Pract. 2020 Feb;8(2):555-564. doi: 10.1016/j.jaip.2019.09.036. Epub 2019 Oct 15.

repository_institution: Monash University - Monash University Research Portal

ReferenceCitation: Carr WW, McDonald M, Meizlik P. Effect of intravenously administered reslizumab on spirometric lung age in patients with moderate-to-severe eosinophilic asthma. Allergy Asthma Proc. 2019 Jul 1;40(4):240-249. doi: 10.2500/aap.2019.40.4225.

publisher_dissemination: Oceanside Publications Inc.

ReferenceCitation: Han S, Kim S, Kim H, Suh HS. Cost-utility analysis of reslizumab for patients with severe eosinophilic asthma inadequately controlled with high-dose inhaled corticosteroids and long-acting beta2-agonists in South Korea. Curr Med Res Opin. 2019 Sep;35(9):1597-1605. doi: 10.1080/03007995.2019.1605159. Epub 2019 May 16.

ReferenceCitation: Bateman ED, Djukanovic R, Castro M, Canvin J, Germinaro M, Noble R, Garin M, Buhl R. Predicting Responders to Reslizumab after 16 Weeks of Treatment Using an Algorithm Derived from Clinical Studies of Patients with Severe Eosinophilic Asthma. Am J Respir Crit Care Med. 2019 Feb 15;199(4):489-495. doi: 10.1164/rccm.201708-1668OC.

publisher_dissemination: American Thoracic Society

ReferenceCitation: Weinstein SF, Katial RK, Bardin P, Korn S, McDonald M, Garin M, Bateman ED, Hoyte FCL, Germinaro M. Effects of Reslizumab on Asthma Outcomes in a Subgroup of Eosinophilic Asthma Patients with Self-Reported Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2019 Feb;7(2):589-596.e3. doi: 10.1016/j.jaip.2018.08.021. Epub 2018 Sep 5.

ReferenceCitation: Brusselle G, Germinaro M, Weiss S, Zangrilli J. Reslizumab in patients with inadequately controlled late-onset asthma and elevated blood eosinophils. Pulm Pharmacol Ther. 2017 Apr;43:39-45. doi: 10.1016/j.pupt.2017.01.011. Epub 2017 Jan 31.

repository_institution: Ghent University - Ghent University Academic Bibliography

ReferenceCitation: Castro M, Zangrilli J, Wechsler ME, Bateman ED, Brusselle GG, Bardin P, Murphy K, Maspero JF, O'Brien C, Korn S. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015 May;3(5):355-66. doi: 10.1016/S2213-2600(15)00042-9. Epub 2015 Feb 23. Erratum In: Lancet Respir Med. 2015 Apr;3(4):e15. Lancet Respir Med. 2016 Oct;4(10 ):e50.

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Germany
Slovakia
Argentina
Romania
Brazil
Mexico
United States
Korea, Republic of
Greece
Taiwan
Peru
Canada
Ukraine
Russian Federation
France

location_facility:
Teva Investigational Site 764
Teva Investigational Site 53
Teva Investigational Site 625
Teva Investigational Site 229
Teva Investigational Site 765
Teva Investigational Site 556
Teva Investigational Site 621
Teva Investigational Site 140
Teva Investigational Site 67
Teva Investigational Site 366
Teva Investigational Site 226
Teva Investigational Site 682
Teva Investigational Site 540
Teva Investigational Site 363
Teva Investigational Site 203
Teva Investigational Site 143
Teva Investigational Site 209
Teva Investigational Site 41
Teva Investigational Site 45
Teva Investigational Site 47
Teva Investigational Site 380
Teva Investigational Site 686
Teva Investigational Site 685
Teva Investigational Site 562
Teva Investigational Site 123
Teva Investigational Site 46
Teva Investigational Site 44
Teva Investigational Site 629
Teva Investigational Site 144
Teva Investigational Site 342
Teva Investigational Site 360
Teva Investigational Site 368
Teva Investigational Site 370
Teva Investigational Site 521
Teva Investigational Site 620
Teva Investigational Site 121
Teva Investigational Site 633
Teva Investigational Site 207
Teva Investigational Site 367
Teva Investigational Site 25
Teva Investigational Site 559
Teva Investigational Site 563
Teva Investigational Site 225
Teva Investigational Site 371
Teva Investigational Site 557
Teva Investigational Site 520
Teva Investigational Site 626
Teva Investigational Site 763
Teva Investigational Site 622
Teva Investigational Site 372
Teva Investigational Site 524
Teva Investigational Site 365
Teva Investigational Site 105
Teva Investigational Site 120
Teva Investigational Site 221
Teva Investigational Site 102
Teva Investigational Site 28
Teva Investigational Site 630
Teva Investigational Site 381
Teva Investigational Site 142
Teva Investigational Site 145
Teva Investigational Site 48
Teva Investigational Site 104
Teva Investigational Site 523
Teva Investigational Site 222
Teva Investigational Site 760
Teva Investigational Site 205
Teva Investigational Site 364
Teva Investigational Site 543
Teva Investigational Site 554
Teva Investigational Site 362
Teva Investigational Site 369
Teva Investigational Site 681
Teva Investigational Site 561
Teva Investigational Site 202
Teva Investigational Site 220
Teva Investigational Site 761
Teva Investigational Site 361
Teva Investigational Site 632
Teva Investigational Site 40
Teva Investigational Site 635
Teva Investigational Site 27
Teva Investigational Site 69
Teva Investigational Site 204
Teva Investigational Site 541
Teva Investigational Site 560
Teva Investigational Site 59
Teva Investigational Site 57
Teva Investigational Site 544
Teva Investigational Site 680
Teva Investigational Site 382
Teva Investigational Site 631
Teva Investigational Site 343
Teva Investigational Site 628
Teva Investigational Site 522
Teva Investigational Site 558
Teva Investigational Site 223
Teva Investigational Site 623
Teva Investigational Site 126
Teva Investigational Site 227
Teva Investigational Site 150
Teva Investigational Site 341
Teva Investigational Site 683
Teva Investigational Site 624


title: A Phase 2a, Randomized, Double-blind, Sponsor Unblinded, Placebo-controlled, Multiple Dose Study To Evaluate The Pharmacodynamics, Pharmacokinetics And Safety Of Anrukinzumab In Subjects With Active Ulcerative Colitis

summary: This study represents the first investigation of anrukinzumab in patients with active ulcerative colitis (UC) and will evaluate proof of mechanism by changes in the mechanism based biomarker (YKL 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and hs-CRP). It will provide further assessment of the safety, tolerability, and pharmacokinetics (PK) by administration of multiple intravenous (IV) doses of anrukinzumab.

ReferenceCitation: Reinisch W, Panes J, Khurana S, Toth G, Hua F, Comer GM, Hinz M, Page K, O'Toole M, Moorehead TM, Zhu H, Sun Y, Cataldi F. Anrukinzumab, an anti-interleukin 13 monoclonal antibody, in active UC: efficacy and safety from a phase IIa randomised multicentre study. Gut. 2015 Jun;64(6):894-900. doi: 10.1136/gutjnl-2014-308337. Epub 2015 Jan 7.

location_country:
Germany
Poland
Hungary
Romania
Netherlands
Austria
United States
Spain
Bulgaria
Canada
France

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Columbia Medical Group - The First Clinic Inc.

location_facility: Centennial Medical Center Tower Medical Imaging

location_facility: Vancouver Coastal Health - Vancouver General Hospital

location_facility: Premier Medical Group of the Hudson Valley

location_facility: MBAL Ruse / MHAT Ruse, Terapevtichno, gastroenterologichno i hematologichno otdelenie

location_facility: Vancouver General Hospital - The Gordon and Leslie Diamond Centre

location_facility: Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology

location_facility: International Clinical Research - US, LLC

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: University Hospitals Case Medical Center - Division of Gastroenterology and Liver Disease

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III

location_facility: DKTs Sveta Anna, Gastroenterologichen cabinet

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: The Religious Hospitallers of St. Joseph of the Hotel Dieu of Kingston

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Centennial Medical Center Physicians Park

location_facility: Heritage Medical Research Clinic - University of Calgary

location_facility: Centralny Szpital Kliniczny MSWiA, Klinika Chorob Wewnetrznych i Gastroenterologii

location_facility: MBAL Voennomeditsinska Akademia / MMA HAT, Klinika po gastroenterologia i hepatologia

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszati-Gasztroenterologiai Osztaly

location_facility: Gastroenterology Research of San Antonio

intervention_type: Other


title: A Prospective, Non-interventional, Longitudinal Cohort Study To Evaluate The Long-term Safety Of Latanoprost Treatment In Pediatric Populations

acronym: LYNX

summary: This is a non-interventional, prospective, longitudinal cohort study. A total of 150 pediatric subjects with glaucoma or elevated intraocular pressure, including 75 latanoprost-treated subjects and 75 non-topical prostaglandin analogue treated subjects, will be enrolled from ophthalmic hospital clinics and academic ophthalmic centers. As a non-interventional study, the study subjects' continued use of latanoprost and assessments of ocular events will be obtained through the routine medical follow-up with treating ophthalmologists or other designated members of the medical care team.

study_type: Observational

time_perspective: Prospective

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

location_country:
Germany
Italy
Colombia
Portugal
Slovakia
United Kingdom
Denmark
Sweden
Belgium
Spain
Greece
Czechia
Peru
France

location_facility: Universitaetsklinikum Giessen und Marburg

location_facility: Unita' Operativa di Oculistica Pediatrica, Azienda Ospedaliera Ospedale Niguarda Ca'Grande

location_facility: Birmingham and Midland Eye Centre, Consultant Ophthalmologist

location_facility: Universitair Ziekenhuis Antwerpen, Dienst Oftalmologie

location_facility: AIBILI - Associação para a Investigação Biomédica e Inovação em Luz e Imagem

location_facility: Istituto Giannina Gaslini, Divisione di Oculistica

location_facility: Detska Fakultna nemocnica s poliklinikou Bratislava

location_facility: Fondation Ophtalmologique Adolphe de Rothschild

location_facility: University General Hospital of Thessaloniki AHEPA

location_facility: Universitair Ziekenhuis Leuven - Campus Sint-Raphaël


acronym: BRITE

lead_sponsor: UCB Pharma

summary: This study will evaluate the efficacy and safety of brivaracetam at doses of 100 and 200mg/day compared to placebo as adjunctive treatment in adult focal epilepsy subjects with partial onset seizures not fully controlled despite current treatment with 1 or 2 concomitant antiepileptic drugs.

ReferenceType: result

ReferenceCitation: Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016 Jul;57(7):1139-51. doi: 10.1111/epi.13416. Epub 2016 Jun 6.

ReferenceCitation: Ben-Menachem E, Mameniskiene R, Quarato PP, Klein P, Gamage J, Schiemann J, Johnson ME, Whitesides J, McDonough B, Eckhardt K. Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies. Neurology. 2016 Jul 19;87(3):314-23. doi: 10.1212/WNL.0000000000002864. Epub 2016 Jun 22.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Klein P, Schiemann J, Sperling MR, Whitesides J, Liang W, Stalvey T, Brandt C, Kwan P. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia. 2015 Dec;56(12):1890-8. doi: 10.1111/epi.13212. Epub 2015 Oct 16.

ReferenceCitation: Brodie MJ, Whitesides J, Schiemann J, D'Souza J, Johnson ME. Tolerability, safety, and efficacy of adjunctive brivaracetam for focal seizures in older patients: A pooled analysis from three phase III studies. Epilepsy Res. 2016 Nov;127:114-118. doi: 10.1016/j.eplepsyres.2016.08.018. Epub 2016 Aug 18.

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Moseley BD, Sperling MR, Asadi-Pooya AA, Diaz A, Elmouft S, Schiemann J, Whitesides J. Efficacy, safety, and tolerability of adjunctive brivaracetam for secondarily generalized tonic-clonic seizures: Pooled results from three Phase III studies. Epilepsy Res. 2016 Nov;127:179-185. doi: 10.1016/j.eplepsyres.2016.09.003. Epub 2016 Sep 3.

ReferenceCitation: Brandt C, Borghs S, Elmoufti S, Mueller K, Townsend R, de la Loge C. Health-related quality of life in double-blind Phase III studies of brivaracetam as adjunctive therapy of focal seizures: A pooled, post-hoc analysis. Epilepsy Behav. 2017 Apr;69:80-85. doi: 10.1016/j.yebeh.2016.11.031. Epub 2017 Feb 23.

ReferenceCitation: Klein P, Johnson ME, Schiemann J, Whitesides J. Time to onset of sustained >/=50% responder status in patients with focal (partial-onset) seizures in three phase III studies of adjunctive brivaracetam treatment. Epilepsia. 2017 Feb;58(2):e21-e25. doi: 10.1111/epi.13631. Epub 2016 Dec 18.

ReferenceCitation: Asadi-Pooya AA, Sperling MR, Chung S, Klein P, Diaz A, Elmoufti S, Schiemann J, Whitesides J. Efficacy and tolerability of adjunctive brivaracetam in patients with prior antiepileptic drug exposure: A post-hoc study. Epilepsy Res. 2017 Mar;131:70-75. doi: 10.1016/j.eplepsyres.2017.02.007. Epub 2017 Feb 27. Erratum In: Epilepsy Res. 2017 Nov;137:165-166.

repository_institution: Thomas Jefferson University - Jefferson Digital Commons

ReferenceCitation: Benbadis S, Klein P, Schiemann J, Diaz A, Elmoufti S, Whitesides J. Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy Behav. 2018 Mar;80:129-134. doi: 10.1016/j.yebeh.2017.12.024. Epub 2018 Feb 3.

ReferenceCitation: Brodie MJ, Fakhoury T, McDonough B, Colson AO, Stockis A, Elmoufti S, Whitesides J. Brivaracetam-induced elevation of carbamazepine epoxide levels: A post-hoc analysis from the clinical development program. Epilepsy Res. 2018 Sep;145:55-62. doi: 10.1016/j.eplepsyres.2018.06.002. Epub 2018 Jun 4.

ReferenceCitation: Klein P, Laloyaux C, Elmoufti S, Gasalla T, Martin MS. Time course of 75%-100% efficacy response of adjunctive brivaracetam. Acta Neurol Scand. 2020 Aug;142(2):175-180. doi: 10.1111/ane.13287. Epub 2020 Jun 9.

ReferenceCitation: Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.

ReferenceCitation: Ryvlin P, Dimova S, Elmoufti S, Floricel F, Laloyaux C, Nondonfaz X, Biton V. Tolerability and efficacy of adjunctive brivaracetam in adults with focal seizures by concomitant antiseizure medication use: Pooled results from three phase 3 trials. Epilepsia. 2022 Aug;63(8):2024-2036. doi: 10.1111/epi.17304. Epub 2022 Jun 10.

ReferenceCitation: Bresnahan R, Panebianco M, Marson AG. Brivaracetam add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2022 Mar 14;3(3):CD011501. doi: 10.1002/14651858.CD011501.pub3.

ReferenceCitation: Lee SK, Heo K, Kim SE, Lee SA, Elmoufti S, Laloyaux C, Hur B. Effect of Number of Previous Antiseizure Medications on Efficacy and Tolerability of Adjunctive Brivaracetam for Uncontrolled Focal Seizures: Post Hoc Analysis. Adv Ther. 2021 Jul;38(7):4082-4099. doi: 10.1007/s12325-021-01816-5. Epub 2021 Jun 21.

ReferenceCitation: Toledo M, Brandt C, Quarato PP, Schulz AL, Cleveland JM, Wagener G, Klein P. Long-term safety, efficacy, and quality of life during adjunctive brivaracetam treatment in patients with uncontrolled epilepsy: An open-label follow-up trial. Epilepsy Behav. 2021 May;118:107897. doi: 10.1016/j.yebeh.2021.107897. Epub 2021 Mar 27.

ReferenceCitation: Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.

title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥16 to 80 Years Old) With Partial Onset Seizures

location_country:
Finland
Germany
Poland
Japan
Brazil
Czechia
Canada
France
Lithuania
Hungary
Hong Kong
United States
Latvia
India
Belgium
Estonia
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Sweden


lead_sponsor: Shire

summary: For children and adolescents, how does SPD503 compare to placebo for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

ReferenceCitation: Hervas A, Huss M, Johnson M, McNicholas F, van Stralen J, Sreckovic S, Lyne A, Bloomfield R, Sikirica V, Robertson B. Efficacy and safety of extended-release guanfacine hydrochloride in children and adolescents with attention-deficit/hyperactivity disorder: a randomized, controlled, phase III trial. Eur Neuropsychopharmacol. 2014 Dec;24(12):1861-72. doi: 10.1016/j.euroneuro.2014.09.014. Epub 2014 Oct 23.

location_facility: Psychiatric Centers at San Diego, Feighner Research

location_facility: Gabinet Psychiatrii Doroslych, Dzieci i Mlodziezy, Miroslaw Dabkowski

location_facility: Spitalul Clinic de Urgenta Pentru Copii Cluj

location_facility: IRCCS Stella Maris - U.O. Psichiatria e Psicofarmacologia Eta' Evolutiva

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

location_facility: Centre HospitalierUniversitaire d'Amiens, Hoptial Nord

location_facility: Centre Hospitalier Charles Perens - Service de Psychiatrie de l'Enfant et de l'Adolescent

location_facility: Praxis Dr. Friedrich Kaiser un Ingrid Marinesse

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: James Paget University Hospital NHS Trust

location_facility: Praxisgemeinschaft Drs. Willem Geraets/Gabriele Lucassen

location_facility: Odesa Regional Psychoneurological Dispensary, Outpatient Dept

location_facility: Barn och Ungdomsmedicin klinik Mölnlycke

location_facility: Medizinische Universitat Graz-Universitaklinik fur Kinder-und Jugendheilkunde

location_facility: Hospital de Dia Infantil y Juvenil Dr Diego Guigou y Costa

location_facility: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden

location_facility: Somni Bene GmbH - Institut für Medizinische Forschung und Schlafmedizin

location_facility: Municipal Institution "Institute of healthcare for children and adolescences NAMNU

location_facility: Klinikum der Johannes-Guttenberg-Universitat Mainz

location_facility: Department of Child and Adolescent Psychiatry

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny

location_facility: Vinnytsia National Medical University - Vinnytsia Regional Psycho-Neurological Hospital

location_facility: O.F. Maltsev Poltava Regional Psychiatric Hospital

location_facility: University of Nebraska Medical Center, Dept. of Psychiatry

location_facility: JPM Van Stralen Medicine Professional Corp.

location_facility: Institut fur Ganzheitiche Medzin und Wissenschaft GmbH

location_facility: Ospedale Policlinico G.B.Rossi - Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska Borys Gniot

location_facility: Lviv Regional Clinical Psychiatric Hospital

location_facility: Centrum Badan Klinicznych PI-House Sp. z o.o.

location_facility: Rochester Center for Behavioral Medicine

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

location_facility: Horsham Child and Adolescent Mental Health Services

location_facility: Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine

location_facility: Instituto Valenciano de Neurología Pediatrica

location_facility: Zentralinstitut fur Seelische Geseundheit Mannheim Klinik for Psuchiatrie und Psychotherapie des Kindes

title: A Phase 3, Randomised, Double-blind, Multicentre, Parallel-group, Placebo- and Active-reference, Dose-optimisation Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 Years With Attention-Deficit/Hyperactivity Disorder

source: euctr

location_country:
Germany
Ireland
Italy
Poland
United Kingdom
Romania
Sweden
Austria
United States
Spain
Canada
Ukraine
France


title: A Phase 4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Efficacy And Safety Of Re-Treatment With Varenicline In Subjects Who Are Currently Smoking, And Who Have Previously Taken Varenicline

summary: The main purpose of this study is to compare the effectiveness and safety of the re-treatment of smokers with varenicline with placebo for smoking cessation during the last 4 weeks of a 12 week course of treatment. The study will also assess whether smokers remain abstinent at Week 24 (12 weeks after the end of treatment) and Week 52 (40 weeks after the end of treatment).

ReferenceCitation: Gonzales D, Hajek P, Pliamm L, Nackaerts K, Tseng LJ, McRae TD, Treadow J. Retreatment with varenicline for smoking cessation in smokers who have previously taken varenicline: a randomized, placebo-controlled trial. Clin Pharmacol Ther. 2014 Sep;96(3):390-6. doi: 10.1038/clpt.2014.124. Epub 2014 Jun 9.

location_country:
France
Germany
United Kingdom
Australia
Belgium
United States
Canada
Czech Republic

location_facility: Cliniques Universitaires U.C.L. de Mont-Godinne/Laboratoire

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Krajska nemocnice Liberec a.s., Plicni oddeleni

location_facility: Ronald Reagan University of California Los Angeles Medical Center

location_facility: Universitaetsklinikum Goettingen Zentrum Innere Medizin Abteilung Kardiologie und Pneumologie

location_facility: Clinique des maladies Lipidiques de Quebec

location_facility: The Center for Pharmaceutical Research, PC

location_facility: Universitair Ziekenhuis Antwerpen, Afdeling Pneumologie

location_facility: Mestska nemocnice Ostrava, Plicni oddeleni

location_facility: CHU Côte de Nacre, Unité de Coordination de Tabacologie

location_facility: University of California Los Angeles David Geffen School of Medicine

location_facility: Central Kentucky Research Associates, Inc.

location_facility: Synexus Lancashire Clinical Research Centre

location_facility: Synexus Scotland Clinical Research Centre

location_facility: Synexus Thames Valley Clinical Research Centre

location_facility: Synexus, Merseyside Clinical Research Centre


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Plaque Psoriasis

acronym: ESTEEM 2

summary: This study will evaluate the effects of an experimental (being tested) study drug called apremilast. Apremilast works by lowering some of the chemicals that affect psoriasis and therefore improves the symptoms of psoriasis. The purpose of this study is to test apremilast and compare its effects to placebo (an inactive substance which contains no medicine but is in the same form as the drug). This study will test efficacy (improvement of signs and symptoms) and safety of apremilast in patients with moderate to severe psoriasis.

ReferenceType: background

ReferenceCitation: Reich K, Mrowietz U, Menter A, Griffiths CEM, Bagel J, Strober B, Nunez Gomez N, Shi R, Guerette B, Lebwohl M. Effect of baseline disease severity on achievement of treatment target with apremilast: results from a pooled analysis. J Eur Acad Dermatol Venereol. 2021 Dec;35(12):2409-2414. doi: 10.1111/jdv.17520. Epub 2021 Aug 23.

location_country:
Germany
Italy
Denmark
Switzerland
Austria
United States
Spain
Canada
France

location_facility: Universita degli Studi di Napoli Federico II

location_facility: Bakersfield Dermatology and Skin Cancer Medical Group

location_facility: Centre de Recherche Dermatologique du Quebec Metropolitain CRDQ

location_facility: Universitatsklinikum Hamburg-Eppendorf / IVDP

location_facility: Istituto Dermatologico San Gallicano IRCCS Dermatologia Clinica

location_facility: A.O.U. Integrata di Verona Universitá degli Studi di Verona Sezione di Dermatologia e Venerologia

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Centre d'lnvestigation Clinique, Hopital Jean Minjoz

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Medizinische Universitat Wien, Universitatsklinik fur Dermatologie. Abteilung fur Immundermatologie

location_facility: Northwestern University Northwestern Medical Faculty Foundation

location_facility: Arizona Skin and Laser Therapy Inst., Ltd.


title: A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 Under Adaptable Dosing Schedules in Patients With Advanced Solid Malignancies

summary: This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future. This study will also investigate how the body handles AZD5363 (ie, how quickly the body absorbs and removes the drug). This study will also investigate anti-tumour activity of AZD5363 in patients with advanced / metastatic breast, gynaecological cancers or other solid cancers bearing either AKT1 / PIK3CA or PTEN mutation.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Smyth LM, Reichel JB, Tang J, Patel JAA, Meng F, Selcuklu DS, Houck-Loomis B, You D, Samoila A, Schiavon G, Li BT, Razavi P, Piscuoglio S, Reis-Filho JS, Taylor BS, Baselga J, Solit DB, Hyman DM, Berger MF, Chandarlapaty S. Utility of Serial cfDNA NGS for Prospective Genomic Analysis of Patients on a Phase I Basket Study. JCO Precis Oncol. 2021 Jan 8;5:PO.20.00184. doi: 10.1200/PO.20.00184. eCollection 2021.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Smyth LM, Batist G, Meric-Bernstam F, Kabos P, Spanggaard I, Lluch A, Jhaveri K, Varga A, Wong A, Schram AM, Ambrose H, Carr TH, de Bruin EC, Salinas-Souza C, Foxley A, Hauser J, Lindemann JPO, Maudsley R, McEwen R, Moschetta M, Nikolaou M, Schiavon G, Razavi P, Banerji U, Baselga J, Hyman DM, Chandarlapaty S. Selective AKT kinase inhibitor capivasertib in combination with fulvestrant in PTEN-mutant ER-positive metastatic breast cancer. NPJ Breast Cancer. 2021 Apr 16;7(1):44. doi: 10.1038/s41523-021-00251-7.

ReferenceCitation: Smyth LM, Tamura K, Oliveira M, Ciruelos EM, Mayer IA, Sablin MP, Biganzoli L, Ambrose HJ, Ashton J, Barnicle A, Cashell DD, Corcoran C, de Bruin EC, Foxley A, Hauser J, Lindemann JPO, Maudsley R, McEwen R, Moschetta M, Pass M, Rowlands V, Schiavon G, Banerji U, Scaltriti M, Taylor BS, Chandarlapaty S, Baselga J, Hyman DM. Capivasertib, an AKT Kinase Inhibitor, as Monotherapy or in Combination with Fulvestrant in Patients with AKT1 E17K-Mutant, ER-Positive Metastatic Breast Cancer. Clin Cancer Res. 2020 Aug 1;26(15):3947-3957. doi: 10.1158/1078-0432.CCR-19-3953. Epub 2020 Apr 20.

repository_institution: University of Illinois at Chicago - INDIGO

repositories_concat: PubMed Central;figshare.com

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Banerji U, Dean EJ, Perez-Fidalgo JA, Batist G, Bedard PL, You B, Westin SN, Kabos P, Garrett MD, Tall M, Ambrose H, Barrett JC, Carr TH, Cheung SYA, Corcoran C, Cullberg M, Davies BR, de Bruin EC, Elvin P, Foxley A, Lawrence P, Lindemann JPO, Maudsley R, Pass M, Rowlands V, Rugman P, Schiavon G, Yates J, Schellens JHM. A Phase I Open-Label Study to Identify a Dosing Regimen of the Pan-AKT Inhibitor AZD5363 for Evaluation in Solid Tumors and in PIK3CA-Mutated Breast and Gynecologic Cancers. Clin Cancer Res. 2018 May 1;24(9):2050-2059. doi: 10.1158/1078-0432.CCR-17-2260. Epub 2017 Oct 24.

evidence: oa repository (via page says license)

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Italy
United Kingdom
Singapore
Denmark
Japan
Netherlands
United States
Spain
Canada
France


title: Two Approaches to Escalate Lispro Therapy in Patients With Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on Basal Insulin Therapy and Oral Agents Alone (AUTONOMY)

acronym: AUTONOMY

summary: Evidence regarding optimal methods of insulin dose adjustment is lacking in the literature. The purpose of this study is to evaluate the efficacy and safety of two approaches to escalate prandial insulin therapy in participants with type 2 diabetes mellitus not achieving adequate glycemic control on basal insulin.

lead_sponsor: Eli Lilly and Company

location_country:
Lithuania
Poland
Argentina
Denmark
Romania
Brazil
Austria
Mexico
United States
South Africa
Croatia
Canada
Puerto Rico
Russian Federation
France

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


title: Evaluation of Novel Biomarkers From Acutely Ill Patients at Risk for Acute Kidney Injury

summary: The purpose of this study is to collect blood and urine samples that may help identify and validate biomarkers for the early detection and risk assessment of acute kidney injury (AKI).

ReferenceCitation: Kashani K, Al-Khafaji A, Ardiles T, Artigas A, Bagshaw SM, Bell M, Bihorac A, Birkhahn R, Cely CM, Chawla LS, Davison DL, Feldkamp T, Forni LG, Gong MN, Gunnerson KJ, Haase M, Hackett J, Honore PM, Hoste EA, Joannes-Boyau O, Joannidis M, Kim P, Koyner JL, Laskowitz DT, Lissauer ME, Marx G, McCullough PA, Mullaney S, Ostermann M, Rimmele T, Shapiro NI, Shaw AD, Shi J, Sprague AM, Vincent JL, Vinsonneau C, Wagner L, Walker MG, Wilkerson RG, Zacharowski K, Kellum JA. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. 2013 Feb 6;17(1):R25. doi: 10.1186/cc12503.

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

repository_institution: RWTH Aachen - RWTH Publications

repository_institution: University of Pittsburgh - D-Scholarship@Pitt

repositories_institution: Ghent University - Ghent University Academic Bibliography

publisher_dissemination: Springer

ReferenceCitation: Kellum JA, Artigas A, Gunnerson KJ, Honore PM, Kampf JP, Kwan T, McPherson P, Nguyen HB, Rimmele T, Shapiro NI, Shi J, Vincent JL, Chawla LS; Sapphire Investigators. Use of Biomarkers to Identify Acute Kidney Injury to Help Detect Sepsis in Patients With Infection. Crit Care Med. 2021 Apr 1;49(4):e360-e368. doi: 10.1097/CCM.0000000000004845.

repositories_concat: PubMed Central;ddd.uab.cat

ReferenceCitation: McCullough PA, Ostermann M, Forni LG, Bihorac A, Koyner JL, Chawla LS, Shi J, Kampf JP, McPherson P, Kellum JA; the Sapphire Investigators. Serial Urinary Tissue Inhibitor of Metalloproteinase-2 and Insulin-Like Growth Factor-Binding Protein 7 and the Prognosis for Acute Kidney Injury over the Course of Critical Illness. Cardiorenal Med. 2019;9(6):358-369. doi: 10.1159/000502837. Epub 2019 Oct 16.

publisher_dissemination: S. Karger AG

ReferenceCitation: Kane-Gill SL, Ostermann M, Shi J, Joyce EL, Kellum JA. Evaluating Renal Stress Using Pharmacokinetic Urinary Biomarker Data in Critically Ill Patients Receiving Vancomycin and/or Piperacillin-Tazobactam: A Secondary Analysis of the Multicenter Sapphire Study. Drug Saf. 2019 Oct;42(10):1149-1155. doi: 10.1007/s40264-019-00846-x.

ReferenceCitation: Hoste EA, McCullough PA, Kashani K, Chawla LS, Joannidis M, Shaw AD, Feldkamp T, Uettwiller-Geiger DL, McCarthy P, Shi J, Walker MG, Kellum JA; Sapphire Investigators. Derivation and validation of cutoffs for clinical use of cell cycle arrest biomarkers. Nephrol Dial Transplant. 2014 Nov;29(11):2054-61. doi: 10.1093/ndt/gfu292. Epub 2014 Sep 18.

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

location_facility: Bruce W. Carter Department of Veterans Affairs Medical Center

location_facility: Joseph M. Still Research Foundation, Inc.

location_facility: Beth Israel Deaconess Med. Center (BIDMC)

location_facility: University of Chicago Medical Center Section of Nephrology

location_facility: Hospital of the University of Pennsylvania

location_facility: Klinik für Anästhesie, Intensivmedizin und Schmerztherapie


title: CHI SQUARE: Can HDL Infusions Significantly Quicken Atherosclerosis Regression? A Phase II, Multi-Center, Double-Blind, Ascending Dose, Placebo-Controlled, Dose-Finding Trial of CER-001 or Placebo in Subjects With Acute Coronary Syndrome

acronym: CHI SQUARE

summary: Cardiovascular disease remains the most pressing healthcare issue for developed countries and is becoming so for developing countries. There are a number of chronic therapies available for long-term management of risk. Short term therapies for subjects with an acute event, such as an episode of acute coronary syndrome (ACS), are focused on reperfusion and removing thrombus but most subsequent events are caused by atherosclerotic plaque rupture at a different site. There are no approved therapies that can rapidly reduce the burden of unstable, inflamed plaque in the overall coronary vascular bed. HDL has multiple actions that could lead to atherosclerotic plaque stabilization, such as rapid removal of large quantities of cholesterol from the vasculature, improvement in endothelial function, protection against oxidative damage and reduction in inflammation. This study will assess the effects of CER-001, an ApoA-I-based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by intravascular ultrasound (IVUS) measurements in patients with (ACS).

ReferenceCitation: Nanjee MN, Doran JE, Lerch PG, Miller NE. Acute effects of intravenous infusion of ApoA1/phosphatidylcholine discs on plasma lipoproteins in humans. Arterioscler Thromb Vasc Biol. 1999 Apr;19(4):979-89. doi: 10.1161/01.atv.19.4.979.

ReferenceCitation: Eriksson M, Carlson LA, Miettinen TA, Angelin B. Stimulation of fecal steroid excretion after infusion of recombinant proapolipoprotein A-I. Potential reverse cholesterol transport in humans. Circulation. 1999 Aug 10;100(6):594-8. doi: 10.1161/01.cir.100.6.594.

ReferenceCitation: Spieker LE, Sudano I, Hurlimann D, Lerch PG, Lang MG, Binggeli C, Corti R, Ruschitzka F, Luscher TF, Noll G. High-density lipoprotein restores endothelial function in hypercholesterolemic men. Circulation. 2002 Mar 26;105(12):1399-402. doi: 10.1161/01.cir.0000013424.28206.8f.

ReferenceCitation: Nieuwdorp M, Vergeer M, Bisoendial RJ, op 't Roodt J, Levels H, Birjmohun RS, Kuivenhoven JA, Basser R, Rabelink TJ, Kastelein JJ, Stroes ES. Reconstituted HDL infusion restores endothelial function in patients with type 2 diabetes mellitus. Diabetologia. 2008 Jun;51(6):1081-4. doi: 10.1007/s00125-008-0975-2. Epub 2008 Apr 4. No abstract available.

ReferenceCitation: Drew BG, Duffy SJ, Formosa MF, Natoli AK, Henstridge DC, Penfold SA, Thomas WG, Mukhamedova N, de Courten B, Forbes JM, Yap FY, Kaye DM, van Hall G, Febbraio MA, Kemp BE, Sviridov D, Steinberg GR, Kingwell BA. High-density lipoprotein modulates glucose metabolism in patients with type 2 diabetes mellitus. Circulation. 2009 Apr 21;119(15):2103-11. doi: 10.1161/CIRCULATIONAHA.108.843219. Epub 2009 Apr 6.

ReferenceCitation: Shaw JA, Bobik A, Murphy A, Kanellakis P, Blombery P, Mukhamedova N, Woollard K, Lyon S, Sviridov D, Dart AM. Infusion of reconstituted high-density lipoprotein leads to acute changes in human atherosclerotic plaque. Circ Res. 2008 Nov 7;103(10):1084-91. doi: 10.1161/CIRCRESAHA.108.182063. Epub 2008 Oct 2.

ReferenceCitation: Waksman R, Torguson R, Kent KM, Pichard AD, Suddath WO, Satler LF, Martin BD, Perlman TJ, Maltais JA, Weissman NJ, Fitzgerald PJ, Brewer HB Jr. A first-in-man, randomized, placebo-controlled study to evaluate the safety and feasibility of autologous delipidated high-density lipoprotein plasma infusions in patients with acute coronary syndrome. J Am Coll Cardiol. 2010 Jun 15;55(24):2727-35. doi: 10.1016/j.jacc.2009.12.067.

ReferenceCitation: Tardif JC, Gregoire J, L'Allier PL, Ibrahim R, Lesperance J, Heinonen TM, Kouz S, Berry C, Basser R, Lavoie MA, Guertin MC, Rodes-Cabau J; Effect of rHDL on Atherosclerosis-Safety and Efficacy (ERASE) Investigators. Effects of reconstituted high-density lipoprotein infusions on coronary atherosclerosis: a randomized controlled trial. JAMA. 2007 Apr 18;297(15):1675-82. doi: 10.1001/jama.297.15.jpc70004. Epub 2007 Mar 26.

ReferenceCitation: Nissen SE, Tsunoda T, Tuzcu EM, Schoenhagen P, Cooper CJ, Yasin M, Eaton GM, Lauer MA, Sheldon WS, Grines CL, Halpern S, Crowe T, Blankenship JC, Kerensky R. Effect of recombinant ApoA-I Milano on coronary atherosclerosis in patients with acute coronary syndromes: a randomized controlled trial. JAMA. 2003 Nov 5;290(17):2292-300. doi: 10.1001/jama.290.17.2292.

ReferenceCitation: Tardif JC, Ballantyne CM, Barter P, Dasseux JL, Fayad ZA, Guertin MC, Kastelein JJ, Keyserling C, Klepp H, Koenig W, L'Allier PL, Lesperance J, Luscher TF, Paolini JF, Tawakol A, Waters DD; Can HDL Infusions Significantly QUicken Atherosclerosis REgression (CHI-SQUARE) Investigators. Effects of the high-density lipoprotein mimetic agent CER-001 on coronary atherosclerosis in patients with acute coronary syndromes: a randomized trial. Eur Heart J. 2014 Dec 7;35(46):3277-86. doi: 10.1093/eurheartj/ehu171. Epub 2014 Apr 29.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: University of California - eScholarship University of California

repository_institution: University of Zurich - Zurich Open Repository and Archive

publisher_dissemination: Oxford University Press

lead_sponsor: Cerenis Therapeutics, SA

location_country:
United States
Canada
Netherlands
France

location_facility: Montreal General Hospital Research Institute

location_facility: Centre Hospitalier Universitaire de Toulouse Rangueil

location_facility: Centre de Santé et de Services Sociaux de Laval

location_facility: Cardiac and Vascular Research Center of Northern Michigan

location_facility: University of North Carolina Medical Center

location_facility: MultiCare Health System Research Institute / Cardiac Study Center

location_facility: LeBauer Cardiovascular Research Foundation

location_facility: Centre Hospitalier Régional de Trois-Rivières

location_facility: Jacksonville Center for Clinical Research

location_facility: Palm Beach Heart Institute, LLC - Zasa Clinical Research

location_facility: Institut Universitaire de Cardiologie et Pneumologie de Québec (IUCPQ)

location_facility: Buffalo Cardiology & Pulmonary Associates

location_facility: Detroit Medical Center (DMC) Cardiovascular Institute


lead_sponsor: Seagen Inc.

summary: The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001

sponsor_collaborators:
Seagen Inc.
Millennium Pharmaceuticals, Inc.

location_facility: Centrum Onkologii Institut im. Marii Sklodowskiej-Curie

location_facility: Fundeni Clinical Institute, Center for Hematology and Bone Marrow Transplantation

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular

location_facility: Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

location_facility: Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN

location_facility: Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova

location_facility: Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno

location_facility: South Lyon Hospital Center, Department of Dermatology

location_facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

location_facility: Klinika Hematologii, Instytut Hematologii i Transfuzjologii

location_facility: Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly

location_facility: Research Institute of Clinical Immunology

location_facility: Polyclinic S. Orsola-Malpighi, Institute of Hematology and Medical Oncology "Lorenzo and Ariosto Seragnoli"

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Clinical Center of Serbia, Clinic of Hematology

location_facility: University Hospital 12 de Octubre, Department of Dermatology

location_facility: Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania

location_facility: Johannes Wesling Hospital Minden, Department of Dermatology

location_facility: Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu

location_facility: University Hospital Zurich, Department of Dermatology

status: No longer available

title: An Open-label, Treatment-option Protocol of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma, Systemic Anaplastic Large Cell Lymphoma, or CD30-positive Cutaneous T-cell Lymphoma

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Romania
Australia
Switzerland
Belgium
United States
Spain
Bulgaria
Serbia
Russian Federation
France

study_type: Expanded Access

status_simplified: Unknown


title: A Multicenter, Multinational Phase II Study to Assess the Clinical Safety and Feasibility of Trastuzumab Emtansine Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage HER2-positive Breast Cancer

summary: This single-arm open-label study assessed the safety, feasibility, and efficacy of trastuzumab emtansine (T-DM1) after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer. Patients received T-DM1 3.6 mg/kg intravenously on Day 1 of each 3-week cycle, for up to 17 cycles.

ReferenceCitation: Krop IE, Suter TM, Dang CT, Dirix L, Romieu G, Zamagni C, Citron ML, Campone M, Xu N, Smitt M, Gianni L. Feasibility and cardiac safety of trastuzumab emtansine after anthracycline-based chemotherapy as (neo)adjuvant therapy for human epidermal growth factor receptor 2-positive early-stage breast cancer. J Clin Oncol. 2015 Apr 1;33(10):1136-42. doi: 10.1200/JCO.2014.58.7782. Epub 2015 Feb 23.

repository_institution: PubMed Central - Europe PMC

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


summary: The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced dyskinesias).

title: An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

location_country:
Germany
Italy
Australia
United States
Canada
France


title: Randomized, Double-blind, Multicenter Two-Stage Adaptive Phase 3 Study of Intravenous Administration of REOLYSIN (Reovirus Type 3 Dearing) in Combination With Paclitaxel and Carboplatin Versus the Chemotherapy Alone in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck Who Have Progressed on or After Prior Platinum-Based Chemotherapy

summary: The purpose of this Phase 3 study is to evaluate overall survival and progression free survival following intravenous administration of REOLYSIN (Reovirus Serotype 3 Dearing) in combination with paclitaxel and carboplatin versus chemotherapy treatment alone, in patients with metastatic or recurrent Squamous Cell Carcinoma of the Head and Neck.

lead_sponsor: Oncolytics Biotech

location_country:
Germany
Italy
Poland
Slovenia
Hungary
United Kingdom
Belgium
United States
Spain
Greece
Canada
Russian Federation
France

location_facility: Federal State Budgetary Institution "N. N. Petrov Oncology Research Institute" of Ministry of Public Health and Social Development of the Russian Federation

location_facility: State Health Care Institution "Oncology Dispensary №2" of Krasnodar Region Health Care Department

location_facility: The Royal Marsden Cancer Center, Fulham Road branch

location_facility: Ufficio Sperimentazioni Cliniche c/o S.C. Oncologia Medica

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Cancer Therapy and Research Center at UTHSCSA

location_facility: Instituto Catlan de Oncologia (ICO) - Hospital Duran i Reynals

location_facility: State Health Care Institution "Republican Clinical Oncology Dispensary of Ministry of Health of the Republic of Tatarstan"

location_facility: Institut Curie / Département d'Oncologie Médicale

location_facility: State Budgetary Health Care Institution "Clinical Oncology Dispensary #1" of Krasnodar Region Health Care Department

location_facility: Centrum Onkologii - Instytyt im.M.Skłodowskiej-Curie

location_facility: Fovarosi Onkormanyzat Uzsoki Utcai Kórház

location_facility: State Health Care Institution "Arkhangelsk Regional Clinical Oncology Dispensary"

location_facility: Centre Antoine Lacassagne / Oncologie Médicale

location_facility: St.Petersburg State Health Care Institution City Clinical Oncology Dispensary"

location_facility: State Budgetary Health Care Institution of the Yaroslavl region "Regional Clinical Oncological Hospital"

location_facility: Mary Bird Perkinds Cancer Center - Baton Rouge

location_facility: State Budgetary Healthcare Institution "Republic Clinical Oncology Dispensary Ministry of Health of Bashkortostan"

location_facility: Federal State Budgetary Institution "Russian Research Centre of Radiology and Surgery technologies" of Ministry of Public Health and Social Development of the Russian Federation

location_facility: Regional Budgetary Health Care Institution "Kursk Regional Oncology Dispensary" of Health Care Committee of Kursk region

location_facility: Clatterbridge Centre for Oncology NHS Foundation Trust

location_facility: State Health Care Institution "Chelyabinsk Regional Oncology Dispensary"

location_facility: State Health Care Institution "Tula Regional Oncology Dispensary"

location_facility: Fondazione IRCCS Istituto Nazionale del Tumori

location_facility: Emory University - Winship Cancer Institute

location_facility: Regional State Health Care Institution "Belgorod Oncology Dispensary"

location_facility: BMS Physician Practice, A Medical Corporation DBA Medical Oncology Care Associates

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: The Royal Marsden Cancer Center, Sutton Branch

location_facility: Hopital Saint-André / Service d'Oncologie-Radiothérapie

location_facility: Wojewódzki Szpital Specjalistyczny im. M.Kopernika

location_facility: Federal State Budgetary Institution "Medical Research Radiology Center" of Ministry of Public Health and Social Development of Russian Federation, Obninsk

location_facility: Case Comprehensive Cancer Center, University Hospitals Case Medical Center

location_facility: Instituto Catlan de Oncologia (ICO) - Hospital Germans Trias I Pujol


title: SERVE-HF: Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation

acronym: MS

summary: The purpose of this study is to assess changes in left ventricular performance using echocardiography as well as ventricular remodelling, changes in sleep and changes in mood, anxiety and cognitive functions occurring as a result of treatment of predominant central sleep apnoea by adaptive servoventilation (ASV) in chronic heart failure in addition to optimal medical therapy in chronic heart failure. This will be a substudy of the SERVE-HF study.

lead_sponsor: ResMed

location_country:
Finland
Germany
United Kingdom
Australia
Netherlands
Switzerland
Czech Republic
France

location_facility: Klinikum der Universität zu Köln- Herzzentrum

location_facility: Augusta-Kranken-Anstalt gGmbH Thoraxzentrum Ruhrgebiet

location_facility: Comprehensive Heart Failure Center, Universitätsklinikum Würzburg

location_facility: Gemeinschaftspraxis Kardiologie Dr. Becker

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck-Schlaflabor

location_facility: Kardiologische Gemeinschaftspraxis Dr. K. Vorbeck

location_facility: Tampere University Hospital, Pirkanmaa sairaanhoitopiiri

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck-Kardiologie

location_facility: Klinikum der Universität zu Köln-Schlaflabor


title: Prevalence of Psoriatic Arthritis in Adults With Psoriasis: An Estimate From Dermatology Practice

acronym: PREPARE

summary: This is a phase 4, multicenter, randomized, non-therapeutic interventional trial in subjects with psoriasis looking for the prevalence of psoriatic arthritis. Subjects will be seen and evaluated by a dermatologist at visit 1 and by a rheumatologist at visit 2. A subset of subjects will then go on to visit 3 for imaging procedures (x-ray, MRI, and ultrasound).

primary_purpose: Diagnostic

ReferenceCitation: Mease PJ, Gladman DD, Papp KA, Khraishi MM, Thaci D, Behrens F, Northington R, Fuiman J, Bananis E, Boggs R, Alvarez D. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol. 2013 Nov;69(5):729-735. doi: 10.1016/j.jaad.2013.07.023. Epub 2013 Aug 24.

location_country:
Germany
Hungary
Denmark
Belgium
United States
Canada
France

location_facility: Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Szent Ferenc Korhaz Telephely

location_facility: Debreceni Egyetem Orvos-és Egészségtudományi Centrum

location_facility: Klinikum der Johann Wolfgang Goethe Universitaet

location_facility: Rheumatology Practive of Scott Zashin, MD

location_facility: Klinik fuer Dermatologie, Allergologie und Venerologie

location_facility: Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum

location_facility: Praxis Dres. Bredlich, Rosenbach und Thiele

location_facility: Centre de Recherche Dermatologique du Quebec metropolitain

location_facility: Klinik und Poliklinik fuer Dermatologie und

location_facility: The Skin Care Centre-Clinical Trials Unit

location_facility: The Toronto Western Hospital-Division of Rheumatology

location_facility: Miskolci Semmelweis Ignac Egeszsegugyi Kozpont es Egyetemi Oktatokorhaz Nonprofit Kft/Borgyogyaszat

intervention_type: Procedure


lead_sponsor: PTC Therapeutics

summary: Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of mutation called a nonsense (premature stop codon) mutation is the cause of CF in approximately 10% of patients with the disease. Ataluren is an orally delivered investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 3 extension trial that will evaluate the long-term safety of ataluren in adult and pediatric participants with nonsense mutation CF (nmCF), as determined by adverse events and laboratory abnormalities. The study will also assess changes in pulmonary function, CF pulmonary exacerbations, health-related quality of life, antibiotic use for CF-related infections, CF-related disruptions to daily living, body weight, and CF pathophysiology. Funding source for this study is the FDA OOPD.

sponsor_collaborators:
PTC Therapeutics
Cystic Fibrosis Foundation

location_facility: Hadassah University Hospital - Mount Scopus

location_facility: Karolinska University Hospital, Huddinge

location_facility: Hôpital Universitaire des Enfants Reine Fabiola

title: A Phase 3 Extension Study of Ataluren (PTC124®) in Subjects With Nonsense-Mutation-Mediated Cystic Fibrosis

type: Other Grant/Funding Number

location_country:
Germany
Italy
Israel
United Kingdom
Sweden
Netherlands
Belgium
United States
Spain
Canada
France


lead_sponsor: Novartis Pharmaceuticals

summary: This study will assess the efficacy of AUY922, when administered weekly at 70 mg/m2, in adult patients with advanced Non-small-cell Lung Cancer (NSCLC), who have received at least two prior lines of chemotherapy. Patients will be retrospectively, and prospectively, stratified based on their molecular tumor etiology. The following strata was assigned: Patients with Epidermal growth factor receptor (EGFR) activating mutations, Patients with Kirstin Raus sarcoma virus (KRAS) activating mutations, Patients with EML4-ALK (anaplastic lymphoma kinase) translocations and patients that were both EGFR and Kras wild type.

ReferenceCitation: Felip E, Barlesi F, Besse B, Chu Q, Gandhi L, Kim SW, Carcereny E, Sequist LV, Brunsvig P, Chouaid C, Smit EF, Groen HJM, Kim DW, Park K, Avsar E, Szpakowski S, Akimov M, Garon EB. Phase 2 Study of the HSP-90 Inhibitor AUY922 in Previously Treated and Molecularly Defined Patients with Advanced Non-Small Cell Lung Cancer. J Thorac Oncol. 2018 Apr;13(4):576-584. doi: 10.1016/j.jtho.2017.11.131. Epub 2017 Dec 13.

license: publisher-specific-oa

license_normalized: publisher-specific

location_facility: Maryland Oncology Hematology, P.A. Dept. of Assoc. Onc/Hem

location_facility: St. Luke's Hospital and Health Network St Luke's

location_facility: University of California at Los Angeles UCLA - Santa Monica

title: A Phase II, Multi-center, Open-label Study of AUY922 Administered IV on a Once-weekly Schedule in Patients With Advanced Non-small-cell Lung Cancer Who Have Received at Least Two Lines of Prior Chemotherapy

location_country:
Germany
Norway
Singapore
Netherlands
United States
Korea, Republic of
Spain
Turkey
Canada
France


summary: This study was designed to evaluate if subjects who achieve complete remission after 8 weeks of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term outcomes and remain in remission longer compared with subjects who demonstrate only partial remission after acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD. Therefore, subjects who achieve either complete or partial remission will enter into a 12-month maintenance phase, during which they will receive MMX mesalamine/mesalazine 2.4g/day given QD. Remission status for the 2 groups will be evaluated and compared at the end of this 12-month maintenance period. The data obtained from this study will provide scientifically meaningful information to demonstrate that achieving complete remission (clinical and endoscopic remission) is important for a better long-term prognosis, or that the current paradigm of symptomatic treatment is appropriate.

ReferenceCitation: Stevens TW, Gecse K, Turner JR, de Hertogh G, Rubin DT, D'Haens GR. Diagnostic Accuracy of Fecal Calprotectin Concentration in Evaluating Therapeutic Outcomes of Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2333-2342. doi: 10.1016/j.cgh.2020.08.019. Epub 2020 Aug 13.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

ReferenceCitation: Willian MK, D'Haens G, Yarlas A, Joshi AV. Changes in health-related quality of life and work-related outcomes for patients with mild-to-moderate ulcerative colitis receiving short-term and long-term treatment with multimatrix mesalamine: a prospective, open-label study. J Patient Rep Outcomes. 2018 Apr 27;2:22. doi: 10.1186/s41687-018-0046-5. eCollection 2018 Dec.

ReferenceCitation: Yarlas A, D'Haens G, Willian MK, Teynor M. Health-Related Quality of Life and Work-Related Outcomes for Patients With Mild-to-Moderate Ulcerative Colitis and Remission Status Following Short-Term and Long-Term Treatment With Multimatrix Mesalamine: A Prospective, Open-Label Study. Inflamm Bowel Dis. 2018 Jan 18;24(2):450-463. doi: 10.1093/ibd/izx041.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

location_facility: Toronto Digestive Disease Associates, Inc.

location_facility: Javorszky Odon Varosi Korhaz, Gasztroenterologia

location_facility: Clinical Applications Laboratories, Inc.

location_facility: Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum III. sz. Belgyogyazati Klinika

location_facility: Regional Gastroenterology Associates of Lancaster, Ltd.

location_facility: Karolina Korhaz, Belgyogyaszat es Gasztroenterologia

location_facility: IKEM (Institute klinicke a experimentalni mediciny)

location_facility: Ohio Gastroenterolgy and Liver Intstitute

location_facility: NZOZ Centrum Medyczne Szpital Sw. Rodziny

location_facility: S R Kalla Memorial Gastro & General Hospital

location_facility: Center for Digestive & Liver Disease, Inc.

location_facility: Atlanta Gastroenterology Associates, LLC

location_facility: Heilig Hart ziekenhuis vzw Roeselare-Menen

location_facility: Orlickoustecka nemocnice a.s. (Hospital)

location_facility: Birmingham Gastroenterology Associates, PC

location_facility: Long Island Clinical Research Associates, LLP

location_facility: Sree Gokulam Medical College and Research Foundation

location_facility: Stawdtisches Klinikum Lueneburg Gastroenterologie

location_facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium

location_facility: Emergency University Clinical Hospital Bucuresti

location_facility: Gastroenterology Clinic of San Antonio, PA

location_facility: Chhatrapati Shahuji Maharaj Medical University

location_facility: Manikya Institute of Gastroenterology & Hepatology

location_facility: Indyw. Spec. Prakt. Lek. w Dziedzinie Chirurgii Ogolnej i Gastroenterologii

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyrtrmi Oktato Korhaz, II. Belgyogyaszat

location_facility: Medizinische Hochschule Hannover/ Zentrum Innere Medizin/Gastroenterologie

title: A Phase 4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/Day MMX Mesalamine/Mesalazine Once Daily in Adult Subjects With Ulcerative Colitis

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Germany
Ireland
Poland
Colombia
India
Hungary
United Kingdom
Romania
Belgium
United States
Spain
South Africa
Czechia
Canada
France

ipd_sharing: Yes


title: Advisa MRI™ System Clinical Investigation

summary: The purpose of the Advisa MRI System clinical study is to confirm safety and effectiveness in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body including the chest).

ReferenceCitation: Gimbel JR, Bello D, Schmitt M, Merkely B, Schwitter J, Hayes DL, Sommer T, Schloss EJ, Chang Y, Willey S, Kanal E; Advisa MRI System Study Investigators. Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Heart Rhythm. 2013 May;10(5):685-91. doi: 10.1016/j.hrthm.2013.01.022. Epub 2013 Jan 17.

repository_institution: Semmelweis University - Semmelweis University Repository

ReferenceCitation: Schwitter J, Kanal E, Schmitt M, Anselme F, Albert T, Hayes DL, Bello D, Toth A, Chang Y, van Osch D, Sommer T; Advisa MRI System Study Investigators. Impact of the Advisa MRI pacing system on the diagnostic quality of cardiac MR images and contraction patterns of cardiac muscle during scans: Advisa MRI randomized clinical multicenter study results. Heart Rhythm. 2013 Jun;10(6):864-72. doi: 10.1016/j.hrthm.2013.02.019. Epub 2013 Feb 19.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Germany
Italy
Hungary
Israel
United Kingdom
Australia
Netherlands
Austria
Belgium
Switzerland
United States
Canada
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Azienda Complesso Ospedaliero San Filippo Neri

location_facility: Onze Lieve Vrouwe Gasthuis - Locatie Oosterpark

location_facility: Universitätsklinikum Rostock Anstalt öffentlichen Rechts und Medizinische Fakultät der Universität

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

location_facility: Centre Hospitalier Universitaire Saint Étienne


title: A Randomized, Double-Blind, Placebo-Controlled, 3-Arm, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Pioglitazone Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are receving treatment with metformin and pioglitazone and have inadequate glycemic (blood sugar) control.

ReferenceCitation: Davies MJ, Merton K, Vijapurkar U, Yee J, Qiu R. Efficacy and safety of canagliflozin in patients with type 2 diabetes based on history of cardiovascular disease or cardiovascular risk factors: a post hoc analysis of pooled data. Cardiovasc Diabetol. 2017 Mar 21;16(1):40. doi: 10.1186/s12933-017-0517-7.

ReferenceCitation: Pfeifer M, Townsend RR, Davies MJ, Vijapurkar U, Ren J. Effects of canagliflozin, a sodium glucose co-transporter 2 inhibitor, on blood pressure and markers of arterial stiffness in patients with type 2 diabetes mellitus: a post hoc analysis. Cardiovasc Diabetol. 2017 Feb 27;16(1):29. doi: 10.1186/s12933-017-0511-0.

ReferenceCitation: Gilbert RE, Mende C, Vijapurkar U, Sha S, Davies MJ, Desai M. Effects of Canagliflozin on Serum Magnesium in Patients With Type 2 Diabetes Mellitus: A Post Hoc Analysis of Randomized Controlled Trials. Diabetes Ther. 2017 Apr;8(2):451-458. doi: 10.1007/s13300-017-0232-0. Epub 2017 Feb 14.

repositories_concat: PubMed Central;University of Melbourne - Minerva Access

ReferenceCitation: Qiu R, Balis D, Xie J, Davies MJ, Desai M, Meininger G. Longer-term safety and tolerability of canagliflozin in patients with type 2 diabetes: a pooled analysis. Curr Med Res Opin. 2017 Mar;33(3):553-562. doi: 10.1080/03007995.2016.1271780. Epub 2017 Jan 4.

ReferenceCitation: John M, Cerdas S, Violante R, Deerochanawong C, Hassanein M, Slee A, Canovatchel W, Hamilton G. Efficacy and safety of canagliflozin in patients with type 2 diabetes mellitus living in hot climates. Int J Clin Pract. 2016 Sep;70(9):775-85. doi: 10.1111/ijcp.12868.

ReferenceCitation: Watts NB, Bilezikian JP, Usiskin K, Edwards R, Desai M, Law G, Meininger G. Effects of Canagliflozin on Fracture Risk in Patients With Type 2 Diabetes Mellitus. J Clin Endocrinol Metab. 2016 Jan;101(1):157-66. doi: 10.1210/jc.2015-3167. Epub 2015 Nov 18.

ReferenceCitation: Blonde L, Woo V, Mathieu C, Yee J, Vijapurkar U, Canovatchel W, Meininger G. Achievement of treatment goals with canagliflozin in patients with type 2 diabetes mellitus: a pooled analysis of randomized controlled trials. Curr Med Res Opin. 2015 Nov;31(11):1993-2000. doi: 10.1185/03007995.2015.1082991. Epub 2015 Sep 28.

ReferenceCitation: Gavin JR 3rd, Davies MJ, Davies M, Vijapurkar U, Alba M, Meininger G. The efficacy and safety of canagliflozin across racial groups in patients with type 2 diabetes mellitus. Curr Med Res Opin. 2015;31(9):1693-702. doi: 10.1185/03007995.2015.1067192. Epub 2015 Sep 4.

ReferenceCitation: Cefalu WT, Stenlof K, Leiter LA, Wilding JP, Blonde L, Polidori D, Xie J, Sullivan D, Usiskin K, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and relationship to HbA1c and blood pressure changes in patients with type 2 diabetes. Diabetologia. 2015 Jun;58(6):1183-7. doi: 10.1007/s00125-015-3547-2. Epub 2015 Mar 27.

ReferenceCitation: Weir MR, Januszewicz A, Gilbert RE, Vijapurkar U, Kline I, Fung A, Meininger G. Effect of canagliflozin on blood pressure and adverse events related to osmotic diuresis and reduced intravascular volume in patients with type 2 diabetes mellitus. J Clin Hypertens (Greenwich). 2014 Dec;16(12):875-82. doi: 10.1111/jch.12425. Epub 2014 Oct 20.

ReferenceCitation: Usiskin K, Kline I, Fung A, Mayer C, Meininger G. Safety and tolerability of canagliflozin in patients with type 2 diabetes mellitus: pooled analysis of phase 3 study results. Postgrad Med. 2014 May;126(3):16-34. doi: 10.3810/pgm.2014.05.2753.

ReferenceCitation: Weir MR, Kline I, Xie J, Edwards R, Usiskin K. Effect of canagliflozin on serum electrolytes in patients with type 2 diabetes in relation to estimated glomerular filtration rate (eGFR). Curr Med Res Opin. 2014 Sep;30(9):1759-68. doi: 10.1185/03007995.2014.919907. Epub 2014 May 22.

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

ReferenceCitation: Sinclair A, Bode B, Harris S, Vijapurkar U, Mayer C, Fung A, Shaw W, Usiskin K, Desai M, Meininger G. Efficacy and safety of canagliflozin compared with placebo in older patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. BMC Endocr Disord. 2014 Apr 18;14:37. doi: 10.1186/1472-6823-14-37.

ReferenceCitation: Nyirjesy P, Sobel JD, Fung A, Mayer C, Capuano G, Ways K, Usiskin K. Genital mycotic infections with canagliflozin, a sodium glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus: a pooled analysis of clinical studies. Curr Med Res Opin. 2014 Jun;30(6):1109-19. doi: 10.1185/03007995.2014.890925. Epub 2014 Feb 21.

location_country:
Germany
Finland
India
United Kingdom
Mexico
United States
Spain
Thailand
Greece
Canada
France


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.

ReferenceCitation: Januzzi JL Jr, Butler J, Jarolim P, Sattar N, Vijapurkar U, Desai M, Davies MJ. Effects of Canagliflozin on Cardiovascular Biomarkers in Older Adults With Type 2 Diabetes. J Am Coll Cardiol. 2017 Aug 8;70(6):704-712. doi: 10.1016/j.jacc.2017.06.016. Epub 2017 Jun 12.

repositories_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Blonde L, Stenlof K, Fung A, Xie J, Canovatchel W, Meininger G. Effects of canagliflozin on body weight and body composition in patients with type 2 diabetes over 104 weeks. Postgrad Med. 2016 May;128(4):371-80. doi: 10.1080/00325481.2016.1169894. Epub 2016 Apr 7.

publisher_dissemination: The Endocrine Society

ReferenceCitation: Bilezikian JP, Watts NB, Usiskin K, Polidori D, Fung A, Sullivan D, Rosenthal N. Evaluation of Bone Mineral Density and Bone Biomarkers in Patients With Type 2 Diabetes Treated With Canagliflozin. J Clin Endocrinol Metab. 2016 Jan;101(1):44-51. doi: 10.1210/jc.2015-1860. Epub 2015 Nov 18.

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

ReferenceCitation: Bode B, Stenlof K, Sullivan D, Fung A, Usiskin K. Efficacy and safety of canagliflozin treatment in older subjects with type 2 diabetes mellitus: a randomized trial. Hosp Pract (1995). 2013 Apr;41(2):72-84. doi: 10.3810/hp.2013.04.1020.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Colombia
India
New Zealand
United Kingdom
Hong Kong
Romania
Australia
Sweden
Switzerland
United States
Spain
Greece
South Africa
Canada
Ukraine
France


title: A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Psoriasis

summary: This study is an open-label extension of study 20090062 to evaluate extended subcutaneous dosing.

status: Terminated

ReferenceCitation: Papp K, Leonardi C, Menter A, Thompson EH, Milmont CE, Kricorian G, Nirula A, Klekotka P. Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment. J Am Acad Dermatol. 2014 Dec;71(6):1183-1190.e3. doi: 10.1016/j.jaad.2014.08.039. Epub 2014 Oct 11.

ReferenceCitation: Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.

ReferenceCitation: Lebwohl MG, Blauvelt A, Menter A, Papp KA, Guenthner S, Pillai R, Israel RJ, Jacobson A. Efficacy, Safety, and Patient-Reported Outcomes in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Brodalumab for 5 Years in a Long-Term, Open-Label, Phase II Study. Am J Clin Dermatol. 2019 Dec;20(6):863-871. doi: 10.1007/s40257-019-00466-2.

ipd_sharing: Undecided

lead_sponsor: Bausch Health Americas, Inc.

location_country:
Denmark
Australia
United States
Canada
France