lead_sponsor: Novartis Pharmaceuticals

summary: The study design was an open-label Phase II pediatric clinical study. The purpose of Study X2203 was to identify any efficacy signal in subjects with the disease subtypes under study, when treated with pazopanib monotherapy. Furthermore, it was to define the toxicities of pazopanib in children, as well as examine biological markers, e.g. cytokines and angiogenic factors, that could help further characterize any response of pazopanib in children. Pazopanib was administered as monotherapy in tablet and powder suspension formulations at daily doses of 450 mg/m2/dose or 225 mg/m2/dose, respectively. The first 6 enrolled subjects receiving oral suspension formulation were assessed for tolerability and extended PK sampling; and, only if pazopanib was tolerated, subsequent subjects were enrolled at the same starting dose with the suspension. Dose escalation was not permitted. For the tablet, a dosing nomogram was used based on the subject's BSA. Dose reduction was dependent upon the toxicity of pazopanib and disease status of the infants, toddlers, children, adolescents, and young adults. Subjects could be as young as 1 year-old infants to screen for enrollment. Subjects were assessed for initial response after 8 weeks of treatment prior to Cycle 3. A cycle was defined as 28 days of pazopanib treatment with no rest period between cycles. Treatment was administered continuously once daily. Treatment was to be discontinued if there was evidence of disease progression, unacceptable treatment-related toxicity, pregnancy. Histological classification was an important diagnostic inclusion in these subjects with a wide variety of refractory solid tumors, i.e. 7 different tumor types and each being a cohort.

sponsor_collaborators:
Novartis Pharmaceuticals
Children's Oncology Group

title: A Phase II Study of Pazopanib GW786034, NSC# 737754 in Children, Adolescents and Young Adults With Refractory Solid Tumors

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

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

location_country:
Slovakia
Hungary
United States
Spain
Czechia
Canada
France


type: EudraCT Number

type: Other Identifier

title: A Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Evaluating the Immunogenicity of FE 999049 in Repeated Cycles of Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme

summary: This trial investigates the immunogenicity of FE 999049 in repeated cycles.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Havelock J, Aaris Henningsen AK, Mannaerts B, Arce JC; ESTHER-1 and ESTHER-2 Trial Groups. Pregnancy and neonatal outcomes in fresh and frozen cycles using blastocysts derived from ovarian stimulation with follitropin delta. J Assist Reprod Genet. 2021 Oct;38(10):2651-2661. doi: 10.1007/s10815-021-02271-5. Epub 2021 Jul 13.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ReferenceCitation: Fernandez-Sanchez M, Fatemi H, Garcia-Velasco JA, Heiser PW, Daftary GS, Mannaerts B. Incidence and severity of ovarian hyperstimulation syndrome (OHSS) in high responders after gonadotropin-releasing hormone (GnRH) agonist trigger in "freeze-all" approach. Gynecol Endocrinol. 2023 Dec;39(1):2205952. doi: 10.1080/09513590.2023.2205952.

oa_host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: closed

publisher_dissemination: Informa

ReferenceType: derived

ReferenceCitation: Nelson SM, Larsson P, Mannaerts BMJL, Nyboe Andersen A, Fauser BCJM. Anti-Mullerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta. Clin Endocrinol (Oxf). 2019 May;90(5):719-726. doi: 10.1111/cen.13956. Epub 2019 Mar 18.

oa_host_type: closed

publisher_dissemination: Wiley

lead_sponsor: Ferring Pharmaceuticals

location_country:
Italy
Poland
United Kingdom
Denmark
Brazil
Belgium
Spain
Czechia
Canada
Russian Federation
France

location_facility: Centro Natalità San Raffaele (there may be other sites in this country)

location_facility: UZ Brussel (there may be other sites in this country)

location_facility: Glasgow Centre for Reproductive Medicine Ltd. (there may be other sites in this country)

location_facility: IVI Sevilla (there may be other sites in this country)

location_facility: Rigshospitalet Fertilitetsklinikken (there may be other sites in this country)

location_facility: IVF & Reproductive Genetics Center (there may be other sites in this country)

location_facility: Fertilitat and PUC-RS (there may be other sites in this country)

location_facility: Department of Endocrine Gynaecology and Reproductive Medicine, Hôpital Jeanne de Flandre (there may be other sites in this country)

location_facility: The nOvum Clinic (there may be other sites in this country)

location_facility: IVF CUBE SE (there may be other sites in this country)

location_facility: Pacific Centre for Reproductive Medicine

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Comparing the Efficacy and Safety of FE 999049 With Follitropin Alfa (GONAL-F) in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme

summary: This trial investigates the effects of FE 999049 compared to GONAL-F.

design_allocation: Randomized

ReferenceCitation: Arce JC, Larsson P, Garcia-Velasco JA. Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa. Reprod Biomed Online. 2020 Oct;41(4):616-622. doi: 10.1016/j.rbmo.2020.07.006. Epub 2020 Jul 15.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: Elsevier

ReferenceCitation: Ishihara O, Nelson SM, Arce JC. Comparison of ovarian response to follitropin delta in Japanese and White IVF/ICSI patients. Reprod Biomed Online. 2022 Jan;44(1):177-184. doi: 10.1016/j.rbmo.2021.09.014. Epub 2021 Sep 23.

ReferenceCitation: Nyboe Andersen A, Nelson SM, Fauser BC, Garcia-Velasco JA, Klein BM, Arce JC; ESTHER-1 study group. Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertil Steril. 2017 Feb;107(2):387-396.e4. doi: 10.1016/j.fertnstert.2016.10.033. Epub 2016 Nov 29.

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

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion


title: Phase II Randomized Double Blind Placebo Controlled Trial of Combination of Pimasertib With SAR245409 or of Pimasertib With SAR245409 Placebo in Subjects With Previously Treated Unresectable Low Grade Ovarian Cancer

summary: This is a double blind, randomized, placebo-controlled, 2-arm, Phase 2 trial investigating the efficacy and safety of combination therapy of pimasertib plus SAR245409 and pimasertib placebo administered once per day compared to pimasertib administered twice per day plus SAR245409 placebo administered once per day in participants with previously treated unresectable low-grade serous ovarian or peritoneal carcinoma or serous borderline ovarian or peritoneal tumors.

lead_sponsor: EMD Serono

sponsor_collaborators:
EMD Serono
Sanofi

location_country:
Poland
Australia
Belgium
United States
Spain
Canada
France


title: OPTIMIS - Outcomes of HCC Patients Treated With TACE Followed or Not Followed by Sorafenib and the Influence of Timing to Initiate Sorafenib

acronym: OPTIMIS

summary: This study will collect data of patients who are treated with TACE followed by sorafenib for hepatocellular carcinoma (HCC) or patients without Sorafenib after TACE. In contrast to a prior observational study on sorafenib (GIDEON study), where pre-treatment with TACE was documented retrospectively, this study will collect more detailed information about the TACE treatment and the status of a patient when treatment with sorafenib is started.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Bayer

location_country:
Poland
Japan
Brazil
Thailand
Kazakhstan
Turkey
Pakistan
Vietnam
Czechia
Canada
France
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
Indonesia
India
China
Egypt
Singapore
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

intervention_type: Procedure


title: A Phase I/II, Multi-center, Dose-escalating Study of the Tolerability, Pharmacokinetics, and Clinical Activity of the Combined Administration of Oral Rigosertib With Azacitidine in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

summary: This study, is a Phase I/II clinical trial in three parts: Phase I Dose Escalation, Phase II, Part 1 RPTD Cohort, and Phase II, Part 2 Expansion. The first two parts have been completed. The Phase II, Part 2 Expansion will assess if treatment with rigosertib in combination with azacitidine, has measurable effects in patients with myelodysplastic syndrome (MDS). Safety of patients is an objective throughout all parts of the study.

ReferenceType: background

ReferenceCitation: Navada SC, Silverman LR. The safety and efficacy of rigosertib in the treatment of myelodysplastic syndromes. Expert Rev Anticancer Ther. 2016 Aug;16(8):805-10. doi: 10.1080/14737140.2016.1209413. Epub 2016 Jul 15.

ReferenceCitation: Chaurasia, P. et al. Rigosertib in Combination with Azacitidine Modulates Epigenetic Pathways and can Overcome Clinical Resistance to Hypomethylating Agents in Myelodysplastic Syndromes (MDS). Leukemia Research , Volume 55 , S121, April 2017; MDS 2017.

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

ReferenceCitation: Navada S, Garcia-Manero G. Combination of Oral Rigosertib and Injectable Azacitidine in Patients with Myelodysplastic Syndromes (MDS): Results from a Phase II Study. Blood Dec 2016, 128 (22) 3167; ASH 2016.

ReferenceCitation: Navada, S. et al. Combination of Oral Rigosertib and Injectable Azacitidine in Patients with Myelodysplastic Syndromes (MDS). Leukemia Research , Volume 55 , S30, April 2017; MDS 2017.

ReferenceCitation: Navada SC, Garcia-Manero G, OdchimarReissig R, Pemmaraju N, Alvarado Y, Ohanian MN, John RB, Demakos EP, Zbyszewski PS, Maniar M, Woodman RC, Fruchtman SM, Silverman LR. Rigosertib in combination with azacitidine in patients with myelodysplastic syndromes or acute myeloid leukemia: Results of a phase 1 study. Leuk Res. 2020 Jul;94:106369. doi: 10.1016/j.leukres.2020.106369. Epub 2020 May 12.

lead_sponsor: Onconova Therapeutics, Inc.

location_country:
United States
France

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Froedtert Hospital and the Medical College of Wisconsin

location_facility: White Plains Hospital Center for Cancer Care

location_facility: Carolina Blood and Cancer Care Associates

location_facility: Desert Hematology Oncology Medical Group, Inc.


title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Dose-finding, Pivotal, Phase 2b/3 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous BYM338 at 52 Weeks on Physical Function, Muscle Strength, and Mobility and Additional Long Term Safety up to 2 Years in Patients With Sporadic Inclusion Body Myositis

acronym: RESILIENT

summary: This study evaluated the efficacy, safety and tolerability of multiple doses of bimagrumab/BYM338 vs placebo, when administered intravenously (i.v.), on physical function, muscle strength, and mobility in patients with sporadic inclusion body myositis (sIBM).

ReferenceCitation: Hanna MG, Badrising UA, Benveniste O, Lloyd TE, Needham M, Chinoy H, Aoki M, Machado PM, Liang C, Reardon KA, de Visser M, Ascherman DP, Barohn RJ, Dimachkie MM, Miller JAL, Kissel JT, Oskarsson B, Joyce NC, Van den Bergh P, Baets J, De Bleecker JL, Karam C, David WS, Mirabella M, Nations SP, Jung HH, Pegoraro E, Maggi L, Rodolico C, Filosto M, Shaibani AI, Sivakumar K, Goyal NA, Mori-Yoshimura M, Yamashita S, Suzuki N, Katsuno M, Murata K, Nodera H, Nishino I, Romano CD, Williams VSL, Vissing J, Auberson LZ, Wu M, de Vera A, Papanicolaou DA, Amato AA; RESILIENT Study Group. Safety and efficacy of intravenous bimagrumab in inclusion body myositis (RESILIENT): a randomised, double-blind, placebo-controlled phase 2b trial. Lancet Neurol. 2019 Sep;18(9):834-844. doi: 10.1016/S1474-4422(19)30200-5.

oa_host_type: repository

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

version: submittedVersion

repository_institution: The University of Manchester - Research Explorer

repositories:
Pure (Denmark)
UCL Discovery

repositories_concat: Pure (Denmark);UCL Discovery

unpaywall_oa_status: green

location_country:
Italy
United Kingdom
Denmark
Australia
Japan
Netherlands
Switzerland
Belgium
United States
France


summary: The main purpose of this prospective, multicenter, open-label phase II study, was to evaluate the efficacy and safety of pasireotide alone or in combination with cabergoline in patients with Cushing's disease.

location_facility: Oregon Health and Science University SOM230B2411

location_facility: University of Alabama at Birmingham The Kirklin Clinic

status: Terminated

title: A Phase II Trial to Assess the Efficacy and Safety of Pasireotide s.c. Alone or in Combination With Cabergoline in Patients With Cushing's Disease

source: euctr

location_country:
Germany
Italy
Colombia
India
Hungary
Argentina
Brazil
Netherlands
Mexico
Belgium
United States
Spain
Greece
Malaysia
Turkey
France

ipd_sharing: Yes

status_simplified: Unknown


lead_sponsor: Sumitomo Pharma America, Inc.

summary: This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326

ReferenceCitation: DelBello MP, Tocco M, Pikalov A, Deng L, Goldman R. Tolerability, Safety, and Effectiveness of Two Years of Treatment with Lurasidone in Children and Adolescents with Bipolar Depression. J Child Adolesc Psychopharmacol. 2021 Sep;31(7):494-503. doi: 10.1089/cap.2021.0040. Epub 2021 Jul 29.

evidence: open (via page says license)

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Mary Ann Liebert Inc

location_facility: CI Lviv Regional Clinical Psychiatric Hospital

location_facility: CI Kherson Regional Psychiatric Hospital of Kherson RC

location_facility: Instituto de Informacion de Investigacion en Salud Mental

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA

location_facility: Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340

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

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu, Oddzial Kliniczmy VI Psychiatrii Mlodziezy

location_facility: Reg. Psych. Hosp.n.a. O.Yuschenko, Dept. #121 VNMI

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

location_facility: State Healthcare Institution of Yaroslavl Rgion "Yaroslavl Regional clinical Mental Hospital"

location_facility: FSBSI "Scientific Research Institute of Mental Health"

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

location_facility: Regional Clinical Mental Hospital of Saint Sofiya

location_facility: State Healthcare Institution of Nizhniy Novgordo region "Clinical Psychiatric Hospital #1 of City of Nizhniy Novgorod"

location_facility: SHI "City Psychoneurological dispensary #7 (with Hospital)"

location_facility: Medical Research Group of Central Florida

location_facility: Vadaskert Alapitvany a Gyermekek Lelki Egeszsegeert

location_facility: University of California San Francisco Medical Center

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

location_facility: Centro de Investigacion Clinica Psiquiatrica

location_facility: Odesa Regional Psychoneurological Dispensary, Outpatient Dept.

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

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

location_facility: Neuropsychiatric Research Center of Orange County

location_facility: The Ohio State University Nisonger Center

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

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

location_facility: SI Institute of Children and Adolescents Healthcare of NAMSU

location_facility: West Visayas State University Medical Center

location_facility: Closed corporation "Scientific Center of Personalized Psychiatry"

location_facility: Alexian Brothers Health and Wellness Center

location_facility: Center of Recovery Treatment "Pediatric Psychiatry" named after S.S. Mnukhin

location_facility: Sverdiovsk Regional Clinical Psychiatric Hospital

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

location_facility: University of South Florida Rothman Center of Neuropychiatry

location_facility: University Hospitals Case Medical Center

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

location_facility: GUZ Lipetsk Regional psychoneurological Hospital #1

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

title: A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects

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


summary: The study will enroll low risk MDS patients who need red blood cell transfusions and who are refractory to or are not using erythropoiesis-stimulating agents. The purpose of the study is to determine whether oral rigosertib treatment results in hematological improvements according to the 2006 International Working Group criteria in these patients. The study will also record any side effects that may occur during the study.

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

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Washington Cancer Institute at Medstar Washington Hospital Center

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

location_facility: Hôpital Saint-Louis, Service d'Hématologie

location_facility: Anschutz Cancer Pavilion University of Colorado

location_facility: Greenbaum Cancer Center University of Maryland

title: A Single-arm Study to Assess the Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Intermediate-1, Myelodysplastic Syndrome Patients Based on the International Prognostic Scoring System

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

location_country:
United States
Germany
France


title: A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Systemic Juvenile Idiopathic Arthritis

summary: This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile Idiopathic Arthritis (sJIA). Participants with body weight less than (<) 30 kilograms (kg) will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with body weight greater than or equal to (>=) 30 kg will receive weekly (QW), for 52 weeks. Tocilizumab was administered every 10 days until pre-planned interim analysis was performed and changed to Q2W in participants with body weight <30 kg.

ReferenceCitation: Ruperto N, Brunner HI, Ramanan AV, Horneff G, Cuttica R, Henrickson M, Anton J, Boteanu AL, Penades IC, Minden K, Schmeling H, Hufnagel M, Weiss JE, Pardeo M, Nanda K, Roth J, Rubio-Perez N, Hsu JC, Wimalasundera S, Wells C, Bharucha K, Douglass W, Bao M, Mallalieu NL, Martini A, Lovell D, Benedetti F; Paediatric Rheumatology INternational Trials Organisation (PRINTO) and the Paediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous dosing regimens of tocilizumab in children with systemic or polyarticular juvenile idiopathic arthritis. Rheumatology (Oxford). 2021 Oct 2;60(10):4568-4580. doi: 10.1093/rheumatology/keab047.

publisher_dissemination: Oxford University Press

lead_sponsor: Hoffmann-La Roche

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

location_facility: Cincinnati Children'S Hospital Medical Center; Division of Rheumatology

location_facility: Hospital das Clinicas - FMUSP Ribeirao Preto; Pediatria - Imunologia e Reumatologia

location_facility: Universidade Federal de Sao Paulo - UNIFESP

location_facility: Asklepios Klinik; Zentrum fuer Allgemeine Paediatrie und Neonatologie

location_facility: Nuovo Ospedale Pediatrico Meyer; Reumatologia - Clinica Pediatrica 1°

location_facility: Levine Children's Hospital; Divison of Pediatric Rheumatology; Department of Pediatrics

location_facility: Great Ormond Street Hospital; Somers Clinical Research Facility

location_facility: Hospital Ramon y Cajal ; Servicio de Reumatologia

location_facility: Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS

location_facility: Hospital das Clinicas - FMUSP; Instituto da Crianca - Reumatologia

location_facility: Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica

location_facility: University of Utah; Immunology/Rheumatology/Allergy

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria

location_facility: Connecticut Children's Medical Center; 5E Clinical Trials Unit

location_facility: Hospital Infantil de México "Federico Gomez"; Rheumatology

location_facility: Arkansas Children's Hospital Research Institute

location_facility: Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina

location_facility: Hackensack University Medical Center; Pediatric Rheumatology

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago; Division of Rheumatology

location_facility: Uniklinikum Freiburg Zentrum für Kinder- und Jugendmedizin; Pädiatrische Infektio- u. Rheumatologie

location_facility: FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences

location_facility: Hospital Sant Joan De Deu; Servicio de Reumatologia Pediatrica

location_facility: Hospital de Ninos de la Santisima Trinidad; Reumatologia Infantil

location_facility: Hospital de La Paz; Unidad de Reumatologia Pediatrica

location_facility: Hospital Infantil Universitario Niño Jesus, Servicio Reumatologia

location_facility: The University of Chicago;Department of Pediatrics

location_facility: SI Sceintific children health center RAMS

location_facility: Royal Children'S Hospital; Paediatric Rheumatology

location_facility: Westmead Hospital; Paediatric Rheumatology


title: A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Polyarticular Juvenile Idiopathic Arthritis

acronym: JIGSAW 117

summary: This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and safety of SC administered TCZ in participants with pJIA.


acronym: PURSUIT PEDS PK

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participants (aged 2 to 17 years) with moderately to severely active Ulcerative Colitis (UC).

title: A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis

location_country:
Germany
Poland
Israel
Denmark
Netherlands
Austria
Belgium
United States
Canada
France


acronym: The DIVERSITY study

lead_sponsor: Boehringer Ingelheim

summary: The main objectives of this large phase IIb/III paediatric study are to assess the efficacy and safety of dabigatran etexilate relative to standard of care and to document the appropriateness of the proposed dabigatran etexilate dosing algorithm for use in patients from birth to less than 18 years of age.

ReferenceCitation: Brandao LR, Tartakovsky I, Albisetti M, Halton J, Bomgaars L, Chalmers E, Luciani M, Saracco P, Felgenhauer J, Lvova O, Simetzberger M, Sun Z, Mitchell LG. Dabigatran in the treatment and secondary prophylaxis of venous thromboembolism in children with thrombophilia. Blood Adv. 2022 Nov 22;6(22):5908-5923. doi: 10.1182/bloodadvances.2021005681.

oa_colors: green gold

unpaywall_oa_status: gold

publisher_dissemination: American Society of Hematology

ReferenceCitation: Halton J, Brandao LR, Luciani M, Bomgaars L, Chalmers E, Mitchell LG, Nurmeev I, Sharathkumar A, Svirin P, Gorbatikov K, Tartakovsky I, Simetzberger M, Huang F, Sun Z, Kreuzer J, Gropper S, Reilly P, Brueckmann M, Albisetti M; DIVERSITY Trial Investigators. Dabigatran etexilate for the treatment of acute venous thromboembolism in children (DIVERSITY): a randomised, controlled, open-label, phase 2b/3, non-inferiority trial. Lancet Haematol. 2021 Jan;8(1):e22-e33. doi: 10.1016/S2352-3026(20)30368-9. Epub 2020 Dec 5.

ReferenceCitation: Albisetti M, Biss B, Bomgaars L, Brandao LR, Brueckmann M, Chalmers E, Gropper S, Harper R, Huang F, Luciani M, Manastirski I, Mitchell LG, Tartakovsky I, Wang B, Halton JML. Design and rationale for the DIVERSITY study: An open-label, randomized study of dabigatran etexilate for pediatric venous thromboembolism. Res Pract Thromb Haemost. 2018 Mar 25;2(2):347-356. doi: 10.1002/rth2.12086. eCollection 2018 Apr.

evidence: oa journal (via doaj)

location_facility: Children Intensive Care Hosp,Anaesthesiology Dept,Vilnius

location_facility: Cukurova Universitesi Tip Fakultesi Cocuk Sagligi

location_facility: Child.CityClin.Hos.na.ZA Bashlyaeva MoscowHealth Dep,Cardiol

location_facility: Science Res.Instit.CV Diseases,Scientific Res.Dept,Kemerovo

location_facility: Providence Sacred Heart Medical Center and Children's Hospital

location_facility: HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Rigshospitalet, København, Børneonkologisk Afsnit 5002

location_facility: Shaare Zedek Medical Center, Jerusalem 91031

location_facility: University Hospital Plzen, Plzen-Lochotin

location_facility: Children Rep.Clin.Hosp of MoH,Cardio Vas.surgery Dept, Kazan

location_facility: Izmilovskaya Child City ClinHosp,Haematological Dept, Moscow

location_facility: Faculdade de Ciencias Medicas da UNICAMP

location_facility: PenSI - Pesquisa e Ensino em Saude Infantil

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi

location_facility: University of Iowa Hospitals and Clinics

location_facility: Hospital General de Niños Pedro de Elizalde

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Ege Universitesi Tip Fakultesi Cocuk Hematolojisi Bilim Dali

location_facility: St.Petersburg State Pediatric Univ.Ministry of Healthcare RF

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Reg Clin.Hosp.#1,Healthcare Tyumen Region,Cardiovas.Surgery

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Instituto de Crianca / Hospital das Clínicas-FMUSP

location_facility: Istanbul Saglik Bilimleri Uni. Kanuni Sultan Suleyman EAH

title: Open-label, Randomized, Parallel-group, Active-controlled, Multi-centre Non-inferiority Study of Dabigatran Etexilate Versus Standard of Care for Venous Thromboembolism Treatment in Children From Birth to Less Than 18 Years of Age

location_country:
Finland
Germany
Argentina
Brazil
Thailand
Turkey
Czechia
Canada
France
Lithuania
Hungary
Denmark
Switzerland
United States
Ukraine
Belgium
Italy
Norway
Sweden
Austria
Mexico
Spain
Greece
Taiwan
Russian Federation
Israel


title: Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone

summary:
Participants suffering from active rheumatoid arthritis despite continued treatment with methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 (3 different doses - 50 milligram [mg], 100 mg and 200 mg daily -, each evaluated as once daily [QD] and twice daily [BID] regimen) or matching placebo for 24 weeks.

•During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses and dose regiments of GLPG0634 administration on participants' disability, fatigue, and quality of life were evaluated.

ReferenceCitation: Combe B, Besuyen R, Gomez-Centeno A, Matsubara T, Sancho Jimenez JJ, Yin Z, Buch MH. Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Feb;10(1):35-51. doi: 10.1007/s40744-022-00494-1. Epub 2022 Oct 7.

repository_institution: University of Illinois at Chicago - INDIGO

repositories_concat: PubMed Central;figshare.com

ReferenceCitation: Tarrant JM, Galien R, Li W, Goyal L, Pan Y, Hawtin R, Zhang W, Van der Aa A, Taylor PC. Filgotinib, a JAK1 Inhibitor, Modulates Disease-Related Biomarkers in Rheumatoid Arthritis: Results from Two Randomized, Controlled Phase 2b Trials. Rheumatol Ther. 2020 Mar;7(1):173-190. doi: 10.1007/s40744-019-00192-5. Epub 2020 Jan 7.

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

repositories_concat: PubMed Central;ora.ox.ac.uk

ReferenceCitation: Westhovens R, Taylor PC, Alten R, Pavlova D, Enriquez-Sosa F, Mazur M, Greenwald M, Van der Aa A, Vanhoutte F, Tasset C, Harrison P. Filgotinib (GLPG0634/GS-6034), an oral JAK1 selective inhibitor, is effective in combination with methotrexate (MTX) in patients with active rheumatoid arthritis and insufficient response to MTX: results from a randomised, dose-finding study (DARWIN 1). Ann Rheum Dis. 2017 Jun;76(6):998-1008. doi: 10.1136/annrheumdis-2016-210104. Epub 2016 Dec 19.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

publisher_dissemination: British Medical Journal

lead_sponsor: Galapagos NV

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Chile
Czechia
France
Colombia
Hungary
United States
Latvia
Ukraine
Belgium
Moldova, Republic of
Guatemala
Austria
Mexico
Spain
Bulgaria
Russian Federation
Israel

location_facility: Artho Care, Arthritis Care & Research P.C.

location_facility: Ambulance Revmatologie a Interniho Lekarstvi

location_facility: Municipal Institution Lutsk City Clinical Hospital

location_facility: Rheumatology Associates of North Alabama, PC

location_facility: Instituto Terapias Oncologicas Providencia

location_facility: Centro Integral de Reumatologia de Caribe

location_facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu

location_facility: Central Outpatient Hospital of Deanyanskyy Distric

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Bekes Megyei Pandy Kalman Korhaz, Reumatologiai Osztaly

location_facility: Fundación del caribe para la investigación medica Fundación BIOS

location_facility: Powiatowy Zakrad Opieki Zdrowotnej w Starachowicach

location_facility: Hospital Regional "Guillermo Grant Benavente"

location_facility: Clinica Medica Especializada en Reumatologia

location_facility: Center for Innovative TherapyDivision of Rheumatology, UCSD

location_facility: I.M. Sechenov First Moscow State Medical University

location_facility: Central regional polyclinic of Pechersk District

location_facility: Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.

location_facility: Schlossparkklinik - Akad. Lehrkrankenhaus Charite

location_facility: Centro Integral de Reumatologia e Inmunologia SAS

location_facility: Instituto de Asistencia Reumatologia Integral

location_facility: Centro de Estudios de Investigacion Basica y Clinica, SC

location_facility: State University of Medicine and Dentistry

location_facility: Arizona Arthritis & Rheumatology Research PLLC

location_facility: Medical University/ AKH Vienna/ Dep.of Rheumatology 6J

location_facility: V. Gusak Institute of Urgent and Recovery Surgery

location_facility: "Multiprofile Hospital for Active Treatment - Kaspela" LTD

location_facility: Centro de Investigacion Clínica del Sur Freire

location_facility: Charite Mitte, Rheumatologie Neue Therapien

location_facility: National Transport Hospital "Tsar Boris" III

location_facility: Diagnostic Consultative Center "Sveta Anna" LTD


title: A Randomized Study Comparing the Safety and Efficacy of the InnFocus MicroShunt® Glaucoma Drainage System to Standard Trabeculectomy In Subjects With Primary Open Angle Glaucoma

acronym: IMS

summary: Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using maximum tolerated glaucoma medications.

ReferenceCitation: Baker ND, Barnebey HS, Moster MR, Stiles MC, Vold SD, Khatana AK, Flowers BE, Grover DS, Strouthidis NG, Panarelli JF; INN005 Study Group. Ab-Externo MicroShunt versus Trabeculectomy in Primary Open-Angle Glaucoma: One-Year Results from a 2-Year Randomized, Multicenter Study. Ophthalmology. 2021 Dec;128(12):1710-1721. doi: 10.1016/j.ophtha.2021.05.023. Epub 2021 May 27.

lead_sponsor: InnFocus Inc.

location_country:
Italy
United Kingdom
Netherlands
United States
Spain
France

location_facility: Glaucoma Consultants of the Capital Region

location_facility: Rashid, Rice, Flynn and Reilley Eye Associates

location_facility: University of California at Davis Eye Center

location_facility: Pole Ophtalmologique de la Clinique Mutualiste

location_facility: Ophthalmic Surgeons and Consultants of Ohio

location_facility: New York Eye and Ear Infirmary of Mt. Sinai

location_facility: Chicago Glaucoma Consultants and CGC Eye Center


acronym: tnAcity

lead_sponsor: Celgene

summary: The purpose of this study is to compare the safety and efficacy of nab-paclitaxel in combination with either gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line treatment in female subjects with triple negative metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer.

ReferenceCitation: Yardley DA, Brufsky A, Coleman RE, Conte PF, Cortes J, Gluck S, Nabholtz JM, O'Shaughnessy J, Beck RM, Ko A, Renschler MF, Barton D, Harbeck N. Phase II/III weekly nab-paclitaxel plus gemcitabine or carboplatin versus gemcitabine/carboplatin as first-line treatment of patients with metastatic triple-negative breast cancer (the tnAcity study): study protocol for a randomized controlled trial. Trials. 2015 Dec 16;16:575. doi: 10.1186/s13063-015-1101-7. Erratum In: Trials. 2016;17:63.

ReferenceCitation: Liu MC, Janni W, Georgoulias V, Yardley DA, Harbeck N, Wei X, McGovern D, Beck R. First-Line Doublet Chemotherapy for Metastatic Triple-Negative Breast Cancer: Circulating Tumor Cell Analysis of the tnAcity Trial. Cancer Manag Res. 2019 Dec 12;11:10427-10433. doi: 10.2147/CMAR.S208712. eCollection 2019.

location_facility: Onkologikoa - Kutxaren Institutu Onkologikoa

location_facility: Investigative Clinical Research of Indiana, LLC

location_facility: Northwest Cancer Specialists, P.C. - Hoyt

location_facility: Instituto Ribeiraopretano de Combate Ao Cancer

location_facility: The Center for Cancer and Blood Disorders

location_facility: Praxis fur interdisziplinare Onkologie & Hamatologie

location_facility: Henry Ford Medical Center - New Center One

location_facility: University of Athens Medical school - Regional General Hospital

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Dartmouth Hitchcock Medical Center Norris Cotton Cancer Center

location_facility: Krankenanstalt Mutterhaus der Borromaerinnen

location_facility: California Cancer Associates for Research and Excellence cCARE

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: University of South Alabama Mitchell Cancer Institute

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

location_facility: Salzburger Landkliniken St. Johanns-Spital

location_facility: Instituto Brasileiro de Controle Do Cancer IBCC

location_facility: IRCCS AziendaOspedaliera Universitaria San Martino

location_facility: Facharztpraxis fur Gynakologie und Geburtshilfe

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Cancer Care Centers of South Texas - Loop

location_facility: Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

location_facility: University of California San Diego Moores Cancer Center

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Schwerpunktpraxis fur Gynakologische Onkologie

location_facility: Hospital das Clinicas da Faculdade de Medicina da USP

location_facility: Joliet Oncology-Hematology Associates, Ltd

location_facility: Hospital Albert Einstein Sociedade Beneficente Israelita Brasileira

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: Instituto Portugues de Oncologia do Porto, Francisco Gentil

location_facility: Hospital de Base Da Faculdade de Medicina de

location_facility: Hospital du Saint Scarement Sacrement Laboratory

location_facility: Chattanooga Oncology Hematology Associates

location_facility: University General Hospital of Heraklion

location_facility: Central Coast Medical Oncology Corporation

location_facility: The East and North Hertfordshire NHS Trust

location_facility: Center for Cancer and Blood Disorders, PC

location_facility: Hematology Oncology Associates of Fredericksburg

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant' Anna

location_facility: Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento

location_facility: Alan Blair Cancer Centre at Pasqua Hosptial

location_facility: Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú

title: A Phase 2/3, Multi-Center, Open-Label, Randomized Study of Weekly Nab®-Paclitaxel in Combination With Gemcitabine or Carboplatin, Compared to Gemcitabine/Carboplatin, as First Line Treatment in Subjects With ER, PgR, and HER2 Negative (Triple Negative) Metastatic Breast Cancer

location_country:
Germany
Italy
Portugal
United Kingdom
Australia
Brazil
Austria
United States
Spain
Greece
Canada
France


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) Or Adalimumab In Subjects With Active Psoriatic Arthritis

acronym: OPAL BROADEN

summary: This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.

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

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

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

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

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

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

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

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

repositories_institution: University of Illinois at Chicago - INDIGO

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

repository_institution: University of Toronto - TSpace

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

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

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

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

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

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

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

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

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

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

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

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

repository_institution: Newcastle Univesity - Newcastle University ePrints

repositories_institution: Newcastle Univesity - Newcastle University ePrints

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

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

repositories_institution: The University of Glasgow - Enlighten: Publications

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

ReferenceCitation: van der Heijde D, Gladman DD, FitzGerald O, Kavanaugh A, Graham D, Wang C, Fallon L. Radiographic Progression According to Baseline C-reactive Protein Levels and Other Risk Factors in Psoriatic Arthritis Treated with Tofacitinib or Adalimumab. J Rheumatol. 2019 Sep;46(9):1089-1096. doi: 10.3899/jrheum.180971. Epub 2019 Mar 1.

ReferenceCitation: Strand V, de Vlam K, Covarrubias-Cobos JA, Mease PJ, Gladman DD, Graham D, Wang C, Cappelleri JC, Hendrikx T, Hsu MA. Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden-a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs. RMD Open. 2019 Jan 11;5(1):e000806. doi: 10.1136/rmdopen-2018-000806. eCollection 2019.

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

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

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

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

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

ReferenceCitation: Mease P, Hall S, FitzGerald O, van der Heijde D, Merola JF, Avila-Zapata F, Cieslak D, Graham D, Wang C, Menon S, Hendrikx T, Kanik KS. Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med. 2017 Oct 19;377(16):1537-1550. doi: 10.1056/NEJMoa1615975.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

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

location_facility: Drug Shipment/Storage: Huntsman Cancer Hospital at the University of Utah

location_facility: ZDROWIE OSTEO-MEDIC s.c. L. i A. Racewicz, A. i J. Supronik

location_facility: Complexo Hospitalario Universitario A Coruna

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a. N.V. Solovyev

location_facility: Sanatorio CEMSI Chapultepec (For Emergencies Only)

location_facility: Synexus Polska Sp. z o.o. Oddz. we Wroclawiu

location_facility: OOO City Neurological Centre "Sibneiromed"

location_facility: Csolnoky Ferenc Korhaz, Reumatologiai Osztaly

location_facility: Rheumatology Associates of North Alabama, PC

location_facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy,

location_facility: State Institution of Healthcare of Yaroslavl Region

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

location_facility: Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie

location_facility: Dynacare Laboratories (Specimen processing for shipment)

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

location_facility: NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.,"

location_facility: Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska

location_facility: Bradford Teaching Hospitals NHS Foundation Trust

location_facility: ClinicMed Badurski i wspolnicy Spolka Jawna

location_facility: York Teaching Hospital NHS Foundation Trust

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Wirral University Teaching Hospital NHS Foundation Trust

location_facility: Hopital Erasme - Clinique Universitaire de Bruxelles

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

location_facility: Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital

location_facility: Zespol Poradni Specjalistycznych Reumed Filia Onyksowa

location_facility: State Budgetary Institution of Healthcare of Moscow City Clinical Hospital

location_facility: Investigational Drug Service Pharmacy, Swedish Medical Center.

location_facility: Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"

location_facility: Klinika Ambroziak Estederm Sp. z o.o. ,S.K.A

location_facility: Revmatologicky Ustav - Lekarna (pharmacy only)

location_facility: Dartmouth-Hitchcock Medical Center (DHMC)

location_facility: Csolnoky Ferenc Korhaz, Radiologiai Osztaly X-Ray Only

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

location_facility: State Institution of Healthcare "Regional Clinical Hospital"

location_facility: Regional State Budgetary Healthcare Institution of Karelia Republic

location_facility: Investigacion y Biomedicina de Chihuahua SC

location_facility: Centro de Investigacion Clinica Pensiones

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

location_facility: West Island Rheumatology Research Associates

location_facility: HOSPITAL STAR MEDICA S.A DE C.V- (emergencies only)

location_facility: Unidad Reumatologica Las Americas, S.C.P.

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: ROMJAN s.r.o., Reumatologicka ambulancia

location_facility: Barking, Havering and Redbridge University Hospitals NHS Trust

location_facility: Centro Integral en Reumatologia SA de CV

location_facility: Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan

location_facility: Chang Gung Medical Foundation-Kaohsiung Branch

location_facility: University Hospital Leuven, Department of Rheumatology

location_facility: Hospital Star Medica Merida (For Emergencies Only)

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont,Reumatologiai osztaly

location_facility: MC "New rehabilitation center" EOOD, Rheumatology Cabinet

location_facility: Hospital General de Culiacán Dr. Bernardo J. Gastélum

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

location_facility: State Budget Educational Institution of Highest Professional Education

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

location_facility: Medical Plus s.r.o. Lekarna Hradebni s. r.o


summary:
Dose Escalation part of the study: To estimate the MTD(s) and/ or RP2D of LEE011 in combination with everolimus + exemestane, and LEE011 in combination with exemestane, and to characterize the safety and tolerability of the combinations of everolimus + exemestane + LEE011 and LEE011 + exemestane in patients with ER+ HER2- advanced breast cancer

Dose Expansion part of the study: To characterize the safety and tolerability of the triplet combination of LEE011 + everolimus + exemestane in patients naïve or refractory to CDK4/6 inhibitor based therapy, and the safety and tolerability of the doublet combination of LEE011 + exemestane in patients refractory to CDK4/6 inhibitor based therapy (except patients treated with prior LEE011 are not allowed in Group 3).

location_facility: Oregon Health and Science University SC-5

location_facility: University of Texas MD Anderson Cancer Center Onc Dept

location_facility: Sylvester Comprehensive Cancer Center Main Center

title: A Phase Ib Trial of LEE011 in Combination With Everolimus (RAD001) and Exemestane in the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

location_country:
Hong Kong
Belgium
United States
Spain
France

ipd_sharing: No


title: A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (Sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T)

acronym: SIRROUND-LTE

summary: The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.

ReferenceCitation: Aletaha D, Bingham CO, Karpouzas GA, Takeuchi T, Thorne C, Bili A, Agarwal P, Hsu B, Rao R, Brown K, Tanaka Y. Long-term safety and efficacy of sirukumab for patients with rheumatoid arthritis who previously received sirukumab in randomised controlled trials (SIRROUND-LTE). RMD Open. 2021 Jan;7(1):e001465. doi: 10.1136/rmdopen-2020-001465.

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

sponsor_collaborators:
Janssen Research & Development, LLC
GlaxoSmithKline

location_country:
Germany
Poland
Argentina
Australia
Japan
Croatia
Chile
Canada
Serbia
France
Lithuania
Colombia
Portugal
United States
Ukraine
Romania
Belgium
Malaysia
Puerto Rico
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation


title: An Open-label, Multicenter Protocol Providing Pegylated Interferon Alfa-2a (Pegasys®) as Monotherapy or in Combination With Ribavirin (Copegus®) for Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols

summary: This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.

location_country:
Italy
Poland
United Kingdom
Australia
Brazil
United States
Spain
Greece
Taiwan
Puerto Rico
France


summary: Phase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with a platinum therapy.The primary endpoint was PFS and the key secondary endpoint was Overall Survival.

ReferenceCitation: Soulieres D, Faivre S, Mesia R, Remenar E, Li SH, Karpenko A, Dechaphunkul A, Ochsenreither S, Kiss LA, Lin JC, Nagarkar R, Tamas L, Kim SB, Erfan J, Alyasova A, Kasper S, Barone C, Turri S, Chakravartty A, Chol M, Aimone P, Hirawat S, Licitra L. Buparlisib and paclitaxel in patients with platinum-pretreated recurrent or metastatic squamous cell carcinoma of the head and neck (BERIL-1): a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Oncol. 2017 Mar;18(3):323-335. doi: 10.1016/S1470-2045(17)30064-5. Epub 2017 Jan 26.

location_facility: The Mount Sinai Hospital Dept of Oncology

location_facility: University of N.C. at Chapel Hill Lineberger Comp. Cancer Ctr.

location_facility: Washington U School of Medicine Center for Clinical Studies SC - BKM120H2201

location_facility: University Hospitals Case Medical Center Univ. Hospitals of Cleveland

title: Double Blind, Placebo Controlled Study Assessing the Efficacy of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Patients With Platinum Pre-treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

location_country:
Germany
Ireland
Italy
Poland
India
Hungary
United Kingdom
Australia
Japan
Switzerland
United States
Korea, Republic of
Spain
Thailand
Taiwan
Canada
Russian Federation
France

ipd_sharing: Undecided


lead_sponsor: Genentech, Inc.

summary:
This multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) in participants with PD-L1-positive locally advanced or metastatic NSCLC. Participants will receive an intravenous (IV) dose of 1200 milligrams (mg) atezolizumab (MPDL3280A) on Day 1 of 21-day cycles until disease progression.

Eligible participants will be categorized in to three groups as follows:

Participants with no prior chemotherapy for advanced disease;
Participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2L+participants);
Participants who are 2L+ and previously treated for brain metastases.

ReferenceCitation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: The Angeles Clinic and Research Institute, Santa Monica Office

location_facility: Penn State Univ. Milton S. Hershey Medical Center; MSHMC Cardiology

location_facility: Carolina BioOncology Institute; Can Therapy & Res Ctr

location_facility: HonorHealth Research Institute - Pima Center

location_facility: Royal Marsden Hospital - Fulham; Oncology Department

location_facility: Penn Presbyterian Medical Center; Abramson Cancer Center

location_facility: Dartmouth Hitchcock Med Center; Norris Cotton Cancer Ctr

location_facility: Huntsman Cancer Institute; University of Utah

location_facility: The University of Chicago Medical Center

location_facility: Stanford University/Lucile Packard Children's Hospital

location_facility: H. Lee Moffitt Cancer Center and Research Inst.

title: A Phase II, Multicenter, Single-arm Study of MPDL3280A in Patients With PD-L1-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer

location_country:
United Kingdom
Netherlands
Belgium
United States
France


title: Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

summary: Frailty is a state of decreased physiologic reserves and vulnerability to stressors. Several tools exist to measure frailty, some based on physical tests and others on questionnaires, yet there is no agreement on which tool to recommend. This multi-center prospective cohort study is aimed at comparing various frailty assessment tools to determine which best predicts death or major complications after cardiac surgery or transcatheter intervention. The population of interest is elderly patients with severe aortic stenosis undergoing surgical or transcatheter aortic valve replacement. The frailty assessment tools under investigation include composite frailty scales, physical performance tests, muscle mass, and biomarker expression. The overall objective is to improve our ability to predict risk by measuring frailty using the optimal tool in elderly cardiovascular patients.

enrollment_type: Anticipated

ReferenceCitation: Shi SM, Sung M, Afilalo J, Lipsitz LA, Kim CA, Popma JJ, Khabbaz KR, Laham RJ, Guibone K, Lee J, Marcantonio ER, Kim DH. Delirium Incidence and Functional Outcomes After Transcatheter and Surgical Aortic Valve Replacement. J Am Geriatr Soc. 2019 Jul;67(7):1393-1401. doi: 10.1111/jgs.15867. Epub 2019 Mar 18.

ReferenceCitation: Afilalo J, Lauck S, Kim DH, Lefevre T, Piazza N, Lachapelle K, Martucci G, Lamy A, Labinaz M, Peterson MD, Arora RC, Noiseux N, Rassi A, Palacios IF, Genereux P, Lindman BR, Asgar AW, Kim CA, Trnkus A, Morais JA, Langlois Y, Rudski LG, Morin JF, Popma JJ, Webb JG, Perrault LP. Frailty in Older Adults Undergoing Aortic Valve Replacement: The FRAILTY-AVR Study. J Am Coll Cardiol. 2017 Aug 8;70(6):689-700. doi: 10.1016/j.jacc.2017.06.024. Epub 2017 Jul 7.

license: publisher-specific-oa

license_normalized: publisher-specific

lead_sponsor: Jewish General Hospital

collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre

collaborators: Ottawa Heart Institute Research Corporation

location_country:
United States
Canada
France

location_facility: Centre Hospitalier Universite de Montreal

lead_sponsor_type: academique


title: A Phase 3, Randomized, Double-Blind, Double-Dummy, Multicenter, Prospective Study to Assess the Efficacy and Safety of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections

summary: This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).

ReferenceCitation: Solomkin JS, Sway A, Lawrence K, Olesky M, Izmailyan S, Tsai L. Eravacycline: a new treatment option for complicated intra-abdominal infections in the age of multidrug resistance. Future Microbiol. 2019 Oct;14:1293-1308. doi: 10.2217/fmb-2019-0135. Epub 2019 Oct 1.

publisher_dissemination: Future Science Ltd

ReferenceCitation: Solomkin JS, Gardovskis J, Lawrence K, Montravers P, Sway A, Evans D, Tsai L. IGNITE4: Results of a Phase 3, Randomized, Multicenter, Prospective Trial of Eravacycline vs Meropenem in the Treatment of Complicated Intraabdominal Infections. Clin Infect Dis. 2019 Aug 30;69(6):921-929. doi: 10.1093/cid/ciy1029.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

ReferenceCitation: Solomkin J, Evans D, Slepavicius A, Lee P, Marsh A, Tsai L, Sutcliffe JA, Horn P. Assessing the Efficacy and Safety of Eravacycline vs Ertapenem in Complicated Intra-abdominal Infections in the Investigating Gram-Negative Infections Treated With Eravacycline (IGNITE 1) Trial: A Randomized Clinical Trial. JAMA Surg. 2017 Mar 1;152(3):224-232. doi: 10.1001/jamasurg.2016.4237.

publisher_dissemination: American Medical Association

lead_sponsor: Tetraphase Pharmaceuticals, Inc.

location_country:
Germany
Lithuania
Argentina
Romania
United States
Latvia
South Africa
Czechia
Ukraine
Bulgaria
Estonia
Russian Federation
France


title: An Open Label Study to Assess the Safety and Efficacy of COR-003 (Levoketoconazole) in the Treatment of Endogenous Cushing's Syndrome

acronym: SONICS

summary: The primary objectives of this study are to evaluate the clinical responder rate, defined as the proportion of subjects with normal UFC after 6 months of treatment with COR-003 in the Maintenance Phase without dose increase, and to evaluate the range of effective doses in subjects with various levels of hypercortisolism.

ReferenceCitation: Fleseriu M, Pivonello R, Elenkova A, Salvatori R, Auchus RJ, Feelders RA, Geer EB, Greenman Y, Witek P, Cohen F, Biller BMK. Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing's syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial. Lancet Diabetes Endocrinol. 2019 Nov;7(11):855-865. doi: 10.1016/S2213-8587(19)30313-4. Epub 2019 Sep 18. Erratum In: Lancet Diabetes Endocrinol. 2019 Nov;7(11):e22.

ReferenceCitation: Geer EB, Salvatori R, Elenkova A, Fleseriu M, Pivonello R, Witek P, Feelders RA, Bex M, Borresen SW, Puglisi S, Biller BMK, Cohen F, Pecori Giraldi F. Levoketoconazole improves clinical signs and symptoms and patient-reported outcomes in patients with Cushing's syndrome. Pituitary. 2021 Feb;24(1):104-115. doi: 10.1007/s11102-020-01103-6. Epub 2020 Nov 20. Erratum In: Pituitary. 2020 Dec 14;:

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

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

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

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repositories_concat: LIRIAS (KU Leuven);PubMed Central;air.unimi.it;iris.unito.it;pure.eur.nl;repub.eur.nl

ReferenceCitation: Pivonello R, Elenkova A, Fleseriu M, Feelders RA, Witek P, Greenman Y, Geer EB, Perotti P, Saiegh L, Cohen F, Arnaldi G. Levoketoconazole in the Treatment of Patients With Cushing's Syndrome and Diabetes Mellitus: Results From the SONICS Phase 3 Study. Front Endocrinol (Lausanne). 2021 Apr 7;12:595894. doi: 10.3389/fendo.2021.595894. eCollection 2021.

publisher_dissemination: Frontiers

lead_sponsor: Cortendo AB

location_country:
Germany
Italy
Poland
Israel
Denmark
Netherlands
Belgium
United States
Spain
Turkey
Czechia
Bulgaria
Canada
Serbia
France

location_facility: Hôpital de la CONCEPTION, Service d'Endocrinologie, Diabète et Maladies Métaboliques

location_facility: Bezmi Alem Vakıf Üniversitesi Endokrinoloji Bölümü Adnan

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego

location_facility: UOC di Endocrinologia, Dipartimento di Medicina Clinica e Sperimentale

location_facility: Sourasky Medical Center, Endocrinology & Metabolism

location_facility: Erasmus MC, Dpt. Of Internal Medicine, Division of Endocrinology

location_facility: Institute of Endocrinology & Metabolism, Rabin Medical Center

location_facility: Endocrinologia, Hospital Sant Pau,Universitat Autònoma de Barcelona

location_facility: Leiden University, Leiden University Medical Center, Dept. of Endocrinology

location_facility: Vseobecna fakultni nemocnice v Praze - III. Interni klinika VFN a 1. LF UK

location_facility: St. Pauls Hospital/Vancouver General Hospital

location_facility: University Hospitals Leuven Department of Endocrinology

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Bnail Zion Medical Center Institute of Endocrinology & Metabolism

location_facility: SCDU Medicina Interna I Università di Torino Dipartimento di Scienze Cliniche e Biologiche

location_facility: Azienda Ospedaliero - Universitaria Città della Salute e della Scienza di Torino

location_facility: University Specialized Hospital for Active Treatment in Endocrinology (USHATE)


title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-38518168 in Symptomatic Adult Subjects With Uncontrolled, Persistent Asthma

summary: The purpose of this study is to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JNJ-38518168 compared with placebo in participants with persistent asthma that is inadequately controlled despite current treatment.

ReferenceCitation: Kollmeier AP, Barnathan ES, O'Brien C, Chen B, Xia YK, Zhou B, Loza MJ, Silkoff PE, Ge M, Thurmond RL. A phase 2a study of toreforant, a histamine H4 receptor antagonist, in eosinophilic asthma. Ann Allergy Asthma Immunol. 2018 Nov;121(5):568-574. doi: 10.1016/j.anai.2018.08.001. Epub 2018 Aug 11.

location_country:
Germany
France
United Kingdom
United States
Canada
Israel


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

summary: The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (explores what the body does to the drug) and pharmacodynamics (the study of the action or effects a drug has on the body) of JNJ-17299425 in participants with traumatic brain injury (acute and chronic injuries to the brain, including the cerebral hemispheres, cerebellum, and brain stem).

title: An Open-Label, Single and Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-17299425 in Patients With Traumatic Brain Injury

location_country: Belgium France


title: International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 A Randomized Phase III Study Conducted by the Resistant Disease Committee of the International BFM Study Group

summary: The main goal of this study is to improve the outcome of children and adolescents with standard risk (SR) first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a large international study group platform allowing for optimization of standard treatment strategies and integration of new agents.

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: Charite University, Berlin, Germany

collaborators: Australian & New Zealand Children's Haematology/Oncology Group

collaborators: St. Anna Kinderkrebsforschung (Co-Sponsor Austria)

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

collaborators: University Hospital Motol (Co-Sponsor Czech Republic)

collaborators: Copenhagen University Hospital (Rigshospitalet) (Co-Sponsor Copenhagen)

collaborators: Centre Hospitalier Universitaire de Nice

collaborators: Our Lady's Chilrden's Hospital (Co-Sponsor Ireland)

collaborators: Tel Aviv Sourasky Medical Centre (Co-Sponsor Israel)

collaborators: Ospedale Pediatrico Bambino Gesù (Co-Sponsor Italy)

collaborators: National Hospital Organization Nagoya Medical Center (Co-Sponsor Japan)

collaborators: Prinses Máxima Centrum (Co-Sponsor Netherlands)

collaborators: Oslo University Hospital (Co-Sponsor Oslo)

collaborators: Medical University of Wroclaw (Co-Sponsor Poland)

collaborators: Instituto Português de Oncologia de Lisboa (Co-Sponsor Lisboa)

collaborators: Spanish Society of Pediatric Hematology and Oncology (SEHOP) (Co-Sponsor Spain)

collaborators: Central Manchester University (Co-Sponsor United Kingdom)

location_country:
Finland
Germany
Italy
Poland
Portugal
Israel
Norway
Denmark
Australia
Japan
Netherlands
Austria
Belgium
Switzerland
United Kingdom
Czechia
France

location_facility: Australian & New Zealand Childhood Hematology & Oncology Group

location_facility: Hòpital Universitaire des Enfants Reine Fabiola

location_facility: Dpt. SCT and Hematology/Oncology University Wroclaw

status_simplified: Ongoing


title: A Single-Arm, Multicenter, Open-Label, Phase 2 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

summary: The purpose of this study is to see how participants with late stage lung cancer do on gemcitabine-cisplatin chemotherapy plus necitumumab. The study will also see how safe the drugs are in combination and to see how long the medicine stays in the body. The study will last approximately 2 years.

lead_sponsor: Eli Lilly and Company

location_country:
Netherlands
Mexico
United States
Spain
Taiwan
Canada
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.


lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this phase Ib/II clinical trial was to: a) evaluate the safety of the co-administration of LDE225 and INC424 in myelofibrosis patients and establish a maximum tolerated dose and/or Recommended Phase II dose of the combination and b) to assess the efficacy of the co-administration of LDE225 and INC424 on spleen volume reduction.

ReferenceCitation: Gupta V, Wolleschak D, Hasselbalch H, Vannucchi AM, Koschmieder S, Cervantes F, Li Y, Dong T, Wroclawska M, Bharathy S, Harrison C. Safety and efficacy of the combination of sonidegib and ruxolitinib in myelofibrosis: a phase 1b/2 dose-finding study. Blood Adv. 2020 Jul 14;4(13):3063-3071. doi: 10.1182/bloodadvances.2019001212.

evidence: open (via free article)

title: A Phase Ib/II, Open-label, Multi-center, Dose-finding Study to Assess the Safety and Efficacy of the Oral Combination of LDE225 and INC424 (Ruxolitinib) in Patients With Myelofibrosis

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

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Germany
Ireland
Italy
United Kingdom
Denmark
Australia
Netherlands
Belgium
Spain
Canada
France


acronym: OCTAVE

summary:
This study will evaluate and compare two individualized ranibizumab treatment regimens in patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual function benefit, while aiming to avoid unnecessary intravitreal injections.

The results will be used to generate further recommendations on functional and anatomical monitoring of the disease and timing of treatment administration for patients with neovascular AMD. In this context, the study will investigate the utility of optical coherence tomography (OCT) to aid retreatment decisions with ranibizumab.

ReferenceCitation: Staurenghi G, Garweg JG, Gerendas BS, Macfadden W, Gekkiev B, Margaron P, Dunger-Baldauf C, Kolar P. Functional versus functional and anatomical criteria-guided ranibizumab treatment in patients with neovascular age-related macular degeneration - results from the randomized, phase IIIb OCTAVE study. BMC Ophthalmol. 2020 Jan 9;20(1):18. doi: 10.1186/s12886-019-1251-6.

evidence: oa repository (via page says license)

repository_normalized: Research Square

repository_institution: Research Square - Research Square

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

repositories_institution:
PubMed Central - Europe PMC
Research Square - Research Square

title: A 24-month, Phase IIIb, Randomized, Double-masked, Multicenter Study Assessing the Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration

location_country:
Finland
Germany
Ireland
Argentina
Turkey
Czechia
Canada
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Switzerland
Italy
Guatemala
United Kingdom
Netherlands
Austria
Mexico
Spain
Greece
Panama
Sweden


title: The Premature Infants Resuscitated With Oxygen or Air (PRESOX) Trial

acronym: PRESOX

summary: The most appropriate initial oxygen concentration for the resuscitation of the extremely low birth weight infant has not been established using large well designed, randomized, blinded, prospective trials and the level of oxygen utilized by practitioners in this situation is highly variable. This proposed trial will use targeted oxygen saturation levels over the first 15 to 20 minutes of life to compare a low and a higher initial oxygen level for the resuscitation of such infants, and will be large enough to evaluate short term outcomes of survival without oxygen at 36 weeks and survival without retinopathy of prematurity, and the long term outcome of survival without significant neurodevelopmental impairment at 2 years of age. Such information is urgently required to provide an evidence basis for the initial oxygen concentration for resuscitation of these very preterm infants.

lead_sponsor: Sharp HealthCare

sponsor_collaborators:
Sharp HealthCare
Thrasher Research Fund

location_country:
Ireland
Germany
Italy
Poland
Slovenia
United Kingdom
Sweden
Austria
United States
Spain
Russian Federation
France

location_facility: Oklahoma University Health Sciences Center

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Sharp Mary Birch Hospital for Women and Newborns

location_facility: St. Petersberg State Pediatric Medical University

location_facility: University of Miami Miller School of Medicine

intervention_type: Other


title: A Multi-Center, Open-Label, Phase 1/1b Study of Escalating Doses of RO5503781 Administered Orally as 1) a Single Agent, 2) In Combination With Cytarabine, or 3) With Cytarabine and Anthracycline and 4) Assessing PK and Safety of New Optimized Formulation of RO5503781 With Cytarabine in Patients With Acute Myelogenous Leukemia (AML)

summary: This Phase 1/1b, open-label study will evaluate the safety and pharmacokinetics of escalating doses of RO5503781 as a single agent or in combination with cytarabine in participants with acute myelogenous leukemia. In Part 1, RO5503781 will be administered in escalating doses as a single agent, and in Part 2, RO5503781 will be administered in combination with cytarabine. An optional Part 3 in which RO5503781 will be administered with cytarabine and anthracycline may be considered . In Part 4, the safety and pharmacokinetic profile of an optimized formulation of RO5503781 in combination with cytarabine will be assessed.

ReferenceCitation: Yee K, Papayannidis C, Vey N, Dickinson MJ, Kelly KR, Assouline S, Kasner M, Seiter K, Drummond MW, Yoon SS, Lee JH, Blotner S, Jukofsky L, Pierceall WE, Zhi J, Simon S, Higgins B, Nichols G, Monnet A, Muehlbauer S, Ott M, Chen LC, Martinelli G. Murine double minute 2 inhibition alone or with cytarabine in acute myeloid leukemia: Results from an idasanutlin phase 1/1b study small star, filled. Leuk Res. 2021 Jan;100:106489. doi: 10.1016/j.leukres.2020.106489. Epub 2020 Dec 1.

location_country:
Italy
United Kingdom
Australia
United States
Korea, Republic of
Canada
France

location_facility: Cancer Therapy & Research Ctr; Dept Institute for Drug Development

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Institut J Paoli I Calmettes; Onco Hematologie 2


title: A Prospective Natural History Study of Progression of Physical Impairment, Activity Limitation and Quality of Life in Duchenne Muscular Dystrophy.

summary: To characterize the natural history and progression of Duchenne Muscular Dystrophy (DMD) to help inform the design of future studies, to capture biomarkers of safety and disease progression and to provide comparative data for the development of rare exons for which formal controlled trials are not feasible.

lead_sponsor: BioMarin Pharmaceutical

location_country:
Germany
Italy
Argentina
Brazil
Netherlands
Sweden
Belgium
United States
Turkey
France

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Policlinico Univsersitario Agostino Gemelli

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Drottning Silvias Barn- ochungdomssjukhus

location_facility: Hospital das Clinicas da Faculdade de Medicina da USP

location_facility: Hospital de Pediatria Prof Dr Juan P Garrahan


title: Vascutek Anaconda™ Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair

summary: The purpose of this observational Post-Market Surveillance Registry is to gather post-market data on the performance of the CE marked Vascutek Anaconda™ Stent Graft System for the repair of Abdominal Aortic Aneurysms (AAA). The Study population consists of patients suitable for endovascular repair of AAA. Patients will be followed at 1, 3, 6, 12, 18, 24, 36, 48 and 60 months post-implantation.

lead_sponsor: Vascutek Ltd.

location_country:
Germany
Italy
New Zealand
United Kingdom
Australia
Spain
France

location_facility: Hospital Universitario Madrid Monteprincipe

intervention_type: Device


title: An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy Phase 3b

summary: N01372 study is to evaluate the long-term safety, tolerability, maintenance of efficacy of Brivaracetam (BRV); as well as the effect of BRV on subjects' health-related quality of life and to explore the direct medical resource use for BRV (for subjects entering N01372 from a study where pharmacoeconomic data was collected). BRV will be used at doses up to maximum of 200 mg/day, as adjunctive treatment in subjects aged 16 years or older with Epilepsy.

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

lead_sponsor: UCB Pharma SA

location_country:
United States
Spain
Germany
France


title: Screening Platform of the EORTC for Clinical Trials in Advanced Colorectal Cancer "SPECTAcolor"

acronym: SPECTAcolor

summary:
The EORTC GastroIntestinal Tract Cancer Group and the EORTC HeadQuarters wish to set up a European screening platform for advanced colo-rectal cancer (CRC) patients. The goal of this screening platform is to provide quick access to new drugs to patients by offering a new structure for clinical trials.

Currently some of the most challenging clinical questions arise from the molecular sub-division of CRC that would theoretically allow to inhibit the specific, altered pathways in the patients.

A major problem for trials in this "personalized medicine" is that the low frequency of the different mutations requires a high effort for screening and identifying the patients.

The EORTC CRC screening platform will hopefully offer a feasible and efficient way to characterize the patients on the molecular basis of their tumors and allow to offer them rapid and preferential participation in clinical studies with new drugs targeted to their specific pathway alterations.

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

location_country: Germany Italy Cyprus Poland Portugal Sweden Switzerland Belgium Spain Greece France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

location_facility: Seconda Universita Degli Studi Di Napoli

location_facility: I.P.O. Francisco Gentil - Centro De Lisboa

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

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino "IST" Istituto Nazionale per la Ricerca sul Cancro

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie

location_facility: Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern

intervention_type: Genetic


title: A Phase 2 Exploratory Study of Mavrilimumab Versus Anti-tumor Necrosis Factor in Subjects With Rheumatoid Arthritis

summary: The primary objectives of this study is to explore the efficacy of mavrilimumab compared with golimumab in the treatment of adult subjects 18-80 years of age with moderate-to-severe active rheumatoid arthritis (RA) who have an inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs) and/or one or two anti-tumor necrosis factor (TNF) agents (excluding golimumab) for efficacy or safety reasons.

lead_sponsor: MedImmune LLC

location_country:
Colombia
Portugal
Slovakia
Hungary
Argentina
Israel
United Kingdom
Mexico
Spain
Greece
Serbia
Czech Republic
Russian Federation
France

intervention_type: Biological


title: A Randomized, 18-week, Placebo-controlled, Double-blind, Parallel Group Study Of The Safety And Efficacy Of Pf-05212377 (Sam-760) In Subjects With Mild-to-moderate Alzheimer's Disease With Existing Neuropsychiatric Symptoms On A Stable Daily Dose Of Donepezil

summary: This study will evaluate safety and efficacy of PF-05212377 in subjects with mild-to-moderate Alzheimer's Disease with existing neuropsychiatric symptoms on a stable dose of Donepezil. The 4-week run-in will minimize placebo effect. The 12-week treatment period is considered the minimum length necessary to reliably evaluate the effect PF-05212377 on cognition and and neuropsychiatric symptoms in this population. The 2-week washout will allow to monitor re-emergence of neuropsychiatric and cognitive symptoms.

ReferenceCitation: Fullerton T, Binneman B, David W, Delnomdedieu M, Kupiec J, Lockwood P, Mancuso J, Miceli J, Bell J. A Phase 2 clinical trial of PF-05212377 (SAM-760) in subjects with mild to moderate Alzheimer's disease with existing neuropsychiatric symptoms on a stable daily dose of donepezil. Alzheimers Res Ther. 2018 Apr 5;10(1):38. doi: 10.1186/s13195-018-0368-9.

repository_institution: PubMed Central - Europe PMC

lead_sponsor: Pfizer

location_country:
Germany
United Kingdom
United States
Spain
Chile
Canada
France

location_facility: Eastside Comprehensive Medical Center, LLC

location_facility: Yale University School of Medicine, MRI Research Center (MRI)

location_facility: True North Clinical Research Halifax, Inc.

location_facility: Surrey and Borders Partnership NHS Foundation Trust

location_facility: Clinical Neuroscience Research Assoc. d/b/a The Memory Clinic

location_facility: The Ohio State University (administrative offices only)

location_facility: Columbus Research & Wellness Institute, Inc.

location_facility: Medical Research Group of Central Florida

location_facility: Cary J. Kohlenberg, MD, dba, IPC Research

location_facility: The Research Institute for the Care of Older People Centre

location_facility: University of Rochester Medical Center AD-CARE Program | University of Rochester Medical Center

location_facility: University of Rochester Medical Center (MRI Imaging Only)

location_facility: Chatham-kent Clinical Trials Research Centre

location_facility: Chatham-Kent Clinical Trials Research Centre

location_facility: Praxis fuer Neurologie / Psychiatrie Prof. Dr. Steinwachs

location_facility: Dean Foundation for Health, Research and Education

location_facility: Behavioral Medical Research of Staten Island

location_facility: Praxis Dr. Franz- Arztehaus am KEH mit Epilepsie-Zentrum

location_facility: Yale-New Haven Hospital, Temple Radiology

location_facility: Dr. med. Volker Schumann, Arzt fuer Nervenheilkunde

location_facility: Roper St. Francis Pharmacy (IP Shipment/Storage)


title: Prospective, Randomized Study of Multicolumn Implantable Lead Stimulation for Predominant Low Back Pain

acronym: PROMISE

summary: The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).

ReferenceCitation: O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

repository_institution: Elsevier - Scopus

repository_institution: Brunel University London - Brunel University Research Archive (BURA)

repositories:
PubMed Central
Pure (Denmark)
bura.brunel.ac.uk

ReferenceCitation: Rigoard P, Basu S, Desai M, Taylor R, Annemans L, Tan Y, Johnson MJ, Van den Abeele C, North R; PROMISE Study Group. Multicolumn spinal cord stimulation for predominant back pain in failed back surgery syndrome patients: a multicenter randomized controlled trial. Pain. 2019 Jun;160(6):1410-1420. doi: 10.1097/j.pain.0000000000001510.

repository_institution: The University of Glasgow - Enlighten: Publications

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

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Rigoard P, Desai MJ, North RB, Taylor RS, Annemans L, Greening C, Tan Y, Van den Abeele C, Shipley J, Kumar K. Spinal cord stimulation for predominant low back pain in failed back surgery syndrome: study protocol for an international multicenter randomized controlled trial (PROMISE study). Trials. 2013 Nov 7;14:376. doi: 10.1186/1745-6215-14-376.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Exeter - Open Research Exeter

ipd_sharing_description: Data will be kept confidential by Medtronic and only be shared with study investigators following Medtronic approval of a data request form.

location_country:
Germany
Colombia
United Kingdom
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: Weill Medical College of Cornell University

location_facility: Department of Neurosurgery: St. Augustinus Ziekenhuizen

location_facility: Nottingham University Hospital NHS Trust

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Hospital Clinico Universitario de Valencia

location_facility: University of Rochester Neurosurgery Partners in Pain Management

location_facility: Centre Hospitalier Universitaire de Poitiers


title: A Randomized, Double-blind 52-week Study to Evaluate the Safety and Efficacy of an LCZ696 Regimen Compared to an Olmesartan Regimen on Arterial Stiffness Through Assessment of Central Blood Pressure in Elderly Patients With Hypertension

summary: The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened pulse pressure (PP).

ReferenceCitation: Williams B, Cockcroft JR, Kario K, Zappe DH, Cardenas P, Hester A, Brunel P, Zhang J. Rationale and study design of the Prospective comparison of Angiotensin Receptor neprilysin inhibitor with Angiotensin receptor blocker MEasuring arterial sTiffness in the eldERly (PARAMETER) study. BMJ Open. 2014 Feb 4;4(2):e004254. doi: 10.1136/bmjopen-2013-004254.

repository_institution: University College London - UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

location_country:
Germany
Italy
Colombia
Argentina
Japan
United States
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
France


title: A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin for 24 Weeks in Subjects With Recurrent Chronic HCV Post Liver Transplant

summary: This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C. The treatment period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last up to 72 weeks not including the screening visit.

ReferenceCitation: Charlton M, Gane E, Manns MP, Brown RS Jr, Curry MP, Kwo PY, Fontana RJ, Gilroy R, Teperman L, Muir AJ, McHutchison JG, Symonds WT, Brainard D, Kirby B, Dvory-Sobol H, Denning J, Arterburn S, Samuel D, Forns X, Terrault NA. Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation. Gastroenterology. 2015 Jan;148(1):108-17. doi: 10.1053/j.gastro.2014.10.001. Epub 2014 Oct 7.

lead_sponsor: Gilead Sciences

location_country:
Germany
New Zealand
United States
Spain
France


title: A Phase II, Multicenter, Single-arm Study of Oral LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer

summary: A single-arm, open-label, two-stage multicenter, phase II study. Patients were pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd was continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anticancer therapy and/or died. LDK378 was continued beyond RECIST defined progressive disease (PD) as assessed by the investigator, if in the judgment of the investigator, there was evidence of clinical benefit. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator. Male and female patients aged 18 or over with ALK-rearranged non-small cell cancer (NSCLC) were screened for eligibility. Patients had to have received no prior crizotinib, and had to be chemotherapy-naïve or been pretreated with cytotoxic chemotherapy (up to three prior lines).

ReferenceCitation: Nishio M, Felip E, Orlov S, Park K, Yu CJ, Tsai CM, Cobo M, McKeage M, Su WC, Mok T, Scagliotti GV, Spigel DR, Viraswami-Appanna K, Chen Z, Passos VQ, Shaw AT. Final Overall Survival and Other Efficacy and Safety Results From ASCEND-3: Phase II Study of Ceritinib in ALKi-Naive Patients With ALK-Rearranged NSCLC. J Thorac Oncol. 2020 Apr;15(4):609-617. doi: 10.1016/j.jtho.2019.11.006. Epub 2019 Nov 25.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

ReferenceCitation: Lin YT, Yu CJ, Yang JC, Shih JY. Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non-Small-Cell Lung Cancer: Analysis and Literature Review. Clin Lung Cancer. 2016 Sep;17(5):e77-e94. doi: 10.1016/j.cllc.2016.03.005. Epub 2016 Mar 30.

location_country:
Italy
New Zealand
Norway
Hong Kong
Singapore
Australia
Japan
Sweden
United Kingdom
Belgium
United States
Korea, Republic of
Spain
Thailand
Taiwan
Canada
Russian Federation
France

location_facility: Massachusetts General Hospital Mass Gen 5

location_facility: Sarah Cannon Research Institute Drug Ship - 4

location_facility: U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office

location_facility: Washington University School of Medicine Washington University (16)