ReferenceCitation: Gracies JM, Francisco GE, Jech R, Khatkova S, Rios CD, Maisonobe P; ENGAGE Study Group. Guided Self-rehabilitation Contracts Combined With AbobotulinumtoxinA in Adults With Spastic Paresis. J Neurol Phys Ther. 2021 Jul 1;45(3):203-213. doi: 10.1097/NPT.0000000000000359.

family: Gracies

full_name: Jean-Michel Gracies

given: Jean-Michel

family: Francisco

full_name: Gerard E. Francisco

given: Gerard E.

family: Jech

full_name: Robert Jech

given: Robert

family: Khatkova

full_name: Svetlana Khatkova

given: Svetlana

family: Rios

full_name: Carl D. Rios

given: Carl D.

family: Maisonobe

full_name: Pascal Maisonobe

given: Pascal

journal_name: Journal of Neurologic Physical Therapy

intervention_type: Other

lead_sponsor: Ipsen

location_country:
United States
Russian Federation
France
Czechia

acronym: ENGAGE

location_facility: Samara Regional Clinical Hospital n.a. V.D.Seredavin

location_facility: Service de Médecine Physique et Réadaptation, Hôpital Albert-Chenevier

location_facility: Neurology Department - Regional Hospital Pardubice

location_facility: University of Pittsburgh Medical Center, Physical Medicine and Rehabilitation

location_facility: Service de Médecine Physique et Réadaptation, Hôpital Sébastopol - CHU de Reims

location_facility: Fakultní nemocnice Královské Vinohrady, Neurologická klinika

location_facility: Saint-Petersburg Bekhterev Psychoneurological Research Institute

location_facility: Department of Neurology, Division of Movement Disorders, Vanderbilt University

location_facility: Department of Neurology and Center of Clinical Neuroscience, Charles University in Prague, 1st Faculty of Medicine and General University Hospital in Prague

location_facility: Fakultní nemocnice Brno Neurologická klinika

location_facility: Service de Médecine Physique et Réadaptation, CHU Saint Etienne - Hôpital Bellevue

location_facility: Federal Siberian Scientific Clinical Center

location_facility: Service de Médecine Physique et de Réadaptation, Bâtiment Tastet-Girard, Groupe Hospitalier Pellegrin

location_facility: Neurology and Physiotherapy Outpatient Clinic

location_facility: UT Health Physical Medicine & Rehabilitation Department, TIRR Memorial Hermann

location_facility: Kansas Institute of Research, Kansas City Bone & Joint Clinic, Division of Signature Medical Group of KC

title: An International, Multicentre, Prospective, Single-Arm Study to Assess the Effect on Voluntary Movements of AbobotulinumtoxinA 1500 U Administered in Both Upper and Lower Limbs in Conjunction With a Guided Self-Rehabilitation Contract in Adult Subjects With Spastic Hemiparesis

summary: The purpose of this clinical study is to assess whether AbobotulinumtoxinA (Dysport®) injections in upper and lower limbs accompanied with a personal exercise plan called "Guided Self-rehabilitation Contract" (GSC) can improve voluntary movements in subjects with hemiparesis.


title: Prospective, Multinational, Non-interventional Post-authorisation Study to Document the Long-term Immunogenicity, Safety, and Efficacy of Human-cl rhFVIII (Simoctocog Alfa) in Patients With Haemophilia A Treated in Routine Clinical Practice

summary: Prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously treated paediatric and adult patients) and routine clinical practice. Besides aspects such as general product safety and efficacy, there will be a focus on immunogenicity, particularly on inhibitor development. The diagnosis of FVIII inhibitor will be based on clinical observations and confirmed by FVIII inhibitor testing in the laboratory.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Octapharma

location_country:
Ecuador
Italy
Guatemala
France
Czechia
Lithuania
Slovakia
Norway
Argentina
Belarus
United States
United Kingdom
Portugal

location_facility: U.O.C. Ematologia, Ospedale San Giacomo Apostolo

location_facility: Dipartimento di Biotecnologie Cellulari ed Ematologia -"Sapienza" Università di Roma

location_facility: S.C. Ematologia U, A.O.U. Città della Salute e della Scienza di Torino

location_facility: L'Azienda Ospedaliero Universitaria Consorziale Policlinico, U.O. di Medicina Trasfusionale, Centro Emofilia e Trombosi

location_facility: Azienda Sanitaria Locale Napoli 1 Centro

location_facility: Centro de Tratamiento de la Hemofilia Cordoba

location_facility: Hospital de Especialidades Teodoro Maldonado Carbo

location_facility: Vilnius University Hospital, Santariskiu Klinikos-Children's Hospital

location_facility: Dipartimento Di Medicina dell'Universita degli Studi di Perugia

location_facility: AOU Federico II - Dipartimento di Medicina Clinica e Chirurgica

location_facility: A.O. Città della Salute e della Scienza di Torino - Ospedale Regina Margherita

location_facility: UOC Malattie emorragiche e della coagulazione, Azienda Ospedaliera Universitaria Careggi

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Gulf States Hemophilia and Thrombophilia

location_facility: CTH Centro de Tratamiento de Hematologia y Hemoterapia Córdoba S.A.

location_facility: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

type: EudraCT Number

title: A Phase 1 Study of LY3200882 in Patients With Solid Tumors

summary: The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Eli Lilly and Company

location_country:
Italy
United States
Switzerland
Germany
France
Japan
Australia
Spain
Canada

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

location_facility: Hospital Clínico Universitario de Valencia

location_facility: University of Texas MD Anderson Cancer Center

intervention_type: Radiation

status_simplified: Ongoing


intervention_type: Drug

lead_sponsor: Cytokinetics

location_country:
Italy
United States
Netherlands
Spain
Germany
France
Ireland
Belgium
Portugal
Canada
United Kingdom

acronym: VIGOR-ALS

location_facility: Providence Brain and Spine Inst. ALS Center

location_facility: Penn State Milton S. Hershey Medical Center

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

location_facility: Vanderbilt University Medical Center - Clinical Research Center

location_facility: Hospital Santa Maria - Centro Hospitalar Lisboa Norte

location_facility: Dipartimento di Neuroscienze "Rita Levi Moltalcini" A.O.U. Citta della Salute e della Scienza di Torino P.O. "Molinette"

location_facility: St. Louis University, Department of Neurology & Psychiatry

location_facility: QE II Health Sciences, Nova Scotia Health Authority

location_facility: Charite Campus Virchow-Klinikum, Department of Neurology

location_facility: IRCCS Istituto Auxologico Italiano - U.O. Neurologia

location_facility: George Washington University Medical Center

location_facility: University of Massachusetts Memorial Medical Center/University of Massachusetts Medical School

location_facility: University of Ulm, Department of Neurology

location_facility: King's College Hospital NHS Foundation Trust

location_facility: University of Miami, Miller School of Medicine

location_facility: Hannover Medical School, Department of Neurology

location_facility: Montreal Neurological Institute and Hospital

location_facility: University of Colorado Hospital Anschutz Outpatient Pavilion

location_facility: University of Iowa Hospitals and Clinics

location_facility: The Ohio State University Wexner Medical Center

location_facility: Hopital Dupuytren, service de neurologie

location_facility: UTHSCSA - First Outpatient Research Unit

location_facility: Department of Neurology, Wake Forest School of Medicine

location_facility: Clinical Research Centre Beaumont Hospital

location_facility: Carol & Frank Morsani Center for Advanced Health Care - University of South Florida

location_facility: Centro Clinico NEMO - Fondazione Serena Onlus, ASST Grande Ospedale Metropolitano Niguarda, Ospedale Niguarda

location_facility: Neurosciences Institute, Neurology - Charlotte

source: euctr

title: A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients With Amyotrophic Lateral Sclerosis (ALS) Who Completed VITALITY-ALS (CY 4031)

summary: The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv in patients with ALS who had completed the double-blind placebo-controlled study of tirasemtiv in ALS (CY 4031).


title: A Multicenter, Open-label, Randomized, Event-driven Study to Assess Efficacy, Safety and Pharmacokinetics of Macitentan Versus Standard of Care in Children With Pulmonary Arterial Hypertension

acronym: TOMORROW

summary: This is a prospective, multicenter, open-label, randomized, controlled, parallel group, group-sequential, event-driven Phase 3 study to evaluate efficacy, safety and pharmacokinetics (PK) of macitentan in children.

status: Recruiting

design_allocation: Randomized

lead_sponsor: Actelion

location_country:
Finland
Malaysia
Australia
Russian Federation
Ukraine
France
Poland
Thailand
Canada
Korea, Republic of
Colombia
South Africa
Vietnam
Philippines
Hungary
Portugal
China
United States
Austria
Brazil
Mexico
Israel
Spain

location_facility: Severance Hospital Yonsei University Health System - PPDS

location_facility: Stollery Children's Hospital University of Alberta

location_facility: University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital

location_facility: The Children's Hospital, Zhejiang University school of Medicine

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: General Hospital of Shenyang Military Region

location_facility: Novosibirsk Research Institue of Blood Circulation Pathology n.a. E.N. Meshalkin

location_facility: Schneider Children's Medical Center of Israel - PIN

location_facility: Maharaj Nakorn Chiang Mai Chiang Mai University

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: GBUZ Children's Hospital named after Bashlyaeva Z.A. Moscow

location_facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu Osrodek Badawczo-Rozwojowy

location_facility: Russian National Research Medical University n.a. N.I.Pirogov

location_facility: Research Institute of Complex Cardiovascular Pathology

location_facility: Saint Petersburg State Pediatric Medical Academy

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Irmandade Da Santa Casa de Misericórdia de São Paulo

location_facility: Unidad de Investigación Clínica En Medicina SC

location_facility: Instituto Nacional de Cardiologia Dr. Ignacio Chavez

location_facility: Municipal Institution of Health Care Regional Children's Clinical Hospital

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka

location_facility: Szpital Kliniczny im. Karola Jonschera Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Santa Cruz

location_facility: Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas

location_facility: MI Dnipropetrovsk Specialized Clin. Med. Center of Mother and Child n.a. prof. M.F. Rudnev of DRC

location_facility: Columbia University Medical Center - PIN

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Beijing Anzhen Hospital of The Capital University of Medical Sciences

location_facility: MI Scientific Practical Medical Center for Children Cardiology and Cardiosurgery of MOH of Ukraine

location_facility: Hôpital Haut-Lévêque - Hôpital cardiologique

location_facility: Royal Children's Hospital Melbourne - PIN

location_facility: Beijing Children's Hospital,Capital Medical University

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet


ReferenceType: derived

ReferenceCitation: Hecht JR, Lonardi S, Bendell J, Sim HW, Macarulla T, Lopez CD, Van Cutsem E, Muñoz Martin AJ, Park JO, Greil R, Wang H, Hozak RR, Gueorguieva I, Lin Y, Rao S, Ryoo BY. Randomized Phase III Study of FOLFOX Alone or With Pegilodecakin as Second-Line Therapy in Patients With Metastatic Pancreatic Cancer That Progressed After Gemcitabine (SEQUOIA). J Clin Oncol. 2021 Apr 1;39(10):1108-1118. doi: 10.1200/JCO.20.02232. Epub 2021 Feb 8.

name: David Geffen School of Medicine at UCLA, Santa Monica, CA

family: Hecht

full_name: J. Randolph Hecht

given: J. Randolph

sequence: first

name: Istituto Oncologico Veneto IRCCS, Padova, Italy

family: Lonardi

full_name: Sara Lonardi

given: Sara

sequence: additional

name: Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN

family: Bendell

full_name: Johanna Bendell

given: Johanna

name: St Vincent's Clinical School, University of New South Wales, Sydney, NSW, Australia

name: Department of Medical Oncology, The Kinghorn Cancer Centre, Sydney, NSW, Australia

family: Sim

full_name: Hao-Wen Sim

given: Hao-Wen

name: Vall dʹHebrón University Hospital and Vall dʹHebrón Institute of Oncology (VHIO), IOB Quirón, Barcelona, Spain

family: Macarulla

full_name: Teresa Macarulla

given: Teresa

name: Oregon Health and Science University, Portland, OR

family: Lopez

full_name: Charles D. Lopez

given: Charles D.

name: University Hospitals Leuven and KULeuven, Leuven, Belgium

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

name: Instituto de Investigaciόn Sanitaria Gregorio Marañόn, Universidad Complutense, Madrid, Spain

family: Muñoz Martin

full_name: Andres J. Muñoz Martin

given: Andres J.

name: Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

family: Park

full_name: Joon Oh Park

given: Joon Oh

name: Paracelsus Medical University Salzburg, Salzburg Cancer Research Institute-CCCIT and Cancer Cluster Salzburg, Salzburg, Austria

family: Greil

full_name: Richard Greil

given: Richard

family: Wang

full_name: Hong Wang

given: Hong

family: Hozak

full_name: Rebecca R. Hozak

given: Rebecca R.

family: Gueorguieva

full_name: Ivelina Gueorguieva

given: Ivelina

family: Lin

full_name: Yong Lin

given: Yong

family: Rao

full_name: Sujata Rao

given: Sujata

name: Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

family: Ryoo

full_name: Baek-Yeol Ryoo

given: Baek-Yeol

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Clinical Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

publisher: American Society of Clinical Oncology (ASCO)

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

location_country:
Italy
Austria
United States
Germany
France
Poland
Australia
Belgium
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan

acronym: Sequoia

location_facility: KH der Barmherzigen Schwestern Linz BetriebsGesmbH

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: TRIO - Translational Research in Oncology-US, Inc.

location_facility: University College London Hospital Foundation Trust

location_facility: Severance Hospital Yonsei University Health System

location_facility: University of Massachusetts Medical Center

location_facility: Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori

location_facility: University of Oklahoma Health Sciences Center

location_facility: MultiCare Regional Cancer Center - Auburn

location_facility: Memorial Regional Hospital/Joe Dimaggio Childrens Hospital

location_facility: AOU dell'Università degli Studi della Campania Luigi Vanvitelli

location_facility: Szp.Kliniczny Przemienienia Panskiego UM im.K.Marcinkowskieg

location_facility: Chonnam National University Hwasun Hospital

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Kliniken Essen-Mitte Ev. Huyssens-Stiftung

location_facility: Committee on Clinical Investigations (CCI)- Beth Isreal Deaconess Medical Center IRB

location_facility: Azienda Ospedaliera Universitaria Ospedale San Martino di Genova

location_facility: North Shore Hematology Oncology Associates

location_facility: Novant Health, Oncology Research Institute

location_facility: Grand Hopital de Charleroi-Site Notre-Dame

location_facility: New England Cancer Specialists - Scarborough

location_facility: Texas Oncology-Wichital Falls Texoma Cancer Center

location_facility: Fondazione Piemonte l'Oncologia-Istituto Ricerca Cura Cancro

location_facility: Central Coast Medical Oncology Corporation

location_facility: Toronto Sunnybrook Regional Cancer Center

ipd_sharing: Yes

title: Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Metastatic Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen

summary: To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in participants with metastatic pancreatic cancer as measured by overall survival.


lead_sponsor: Merus N.V.

location_country:
Italy
Netherlands
France
Japan
Korea, Republic of
Israel
Norway
Singapore
Spain
United States
Canada
Taiwan

location_facility: Vall D'Hebron Institute of Oncology (VHIO)

location_facility: START Hospital Universitario Madrid Sanchinarro

location_facility: St. Marianna University School of Medicine Hospital

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Seoul National University College of Medicine

location_facility: National Cancer Centre of Singapore PTE LTD

ipd_sharing: No

title: A Phase I/II Study of MCLA-128, a Full Length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients With Solid Tumors

summary: This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1 fusion.


title: Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacodynamics (PD) of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)

summary: The purpose of this study is to combine the PDR001 checkpoint inhibitor with each of four agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
France
Israel
Singapore
Belgium
Spain
Canada
Taiwan

location_facility: Sidney Kimmel Comprehensive Cancer Center SC-3

location_facility: University of Texas MD Anderson Cancer Center


title: Open-Label, Randomized Trial of Nivolumab (BMS-936558) Plus Pemetrexed/Platinum or Nivolumab Plus Ipilimumab (BMS-734016) vs Pemetrexed Plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Subjects With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor Therapy

summary: The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.

lead_sponsor: Bristol-Myers Squibb

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

location_facility: Baylor Scott and White Research Institute

location_facility: University of Utah - Huntsman Cancer Institute - PPDS

location_facility: Los Angeles Hematology Oncology Medical Group


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Crenolanib in Subjects With Advanced or Metastatic Gastrointestinal Stromal Tumors With a D842V Mutation in the PDGFRA Gene

summary: This is a multicenter, randomized, double-blinded, placebo-controlled, trial of oral crenolanib versus oral placebo in combination with best supportive care in subjects with advanced or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120 subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching placebo orally (PO) 3 times daily (TID) in combination with best supportive care.

lead_sponsor: Arog Pharmaceuticals, Inc.

location_country:
Italy
United States
France
Poland
Norway
Spain
Germany

location_facility: Fundación Instituto Valenciano de Oncología

location_facility: M Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology

location_facility: Mannheim University Medical Centre, University of Heidelberg

location_facility: University Hospital The Norwegian Radium Hospital

location_facility: Centre Hospitalier Universitaire (CHU) de Reims


publications_result: Hare B. The Phase 3 DISCOVER Study: Daily F/TAF or F/TDF for HIV Preexposure Prophylaxis [Presentation]. Conference on Retroviruses and Opportunistic Infections (CROI); 2019 04-07 March; Seattle, WA.

ReferenceType: result

ReferenceCitation: Mayer KH, Molina JM, Thompson MA, Anderson PL, Mounzer KC, De Wet JJ, DeJesus E, Jessen H, Grant RM, Ruane PJ, Wong P, Ebrahimi R, Zhong L, Mathias A, Callebaut C, Collins SE, Das M, McCallister S, Brainard DM, Brinson C, Clarke A, Coll P, Post FA, Hare CB. Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet. 2020 Jul 25;396(10246):239-254. doi: 10.1016/S0140-6736(20)31065-5.

family: Mayer

full_name: Kenneth H Mayer

given: Kenneth H

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Thompson

full_name: Melanie A Thompson

given: Melanie A

family: Anderson

full_name: Peter L Anderson

given: Peter L

family: Mounzer

full_name: Karam C Mounzer

given: Karam C

family: De Wet

full_name: Joss J De Wet

given: Joss J

family: DeJesus

full_name: Edwin DeJesus

given: Edwin

family: Jessen

full_name: Heiko Jessen

given: Heiko

family: Grant

full_name: Robert M Grant

given: Robert M

family: Ruane

full_name: Peter J Ruane

given: Peter J

family: Wong

full_name: Pamela Wong

given: Pamela

family: Ebrahimi

full_name: Ramin Ebrahimi

given: Ramin

family: Zhong

full_name: Lijie Zhong

given: Lijie

family: Mathias

full_name: Anita Mathias

given: Anita

family: Callebaut

full_name: Christian Callebaut

given: Christian

family: Collins

full_name: Sean E Collins

given: Sean E

family: Das

full_name: Moupali Das

given: Moupali

family: McCallister

full_name: Scott McCallister

given: Scott

family: Brainard

full_name: Diana M Brainard

given: Diana M

family: Brinson

full_name: Cynthia Brinson

given: Cynthia

family: Clarke

full_name: Amanda Clarke

given: Amanda

family: Coll

full_name: Pep Coll

given: Pep

family: Post

full_name: Frank A Post

given: Frank A

family: Hare

full_name: C Bradley Hare

given: C Bradley

ReferenceCitation: Ogbuagu O, Ruane PJ, Podzamczer D, Salazar LC, Henry K, Asmuth DM, Wohl D, Gilson R, Shao Y, Ebrahimi R, Cox S, Kintu A, Carter C, Das M, Baeten JM, Brainard DM, Whitlock G, Brunetta JM, Kronborg G, Spinner CD; DISCOVER study team. Long-term safety and efficacy of emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV-1 pre-exposure prophylaxis: week 96 results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet HIV. 2021 Jul;8(7):e397-e407. doi: 10.1016/S2352-3018(21)00071-0. Erratum in: Lancet HIV. 2021 Sep 24;:.

ReferenceCitation: Glidden DV, Das M, Dunn DT, Ebrahimi R, Zhao Y, Stirrup OT, Baeten JM, Anderson PL. Using the adherence-efficacy relationship of emtricitabine and tenofovir disoproxil fumarate to calculate background hiv incidence: a secondary analysis of a randomized, controlled trial. J Int AIDS Soc. 2021 May;24(5):e25744. doi: 10.1002/jia2.25744.

name: School of Medicine University of California San Francisco San Francisco CA USA

name: Department of Epidemiology and Biostatistics San Francisco CA USA

name: Centre for Clinical Research in Infection and Sexual Health Institute for Global Health University College London London UK

name: University of Colorado Denver ‐ Anschutz Medical Campus Aurora CO USA

journal_name: Journal of the International AIDS Society

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

repository_institution: University College London - UCL Discovery

title: Using the adherence‐efficacy relationship of emtricitabine and tenofovir disoproxil fumarate to calculate background hiv incidence: a secondary analysis of a randomized, controlled trial

location_country:
Italy
Austria
Netherlands
Germany
France
Ireland
Spain
Denmark
United States
United Kingdom
Canada

title: A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection

summary: The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM) and transgender women (TGW) who have sex with men and who are administered daily emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF) with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks of follow-up after randomization.


title: Study 200622: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Adolescent and Adult Subjects With Severe Hypereosinophilic Syndrome

summary: Mepolizumab is a humanized monoclonal antibody. In conditions where eosinophilia is considered to play an important part in the pathology, including eosinophilic asthma, HES, and eosinophilic granulomatosis with polyangiitis, a consistent reduction in blood eosinophil counts is observed in association with mepolizumab administration, with concomitant clinical improvement. This is a 32-week treatment period, randomized, double-blind, placebo-controlled, parallel group, multicentre study of mepolizumab in adolescent and adult subjects with severe HES receiving standard of care (SoC) therapy. This study will demonstrate the efficacy of mepolizumab compared with placebo based on maintenance of control of HES symptoms during the treatment period. The study will comprise of a screening period of up to approximately 4 weeks followed by a 32-Week study treatment period (subjects will be randomized 1:1 to placebo or mepolizumab) and up to 8-week additional follow-up period (12 weeks after the last dose of study treatment).

ReferenceCitation: Roufosse F, Kahn JE, Rothenberg ME, Wardlaw AJ, Klion AD, Kirby SY, Gilson MJ, Bentley JH, Bradford ES, Yancey SW, Steinfeld J, Gleich GJ; HES Mepolizumab study group. Efficacy and safety of mepolizumab in hypereosinophilic syndrome: A phase III, randomized, placebo-controlled trial. J Allergy Clin Immunol. 2020 Dec;146(6):1397-1405. doi: 10.1016/j.jaci.2020.08.037. Epub 2020 Sep 18.

family: Roufosse

full_name: Florence Roufosse

given: Florence

family: Kahn

full_name: Jean-Emmanuel Kahn

given: Jean-Emmanuel

family: Rothenberg

full_name: Marc E. Rothenberg

given: Marc E.

family: Wardlaw

full_name: Andrew J. Wardlaw

given: Andrew J.

family: Klion

full_name: Amy D. Klion

given: Amy D.

family: Kirby

full_name: Suyong Yun Kirby

given: Suyong Yun

family: Gilson

full_name: Martyn J. Gilson

given: Martyn J.

family: Bentley

full_name: Jane H. Bentley

given: Jane H.

family: Bradford

full_name: Eric S. Bradford

given: Eric S.

family: Yancey

full_name: Steven W. Yancey

given: Steven W.

family: Steinfeld

full_name: Jonathan Steinfeld

given: Jonathan

family: Gleich

full_name: Gerald J. Gleich

given: Gerald J.

journal_name: Journal of Allergy and Clinical Immunology

evidence: open (via crossref license)

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

repository_normalized: HAL

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Brazil
Mexico
Germany
France
Poland
Romania
Belgium
Argentina
Russian Federation
Spain
United States
United Kingdom


title: An Open-Label Multicenter Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Subjects With Advanced Hepatocellular Carcinoma

summary: The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics of H3B-6527.

lead_sponsor: H3 Biomedicine Inc.

location_country:
Italy
United States
France
Singapore
Belgium
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Georgetown Unversity Lombardi Comprehensive Cancer Center

location_facility: IRCCS Istituto Scientifico Romagnolo per lo studio e la cura dei tumori - U.O. di Oncologia Medica

location_facility: University of Cincinnati Cancer Institute

location_facility: Sarah Cannon Research Institute UK - SCRI - PPDS

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: START Madrid FJD, Hospital Universitario Fundacion Jimenez Diaz

location_facility: John theurer Cancer Center at Hackensack University Medical Center

location_facility: Russian Oncology Research Center n a N N Blokhin

location_facility: IRCCS Ospedale San Raffaele S.r.l. - PPDS

location_facility: University of Pennsylsvania - Perelman Cancer Center for Advanced Medicine

location_facility: Azienda Ospedaliero Universitaria - Policlinico di Modena

location_facility: University of Texas Southwestern Medical Center


ReferenceCitation: Hauser SL, Bar-Or A, Cohen JA, Comi G, Correale J, Coyle PK, Cross AH, de Seze J, Leppert D, Montalban X, Selmaj K, Wiendl H, Kerloeguen C, Willi R, Li B, Kakarieka A, Tomic D, Goodyear A, Pingili R, Häring DA, Ramanathan K, Merschhemke M, Kappos L; ASCLEPIOS I and ASCLEPIOS II Trial Groups. Ofatumumab versus Teriflunomide in Multiple Sclerosis. N Engl J Med. 2020 Aug 6;383(6):546-557. doi: 10.1056/NEJMoa1917246.

name: From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis...

family: Hauser

full_name: Stephen L. Hauser

given: Stephen L.

family: Bar-Or

full_name: Amit Bar-Or

given: Amit

family: Cohen

full_name: Jeffrey A. Cohen

given: Jeffrey A.

family: Comi

full_name: Giancarlo Comi

given: Giancarlo

family: Correale

full_name: Jorge Correale

given: Jorge

family: Coyle

full_name: Patricia K. Coyle

given: Patricia K.

family: Cross

full_name: Anne H. Cross

given: Anne H.

family: de Seze

full_name: Jerome de Seze

given: Jerome

family: Leppert

full_name: David Leppert

given: David

family: Montalban

full_name: Xavier Montalban

given: Xavier

family: Selmaj

full_name: Krzysztof Selmaj

given: Krzysztof

family: Wiendl

full_name: Heinz Wiendl

given: Heinz

family: Kerloeguen

full_name: Cecile Kerloeguen

given: Cecile

family: Willi

full_name: Roman Willi

given: Roman

family: Li

full_name: Bingbing Li

given: Bingbing

family: Kakarieka

full_name: Algirdas Kakarieka

given: Algirdas

family: Tomic

full_name: Davorka Tomic

given: Davorka

family: Goodyear

full_name: Alexandra Goodyear

given: Alexandra

family: Pingili

full_name: Ratnakar Pingili

given: Ratnakar

family: Häring

full_name: Dieter A. Häring

given: Dieter A.

family: Ramanathan

full_name: Krishnan Ramanathan

given: Krishnan

family: Merschhemke

full_name: Martin Merschhemke

given: Martin

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

journal_name: New England Journal of Medicine

oa_colors: green other

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:
Greece
Belgium
Australia
Russian Federation
Denmark
India
Croatia
France
Poland
Slovakia
Thailand
Argentina
Canada
Turkey
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Puerto Rico
Germany
United States
United Kingdom
Italy
Mexico
Czechia
Israel
Spain
Estonia

title: A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis

summary: To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis


type: Registry Identifier

title: A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis (EARNEST)

acronym: EARNEST

summary: The purpose of this study is to compare the efficacy of vedolizumab intravenous (IV) and placebo in terms of the percentage of participants with chronic or recurrent pouchitis achieving clinically relevant remission.

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

lead_sponsor: Takeda

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

location_facility: Carolinas HealthCare System Digestive Health

location_facility: Praxis fuer Gastroenterologie, Drs. Ehehalt/ Helmstaedter

location_facility: Klinikum Mannheim GmbH Universitaetsklinikum

location_facility: Charite Universitatsmedizin Berlin -Campus Virchow Klinikum

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: UZ Leuven - University Hospital Gasthuisberg

location_facility: University of Utah Health Sciences Center


title: A Multicenter, Global, Retrospective, Observational Study to Characterize Real-world Clinical Outcomes in Patients With Relapsing-remitting Multiple Sclerosis Treated With Disease-modifying Therapies (Tecfidera®, Copaxone®, Aubagio®, or Gilenya®)

acronym: EFFECT

summary:
The primary objective of the study is to evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with dimethyl fumarate (DMF).

Secondary objectives of the study are: To evaluate the real-world clinical effectiveness, as measured by the proportion of participants relapsed at 12 months, in participants treated with DMF, glatiramer acetate (GA), teriflunomide, or fingolimod both in the overall participant cohort and in a subset of participants who were naïve to disease-modifying therapy (DMT) and were diagnosed with multiple sclerosis (MS) within 3 years of starting the index therapy; To compare relapse activity, defined as annualized relapse rate (ARR), among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare MS-related hospitalizations among participants treated with DMF, GA, teriflunomide, or fingolimod; To compare intravenous corticosteroid use among participants treated with DMF, GA, teriflunomide, or fingolimod.

time_perspective: Retrospective

ReferenceCitation: Min J, Cohan S, Alvarez E, Sloane J, Phillips JT, van der Walt A, Koulinska I, Fang F, Miller C, Chan A. Real-World Characterization of Dimethyl Fumarate-Related Gastrointestinal Events in Multiple Sclerosis: Management Strategies to Improve Persistence on Treatment and Patient Outcomes. Neurol Ther. 2019 Jun;8(1):109-119. doi: 10.1007/s40120-019-0127-2. Epub 2019 Jan 31.

family: Min

full_name: Jinny Min

given: Jinny

family: Cohan

full_name: Stanley Cohan

given: Stanley

family: Alvarez

full_name: Enrique Alvarez

given: Enrique

family: Sloane

full_name: Jacob Sloane

given: Jacob

family: Phillips

full_name: J. Theodore Phillips

given: J. Theodore

family: van der Walt

full_name: Anneke van der Walt

given: Anneke

family: Koulinska

full_name: Irene Koulinska

given: Irene

family: Fang

full_name: Fang Fang

given: Fang

family: Miller

full_name: Catherine Miller

given: Catherine

family: Chan

full_name: Andrew Chan

given: Andrew

journal_name: Neurology and Therapy

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_institution: University of Melbourne - Minerva Access

version: submittedVersion

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Biogen

location_country:
Italy
United States
Switzerland
United Kingdom
Germany
Croatia
France
Hungary
Argentina
Australia
Spain
Canada
Czech Republic


title: A Phase 1b/2a Multicenter, Open-label, Dose-escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 as Monotherapy and in Combination With Other Treatments in Subjects With Multiple Myeloma

summary: This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.

lead_sponsor: Celgene

location_country:
Italy
United States
Netherlands
France
Japan
Spain
Germany
United Kingdom
Canada

location_facility: Icahn School of Medicine at Mount Sinai Medical Center

location_facility: Dana-Farber/Mass General Brigham Cancer Care, Inc

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Instituto Catalan de Oncologia-Hospital Duran i Reynals

location_facility: I.R.C.C.S. Policlinico San Matteo - Universita di Pavia

location_facility: University of Arkansas for Medical Sciences

location_facility: Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma - Centro di Ematologia

location_facility: Huntsman Cancer Institute at the University of Utah

location_facility: Robert H Lurie Comprehensive Cancer Center NW Univ

location_facility: Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: Winship Cancer Institute of Emory University

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Hospital Universitari Germans Trias i Pujol Can Ruti

location_facility: McGill University Health Center - Royal Victoria Hospital

location_facility: New York Presbyterian Hospital Weil Cornell Medical College

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova

location_facility: University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: Queen Elizabeth II Health Sciences Centre


ReferenceCitation: Liu SV, Reck M, Mansfield AS, Mok T, Scherpereel A, Reinmuth N, Garassino MC, De Castro Carpeno J, Califano R, Nishio M, Orlandi F, Alatorre-Alexander J, Leal T, Cheng Y, Lee JS, Lam S, McCleland M, Deng Y, Phan S, Horn L. Updated Overall Survival and PD-L1 Subgroup Analysis of Patients With Extensive-Stage Small-Cell Lung Cancer Treated With Atezolizumab, Carboplatin, and Etoposide (IMpower133). J Clin Oncol. 2021 Feb 20;39(6):619-630. doi: 10.1200/JCO.20.01055. Epub 2021 Jan 13.

name: Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC

family: Liu

full_name: Stephen V. Liu

given: Stephen V.

name: Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany

family: Reck

full_name: Martin Reck

name: Division of Medical Oncology, Mayo Clinic, Rochester, MN

family: Mansfield

full_name: Aaron S. Mansfield

given: Aaron S.

name: State Key Laboratory of Translational Oncology, The Chinese University of Hong Kong, Hong Kong, PR China

family: Mok

full_name: Tony Mok

given: Tony

name: University of Lille, CHU Lille, Inserm, Lille, France

family: Scherpereel

full_name: Arnaud Scherpereel

given: Arnaud

name: Thoracic Oncology, Asklepios Clinics Munich-Gauting, Gauting, Germany

family: Reinmuth

full_name: Niels Reinmuth

given: Niels

name: Thoracic Oncology Unit, Instituto Nazionale dei Tumori, Milan, Italy

family: Garassino

full_name: Marina Chiara Garassino

given: Marina Chiara

name: Hospital Universitario La Paz, IDIPAZ, Madrid, Spain

family: De Castro Carpeno

full_name: Javier De Castro Carpeno

given: Javier

name: Department of Medical Oncology, Christie NHS Foundation Trust, Manchester, UK Division of Cancer Sciences, University of Manchester, Manchester, UK

family: Califano

full_name: Raffaele Califano

given: Raffaele

name: The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan

family: Nishio

full_name: Makoto Nishio

given: Makoto

name: Instituto Nacional del Tórax, Prosalud Oncología, Santiago, Chile

family: Orlandi

full_name: Francisco Orlandi

given: Francisco

name: Health Pharma Professional Research, Mexico City, Mexico

family: Alatorre-Alexander

full_name: Jorge Alatorre-Alexander

given: Jorge

name: University of Wisconsin Carbone Cancer Center, Madison, WI

family: Leal

full_name: Ticiana Leal

given: Ticiana

family: Cheng

full_name: Ying Cheng

given: Ying

name: Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea

family: Lee

full_name: Jong-Seok Lee

given: Jong-Seok

name: Genentech, Inc., South San Francisco, CA

family: Lam

full_name: Sivuonthanh Lam

given: Sivuonthanh

family: McCleland

full_name: Mark McCleland

given: Mark

family: Deng

full_name: Yu Deng

given: Yu

family: Phan

full_name: See Phan

given: See

name: Vanderbilt University Medical Center, Nashville, TN

family: Horn

full_name: Leora Horn

given: Leora

oa_host_type: publisher

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Mansfield AS, Każarnowicz A, Karaseva N, Sánchez A, De Boer R, Andric Z, Reck M, Atagi S, Lee JS, Garassino M, Liu SV, Horn L, Wen X, Quach C, Yu W, Kabbinavar F, Lam S, Morris S, Califano R. Safety and patient-reported outcomes of atezolizumab, carboplatin, and etoposide in extensive-stage small-cell lung cancer (IMpower133): a randomized phase I/III trial. Ann Oncol. 2020 Feb;31(2):310-317. doi: 10.1016/j.annonc.2019.10.021. Epub 2019 Dec 9.

full_name: A.S. Mansfield

family: Każarnowicz

full_name: A. Każarnowicz

given: A.

ReferenceCitation: Nishio M, Sugawara S, Atagi S, Akamatsu H, Sakai H, Okamoto I, Takayama K, Hayashi H, Nakagawa Y, Kawakami T. Subgroup Analysis of Japanese Patients in a Phase III Study of Atezolizumab in Extensive-stage Small-cell Lung Cancer (IMpower133). Clin Lung Cancer. 2019 Nov;20(6):469-476.e1. doi: 10.1016/j.cllc.2019.07.005. Epub 2019 Jul 31.

ReferenceCitation: Horn L, Mansfield AS, Szczęsna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.

name: From Vanderbilt University Medical Center (L. Horn) and Sarah Cannon Research Institute–Tennessee Oncology (M.L.J.), Nashville; Mayo Clinic, Rochester, MN (A.S.M.); Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy, Otwock (A. Szczęsna), and Centrum Onkologii–Instytut im. Marii Skłodowskiej-Curie w Warszawie, Warsaw (M.K.) — both in Poland; Thomayerova Nemocnice, Pneumologická Klinika 1.LF UK, Prague, Czech Republic (L. Havel); the Department of Respiratory and Critical Care Medicine (M.J.H.) and the...

location_country:
Greece
Australia
Russian Federation
Taiwan
France
Japan
Poland
Korea, Republic of
Chile
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Spain

location_facility: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

location_facility: Cancer Treatment Centers of America - Midwestern Regional Medical Center

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial V Chemioterapii Nowotworow Pluc

location_facility: Royal Devon & Exeter Hospital; Oncology Centre

location_facility: SMZ - Baumgartner Hohe, Otto-Wagner-Spital; 2.Interne Lungenabteilung

location_facility: University Hospital of Patras Medical Oncology

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: The Cancer Institute Hospital of JFCR, Respiratory Medicine

location_facility: Kanagawa Cancer Center;Thoracic Oncology

location_facility: Scientific Research Oncology Institute named after N.N. Petrov; Oncology

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia

location_facility: N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

location_facility: Hopital Calmette; Pneumologie Oncologie Ouest

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin

location_facility: The Prince Charles Hospital; Oncology Dept.

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

location_facility: Tokyo Metropolitan Komagome Hospital; Thoracic Oncology and Respiratory Medicine

location_facility: National Taiwan Uni Hospital; Internal Medicine

location_facility: University Hospital Kyoto Prefectural University of Medicine, Pulmonary Medicine

location_facility: Salzburger Landeskliniken; Universitätsklinik für Pneumologie/ Lungenheilkunde

location_facility: Tennessee Oncology PLLC - Nashville (20th Ave)

location_facility: Clinical Center Nis; Clinic for pulmonary diseases

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten

location_facility: Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Agioi Anargyroi; 3Rd Dept. of Medical Oncology

location_facility: Kindai University Hospital; Medical Oncology

location_facility: Hosp Clinico Univ Lozano Blesa; División De Oncología Médica

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Seoul National University Bundang Hospital

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

location_facility: Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

location_facility: Harbin Medical University Cancer Hospital

location_facility: Sendai Kousei Hospital; Pulmonary Medicine

location_facility: Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie

location_facility: Kurashiki Central Hospital; Respiratory Medicine

location_facility: Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Royal Melbourne Hospital; Hematology and Medical Oncology

location_facility: Saitama Cancer Center; Thoracic Oncology

location_facility: Chang Gung Medical Foundation - Linkou; Chest Dept

location_facility: Shizuoka Cancer Center; Thoracic Oncology

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Semmelweis Egyetem, AOK, Pulmonologiai Klinika

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Wakayama Medical University Hospital; Respiratory Medicine and Medical Oncology

location_facility: Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

title: A Phase I/III, Randomized, Double-Blind, Placebo-Controlled Study of Carboplatin Plus Etoposide With or Without Atezolizumab (Anti-PD-L1 Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

summary: This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.


title: A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors

summary: The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.

location_country:
Italy
United States
Netherlands
Germany
France
Australia
Canada

location_facility: Instituto Nazionale Tumori Fondazione G. Pascale

location_facility: Klinikum rechts der Isar der Technischen Universitat Muenchen Klinik und Poliklinik fur Innere Mediz

location_facility: Columbia University Medical Center (Cumc)

location_facility: Sir Mortimer B Davis Jewish General Hospital

location_facility: Northwestern University Feinberg School of Medicine

intervention_type: Biological


title: A Phase 2 Study of LY2606368 in Patients With Extensive Stage Disease Small Cell Lung Cancer

summary: The purpose of this study is to evaluate the safety and efficacy of prexasertib when given to participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will evaluate how the body processes the drug and how the drug affects the body. The study will also evaluate the association between tumor response and the participant's perceived quality of life.

ReferenceCitation: Jin T, Xu L, Wang P, Hu X, Zhang R, Wu Z, Du W, Kan W, Li K, Wang C, Zhou Y, Li J, Liu T. Discovery and Development of a Potent, Selective, and Orally Bioavailable CHK1 Inhibitor Candidate: 5-((4-((3-Amino-3-methylbutyl)amino)-5-(trifluoromethyl)pyrimidin-2-yl)amino)pico linonitrile. J Med Chem. 2021 Oct 28;64(20):15069-15090. doi: 10.1021/acs.jmedchem.1c00994. Epub 2021 Oct 19.

location_country:
United States
Netherlands
France
Greece
Spain
Turkey
Germany
United Kingdom
Korea, Republic of
Ukraine

location_facility: The Center for Cancer and Blood Disorders

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

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Florida Cancer Specialists and Research Institute

location_facility: Chattanooga Oncology Hematology Associates


title: A Phase I Open Label Study of GSK3359609 Administered Alone and in Combination With Anticancer Agents in Subjects With Selected Advanced Solid Tumors

summary: GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary antitumor activity in participants with selected, advanced or recurrent solid tumors with the aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and in combination with pembrolizumab or chemotherapy regimens. The study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part 2: GSK3359609 combination therapy with Part 2A pembrolizumab or GSK3174998 or dostarlimab or dostarlimab plus cobolimab or Bintrafusp alfa combination dose escalation phase and Part 2B expansion phase with pembrolizumab. Part 2A GSK3359609 combinations with chemotherapy will only consist of safety run-in cohorts. Each part and phase of the study includes a screening period, a treatment period, and a follow-up period. The primary objective of the study is to determine the safety, tolerability, maximum tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.

location_country:
Italy
United States
Netherlands
Spain
France
Japan
Australia
China
Canada


lead_sponsor: Parion Sciences

location_country:
United States
Ireland
France
United Kingdom

title: A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi

summary: The purpose of this study is to evaluate the safety and efficacy of treatment with VX-371 in hypertonic saline compared to hypertonic saline alone in subjects with cystic fibrosis (CF) who are ≥12 years of age, homozygous for the F508del-cystic fibrosis transmembrane conductance regulator (CFTR) mutation, and being treated with Orkambi


ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

name: Dermatologist, Masters of Public Health Program; Harvard School of Public Health; Boston Massachusetts USA

family: Hannon

full_name: Cora W Hannon

given: Cora W

name: Department of Dermatology; Royal Victoria Hospital; Belfast UK

family: McCourt

full_name: Collette McCourt

given: Collette

name: Department of Dermatology, Clinical Unit for Research Trials and Outcomes in Skin (CURTIS); Massachusetts General Hospital; Boston Massachusetts USA

family: Lima

full_name: Hermenio C Lima

given: Hermenio C

name: Emory University Hospital; Emory Healthcare; Atlanta Georgia USA

family: Chen

full_name: Suephy Chen

given: Suephy

name: Office of Research and Innovation; Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn; Dublin Ireland

family: Bennett

full_name: Cathy Bennett

given: Cathy

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Wallace DJ, Furie RA, Tanaka Y, Kalunian KC, Mosca M, Petri MA, Dörner T, Cardiel MH, Bruce IN, Gomez E, Carmack T, DeLozier AM, Janes JM, Linnik MD, de Bono S, Silk ME, Hoffman RW. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. 2018 Jul 21;392(10143):222-231. doi: 10.1016/S0140-6736(18)31363-1. Erratum in: Lancet. 2018 Aug 11;392(10146):476.

family: Wallace

full_name: Daniel J Wallace

given: Daniel J

family: Furie

full_name: Richard A Furie

given: Richard A

family: Tanaka

full_name: Yoshiya Tanaka

given: Yoshiya

family: Kalunian

full_name: Kenneth C Kalunian

given: Kenneth C

family: Mosca

full_name: Marta Mosca

given: Marta

family: Petri

full_name: Michelle A Petri

given: Michelle A

family: Dörner

full_name: Thomas Dörner

given: Thomas

family: Cardiel

full_name: Mario H Cardiel

given: Mario H

family: Bruce

full_name: Ian N Bruce

given: Ian N

family: Gomez

full_name: Elisa Gomez

given: Elisa

family: Carmack

full_name: Tara Carmack

given: Tara

family: DeLozier

full_name: Amy M DeLozier

given: Amy M

family: Janes

full_name: Jonathan M Janes

given: Jonathan M

family: Linnik

full_name: Matthew D Linnik

given: Matthew D

family: de Bono

full_name: Stephanie de Bono

given: Stephanie

family: Silk

full_name: Maria E Silk

given: Maria E

family: Hoffman

full_name: Robert W Hoffman

given: Robert W

repository_institution: The University of Manchester - Research Explorer

location_country:
Austria
Mexico
France
Japan
Poland
Romania
Argentina
Puerto Rico
Spain
United States
Korea, Republic of
Taiwan

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

location_facility: Clinical Research Center of Reading, LLC

location_facility: Louisiana State University Health Sciences Center

location_facility: Accent Clinical Research Professionals, LLC

location_facility: West Broward Rheumatology Associates, Inc

location_facility: The Oklahoma Center For Arthritis Therapy

location_facility: Arthritis & Rheumatology Center of Oklahoma PLLC

location_facility: North Shore University Hospital at Great Neck

title: A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)

summary: The main purpose of this study is to evaluate the efficacy and safety of the study drug known as baricitinib in participants with systemic lupus erythematosus.


lead_sponsor: Hoffmann-La Roche

location_country:
United States
France
Poland
Portugal
Germany
United Kingdom

location_facility: Shanahan Rheumatology & Immunology, PLLC

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust; Royal Hallamshire Hospital

location_facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob

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

location_facility: Great Western Hospitals NHS Foundation Trust.

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria

location_facility: Hopital Lapeyronie; Immunologie Rhumatologie

location_facility: Niepubliczny Opieki Zdrowotnej; Reumatika - Ctr Reum.

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2A Study to Assess the Efficacy of RO5459072 in Patients With Primary Sjogren's Syndrome

summary: This is a randomized, double-blind, placebo-controlled, two-treatment arm, parallel-group study designed to evaluate the effects of RO5459072 treatment on disease activity and symptoms of Sjogren's syndrome in adult participants with moderate to severe primary Sjogren's syndrome. The total duration of the study for each participant will be approximately 18 weeks (including screening).


title: Phase 3, Multicenter, Randomized, 48 Week, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate Efficacy and Safety of CER-001 on Vessel Wall Area in Patients With Genetically Defined Familial Primary Hypoalphalipoproteinemia

acronym: TANGO

summary: The purpose of this study is to assess the impact of 29 intravenous infusions of CER-001 vs. placebo, given at weekly (9 infusions) and biweekly (20 infusions) intervals on carotid vessel wall area as measured by 3TMRI, when administered to patients with familial primary hypoalphalipoproteinemia with proven CVD and appropriate background lipid-lowering therapy.

status: Terminated

ipd_sharing: Undecided

ipd_sharing_description: To be determined

lead_sponsor: Cerenis Therapeutics, SA

location_country:
Italy
United States
Netherlands
France
Israel
Belgium
Canada

status_simplified: Unknown


title: A Randomized, Double-blind Trial to Evaluate the Efficacy, Safety and Immunogenicity of MSB11022 Compared With Humira® in Subjects With Moderate to Severe Chronic Plaque Psoriasis

acronym: AURIEL-PsO

summary: The purpose of this study was to compare the efficacy, safety and immunogenicity of MSB11022 and Humira® in adult subjects with moderate to severe chronic plaque type psoriasis.

lead_sponsor: Fresenius Kabi SwissBioSim GmbH

location_country:
Mexico
Germany
France
Czechia
Bulgaria
Poland
Hungary
Russian Federation
Estonia
United States
United Kingdom
Canada

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

location_facility: Florida Academic Centers Research and Education

location_facility: San Luis Dermatology & Laser Clinic, Inc.

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: Centrum Kliniczno - Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spółka Partnerska

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej "Med-Laser"

location_facility: Grazyna Pulka Specjalistyczny Osrodek "ALL-MED"

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C.

location_facility: Diagnostic Consultative Center II - Sofia OOD

location_facility: SBEI HPE "Kazan State Medical University" of the MoH of the RF

location_facility: Centre de Recherche Dermatologique du Quebec Metropolitain

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Haut Lévêque

location_facility: Ambrozia Gondozohaz Szolg. Nonprofit Kft.

location_facility: NZOZ ALL-MED Centrum Medyczne Specjalistyczne Gabinety Lekarskie

location_facility: Dermatology Treatment and Research Center

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

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: LLC "Alliance Biomedical - Russian Group"

location_facility: Dr Melinda Gooderham Medicine Professional Corporation

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

location_facility: SBEI HPE "Yaroslavl State Medical University" of the MoH of the RF

location_facility: Praxis fuer Dermatologie und Venerologie

location_facility: Unidad de Investigacion de las Enfermedades Reumaticas


title: Efficacy and Safety of Lanreotide Autogel® 120 mg Administered Every 14 Days in Well Differentiated, Metastatic or Locally Advanced, Unresectable Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg Administered Every 28 Days

acronym: CLARINET FORTE

summary: This study aims to explore the efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in subjects with grade 1 or 2, metastatic or locally advanced, unresectable pancreatic or intestinal neuroendocrine tumours (NETs) once they have progressed on the standard dose of lanreotide Autogel® 120 mg every 28 days.

lead_sponsor: Ipsen

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

location_facility: Università degli Studi "Federico II" di Napoli

location_facility: Azienda Ospedaliera - Universitaria Careggi

location_facility: Nationales Centrum für Tumorerkrankungen (NCT)

location_facility: Fondacione IRCCS Istituto Nazionale Dei Tumori

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 5

location_facility: The Christie Hospital NHS Foundation Trust

location_facility: Hospital Universitario Central de Asturias


title: A Phase 1/2, Open-Label, Dose-Escalation And Expansion Study Of Entrectinib (Rxdx-101) In Pediatrics With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options

acronym: STARTRK-NG

summary: This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain tumors harboring NTRK1/2/3 or ROS1 gene fusions, and extracranial solid tumors harboring NTRK1/2/3 or ROS1 gene fusions.

ReferenceCitation: Doebele RC, Drilon A, Paz-Ares L, Siena S, Shaw AT, Farago AF, Blakely CM, Seto T, Cho BC, Tosi D, Besse B, Chawla SP, Bazhenova L, Krauss JC, Chae YK, Barve M, Garrido-Laguna I, Liu SV, Conkling P, John T, Fakih M, Sigal D, Loong HH, Buchschacher GL Jr, Garrido P, Nieva J, Steuer C, Overbeck TR, Bowles DW, Fox E, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Demetri GD; trial investigators. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):271-282. doi: 10.1016/S1470-2045(19)30691-6. Epub 2019 Dec 11. Erratum in: Lancet Oncol. 2020 Feb;21(2):e70. Lancet Oncol. 2020 Jul;21(7):e341. Lancet Oncol. 2020 Aug;21(8):e372. Lancet Oncol. 2021 Oct;22(10):e428.

family: Doebele

full_name: Robert C Doebele

given: Robert C

family: Drilon

full_name: Alexander Drilon

given: Alexander

family: Paz-Ares

full_name: Luis Paz-Ares

given: Luis

family: Siena

full_name: Salvatore Siena

given: Salvatore

family: Shaw

full_name: Alice T Shaw

given: Alice T

family: Farago

full_name: Anna F Farago

given: Anna F

family: Blakely

full_name: Collin M Blakely

given: Collin M

family: Seto

full_name: Takashi Seto

given: Takashi

family: Cho

full_name: Byung Chul Cho

given: Byung Chul

family: Tosi

full_name: Diego Tosi

given: Diego

family: Besse

full_name: Benjamin Besse

given: Benjamin

family: Chawla

full_name: Sant P Chawla

given: Sant P

family: Bazhenova

full_name: Lyudmila Bazhenova

given: Lyudmila

family: Krauss

full_name: John C Krauss

given: John C

family: Chae

full_name: Young Kwang Chae

given: Young Kwang

family: Barve

full_name: Minal Barve

given: Minal

family: Garrido-Laguna

full_name: Ignacio Garrido-Laguna

given: Ignacio

family: Liu

full_name: Stephen V Liu

given: Stephen V

family: Conkling

full_name: Paul Conkling

given: Paul

family: John

full_name: Thomas John

family: Fakih

full_name: Marwan Fakih

given: Marwan

family: Sigal

full_name: Darren Sigal

given: Darren

family: Loong

full_name: Herbert H Loong

title: Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1–2 trials

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

location_facility: Egleston Children's Hospital at Emory University Atlanta; Pediatric Hematology/Oncology

location_facility: Washington University,St. Louis Children's Hospital; Neurology, Movement Disorder

location_facility: Institut Gustave Roussy; Service de Pathologie Morphologique

location_facility: Children's Hospital Colorado; Center For Cancer/Blood Disorder

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Memorial Sloan Kettering Cancer Center; Pediatrics

location_facility: UCSF Benioff Children's Hospital; UCSF Pediatrics Hematology Oncology

location_facility: Hopital Purpan; Pédiatrie - Hématologie - Oncologie pédiatrique

location_facility: Texas Children's Cancer and Hematology Center

location_facility: University of Minnesota Childrens' Hospital

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori; Struttura Complessa di Pediatria Oncologica

location_facility: National Taiwan University Hospital; Department of Paediatrics

location_facility: Chang Gung Memorial Hospital, Linkou; Department of Pediatric Internal Medicine

location_facility: Hospital Sant Joan de Deu; Servicio de Oncologia y Hematologia

location_facility: Morgan Stanley Children's Hospital; Herbert Irving Cancer Center

location_facility: Hospital Infantil Universitario Niño Jesus; Servicio de Onco-hematologia

location_facility: Children's National Medical Center; Department of Pediatrics

location_facility: University of Chicago; Comer Children's Hospital/Department of Pediatrics

location_facility: Nationwide Children's Hospital; Dept. of Pulmonology

location_facility: A. O. Città della Salute e della Scienza di Torino; SC Oncoematologia e Centro Trapianti AOOIRM

location_facility: Hôpital de la Timone, Oncologie Pédiatrique


location_country:
Italy
Austria
United States
Brazil
South Africa
Mexico
Netherlands
Germany
France
Japan
Poland
Argentina
Russian Federation
Spain
Canada
Korea, Republic of
Taiwan

location_facility: Universitaetsklinik Fuer Innere Medizin 3

location_facility: Paramount Medical Research & Consulting, Llc

location_facility: Rheumatology Associates Of North Alabama, P.C.

location_facility: Nzoz Osteo-Medic S.C. A. Racewicz, J.Supronik

location_facility: Integral Rheumatology & Immunology Specialists

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C.

location_facility: CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.

location_facility: Advanced Rheumatology & Arthritis Research Center, P.C

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

location_facility: Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.

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

location_facility: Centrum Badan Klinicznych JCI Life Science Park

title: Phase 2, Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety/Pharmacokinetics of BMS-986142 in Subjects With Moderate to Severe Rheumatoid Arthritis With an Inadequate Response to Methotrexate With or Without TNF Inhibitors

summary: The purpose of this study is to determine whether the study drug, BMS-986142, is safe and effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors. Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in 1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the course of the study.


title: An Open-label Extension Study of the Long-term Safety, Tolerability and Efficacy of Drisapersen in Subjects With Duchenne Muscular Dystrophy.

summary: This is a phase IIIb, multi-centre, open-label extension study in male subjects with DMD who previously have been treated with drisapersen, aiming at assessing the safety and efficacy of drisapersen.

status: No longer available

study_type: Expanded Access

lead_sponsor: BioMarin Pharmaceutical

location_country:
Italy
Netherlands
Spain
Germany
France
Bulgaria
Czechia
Israel
Japan
Norway
Poland
Belgium
Argentina
Australia
Russian Federation
Turkey
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: National Center Hospital of Neurology and Psychiatry

location_facility: IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: Seoul National University Children's Hospital

location_facility: Royal Children's Hosital, Children's Neuroscience Centre

location_facility: Hôpital de La Citadelle, Centre de référence des Maladies

location_facility: Universitair Ziekenhuis Gent, Afdeling Neurologie

location_facility: Queen Fabiola Children's University Hospital

location_facility: Hadassah, Hebrew University Medical Center


title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis Who Have Persistent Cardiac Dysfunction

acronym: PRONTO

summary: This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who had a hematologic response to previous treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT]) and have persistent cardiac dysfunction.

lead_sponsor: Prothena Biosciences Ltd.

location_country:
Italy
Austria
Germany
France
Greece
Israel
Australia
Spain
United States
United Kingdom

location_facility: Froedtert & Medical College of Wisconsin, Cancer Center - Froedtert Hospital

location_facility: University of Washington/Seattle Cancer Care Alliance

location_facility: Hospital of the University of Pennsylvania

location_facility: University of Texas; MD Anderson Cancer Center

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien

location_facility: The University of Queensland - Princess Alexandra Hospital (PAH)

location_facility: The Royal Free London NHS Foundation Trust - The Royal Free Hospital


lead_sponsor: Kite, A Gilead Company

location_country:
United States
Netherlands
Germany
France
Belgium
Spain
Canada

location_facility: Monroe-Carell Jr. Children's Hospital at Vanderbilt

location_facility: Medical College of Wisconsin (Administrative Offices)

location_facility: Unité d'Oncologie et Hématologie Pédiatriques

location_facility: Hopital Robert Debre - Sevice d'Hemato-immunologic

location_facility: University of Virginia Health System, Pediatric Hematology/Oncology Clinic

location_facility: Ann & Robert H. Lurie Children's Hospital

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Children's Hospitals and Clinics of Minnesota

location_facility: University Medical Center Hamburg-Eppendorf (UKE)

location_facility: Institut d'Hematologie et Oncologie Pediatrique

location_facility: Columbia University Irving Medical Center/Morgan Stanley Children's Hospital-NYP

location_facility: The University of Texas M.D. Anderson Cancer Center

title: A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4)

summary: The primary objectives of this study are to evaluate the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in pediatric and adolescent participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL) or relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (NHL).


ReferenceCitation: Oldenburg J, Mahlangu JN, Kim B, Schmitt C, Callaghan MU, Young G, Santagostino E, Kruse-Jarres R, Negrier C, Kessler C, Valente N, Asikanius E, Levy GG, Windyga J, Shima M. Emicizumab Prophylaxis in Hemophilia A with Inhibitors. N Engl J Med. 2017 Aug 31;377(9):809-818. doi: 10.1056/NEJMoa1703068. Epub 2017 Jul 10.

family: Oldenburg

full_name: Johannes Oldenburg

given: Johannes

family: Mahlangu

full_name: Johnny N. Mahlangu

given: Johnny N.

family: Kim

full_name: Benjamin Kim

family: Schmitt

full_name: Christophe Schmitt

given: Christophe

family: Callaghan

full_name: Michael U. Callaghan

given: Michael U.

family: Young

full_name: Guy Young

given: Guy

family: Santagostino

full_name: Elena Santagostino

given: Elena

family: Kruse-Jarres

full_name: Rebecca Kruse-Jarres

given: Rebecca

family: Negrier

full_name: Claude Negrier

given: Claude

family: Kessler

full_name: Craig Kessler

given: Craig

family: Valente

full_name: Nancy Valente

given: Nancy

family: Asikanius

full_name: Elina Asikanius

given: Elina

family: Levy

full_name: Gallia G. Levy

given: Gallia G.

family: Windyga

full_name: Jerzy Windyga

given: Jerzy

family: Shima

full_name: Midori Shima

given: Midori

evidence: open (via free article)

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

location_country:
Italy
United States
South Africa
Costa Rica
France
Japan
Poland
Australia
New Zealand
Spain
Germany
United Kingdom
Korea, Republic of
Taiwan

acronym: HAVEN 1

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: CTC North GmbH & Co. KG am Universitätsklinikum Hamburg-Eppendorf

location_facility: Hospital of the University of Occupational and Environmental Health,Japan

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: ALVAMED Lekarskie Gabinety Specjalistyczne

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Children's Hospital of Michigan; Pediatrics

location_facility: St Thomas' Hospital; Haemostasis & Thromboisis Centre

location_facility: The Alfred Hospital, Melbourne; Thrombosis and Haemostasis Unit

location_facility: Oregon Health & Science Uni ; Dept of Pediatrics

location_facility: Bloodworks Northwest (formerly Puget Sound Blood Center); Hemophilia

location_facility: Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych

location_facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico; Centro Emofilia e Trombosi "Angelo Bianchi e Bonomi"

location_facility: CH de Bicetre; Centre de Traitement d' Hemophilie

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Cornell Univ Medical College; Hematology-Oncolog

location_facility: Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center

location_facility: Hospital Universitario la Fe; Servicio de Hematologia

location_facility: Royal Prince Alfred Hospital; Haematology

location_facility: Univ of TX Health Science Ctr; Gulf States Hemo and Throm Ctr

location_facility: Pennsylvania State Hershey Medical Center; Division of Hematology/Oncology, H046

location_facility: Auckland City Hospital; Auckland Haemophilia Centre

location_facility: University of Colorado Denver, Children's Hospital

location_facility: Hopital Cardio-vasculaire Louis Pradel; Hemostase clinique

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Universitätsklinikum Bonn; Institut für Experimentelle Hämatologie und Transfusionsmedizin

title: A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Patients With Inhibitors

summary: This multicenter, open-label study will evaluate the safety, efficacy and pharmacokinetics of prophylactic emicizumab treatment in participants previously treated with episodic or prophylactic bypassing agents. Episodic bypassing agent participants will be randomized in a 2:1 fashion to receive emicizumab prophylaxis (Arm A) versus no prophylaxis (Arm B) and will be stratified across Arms A and B according to the number of bleeds they experienced over the last 24 weeks prior to study entry (less than [<] 9 or greater than or equal to [>/=] 9 bleeds); Arm B participants will have the opportunity to switch to emicizumab prophylaxis after at least 24 weeks on-study. Prophylactic bypassing agent participants will switch to emicizumab prophylaxis (Arm C) from the start of the trial; enrollment will be extended for 24 weeks after the last participant has enrolled in Arms A or B or until approximately 50 participants have enrolled in Arm C, whichever occurs first. Episodic bypassing agent participants who previously participated in the non-interventional study BH29768 (NCT02476942) who were unable to enroll in Arms A or B, or participants on prophylactic bypassing agents who were unable to enroll in Arm C, prior to their closure will have the opportunity to enroll in Arm D. Like participants in Arms A and C, Arm D participants will receive emicizumab prophylaxis from the start of the trial. All participants will continue to receive episodic bypassing agent therapy to treat breakthrough bleeds, preferably with recombinant activated factor VII (rFVIIa).


ReferenceCitation: Fontaine-Sylvestre C, Létourneau-Guillon L, Moumdjian RA, Berthelet F, Lacroix A. Corticotroph tumor progression during long-term therapy with osilodrostat in a patient with persistent Cushing's disease. Pituitary. 2021 Apr;24(2):207-215. doi: 10.1007/s11102-020-01097-1. Epub 2020 Oct 19.

family: Fontaine-Sylvestre

full_name: Cédric Fontaine-Sylvestre

given: Cédric

family: Létourneau-Guillon

full_name: Laurent Létourneau-Guillon

given: Laurent

family: Moumdjian

full_name: Robert A. Moumdjian

given: Robert A.

family: Berthelet

full_name: France Berthelet

given: France

family: Lacroix

full_name: André Lacroix

given: André

journal_name: Pituitary

title: Corticotroph tumor progression during long-term therapy with osilodrostat in a patient with persistent Cushing’s disease

ReferenceCitation: Pivonello R, Fleseriu M, Newell-Price J, Bertagna X, Findling J, Shimatsu A, Gu F, Auchus R, Leelawattana R, Lee EJ, Kim JH, Lacroix A, Laplanche A, O'Connell P, Tauchmanova L, Pedroncelli AM, Biller BMK; LINC 3 investigators. Efficacy and safety of osilodrostat in patients with Cushing's disease (LINC 3): a multicentre phase III study with a double-blind, randomised withdrawal phase. Lancet Diabetes Endocrinol. 2020 Sep;8(9):748-761. doi: 10.1016/S2213-8587(20)30240-0. Epub 2020 Jul 27. Erratum in: Lancet Diabetes Endocrinol. 2020 Aug 5;:.

family: Pivonello

full_name: Rosario Pivonello

given: Rosario

family: Fleseriu

full_name: Maria Fleseriu

given: Maria

family: Newell-Price

full_name: John Newell-Price

given: John

family: Bertagna

full_name: Xavier Bertagna

given: Xavier

family: Findling

full_name: James Findling

given: James

family: Shimatsu

full_name: Akira Shimatsu

given: Akira

family: Gu

full_name: Feng Gu

given: Feng

family: Auchus

full_name: Richard Auchus

given: Richard

family: Leelawattana

full_name: Rattana Leelawattana

given: Rattana

family: Lee

full_name: Eun Jig Lee

given: Eun Jig

full_name: Jung Hee Kim

given: Jung Hee

family: Laplanche

full_name: Audrey Laplanche

given: Audrey

family: O'Connell

full_name: Paul O'Connell

given: Paul

family: Tauchmanova

full_name: Libuse Tauchmanova

given: Libuse

family: Pedroncelli

full_name: Alberto M Pedroncelli

given: Alberto M

family: Biller

full_name: Beverly M K Biller

given: Beverly M K

location_country:
Italy
Austria
United States
India
Netherlands
Spain
Germany
France
Bulgaria
Japan
Thailand
Argentina
Russian Federation
China
Turkey
Canada
United Kingdom
Korea, Republic of
Colombia

location_facility: Northwestern University SC - LCI699C2301

location_facility: Emory University School of Medicine G2304 - C2301

location_facility: Columbia University Medical Center New York Presbyterian SC - LCI699C2301

location_facility: The Johns Hopkins University School of Medicine Johns Hopkins University

location_facility: Massachusetts General Hospital Neuroendocrine Unit

location_facility: Mount Sinai School of Medicine SC - LCI699C2301

location_facility: Oregon Health and Science University SC LCI699C2301

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: University of Pennsylvania Clinical Studies Unit Unniv SC

location_facility: University of Colorado Hospital SC - LCI699C2301

title: Phase III, Multi-center, Double-blind, Randomized Withdrawal Study of LCI699 Following a 24 Week, Single-arm, Open-label Dose Titration and Treatment Period to Evaluate the Safety and Efficacy of LCI699 for the Treatment of Patients With Cushing's Disease

summary:
The study aimed to confirm long-term efficacy and safety of LCI699 for the treatment of patients with Cushing's disease. It was a pivotal trial which supported the registration of LCI699 for the treatment of patients with Cushing's disease in the US and the EU.

This is a phase lll, multi-center, double-blind, randomized withdrawal study of LCI699 following a 24 week, single-arm, open-label dose titration and treatment period which evaluated the safety and efficacy of LCI699 for the treatment of patients with Cushing's disease.


title: A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects With Severe Hemophilia A

summary: This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to rVIII-SingleChain in this study, as well as in previously untreated patients (PUPs) with no previous exposure to any FVIII product who achieve at least 50 EDs to rVIII-SingleChain in this study. A substudy (open to both PTPs and PUPs) will investigate the use of rVIII-SingleChain in surgery. A substudy (open to PUPs who develop an inhibitor to rVIII-SingleChain) will investigate the use of rVIII-SingleChain in immune tolerance induction (ITI) therapy.

lead_sponsor: CSL Behring

location_country:
Malaysia
Romania
Australia
Ukraine
France
Japan
Poland
Thailand
Canada
South Africa
Switzerland
Netherlands
Philippines
Hungary
Ireland
Portugal
United States
Germany
United Kingdom
Italy
Austria
Lebanon
Czechia
Georgia
Spain

location_facility:
Study Site 2500015
Study Site 5280007
Study Site 0400003
Study Site 6420037
Study Site 0360014
Study Site 2760066
Study Site 6160014
Study Site 6420030
Study Site 3920031
Study Site 3920029
Study Site 2030017
Study Site 0400001
Study Site 8400116
Study Site 8040005
Study Site 6160035
Study Site 7560010
Study Site 6160013
Study Site 7240021
Study Site 8400184
Study Site 2680001
Study Site 8400204
Study Site 8400041
Study Site 1240022
Study Site 4580001
Study Site 6080002
Study Site 8400154
Study Site 8260008
Study Site 2760034
Study Site 2500018
Study Site 3720002
Study Site 7640001
Study Site 2760087
Study Site 8400213
Study Site 7100001
Study Site 5280006
Study Site 6080001
Study Site 3800023
Study Site 7240008
Study Site 4220007
Study Site 2760091
Study Site 8040007
Study Site 7640003
Study Site 3920064
Study Site 6200001
Study Site 2500017
Study Site 7640002
Study Site 8400240
Study Site 5280008
Study Site 6160038
Study Site 7640005
Study Site 8400241
Study Site 0400002
Study Site 0360031
Study Site 7240007
Study Site 7240023
Study Site 3920033
Study Site 2500028
Study Site 3480007
Study Site 0360028
Study Site 2500002
Study Site 8400118
Study Site 7640004
Study Site 0400012
Study Site 3920025