title: A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

acronym: DUET-CD

summary: The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.

location_country:
Germany
Poland
Taiwan
New Zealand
Australia
Japan
Croatia
Czechia
Canada
France
Slovenia
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
China
Malaysia
Estonia
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Jordan
Bulgaria
Israel

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Hospital of the University of Occupational and Environmental Health

location_facility: Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH

location_facility: CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont

location_facility: Curiositas ad Sanum Studien und Beratungs GmBH

location_facility: GIRI Gastrointestinal Research Institute

location_facility: Medizinische Fakultät Mannheim der Universität Heidelberg

location_facility: Niigata University Medical & Dental Hospital

location_facility: Marshall Health Clinical Research Center

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

location_facility: Gastroenterologische Spezialpraxis - Berlin-Karlshorst

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Medizinisches Versorgungszentrum (MVZ) Dachau

location_facility: KL Ling Gastroenterology and Liver Clinic

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Tokitokai Tokito Clinic Coloproctology Center

location_facility: University Hospitals Case Medical Center

location_facility: Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio

location_facility: Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk

location_facility: University of Mississippi Medical Center

location_facility: Academisch Medisch Centrum Universiteit van Amsterdam

location_facility: Worthwhile Clinical Trials Lakeview Hospital

location_facility: Gastroenterology and Internal Medicine Research Institute (GIRI)

location_facility: Clinical Research Centre University of Cape Town

location_facility: Herlev Hospital, University of Copenhagen

location_facility: The second Xiangya Hospital of Central South University

location_facility: Japan Community Health Care Organization Osaka Hospital

location_facility: Osceola Mental Health D/B/A Park Place Behavioral Health Care

location_facility: The Hospital of Hyogo College of Medicine

location_facility: University of Pennsylvania - Perelman School of Medicine

location_facility: Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital

location_facility: Saitama Medical University Saitama Medical Center

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Guangzhou First Municipal People's Hospital

location_facility: Shiga University of Medical Science Hospital

location_facility: Gastroenterology Outpatient Clinic Prof. Ehehalt/Dr. Hemstäd

location_facility: Huron Gastroenterology Associates Center for Digestive Care

location_facility: Toronto Immune & Digestive Health Institute Inc.

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor

location_facility: Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. Szpital Specjalistyczny Barska

location_facility: Hopital Saint Louis - Service de Gastro-Entérologie, 1 Avenue Claude Vellefaux

location_facility: The Catholic University of Korea, Seoul St.Mary's Hospital

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Ruijin Hospital, Shanghai Jiao Tong University

location_facility: Hunter Holmes McGuire Veterans Affairs Medical Center

location_facility: University of Washington Digestive Disease Center

location_facility: Azienda Ospedaliero Universitaria di Cagliari - Policlinico Duilio Casula di Monserrato

location_facility: General Hospital of Athens 'Ippokrateion'

location_facility: National Center for Global Health and Medicine

location_facility: Centrum Zdrowia Matki, Dziecka i Młodzieży

location_facility: Sotiria General State Hospital of Chest Diseases

location_facility: A.O. Per L' Emergenza Cannizzaro - U.O. Chirurgia Generale

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Ospedale Specializzato in Gastroenterologia Saverio de Bellis

location_facility: Gastroenterology Clinic Of San Antonio P A

location_facility: McGill University - Health Centre - Montreal General Hospital

location_facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

location_facility: Gastroenterologische Praxis Balsiger und Seibold

location_facility: Semmelweis Egyetem I.Belgyogyaszati Klinika

location_facility: Gastroenterolgy Associates of Central GA

location_facility: Seoul National University Bundang Hospital

location_facility: National Hospital Organization Hirosaki General Medical Center

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

location_facility: Northshore Gastroenterology Research, LLC

location_facility: Hallym University Dongtan Sacred Heart Hospital

location_facility: Oslo University Hospital HF Ullevål sykehus

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E

location_facility: Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa Maria

location_facility: Centre hospitalier universitaire de St Etienne

location_facility: Nanfang Hospital of Southern Medical Hospital


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Boehringer Ingelheim

summary:
This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called Iclepertin improves learning and memory in people with schizophrenia.

Participants are put into two groups randomly, which means by chance. One group takes Iclepertin tablets and the other group takes placebo tablets. Placebo tablets look like Iclepertin tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia.

During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups.

Participants are in the study for about 8 months. During this time, they visit the study site about 15 times and get about 3 phone calls from the study team. The doctors also regularly check participants' health and take note of any unwanted effects.

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Hospital Provincial. Complejo Asistencial de Zamora

location_facility: University of Debrecen, Gyula Kenezi University Hospital

location_facility: National Hospital Organization Shimofusa Psychiatric Medical Center

location_facility: Benito Menni Complejo Asistencial en Salud Mental

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: ASCLEPES Research Centers, P.C. dba Alliance Research

location_facility: Clinica Privada de Salud Mental Santa Teresa de Avila

location_facility: Clínica Viver - Centro de Desospitalização Humana

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Psychiatria, Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach

location_facility: Fundación FunDaMos para la asistencia e investigación en psiquiatría

location_facility: Medical Corporation Yamadakai Yatsushiro Welfare Hospital

location_facility: Centro de Investigacion y Asistencia en Psiquiatria (CIAP)

location_facility: CENYDET-Centro Neurobiológico y de Estres Traumático (Biopsychomedical Research Group S.R.L.)

location_facility: Daegu Catholic University Medical Center

location_facility: Communal Non-Profit Enterprise "Regional Clinical Psychiatric Hospital" of Kirovohrad Regional Council

location_facility: Psychiatric Doctor's Office Ireneusz Kaczorowski

location_facility: Psychiatricka Ambulancia Psycholine s.r.o.

location_facility: Resolution Psychopharmacology Research Institute

location_facility: Provincial Hospital for Nervous and Mentally Ill in Swiecie

location_facility: Collaborative Neuroscience Research, LLC

location_facility: Special Hospital for Psychiatric Diseases Sveti Vračevi

location_facility: Okehazama Hospital Fujita Kokoro Care Center

location_facility: CEN (Centro Especializado Neurociencias)

location_facility: University Clinical Center of Kragujevac

location_facility: Osaka City Hospital Organization Osaka City General Hospital

status: Recruiting

title: A Phase III Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of Iclepertin Once Daily Over 26 Week Treatment Period in Patients With Schizophrenia (CONNEX-2)

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Anticipated

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

design_allocation: Randomized

study_completion_date_type: Anticipated

location_country:
Poland
Slovakia
Hungary
Argentina
Romania
Japan
Brazil
Netherlands
Singapore
United States
Korea, Republic of
Spain
Malaysia
Croatia
Chile
Ukraine
Serbia
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy in Newly Diagnosed Intermediate- and High-risk PAH Patients

acronym: HYPERION

summary: The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high risk of disease progression.

lead_sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Croatia
Czechia
Canada
Serbia
France
Colombia
Portugal
Denmark
Switzerland
United States
Belgium
Italy
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Israel

location_facility: Instituto Medico Rio Cuarto ( Site 1907)

location_facility: Aarhus Universitetshospital, Skejby ( Site 3801)

location_facility: Kaohsiung Veterans General Hospital ( Site 3702)

location_facility: Nazih Zuhdi Transplantation Institute ( Site 1084)

location_facility: Universitaetsklinik und Poliklinik Halle/Saale ( Site 1502)

location_facility: David Geffen School of Medicine at UCLA ( Site 1068)

location_facility: University of North Carolina at Chapel Hill ( Site 1042)

location_facility: Medizinische Hochschule Hannover ( Site 1505)

location_facility: Instituto De Enfermedades Respiratorias E Investigacion Medica ( Site 1910)

location_facility: Washington University School of Medicine ( Site 1022)

location_facility: Maastricht University Medical Center ( Site 2603)

location_facility: Onassis Cardiac Surgery Center ( Site 3602)

location_facility: Gachon University Gil Medical Center ( Site 3103)

location_facility: Medizinische Universitat Innsbruck ( Site 2004)

location_facility: DRK Kliniken Berlin Westend ( Site 1507)

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)

location_facility: Azienda Ospedaliera San Gerardo di Monza ( Site 2406)

location_facility: CHU de Grenoble - Hopital Michallon ( Site 1303)

location_facility: University of Kansas Medical Center ( Site 1020)

location_facility: University of Colorado Hospital ( Site 1013)

location_facility: Universitaetsklinik Regensburg ( Site 1503)

location_facility: AdventHealth Medical Group Advanced Lung Disease ( Site 1058)

location_facility: Norrlands Universitetssjukhus ( Site 3205)

location_facility: Royal Free London NHS Foundation Trust ( Site 1202)

location_facility: Seoul National University Hospital ( Site 3102)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 2002)

location_facility: The Cleveland Clinic Foundation Taussig Cancer Center ( Site 1065)

location_facility: Hopital de la Cote de Nacre - Caen ( Site 1325)

location_facility: Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)

location_facility: China Medical University Hospital ( Site 3701)

location_facility: Sir Mortimer B Davis Jewish General Hospital ( Site 2103)

location_facility: St Boniface General Hospital ( Site 2106)

location_facility: University of Cincinnati Health ( Site 1035)

location_facility: AHEPA University General Hospital of Thessaloniki ( Site 3601)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 1501)

location_facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)

location_facility: The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)

location_facility: Medical University of South Carolina ( Site 1003)

location_facility: Hospital Universitario 12 de Octubre ( Site 1603)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 3404)

location_facility: University of Iowa Hospital and Clinics ( Site 1050)

location_facility: Akademiska Sjukhuset [Uppsala, Sweden] ( Site 3204)

location_facility: University of Texas Southwestern Medical Center ( Site 1038)

location_facility: Hopitaux Universitaires de Strasbourg ( Site 1307)

location_facility: Lady Davis Carmel Medical Center ( Site 1705)

location_facility: Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1604)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1601)

location_facility: Institut Klinicke a Experimentalni Mediciny ( Site 2202)

location_facility: Hospital Universitario Austral ( Site 1901)

location_facility: Papworth Hospital NHS Foundation Trust ( Site 1208)

location_facility: University of Alberta Hospital ( Site 2101)

location_facility: Princess Alexandra Hospital ( Site 1108)

location_facility: Hospital Universitario de Toledo ( Site 1607)

location_facility: Hospital Universitario de Son Espases ( Site 1611)

location_facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608)

location_facility: Klinicki Bolnicki Centar Zagreb ( Site 3902)

location_facility: C.H.U. de Tours - Hopital Bretonneau ( Site 1310)

location_facility: Hospital Universitario La Paz ( Site 1610)

location_facility: Hospital Provincial del Centenario ( Site 1912)

location_facility: Sheffield Teaching Hospital NHS Foundation Trust ( Site 1207)

location_facility: Golden Jubilee National Hospital ( Site 1204)

location_facility: Oregon Health & Science University ( Site 1054)

location_facility: Severance Hospital Yonsei University Health System - PPDS ( Site 3101)

location_facility: Imperial College Healthcare NHS Trust ( Site 1203)

location_facility: Azienda Policlinico Umberto I ( Site 2402)

location_facility: Royal Prince Alfred Hospital ( Site 1106)

location_facility: Arizona Pulmonary Specialists ( Site 1010)

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre ( Site 1805)

location_facility: Ospedale S. Giuseppe Multimedica ( Site 2403)

location_facility: Vseobecna fakultni nemocnice v Praze ( Site 2201)

location_facility: Medizinische Universitat Wien ( Site 2001)

location_facility: University Clinical Center Nis ( Site 2904)

location_facility: Assuta Ashdod Medical Center ( Site 1710)

location_facility: Medizinische Universität Graz ( Site 2003)

location_facility: Instituto do Coracao - HCFMUSP ( Site 1803)

location_facility: Instituto de Investigaciones Clinicas Quilmes ( Site 1903)

location_facility: St. Joseph's Healthcare Hamilton ( Site 2105)

location_facility: Instituto Cardiovascular de Rosario ( Site 1906)

location_facility: National Cheng Kung University Hospital ( Site 3703)

location_facility: Hospital Provincial Dr. Jose M. Cullen ( Site 1902)

location_facility: Chonnam National University Hospital ( Site 3105)

location_facility: Hospital Universitari Vall de Hebron ( Site 1605)

location_facility: Centro Cardiovascular Colombiano Clínica Santa María Clínica Cardio VID ( Site 3402)

location_facility: Universitaetsklinikum Giessen und Marburg GmbH ( Site 1512)

location_facility: University of California Irvine ( Site 1086)

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802)

location_facility: Azienda Ospedaliera R. N. V. Monaldi ( Site 2407)

location_facility: Skanes Universitetssjukhus Lund ( Site 3203)

location_facility: Radboud University Nijmegen Medical Centre ( Site 2605)

location_facility: Jeffrey S.Sager MD Medical Corporation ( Site 1060)

location_facility: Universitatsklinikum Leipzig ( Site 1508)

location_facility: The Catholic University of Korea St. Mary s Hospital ( Site 3104)

location_facility: Fundacion Neumologica Colombiana ( Site 3403)

location_facility: C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)

location_facility: Attikon University General Hospital of Athens ( Site 3604)

location_facility: Waikato District Health Board ( Site 2702)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 1315)

location_facility: Evangelismos General Hospital of Athens ( Site 3605)

location_facility: University of California San Diego ( Site 1002)

location_facility: Centro Hospitalar E Universitário De Coimbra ( Site 3502)

location_facility: University of California Davis Medical Center ( Site 1064)

location_facility: Institute for pulmonary diseases of Vojvodina ( Site 2906)

location_facility: University Hospital Centre Split city ( Site 3901)

location_facility: Thoraxklinik-Heidelberg gGmbH ( Site 1509)

location_facility: University of New Mexico, Health Sciences Center ( Site 1048)

location_facility: Universitatsklinikum des Saarlandes ( Site 1513)


title: Phase III Study of Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)

summary: The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment in the metastatic setting.

status: Active, not recruiting

enrollment_type: Actual

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Daiichi Sankyo, Inc.

location_country:
Germany
Argentina
Japan
Brazil
Turkey
Canada
France
Hungary
Denmark
United States
India
Romania
Belgium
China
Peru
Philippines
Italy
United Kingdom
Sweden
Mexico
Korea, Republic of
Saudi Arabia
Spain
South Africa
Taiwan
Russian Federation
Israel


acronym: PADOVA

lead_sponsor: Hoffmann-La Roche

summary: This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.

sponsor_collaborators:
Hoffmann-La Roche
Prothena Biosciences Limited

location_facility: Henry Ford Hospital; Henry Ford Medical Center

location_facility: Hospital Virgen del Rocío; Servicio de Neurología

location_facility: Policlínica Guipuzkoa; Servicio de Neurología

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: NeuroKlinika Gabinet Lekarski Prof. Andrzej Bogucki

location_facility: Hôpital Michallon - Centre d'Investigation Clinique; Unité de Pharmacologie Clinique - Inserm

location_facility: Hospital Universitario Fundación Alcorcón; Servicio de Neurología

location_facility: Samodzielny Publiczny Szpital Kliniczny im. prof. Orlowskiego; Klinika Neurologii i Epileptologii

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Neurología

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia

location_facility: Azienda Ospedaliera S. Maria; SC Neurologia

location_facility: IRCCS San Raffaele Pisana; Clinical Trial Center

location_facility: HM Universitario Puerta del Sur CINAC (C.Integ.Neuroc);; Servicio de Psiquiatría

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: Servicio de Neurología Hospital Viamed Montecanal.

location_facility: CenExel Rocky Mountain Clinical Research, LLC

location_facility: Hospital Universitario Dr. Peset; Servicio de Neurologia

location_facility: Montreal Neurological Institute and Hospital

location_facility: Mazowiecki Szpital Bródnowski w Warszawie Sp. z o.o.; Klinika Neurologii

location_facility: IRCCS Ospedale San Raffaele; U.O. di Neurologia

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Klinik Ottakring; Neurologische Abteilung

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Neurologia

location_facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

location_facility: Hospital General Universitario de Elche; Servicio de Neurología

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Neurologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: Hôpital Henri Mondor; Centre Expert Parkinson

location_facility: Medizinische Universität Graz; Universitätsklinik für Neurologie

location_facility: Groupement Hospitalier Est - Hôpital Neurologique; Neurologie A (U502)

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

location_facility: IRCCS Istituto Neurologico Carlo Besta; UOC Neurologia 1

location_facility: Szpital Sw. Wojciecha; Oddzial Neurologiczny

location_facility: Southern Illinois University, School of Medicine

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: Hospital Universitario de la Princesa; Servicio de Neurologia

location_facility: Institute for Neurodegenerative Disorders

location_facility: CHU Rouen Charles Nicolle; Centre Expert Parkinson Hôpitaux de Rouen

location_facility: The Movement Disorder Clinic of Oklahoma

location_facility: Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

location_facility: AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica

location_facility: A.O.U. Policlinico "G.Rodolico - San Marco"; Clinica Neurologica

location_facility: Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona; Center for Neurodegenerative Disease

location_facility: Hospital Universitario de Burgos. Servicio de Neurología

location_facility: Hospital Universitari i Politecnic La Fe; Servicio de Neurología

location_facility: Policlinico Universitario Agostino Gemelli; UOC Neurologia

location_facility: Azienda Ospedaliera di Padova; Dipartimento di Neuroscienze

location_facility: Ninewells Hospital, Dundee- Scotland; Neurology

location_facility: Northwestern University Feinberg School Of Medicine

location_facility: Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie

location_facility: Baylor College of Medicine Medical Center

location_facility: Università degli studi della Campania Luigi Vanvitelli; Dip.Ass Int Med Int-I Clinica Neurologica

location_facility: Azienda Ospedaliera Spedali Civili; Scienze Neurologiche

location_facility: Hospital General De Catalunya; Servicio de Neurologia

location_facility: Ospedale Bellaria; Istituto delle Scienze Neurologiche

title: A Phase IIB, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Italy
Poland
United Kingdom
Austria
United States
Spain
Luxembourg
Canada
France


title: A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2)

summary: This study is a Phase 3 global, multicenter, placebo-controlled double-blind randomized study that will enroll participants with inoperable locally recurrent or metastatic SCAC not previously treated with systemic chemotherapy.

ReferenceType: derived

ReferenceCitation: Rao S, Jones M, Bowman J, Tian C, Spano JP. POD1UM-303/InterAACT 2: A phase III, global, randomized, double-blind study of retifanlimab or placebo plus carboplatin-paclitaxel in patients with locally advanced or metastatic squamous cell anal carcinoma. Front Oncol. 2022 Aug 24;12:935383. doi: 10.3389/fonc.2022.935383. eCollection 2022.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Germany
Italy
Norway
United Kingdom
Denmark
Australia
Japan
Sweden
Belgium
United States
Spain
Puerto Rico
France

location_facility: Institut de Cancerologie de L Ouest - Site Paul Papin

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: Stockholm South General Hospital Sodersjukhuset

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

location_facility: Texas Oncology-Wichita Falls Texoma Cancer Center

location_facility: University Di Cagliari-Presidio Policlinico Monserrato

location_facility: Panoncology Trials Pan American Center For Oncology Trials, Llc

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: I.R.C.C.S. Casa Sollievo Della Sofferenza

location_facility: Saitama Medical University International Medical Center

location_facility: The Royal Marsden Nhs Foundation Trust - Chelsea

location_facility: Center Hospital of the National Center For Global Health and Medicine

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: The Royal Marsden Nhs Foundation Trust - Sutton

location_facility: University Clinic Carl Gustav Carus Technical University Dresden

location_facility: Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Royal Cornwall Hospital Truro Sunrise Centre

location_facility: Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Baylor Scott and White Research Institute

location_facility: Azienda Ospedaliera Universitaria University Degli Studi Della Campania Luigi Vanvitelli


title: A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer

summary: This is a Phase 3, multi-center, randomized, open-label, controlled study designed to evaluate the safety and efficacy of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with one, and only one, NHT for their prostate cancer disease.

ReferenceCitation: Agarwal N, Azad A, Carles J, Chowdhury S, McGregor B, Merseburger AS, Oudard S, Saad F, Soares A, Benzaghou F, Kerloeguen Y, Kimura A, Mohamed N, Panneerselvam A, Wang F, Pal S. A phase III, randomized, open-label study (CONTACT-02) of cabozantinib plus atezolizumab versus second novel hormone therapy in patients with metastatic castration-resistant prostate cancer. Future Oncol. 2022 Mar;18(10):1185-1198. doi: 10.2217/fon-2021-1096. Epub 2022 Jan 17.

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

ipd_sharing: No

lead_sponsor: Exelixis

collaborators: Roche-Genentech Takeda

sponsor_collaborators: Exelixis Roche-Genentech Takeda

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Chile
Czechia
Canada
France
Portugal
Hungary
United States
Ukraine
Belgium
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Georgia
Russian Federation
Israel

location_facility: Odensklinikum Linz GmbH Elisabethinen #156


title: A Phase III, Multicentre, Prospective, Double Blind, Randomised, Placebo Controlled Study, Assessing the Efficacy and Safety of Dysport® Intramuscular Injections Used for the Treatment of Upper Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury

summary: The purpose of this research study is to assess the efficacy of Dysport compared to placebo in improving muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury.

status: Completed

study_completion_date_type: Actual

ReferenceCitation: Delafont B, Carroll K, Vilain C, Pham E. Investigation of mixed model repeated measures analyses and non-linear random coefficient models in the context of long-term efficacy data. Pharm Stat. 2018 Sep;17(5):515-526. doi: 10.1002/pst.1868. Epub 2018 May 20.

oa_host_type: closed

publisher_dissemination: Wiley

ReferenceCitation: O'Dell MW, Brashear A, Jech R, Lejeune T, Marque P, Bensmail D, Ayyoub Z, Simpson DM, Volteau M, Vilain C, Picaut P, Gracies JM. Dose-Dependent Effects of AbobotulinumtoxinA (Dysport) on Spasticity and Active Movements in Adults With Upper Limb Spasticity: Secondary Analysis of a Phase 3 Study. PM R. 2018 Jan;10(1):1-10. doi: 10.1016/j.pmrj.2017.06.008. Epub 2017 Jun 19.

evidence: open (via crossref license)

ReferenceCitation: Marciniak C, McAllister P, Walker H, Brashear A, Edgley S, Deltombe T, Khatkova S, Banach M, Gul F, Vilain C, Picaut P, Grandoulier AS, Gracies JM; International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group. Efficacy and Safety of AbobotulinumtoxinA (Dysport) for the Treatment of Hemiparesis in Adults With Upper Limb Spasticity Previously Treated With Botulinum Toxin: Subanalysis From a Phase 3 Randomized Controlled Trial. PM R. 2017 Dec;9(12):1181-1190. doi: 10.1016/j.pmrj.2017.06.007. Epub 2017 Jun 16.

oa_colors: green hybrid

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

ReferenceCitation: Gracies JM, Brashear A, Jech R, McAllister P, Banach M, Valkovic P, Walker H, Marciniak C, Deltombe T, Skoromets A, Khatkova S, Edgley S, Gul F, Catus F, De Fer BB, Vilain C, Picaut P; International AbobotulinumtoxinA Adult Upper Limb Spasticity Study Group. Safety and efficacy of abobotulinumtoxinA for hemiparesis in adults with upper limb spasticity after stroke or traumatic brain injury: a double-blind randomised controlled trial. Lancet Neurol. 2015 Oct;14(10):992-1001. doi: 10.1016/S1474-4422(15)00216-1. Epub 2015 Aug 26.

publisher_dissemination: Elsevier

ipd_sharing_description:
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

lead_sponsor: Ipsen

location_country:
Italy
Poland
Slovakia
Hungary
Belgium
United States
Czechia
Russian Federation
France

location_facility: Centre Hospitalier Albert Chenevier-Hopital Henri Mondor

location_facility: National Institut for Medical Rehabilitation

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Associated Neurologist of Southern CT, PT

location_facility: Parkinson's Disease & Movement Disorders Center of Boca Raton

location_facility: Université catholique de Louvain av Hippocrate 10

location_facility: Rancho Los Amigos National Rehabilitation Center

status_simplified: Completed


title: LY2216684 Compared to Placebo as Adjunctive Therapy to SSRI in the Prevention of Symptom Re-emergence in Major Depressive Disorder

summary:
The primary objective of this study was to assess the maintenance of efficacy of LY2216684 compared with placebo as adjunctive therapy to selective serotonin reuptake inhibitors (SSRIs) as measured by the time-to-symptom reemergence among participants with major depressive disorder (MDD) who met randomization criteria with adjunctive LY2216684 during the stabilization period.

This trial consists of two distinct periods: an open-label treatment period, which consists of two parts, 8 weeks acute open-label with movement to 12 weeks open-label stabilization if participants are in remission at end of 8 weeks (open-label for 20 weeks total) followed by a randomized, double-blind, placebo-controlled period for 24 weeks.

ReferenceCitation: Oakes TM, Dellva MA, Waterman K, Greenbaum M, Poppe C, Goldberger C, Ahl J, Perahia DG. Edivoxetine compared to placebo as adjunctive therapy to selective serotonin reuptake inhibitors in the prevention of symptom re-emergence in major depressive disorder. Curr Med Res Opin. 2015 Jun;31(6):1179-89. doi: 10.1185/03007995.2015.1037732. Epub 2015 May 6.

publisher_dissemination: Informa

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Italy
Slovakia
Argentina
Romania
Mexico
Belgium
United States
Korea, Republic of
Spain
Greece
Croatia
Turkey
Puerto Rico
Russian Federation
France

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


title: A Multicenter Open-label Extension Study To Assess Long-term Safety Of PF-00547659 In Subjects With Crohn's Disease OPERA II

acronym: OPERA II

summary: This study provides open-label drug to eligible patients who have completed a prior study of PF-00547659. The primary endpoint for this study is long-term safety.

ReferenceCitation: D'Haens GR, Reinisch W, Lee SD, Tarabar D, Louis E, Klopocka M, Klaus J, Schreiber S, Il Park D, Hebuterne X, Nagy P, Cataldi F, Martin SW, Nayak S, Banerjee A, Gorelick KJ, Sandborn WJ. Long-Term Safety and Efficacy of the Anti-Mucosal Addressin Cell Adhesion Molecule-1 Monoclonal Antibody Ontamalimab (SHP647) for the Treatment of Crohn's Disease: The OPERA II Study. Inflamm Bowel Dis. 2022 Jul 1;28(7):1034-1044. doi: 10.1093/ibd/izab215.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

version: submittedVersion

repositories_concat: PubMed Central;orbi.ulg.ac.be

publisher_dissemination: Oxford University Press

lead_sponsor: Shire

location_country:
Germany
Poland
Slovakia
Norway
Japan
Netherlands
Austria
Belgium
United States
Korea, Republic of
Spain
South Africa
Canada
Serbia
France

location_facility: Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum

location_facility: University of Miami Hospital and Clinic (IP Shipment Only)

location_facility: Iowa Endoscopy Center (Colonoscopy Only)

location_facility: Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research

location_facility: University of Miami Crohn's and Colitis Center

location_facility: Nassau Gastroenterology Associates Office Based Surgery

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: North Carolina Memorial Hospital Endoscopy Center

location_facility: Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.

location_facility: NZOZ Centrum Medyczne Szpital Sw. Rodziny

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

location_facility: Clinical Hospital Center Zemun, Clinical Department for Gastroenterology and Hepatology

location_facility: Nassau Gastroenterology Associates, P.C.

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centre Hospitalier Universitaire De Liege-Domaine Universitaire du Sart Tilman

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: Long Island Clinical Research Associates, LLP

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Washington University School of Medicine

location_facility: Center for Digestive and Liver Diseases, Inc.

location_facility: Toronto Digestive Disease Associates Inc.

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych W Warszawie

location_facility: Corporacio Sanitaria Parc Tauli de Sabadell

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: "Charite - Campus Berlin Mitte Medizinische Klinik

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH

location_facility: Barnes-Jewish Hospital - Investigational Drug Services

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: Clinical Hospital Centre Bezanijska Kosa


title: A Randomized, Double-Blind, Phase II, Efficacy and Safety Study of MDV3100 Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer

summary: The purpose of this study was to determine the efficacy and safety of oral enzalutamide compared to bicalutamide in castrate men with metastatic prostate cancer who have progressed while on Luteinizing Hormone Receptor Hormone (LHRH) agonist/antagonist or after receiving a bilateral orchiectomy.

ReferenceCitation: Heidenreich A, Chowdhury S, Klotz L, Siemens DR, Villers A, Ivanescu C, Holmstrom S, Baron B, Wang F, Lin P, Shore ND. Impact of Enzalutamide Compared with Bicalutamide on Quality of Life in Men with Metastatic Castration-resistant Prostate Cancer: Additional Analyses from the TERRAIN Randomised Clinical Trial. Eur Urol. 2017 Apr;71(4):534-542. doi: 10.1016/j.eururo.2016.07.027. Epub 2016 Aug 3.

ReferenceCitation: Shore ND, Chowdhury S, Villers A, Klotz L, Siemens DR, Phung D, van Os S, Hasabou N, Wang F, Bhattacharya S, Heidenreich A. Efficacy and safety of enzalutamide versus bicalutamide for patients with metastatic prostate cancer (TERRAIN): a randomised, double-blind, phase 2 study. Lancet Oncol. 2016 Feb;17(2):153-163. doi: 10.1016/S1470-2045(15)00518-5. Epub 2016 Jan 14.

ipd_sharing_description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

lead_sponsor: Astellas Pharma Inc

collaborators: Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

location_country:
Germany
United Kingdom
Denmark
Romania
Belgium
United States
Canada
France

location_facility:
Site GB3244
Site US44
Site CA170
Site BE3289
Site US3630
Site DE2995
Site GB1862
Site US2185
Site DK1857
Site CA166
Site US2977
Site DK1263
Site US1709
Site US1598
Site DK3356
Site RO3035
Site GB2702
Site DE2992
Site US1680
Site CA2984
Site GB2624
Site CA3084
Site US2968
Site US3078
Site DK3354
Site DE3286
Site US2027
Site GB3028
Site CA3104
Site BE1322
Site US2976
Site GB3027
Site DE2989
Site GB3245
Site US464
Site US2067
Site BE3288
Site FR3009
Site US2945
Site US1580
Site BE3018
Site US3026
Site DE2988
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Site FR3005
Site US2926
Site US1657
Site DE2990
Site US81
Site US1675
Site US2934
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Site US1838
Site US892
Site US2104
Site DE3287
Site FR442
Site RO3042
Site FR3007
Site US20
Site US2975
Site CA3242
Site CA2646
Site RO3039
Site BE3013
Site DE3270
Site GB3029
Site FR1091
Site GB3355
Site US1653
Site US1527
Site FR3003
Site DE2993
Site FR3002
Site US62
Site DE4000
Site GB3030
Site GB3166
Site US2014
Site BE3015
Site GB3290
Site DE2994
Site US2935
Site US2978
Site FR3000
Site US51
Site GB3163


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 vs Placebo as Part of a Treatment Regimen Including Peginterferon α-2a and Ribavirin in Hepatitis C, Genotype 1 Infected Subjects Who Relapsed After Previous Interferon-based Therapy

acronym: PROMISE

summary: The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed after previous interferon-based therapy. Patients will also receive peginterferon alfa-2a and ribavirin as part of their treatment.

ReferenceCitation: Lenz O, Verbinnen T, Fevery B, Tambuyzer L, Vijgen L, Peeters M, Buelens A, Ceulemans H, Beumont M, Picchio G, De Meyer S. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol. 2015 May;62(5):1008-14. doi: 10.1016/j.jhep.2014.11.032. Epub 2014 Nov 28.

ReferenceCitation: Forns X, Lawitz E, Zeuzem S, Gane E, Bronowicki JP, Andreone P, Horban A, Brown A, Peeters M, Lenz O, Ouwerkerk-Mahadevan S, Scott J, De La Rosa G, Kalmeijer R, Sinha R, Beumont-Mauviel M. Simeprevir with peginterferon and ribavirin leads to high rates of SVR in patients with HCV genotype 1 who relapsed after previous therapy: a phase 3 trial. Gastroenterology. 2014 Jun;146(7):1669-79.e3. doi: 10.1053/j.gastro.2014.02.051. Epub 2014 Mar 3.

lead_sponsor: Janssen R&D Ireland

location_country:
Germany
Poland
New Zealand
United Kingdom
Australia
Austria
Belgium
United States
Spain
Canada
Puerto Rico
Russian Federation
France


lead_sponsor: Gilead Sciences

summary:
The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon α-2a (Peg-IFN) combination therapy for 48 weeks versus standard of care TDF monotherapy or Peg-IFN monotherapy for 48 weeks in non-cirrhotic adults with chronic hepatitis B virus (HBV) as determined by loss of hepatitis B surface antigen (HBsAg).

The study will consist of 2 phases for participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups. Following an initial 48 weeks of treatment, participants in these groups will be monitored for 24 weeks for signs of worsening HBV, and those meeting TDF retreatment and flare management criteria will be eligible to receive TDF monotherapy during a retreatment phase, up to Week 120.

ReferenceType: result

ReferenceCitation: Marcellin P, Ahn SH, Ma X, Caruntu FA, Tak WY, Elkashab M, Chuang WL, Lim SG, Tabak F, Mehta R, Petersen J, Foster GR, Lou L, Martins EB, Dinh P, Lin L, Corsa A, Charuworn P, Subramanian GM, Reiser H, Reesink HW, Fung S, Strasser SI, Trinh H, Buti M, Gaeta GB, Hui AJ, Papatheodoridis G, Flisiak R, Chan HL; Study 149 Investigators. Combination of Tenofovir Disoproxil Fumarate and Peginterferon alpha-2a Increases Loss of Hepatitis B Surface Antigen in Patients With Chronic Hepatitis B. Gastroenterology. 2016 Jan;150(1):134-144.e10. doi: 10.1053/j.gastro.2015.09.043. Epub 2015 Oct 8.

ReferenceCitation: Chan HL, Elkhashab M, Trinh H, Tak WY, Ma X, Chuang WL, Kim YJ, Martins EB, Lin L, Dinh P, Charuworn P, Foster GR, Marcellin P. Association of baseline vitamin D levels with clinical parameters and treatment outcomes in chronic hepatitis B. J Hepatol. 2015 Nov;63(5):1086-92. doi: 10.1016/j.jhep.2015.06.025. Epub 2015 Jul 2.

location_facility: All India Institute of Medical Sciences, Ansari Nagar

location_facility: LSU Gastroenterology/Center for Digestive Diseases

location_facility: Institute of Post Graduate Medical Education And Research

location_facility: Fondazione IRCCS Ca Granda - Ospedale Maggiore Policlinico

location_facility: Seconda Universita degli Studi di Napoli

location_facility: Heritage Med Research Clinic, Univ of Calgary

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: University of Milan,Azienda Ospedaliera San Giovanni, Battista di Torino,Dipartimento di Gastroenterologia

location_facility: Samodzielny Publiczny Szpital Kliniczny 1,Klinika Chorób Zakaznych,ulica Staszica 16

location_facility: Liver Institute of Virginia, Bon Secours Health System

location_facility: Seth GS Medical College and KEM Hospital, Acharya Donde Marg,Parel

location_facility: Wojewódzki Szpital Obserwacyjno Zakazny im. Tadeusza Browicza

location_facility: Azienda Ospedaliero-Universitaria di Cagliari

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Cabinet Particular Policlinic Algomed SRL-Gastroenterologie

location_facility: Wojewodzki Szpital Specjalistyczny Kazimierza Dluskeigo w Bialymstoku

location_facility: Hippokration General Hospital of Thessaloniki

location_facility: Centre Hospitalier Regional et Universitaire de Strasbourg, Hopital Civil

location_facility: Fondazione PTV - Policlinico Tor Vergata

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

location_facility: Pusan National University Yangsan Hospital

location_facility: Gordon & Leslie Diamond Health Care Centre

location_facility: Medizinische Hochschule Hannover,Hastroenterologie und Hepatologie

location_facility: Weill Cornell Medical College of Cornell University

location_facility: University of Alberta, Zeidler Ledcore Centre

location_facility: Wojewódzki Specjalistyczny Szpital im. Dr Wladyslawa Bieganskiego w Lodzi

location_facility: Azienda Ospedaliera di Parma,Department of Infectious Diseases and hepatology

location_facility: Hospital General Universitari Vall d' Hebron

location_facility: Hôpital Beaujon, Service Hepatologie- Centre Pierre Abrami

location_facility: Digestive Disease Cntr, Konkuk Univ Hosp

location_facility: Institute of digestive and liver disease, Dispur Hospital Ganeshguri

location_facility: Mersin Üniversitesi Tip Fakültesi, Saglik Arastirma ve Uygulama Hastanesi

location_facility: Spitalul Clinic de Boli Infectioase si Tropicale "Dr. Victor Babes"

location_facility: Gaziantep Üniversitesi Tip Fakültesi, Sahinbey Arastirma ve Uygulama Hastanesi

location_facility: Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie,

location_facility: Yonsei Unversity Wonju College of Medicine Wonju Christian Hospital

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

location_facility: Dharamasi Hospital,Chandni Chowk, South Shivajinagar,

location_facility: University of Miami / Jackson Memorial Medical Center

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Department of Hepatology, Institute of Liver Diseases, HPB Surgery and Transplant, Global Hospital

location_facility: CHA Bundang Medical Center, CHA University

location_facility: SoonChunHyang University Hospital Cheonan

location_facility: The Ottawa Hospital,Division of Infectious Diseases

location_facility: Chang Gung Medical Foundation.LinKou Branch

location_facility: Advanced Liver Therapies at St. Luke's Episcopal Hospital

title: A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon α-2a (Pegasys®) Versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)

location_country:
Germany
Poland
Australia
Turkey
Canada
France
Portugal
Hong Kong
United States
India
Romania
Italy
United Kingdom
Singapore
Netherlands
Korea, Republic of
Spain
Greece
Taiwan


title: A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera)

acronym: OPERA

summary: Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.

ReferenceCitation: Saruta M, Park DI, Kim YH, Yang SK, Jang BI, Cheon JH, Im JP, Kanai T, Katsuno T, Ishiguro Y, Nagaoka M, Isogawa N, Li Y, Banerjee A, Ahmad A, Hassan-Zahraee M, Clare R, Gorelick KJ, Cataldi F, Watanabe M, Hibi T. Anti-MAdCAM-1 antibody (PF-00547659) for active refractory Crohn's disease in Japanese and Korean patients: the OPERA study. Intest Res. 2020 Jan;18(1):45-55. doi: 10.5217/ir.2019.00039. Epub 2020 Jan 30.

oa_colors: green diamond

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

publisher_dissemination: Korean Association for the Study of Intestinal Diseases

ReferenceCitation: Sandborn WJ, Lee SD, Tarabar D, Louis E, Klopocka M, Klaus J, Reinisch W, Hebuterne X, Park DI, Schreiber S, Nayak S, Ahmad A, Banerjee A, Brown LS, Cataldi F, Gorelick KJ, Cheng JB, Hassan-Zahraee M, Clare R, D'Haens GR. Phase II evaluation of anti-MAdCAM antibody PF-00547659 in the treatment of Crohn's disease: report of the OPERA study. Gut. 2018 Oct;67(10):1824-1835. doi: 10.1136/gutjnl-2016-313457. Epub 2017 Oct 5.

repository_institution: University of Liège - Open Repository and Bibliography

publisher_dissemination: British Medical Journal

ReferenceCitation: Hassan-Zahraee M, Banerjee A, Cheng JB, Zhang W, Ahmad A, Page K, von Schack D, Zhang B, Martin SW, Nayak S, Reddy P, Xi L, Neubert H, Fernandez Ocana M, Gorelick K, Clare R, Vincent M, Cataldi F, Hung K. Anti-MAdCAM Antibody Increases ss7+ T Cells and CCR9 Gene Expression in the Peripheral Blood of Patients With Crohn's Disease. J Crohns Colitis. 2018 Jan 5;12(1):77-86. doi: 10.1093/ecco-jcc/jjx121.

location_country:
Germany
Poland
Slovakia
Norway
Japan
Netherlands
Austria
Belgium
United States
Korea, Republic of
Spain
South Africa
Bulgaria
Canada
Serbia
France

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Shands Hospital at the University of Florida

location_facility: Iowa Endoscopy Center (Colonoscopy Only)

location_facility: Vancouver Coastal Health - Vancouver General Hospital

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych w Warszawie

location_facility: Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research

location_facility: Consulting Radiology (Xray testing only)

location_facility: Nassau Gastroenterology Associates Office Based Surgery

location_facility: Pasadena Gastroenterology Associates, P.A. dba Digestive Health Center

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: North Carolina Memorial Hospital Endoscopy Center

location_facility: The Offices of Dr. Vincent Armenio, M.D.

location_facility: Vancouver Coastal Health - Vancouver Hospital

location_facility: East side Endoscopy, LLC (for colonscopy testing only)

location_facility: Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.

location_facility: Premier Medical Group of the Hudson Valley

location_facility: Szpital Uniwersytecki nr 2 im dr. Jana Bizieta w Bydgoszczy Centrum Endoskopii Zabiegowej

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin III

location_facility: CHU Amiens Hopital Nord Service d'Hepato-Gastroenterologie

location_facility: Gastroenterologicke a hepatologicke centrum Nitra, KM Management spol. s r.o.

location_facility: Nassau Gastroenterology Associates, P.C.

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Connecticut Clinical Research Foundation

location_facility: Yonsei University College of Medicine, Severance Hospital

location_facility: Long Island Clinical Research Associates, LLP

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Inland Gastroenterology Medical Associates, Inc.

location_facility: Washington University School of Medicine

location_facility: Beth Israel Medical Center - Phillip Ambulatory Care Center

location_facility: Center for Digestive and Liver Diseases, Inc.

location_facility: Toronto Digestive Disease Associates Inc.

location_facility: Charite - Campus Berlin Mitte Medizinische Klinik

location_facility: Minneapolis Heart Institute, West Health Campus

location_facility: Clinical Center Nis Clinic for Gastroenterology and Hepatology

location_facility: Corporacio Sanitaria Parc Tauli de Sabadell

location_facility: MBAL Sofiamed OOD,Otdelenie po gastroenterologia

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH

location_facility: University Medical Center Groningen (UMCG)

location_facility: Universitaetsfrauenklinikum Schleswig-Holstein Medizinische Klinik I, Gastroenterologie/Hepatologie

location_facility: Barnes-Jewish Hospital - Investigational Drug Services

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: Gastroenterology Specialists of Arkansas

location_facility: Centre Hospitalier Universitaire de Liège - Labo Biologie Clinique

location_facility: Centrum Medyczne-Szpital Swietej Rodziny Sp. z o.o.

location_facility: Clinical Hospital Centre Bezanijska Kosa

location_facility: Heartland Medical Research (Administrative Only)


lead_sponsor: Novo Nordisk A/S

summary:
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this trial is to investigate the potential of liraglutide to induce and maintain weight loss in overweight or obese subjects with type 2 diabetes. Treatment will be added onto subject's pre-trial background diabetes treatment of either diet and exercise only or single compound oral antidiabetic drug (OAD) treatment (metformin, sulphonylurea [SU] or glitazone) or combination OAD treatment (metformin, sulphonylurea or glitazone). The duration of the trial will be 56 weeks followed by a 12 week observational follow-up period.

ReferenceType: background

ReferenceCitation: le Roux C, Aroda V, Hemmingsson J, Cancino AP, Christensen R, Pi-Sunyer X. Comparison of Efficacy and Safety of Liraglutide 3.0 mg in Individuals with BMI above and below 35 kg/m(2): A Post-hoc Analysis. Obes Facts. 2017;10(6):531-544. doi: 10.1159/000478099. Epub 2017 Nov 17.

publisher_dissemination: S. Karger AG

ReferenceCitation: Overgaard RV, Petri KC, Jacobsen LV, Jensen CB. Liraglutide 3.0 mg for Weight Management: A Population Pharmacokinetic Analysis. Clin Pharmacokinet. 2016 Nov;55(11):1413-1422. doi: 10.1007/s40262-016-0410-7.

publisher_dissemination: Springer-Nature

ReferenceCitation: O'Neil PM, Garvey WT, Gonzalez-Campoy JM, Mora P, Ortiz RV, Guerrero G, Claudius B, Pi-Sunyer X; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. EFFECTS OF LIRAGLUTIDE 3.0 MG ON WEIGHT AND RISK FACTORS IN HISPANIC VERSUS NON-HIPANIC POPULATIONS: SUBGROUP ANALYSIS FROM SCALE RANDOMIZED TRIALS. Endocr Pract. 2016 Nov;22(11):1277-1287. doi: 10.4158/EP151181.OR. Epub 2016 Aug 2.

ReferenceCitation: Fujioka K, O'Neil PM, Davies M, Greenway F, C W Lau D, Claudius B, Skjoth TV, Bjorn Jensen C, P H Wilding J. Early Weight Loss with Liraglutide 3.0 mg Predicts 1-Year Weight Loss and is Associated with Improvements in Clinical Markers. Obesity (Silver Spring). 2016 Nov;24(11):2278-2288. doi: 10.1002/oby.21629.

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

repository_institution: University of Illinois at Chicago - INDIGO

repository_institution: University of Leicester - Leicester Research Archive

ReferenceCitation: Bays H, Pi-Sunyer X, Hemmingsson JU, Claudius B, Jensen CB, Van Gaal L. Liraglutide 3.0 mg for weight management: weight-loss dependent and independent effects. Curr Med Res Opin. 2017 Feb;33(2):225-229. doi: 10.1080/03007995.2016.1251892. Epub 2016 Nov 6.

ReferenceCitation: Ard J, Cannon A, Lewis CE, Lofton H, Vang Skjoth T, Stevenin B, Pi-Sunyer X. Efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: subgroup analysis across the SCALE and phase II randomized trials. Diabetes Obes Metab. 2016 Apr;18(4):430-5. doi: 10.1111/dom.12632. Epub 2016 Feb 11.

ReferenceCitation: Wilding JP, Overgaard RV, Jacobsen LV, Jensen CB, le Roux CW. Exposure-response analyses of liraglutide 3.0 mg for weight management. Diabetes Obes Metab. 2016 May;18(5):491-9. doi: 10.1111/dom.12639. Epub 2016 Mar 1.

ReferenceCitation: Davies MJ, Bergenstal R, Bode B, Kushner RF, Lewin A, Skjoth TV, Andreasen AH, Jensen CB, DeFronzo RA; NN8022-1922 Study Group. Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes: The SCALE Diabetes Randomized Clinical Trial. JAMA. 2015 Aug 18;314(7):687-99. doi: 10.1001/jama.2015.9676. Erratum In: JAMA. 2016 Jan 5;315(1):90.

ReferenceCitation: McEvoy BW. Missing data in clinical trials for weight management. J Biopharm Stat. 2016;26(1):30-6. doi: 10.1080/10543406.2015.1094814.

ReferenceCitation: Steinberg WM, Rosenstock J, Wadden TA, Donsmark M, Jensen CB, DeVries JH. Impact of Liraglutide on Amylase, Lipase, and Acute Pancreatitis in Participants With Overweight/Obesity and Normoglycemia, Prediabetes, or Type 2 Diabetes: Secondary Analyses of Pooled Data From the SCALE Clinical Development Program. Diabetes Care. 2017 Jul;40(7):839-848. doi: 10.2337/dc16-2684. Epub 2017 May 4. Erratum In: Diabetes Care. 2018 Jul;41(7):1538.

ReferenceCitation: von Scholten BJ, Davies MJ, Persson F, Hansen TW, Madsbad S, Endahl L, Jepsen CH, Rossing P. Effect of weight reductions on estimated kidney function: Post-hoc analysis of two randomized trials. J Diabetes Complications. 2017 Jul;31(7):1164-1168. doi: 10.1016/j.jdiacomp.2017.04.003. Epub 2017 Apr 11.

ReferenceCitation: O'Neil PM, Aroda VR, Astrup A, Kushner R, Lau DCW, Wadden TA, Brett J, Cancino AP, Wilding JPH; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Neuropsychiatric safety with liraglutide 3.0 mg for weight management: Results from randomized controlled phase 2 and 3a trials. Diabetes Obes Metab. 2017 Nov;19(11):1529-1536. doi: 10.1111/dom.12963. Epub 2017 Jul 21.

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

ReferenceCitation: Davies MJ, Aronne LJ, Caterson ID, Thomsen AB, Jacobsen PB, Marso SP; Satiety and Clinical Adiposity - Liraglutide Evidence in individuals with and without diabetes (SCALE) study groups. Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials. Diabetes Obes Metab. 2018 Mar;20(3):734-739. doi: 10.1111/dom.13125. Epub 2017 Nov 1.

title: Effect of Liraglutide on Body Weight in Overweight or Obese Subjects With Type 2 Diabetes: A 56 Week Randomised, Double-blind, Placebo-controlled, Three Armed Parallel Group, Multi-centre, Multinational Trial With a 12 Week Observational Follow-up Period

location_country:
Germany
France
Italy
India
United Kingdom
Sweden
United States
Spain
South Africa
Turkey
Taiwan
Puerto Rico
Israel


title: An Open-label Trial With TMC278 25 mg q.d. in Combination With a Background Regimen Containing 2 N(t)RTI's in HIV-1 Infected Subjects Who Participated in TMC278 Clinical Trials and Were Still Benefitting From Treatment With TMC278

summary: The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.

location_country:
Germany
Argentina
Australia
Thailand
Chile
Canada
France
Denmark
United States
Romania
Belgium
China
Puerto Rico
United Kingdom
Netherlands
Austria
Spain
South Africa
Taiwan
Russian Federation
Sweden


title: A Multi-center, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of MP4OX Treatment, in Addition to Standard Treatment, in Severely Injured Trauma Patients With Lactic Acidosis Due to Hemorrhagic Shock

summary: MP4OX is a novel oxygen therapeutic agent being developed as an ischemic rescue therapy to enhance perfusion and oxygenation of tissues at risk during hemorrhagic shock. MP4OX is a pegylated hemoglobin-based colloid. Due to its molecular size and unique oxygen dissociation characteristics, MP4OX targets delivery of oxygen to ischemic tissues. This study will evaluate the safety and efficacy of MP4OX treatment in trauma patients suffering from lactic acidosis due to severe hemorrhagic shock. The study hypothesis is that MP4OX will reverse the lactic acidosis by enhancing perfusion and oxygenation of ischemic tissues and thereby prevent and reduce the duration of organ failure and improve outcome in these patients.

ReferenceCitation: Young MA, Lohman J, Malavalli A, Vandegriff KD, Winslow RM. Hemospan improves outcome in a model of perioperative hemodilution and blood loss in the rat: comparison with hydroxyethyl starch. J Cardiothorac Vasc Anesth. 2009 Jun;23(3):339-47. doi: 10.1053/j.jvca.2008.08.006. Epub 2008 Oct 22.

ReferenceCitation: Young MA, Riddez L, Kjellstrom BT, Winslow RM. Effect of maleimide-polyethylene glycol hemoglobin (MP4) on hemodynamics and acid-base status after uncontrolled hemorrhage in anesthetized swine: comparison with crystalloid and blood. J Trauma. 2007 Dec;63(6):1234-44. doi: 10.1097/TA.0b013e31815bd7b0.

ReferenceCitation: Young MA, Riddez L, Kjellstrom BT, Bursell J, Winslow F, Lohman J, Winslow RM. MalPEG-hemoglobin (MP4) improves hemodynamics, acid-base status, and survival after uncontrolled hemorrhage in anesthetized swine. Crit Care Med. 2005 Aug;33(8):1794-804. doi: 10.1097/01.ccm.0000172648.55309.13.

ReferenceCitation: Drobin D, Kjellstrom BT, Malm E, Malavalli A, Lohman J, Vandegriff KD, Young MA, Winslow RM. Hemodynamic response and oxygen transport in pigs resuscitated with maleimide-polyethylene glycol-modified hemoglobin (MP4). J Appl Physiol (1985). 2004 May;96(5):1843-53. doi: 10.1152/japplphysiol.00530.2003. Epub 2004 Jan 16.

ReferenceCitation: Vandegriff KD, Winslow RM. Hemospan: design principles for a new class of oxygen therapeutic. Artif Organs. 2009 Feb;33(2):133-8. doi: 10.1111/j.1525-1594.2008.00697.x.

ReferenceCitation: Vandegriff KD, Malavalli A, Mkrtchyan GM, Spann SN, Baker DA, Winslow RM. Sites of modification of hemospan, a poly(ethylene glycol)-modified human hemoglobin for use as an oxygen therapeutic. Bioconjug Chem. 2008 Nov 19;19(11):2163-70. doi: 10.1021/bc8002666.

ReferenceCitation: Svergun DI, Ekstrom F, Vandegriff KD, Malavalli A, Baker DA, Nilsson C, Winslow RM. Solution structure of poly(ethylene) glycol-conjugated hemoglobin revealed by small-angle X-ray scattering: implications for a new oxygen therapeutic. Biophys J. 2008 Jan 1;94(1):173-81. doi: 10.1529/biophysj.107.114314. Epub 2007 Sep 7.

ReferenceCitation: Winslow RM, Lohman J, Malavalli A, Vandegriff KD. Comparison of PEG-modified albumin and hemoglobin in extreme hemodilution in the rat. J Appl Physiol (1985). 2004 Oct;97(4):1527-34. doi: 10.1152/japplphysiol.00404.2004. Epub 2004 Jun 18.

ReferenceCitation: Tsai AG, Cabrales P, Manjula BN, Acharya SA, Winslow RM, Intaglietta M. Dissociation of local nitric oxide concentration and vasoconstriction in the presence of cell-free hemoglobin oxygen carriers. Blood. 2006 Nov 15;108(10):3603-10. doi: 10.1182/blood-2006-02-005272. Epub 2006 Jul 20.

ReferenceCitation: Tsai AG, Vandegriff KD, Intaglietta M, Winslow RM. Targeted O2 delivery by low-P50 hemoglobin: a new basis for O2 therapeutics. Am J Physiol Heart Circ Physiol. 2003 Oct;285(4):H1411-9. doi: 10.1152/ajpheart.00307.2003. Epub 2003 Jun 12.

ReferenceCitation: Olofsson CI, Gorecki AZ, Dirksen R, Kofranek I, Majewski JA, Mazurkiewicz T, Jahoda D, Fagrell B, Keipert PE, Hardiman YJ, Levy H; Study 6084 Clinical Investigators. Evaluation of MP4OX for prevention of perioperative hypotension in patients undergoing primary hip arthroplasty with spinal anesthesia: a randomized, double-blind, multicenter study. Anesthesiology. 2011 May;114(5):1048-63. doi: 10.1097/ALN.0b013e318215e198.

ReferenceCitation: van der Linden P, Gazdzik TS, Jahoda D, Heylen RJ, Skowronski JC, Pellar D, Kofranek I, Gorecki AZ, Fagrell B, Keipert PE, Hardiman YJ, Levy H; 6090 Study Investigators. A double-blind, randomized, multicenter study of MP4OX for treatment of perioperative hypotension in patients undergoing primary hip arthroplasty under spinal anesthesia. Anesth Analg. 2011 Apr;112(4):759-73. doi: 10.1213/ANE.0b013e31820c7b5f. Epub 2011 Feb 11.

lead_sponsor: Sangart

location_country:
Germany
Colombia
New Zealand
Israel
Norway
Singapore
Australia
Brazil
Switzerland
Austria
United Kingdom
Spain
South Africa
France

location_facility: Hospital Universitário - USP Ribeirão Preto

location_facility: Centre Hospitalier Universitaire Vaudois CHUV

location_facility: Faculdade de Medicina de S. J. Do Rio Preto

location_facility: Klinikum der Johann-Wolfgang-Goethe-Universität Frankfurt a.M.


title: A Phase III, Prospective, Multicentre, Open Label, Extension Study, to Assess the Long Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injection in the Treatment of Lower Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury

summary: The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

ReferenceCitation: Esquenazi A, Brashear A, Deltombe T, Rudzinska-Bar M, Krawczyk M, Skoromets A, O'Dell MW, Grandoulier AS, Vilain C, Picaut P, Gracies JM. The Effect of Repeated abobotulinumtoxinA (Dysport(R)) Injections on Walking Velocity in Persons with Spastic Hemiparesis Caused by Stroke or Traumatic Brain Injury. PM R. 2021 May;13(5):488-495. doi: 10.1002/pmrj.12459. Epub 2020 Sep 11.

oa_host_type: repository

unpaywall_oa_status: green

ReferenceCitation: Esquenazi A, Stoquart G, Hedera P, Jacinto LJ, Dimanico U, Constant-Boyer F, Brashear A, Grandoulier AS, Vilain C, Picaut P, Gracies JM. Efficacy and Safety of AbobotulinumtoxinA for the Treatment of Hemiparesis in Adults with Lower Limb Spasticity Previously Treated With Other Botulinum Toxins: A Secondary Analysis of a Randomized Controlled Trial. PM R. 2020 Sep;12(9):853-860. doi: 10.1002/pmrj.12348. Epub 2020 Mar 27.

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

ReferenceCitation: McAllister PJ, Khatkova SE, Faux SG, Picaut P, Raymond R, Gracies JM. Effects on walking of simultaneous upper/lower limb abobotulinumtoxina injections in patients with stroke or brain injury with spastic hemiparesis. J Rehabil Med. 2019 Oct 29;51(10):813-816. doi: 10.2340/16501977-2604.

publisher_dissemination: Medical Journals Sweden AB

ReferenceCitation: Gracies JM, Esquenazi A, Brashear A, Banach M, Kocer S, Jech R, Khatkova S, Benetin J, Vecchio M, McAllister P, Ilkowski J, Ochudlo S, Catus F, Grandoulier AS, Vilain C, Picaut P; International AbobotulinumtoxinA Adult Lower Limb Spasticity Study Group. Efficacy and safety of abobotulinumtoxinA in spastic lower limb: Randomized trial and extension. Neurology. 2017 Nov 28;89(22):2245-2253. doi: 10.1212/WNL.0000000000004687. Epub 2017 Nov 1.

repositories_concat: PubMed Central;ruj.uj.edu.pl

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

publisher_dissemination: Wolters Kluwer Health

location_country:
Italy
Poland
Portugal
Slovakia
Hungary
Australia
Belgium
United States
Czechia
Russian Federation
France

location_facility: The University of Texas Southwestern Medical Center at Dalla

location_facility: Associated Neurologist of Southern CT, PC

location_facility: University of North Texas HSC at Ben Hogan Center

location_facility: Azienda Ospedaliero Universitaria "Policlinico Vittorio Emanuele"

location_facility: Wake Forest University Baptist Medical Center

location_facility: Centre Hospitalier Albert Chenevier-Hopital Henri Mondor

location_facility: Krakowska Akademia Neurologii Sp. z o.o.

location_facility: Scientific Research Institute of Neurology

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: University of North Carolina - Chapel Hill

location_facility: National Institute for Medical Rehabilitation

location_facility: Université catholique de Louvain av Hippocrate 10

intervention_type: Biological


title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer

summary:
This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo.

Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1 ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day; n=800) or Treatment Group B (placebo; n=400).

ReferenceCitation: Armstrong AJ, Anand A, Edenbrandt L, Bondesson E, Bjartell A, Widmark A, Sternberg CN, Pili R, Tuvesson H, Nordle O, Carducci MA, Morris MJ. Phase 3 Assessment of the Automated Bone Scan Index as a Prognostic Imaging Biomarker of Overall Survival in Men With Metastatic Castration-Resistant Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):944-951. doi: 10.1001/jamaoncol.2018.1093.

oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

ReferenceCitation: Sternberg C, Armstrong A, Pili R, Ng S, Huddart R, Agarwal N, Khvorostenko D, Lyulko O, Brize A, Vogelzang N, Delva R, Harza M, Thanos A, James N, Werbrouck P, Bogemann M, Hutson T, Milecki P, Chowdhury S, Gallardo E, Schwartsmann G, Pouget JC, Baton F, Nederman T, Tuvesson H, Carducci M. Randomized, Double-Blind, Placebo-Controlled Phase III Study of Tasquinimod in Men With Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2016 Aug 1;34(22):2636-43. doi: 10.1200/JCO.2016.66.9697. Epub 2016 Jun 13.

repository_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

repository_institution: Indiana University - IUScholarWorks

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Active Biotech AB

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Turkey
Chile
Canada
France
Czech Republic
Lithuania
Colombia
Slovakia
United States
Latvia
Ukraine
India
Romania
Lebanon
Belgium
China
Peru
Estonia
Italy
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Panama
Taiwan
Bulgaria
Russian Federation
Israel


title: AN OPEN-LABEL, RANDOMIZED, PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN ADMINISTERED IN COMBINATION WITH RITUXIMAB COMPARED TO DEFINED INVESTIGATOR'S CHOICE THERAPY IN SUBJECTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE AGGRESSIVE NON-HODGKIN LYMPHOMA WHO ARE NOT CANDIDATES FOR INTENSIVE HIGH-DOSE CHEMOTHERAPY

summary: The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator's choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival.

status: Terminated

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

lead_sponsor: Pfizer

sponsor_collaborators:
Pfizer
UCB Pharma

location_country:
Germany
Ireland
Poland
Japan
Thailand
Croatia
Czechia
Canada
France
Lithuania
Slovakia
Hungary
United States
Ukraine
India
Belgium
Puerto Rico
United Kingdom
Singapore
Mexico
Spain
Taiwan
Bulgaria
Russian Federation
Sweden

location_facility: Shands Hospital at the University of Florida

location_facility: Pharmacy Nottingham University Hospital - City Hospital Campus

location_facility: Hospital Espanol Auxilio Mutuo de Puerto Rico Inc

location_facility: Chang Gung Medical Foundation - Linkou Branch

location_facility: Barts Cancer Centre Dept Haemato-oncology St. Bartholomew's Hospital Barts Health NHS Trust

location_facility: Mount Sinai Comprehensive Cancer Center at Aventura

location_facility: Sahyadri Clinical Research and Development Center

location_facility: University of Kentucky A.B. Chandler Medical Center

location_facility: Department of Clinical Biochemistry Newcastle upon Tyne Hospitals

location_facility: 21st Century Oncology of Jacksonville, Inc.

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz /

location_facility: Department of Medical Oncology St. Bartholomew's Hospital

location_facility: University of Kentucky Markey Cancer Center

location_facility: Spetsializirana Bolnitsa za Aktivno Lechenie na Hematologichni Zabolyavania, CTH Sofia

location_facility: Local Laboratory Nottingham University Hospital - City Hospital Campus

location_facility: Regional Treatment and Diagnostic Hematology Center Communal Establishment

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Barbara Ann Karmanos Cancer Institute at farmington Hills

location_facility: Moscow State Healthcare Institution City clinical hospital S.P. Botkin

location_facility: Southeast Nebraska Hematology & Oncology Consultants, P.C. d/b/a Southeast Nebraska Cancer Center

location_facility: Shands Cancer Hospital at the University of Florida

location_facility: Institute of Pediatric Hematology and Transplantology R.M.Gorbacheva

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: University Hospital Dubrava Department of Internal Medicine Division of Hematology

location_facility: Disney Family Cancer Center at Providence St Joseph Medical Center

location_facility: Baylor: Charles A. Sammons Cancer Center

location_facility: Peggy and Charles Stephenson Cancer Center (chemo & infusion)

location_facility: OU Medical Center Presbyterian Professional Building

location_facility: Somongy Megyei Kaposi Mor Okato Korhaz/ Belgyogyaszati osztaly

location_facility: Department of Oncology and Medical Radiology of State Institution

location_facility: 21st Century Oncology of Jacksonville, LLC

location_facility: Chemotherapy Preparative Unit St. Bartholomew's Hospital

location_facility: National Taiwan University Hospital, Department of Internal Medicine

location_facility: UF Health Davis Cancer Pavillion and Shands Med Plaza

location_facility: The Christie NHS Foundation Trust - Christie Hospital

location_facility: Federal State Budgetary Institution Hematology Scientific Centre of Ministry of

location_facility: Cliniques universitaires UCL de Mont-Godinne,

location_facility: Washington University School of Medicine

location_facility: Peggy and Charles Stephenson Cancer Center (clinic location)

location_facility: Hematology Division Department of Medicine Faculty of Medicine Siriraj Hospital Mahidol University

location_facility: Davis Cancer Pavilion and Shands Medical Plaza

location_facility: Stony Brook University Medical Center, The Cancer Center

location_facility: Pathology Department Nottingham University Hospital - City Hospital Campus

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: SI"Research Center for Radiation Medicine of NAMS of Ukraine"

location_facility: SBAL na Hematologichnichni Zabolyavania,CTH Sofia

location_facility: UMBAL Sveti Georgi, Klinika po hematologia

location_facility: Department of Clinical Pathology Newcastle upon Tyne Hospitals NHS Foundation Trust Royal Victoria I

location_facility: Hematology-Oncology Medical Group of Fresno Inc

location_facility: Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services

location_facility: University of Kansas Cancer Center and Medical Pavilion

location_facility: OEC Record Management Company Pvt. Ltd.,

location_facility: Centre Hospitalier Universitaire de Sherbrooke (CHUS), Hopital Fleurimont

location_facility: Cancer Institute Hospital, Japanese Foundation For Cancer Research

location_facility: Klaipeda Seamen's Hospital, Public Institution, department of Oncology

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej AVI Diagnostyka Obrazowa

location_facility: Instituto Biomédico de Investigación A.C.

status_simplified: Unknown


title: A Phase III Randomized, Open-label Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma

summary: BRF113683 is a Phase III, randomized, open-label study comparing the efficacy, safety, and tolerability of GSK2118436 to dacarbazine (DTIC), in subjects with BRAF mutant advanced (Stage III) or metastatic (Stage IV) melanoma. Subjects will be randomized to receive 150 mg of GSK2118436 twice daily or 1000 mg/m2 DTIC every 3 weeks and continue on treatment until disease progression, death, or unacceptable adverse event. Subjects who progress on DTIC will be allowed to crossover to an optional extension arm of the study to receive GSK2118436.

ReferenceCitation: Hauschild A, Grob JJ, Demidov LV, Jouary T, Gutzmer R, Millward M, Rutkowski P, Blank CU, Miller WH Jr, Kaempgen E, Martin-Algarra S, Karaszewska B, Mauch C, Chiarion-Sileni V, Martin AM, Swann S, Haney P, Mirakhur B, Guckert ME, Goodman V, Chapman PB. Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2012 Jul 28;380(9839):358-65. doi: 10.1016/S0140-6736(12)60868-X. Epub 2012 Jun 25.

ReferenceCitation: Hauschild A, Ascierto PA, Schadendorf D, Grob JJ, Ribas A, Kiecker F, Dutriaux C, Demidov LV, Lebbe C, Rutkowski P, Blank CU, Gutzmer R, Millward M, Kefford R, Haas T, D'Amelio A Jr, Gasal E, Mookerjee B, Chapman PB. Long-term outcomes in patients with BRAF V600-mutant metastatic melanoma receiving dabrafenib monotherapy: Analysis from phase 2 and 3 clinical trials. Eur J Cancer. 2020 Jan;125:114-120. doi: 10.1016/j.ejca.2019.10.033.

version: acceptedVersion

repository_institution: UWA - UWA Profiles and Research Repository

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)
escholarship.org

repositories_institution: California Digital Library - eScholarship

ReferenceCitation: Santiago-Walker A, Gagnon R, Mazumdar J, Casey M, Long GV, Schadendorf D, Flaherty K, Kefford R, Hauschild A, Hwu P, Haney P, O'Hagan A, Carver J, Goodman V, Legos J, Martin AM. Correlation of BRAF Mutation Status in Circulating-Free DNA and Tumor and Association with Clinical Outcome across Four BRAFi and MEKi Clinical Trials. Clin Cancer Res. 2016 Feb 1;22(3):567-74. doi: 10.1158/1078-0432.CCR-15-0321. Epub 2015 Oct 7.

evidence: oa repository (via page says license)

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Latimer NR, Abrams KR, Amonkar MM, Stapelkamp C, Swann RS. Adjusting for the Confounding Effects of Treatment Switching-The BREAK-3 Trial: Dabrafenib Versus Dacarbazine. Oncologist. 2015 Jul;20(7):798-805. doi: 10.1634/theoncologist.2014-0429. Epub 2015 Jun 3.

evidence: open (via free article)

ReferenceCitation: Grob JJ, Amonkar MM, Martin-Algarra S, Demidov LV, Goodman V, Grotzinger K, Haney P, Kampgen E, Karaszewska B, Mauch C, Miller WH Jr, Millward M, Mirakhur B, Rutkowski P, Chiarion-Sileni V, Swann S, Hauschild A. Patient perception of the benefit of a BRAF inhibitor in metastatic melanoma: quality-of-life analyses of the BREAK-3 study comparing dabrafenib with dacarbazine. Ann Oncol. 2014 Jul;25(7):1428-1436. doi: 10.1093/annonc/mdu154. Epub 2014 Apr 25.

license: publisher-specific-oa

license_normalized: publisher-specific

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg (KOBV), on behalf of the Universitätsbibliothek Erlangen-Nürnberg - OPUS FAU - Online-Publikationssystem der Friedrich-Alexander-Universität Erlangen-Nürnberg

ReferenceCitation: Ouellet D, Gibiansky E, Leonowens C, O'Hagan A, Haney P, Switzky J, Goodman VL. Population pharmacokinetics of dabrafenib, a BRAF inhibitor: effect of dose, time, covariates, and relationship with its metabolites. J Clin Pharmacol. 2014 Jun;54(6):696-706. doi: 10.1002/jcph.263. Epub 2014 Jan 17.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Ireland
Italy
Poland
Hungary
Australia
Netherlands
United States
Spain
Canada
Russian Federation
France


title: A Ph II/III Seamless, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Reduction in Signs and Symptoms and Inhibition of Structural Damage During Treatment With Tocilizumab Versus Placebo in Patients With Ankylosing Spondylitis Who Have Failed Non-steroidal Anti-inflammatory Drugs and Are naïve to TNF Antagonist Therapy NSAIDs

summary: This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with ankylosing spondylitis (AS) who have failed treatment with non-steroidal anti-inflammatory drugs and are naïve to tumor necrsos factor (TNF) antagonist therapy. In Part 1 of the study, patients will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) or placebo every 4 weeks for 12 weeks. In Part 2, patients will be randomized to receive RoActemra at either 8 mg/kg or 4 mg/kg IV or placebo every 4 weeks for 24 weeks. The double-blind treatment period will be followed by open-label treatment with RoActemra/Actemra 8 mg/kg iv every 4 weeks until Week 208 for all patients. Anticipated time on study treatment is 208 weeks.

ReferenceCitation: Sieper J, Porter-Brown B, Thompson L, Harari O, Dougados M. Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials. Ann Rheum Dis. 2014 Jan;73(1):95-100. doi: 10.1136/annrheumdis-2013-203559. Epub 2013 Jun 13.

location_country:
France
Germany
Italy
Lithuania
India
Poland
Slovakia
United Kingdom
Australia
Brazil
Belgium
United States
Spain
South Africa
Bulgaria
Canada
Russian Federation
Czech Republic


title: Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety & Tolerability of Two Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered up to Twenty-eight Weeks in Patients With Moderate to Severe Chronic Plaque Psoriasis

summary: This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in patients with moderate-to-severe chronic plaque psoriasis.

ReferenceCitation: Vaclavkova A, Chimenti S, Arenberger P, Hollo P, Sator PG, Burcklen M, Stefani M, D'Ambrosio D. Oral ponesimod in patients with chronic plaque psoriasis: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet. 2014 Dec 6;384(9959):2036-45. doi: 10.1016/S0140-6736(14)60803-5. Epub 2014 Aug 10.

lead_sponsor: Actelion

location_country:
Italy
Lithuania
Slovakia
Hungary
United Kingdom
Denmark
Romania
Sweden
Switzerland
Austria
Belgium
Spain
Czechia
Bulgaria
Ukraine
Russian Federation
France

location_facility:
Clinical Investigative Site 1703
Clinical Investigative Site 2309
Clinical Investigative Site 3001
Clinical Investigative Site 2608
Clinical Investigative Site 3512
Clinical Investigative Site 1001
Clinical Investigative Site 1402
Clinical Investigative Site 1006
Clinical Investigative Site 2003
Clinical Investigative Site 1707
Clinical Investigative Site 2606
Clinical Investigative Site 3410
Clinical Investigative Site 1704
Clinical Investigative Site 1406
Clinical Investigative Site 2310
Clinical Investigative Site 1002
Clinical Investigative Site 2317
Clinical Investigative Site 2307
Clinical Investigative Site 3514
Clinical Investigative Site 3306
Clinical Investigative Site 1203
Clinical Investigative Site 2602
Clinical Investigative Site 2607
Clinical Investigative Site 1102
Clinical Investigative Site 1007
Clinical Investigative Site 1201
Clinical Investigative Site 1204
Clinical Investigative Site 1701
Clinical Investigative Site 1401
Clinical Investigative Site 1705
Clinical Investigative Site 1103
Clinical Investigative Site 1504
Clinical Investigative Site 2701
Clinical Investigative Site 1205
Clinical Investigative Site 2002
Clinical Investigative Site 2708
Clinical Investigative Site 2907
Clinical Investigative Site 2902
Clinical Investigative Site 2705
Clinical Investigative Site 3006
Clinical Investigative Site 1202
Clinical Investigative Site 3103
Clinical Investigative Site 1101
Clinical Investigative Site 2316
Clinical Investigative Site 1405
Clinical Investigative Site 1710
Clinical Investigative Site 2005
Clinical Investigative Site 2601
Clinical Investigative Site 2004
Clinical Investigative Site 2603
Clinical Investigative Site 3801
Clinical Investigative Site 2704
Clinical Investigative Site 2901
Clinical Investigative Site 1502
Clinical Investigative Site 3101
Clinical Investigative Site 2001
Clinical Investigative Site 2303
Clinical Investigative Site 2904
Clinical Investigative Site 2006
Clinical Investigative Site 2315
Clinical Investigative Site 3304
Clinical Investigative Site 1004
Clinical Investigative Site 1206
Clinical Investigative Site 1702
Clinical Investigative Site 2304
Clinical Investigative Site 2605
Clinical Investigative Site 2604


lead_sponsor: Alexion Pharmaceuticals, Inc.

summary: The record Primary purpose is to assess the efficacy of eculizumab in adult patients with Atypical Hemolytic- Uremic Syndrome (aHUS) to control Thrombotic Microangiopathy (TMA) as characterized by thrombocytopenia, hemolysis and renal impairment.

ReferenceCitation: Pugh D, O'Sullivan ED, Duthie FA, Masson P, Kavanagh D. Interventions for atypical haemolytic uraemic syndrome. Cochrane Database Syst Rev. 2021 Mar 23;3(3):CD012862. doi: 10.1002/14651858.CD012862.pub2.

ReferenceCitation: Cofiell R, Kukreja A, Bedard K, Yan Y, Mickle AP, Ogawa M, Bedrosian CL, Faas SJ. Eculizumab reduces complement activation, inflammation, endothelial damage, thrombosis, and renal injury markers in aHUS. Blood. 2015 May 21;125(21):3253-62. doi: 10.1182/blood-2014-09-600411. Epub 2015 Apr 1.

publisher_dissemination: American Society of Hematology

title: An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome

location_country:
Germany
Italy
United Kingdom
Belgium
United States
Spain
France


title: A Randomized, Double-blind, Parallel Group Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Active Rheumatoid Arthritis

summary: This randomized, double-blind, parallel group study compares the efficacy and safety of subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with moderate to severe active rheumatoid arthritis. Participants were randomized to receive either tocilizumab 162 mg sc weekly plus iv placebo every 4 weeks, or tocilizumab 8 mg/kg iv every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week 24. The double-blind period was followed by a 72-week open-label treatment with some switching of sc and iv administration. No placebo was administered in the open-label phase. Participants continued on their stable dose of disease-modifying antirheumatic drugs (DMARDs) throughout the study. Anticipated time on study treatment was 2 years.

ReferenceCitation: Burmester GR, Rubbert-Roth A, Cantagrel A, Hall S, Leszczynski P, Feldman D, Rangaraj MJ, Roane G, Ludivico C, Bao M, Rowell L, Davies C, Mysler EF. Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA). Ann Rheum Dis. 2016 Jan;75(1):68-74. doi: 10.1136/annrheumdis-2015-207281. Epub 2015 Jun 8.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Thailand
Canada
France
Lithuania
Colombia
Hong Kong
United States
Romania
Peru
Puerto Rico
Philippines
Italy
Guatemala
United Kingdom
Singapore
Mexico
Spain
South Africa
Bulgaria
Russian Federation


title: TRUSTS: A Phase IIB/III Multicenter Study Comparing the Efficacy of TRabectedin Administered as a 3-Hour or 24-Hour Infusion to Doxorubicin in Patients With Advanced or Metastatic Untreated Soft Tissue Sarcoma

summary:
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether trabectedin is more effective than doxorubicin hydrochloride in treating patients with advanced or metastatic soft tissue sarcoma.

PURPOSE: This randomized phase II/III trial is studying the safety of trabectedin compared with doxorubicin hydrochloride and to see how well they work in treating patients with advanced or metastatic soft tissue sarcoma.

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

collaborators: Sarcoma Alliance for Research through Collaboration

location_country:
Germany
Poland
Slovakia
Hungary
United Kingdom
Denmark
Netherlands
Austria
Belgium
Switzerland
United States
Spain
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Nhs Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre

location_facility: ASSISTANCE PUBLIQUE - HôPITAUX DE MARSEILLE - HôPITAL DE LA TIMONE

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia

location_facility: Nottingham University Hospitals Nhs Trust - City Hospital Campus

location_facility: Holden Comprehensive Cancer Center at University of Iowa

location_facility: Erasmus Mc - Daniel Den Hoed Cancer Center

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Institut de Cancerologie de L'Ouest (Ico) - Centre Rene Gauducheau

location_facility: HôPITAUX UNIVERSITAIRES BORDET-ERASME - INSTITUT JULES BORDET

location_facility: Klinikum Grosshadern Ludwig-Maximilians Univ. Muenchen

location_facility: Radboud University Nijmegen Medical Centre


title: A Phase-3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Compare Efficacy and Safety of Pomalidomide in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis and Red Blood Cell-Transfusion-Dependence

acronym: RESUME

summary: The objective of this study is to determine whether pomalidomide is safe and effective in reversing red blood cell (RBC)-transfusion-dependence in persons with myeloproliferative neoplasm (MPN)-associated myelofibrosis (global study) and in reversing anemia in Chinese with MPN-associated myelofibrosis and severe anemia not receiving RBC-transfusions (China extension study only)

ReferenceCitation: Tefferi A, Al-Ali HK, Barosi G, Devos T, Gisslinger H, Jiang Q, Kiladjian JJ, Mesa R, Passamonti F, McMullin MF, Ribrag V, Schiller G, Vannucchi AM, Zhou D, Reiser D, Zhong J, Gale RP. A randomized study of pomalidomide vs placebo in persons with myeloproliferative neoplasm-associated myelofibrosis and RBC-transfusion dependence. Leukemia. 2017 Apr;31(4):896-902. doi: 10.1038/leu.2016.300. Epub 2016 Oct 24. Erratum In: Leukemia. 2017 May;31(5):1252.

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

repository_institution: Queen's University Belfast - Research Portal

ReferenceCitation: Begna KH, Pardanani A, Mesa R, Litzow MR, Hogan WJ, Hanson CA, Tefferi A. Long-term outcome of pomalidomide therapy in myelofibrosis. Am J Hematol. 2012 Jan;87(1):66-8. doi: 10.1002/ajh.22233. Epub 2011 Nov 12.

lead_sponsor: Celgene

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Japan
Netherlands
Austria
Belgium
Sweden
United States
China
Spain
Canada
Russian Federation
France

location_facility: Universitaire Ziekenhuis Leuven Gathuisberg

location_facility: Azienda Ospedaliera Universitaria Federico II di Napoli

location_facility: Weill Medical College of Cornell University

location_facility: University of Florida Shands Cancer Center

location_facility: Mount Sinai School of Medicine Brookdale University Hospital

location_facility: Federal State Institution "Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies named after V.A. Almazov"

location_facility: Federal State Institution Russian Scientific-research Institute of Hematology and Transfusiology of Federal Medical-Biological Agency of Russia

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Blood Disease Hospital Chinese Academy of Medical Sciences

location_facility: Wojewodzki Szpital Specjalistyczny im. F.Chopina

location_facility: IRCCS Fondazione Policlinico San Matteo, Universita di Pavia, Centro per lo Studio della Mielofibrosi

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 PAM

location_facility: Ospedale di Circolo e Fondazione Macchi Varese

location_facility: Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

location_facility: IRCCS Fondazione Policlinico San Matteo, Universita di Pavia, Ematologia

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Hopitaux Universitaires de Strasbourg, CHU Haute-Pierre

location_facility: Hospital Universitario Puerta De Hierro Majadahonda

location_facility: Centre Hospitalier de L'Universite de Montreal