title: A Phase 3, 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study With Open-Label Extension of BLU-5937 in Adult Participants With Refractory Chronic Cough, Including Unexplained Chronic Cough

summary: This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 3 study of BLU-5937 in participants with Refractory Chronic Cough (RCC).

ipd_sharing: No

lead_sponsor: Bellus Health Inc. - a GSK company

location_country:
Poland
Colombia
India
Hungary
Argentina
Israel
United Kingdom
Netherlands
Belgium
United States
Spain
South Africa
Turkey
Canada
France

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Asociacion IPS Medicos Internistas de Caldas

location_facility: Michigan Medicine Investigational Drug Services

location_facility: Ostrowieckie Centrum Medyczne spółka cywilna Anna Olech-Cudzik, Krzysztof Cudzik

location_facility: Instituto Medico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

location_facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. Z .O.O.

location_facility: Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: McMaster University Health Sciences Center

location_facility: Instituto de Especialidades de la Salud Rosario

location_facility: Dr. Syed Anees Medicine Professional Corporation

location_facility: Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego w Lodzi

location_facility: CEMER - Centro Medico de Enfermedades Respiratorias

location_facility: Centro de Investigaciones Medicas Mar del Plata

location_facility: University of Oklahoma Health Sciences Center

location_facility: Clinique de pneumologie et du sommeil de Lanaudière

location_facility: Well Pharma Medical Research Corporation

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Vital Prospects Clinical Research Institute, P.C.

location_facility: Pharmaceutical Research & Consulting, Inc.

location_facility: Bellingham Asthma, Allergy & Immunology Clinic

location_facility: Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca

location_facility: Puspokladanyi Egeszsegugyi Szolgaltato Nonprofit Kft.

location_facility: CINME - Centro De Investigaciones Metabolicas

location_facility: Clinique Specialisee en Allergie de la Capitale

location_facility: North Florida Foundation for Research and Education, Inc.

location_facility: CHU de Dijon - Hôpital François Mitterand

location_facility: Innovative Research of West Florida, Inc.

location_facility: Institute of Medical Sciences and SUM Hospital

location_facility: Little Rock Allergy & Asthma, P.A. Clinical Research Center

location_facility: TC SBU Izmir Dr Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma

location_facility: Centrum Medyczne Lucyna Andrzej Dymek s.c.

location_facility: Clinical Research Associates of Central PA, LLC

location_facility: Expertia S.A- Mautalen Salud e Investigación

location_facility: University of Calgary - Health Sciences Centre

location_facility: Kocaeli Universitesi - Kocaeli Universitesi Tip Fakultesi

location_facility: Bhaktivedanta Hospital and Research Institute

location_facility: The Curators of the University of Missouri on behalf of University of Missouri Health Care

location_facility: Allergy & Asthma Research of Southern California

location_facility: Yedikule Pulmonary Dis. and Surgery Edu. and Res. Hosp.

location_facility: University of Texas Health Science Center at Houston

location_facility: Fundacion Centro de Investigacion Clinica CIC

location_facility: Sureyyapasa Pulmonary Diseases and Cardiothoracic Surgery Education and Research Hospital


type: EudraCT Number

title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 2 Study to Assess the Efficacy and Safety of ATX01 (Topical Amitriptyline Hydrochloride 10% and 15% w/w) in Comparison to Placebo, in Cancer Survivor Adult Patients With Chemotherapy-induced Peripheral Neuropathy (CIPN)

acronym: ACT

summary: The purpose of this clinical trial is to compare the efficacy of twice daily applications of ATX01 (10% & 15%) versus placebo during a 12-week treatment period in treating chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer survivor patients.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: AlgoTherapeutix

location_country:
Italy
Poland
Belgium
United States
Spain
Czechia
France

location_facility: Univerzita Karlova v Praze - Vseobecna Fakultni Nemocnice v Praze (VFN)

location_facility: The Center for Cancer and Blood Disorders (CCBD)

location_facility: Hospital Universitario Mutua de Terrassa

location_facility: UZ Leuven / Campus Pellenberg / Pain Center

location_facility: Fondazione IRCCS Ca' Granda Ospedale -. Maggiore Policlinico

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Poradnia Leczenia Bolu Przewleklego

location_facility: Azienda Ospedaliera San Camillo-Forlanini

location_facility: ASST Monza - Ospedale S. Gerardo di Monza

location_facility: Istituto Scientifico Romagnolo per lo Studio e La cura dei Tumori Srl (IRST)

location_facility: Hospital Universitario La Paz (HULP), Servicio de Oncologia Medica

location_facility: Przychodnia Lekarska "Komed" Roman Karaszewski Oddzial Chemioterapii Jednego Dnia

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Fondazione IRCCS Policlinico San Matteo - Universita degli Studi di Pavia

location_facility: Instytut "Centrum Zdrowia Matki Polki" Klinika Onkologii

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase II/III - EU/EEA Member States)

summary: In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Ding WY, Lane DA, Gupta D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Incidence and Risk Factors for Residual Adverse Events Despite Anticoagulation in Atrial Fibrillation: Results From Phase II/III of the GLORIA-AF Registry. J Am Heart Assoc. 2022 Aug 2;11(15):e026410. doi: 10.1161/JAHA.122.026410. Epub 2022 Jul 25.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: Aalborg Universitet - VBN Forskningsportal

repository_normalized: Pure (Denmark)

repository_institution: Leiden University - Leiden Repository

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_institution: Aalborg Universitet - VBN Forskningsportal

unpaywall_oa_status: gold

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Ding WY, Calvert P, Gupta D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Impact of early ablation of atrial fibrillation on long-term outcomes: results from phase II/III of the GLORIA-AF registry. Clin Res Cardiol. 2022 Sep;111(9):1057-1068. doi: 10.1007/s00392-022-02022-1. Epub 2022 Apr 29.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ReferenceCitation: Lip GYH, Kotalczyk A, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Marler S, Gurusamy VK, Huisman MV; GLORIA-AF Investigators. Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry. Clin Res Cardiol. 2022 May;111(5):560-573. doi: 10.1007/s00392-022-01996-2. Epub 2022 Mar 16. Erratum In: Clin Res Cardiol. 2022 Apr 6;:

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

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

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

ReferenceCitation: Huisman MV, Teutsch C, Lu S, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Lohmann R, Gurusamy VK, Bartels DB, Lip GYH; GLORIA-AF Investigators. Dabigatran versus vitamin K antagonists for atrial fibrillation in clinical practice: final outcomes from Phase III of the GLORIA-AF registry. Clin Res Cardiol. 2022 May;111(5):548-559. doi: 10.1007/s00392-021-01957-1. Epub 2022 Mar 16.

ReferenceCitation: Bayer V, Kotalczyk A, Kea B, Teutsch C, Larsen P, Button D, Huisman MV, Lip GYH, Olshansky B. Global Oral Anticoagulation Use Varies by Region in Patients With Recent Diagnosis of Atrial Fibrillation: The GLORIA-AF Phase III Registry. J Am Heart Assoc. 2022 Mar 15;11(6):e023907. doi: 10.1161/JAHA.121.023907. Epub 2022 Mar 4.

ReferenceCitation: Ntaios G, Huisman MV, Diener HC, Halperin JL, Teutsch C, Marler S, Gurusamy VK, Thompson M, Lip GYH, Olshansky B; GLORIA-AF Investigators. Anticoagulant selection in relation to the SAMe-TT2R2 score in patients with atrial fibrillation: The GLORIA-AF registry. Hellenic J Cardiol. 2021 Mar-Apr;62(2):152-157. doi: 10.1016/j.hjc.2020.11.009. Epub 2020 Dec 15.

repository_institution: University of Modena and Reggio Emilia - IRIS UNIMORE

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Huisman MV, Rothman KJ, Paquette M, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Zint K, Elsaesser A, Lu S, Bartels DB, Lip GYH; GLORIA-AF Investigators. Two-year follow-up of patients treated with dabigatran for stroke prevention in atrial fibrillation: Global Registry on Long-Term Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) registry. Am Heart J. 2018 Apr;198:55-63. doi: 10.1016/j.ahj.2017.08.018. Epub 2017 Aug 31.

repository_institution: University of Birmingham - University of Birmingham Research Portal

ReferenceCitation: Huisman MV, Lip GY, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Teutsch C, Zint K, Ackermann D, Clemens A, Bartels DB. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation. Am Heart J. 2014 Mar;167(3):329-34. doi: 10.1016/j.ahj.2013.12.006. Epub 2013 Dec 19.

location_country:
Germany
Ireland
Poland
Croatia
Czechia
France
Slovenia
Portugal
Denmark
Latvia
Romania
Belgium
Estonia
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Greece
Bulgaria
Sweden

location_facility: HOP de Courbevoie, Spécialités Med, Neuilly sur Seine

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Clinical Hosp.Merkur,Clin.Internal Med,Cardiology Dep,Zagreb

location_facility: UMHAT, Clinic of Cardiology, Stara Zagora

location_facility: CAB Brunehaut M, Cardio, Clermont Ferrand

location_facility: Private Practice of Heart Diseases Malgorzata Lelonek,Lodz

location_facility: CLI les Cedres, Cardio, Brive La Gaillarde

location_facility: HOP Louis Pasteur, Cardio, Bagnols sur Ceze

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: CHLO, EPE - Hospital S. Francisco Xavier

location_facility: Ziekenhuis Oost-Limburg - Campus Sint-Jan

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: MHAT "Dr.Stambolski", Cardiology&Intensiv Care Dept,Kazanlak

location_facility: Sykehuset Innlandet HF, Avd. Lillehammer

location_facility: Thalassoterapia,Rehab.of heart&lung,Cardiology Clin, Opatija

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: Individual Specialistic Private Practice,Dr.A.Tomasik,Zabrze

location_facility: CAB Houppe Nousse MP, Cardio, Thionville

location_facility: General Hospital of Edessa, Cardiology Clinic

location_facility: General Hosp. Zadar, Clinic of Internal Med, Cardiology Dept

location_facility: METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht

location_facility: Ospedale Santa Corona Azienda Sanitaria Locale n.2 Savonese

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Ospedale S.Maria della Misericordia, AO di Perugia

location_facility: Azienda Sanitaria Ospedale S. Luigi Gonzaga

location_facility: Osp. Guglielmo da Saliceto AUSL di Piacenza

location_facility: Azienda Unità Sanitaria Locale di Reggio Emilia

location_facility: MHAT "National Cardiology Hosp." Cardiology Dept., Sofia

location_facility: Cardiology Out-patient Clinic "Cardio-Plus", Radlin

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: Nuovo Ospedale Civile S. Agostino-Estense

location_facility: A.O. Univ. Vittorio Ferrarotto S. Bambino

location_facility: Royal Bournemouth and Christchurch Hospital

location_facility: Individual Specialist.Private Practice Dr.W.Krysiak,Szczecin

location_facility: Specialistic Cardiology&Hypertension Out-patient Clin,Kielce

location_facility: Univ. Hosp. Sisters of Mercy, Cardiology Dept., Zagreb

location_facility: Sydvestjysk Sygehus Esbjerg, Hjertemedicinsk afd.

location_facility: CAB Phan Cao Phai, Cardio, Levallois Perret

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Evangelisches Elisabeth-Krankenhaus, Berlin Mitte

location_facility: Gemeinschaftspraxis Dr. med. J. Sek, Chemnitz

location_facility: Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã

location_facility: Gen. Hosp. of Thessaloniki "Hippokation", Cardiology Clinic

location_facility: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH

location_facility: HOP William Morey, Cardio, Chalon-Sur-Saône

location_facility: Praxis Dr.med. Jens Taggeselle, Markkleeberg

location_facility: Hospital Regional Universitario de Málaga

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: Klinik Pirawarth, Therapie und Rehabilitation, Bad Pirawarth

location_facility: Praxis für Herz-Kreislauf-Erkrankungen Zeulenroda-Greiz

location_facility: Policlinico Universitario Mater Domini, Universita di Catanzaro

location_facility: Univ. Medical Centre Ljubljana, Dept. of Vascular Diseases

location_facility: Specialist Out-patient Clinics 'Na Gornej',Cieszyn

location_facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

location_facility: General Panarkadiko Hospital of Tripolis, Cardiology Clinic

location_facility: Research Unit, Liverpool Heart and Chest Hospital

location_facility: HOP d'Aix en Provence, cardio, Aix-en-Provence

location_facility: Med.Centre Diagnosis,Treatm&Prev Med.Cardiol.Dept, Bucharest

location_facility: Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO

location_facility: North Estonia Med.Centre,Internal Med.Clin/Cardiology,Tallin

location_facility: MHAT "Tsaritsa Yoanna-ISUL" Clinic of Cardiology, Sofia

location_facility: Ordination Dr. Martin Koschutnik, Oberwart

location_facility: Asclepion Voulas Hospital, Cardiological Clinic

location_facility: Emergency University Hospital, Bucharest

location_facility: HOP Raincy Montfermeil, Cardio, Montfermeil

location_facility: KH d. Barmherzigen Brüder Wien, Neurologie

location_facility: Slaskie Center Heart Disease SUM,Cardiol.&Electr.Clin.Zabrze

location_facility: Gesundheit Nord gGmbH | Klinikverbund Bremen

location_facility: HOP Sud Francilien, Cardio, Corbeil-Essonnes

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Cardiology Private Practice, Roznov pod Radhostem

location_facility: HOP Privé de la Loire, Cardio, Saint Etienne

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: "Korgialeneio-Benakeio" Hellenic Red Cross Hospital

location_facility: Centro Hospitalar Universitário São João,EPE

location_facility: Polyclinic St. Luke, Cardiology Dept., Zagreb

location_facility: HOP de la région d'Annecy, Cardio, Metz-Tessy

location_facility: MHAT, Fourth Dept. of Internal Medicine, Rousse

location_facility: Azienda Complessa Ospedaliera Ospedale San Fiippo Neri

location_facility: Reg.Hosp, Intern.Med.Ward w/ Intensive Cardiol.Care, Opoczno

location_facility: University Multiprofile Hospital 'Alexandrovska', Sofia

location_facility: Univ. Hosp. Sisters of Mercy, Neurology Clinic, Zagreb

location_facility: MHAT "Deva Maria", Dept. of Cardiology, Burgas

location_facility: CAB Dascotte O, Cardio, St André lez Lille

location_facility: Hospital General Universitario de Valencia

location_facility: Hospital General Universitario de Alicante

location_facility: Sotiria Hosp.,Hypertension Unit,3rd Clinic of Internal Med.

location_facility: Liepaja Regional Hospital, Therapy Department

location_facility: Az.Osp. Universitaria "Ospedali Riuniti"

location_facility: University General Hospital of Heraklion

location_facility: Specialized Hosp.f.Active Treatment, Cardiology Dept, Yambol

location_facility: Multiprofile Hospital for Active Treatment, Sliven

location_facility: Diagnostic & Consultancy Center "Ascendent", Sofia

location_facility: "Papageorgiou" General Hospital of Thessaloniki, B' Cardiolo


title: A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors With FGFR2b Overexpression (FORTITUDE-301)

summary: The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.

design_allocation: Non-Randomized

ipd_sharing: Yes

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

lead_sponsor: Amgen

location_country:
Finland
Poland
Argentina
Australia
Brazil
Japan
Czechia
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Bulgaria
Israel

location_facility: Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: Azienda Unità Locale Socio Sanitaria 3 Presidio Ospedaliero di Mirano

location_facility: Severance Hospital Yonsei University Health System

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

location_facility: Health Pharma Professional Research SA de CV

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Centro de Infusion e InvestigacIón Oncología de Saltillo S.C.

location_facility: Centre Hospitalier Régional Universitaire de Besançon, Hôpital Jean Minjoz

location_facility: US Oncology Regulatory Affairs Corporate Office

location_facility: Instituto do Cancer Arnaldo Vieira de Carvalho

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research

location_facility: Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

location_facility: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.

location_facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

location_facility: Investigación Onco Farmacéutica S de RL de CV

location_facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE, Hospital Sao Francisco Xavier

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Sociedad de Beneficencia Hospital Italiano

location_facility: Hospital Clinico Universitario de Santiago

location_facility: US Oncology Research Investigational Products Center

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc

location_facility: Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Institut de Cancerologie de l Ouest Rene Gauducheau

location_facility: Community Health Network MD Anderson Cancer Center - North

location_facility: Mazowiecki Szpital Wojewodzki im Sw Jana Pawla II w Siedlcach spzoo

location_facility: Azienda Ospedaliero Universitaria Pisana


title: A Multicenter, Prospective, Observational Study of the Progression of Intermediate Age-Related Macular Degeneration

acronym: HONU

summary: This is a multicenter prospective study in participants with intermediate age-related macular degeneration (iAMD). One primary objective of this study is to assess iAMD disease progression, by the timeline and rates of conversion for high-risk iAMD at baseline to more advanced atrophic AMD stages. The other primary objective of this observational study is to assess the feasibility of measuring the rate of photoreceptor loss as a potential clinical endpoint. The study will consist of an observation period of approximately 3 years (~144 weeks) for participants.

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).

lead_sponsor: Genentech, Inc.

location_country:
Germany
France
Italy
Australia
United States
Puerto Rico
Israel

location_facility: Retina Partners of Northwest Arkansas, PLLC

location_facility: Universitätsklinikum Bonn; Medizinische Klinik II, Zentrum für Integrative Medizin (ZIM)

location_facility: Centre ophtalmologique Rabelais; Ophtalmologie

location_facility: Medizinische Hochschule Hannover, Innere Abteilung/Pneumologie

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Fondazione G.B. Bietti Per Lo Sudio E La Ricerca In Oftalmologia-Presidio Ospedaliero Britannico

location_facility: Emanuelli Research and Development Center LLC

location_facility: University Retina and Macula Associates, PC

location_facility: Azienda Sanitaria Universitaria Friuli Centrale ? PO Universitario Santa Maria della Misericordia

location_facility: Hospital Foundation Adolphe De Rothschild

location_facility: Northern California Retina Vitreous Associates

location_facility: Vitreous Retina Macula Consultants of New York

location_facility: University of Wisconsin Hospital and Clinics

location_facility: ASST Fatebenefratelli Sacco - Ospedale Luigi Sacco

intervention_type: Other


title: A Multicentre, Single-arm, Phase 3b Efficacy and Safety Study of Tezepelumab 210 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Participants With Severe Asthma on High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Long-term Oral Corticosteroid Therapy (WAYFINDER)

acronym: WAYFINDER

summary: This is a study designed to evaluate efficacy and safety of Tezepelumab in reducing oral corticosteroid use in adult patients with severe asthma who are receiving oral corticosteroids with or without additional asthma controller medications.

status: Active, not recruiting

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

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

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

lead_sponsor: AstraZeneca

location_country:
Germany
Poland
United Kingdom
Argentina
Mexico
Belgium
United States
Latvia
Spain
Bulgaria
France

intervention_type: Biological


title: Brightline-1: A Phase II/III, Randomized, Open-label, Multi-center Study of Brigimadlin (BI 907828) Compared to Doxorubicin as First Line Treatment of Patients With Advanced Dedifferentiated Liposarcoma

summary:
This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate.

The purpose of this study is to compare a medicine called brigimadlin (BI 907828) with doxorubicin in people with liposarcoma. Brigimadlin (BI 907828) is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma.

During the study, participants get either brigimadlin (BI 907828) or doxorubicin. Every 3 weeks, participants take brigimadlin (BI 907828) as tablets or doxorubicin as an infusion into a vein. Participants can switch to brigimadlin (BI 907828) treatment if they did not benefit from doxorubicin treatment.

Participants can continue treatment in the study as long as they benefit from it and can tolerate it.

Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

ipd_sharing_description:
Once the time frame criteria given under number 4 are fulfilled, researchers can use the 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".

Furthermore, researchers can 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.

lead_sponsor: Boehringer Ingelheim

location_country:
Finland
Germany
Australia
Japan
Czechia
Canada
France
Portugal
Hong Kong
Denmark
United States
Belgium
China
Italy
Norway
United Kingdom
Netherlands
Spain
Greece
Taiwan
Sweden

location_facility: Istituto Nazionale IRCCS Tumori Fondazione Pascale

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Harbin Medical University cancer hospital

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

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: HUCH Comprehensive Cancer Center, building 2

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: Cancer Hospital of Chinese Academy of Medical Science

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: "Attikon" University General Hospital of Attica

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Oslo Universitetssykehus HF, Radiumhospitalet


title: A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients With Polycythemia Vera

acronym: VERIFY

summary: The study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (PV) in maintaining hematocrit control and in improving symptoms of PV.

ReferenceCitation: Pemmaraju N, Kuykendall A, Kremyanskaya M, Ginzburg Y, Ritchie E, Gotlib J, Gerds A, Palmer J, Valone F, O'Connor P, Modi N, Gupta S, Hoffman R, Verstovsek S. MPN-469 Rusfertide (PTG-300) Treatment Interruption Reverses Hematological Gains and Upon Reinitiation, Restoration of Clinical Benefit Observed in Patients With Polycythemia Vera. Clin Lymphoma Myeloma Leuk. 2022 Oct;22 Suppl 2:S338-S339. doi: 10.1016/S2152-2650(22)01462-8.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

lead_sponsor: Protagonist Therapeutics, Inc.

location_country:
Germany
Poland
Australia
Turkey
Chile
Czechia
Canada
France
Portugal
Hungary
Hong Kong
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Israel

location_facility: New York Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Karadeniz Technical University Medical Faculty Farabi Hospital

location_facility: Markhot Ferenc Oktatokorhaz es Rendelointezet

location_facility: Uniklinik RWTH Aachen - Klinik fuer Haematologie, Onkologie, Haemostaseologie und Stammzelltransplantation (Med. Klinik IV)

location_facility: Rabin Medical Center - Davidoff Hematology Center

location_facility: Centro de Estudios de Investigacion SIYODE

location_facility: InVo-Institut fuer Versorgungsforschung in der Onkologie GbR

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Memorial Sloan Kettering Cancer Center - KOCH

location_facility: Good Samaritan Infusion Center - Kenwood

location_facility: Klinika Hematologii I Transplantologii - Uniwersyteckie Centrum Kliniczne

location_facility: Wilmot Cancer Institute, University of Rochester

location_facility: Memorial Sloan Kettering Cancer Center - BERGEN

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Gemeinschaftspraxis Haematologie - Onkologie - Hauptstelle

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

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im.ks.B.Markiewicza

location_facility: Ankara Universitesi Tip Fakultesi Hematologi Bilim dali Ankara

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Ege University Hospital Department of Hematology

location_facility: TriHealth Cancer Institute - Good Samaritan Hospital

location_facility: Memorial Sloan Kettering Cancer Center - MONMOUTH

location_facility: Oregon Health and Science University (OHSU) Knight Cancer Institute

location_facility: Sanko Universitesi tip Fakultesi Ic Hastaliklari Anabilim Dali

location_facility: Memorial Sloan Kettering Cancer Center - WESTCHESTER

location_facility: Boca Clinical Trials Mexico S.C. - Ciudad de Mexico

location_facility: University of California, San Diego (UCSD) - Moores Cancer Center

location_facility: American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)

location_facility: Wiener Gesundheitsverbund-Klinik Hietzing 5-Med.

location_facility: Memorial Sloan Kettering Cancer Center - COMMACK

location_facility: Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz

location_facility: Marmara University Pendik Training & Research Hospital

location_facility: California Cancer Associates for Research and Excellence - Fresno

location_facility: Montefiore Einstein Center for Cancer Care

location_facility: BayCare Suncoast Medical Clinic - Hematology/Oncology

location_facility: IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadon"

location_facility: Biocenter Centro Clinico de Investigacion

location_facility: Azienda ASST-SETTELAGHI, Ospedale di Circolo e Fond. Macchi di Varese Ospedael Vecchio

location_facility: UOC Ematologia - ASST Spedail Civill Brescia

location_facility: Memorial Sloan Kettering Cancer Center - BASKING RIDGE

location_facility: AOU Citta della Salute e della Scienza di Torino

location_facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

location_facility: Fondazione Policlinico Univ. A . Gemelli IRCCS

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

location_facility: University of Iowa Hospitals and Clinics

location_facility: Erciyes Universitesi Tip Fakultesi Hastanesi, Dedeman Hospital

location_facility: University of California, Los Angeles (UCLA) - Medical Center

location_facility: IRCCS Azienda Ospedaliero-Universtaria di Bologna

location_facility: University of Colorado - Aurora Cancer Center

location_facility: Royal Free Hospital, Royal Free London NHSFT

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

location_facility: SUPERARE Centro de Infusion S.A. de C.V.

location_facility: Memorial Sloan Kettering Cancer Center - NASSAU


title: A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors

summary: This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 426 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for GIST and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner.

lead_sponsor: Cogent Biosciences, Inc.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Chile
Czechia
Canada
France
Hungary
Hong Kong
Denmark
United States
Italy
Norway
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Sweden

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola

location_facility: Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

location_facility: Chang Gung Memorial Hospital - Linkou Branch (CGMHLK)

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Debreceni Egyetem, Klinikai Központ, Onkológiai Klinika

location_facility: Stichting Radboud Universitair Medisch Centrum

location_facility: Mid Florida Hematology and Oncology Center

location_facility: Medizinische Hochschule Hannover- Urology Oncology

location_facility: Taipei Veterans General Hospital (VGHTP)

location_facility: IRCCS La Fondazione e l'Istituto di Candiolo

location_facility: University of Miami - Sylvester Comprehensive Cancer Center

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka

location_facility: University of California, San Diego (UCSD)

location_facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"

location_facility: Centro de Oncologia de Precision, Universidad Mayor

location_facility: University of Pittsburgh Medical Center - Hillman Cancer Center

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach, Oddzial Chemioterapii Dziennej

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Fakultni nemocnice Olomouc - Oncology clinic

location_facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Institut Catala d'Oncologia - L'Hospitalet

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Hospital das Clinicas da Universidade Estadual de Campinas (UNICAMP)

location_facility: University of California, Los Angeles (UCLA)

location_facility: Oregon Health & Science University (OHSU)

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Centro de Investigacion Medica Aquascalientes (CIMA)

location_facility: Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

location_facility: University of Wisconsin - Carbone Cancer Center


title: A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T Versus Hormone Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer

summary: A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer.

lead_sponsor: Curium US LLC

location_country:
United States
Italy
Spain
France

location_facility: University of Alabama at Birmingham Hospital

location_facility: Kaiser Permanente Gaithersburg Medical Center

location_facility: Hospital Regional Universitario de Malaga

location_facility: Excel Diagnostics & Nuclear Oncology Center

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Columbia University Medical Center - Herbert Irving Pavilion

location_facility: Istituto Europeo di Oncologia (IEO) -IRCCS

location_facility: Center for Clinical Theranostics Research, Washington University

location_facility: NorthShore University HealthSystem-Evanston Hospital

location_facility: Institut de Cancérologie de l'Ouest (ICO) St Herblain

location_facility: Hospital General Universitario Ciudad Real

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists


title: A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

acronym: IRIS

summary: The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis

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

Yes, indicates that AZ are accepting requests for IPD, but this does not mean that all requests will be shared.

location_country:
Germany
Poland
Argentina
Japan
Brazil
Thailand
Vietnam
Turkey
France
Hungary
United States
India
Belgium
China
Peru
Italy
Netherlands
Mexico
Taiwan
Bulgaria
Russian Federation


summary: The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) in participants with inoperable or metastatic HR-positive, HER2- negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy.

sponsor_collaborators:
AstraZeneca
Daiichi Sankyo, Inc.

title: A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

source: euctr

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

location_country:
Germany
Poland
Argentina
Japan
Brazil
Canada
France
Hungary
United States
India
Belgium
China
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation


lead_sponsor: UCB Biopharma SRL

summary: The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.

title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Outpatient, Parallel-Group Study to Assess the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of reidentifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Australia
Japan
United States
China
Spain
Czechia
Bulgaria
France


title: Phase 3, Randomized, Open-Label, Parallel Arm Study to Evaluate the Efficacy and Safety of 180 mcg Peginterferon Lambda-1a (Lambda) Subcutaneous Injection for 48 Weeks in Patients With Chronic Hepatitis Delta Virus (HDV) Infection (LIMT-2)

summary: The Phase 3 LIMT-2 study will evaluate the safety and efficacy of Peginterferon Lambda treatment for 48 weeks with 24 weeks follow-up compared to no treatment for 12 weeks in patients chronically infected with HDV. The primary analysis will compare the proportion of patients with HDV RNA < LLOQ at the 24-week post-treatment visit in the Peginterferon Lambda treatment group vs the proportion of patients with HDV RNA < LLOQ at the Week 12 visit in the no-treatment comparator group.

lead_sponsor: Eiger BioPharmaceuticals

location_country:
Germany
Italy
Moldova, Republic of
Israel
Romania
Belgium
United States
Spain
Turkey
Bulgaria
Georgia
France

location_facility: The Liver Diseases Center, Sheba Medical Center

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: LTD,Tbilisi State Medical Univeristy and lngorokva High Medical Technology University Clinic

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: National Institute for Infectious Diseases "Matei Bals"

location_facility: Medical Center "Nov Rehabilitatsionen Centre" EOOD

location_facility: ZIM 1, Gastroenterologie, University Hospital Frankfurt

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Istanbul Universitry-Cerrahapasa, Cerrahpasa School of Medicine

location_facility: LTD Academician Nikoloz Kipshidze Central University Clinic

location_facility: Sutter Pacific Medical Foundation - California Pacific Medical Center

location_facility: Icahn School of Medicine - Mount Sinai Medical Center

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

location_facility: Universitätsmedizin Mainz, I. Med. Klinik

location_facility: NYU Langone Health / NYU Grossman School of Medicine

location_facility: Infectious diseases, AIDS and Clinical Immunology Research Center

location_facility: Asian Pacific Liver Center at Coalition of Inclusive Medicine

location_facility: Azienda Ospedaliero Universitaria Pisana


type: Other Identifier

title: A Multi-centre Prospective Non-interventional Clinical Investigation Studying the Glycaemic Control in Patients With Type 1 Diabetes When Introducing a NovoPen® 6 for Treatment With Tresiba® (Insulin Degludec) & Fiasp® (Fast-acting Insulin Aspart) in a Real-world Setting

acronym: CONNECT 1

summary:
The purpose of this study is to collect information on how NovoPen® 6 works with Tresiba® & Fiasp® for treatment of people with type 1 diabetes and see if the use of NovoPen® 6 can help participants achieve better blood sugar levels.

Participants will use Tresiba® & Fiasp® in NovoPen® 6 as prescribed to participants by the study doctor.

NovoPen® 6 is a smart pen, which collects and stores the date and time of injections and number of units of insulin participants have taken.

NovoPen® 6 can transfer participants insulin dosing information to the mobile application, which participants use to see their continuous blood sugar level. This will allow participants to see their insulin doses along with continuous blood sugar level in the mobile application.

Participants will keep using their own continuous blood sugar monitoring device and the mobile application to see these data during the study.

The study will last for about 9-11 months. Participants will be asked to complete 2 questionnaires in this study. One questionnaire is about overall satisfaction of using a digital health solution and other is about quality of life. Participants will complete these questionnaires during their normally scheduled visit with the study doctor, on 2 separate occasions

status: Enrolling by invitation

ipd_sharing_description: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

lead_sponsor: Novo Nordisk A/S

location_country: Denmark Sweden Belgium France

status_simplified: Unknown


summary: The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab or AZD0171 and platinum doublet chemotherapy; or MEDI5752 in combination with platinum doublet chemotherapy or datopotamab deruxtecan (Dato-DXd) in combination with durvalumab and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer.

sponsor_collaborators: AstraZeneca Parexel

title: A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2)

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

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Ireland
Italy
Portugal
Hungary
Belgium
United States
Korea, Republic of
Spain
Turkey
Taiwan
Canada
France


title: A Phase 2, Single Arm Study of Mirvetuximab Soravtansine in Recurrent Platinum-Sensitive, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (PICCOLO)

summary: PICCOLO (IMGN853-0419) is a Phase 2 multicenter, open label study designed to evaluate the safety and efficacy of Mirvetuximab Soravtansine in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.

lead_sponsor: ImmunoGen, Inc.

location_country:
Ireland
Italy
Australia
Belgium
United States
Spain
Canada
France

location_facility: Zangmeister Cancer Center / Sarah Cannon Research Institute

location_facility: Groupe Hospitalier Diaconesse, Croix Saint-Simon

location_facility: The University of Alabama at Birmingham - Division of Gynecology Oncology O'Neal Comprehensive Cancer Center

location_facility: Institut Català d' Oncologia L' Hospitalet

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Burnside War Memorial Hospital - The Brian Fricker Oncology Centre

location_facility: Florida Cancer Specialist North Division

location_facility: Hospital MD Anderson Cancer Center Madrid

location_facility: Institut de Cancerologie Strabsourg Europe Unité de recherche clinique

location_facility: Complejo Hospitalario Provincial de Castellón

location_facility: Alaska Women's Cancer Care/Providence Alaska Medical Center

location_facility: Cleveland Clinic Fairview Hospital-Moll Cancer Center

location_facility: Institut Català d'Oncologia - Hospital Universitari Germans Trias i Pujol, Unidad de Investigación Clínica, Servicio de Oncología, Institut Josep Carreres (IJC, 1ª planta)

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS

location_facility: Tennessee Oncology / Sarah Cannon Research Institute

location_facility: University of Colorado School of Medicine

location_facility: Women & Infants Hospital of Rhode Island Oncology Research

location_facility: Washington University School of Medicine

location_facility: UCLA-JCCC Dept of OBGYN - Women's Health Clinical Research Unit

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Princess Margaret Cancer Centre - University Health Network

location_facility: Azienda Unita Sanitaria Locale di Ravenna


title: A Phase 1 First in Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-400 in Adult Subjects With Advanced Solid Tumors

summary:
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors.

ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose. Approximately 460 adult participants with NSCLC, gastroesophageal adenocarcinoma/gastroesophagel junction adenocarcinoma (GEA) and colorectal cancer (CRC) or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 85-95 sites in the Dose Expansion phase worldwide.

In the dose expansion arms, participants in the following advanced solid tumor indications: non-squamous NSCLC with wildtype EGFR-expression (wtEGFR NSCLC) (Part 2i) or mutated EGFR-expression (mutEGFR NSCLC) (Part 2ii), squamous NSCLC (Part 2iii), GEA [Part 3] will receive intravenous (IV) ABBV-400 monotherapy, participants CRC will receive intravenous (IV) ABBV-400 monotherapy in expansion [Part 4], and participants MET amplification will receive intravenous (IV) ABBV-400 monotherapy in expansion [Part 5].

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

lead_sponsor: AbbVie

location_country:
France
Poland
Japan
United States
Korea, Republic of
Spain
Taiwan
Puerto Rico
Israel

location_facility: Nagasaki University Hospital /ID# 250290

location_facility: Univ of Colorado Cancer Center /ID# 231574

location_facility: Hospital Universitario HM Sanchinarro /ID# 244721

location_facility: AP-HP - Hopital Européen Georges Pompidou/ID# 250481

location_facility: Inje University Haeundae Hospital / ID# 244451

location_facility: Taipei Veterans General Hospital /ID# 250652

location_facility: Community Health Network, Inc. /ID# 245331

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 248816

location_facility: Niigata University Medical & Dental Hospital /ID# 250952

location_facility: Taipei Medical University Hospital /ID# 245732

location_facility: National Cancer Center Hospital /ID# 232007

location_facility: Comprehensive Cancer Centers of Nevada /ID# 242930

location_facility: Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie /ID# 250466

location_facility: Korea University Guro Hospital /ID#244504

location_facility: Carolina BioOncology Institute /ID# 231541

location_facility: Pan American Center for Oncology Trials, LLC /ID# 231580

location_facility: University of California, Los Angeles/ID# 243841

location_facility: Hospital Universitario Miguel Servet /ID# 244456

location_facility: Hospital Universitario Fundacion Alcorcon /ID# 244505

location_facility: The Chaim Sheba Medical Center /ID# 231217

location_facility: Wakayama Medical University Hospital /ID# 250283

location_facility: CHA University Bundang Medical Center/ID# 247115

location_facility: Hospital Universitario 12 de Octubre /ID# 248417

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 231464

location_facility: National Cancer Center Hospital East /ID# 232008

location_facility: Hospital Universitario Virgen Macarena /ID# 245213

location_facility: SMG-SNU Boramae Medical Center /ID#248421

location_facility: The Cancer Institute Hospital Of JFCR / ID#248447

location_facility: Yonsei University Health System Severance Hospital/ID# 245218

location_facility: Virginia Cancer Specialists - Fairfax /ID# 231575

location_facility: CHU de Nantes, Hotel Dieu -HME / ID# 245266

location_facility: Indiana University Melvin and Bren Simon Cancer Center/ID# 245133

location_facility: Centre Georges François Leclerc/ID# 244450

location_facility: Seoul National University Hospital / ID# 244667

location_facility: Centre Antoine Lacassagne - Nice/ ID# 231730

location_facility: Gabrail Cancer Center Research /ID# 248419

location_facility: Institut de Cancérologie de l'Ouest René Gauducheau /ID# 248399

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu /ID# 251846

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 245378

location_facility: Tri-Service General Hospital /ID# 245733

location_facility: Hospital Universitario de Jaen /ID# 249201

location_facility: Chungbuk National University Hospital / ID# 244452

location_facility: MD Anderson Cancer Center at Texas Medical Center/ID# 248656

location_facility: Yokohama Municipal Citizen's Hospital/ID# 248842

location_facility: Gyeongsang National University Hospital / ID# 248420

location_facility: Hospital Clinic de Barcelona /ID# 245374


summary:
This study is being done to see if a combination of 2 medicines (called NNC0194-0499 and semaglutide) can reduce liver damage in patients with non alcoholic steatohepatitis (NASH).

NNC0194-0499 is a new medicine which works in the liver. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. It also helps with weight loss and may reduce liver damage, and so prevent future liver complications. It works in a different way to NNC0194 0499. The 2 medicines may work better together than on their own.

The study will also look at a combination of semaglutide and another weight-loss medicine called NNC0174-0833, which may be another treatment option for NASH.

Each week, participants will get 2 injections. These could be 2 of the 3 medicines OR 1 of the medicines and a placebo OR 2 placebo injections. Which treatment participants get is decided by chance. A placebo is a dummy medicine which looks like the real medicine but doesn't contain any active medicine.

The study will last for about 19 months. Participants will have 14 clinic visits and 9 phone calls with the study doctor.

Participants will have 1 or 2 liver biopsies (tiny pieces of liver tissue) - one at the start (if participants have not had a biopsy recently) and one at the end of the study treatment.

Women: Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

title: Efficacy and Safety Investigation of NNC0194-0499 Co-administered With Semaglutide in Subjects With Non-alcoholic Steatohepatitis: a Dose-ranging, Placebo Controlled Trial

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

location_country:
Germany
Poland
Australia
Japan
Turkey
Czechia
Canada
France
Portugal
Denmark
United States
India
Belgium
Malaysia
Puerto Rico
Italy
United Kingdom
Singapore
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation


title: A Patient- and Investigator-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Study Participants With Prodromal to Mild Alzheimer's Disease (AD), Followed by an Open-Label Extension Period

summary: The purpose of the study is to investigate the effect of bepranemab versus (vs) placebo on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) up to Week 80 in study participants with prodromal or mild Alzheimer's Disease (AD).

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


summary: A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

title: A Phase Ib/III, Open-label, Randomised Study of Capivasertib Plus CDK4/6 Inhibitors and Fulvestrant Versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

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

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Germany
Poland
Argentina
Australia
Japan
Thailand
Vietnam
Turkey
Canada
France
Denmark
United States
India
Belgium
China
Italy
United Kingdom
Korea, Republic of
Spain
Sweden


acronym: ONWARDS 3

summary:
This study compares insulin icodec (a new insulin taken once a week) to insulin degludec (an insulin taken once daily which is already available on the market) in people with type 2 diabetes.

The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily.

Participants will get their study medicine in an injection pen. Participants will get a pen for weekly injection and one for daily injection. One will be icodec or degludec and the other will be dummy medicine. The treatment participants get is decided by chance. Participants and the study staff will not know which active medicine they get.

The insulin is injected with a needle in a skin fold in the thigh. The study could last for about 8 months. Participants will have 13 clinic visits and 17 phone calls with the study doctor. At 8 clinic visits participants will have blood samples taken. At 4 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.

Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

ReferenceType: result

ReferenceCitation: Philis-Tsimikas A, Bajaj HS, Begtrup K, Cailleteau R, Gowda A, Lingvay I, Mathieu C, Russell-Jones D, Rosenstock J. Rationale and design of the phase 3a development programme (ONWARDS 1-6 trials) investigating once-weekly insulin icodec in diabetes. Diabetes Obes Metab. 2023 Feb;25(2):331-341. doi: 10.1111/dom.14871. Epub 2022 Oct 14.

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

publisher_dissemination: Wiley

title: A 26-week Double Blinded, Multiregional, Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Drugs, in Insulin naïve Subjects With Type 2 Diabetes.

location_country:
Argentina
Denmark
Brazil
Austria
Mexico
United States
China
Taiwan
Czechia
Canada
Puerto Rico
France

status_simplified: Completed


title: A Multicenter, Open-Label Study With a Randomized Control Arm of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme After Failure of Standard First Line Therapy

summary:
This is an open-label, multicenter, randomized, parallel, 2-arm, efficacy and safety study. Patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive berubicin or lomustine for the evaluation of OS. Additional endpoints will include response and progression outcomes evaluated by a blinded central reviewer for each patient according to RANO criteria.

A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

ipd_sharing_description: Study data will be shared with WPD Pharmaceuticals, Inc., sub-licensee of Berubicin.

lead_sponsor: CNS Pharmaceuticals, Inc.

sponsor_collaborators:
CNS Pharmaceuticals, Inc.
Worldwide Clinical Trials

location_country:
Italy
Switzerland
United States
Spain
France

location_facility: Institut de Recherche en Cancerologie de Montpellier

location_facility: Southern California Permanente Medical Group

location_facility: Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituti Fisioterapici Ospitalieri (IFO) - Istituto Nazionale Tumori Regina Elena (IRE)

location_facility: Hospital Regional Universitario de Malaga Carlos Haya

location_facility: University of Califonia San Diego Moores Cancer Center

location_facility: Saint John's Cancer Institute at Providence Saint John's Health Center

location_facility: UMass (ACC) - Hollings Cancer Center (HCC)

location_facility: Ospedale Busonera - IRCCS Istituto Oncologico Veneto (IOV)

location_facility: Servizio Sanitario Regionale Emilia-Romagna - Azienda USL di Bologna - Ospedale Bellaria

location_facility: nstitut Universitaire du Cancer de Toulouse-

location_facility: University of Texas Health Science Center at Houston

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Hospital Universitari Germans Trias i Pujol


acronym: TRISTARDS

summary:
This is a study in adults with severe breathing problems because of COVID-19. People who are in hospital on breathing support can participate in the study. The purpose of the study is to find out whether a medicine called alteplase helps people get better faster.

The study has 2 parts. In the first part, participants are put into 3 groups by chance. Participants in 2 of the groups get 2 different doses of alteplase, in addition to standard treatment.

Participants in the third group get standard treatment. In the second part of the study, participants are put into 2 groups by chance. One group gets alteplase and standard treatment. The other group gets only standard treatment. Alteplase is given as an infusion into a vein. In both study parts, treatments are given for 5 days. Doctors monitor patients and check whether their breathing problems improve. They compare results between the groups after 1 month.

Participants are in the study for 3 months.

location_facility: City Clinical Hospital # 40 of the Moscow Health Department

location_facility: Moscow 1st State Med.Univ.n.a.I.M.Sechenov

location_facility: Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: Wiener Gesundheitsverbund Klinik Favoriten

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: State Budget Institution of Healthcare Leningradskaya region "Kirovskaya Interdistrict Hospital"

location_facility: Klinikum der Universität München - Campus Großhadern

status: Terminated

title: The TRISTARDS Trial - ThRombolysIS Therapy for ARDS A Phase IIb/III Operationally Seamless, Open-label, Randomised, Sequential, Parallel-group Adaptive Study to Evaluate the Efficacy and Safety of Daily Intravenous Alteplase Treatment Given up to 5 Days on Top of Standard of Care (SOC) Compared With SOC Alone, in Patients With Acute Respiratory Distress Syndrome (ARDS) Triggered by COVID-19

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.

location_country:
Germany
Italy
India
Brazil
Netherlands
Austria
Belgium
Mexico
Spain
Malaysia
Turkey
Russian Federation
France


lead_sponsor: Daiichi Sankyo, Inc.

summary: This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen.

sponsor_collaborators:
Daiichi Sankyo, Inc.
Daiichi Sankyo Co., Ltd.

location_facility: University of Washington/Seattle Cancer Care Alliance

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: The Catholic University of Korea, Seoul St. Marys Hospital

location_facility: Catalan Institute of Badalona Hospital Germans Trias i Pujol ICO

location_facility: IRCCS - Istituto Scientifico Romagnolo per lo Studio e La Cura Dei Tumori ISRT

location_facility: Fudan University - Shanghai Cancer Center FUSCC

location_facility: Chang Gung Memorial Hospital CGMH - Kaohsiung Branch

location_facility: The First Hospital of China Medical University

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Massachusetts General Hospital (MGH) - Hematology/Oncology

location_facility: Harbin Medical University - Tumor Hospital (The Third Affiliated Hospital)

location_facility: University of Maryland - Marlene and Stewart Greenebaum Cancer Center

location_facility: University of Virginia Cancer Center - Emily Couric Clinical Cancer Center

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: University Hospital Birmingham NHS Trust

location_facility: The First Affiliated Hospital of College of Medicine Zhejiang University

location_facility: Sarah Cannon Research Institute at Tennessee Oncology - Chattanooga

location_facility: University Hospital of Nantes - Thoracic Oncology

location_facility: Guangdong Academy of Medical Science (GAMS) - Guangdong Provincial Peoples Hospital

location_facility: Beth Israel Deaconess Medical Center, Harvard Medical School

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

location_facility: Kliniken der Stadt Koeln gGmbH Lungenklinik Merheim

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Henry Ford Cancer Institute/Henry Ford Hospital

location_facility: University of Colorado Denver - Anschutz Medical Campus

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Seoul National University Bundang Hospital

location_facility: General Hospital of Eastern Theater Command

location_facility: Karl Landsteiner Institut fÃ¼r Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf

location_facility: National University Cancer Institute National University Hospital

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: START Madrid - Hospital Universitario HM Sanchinarro

location_facility: University of Electronic Science & Technology of China (UESTC) - Sichuan Cancer Hospital & Institute (Sichuan Provincial Tumor Hospital

location_facility: National Taiwan University Hospital NTUH

location_facility: Union Hospital of Tongji Medical College Huazhong University of Science and Technology

location_facility: Hospital Clinico Universitario Lozano Bleza

location_facility: Moores Cancer Center at the UC San Diego Health

location_facility: OncoCare Cancer Centre- Gleneagles Medical Centre

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Chang Gung Memorial Hospital - Linkou Branch

location_facility: Kyungpook National University Chilgok Hospital

title: HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

location_country:
Germany
Italy
United Kingdom
Singapore
Australia
Japan
Netherlands
Austria
Belgium
United States
China
Korea, Republic of
Spain
Taiwan
Bulgaria
France


acronym: ENSEMBLE 2

lead_sponsor: Janssen Vaccines & Prevention B.V.

summary: The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical coronavirus disease-2019 (COVID-19), as compared to placebo, in SARS-CoV-2 seronegative adults in the double-blind phase and to describe COVID-19 outcomes, safety, and immunogenicity in the different study cohorts in open-label phase.

ReferenceCitation: Hardt K, Vandebosch A, Sadoff J, Le Gars M, Truyers C, Lowson D, Van Dromme I, Vingerhoets J, Kamphuis T, Scheper G, Ruiz-Guinazu J, Faust SN, Spinner CD, Schuitemaker H, Van Hoof J, Douoguih M, Struyf F; ENSEMBLE2 study group. Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2): results of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2022 Dec;22(12):1703-1715. doi: 10.1016/S1473-3099(22)00506-0. Epub 2022 Sep 13. Erratum In: Lancet Infect Dis. 2022 Nov 7;:

oa_host_type: repository

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

repository_institution: California Digital Library - eScholarship

repository_institution: University of Southampton - ePrints Soton

version: acceptedVersion

unpaywall_oa_status: green

location_facility: Ministerio da Saude - Hospital dos Servidores do Estado - RJ

location_facility: Brighton & Sussex University Hospitals NHS Trust

location_facility: Allergy Asthma Immunology of Rochester, PC (AAIR) - Research Center

location_facility: Powys Teaching Local Health Board - Bronllys Hospital

location_facility: The South Bend Clinic Center for Research

location_facility: Instituto Nacional de Infectologia Evandro Chagas (INI) - FIOCRUZ

location_facility: Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: IPS Centro Cientifico Asisitencial Jose Luis Accini S.A.S.

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Central Manchester University Hospitals NHS Foundation Trust

location_facility: Quality of Life Medical & Research Center, LLC

location_facility: Centro de Referencia E Treinamento Dst/Aids

location_facility: Washington University School of Medicine

location_facility: Groupe Hospitalier Sud Hôpital Haut-Leveque Service d'hematologie

location_facility: Asistencia Cientifica de Alta Complejidad S.A.S

location_facility: West Visayas State University Medical Center

location_facility: Velocity Clinical Research, Hallandale Beach

location_facility: Paradigm Clinical Research Centers, Inc.

location_facility: Imperial College London and Imperial College Healthcare NHS Trust

location_facility: CTI Clinical Trial and Consulting Services

location_facility: Centre of Tuberculosis Research Innovation

title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older

primary_purpose: Prevention

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

location_country:
Germany
Colombia
United Kingdom
Brazil
Belgium
United States
Spain
South Africa
Philippines
France


acronym: BEACON

lead_sponsor: Kodiak Sciences Inc

summary: This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).

location_facility: Jahn Ferenc Dél-Pesti Kórház és Rendelointézet

location_facility: Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia

location_facility: Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi

location_facility: Retina Consultants of Southern California

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Riga Eastern Clinical University Hospital Clinic Bikernieki

location_facility: Instituto Clinico Quirurgico de Oftalmologia

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

location_facility: Bajcsy-Zsilinszky Korhaz es Rendelointezet

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta

location_facility: Gabinet Okulistyczny Prof. Edward Wylegala

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

location_facility: Northern California Retina Vitreous Associates

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Retina Consultants of Texas - (Woodlands)

location_facility: Dr Nowosielska Okulistyka i Chirurgia Oka

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: The Macula Center/ Blue Ocean Clinical Research

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Signes Ozolinas Doctor Praxis In Ophthalmology

location_facility: Charlotte Eye Ear Nose & Throat Associates, P.A.

location_facility: Hôpital Lariboisière - Service Pharmacie

location_facility: Emanuelli Research & Development Center LLC

location_facility: Dietrich Bonhoeffer Klinikum Neubrandenburg

location_facility: Hospital Universitari General de Catalunya - Grupo Quironsalud

location_facility: Miriam Kannenbaeumer or Andrea Koschinski

title: A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Due to Treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion (RVO)

location_country:
Germany
Italy
Poland
Slovakia
Hungary
Israel
United States
Latvia
Spain
Czechia
Puerto Rico
France


summary: This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in Participants with recurrent or metastatic head and neck cancer.

sponsor_collaborators:
AstraZeneca
Innate Pharma

title: A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor

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 requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Canada
France
Portugal
Switzerland
United States
Belgium
Philippines
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation


acronym: MK-4482 Ph 2/3 Study in Non-Hospitalized Adults with COVID-19

lead_sponsor: Merck Sharp & Dohme LLC

summary: This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through Day 29

ReferenceCitation: Caraco Y, Crofoot GE, Moncada PA, Galustyan AN, Musungaie DB, Payne B, Kovalchuk E, Gonzalez A, Brown ML, Williams-Diaz A, Gao W, Strizki JM, Grobler J, Du J, Assaid CA, Paschke A, Butterton JR, Johnson MG, De Anda C, for the MOVe-OUT Study Group. Phase 2/3 Trial of Molnupiravir for Treatment of Covid-19 in Nonhospitalized Adults.NEJM Evid 2021;1(2). DOI: 10.1056/EVIDoa2100043. Published December 16, 2021. https://evidence.nejm.org/doi/full/10.1056/EVIDoa2100043

doi: caraco

ReferenceCitation: Johnson MG, Puenpatom A, Moncada PA, Burgess L, Duke ER, Ohmagari N, Wolf T, Bassetti M, Bhagani S, Ghosn J, Zhang Y, Wan H, Williams-Diaz A, Brown ML, Paschke A, De Anda C. Effect of Molnupiravir on Biomarkers, Respiratory Interventions, and Medical Services in COVID-19 : A Randomized, Placebo-Controlled Trial. Ann Intern Med. 2022 Aug;175(8):1126-1134. doi: 10.7326/M22-0729. Epub 2022 Jun 7.

publisher_dissemination: American College of Physicians

ReferenceCitation: Jayk Bernal A, Gomes da Silva MM, Musungaie DB, Kovalchuk E, Gonzalez A, Delos Reyes V, Martin-Quiros A, Caraco Y, Williams-Diaz A, Brown ML, Du J, Pedley A, Assaid C, Strizki J, Grobler JA, Shamsuddin HH, Tipping R, Wan H, Paschke A, Butterton JR, Johnson MG, De Anda C; MOVe-OUT Study Group. Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients. N Engl J Med. 2022 Feb 10;386(6):509-520. doi: 10.1056/NEJMoa2116044. Epub 2021 Dec 16.

oa_colors: green other

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

location_facility: Indago Research & Health Center, Inc ( Site 1809)

location_facility: Advanced Research For Health Improvement LLC ( Site 1816)

location_facility: National Hepatology & Tropical Medicine Research Institute (NHTMRI) ( Site 3300)

location_facility: Carbon Health Technologies Inc ( Site 2505)

location_facility: Centre Hospitalier de Tourcoing ( Site 0502)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 2100)

location_facility: Instituto de Infectologia Emilio Ribas ( Site 0153)

location_facility: Smolensk State Medical University ( Site 1110)

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0803)

location_facility: Clinical Projects Research Centre ( Site 1215)

location_facility: ARTEM. State Holding Company ( Site 1618)

location_facility: Newcastle upon Tyne Hospitals NHS Foundation Trust ( Site 1704)

location_facility: ICARO Investigaciones en Medicina ( Site 0812)

location_facility: Instituto Medico de la Fundacion Estudios Clinicos ( Site 3401)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 1303)

location_facility: Ruane Clinical Research Group, Inc. ( Site 2406)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0200)

location_facility: Clinica Universidad de los Andes ( Site 0302)

location_facility: Caja de Compensación Familiar CAFAM. Sede Centro de Atención en Salud CAFAM Floresta ( Site 0406)

location_facility: Hopital Bichat Claude Bernard ( Site 0503)

location_facility: Limited liability company "Scientific research center Eco-safety" ( Site 1117)

location_facility: Wits Baragwanath Clinical Trial Site ( Site 1214)

location_facility: Fundacion Arturo Lopez Perez ( Site 0305)

location_facility: Fundacion Cardiovascular de Colombia ( Site 0402)

location_facility: Centro de Investigacion Clinica UC CICUC ( Site 0309)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1302)

location_facility: ClinSmart Sweden AB.Uppsala ( Site 1402)

location_facility: PCNE Kharkiv City polyclinic 9 of the Kharkiv City Council ( Site 1627)

location_facility: Centro de Pesquisa Clinica II - ICHC - FMUSP ( Site 0152)

location_facility: CNE Central city clinical hospital of Ivano-Frankivsk city council ( Site 1604)

location_facility: Open Joint Stock Company Clinical and Diagnostic Center Euromedservice ( Site 1122)

location_facility: Azienda Sanitaria Universitaria Friuli Centrale -ASU FC ( Site 0607)

location_facility: SPb SBHI City outpatient clinic 4 ( Site 1131)

location_facility: Limpopo Clinical Research Initiative ( Site 1227)

location_facility: Royal Free London NHS Foundation Trust ( Site 1700)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 1400)

location_facility: Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 0504)

location_facility: Hospital de Clinicas da Universidade Federal do Parana ( Site 0154)

location_facility: The Crofoot Research Center, Inc. ( Site 1812)

location_facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 0601)

location_facility: Chiba Aoba Municipal Hospital ( Site 0702)

location_facility: Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 1219)

location_facility: Central Scientific Research Institute of Epidemiology ( Site 1104)

location_facility: Köhler & Milstein Research S.A. de C.V. ( Site 0809)

location_facility: McGill University Health Centre ( Site 0204)

location_facility: Michigan Center of Medical Research ( Site 2500)

location_facility: Universitaetsklinikum Frankfurt ( Site 2302)

location_facility: Fundacion Santa Fe de Bogota ( Site 0412)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1301)

location_facility: Clinical Research Chile SpA ( Site 0308)

location_facility: Hamilton Medical Research Group ( Site 0207)

location_facility: Non profit municipal enterprise City hospital student of Kharkiv city council ( Site 1621)

location_facility: Limited Liability Company Medical center Healthy Happy ( Site 1625)

location_facility: Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 0600)

location_facility: Policlinico S. Orsola-Malpighi ( Site 0604)

location_facility: University of Nebraska Medical Center ( Site 2414)

location_facility: FUNFARME Hospital de Base Centro Integrado de Pesquisa ( Site 0151)

location_facility: Centro Cientifico Asistencial Jose Luis Accini ( Site 0416)

location_facility: Accellacare South London Quality Research Centre ( Site 1709)

location_facility: ICH Study Center GmbH & Co.KG ( Site 2306)

location_facility: Midway Immunology and Research Center ( Site 1837)

location_facility: Fundacion Hospital Alcorcon de Madrid ( Site 1314)

location_facility: Centrum Medyczne MEDYK Sp. z o.o. Sp.k. ( Site 1009)

location_facility: Mzansi Ethical Research Centre ( Site 1225)

location_facility: C.H.U. de Toulouse Hopital Purpan ( Site 0501)

location_facility: IRCCS Ospedale Policlinico San Martino ( Site 0603)

location_facility: St.Petersburg Outpatient Clinic No. 109 ( Site 1119)

location_facility: Municipal Enterprise Poltava Regional Clinical Infectious Hospital ( Site 1614)

location_facility: Advanced Research For Health Improvement LLC ( Site 1813)

location_facility: Lung Center of the Philippines ( Site 0902)

location_facility: Clinical Research Institute S.C. ( Site 0813)

location_facility: MNE Ivano-Frankivsk Regional Phthisiology-Pulmonology Center ( Site 1603)

location_facility: Medical Center Health Clinic ( Site 1623)

location_facility: Smorodintsev Research Institute of Influenza ( Site 1129)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800)

location_facility: Hospital Universitario La Paz ( Site 1300)

location_facility: Medical College Of Wisconsin ( Site 2510)

location_facility: Kyiv railway clinical hospital 2 of Branch Health center ( Site 1602)

location_facility: Centrum Medyczne Pulawska Sp. z o.o. ( Site 1007)

location_facility: Strategic Medical System LLC ( Site 1114)

location_facility: Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 2601)

location_facility: Right To Care Research - Esizayo ( Site 1229)

location_facility: Central Clinical Hospital with Polyclinic ( Site 1105)

location_facility: Clinical Research Partners, LLC. ( Site 2503)

location_facility: Enhancing Care Foundation-DICRS ( Site 1216)

location_facility: Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0810)

location_facility: MNCE -Odesa regional clinical hospital of Odesa regional council ( Site 1626)

location_facility: City Hospital No.33 of Leninsky ( Site 1127)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0415)

location_facility: Oaxaca Site Management Organization S.C. ( Site 0811)

location_facility: Hospital Regional de Alta Especialidad del Bajio ( Site 0807)

location_facility: Clinica Privada Dr. Jose Francisco Flores Lopez ( Site 2600)

location_facility: SPb SBHI City outpatient clinic 112 ( Site 1128)

location_facility: Swedish Medical Center First Hill ( Site 1807)

location_facility: CHU de la Reunion - Groupe Hospitalier Sud ( Site 0514)

location_facility: Groupe Hospitalier Pellegrin ( Site 0511)

location_facility: Fred Hutchinson Cancer Center ( Site 1829)

location_facility: Universitaetsklinikum Essen ( Site 2305)

location_facility: Amici Clinical Research LLC ( Site 2507)

location_facility: Hospital Universitario Infanta Leonor ( Site 1310)

location_facility: Ospedale Amedeo di Savoia, Malattie Infettive ( Site 0602)

location_facility: University of New Mexico, Health Sciences Center ( Site 1819)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0802)

location_facility: Santa Casa de Misericordia de Belo Horizonte ( Site 0150)

location_facility: Centro de Atencion e Investigacion Medica CAIMED ( Site 0413)

location_facility: ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 2301)

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 0700)

location_facility: Quirino Memorial Medical Center ( Site 0903)

location_facility: Jadestone Clinical Research, LLC ( Site 2502)

location_facility: AOU Policlinico Paolo Giaccone ( Site 0609)

location_facility: Medical Research Institute LLC ( Site 1116)

location_facility: Saint Hope Foundation, Inc. ( Site 1830)

location_facility: Advanced Medical Research, LLC ( Site 1864)

location_facility: National Taiwan University Hospital ( Site 3100)

location_facility: National Center for allergies and chest ( Site 3320)

location_facility: Emerson Clinical Research Institute ( Site 1828)

location_facility: Krakowskie Centrum Medyczne Sp. z o.o ( Site 1008)

location_facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0606)

location_facility: Municipal Noncommercial Enterprise Lviv 4th City Clinical Hospital ( Site 1622)

location_facility: Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ( Site 1605)

location_facility: NZOZ Centrum Medyczne Szpital Swietej Rodziny ( Site 1006)

location_facility: University Health Network - Toronto General Hospital ( Site 0201)

location_facility: Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 1100)

location_facility: Sahlgrenska Universitetssjukhuset Ostra ( Site 1401)

title: A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults With COVID-19.

type: Registry Identifier

location_country:
Germany
Poland
Argentina
Japan
Brazil
Chile
Canada
France
Colombia
United States
Ukraine
Philippines
Egypt
Italy
Guatemala
United Kingdom
Sweden
Mexico
Spain
South Africa
Taiwan
Russian Federation
Israel


acronym: SANCTUARY

lead_sponsor: Alexion Pharmaceuticals, Inc.

summary: The objectives of this study are to evaluate the safety and efficacy of ravulizumab administered by intravenous (IV) infusion compared to placebo and demonstrate proof-of-concept of the efficacy of terminal complement inhibition in participants with LN (LN Cohort) or IgAN (IgAN Cohort).

title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

location_country:
Germany
Italy
Poland
United Kingdom
Singapore
Australia
Sweden
Netherlands
United States
Korea, Republic of
Spain
Taiwan
Canada
France


title: A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center, International Study of Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma (KUNLUN)

acronym: KUNLUN

summary: This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study to assess the efficacy and safety of durvalumab administered concurrently with dCRT in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).

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.

location_country:
Poland
Japan
Brazil
Mexico
Belgium
United States
China
Korea, Republic of
Spain
Thailand
Turkey
Vietnam
Taiwan
Canada
Russian Federation
France


title: A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches

acronym: PANTHER

summary:
The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice.

Data will be collected both retrospectively and prospectively.

time_perspective: Other

lead_sponsor: Vascutek Ltd.

location_country:
Germany
Hungary
Netherlands
Belgium
United States
Canada
France

location_facility: University Hospitals Cleveland Medical Center

location_facility: University of South Florida - Tampa General

location_facility: Universitätsmedizin Mainz (University Hospital Mainz)

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital Civil

location_facility: Ludwig-Maximilian Universität (LMU) Klinikum

location_facility: Semmelweis University Heart and Vascular Center

intervention_type: Device


acronym: SOLAR

lead_sponsor: ViiV Healthcare

summary: This study is designed to assess the antiviral activity and safety of a two-drug regimen of CAB LA + RPV LA compared with maintenance of BIK. BIKTARVY is a registered trademark of Gilead Sciences.

ReferenceType: background

ReferenceCitation: Karver TS, Pascual-Bernaldez M, Berni A, Hnoosh A, Castagna A, Messiaen P, Puerto MJG, Bloch M, Adachi E, Sinclair G, Felizarta F, Angel JB, Sutton K, Sutherland-Phillips D, D'Amico R, Kerrigan D. Factors Associated with Health Care Providers' Preference for Forgoing an Oral Lead-In Phase When Initiating Long-Acting Injectable Cabotegravir and Rilpivirine in the SOLAR Clinical Trial. AIDS Patient Care STDS. 2023 Jan;37(1):53-59. doi: 10.1089/apc.2022.0168.

sponsor_collaborators:
ViiV Healthcare
Janssen, LP

title: A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every Two Months From a Bictegravir/Emtricitabine/Tenofovir Alafenamide Single Tablet Regimen in HIV-1 Infected Adults Who Are Virologically Suppressed

ipd_sharing_description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on ViiV's data sharing criteria can be found at: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/

location_country:
Germany
Ireland
Italy
United Kingdom
Australia
Japan
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Canada
France


title: A Non-Interventional Prospective Cohort Study of Patients With Persistent Symptoms of Schizophrenia to Describe The Course and Burden of Illness

summary: This multicenter, prospective, non-interventional study will evaluate the prevalence and characteristics of patients with persistent symptoms of schizophrenia and the course of their illness over 24 months.

ReferenceCitation: Domenech C, Pastore A, Altamura AC, Bernasconi C, Corral R, Elkis H, Evans J, Malla A, Margari F, Krebs MO, Nordstroem AL, Zink M, Haro JM. Correlation of Health-Related Quality of Life in Clinically Stable Outpatients with Schizophrenia. Neuropsychiatr Dis Treat. 2019 Dec 20;15:3475-3486. doi: 10.2147/NDT.S218578. eCollection 2019.

repository_institution: PubMed Central - Europe PMC

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

publisher_dissemination: Informa

ReferenceCitation: Franklin M, Mukuria C, Mulhern B, Tran I, Brazier J, Watson S. Measuring the Burden of Schizophrenia Using Clinician and Patient-Reported Measures: An Exploratory Analysis of Construct Validity. Patient. 2019 Aug;12(4):405-417. doi: 10.1007/s40271-019-00358-x.

evidence: open (via page says license)

repository_institution: University of Technology Sydney - Open Publications Of UTS Scholars

repository_institution: Newcastle Univesity - Newcastle University ePrints

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

ReferenceCitation: Domenech C, Bernasconi C, Moneta MV, Nordstroem AL, Cristobal-Narvaez P, Vorstenbosch E, Cobo J, Ochoa S, Haro JM. Health-related quality of life associated with different symptoms in women and in men who suffer from schizophrenia. Arch Womens Ment Health. 2019 Jun;22(3):357-365. doi: 10.1007/s00737-018-0896-0. Epub 2018 Aug 7.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
United Kingdom
Argentina
Brazil
Spain
Canada
France