title: A Descriptive Pharmaco-epidemiological Study of a Hypertensive Patient Population Treated With a Fixed-dose Combination of Telmisartan 80 mg and Hydrochlorothiazide 25 mg and of Conditions for the Management of Arterial Hypertension

summary: It is a national, retrospective , observational study in hypertensive patients treated for at least 8 weeks with the fixed dose combination of telmisartan 80 mg and hydrochlorothiazide 25 mg. The primary objective is to assess the control rate (systolic and diastolic blood pressure). Key secondary objectives are to assess the blood pressure reduction after at least 8 weeks of treatment, describe the population treated with this new fixed dose combination

lead_sponsor: Boehringer Ingelheim

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title: A Mirror Assessment of the Words Used By Patients and Physicians to Express Asthma Symptoms, According To the Patient's Level of Asthma Control In General Medicine

acronym: SYMPTOMES

summary: To evaluate the concordance of the most frequently used words by the patients and the physicians to express asthma symptoms, according to the patient's level of asthma control.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Cross-Sectional

enrollment_type: Actual

lead_sponsor: AstraZeneca

lead_sponsor_type: industriel

status_simplified: Completed


title: A European Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Enzalutamide Treatment in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

acronym: PREMISE

summary: The purpose of this study is to evaluate the effectiveness of enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) in the clinical practice setting as measured by time to treatment failure defined as the time from baseline (treatment initiation) to treatment discontinuation of enzalutamide for any reason including disease progression, skeletal related events, treatment toxicity, patient preference, or death.

study_start_date_type: Actual

time_perspective: Prospective

ipd_sharing: No

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

lead_sponsor: Astellas Pharma Europe Ltd.

sponsor_collaborators:
Astellas Pharma Europe Ltd.
Medivation, Inc.

location_country:
Germany
Ireland
Italy
Slovenia
Portugal
Hungary
United Kingdom
Denmark
Netherlands
Austria
Belgium
Spain
Greece
Czechia
Bulgaria
France

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intervention_type: Drug


title: Profile of Hypertensive Patients Seen in General Practitioner Consultation

acronym: Prophyl GP

summary: To evaluate (with sufficient accuracy) the profile(demographic and clinical characteristics, health care management) of hypertensive patients seen in general practitioner consultation.


title: Kinetics of Physiological and Symptomatic Responses to CardioPulmonary Exercise Testing (CPET) in Subjects With Persistent Exercise Intolerance After COVID-19: an Open-Source Exercise Network

summary:
This retrospective collaborative study on persistent exercise intolerance after COVID-19 offers to perform a large descriptive analysis of CPET performed in real-life by pulmonologists, cardiologists and physiologists. Indeed, these practicians are regularly consulted for a persistent intolerance to exercise expressed by dyspnea and/or frank fatigability sometimes associated with muscular or thoracic pain. When these complaints persist beyond 3 months after the first symptoms, it is legitimate to perform a CPET:

Either to evaluate the functional impact of an identified organ deficiency (e.g. myocarditis, pulmonary fibrosis, etc.),
Or, in the absence of formal arguments for an identified organ deficiency, to observe possible abnormalities in physiological responses during an incremental exercise test, likely to explain the persistence of symptoms and intolerance to exercise. Indeed, the recent literature highlights the presence of non-specific ventilatory and cardio-circulatory abnormalities leading to various physio-pathological observations. Unfortunately, these reports now concern relatively small numbers of patients with very diverse clinical forms of Covid, comorbidities and habitus.

In order to improve the understanding of persistent symptoms and in particular the diversity of physiological response presentations, the investigators propose to collect a very large amount of data through a web-based platform designed to collect the measurements made throughout the exercise test directly from the ergospirometer.

The relevant data covers the period from January 2, 2020 to December 31, 2022 (i.e. 35 months), The retrospective data collection will be carried out from February 1, 2023 to December 31, 2023.

The descriptive analysis will focus on the kinetics of all the variables measured and calculated on subgroups defined a priori on age, sex, comorbidities, acute covid severity, persistent symptoms post covid, regular habitual physical activity level, etc. according to the sample.

The study is expected to collect data from around 1000 patients and to involve around 40 French-speaking investigators. However, this collaborative study is open on request to all centers wishing to participate, as the web platform has been developed for data collection in English.

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Retrospective

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Gao Y, Chen R, Geng Q, Mo X, Zhan C, Jian W, Li S, Zheng J. Cardiopulmonary exercise testing might be helpful for interpretation of impaired pulmonary function in recovered COVID-19 patients. Eur Respir J. 2021 Jan 28;57(1):2004265. doi: 10.1183/13993003.04265-2020. Print 2021 Jan.

ReferenceCitation: Cortes-Telles A, Lopez-Romero S, Figueroa-Hurtado E, Pou-Aguilar YN, Wong AW, Milne KM, Ryerson CJ, Guenette JA. Pulmonary function and functional capacity in COVID-19 survivors with persistent dyspnoea. Respir Physiol Neurobiol. 2021 Jun;288:103644. doi: 10.1016/j.resp.2021.103644. Epub 2021 Feb 27.

ReferenceCitation: Gervasi SF, Pengue L, Damato L, Monti R, Pradella S, Pirronti T, Bartoloni A, Epifani F, Saggese A, Cuccaro F, Bianco M, Zeppilli P, Palmieri V. Is extensive cardiopulmonary screening useful in athletes with previous asymptomatic or mild SARS-CoV-2 infection? Br J Sports Med. 2021 Jan;55(1):54-61. doi: 10.1136/bjsports-2020-102789. Epub 2020 Oct 5.

ReferenceCitation: Mohr A, Dannerbeck L, Lange TJ, Pfeifer M, Blaas S, Salzberger B, Hitzenbichler F, Koch M. Cardiopulmonary exercise pattern in patients with persistent dyspnoea after recovery from COVID-19. Multidiscip Respir Med. 2021 Jan 25;16(1):732. doi: 10.4081/mrm.2021.732. eCollection 2021 Jan 15.

ReferenceCitation: Townsend L, Moloney D, Finucane C, McCarthy K, Bergin C, Bannan C, Kenny RA. Fatigue following COVID-19 infection is not associated with autonomic dysfunction. PLoS One. 2021 Feb 25;16(2):e0247280. doi: 10.1371/journal.pone.0247280. eCollection 2021.

ReferenceCitation: Motiejunaite J, Balagny P, Arnoult F, Mangin L, Bancal C, d'Ortho MP, Frija-Masson J. Hyperventilation: A Possible Explanation for Long-Lasting Exercise Intolerance in Mild COVID-19 Survivors? Front Physiol. 2021 Jan 18;11:614590. doi: 10.3389/fphys.2020.614590. eCollection 2020.

ReferenceCitation: Debeaumont D, Boujibar F, Ferrand-Devouge E, Artaud-Macari E, Tamion F, Gravier FE, Smondack P, Cuvelier A, Muir JF, Alexandre K, Bonnevie T. Cardiopulmonary Exercise Testing to Assess Persistent Symptoms at 6 Months in People With COVID-19 Who Survived Hospitalization: A Pilot Study. Phys Ther. 2021 Jun 1;101(6):pzab099. doi: 10.1093/ptj/pzab099.

ReferenceCitation: Dorelli G, Braggio M, Gabbiani D, Busti F, Caminati M, Senna G, Girelli D, Laveneziana P, Ferrari M, Sartori G, Dalle Carbonare L, Crisafulli E, On Behalf Of The Respicovid Study Investigators. Importance of Cardiopulmonary Exercise Testing amongst Subjects Recovering from COVID-19. Diagnostics (Basel). 2021 Mar 12;11(3):507. doi: 10.3390/diagnostics11030507.

ipd_sharing: Undecided

lead_sponsor: Association pour la Complementarite des Connaissances et des Pratiques de la Pneumologie

collaborators:
Menarini Group
Hylab, Grenoble
AstraZeneca

location_country: Canada Martinique Switzerland France

location_facility: Grenoble Alpes University Hosp. Michallon Nord

location_facility: Hosp. St Philibert GH Catholique Institute Lille

location_facility: Centre de Réadaptation Cardio-Respiratoire Dieulefit Santé

location_facility: Grenoble Alpes University Hosp. Michallon Sud

location_facility: AP-HP University Hosp. Pitié Salpêtrière

location_facility: SSR Marguerite Boucicaut French Red Cross

status_simplified: Ongoing


title: A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (Resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation

acronym: MAESTRO-NASH

summary: A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease

status: Active, not recruiting

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Harrison SA, Bashir M, Moussa SE, McCarty K, Pablo Frias J, Taub R, Alkhouri N. Effects of Resmetirom on Noninvasive Endpoints in a 36-Week Phase 2 Active Treatment Extension Study in Patients With NASH. Hepatol Commun. 2021 Jan 4;5(4):573-588. doi: 10.1002/hep4.1657. eCollection 2021 Apr.

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 pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Madrigal Pharmaceuticals, Inc.

location_country:
Germany
Italy
Poland
Hungary
Israel
United Kingdom
Australia
Switzerland
Austria
Belgium
Mexico
United States
Spain
Canada
Puerto Rico
France

location_facility: Gastrointestinal Associates and Endoscopy Center - Madison

location_facility: Nottingham University Hospitals NHS Trust

location_facility: University of Kansas Medical Center Research Institute

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: Texas Digestive Disease Consultants - San Marcos

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház

location_facility: Consorci Hospital General Universitari de València

location_facility: Covenant Metabolic Specialists - Fort Myers

location_facility: Centre Hospitalier Universitaire de Toulouse - Hôpital Rangueil

location_facility: The Institute for Liver Health - Glendale

location_facility: Charité Universitätsmedizin Berlin - Campus Mitte

location_facility: Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)

location_facility: Hunter Holmes McGuire Veterans Administration Medical Center

location_facility: Saint George's University Hospitals NHS Foundation Trust

location_facility: National Research Institute - Los Angeles

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Aintree University Hospitals NHS Foundation Trust

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: University of North Carolina Medical Center - Chapel Hill

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Kansas Medical Clinic - Gastroenterology

location_facility: Texas Digestive Disease Consultants - Bay Area Gastroenterology

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: University of Florida Hepatology Research at CTRB

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Walter Reed National Military Medical Center

location_facility: Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Texas Digestive Disease Consultants - Fort Worth

location_facility: Azienda Ospedaliera Universitaria Policlinico Gaetano Martino

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Gastro One - Germantown - Centre Oak Way

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: National Research Institute - Panorama City

location_facility: Bon Secours St. Mary's Hospital of Richmond

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern

location_facility: Centro de Investigacion y Gastroenterologia

location_facility: Centre Hospitalier Universitaire Amiens-Picardie

location_facility: Azienda Ospedaliera Universitaria-Maggiore della Carità di Novara

location_facility: Centro Mexicano de Desarrollo de Estudios Clínicos

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Toronto General Hospital - Clinical Trials Pharmacy

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: Abertawe Bro Morgannwg University Health Board

location_facility: Polo Universitario - L'Azienda Ospedaliera Luigi Sacco

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: South Texas Research Institute - Brownsville

location_facility: The Liver Institute at Methodist Dallas Medical Center

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

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Les Hôpitaux Universitaires de Strasbourg - Hôpital Hautepierre

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Magyarország Egészségügyi Szolgáltató - Gyula

location_facility: National Research Institute - Huntington Park

location_facility: Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge

location_facility: South Denver Gastroenterology - Swedish Medical Center Office

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: Debreceni Egyetem Kenézy Gyula Egyetemi Kórház

location_facility: The Institute for Liver Health - Chandler

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Center Hospitalier Universitaire d'Angers

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Centre Hospitalier Universitaire de Nice Hôpital l'Archet

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello

location_facility: Rambam Health Care Campus - Rambam Medical Center

location_facility: Assistance Publique-Hôpitaux de Paris Hôpital Cochin


acronym: (DECIDE)

lead_sponsor: Biogen

summary:
The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in participants with relapsing remitting multiple sclerosis.

The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population.

ReferenceCitation: Cohan S, Kappos L, Giovannoni G, Wiendl H, Selmaj K, Havrdova EK, Rose J, Greenberg S, Phillips G, Ma W, Wang P, Lima G, Sabatella G. Efficacy of daclizumab beta versus intramuscular interferon beta-1a on disability progression across patient demographic and disease activity subgroups in DECIDE. Mult Scler. 2018 Dec;24(14):1883-1891. doi: 10.1177/1352458517735190. Epub 2017 Oct 6.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: PubMed Central - Europe PMC

unpaywall_oa_status: hybrid

publisher_dissemination: SAGE Publications

ReferenceCitation: Benedict RH, Cohan S, Lynch SG, Riester K, Wang P, Castro-Borrero W, Elkins J, Sabatella G. Improved cognitive outcomes in patients with relapsing-remitting multiple sclerosis treated with daclizumab beta: Results from the DECIDE study. Mult Scler. 2018 May;24(6):795-804. doi: 10.1177/1352458517707345. Epub 2017 May 9.

ReferenceCitation: Liu Y, Vollmer T, Havrdova E, Riester K, Lee A, Phillips G, Wang P, Sabatella G. Impact of daclizumab versus interferon beta-1a on patient-reported outcomes in relapsing-remitting multiple sclerosis. Mult Scler Relat Disord. 2017 Jan;11:18-24. doi: 10.1016/j.msard.2016.11.005. Epub 2016 Nov 13.

oa_host_type: publisher

evidence: open (via crossref license)

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Krueger JG, Kircik L, Hougeir F, Friedman A, You X, Lucas N, Greenberg SJ, Sweetser M, Castro-Borrero W, McCroskery P, Elkins J. Cutaneous Adverse Events in the Randomized, Double-Blind, Active-Comparator DECIDE Study of Daclizumab High-Yield Process Versus Intramuscular Interferon Beta-1a in Relapsing-Remitting Multiple Sclerosis. Adv Ther. 2016 Jul;33(7):1231-45. doi: 10.1007/s12325-016-0353-2. Epub 2016 Jun 1.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Springer-Nature

ReferenceCitation: Kappos L, Wiendl H, Selmaj K, Arnold DL, Havrdova E, Boyko A, Kaufman M, Rose J, Greenberg S, Sweetser M, Riester K, O'Neill G, Elkins J. Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2015 Oct 8;373(15):1418-28. doi: 10.1056/NEJMoa1501481.

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

sponsor_collaborators: Biogen AbbVie

title: Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon β 1a) in Patients With Relapsing-Remitting Multiple Sclerosis

source: euctr

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Canada
Serbia
France
Czech Republic
Hungary
Denmark
Switzerland
United States
Ukraine
India
Romania
Moldova, Republic of
Italy
United Kingdom
Sweden
Mexico
Spain
Greece
Georgia
Russian Federation
Israel


lead_sponsor: Merck Sharp & Dohme LLC

summary: The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (DOR 100mg) and islatravir (ISL 0.75mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.

location_facility: Wojewódzki Szpital Zakaźny w Warszawie ( Site 1702)

location_facility: Holdsworth House Medical Practice ( Site 0700)

location_facility: Desmond Tutu Health Foundation ( Site 2402)

location_facility: Penn Medicine: University of Pennsylvania Health System-Perelman Center for Advanced Medicine ( Site

location_facility: Cantonal Hospital St.Gallen ( Site 2001)

location_facility: Hospital Universitario Fundación Jiménez Díaz-Internal Medicine. Infectious disease ( Site 1902)

location_facility: Bliss Healthcare Services-Research ( Site 0030)

location_facility: Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0202)

location_facility: Christchurch Hospital-Infectious Diseases ( Site 0800)

location_facility: North Texas Infectious Diseases Consultants, P.A-Research ( Site 0004)

location_facility: CHU Charles Nicolle-Inefectious disease ( Site 1506)

location_facility: Kuzbasskiy Center for the Prevention and Control of AIDS ( Site 2305)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 0903)

location_facility: CHU de Bordeaux Hop St ANDRE-Médecine interne et maladies infectieuses ( Site 1512)

location_facility: Fondazione IRCCS Policlinico San Matteo-Dipartimento di Malattie Infettive: SC Malattie Infettive (

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 0901)

location_facility: Ospedale Luigi Sacco-UOC Malattie Infettive I ( Site 1600)

location_facility: Krasnoyarsk Regional Center for the Prevention and Control of AIDS ( Site 2304)

location_facility: Tokyo Medical University Hospital ( Site 0904)

location_facility: Wrocl.Centr.Zdrowia SPZOZ Osr. Prof-Lecz Ch. Zak. i Terapii Uzaleznien ( Site 1703)

location_facility: Hôpital Saint-Louis-Infectious Diseases and tropical diseases ( Site 1511)

location_facility: KC CARE Health Center-Clinical Trials ( Site 0012)

location_facility: Sheldon M. Chumir Health Centre-Southern Alberta Clinic ( Site 0106)

location_facility: Hôpitaux Universitaires de Genève (HUG)-Infectious Disease Department ( Site 2004)

location_facility: Centro de Investigacion Clinicadela Universidad Catolica ( Site 0204)

location_facility: Brighton and Sussex University Hospitals NHS Trust ( Site 2104)

location_facility: Triple O Research Institute, P.A ( Site 0031)

location_facility: Icahn School of Medicine at Mount Sinai-Clinical and Translational Research Center ( Site 0006)

location_facility: Ospedale Regionale di Lugano, Sede Civico-Servizio Malattie Infettive ( Site 2005)

location_facility: Hospital Germans Trias i Pujol-Fundació Lluita contra la Sida ( Site 1901)

location_facility: Vancouver Infectious Diseases Centre ( Site 0100)

location_facility: The Crofoot Research Center ( Site 0008)

location_facility: Republican Clinical Hospital for Infectious Diseases A.F. Agafonova ( Site 2303)

location_facility: Fundacion Valle del Lili- CIC ( Site 0300)

location_facility: Scientific Advisory Clinical Diagnostic Center Central Resea-Federal AIDS Center ( Site 2302)

location_facility: Medizinische Hochschule Hannover-Department of Immunology and Rheumatology ( Site 1661)

location_facility: University Hospital Basel-Infectiology ( Site 2002)

location_facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 09

location_facility: Hospital General Universitario de Elche-Infectius Disease ( Site 1908)

location_facility: Hôpital Bichat - Claude-Bernard-infectious diseases ( Site 1523)

location_facility: WSS im. W Bieganskiego O. Chorob Zakaznych i Hepatologii-F ( Site 1701)

location_facility: Saint-Petersburg Center for Prophylactic of AIDS and Infecti-Saint-Petersburg Center for Prophylact

location_facility: Fondazione Policlinico Universitario Agostino Gemelli-UOC Malattie Infettive ( Site 1606)

location_facility: Hospital Universitario La Paz-Internal Medicine ( Site 1904)

location_facility: Texas Center for Infectious Disease Associates-Clinical Research ( Site 0026)

location_facility: Clinique de médecine Urbaine du Quartier Latin ( Site 0110)

location_facility: North Manchester General Hospital ( Site 2105)

location_facility: Inselspital Bern-Inselspital Infektiologie ( Site 2003)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 0906)

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu ( Site 1517)

location_facility: Moscow Infectious Diseases Clinical Hospital Number 2 ( Site 2306)

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1516)

location_facility: Chatham County Health Department - Chatham CARE Center-Infectious Disease ( Site 0015)

location_facility: Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 1508)

location_facility: Hospital Universitario Infanta Leonor ( Site 1906)

location_facility: Midway Immunology and Research Center ( Site 0033)

location_facility: Republican Clinical Infectious Hospital ( Site 2300)

location_facility: CHU de Toulouse-Infectious Disease-Tropical Diseases ( Site 1505)

location_facility: HOSPITAL CLÍNIC DE BARCELONA-Infection Day Hospital ( Site 1900)

location_facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-Unidad de Enfermedades Infecciosas ( Site 1903)

location_facility: Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0200)

location_facility: Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 0109)

location_facility: Tourcoing Hospital-Service Universitaire des Maladies Infectieuses et du Voyageur ( Site 1519)

location_facility: Georgetown University Medical Center-Clinical Trials Unit Division of Infectious Diseases ( Site 002

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1504)

location_facility: Hôpital de la Croix Rousse-Service des Maladies infectieuses et tropicales ( Site 1503)

location_facility: Smolensk Center for prevention and control of AIDS ( Site 2308)

location_facility: Biomedica Research Group-Infectology ( Site 0201)

location_facility: EMC Instytut Medyczny S. A. Przychodnia przy ul. Lowieckiej we Wroclawiu ( Site 1700)

location_facility: Ospedale San Raffaele-U.O. Malattie Infettive ( Site 1602)

title: A Phase 3 Open-label Rollover Clinical Study of Doravirine/Islatravir (DOR/ISL) Once-daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL Clinical Study

type: Other Identifier

type: Registry Identifier

type: EudraCT Number

location_country:
Germany
Italy
Poland
Colombia
New Zealand
United Kingdom
Australia
Japan
Switzerland
United States
Spain
South Africa
Chile
Canada
Russian Federation
France

ipd_sharing: Yes


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

acronym: RAINIER

summary: The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified level in serum at baseline.

status: Terminated

ReferenceCitation: Raghu G, Brown KK, Collard HR, Cottin V, Gibson KF, Kaner RJ, Lederer DJ, Martinez FJ, Noble PW, Song JW, Wells AU, Whelan TP, Wuyts W, Moreau E, Patterson SD, Smith V, Bayly S, Chien JW, Gong Q, Zhang JJ, O'Riordan TG. Efficacy of simtuzumab versus placebo in patients with idiopathic pulmonary fibrosis: a randomised, double-blind, controlled, phase 2 trial. Lancet Respir Med. 2017 Jan;5(1):22-32. doi: 10.1016/S2213-2600(16)30421-0. Epub 2016 Dec 7.

ReferenceType: result

ReferenceCitation: Humphries SM, O'Riordan TG, Zhang JJ, Bayly S, Sood R, Hayden A, Lynch DA; Relationship Baseline Fibrosis Score to Lung Function in A Clinical Trial Population with Idiopathic Pulmonary Fibrosis. ATS International Conference, 2016 May 13-18, San Francisco CA.

ReferenceCitation: Raghu G, Brown K, Collard H, Lederer D, Martinez F, Noble P, Song JW, Wells A, Whelan T, Moreau E, Patterson S, Bayly S, Chien J, Zhang J, O'Riordan T; Simtuzumab in Idiopathic Pulmonary Fibrosis: Results of a Randomized Clinical Trial. ERS Congress, 2016 September 3-7, London, UK.

ReferenceCitation: Raghu G, Brown KK, Collard HR, Lederer DJ, Martinez FJ, Noble PW, Song JW, Wells AU, Whalen TP, Lambert L, Chien JW, Zhang JJ, O'Riordan TG; Simtuzumab in Idiopathic Pulmonary Fibrosis (IPF): Baseline Demographic and Lung Function Data from a Clinical Trial. ATS International Conference, 2016 May 13-18, San Francisco CA.

lead_sponsor: Gilead Sciences

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Australia
Switzerland
Belgium
United States
Korea, Republic of
Spain
Czechia
Canada
France

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Università degli studi Federico II di Napoli

location_facility: Centre Hospitalier de L'Université de Montréal Hôtel-Dieu

location_facility: Froedtert Hospital and Medical College of Wisconsin

location_facility: Aintree University Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou

location_facility: Centre Hospitalier Universitaire Hôpital Nord

location_facility: Klinikum Großhadern der Ludwig-Maximilians-Universität München

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: University Hospital of South Manchester NHS Foundation Trust

location_facility: Temple University Hospital, Temple Lung Center

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)

location_facility: Universität Freiburg, Klinikum, Abt für Pneumologie

location_facility: University of California Davis Medical Center

location_facility: Hadassah-Hebrew University Medical Center

location_facility: Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH

location_facility: Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

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

location_facility: San Giuseppe Hospital, Dept. of Internal Medicine

location_facility: Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)

location_facility: Fondazione PTV - Policlinico Tor Vergata

location_facility: Saint Joseph's Hospital and Medical Center

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: Masarykova nemocnice v Ústí nad Labem o.z.

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: Hôpital Larrey, CHU de Toulouse, Service de Pneumologie

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: Hospital Universitario Central de Asturias

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 3 w Zabrzu Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec

location_facility: University of Pittsburgh Presbyterian - Montefiore

location_facility: 10 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ w Bydgoszczy

location_facility: Centre Hospitalier Universitaire de Nice-Hôpital Pasteur

location_facility: University of Iowa Hospitals and Clinics

location_facility: Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn

location_facility: Saint Luke's Midwest Pulmonary Consultants

location_facility: Centre Hospitalier Universitaire Grenoble Hopital Michalon

location_facility: Centre Hospitalier Universitaire Hôpital Avicenne

location_facility: Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau

status_simplified: Unknown


lead_sponsor: Celgene

summary: The purpose of this study is to compare the effect of azacitidine (Vidaza) to conventional care regimens on overall survival in elderly AML patients.

ReferenceCitation: Seymour JF, Dohner H, Butrym A, Wierzbowska A, Selleslag D, Jang JH, Kumar R, Cavenagh J, Schuh AC, Candoni A, Recher C, Sandhu I, Del Castillo TB, Al-Ali HK, Falantes J, Stone RM, Minden MD, Weaver J, Songer S, Beach CL, Dombret H. Azacitidine improves clinical outcomes in older patients with acute myeloid leukaemia with myelodysplasia-related changes compared with conventional care regimens. BMC Cancer. 2017 Dec 14;17(1):852. doi: 10.1186/s12885-017-3803-6.

license: cc-by

license_normalized: cc-by

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

repository_institution: Spanish National Research Council (CSIC) - DIGITAL.CSIC

repository_normalized: DIGITAL.CSIC (Spain)

repositories_concat: DIGITAL.CSIC (Spain);PubMed Central;University of Melbourne - Minerva Access;iris.unimore.it;www.repositoriosalud.es

ReferenceCitation: Dombret H, Seymour JF, Butrym A, Wierzbowska A, Selleslag D, Jang JH, Kumar R, Cavenagh J, Schuh AC, Candoni A, Recher C, Sandhu I, Bernal del Castillo T, Al-Ali HK, Martinelli G, Falantes J, Noppeney R, Stone RM, Minden MD, McIntyre H, Songer S, Lucy LM, Beach CL, Dohner H. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood. 2015 Jul 16;126(3):291-9. doi: 10.1182/blood-2015-01-621664. Epub 2015 May 18.

oa_colors: green other

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

version: acceptedVersion

repositories_concat: PubMed Central;repository.unab.edu.co

publisher_dissemination: American Society of Hematology

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Fakultni nemocnice Olomouc, hemato-onkologicka klinika

location_facility: Centre Hopitalier Universitaire Dupuytren

location_facility: IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Centre Hospitalier de l'Université de Montréal pavilion Notre Dame

location_facility: Katedra i Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku

location_facility: Azienda Sanitaria Ospedaliera "San Luigi Gonzaga"

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Chaim Sheba Medical Center - Tel Hashomer, Heart Institute

location_facility: Taipei Veterans General Hospital Pei-Tou District

location_facility: Centre Hospitalier Universitaire de Lyon-Hôpital Edouard Herriot

location_facility: Samodzielny Publiczny SK im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria

location_facility: University of Rostock, Div. of Haematology and Oncology

location_facility: Landeskliniken Salzburg Saint Johanns-Spital, III Medizinische Abteilung

location_facility: Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika

location_facility: Universitatsklinikum Essen, Zentrum fur Tumorforschung und Tumortherapie

location_facility: Hospital Avicenne, Service d'hematologie Clinique

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: State Healthcare Institution "Nizhny Novgorod N.A. Semashko Regional Clinical Hospital"

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Centre Hospitalier Universitaire Nantes, Hotel Dieu

location_facility: Azienda Ospedaliera Universitaria - Ospedali Riuniti di Ancona

location_facility: City Clinical Hospital n.a. S. P. Botkin

location_facility: Centre Hospitalier Régional Universitaire, Hôpital de Hautepierre

location_facility: Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine

location_facility: Azienda Ospedaliera Sant'Orsola Malpighi

location_facility: Centre Hospitalier Universitaire d'Amiens, Groupe Hospitalier Sud

location_facility: Saint Petersburg State Academician I.P. Pavlov Medical University

location_facility: Shanghai Changhai Hospital,the Second Military Medical University

location_facility: Dolnoslaskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku

title: A Phase 3, Multicenter, Randomized, Open-Label, Study of Azacitidine (Vidaza®) Versus Conventional Care Regimens for the Treatment of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Australia
Netherlands
Austria
Belgium
United States
China
Korea, Republic of
Spain
Taiwan
Czechia
Canada
Russian Federation
France