title: BREATHER (PENTA 16) Short-Cycle Therapy (SCT) (5 Days on/2 Days Off) in Young People With Chronic HIV-infection

acronym: BREATHER

summary:
The overall aim of the BREATHER trial is to evaluate the role of Short-Cycle Therapy (SCT) in the management of HIV-infected young people who have responded well to antiretroviral therapy (ART) and to determine whether young people with chronic HIV infection undergoing Short-Cycle Therapy of five days on ART and two days off maintain the same level of viral load suppression as those on continuous therapy, over 48 weeks.

To assess the advantages and disadvantages of the strategy, the incidence of toxicities, immunological control, resistance mutations, acceptability, quality of life and adherence to the randomised strategy will also be compared.

Importantly, because of insufficient data on short-term viral load rebound after stopping ART in this population, the trial will incorporate an initial pilot phase in selected centres, to assess the safety of the SCT strategy by evaluating detailed HIV-1 RNA profiles of participants on the SCT strategy.

ReferenceCitation: Turkova A, Moore CL, Butler K, Compagnucci A, Saidi Y, Musiime V, Nanduudu A, Kaudha E, Cressey TR, Chalermpantmetagul S, Scott K, Harper L, Montero S, Riault Y, Bunupuradah T, Volokha A, Flynn PM, Bologna R, Ramos Amador JT, Welch SB, Nastouli E, Klein N, Giaquinto C, Ford D, Babiker A, Gibb DM; BREATHER (PENTA 16) trial Group. Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents and young adults (BREATHER): Extended follow-up results of a randomised, open-label, non-inferiority trial. PLoS One. 2018 Apr 23;13(4):e0196239. doi: 10.1371/journal.pone.0196239. eCollection 2018.

repository_institution: University of Padova - Padua Research Archive

repository_institution: University College London - UCL Discovery

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

repository_normalized: dnet

ReferenceCitation: Bernays S, Paparini S, Seeley J, Namukwaya Kihika S, Gibb D, Rhodes T. Qualitative study of the BREATHER trial (Short Cycle antiretroviral therapy): is it acceptable to young people living with HIV? BMJ Open. 2017 Feb 17;7(2):e012934. doi: 10.1136/bmjopen-2016-012934.

repositories:
PubMed Central
UCL Discovery
researchonline.lshtm.ac.uk

publisher_dissemination: British Medical Journal

sponsor_collaborators:
PENTA Foundation
Medical Research Council
ANRS, Emerging Infectious Diseases

location_country:
Ireland
Germany
Uganda
United Kingdom
United States
Thailand
Ukraine
France

location_facility: HIV-NAT Thai Red Cross AIDS Research Centre

location_facility: Program for HIV Prevention and Treatment (PHPT)/IRD 174


title: Screening for Advanced Heart Failure Treatment (SEE-HF)

acronym: SEE-HF

summary: Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients are underserved. The purpose of this prospective, observational study is to obtain multi-center data on the proportion of patients with CRT and/or ICD who are candidates for advanced heart failure treatment and obtain insights into patient and physician decisions regarding referral for advanced heart failure therapy.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Abbott Medical Devices

sponsor_collaborators:
Abbott Medical Devices
Thoratec Europe Ltd

location_country:
Germany
France
United Kingdom
Denmark
Netherlands
Sweden

location_facility: University Hospital of South Manchester NHS Trust

lead_sponsor_type: industriel

status_simplified: Completed


title: Airflow Limitation in Cardiac Diseases in Europe

acronym: ALICE

summary: This is a cross-sectional, observational study, investigating the point prevalence of Airflow Limitation in current or former smokers with established ischemic heart disease. The study will recruit up to 3000 patients from cardiology clinics at hospitals across Europe.

time_perspective: Cross-Sectional

ReferenceType: derived

ReferenceCitation: Franssen FM, Soriano JB, Roche N, Bloomfield PH, Brusselle G, Fabbri LM, Garcia-Rio F, Kearney MT, Kwon N, Lundback B, Rabe KF, Raillard A, Muellerova H, Cockcroft JR. Lung Function Abnormalities in Smokers with Ischemic Heart Disease. Am J Respir Crit Care Med. 2016 Sep 1;194(5):568-76. doi: 10.1164/rccm.201512-2480OC.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: American Thoracic Society

lead_sponsor: GlaxoSmithKline

location_country: Germany Ireland Italy Sweden Netherlands Belgium Spain Greece France

intervention_type: Procedure


intervention_type: Drug

lead_sponsor: Chiesi Farmaceutici S.p.A.

summary: The purpose of this study is to demonstrate that CHF 1535 in pressurized metered dose inhaler (pMDI) is non-inferior to the corresponding dose of free combination of Beclomethasone (BDP) and Formoterol Fumarate (FF) and superior to the corresponding dose of BDP in terms of lung functions in asthmatic children patients.

location_facility: Spitalul Clinic Universitar de Urgenta Elias

location_facility: NZZ- Detská pneumologická a ftizeologická ambulanci

title: A Phase III, 12-week, Multicentre, Multinational, Randomised, Double-blind, Double-dummy, 3 Arm-parallel Group Study to Test the Efficacy of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate (BDP) Plus Formoterol Fumarate (FF)) Versus a Free Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate and Versus a Monotherapy of Beclomethasone Dipropionate in Partly Controlled Asthmatic Children

primary_purpose: Treatment

type: EudraCT Number

source: euctr

design_allocation: Randomized

location_country:
Germany
Italy
Poland
Slovakia
Hungary
Romania
Spain
Bulgaria
Ukraine
Russian Federation
France

study_type: Interventional


title: A Single-arm Dose-finding Phase Ib Multicenter Study of the Oral Smoothened Antagonist LDE225 in Combination With Nilotinib in Chronic or Accelerated Phase of Chronic Myeloid Leukemia Patients Who Have Failed Prior Therapy With Other BCR-ABL Tyrosine-kinase Inhibitors

summary: The purpose of this study is to determine the feasibility of administering the combination of nilotinib and LDE225 to patients with chronic or accelerated phase of chronic myeloid leukemia and to establish the maximum tolerated dose (MTD) and/or recommended Phase II dose level (RP2D) of LDE225 in combination with nilotinib.

lead_sponsor: Novartis Pharmaceuticals

location_country: Germany Italy Spain Canada France


title: A Registry Study of the AeriSeal® System or Lung Volume Reduction in Patients With Advanced Emphysema

summary: The purpose of this study is to provide post market clinical follow-up (PMCF) to obtain long term safety and efficacy information about the AeriSeal System treatment in patients with advanced emphysema.

status: Terminated

enrollment_type: Anticipated

lead_sponsor: Aeris Therapeutics

location_country: Germany Israel Austria France

location_facility: LMU Medizinische Klinik und Poliklinik Klinikum Großhadern

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Service de Pneumologie, Hôpital Pasteur, Centre Hospitalier Universitaire de Nice

status_simplified: Unknown


acronym: Bimatoprost 0.03% Preservative-free Ophthalmic Solution in Paediatric Glaucoma

lead_sponsor: Allergan

summary: The purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.

title: A Multicenter, Double-masked, Randomized, Active-controlled, Parallel Study of the Safety and Efficacy of Once-daily Bimatoprost Preservative-free Ophthalmic Solution Compared to Twice-daily Timolol Ophthalmic Solution in Paediatric Patients With Glaucoma

location_country:
Italy
United Kingdom
United States
Korea, Republic of
Taiwan
Philippines
France


study_start_date_type: Actual

acronym: OPTION

lead_sponsor: Astellas Pharma Europe Ltd.

summary: The purpose of this study is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body (Pharmacokinetics). The results will then help to decide how much Modigraf in future can be given safely to children and young people following transplantation.

ReferenceCitation: Webb NJA, Baumann U, Camino M, Frauca E, Undre N; OPTION Study Group. Pharmacokinetics of tacrolimus granules in pediatric de novo liver, kidney, and heart transplantation: The OPTION study. Pediatr Transplant. 2019 Feb;23(1):e13328. doi: 10.1111/petr.13328. Epub 2019 Jan 21.

oa_host_type: publisher

evidence: open (via page says Open Access)

host_type: publisher

license: unspecified-oa

license_normalized: unspecified-oa

version: publishedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: Wiley

location_facility:
Site 20
Site 31
Site 10
Site 50
Site 40
Site 22
Site 21
Site: 60
Site 13
Site 30

title: A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus Granules) in de Novo Paediatric Allograft Recipients

primary_purpose: Prevention

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Germany
Poland
United Kingdom
Belgium
Spain
France

ipd_sharing: Yes


title: Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)

summary: A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical delivery system, and crimper accessories.

ipd_sharing: No

lead_sponsor: Edwards Lifesciences

location_country:
Germany
United Kingdom
Austria
France

location_facility: University Hospital Essen, West German Heart Center

location_facility: Medizinische Universitat Wien Univ.Klinik f.Chirurgie

intervention_type: Device


type: Other Identifier

title: BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus Program

summary: This is an observational survey to assess the factors that influence adherence to Betaferon therapy in multiple sclerosis patients using elements of the BetaPlus support program, including the nurse support and auto-injectors. The patients were evaluated under normal clinical practice and were asked to fill out the quality of life FAMS questionnaire, Coping processes (WCQ - Ways of Coping Questionnaire) and depression questionnaire CES-D.

ReferenceType: result

ReferenceCitation: Pozzilli C, Schweikert B, Ecari U, Oentrich W; BetaPlus Study group. Supportive strategies to improve adherence to IFN beta-1b in multiple sclerosis--results of the betaPlus observational cohort study. J Neurol Sci. 2011 Aug 15;307(1-2):120-6. doi: 10.1016/j.jns.2011.04.026. Epub 2011 Jun 1.

lead_sponsor: Bayer

location_country:
Germany
Italy
Taiwan
Portugal
Israel
Iran, Islamic Republic of
Netherlands
Lebanon
Korea, Republic of
Saudi Arabia
Spain
Turkey
Jordan
Czech Republic
France


title: VANTAGE STUDY Vercise™ Implantable Stimulator for Treating Parkinson's Disease

acronym: VANTAGE

summary: The purpose of this study is to document patient outcomes, including effectiveness, safety, and health economic data, for the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) in the treatment of moderate to severe idiopathic Parkinson's Disease (PD).

ReferenceCitation: Timmermann L, Jain R, Chen L, Maarouf M, Barbe MT, Allert N, Brucke T, Kaiser I, Beirer S, Sejio F, Suarez E, Lozano B, Haegelen C, Verin M, Porta M, Servello D, Gill S, Whone A, Van Dyck N, Alesch F. Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study. Lancet Neurol. 2015 Jul;14(7):693-701. doi: 10.1016/S1474-4422(15)00087-3. Epub 2015 May 28.

publisher_dissemination: Elsevier

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Italy
United Kingdom
Austria
Spain
France

location_facility:
Uniklinik Köln
Allgemeines Krankenhaus AKH
Frenchay Hospital
CHU de Rennes-Pontchaillou
IRCCS Istituto Ortopedico Galeazzi
Hospital Central de Asturias
Southmead Hospital Bristol


title: A 24-Week, Flexible-Dose, Open-Label Extension Study of Lurasidone for the Treatment of Bipolar I Depression

summary: This clinical study is designed to test the hypothesis that lurasidone is effective, tolerable, and safe for the treatment of patients with bipolar I depression

ReferenceCitation: Forester BP, Sajatovic M, Tsai J, Pikalov A, Cucchiaro J, Loebel A. Safety and Effectiveness of Long-Term Treatment with Lurasidone in Older Adults with Bipolar Depression: Post-Hoc Analysis of a 6-Month, Open-Label Study. Am J Geriatr Psychiatry. 2018 Feb;26(2):150-159. doi: 10.1016/j.jagp.2017.08.013. Epub 2017 Oct 10.

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

lead_sponsor: Sumitomo Pharma America, Inc.

location_country:
Lithuania
Poland
Colombia
India
Slovakia
Romania
Japan
United States
South Africa
Peru
Canada
Ukraine
Czech Republic
Russian Federation
France

location_facility: Crimean republican Clinical Psychiatric Hospital

location_facility: Spitalul Clinic Judetean de Urgenta Cluj

location_facility: Kaunas Hospital Division Marui Hospital, Public Institution

location_facility: City Psychiatric Hospital #2 of St. Nikolay Chudotvorets

location_facility: Brij Psychiatry Hospital & Muskaan Research Centre

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

location_facility: Cosmos Hospitals-Delhi Psychiatry Center-Dept. of Psychiatry

location_facility: Vijayawada Institute of Mental Health and Neurosciences, Psychiatry

location_facility: Bekhterev Scientific Research Psychoneurological Institute

location_facility: Pro mente sana s.r.o. Psychiaricka ambulancia

location_facility: Com. Inst. "Dnipropetrovsk Reg. Cl. Psych. Hosp." DSMA

location_facility: Kyiv City Psychoneurological Hospital #2

location_facility: Hopital Caremeau, Service de Psychiatrie A

location_facility: Spitalul Clinic de Neuropsihiatrie Craiova

location_facility: Reg. Ci.Ps.H.n.a.O.F.Maltsev, Fem.Ac.Gen.Ps. D.5B,HESIU UM

location_facility: University of South Florida Institute - Tampa

location_facility: University of California at Irvine Medical Center

location_facility: Centro de Investigaciones del Sistema Nerviosa Limitada-Gr

location_facility: Centrum zdravia R. B.K. s.r.o. Psychiatricka ambulancia

location_facility: Silutes Mental Health and Psychotherapy Center, JSC

location_facility: Russian State Medical University of RosZdrav

location_facility: Kohnodai Hp., National Center for Global Health and Medicine

location_facility: Artemis Institute for Clinical Research LLC

location_facility: Zapor Reg. Cl. Hosp., Zaporizhzhia SMU, ENT Dept.

location_facility: Zirmunai Mental Health Center, Public Institution

location_facility: Seskines Outpatient Clinic, Public Institution

location_facility: R.K. Yadav Memorial Mental Health & De-Addiction Hospital Psychiatry

location_facility: Mental Illness Treatment Rehabilitation Foundation (MITR)

location_facility: Spitalul Clinic de Urgenta Militar Central

location_facility: Odesa SMU, based on Odessa Reg. Psychiatric Hosp.#1

location_facility: Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital

location_facility: Nemocnica s poliklinikou sv Barbory Roznava a.s. Psychiatricke oddelenie

location_facility: Seth K M School of P G Medicine & Research

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

location_facility: Brain Mind Behaviour Neurosciences Research Institute

location_facility: Reg. Clin. Psychiatric Hosp. DSMU n.af.M.Gorkiy

location_facility: Mahatma Gandhi Institute of Medical Sciences

location_facility: Saint Anne, s.r.o., Psychiatricke oddeleni

location_facility: Spitalul Clinic de Neurologie si Psihiatrie Oradea

location_facility: Centro de Investigacion y Atencion para la Salud Mental

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Psychiatricka klinika

location_facility: National Center of Neurology and Psychiatry

location_facility: Nemocnica s poliklinikou Liptovsky Mikulas Psychiatricke oddelenie

location_facility: LLC International Medical Centre "SOGAZ"

location_facility: PsychoLine s.r.o. Psychiatricka ambulancia

location_facility: Lviv Reg.St.Cl.Psych.Hosp.Dept.#20, LNMU n.a.D. Halytskiy Chair of Psychiatry, Psychology and Sexololgy

location_facility: California Neuropsychopharmacology Clinical Research Instit

location_facility: Ternopil Regional Municipal Dispensary, Narcology Dept., Ch. of Neurol. Psych. Narcol. & Med. Psychol.

location_facility: St.In."Inst. of Neurol., Psych. and Narcol. of the AMSU"

location_facility: Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach Psychiatricke oddelenie

location_facility: Centrul de Recuperare si Reabilitare Gura Ocnitei

location_facility: Moscow Medical Academy name I.M. Sechenov

location_facility: MCB Clinical Research Centers-Colorado Springs

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations


title: A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression

ReferenceCitation: Loebel A, Cucchiaro J, Silva R, Kroger H, Hsu J, Sarma K, Sachs G. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014 Feb;171(2):160-8. doi: 10.1176/appi.ajp.2013.13070984.

publisher_dissemination: American Psychiatric Association Publishing

ReferenceCitation: Raison CL, Pikalov A, Siu C, Tsai J, Koblan K, Loebel A. C-reactive protein and response to lurasidone in patients with bipolar depression. Brain Behav Immun. 2018 Oct;73:717-724. doi: 10.1016/j.bbi.2018.08.009. Epub 2018 Aug 10.

license: cc-by

license_normalized: cc-by

ReferenceCitation: Sajatovic M, Forester BP, Tsai J, Kroger H, Pikalov A, Cucchiaro J, Loebel A. Efficacy of Lurasidone in Adults Aged 55 Years and Older With Bipolar Depression: Post Hoc Analysis of 2 Double-Blind, Placebo-Controlled Studies. J Clin Psychiatry. 2016 Oct;77(10):e1324-e1331. doi: 10.4088/JCP.15m10261.

evidence: open (via free pdf)

license_normalized: no license

unpaywall_oa_status: bronze

publisher_dissemination: Physicians Postgraduate Press, Inc

ReferenceCitation: Rajagopalan K, Bacci ED, Ng-Mak D, Wyrwich K, Pikalov A, Loebel A. Effects on health-related quality of life in patients treated with lurasidone for bipolar depression: results from two placebo controlled bipolar depression trials. BMC Psychiatry. 2016 May 23;16:157. doi: 10.1186/s12888-016-0865-y.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Chapel S, Chiu YY, Hsu J, Cucchiaro J, Loebel A. Lurasidone Dose Response in Bipolar Depression: A Population Dose-response Analysis. Clin Ther. 2016 Jan 1;38(1):4-15. doi: 10.1016/j.clinthera.2015.11.013. Epub 2015 Dec 22.

ReferenceCitation: Loebel A, Siu C, Rajagopalan K, Pikalov A, Cucchiaro J, Ketter TA. Recovery in bipolar depression: Post-hoc analysis of a placebo-controlled lurasidone trial followed by a long-term continuation study. J Affect Disord. 2015 Nov 1;186:376-82. doi: 10.1016/j.jad.2015.07.033. Epub 2015 Aug 5.

ReferenceCitation: McIntyre RS, Cucchiaro J, Pikalov A, Kroger H, Loebel A. Lurasidone in the treatment of bipolar depression with mixed (subsyndromal hypomanic) features: post hoc analysis of a randomized placebo-controlled trial. J Clin Psychiatry. 2015 Apr;76(4):398-405. doi: 10.4088/JCP.14m09410.

location_country:
India
Romania
United States
South Africa
Ukraine
Czech Republic
Russian Federation
France

location_facility: Collaborative Neuroscience Network Inc.,12772 Valley View Street,Suite 3

location_facility: Excell Research, Inc,3998 Vista Way,Suite 100

location_facility: Spitalul Clinic de Urgenta Militar Central

location_facility: Chair of Psychiatry and Medical Psychology

location_facility: Reg Cl.Ps.H.n.a.O.F. Malstev, Fem.Ac. Gen. Ps.D.5B

location_facility: Spitalul Clinic Judetean de Urgenta Cluj

location_facility: Reg. Psych. Hosp.n.a.O.Yuschenko, Dept #21

location_facility: Albuquerque Neuroscience Inc., 101 Hospital Loop, NE, Suite 209

location_facility: Hopital Caremeau, Service de Psychiatrie A

location_facility: Spitalul Clinic de Neuropsihiatrie Craiova

location_facility: City Psychiatric Hospital #2 of St. Nikolay Chudotvorets

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

location_facility: Florida Clinical Research Center, LLC,2300 Maitland Center Parkway,Suite 230

location_facility: University of California at Irvine Medical Center

location_facility: Seth K M School of P G Medicine & Research

location_facility: California Neuropsychopharmacology,CNRI - Los Angeles LLC,8309 Telegraph Road

location_facility: Depression and Anxiety Disorders Research Institute

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

location_facility: California Neuropsychopharmacology Clinical Research Institute, LLC,466 26th Street,6th Floor

location_facility: Vijayawada Institute of Mental Health and Neurosciences, Psychiatry

location_facility: Bekhterev Scientific Research Psychoneurological Institute

location_facility: FutureSearch Clinical Trials, LLC.,4200 Marathon Blvd.,Suite 200

location_facility: Richard H. Weisler., M.D., P.A., & Associates,700 Spring Forest Road,Suite 125

location_facility: Janus Center for Psychiatric Research,5601 Corporate Way,Suite 103

location_facility: CRI Cl.Psych.Hosp. #1, Fem. Psych. Dept. #2, Male I

location_facility: Sheppard Pratt Health System,6501 North Charles Street

location_facility: R.K. Yadav Memorial Mental Health & De-Addiction Hospital

location_facility: Mental Illness Treatment Rehabilitationi Foundation

location_facility: American Medical Research Inc.,1200 Harger Road Suite 415

location_facility: Florida Clinical Research Center, LLC,3914 State Road 64 East


type: Other Grant/Funding Number

title: Evaluation of Integrated Cardiac Imaging for the Detection and Characterization of Ischemic Heart Disease

acronym: EVINCI

summary:
Main purpose of the study:

To comparatively assess the diagnostic performance of non invasive anatomical and functional imaging modalities to detect significant obstructive coronary artery disease as demonstrated at invasive coronary angiography and functional evaluation of coronary lesions (fractional flow reserve).

primary_purpose: Diagnostic

ReferenceCitation: Caselli C, De Caterina R, Smit JM, Campolo J, El Mahdiui M, Ragusa R, Clemente A, Sampietro T, Clerico A, Liga R, Pelosi G, Rocchiccioli S, Parodi O, Scholte A, Knuuti J, Neglia D; EVINCI and SMARTool. Triglycerides and low HDL cholesterol predict coronary heart disease risk in patients with stable angina. Sci Rep. 2021 Oct 20;11(1):20714. doi: 10.1038/s41598-021-00020-3.

repository_institution: Leiden University - Leiden Repository

ReferenceCitation: Caselli C, Del Turco S, Ragusa R, Lorenzoni V, De Graaf M, Basta G, Scholte A, De Caterina R, Neglia D. Association of PCSK9 plasma levels with metabolic patterns and coronary atherosclerosis in patients with stable angina. Cardiovasc Diabetol. 2019 Oct 31;18(1):144. doi: 10.1186/s12933-019-0949-3.

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_normalized: Zenodo

repositories:
PubMed Central
Zenodo
www.iris.sssup.it

repositories_concat: PubMed Central;Zenodo;www.iris.sssup.it

ReferenceCitation: Carpeggiani C, Picano E, Brambilla M, Michelassi C, Knuuti J, Kauffman P, Underwood SR, Neglia D; EVINCI Study Investigators. Variability of radiation doses of cardiac diagnostic imaging tests: the RADIO-EVINCI study (RADIationdOse subproject of the EVINCI study). BMC Cardiovasc Disord. 2017 Feb 16;17(1):63. doi: 10.1186/s12872-017-0474-9.

repository_institution: University of Turku - UTUPub

repository_institution: Imperial College London - Spiral

ReferenceCitation: Neglia D, Rovai D, Caselli C, Pietila M, Teresinska A, Aguade-Bruix S, Pizzi MN, Todiere G, Gimelli A, Schroeder S, Drosch T, Poddighe R, Casolo G, Anagnostopoulos C, Pugliese F, Rouzet F, Le Guludec D, Cappelli F, Valente S, Gensini GF, Zawaideh C, Capitanio S, Sambuceti G, Marsico F, Perrone Filardi P, Fernandez-Golfin C, Rincon LM, Graner FP, de Graaf MA, Fiechter M, Stehli J, Gaemperli O, Reyes E, Nkomo S, Maki M, Lorenzoni V, Turchetti G, Carpeggiani C, Marinelli M, Puzzuoli S, Mangione M, Marcheschi P, Mariani F, Giannessi D, Nekolla S, Lombardi M, Sicari R, Scholte AJ, Zamorano JL, Kaufmann PA, Underwood SR, Knuuti J; EVINCI Study Investigators. Detection of significant coronary artery disease by noninvasive anatomical and functional imaging. Circ Cardiovasc Imaging. 2015 Mar;8(3):e002179. doi: 10.1161/CIRCIMAGING.114.002179.

repository_institution: University of Zurich - Zurich Open Repository and Archive

lead_sponsor: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

location_country:
Finland
Italy
Germany
Poland
United Kingdom
Netherlands
Switzerland
Spain
France

location_facility:
TUM
UniNA
NIC
U.Turku
Ospedale Versilia
QUEEN MARY Hospital London
APHP
UZH
FGM
LUMC
KAE Goeppingen
UniGE
SERMAS
RBHT
CNR
Huvhebron


lead_sponsor: Ineos Healthcare Limited

summary:
Magnesium iron hydroxycarbonate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.

The purpose of this study is to assess the efficacy of magnesium iron hydroxycarbonate in subjects requiring hemodialysis, compared with a marketed phosphate binder, lanthanum carbonate and placebo.

location_facility: Western Nephrology & Metabolic Bone Disease PC

location_facility: Faculdade de Ciencias Medicas de Sorocaba - Hosp Santa Lucin

location_facility: Internal Medicine Kidney and Hypertension Center

location_facility: Scott and White Memorial Hospital and Clinic

location_facility: Kansas Nephrology Research Institute LLC

location_facility: NZOZ Miedzynarodowe Centrum Dializ Poznan Odz. Rawicz

location_facility: SC Nephrology & Hypertension Center Inc.

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Hospital Universitario da Univ Federal de Juiz de Fora

location_facility: Nephrology Associates of Northern Virginia

location_facility: London Health Science Centre - University Campus Site

location_facility: Universidade Federal de Sao Paulo - UNIFESP

location_facility: Nephrology Educational Services and Research

location_facility: Brookdale Physicians Dialysis Associates

location_facility: Long Island Hypertension and Nephrology PLLC

location_facility: Arizona Kidney Disease and Hypertension Center

location_facility: Clinical Research Associates of Tidewater

title: An Open, Randomized, Controlled, Parallel Group, Phase III Study to Investigate the Safety and Efficacy of Fermagate and Lanthanum Carbonate Together With a Randomized Placebo Controlled Double Blind Fermagate Comparison in Hemodialysis Patients With Hyperphosphatemia

study_completion_date_type: Anticipated

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Malta
United States
Spain
South Africa
Canada
France


summary: The purpose of this multicenter, single-arm, exact binomial single-stage, phase II trial is to evaluate the efficacy of Nilotinib in patients with unresectable or metastatic gastrointestinal stromal tumors

status: Active, not recruiting

title: An Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy of Nilotinib in Adult Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line Treatment

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

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

design_allocation: Non-Randomized

location_country: Finland Italy Germany France

status_simplified: Ongoing


title: A Randomized, Placebo-controlled Study of the Safety, Tolerability and Effect on Endothelial Function, as Measured by Flow Mediated Dilatation, of RO4607381 in Patients With Coronary Heart Disease (CHD) or CHD Risk Equivalents.

summary: This study will assess the safety, tolerability and efficacy of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents. Patients will be randomized to receive either RO4607381 600mg po daily or placebo po daily. Endothelial function will be measured by flow mediated dilatation and blood pressure monitoring will be assessed. The anticipated time on study treatment is up to 12 months, and the target sample size is up to 500 individuals.

ReferenceCitation: Luscher TF, Taddei S, Kaski JC, Jukema JW, Kallend D, Munzel T, Kastelein JJ, Deanfield JE; dal-VESSEL Investigators. Vascular effects and safety of dalcetrapib in patients with or at risk of coronary heart disease: the dal-VESSEL randomized clinical trial. Eur Heart J. 2012 Apr;33(7):857-65. doi: 10.1093/eurheartj/ehs019. Epub 2012 Feb 16.

ReferenceCitation: Kastelein JJ, Duivenvoorden R, Deanfield J, de Groot E, Jukema JW, Kaski JC, Munzel T, Taddei S, Lehnert V, Burgess T, Kallend D, Luscher TF. Rationale and design of dal-VESSEL: a study to assess the safety and efficacy of dalcetrapib on endothelial function using brachial artery flow-mediated vasodilatation. Curr Med Res Opin. 2011 Jan;27(1):141-50. doi: 10.1185/03007995.2010.536207. Epub 2010 Dec 6.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
United Kingdom
Netherlands
Austria
Switzerland
France


title: Idiopathic Pulmonary Fibrosis International Group Exploring NAC I Annual Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF)

acronym: IFIGENIA

summary: The purpose of this study is to determine whether NAC added to prednisone, and azathioprine has a better effect on lung function, radiology and clinical condition than placebo + prednisone in combination with azathioprine after 6 and 12 months.

ReferenceCitation: Demedts M, Behr J, Buhl R, Costabel U, Dekhuijzen R, Jansen HM, MacNee W, Thomeer M, Wallaert B, Laurent F, Nicholson AG, Verbeken EK, Verschakelen J, Flower CD, Capron F, Petruzzelli S, De Vuyst P, van den Bosch JM, Rodriguez-Becerra E, Corvasce G, Lankhorst I, Sardina M, Montanari M; IFIGENIA Study Group. High-dose acetylcysteine in idiopathic pulmonary fibrosis. N Engl J Med. 2005 Nov 24;353(21):2229-42. doi: 10.1056/NEJMoa042976.

ReferenceCitation: Behr J, Demedts M, Buhl R, Costabel U, Dekhuijzen RP, Jansen HM, MacNee W, Thomeer M, Wallaert B, Laurent F, Nicholson AG, Verbeken EK, Verschakelen J, Flower CD, Petruzzelli S, De Vuyst P, van den Bosch JM, Rodriguez-Becerra E, Lankhorst I, Sardina M, Boissard G; IFIGENIA study group. Lung function in idiopathic pulmonary fibrosis--extended analyses of the IFIGENIA trial. Respir Res. 2009 Oct 27;10(1):101. doi: 10.1186/1465-9921-10-101.

lead_sponsor: Zambon SpA

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
Spain
France

location_facility: The University of Edinburgh-Medical School


title: Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants

acronym: NEOBRAIN

summary: NEOBRAIN brings together small and medium sized enterprises (SMEs), industry and academic groups devoted to the diagnosis, management, and neuroprotection in newborns with perinatal brain damage. The focus of NEOBRAIN is to identify strategies prevention of brain damage mainly observed in preterm newborns. (Copy from www.neobrain.eu)

ReferenceType: background

ReferenceCitation: Dammann O, Cesario A, Hallen M. NEOBRAIN--an EU-funded project committed to protect the newborn brain. Neonatology. 2007;92(4):217-8. doi: 10.1159/000102967. Epub 2007 May 21. No abstract available.

lead_sponsor: Hannover Medical School

sponsor_collaborators:
Hannover Medical School
European Commission

location_country: Germany Italy Sweden Netherlands Austria Switzerland France

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Fondazione I.R.C.C.S Ospedale Maggiore Policlinico MA.RE.


title: A Randomized, Open-label, Active-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride (HCl) Formulation Versus 5% Amorolfine Nail Lacquer for 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis

summary: This study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in patients with mild to moderate toenail onychomycosis, for a total treatment duration of 48 weeks.

lead_sponsor: Novartis

location_country:
Finland
Germany
Poland
Hungary
Norway
Spain
Turkey
Iceland
Russian Federation
France


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Fixed-Dose, 8-Week Treatment, Multi-Center Trial Evaluating the Efficacy and the Safety of 3 Oral Doses of Surinabant as an Aid to Smoking Cessation in Cigarette Smokers

summary:
Surinabant is a new, potent and selective antagonist for the cannabinoid CB1 receptor, which might be clinically useful in the treatment of dependence to nicotine.

The primary study objective is the assessment of efficacy of 3 doses of surinabant on abstinence from smoking in cigarette smokers. The main secondary objectives are the effect of surinabant on body weight and its clinical and biological safety.

ReferenceCitation: Tonstad S, Aubin HJ. Efficacy of a dose range of surinabant, a cannabinoid receptor blocker, for smoking cessation: a randomized controlled clinical trial. J Psychopharmacol. 2012 Jul;26(7):1003-9. doi: 10.1177/0269881111431623. Epub 2012 Jan 4.

lead_sponsor: Sanofi

location_country: Germany Italy Norway Sweden Switzerland Belgium Spain France


title: A Randomized Comparison of a Biolimus-Eluting Stent With a Sirolimus-Eluting Stent for Percutaneous Coronary Intervention

acronym: LEADERS

summary: The purpose of this study is to compare the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a non-inferiority trial.

ReferenceCitation: Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Juni P. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008 Sep 27;372(9644):1163-73. doi: 10.1016/S0140-6736(08)61244-1. Epub 2008 Aug 31.

ReferenceCitation: Garg S, Sarno G, Serruys PW, de Vries T, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, Di Mario C, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Juni P, Windecker S. The twelve-month outcomes of a biolimus eluting stent with a biodegradable polymer compared with a sirolimus eluting stent with a durable polymer. EuroIntervention. 2010 Jun;6(2):233-9.

ReferenceCitation: Sarno G, Garg S, Onuma Y, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, van Geuns RJ, Eerdmans P, Garcia-Garcia HM, van Es GA, Goedhart D, de Vries T, Juni P, Meier B, Windecker S, Serruys P. The impact of body mass index on the one year outcomes of patients treated by percutaneous coronary intervention with Biolimus- and Sirolimus-eluting stents (from the LEADERS Trial). Am J Cardiol. 2010 Feb 15;105(4):475-9. doi: 10.1016/j.amjcard.2009.09.055. Epub 2010 Jan 5.

ReferenceCitation: Wykrzykowska JJ, Serruys PW, Onuma Y, de Vries T, van Es GA, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di Mario C, van Geuns RJ, Juni P, Windecker S. Impact of vessel size on angiographic and clinical outcomes of revascularization with biolimus-eluting stent with biodegradable polymer and sirolimus-eluting stent with durable polymer the LEADERS trial substudy. JACC Cardiovasc Interv. 2009 Sep;2(9):861-70. doi: 10.1016/j.jcin.2009.05.024.

ReferenceCitation: Wykrzykowska JJ, Raber L, de Vries T, Bressers M, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Regar E, Juni P, Windecker S, Serruys PW. Biolimus-eluting biodegradable polymer versus sirolimus-eluting permanent polymer stent performance in long lesions: results from the LEADERS multicentre trial substudy. EuroIntervention. 2009 Aug;5(3):310-7. doi: 10.4244/v5i3a49.

ReferenceCitation: Yuan H, Wu Z, Lu T, Wei T, Zeng Y, Liu Y, Huang C. Comparison of biodegradable and durable polymer drug-eluting stents in acute coronary syndrome: a meta-analysis. BMJ Open. 2022 Jun 8;12(6):e058075. doi: 10.1136/bmjopen-2021-058075.

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Koskinas KC, Siontis GC, Piccolo R, Franzone A, Haynes A, Rat-Wirtzler J, Silber S, Serruys PW, Pilgrim T, Raber L, Heg D, Juni P, Windecker S. Impact of Diabetic Status on Outcomes After Revascularization With Drug-Eluting Stents in Relation to Coronary Artery Disease Complexity: Patient-Level Pooled Analysis of 6081 Patients. Circ Cardiovasc Interv. 2016 Feb;9(2):e003255. doi: 10.1161/CIRCINTERVENTIONS.115.003255.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Grundeken MJ, Wykrzykowska JJ, Ishibashi Y, Garg S, de Vries T, Garcia-Garcia HM, Onuma Y, de Winter RJ, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Meier B, Juni P, Yazdani A, Copt S, Windecker S, Serruys PW. First generation versus second generation drug-eluting stents for the treatment of bifurcations: 5-year follow-up of the LEADERS all-comers randomized trial. Catheter Cardiovasc Interv. 2016 Jun;87(7):E248-60. doi: 10.1002/ccd.26344. Epub 2015 Dec 9.

ReferenceCitation: Zhang YJ, Iqbal J, Windecker S, Linke A, Antoni D, Sohn HY, Corti R, van Es GA, Copt S, Eerdmans P, Saitta R, Morice MC, Di Mario C, Juni P, Wijns W, Buszman P, Serruys PW. Biolimus-eluting stent with biodegradable polymer improves clinical outcomes in patients with acute myocardial infarction. Heart. 2015 Feb;101(4):271-8. doi: 10.1136/heartjnl-2014-306359. Epub 2014 Nov 25.

oa_host_type: repository

version: acceptedVersion

unpaywall_oa_status: green

ReferenceCitation: Vranckx P, Kalesan B, Stefanini GG, Farooq V, Onuma Y, Silber S, de Vries T, Juni P, Serruys PW, Windecker S. Clinical outcome of patients with stable ischaemic heart disease as compared to those with acute coronary syndromes after percutaneous coronary intervention. EuroIntervention. 2015 Jun;11(2):171-9. doi: 10.4244/EIJV11I2A31.

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

repository_institution: University of Bern - Bern Open Repository and Information System

publisher_dissemination: Europa Digital & Publishing

ReferenceCitation: Serruys PW, Farooq V, Kalesan B, de Vries T, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Morice MC, Di Mario C, Corti R, Antoni D, Sohn HY, Eerdmans P, Rademaker-Havinga T, van Es GA, Meier B, Juni P, Windecker S. Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. JACC Cardiovasc Interv. 2013 Aug;6(8):777-89. doi: 10.1016/j.jcin.2013.04.011.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Gutierrez-Chico JL, Raber L, Regar E, Okamura T, di Mario C, van Es GA, Windecker S, Serruys PW. Tissue coverage and neointimal hyperplasia in overlap versus nonoverlap segments of drug-eluting stents 9 to 13 months after implantation: in vivo assessment with optical coherence tomography. Am Heart J. 2013 Jul;166(1):83-94. doi: 10.1016/j.ahj.2013.04.001. Epub 2013 May 3.

evidence: open (via free article)

ReferenceCitation: Stefanini GG, Kalesan B, Pilgrim T, Raber L, Onuma Y, Silber S, Serruys PW, Meier B, Juni P, Windecker S. Impact of sex on clinical and angiographic outcomes among patients undergoing revascularization with drug-eluting stents. JACC Cardiovasc Interv. 2012 Mar;5(3):301-10. doi: 10.1016/j.jcin.2011.11.011.

ReferenceCitation: Gutierrez-Chico JL, Juni P, Garcia-Garcia HM, Regar E, Nuesch E, Borgia F, van der Giessen WJ, Davies S, van Geuns RJ, Secco GG, Meis S, Windecker S, Serruys PW, di Mario C. Long-term tissue coverage of a biodegradable polylactide polymer-coated biolimus-eluting stent: comparative sequential assessment with optical coherence tomography until complete resorption of the polymer. Am Heart J. 2011 Nov;162(5):922-31. doi: 10.1016/j.ahj.2011.09.005. Epub 2011 Oct 7.

ReferenceCitation: Stefanini GG, Kalesan B, Serruys PW, Heg D, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Morice MC, Di Mario C, Corti R, Antoni D, Sohn HY, Eerdmans P, van Es GA, Meier B, Windecker S, Juni P. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial. Lancet. 2011 Dec 3;378(9807):1940-8. doi: 10.1016/S0140-6736(11)61672-3. Epub 2011 Nov 8.

ReferenceCitation: Klauss V, Serruys PW, Pilgrim T, Buszman P, Linke A, Ischinger T, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, van Geuns RJ, van Es GA, Kalesan B, Wenaweser P, Juni P, Windecker S. 2-year clinical follow-up from the randomized comparison of biolimus-eluting stents with biodegradable polymer and sirolimus-eluting stents with durable polymer in routine clinical practice. JACC Cardiovasc Interv. 2011 Aug;4(8):887-95. doi: 10.1016/j.jcin.2011.03.017.

ReferenceCitation: Gutierrez-Chico JL, Regar E, Nuesch E, Okamura T, Wykrzykowska J, di Mario C, Windecker S, van Es GA, Gobbens P, Juni P, Serruys PW. Delayed coverage in malapposed and side-branch struts with respect to well-apposed struts in drug-eluting stents: in vivo assessment with optical coherence tomography. Circulation. 2011 Aug 2;124(5):612-23. doi: 10.1161/CIRCULATIONAHA.110.014514. Epub 2011 Jul 18.

ReferenceCitation: Wykrzykowska JJ, Garg S, Onuma Y, de Vries T, Goedhart D, Morel MA, van Es GA, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di Mario C, van Geuns RJ, Juni P, Windecker S, Serruys PW. Value of age, creatinine, and ejection fraction (ACEF score) in assessing risk in patients undergoing percutaneous coronary interventions in the 'All-Comers' LEADERS trial. Circ Cardiovasc Interv. 2011 Feb 1;4(1):47-56. doi: 10.1161/CIRCINTERVENTIONS.110.958389. Epub 2011 Jan 4.

ReferenceCitation: Wykrzykowska JJ, Garg S, Girasis C, de Vries T, Morel MA, van Es GA, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di Mario C, van Geuns RJ, Juni P, Windecker S, Serruys PW. Value of the SYNTAX score for risk assessment in the all-comers population of the randomized multicenter LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) trial. J Am Coll Cardiol. 2010 Jul 20;56(4):272-7. doi: 10.1016/j.jacc.2010.03.044.

lead_sponsor: Biosensors Europe SA

location_country:
Germany
Poland
United Kingdom
Netherlands
Switzerland
Belgium
France

location_facility: University Medical Center Rotterdam Erasmus, Thoraxcentrum

location_facility: Universitatsklinikum Munchen, Medizinische Klinik Kardiologie, Ziemssenstrasse 1

location_facility: Onze Lieve Vrouw Ziekenhuis, Cardiologisch Centrum, Moorselbaan 164

location_facility: University Hospital Zürich, Director of Invasive Cardiology, Rämistrasse 100

location_facility: Medizinische Universitätsklinik, Swiss Cardiovacular Center Bern, Inselspital

location_facility: Klinikum Bogenhausen der Stad München, Abteilung für Kardiologie und Pnemlogie, Englschalkstrasse 77

location_facility: L'Institut Cardiovasculaire Paris Sud, Institut Hospitalier Jacques Cartier, Service de Coronarographie, 6, Avenue du Noyer Lambert

location_facility: Herzzentrum Leipzig, Innere Medizin/Kardiologie, Struimpellstrasse 39


title: Phase I/II/III Pharmacokinetic and Outcome Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B

summary:
Primary Objective:

To evaluate the safety (acute effects associated with infusions, and inhibitor development), pharmacokinetics (PK), and efficacy with respect to breakthrough bleeding during prophylaxis and with respect to control of hemorrhaging in both the prophylaxis and on demand groups of IB1001 in subjects with hemophilia B.

Key Secondary Objectives:

To evaluate the ability of IB1001 to provide coverage against bleeding under surgical circumstances; To evaluate the long-term safety and efficacy of IB1001

primary_purpose: Supportive Care

ReferenceCitation: Collins PW, Quon DVK, Makris M, Chowdary P, Kempton CL, Apte SJ, Ramanan MV, Hay CRM, Drobic B, Hua Y, Babinchak TJ, Gomperts ED. Pharmacokinetics, safety and efficacy of a recombinant factor IX product, trenonacog alfa in previously treated haemophilia B patients. Haemophilia. 2018 Jan;24(1):104-112. doi: 10.1111/hae.13324. Epub 2017 Aug 17.

oa_colors: green hybrid

repository_institution: Cardiff University - ORCA Online Research @Cardiff

ReferenceCitation: Martinowitz U, Shapiro A, Quon DV, Escobar M, Kempton C, Collins PW, Chowdary P, Makris M, Mannucci PM, Morfini M, Valentino LA, Gomperts E, Lee M. Pharmacokinetic properties of IB1001, an investigational recombinant factor IX, in patients with haemophilia B: repeat pharmacokinetic evaluation and sialylation analysis. Haemophilia. 2012 Nov;18(6):881-7. doi: 10.1111/j.1365-2516.2012.02897.x. Epub 2012 Jul 5.

lead_sponsor: Medexus Pharma, Inc.

location_country:
France
Italy
Poland
India
United Kingdom
United States
Israel

location_facility: Rush University Medical Center-Pediatric Hematology Oncology

location_facility: Centre for Haemostasis and Thrombosis, Basingstoke and North Hampshire Foundation Trust

location_facility: The Hemophilia Treatment Center of Orthopaedic Hospital

location_facility: Hemophilia Treatment Center of Las Vegas

location_facility: Centre Regional de Traitement de l 'Hemophilie

location_facility: University Hospital of Wales Health Park

location_facility: University of Texas Health Science Center-Houston, Gulf States Hemophilia & Thrombophilia Center

location_facility: Sahyadri Specialty Hospital, Deccan Gymkhana

location_facility: Manchester Haemophilia Comprehensive Care Manchester Royal Infirmary

location_facility: University of Minnesota Center for Bleeding and Clotting Disorder

location_facility: Emory University School of Medicine Pediatric Hematology

intervention_type: Biological


lead_sponsor: UCB Pharma

summary: The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16 years and older with epilepsy. This study permits continued access to treatment for subjects who participated in a previous epilepsy study. The study will explore the long-term safety and efficacy of brivaracetam.

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

title: An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy.

location_country:
Germany
Italy
Hungary
Australia
Sweden
Belgium
United States
Spain
Czechia
Canada
France


title: Phase II Study of Irinotecan (CPT 11) and Cisplatin (CDDP) in Metastatic or Locally Advanced Penile Carcinoma

summary:
RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining irinotecan with cisplatin may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining irinotecan with cisplatin in treating patients who have locally advanced or metastatic penile cancer.

ReferenceCitation: Theodore C, Skoneczna I, Bodrogi I, Leahy M, Kerst JM, Collette L, Ven K, Marreaud S, Oliver RDT; EORTC Genito-Urinary Tract Cancer Group. A phase II multicentre study of irinotecan (CPT 11) in combination with cisplatin (CDDP) in metastatic or locally advanced penile carcinoma (EORTC PROTOCOL 30992). Ann Oncol. 2008 Jul;19(7):1304-1307. doi: 10.1093/annonc/mdn149. Epub 2008 Apr 15.

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

location_country:
Poland
Hungary
United Kingdom
Netherlands
Belgium
France

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Leeds Cancer Centre at St. James's University Hospital


title: A Phase III, Randomised, Parallel Group, Double-blind, Double-dummy, Active Comparator-controlled, Multicenter Study to Assess the Efficacy and Safety of PGL4001 vs GnRH-agonist for Pre-operative Ttt of Symptomatic Uterine Myomas

acronym: PEARLII

summary: This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

ReferenceCitation: Donnez J, Tomaszewski J, Vazquez F, Bouchard P, Lemieszczuk B, Baro F, Nouri K, Selvaggi L, Sodowski K, Bestel E, Terrill P, Osterloh I, Loumaye E; PEARL II Study Group. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med. 2012 Feb 2;366(5):421-32. doi: 10.1056/NEJMoa1103180.

lead_sponsor: PregLem SA

location_country: Germany France Italy Poland Netherlands Austria Belgium Spain Israel

location_facility: Landesklinikum Thermenregion Neunkirchen; Dept. For Gynecology

location_facility: Rabin Medical Center, Helen Schneider Hospital for Women

location_facility: Gabinet Lekarski Specjalistyczny "Sonus"

location_facility: Universita di Padova-Dip scienze ginecologiche e della riproduzione umana

location_facility: Clinica Obstetrica - Azienda Ospedaliera Universitaria di Cagliari

location_facility: CHU de Clermont-Ferrand - Polyclinique Gynécologie-Obstétrique

location_facility: Clinica Ostetrica e Ginecologica II - Università degli Studi di Bari

location_facility: Soroka University Medical Center, Division of Obstetrics & Gynecology

location_facility: Policlinico Universitario "Agostino Gemelli"

location_facility: Samodzielny Publiczny Szpital Klinika Ginekologii Onkologicznej i Ginekologii

location_facility: Hopital Erasme, Department of Obstetrics and Gynecology,

location_facility: Poliklinik fur Frauenheilkunde und Geburtshilfe

location_facility: Hadassah University Hospital, Mount Scopus

location_facility: Medizinische Hochschule Hannover, Frauenklinik, Abt. I für Frauenheilkunde und Geburtshilfe,

location_facility: Hospital Virgen de la Arrixaca Servicio de Ginecología Carretera Madrid-Cartagena

location_facility: University Medical Center Utrecht, Gynecologist Reproductive Medicine and Surgery, Division for Reproductive Medicine

location_facility: Universitätsklinikum Köln Klinik und poliklinik für Frauenheilkunde und Geburtshilfe

location_facility: Azienda Ospedaliera S. Gerardo - U. O. Ostetricia e Ginecologia

location_facility: Clinica Ostetrica e Ginecologica - A. O. U. Policlinico Paolo Giaccone

location_facility: Universität zu Lübeck, Klinik für Gynäkologie und Geburtshilfe


title: A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Activity of GS 9450 in Adults With Non-Alcoholic Steatohepatitis (NASH)

summary: The overall purpose of this study is to examine the safety, tolerability, pharmacokinetics (how the body processes a drug), and activity of GS-9450 in preventing liver damage due to scarring, or fibrosis, caused by Non-Alcoholic Steatohepatitis (also known as NASH).

lead_sponsor: Gilead Sciences

location_country:
United States
France


title: Chlorambucil Versus 2x2 Gy Involved Field Radiotherapy in Stage III/IV Previously Untreated Follicular Lymphoma Patients. A Prospective, Randomized Phase III Clinical Trial

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chlorambucil is more effective than radiation therapy in treating follicular lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of chlorambucil with that of radiation therapy in treating patients who have stage III or stage IV follicular lymphoma that has not been previously treated.

status: Unknown status

ReferenceCitation: Haas RL, Girinsky T. HOVON 47/EORTC 20013: chlorambucil vs 2x2 Gy involved field radiotherapy in stage III/IV previously untreated follicular lymphoma patients. Ann Hematol. 2003 Jul;82(7):458-62. doi: 10.1007/s00277-003-0655-8. Epub 2003 May 20. No abstract available.

lead_sponsor: Commissie Voor Klinisch Toegepast Onderzoek

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

location_country: Netherlands Belgium France

location_facility: Daniel Den Hoed Cancer Center at Erasmus University Medical Center


title: Focal Fractionated Conformal Stereotactic Boost Following Conventional Radiotherapy of High Grade Gliomas: A Randomized Phase III Study

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for patients with glioma. Stereotactic radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if standard radiation therapy is more effective when followed by stereotactic radiation therapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation therapy with or without stereotactic radiation therapy in treating patients who have glioma.

ReferenceCitation: Baumert BG, Brada M, Bernier J, Kortmann RD, Dehing-Oberije C, Collette L, Davis JB. EORTC 22972-26991/MRC BR10 trial: fractionated stereotactic boost following conventional radiotherapy of high grade gliomas. Clinical and quality-assurance results of the stereotactic boost arm. Radiother Oncol. 2008 Aug;88(2):163-72. doi: 10.1016/j.radonc.2008.03.025. Epub 2008 Apr 30.

ReferenceCitation: Brada M, Baumert B. Focal fractionated conformal stereotactic boost following conventional radiotherapy of high-grade gliomas: a randomized phase III study. A joint study of the EORTC (22972) and the MRC (BR10). Front Radiat Ther Oncol. 1999;33:241-3. doi: 10.1159/000061233. No abstract available.

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

location_country:
Germany
United Kingdom
Australia
Netherlands
Switzerland
Spain
France

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

intervention_type: Radiation


title: Evaluating the MBVP Chemotherapy Schedule Followed by Consolidating Radiotherapy in Non-AIDS Related Primary Central Nervous System Lymphoma (NAPCL)

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of methotrexate and cytarabine plus radiation therapy in treating patients who have primary CNS lymphoma.

ReferenceCitation: Harder H, Holtel H, Bromberg JE, Poortmans P, Haaxma-Reiche H, Kluin-Nelemans HC, Menten J, van den Bent MJ. Cognitive status and quality of life after treatment for primary CNS lymphoma. Neurology. 2004 Feb 24;62(4):544-7. doi: 10.1212/wnl.62.4.544.

ReferenceCitation: Poortmans PM, Kluin-Nelemans HC, Haaxma-Reiche H, Van't Veer M, Hansen M, Soubeyran P, Taphoorn M, Thomas J, Van den Bent M, Fickers M, Van Imhoff G, Rozewicz C, Teodorovic I, van Glabbeke M; European Organization for Research and Treatment of Cancer Lymphoma Group. High-dose methotrexate-based chemotherapy followed by consolidating radiotherapy in non-AIDS-related primary central nervous system lymphoma: European Organization for Research and Treatment of Cancer Lymphoma Group Phase II Trial 20962. J Clin Oncol. 2003 Dec 15;21(24):4483-8. doi: 10.1200/JCO.2003.03.108. Epub 2003 Nov 3.

ReferenceCitation: Kluin-Nelemans JC, Poortmans P, Haaxma-Reicher H, et al.: Final results of the EORTC phase II trial 20962 evaluating high-dose MTX-based chemotherapy followed by consolidating radiotherapy in non-Aids related primary central nervous system lymphoma. [Abstract] Blood 100 (11 pt 1): A-3071, 776a, 2002.

location_facility:
Academisch Ziekenhuis Utrecht
U.Z. Gasthuisberg
Atrium Medical Centre
Academisch Ziekenhuis Maastricht
Dr. Bernard Verbeeten Instituut
Institut Gustave Roussy
Rotterdam Cancer Institute


title: A Phase II Trial in Patients With Early Cervical Cancer to Study The Safety and The Immunological Effects of Vaccination With TA-HPV, A Live Recombinant Vaccinia Virus Expressing The Human Papilloma Virus 16 and 18 E6 and E7 Proteins

summary:
RATIONALE: Vaccines made from human papillomavirus may make the body build an immune response to and kill cervical cancer cells. Combining vaccine therapy with surgery may be a more effective treatment for cervical cancer.

PURPOSE: This phase II trial is studying how well giving vaccine therapy together with surgery works in treating patients with early cervical cancer.

location_country:
Germany
Norway
United Kingdom
Sweden
Netherlands
Austria
France

location_facility: Nijmegen Cancer Center at Radboud University Medical Center

location_facility: I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen

location_facility: Velindre Cancer Center at Velinde Hospital


title: International obServational sTudy on AiRway manaGement in operAting Room and Non-operaTing Room anaEsthesia

acronym: STARGATE

summary:
According to WHO, more than 230 million major surgical procedures are carried out under general anaesthesia each year worldwide. Despite important technological advances, airway management remains a major challenge in anaesthesiology. Data from large perspective studies on current incidence of major peri-intubation adverse events are lacking in the anaesthesia setting, especially on outcomes such as peri-intubation cardiovascular collapse, severe hypoxemia, and cardiac arrest. These events are more common in case of difficulties with airway management so that first pass intubation failure significantly increase the risks. Moreover, it has been documented that even transient hypotension during general anaesthesia, may have long-term consequences and may be associated with a worse outcome in patients undergoing non-cardiac surgery. The primary aim of the study is to assess the current incidence of major peri-intubation adverse events during anaesthesia in patients undergoing elective or emergency surgery and in the setting of nonoperating room anesthesia. The secondary aim is to assess the current practice of airway management during anesthesia worldwide.

STARGATE Study will be a large international observational study recruiting all consecutive adult (≥ 18 years old) patients undergoing general anesthesia in operating room and outside operating room. Primary outcome will be a composite of cardiovascular collapse, cardiac arrest and severe hypoxemia.

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceCitation: Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.

ReferenceCitation: Cook TM, Woodall N, Frerk C; Fourth National Audit Project. Major complications of airway management in the UK: results of the Fourth National Audit Project of the Royal College of Anaesthetists and the Difficult Airway Society. Part 1: anaesthesia. Br J Anaesth. 2011 May;106(5):617-31. doi: 10.1093/bja/aer058. Epub 2011 Mar 29.

ReferenceCitation: Cook TM. Strategies for the prevention of airway complications - a narrative review. Anaesthesia. 2018 Jan;73(1):93-111. doi: 10.1111/anae.14123.

ReferenceCitation: Russotto V, Myatra SN, Laffey JG, Tassistro E, Antolini L, Bauer P, Lascarrou JB, Szuldrzynski K, Camporota L, Pelosi P, Sorbello M, Higgs A, Greif R, Putensen C, Agvald-Ohman C, Chalkias A, Bokums K, Brewster D, Rossi E, Fumagalli R, Pesenti A, Foti G, Bellani G; INTUBE Study Investigators. Intubation Practices and Adverse Peri-intubation Events in Critically Ill Patients From 29 Countries. JAMA. 2021 Mar 23;325(12):1164-1172. doi: 10.1001/jama.2021.1727. Erratum In: JAMA. 2021 May 24;:null.

oa_colors: green other

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

repositories_concat: PubMed Central;iris.unife.it

publisher_dissemination: American Medical Association

ReferenceCitation: Russotto V, Tassistro E, Myatra SN, Parotto M, Antolini L, Bauer P, Lascarrou JB, Szuldrzynski K, Camporota L, Putensen C, Pelosi P, Sorbello M, Higgs A, Greif R, Pesenti A, Valsecchi MG, Fumagalli R, Foti G, Bellani G, Laffey JG. Peri-intubation Cardiovascular Collapse in Patients Who Are Critically Ill: Insights from the INTUBE Study. Am J Respir Crit Care Med. 2022 Aug 15;206(4):449-458. doi: 10.1164/rccm.202111-2575OC.

ReferenceCitation: Green RS, Erdogan M. Are outcomes worse in patients who develop post-intubation hypotension? CJEM. 2022 Aug;24(5):465-466. doi: 10.1007/s43678-022-00340-x. Epub 2022 Aug 2. No abstract available.

ReferenceCitation: Green RS, Butler MB. Postintubation Hypotension in General Anesthesia: A Retrospective Analysis. J Intensive Care Med. 2016 Dec;31(10):667-675. doi: 10.1177/0885066615597198. Epub 2016 Jul 7.

ReferenceCitation: Apfelbaum JL, Hagberg CA, Connis RT, Abdelmalak BB, Agarkar M, Dutton RP, Fiadjoe JE, Greif R, Klock PA, Mercier D, Myatra SN, O'Sullivan EP, Rosenblatt WH, Sorbello M, Tung A. 2022 American Society of Anesthesiologists Practice Guidelines for Management of the Difficult Airway. Anesthesiology. 2022 Jan 1;136(1):31-81. doi: 10.1097/ALN.0000000000004002.

ReferenceCitation: Cook TM, MacDougall-Davis SR. Complications and failure of airway management. Br J Anaesth. 2012 Dec;109 Suppl 1:i68-i85. doi: 10.1093/bja/aes393.

ReferenceCitation: Rose DK, Cohen MM. The incidence of airway problems depends on the definition used. Can J Anaesth. 1996 Jan;43(1):30-4. doi: 10.1007/BF03015954.

ReferenceCitation: Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127.

lead_sponsor: University of Turin, Italy

location_country:
Ireland
Italy
India
United States
France

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Fondazione IRCCS San Gerardo dei Tintori

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: University of Texas Southwestern Medical Center

location_facility: A.O.U. Città della Salute e della Scienza

location_facility: Cochin University Hospital, Assistance Publique - Hôpitaux de Paris

lead_sponsor_type: academique


acronym: B-Well 1

lead_sponsor: GlaxoSmithKline

summary: This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: a) Double-blind treatment (bepirovirsen or placebo) for 24 weeks. b) Nucleos(t)ide analogue (NA) treatment for 24 weeks. c) NA cessation stage OR Continue NA for 24 weeks. d) Durability of response and follow up for further 24 weeks for participants who stopped NA treatment at Week 48. The arms will be stratified based on HBsAg level (HBsAg greater than or equal to [≥] 100 international unit per milliliter [IU/mL] to less than or equal [≤]1000 IU/mL or greater than [>] 1000 IU/mL to ≤3000 IU/mL) at screening. The total duration of the study, including screening (up to 60 days), the double-blind treatment stage (24 weeks), the On NA only stage (24 weeks), and the NA cessation and durability stages (48 weeks) is up to approximately 104 weeks at maximum for each participant.

status: Recruiting

title: Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment With Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B Virus (B-Well 1)

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 GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

location_country:
Italy
Poland
Argentina
Japan
Korea, Republic of
Spain
Canada
France


title: A Phase 1, Multicenter, Open-Label, First-in-Human Study of the Safety and Pharmacokinetics of AMX-818 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

summary:
This first-in-human (FIH) Phase 1 open-label multicenter dose-escalation and dose-expansion study is designed to evaluate the safety, pharmacokinetics, and preliminary activity of AMX-818 as a single agent and in combination with pembrolizumab in participants with HER2+ tumors across multiple tumor types. The study will be conducted in four parts:

Part 1 (dose escalation): Single-agent AMX-818
Part 2 (dose escalation): AMX-818 plus pembrolizumab
Part 3 (dose expansion): Single-agent AMX-818
Part 4 (dose expansion): AMX-818 plus pembrolizumab

The total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 52 months.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Amunix, a Sanofi Company

location_country: Spain Australia Portugal France

location_facility:
Investigational site number #253
Investigational site number #200
Investigational site number #250
Investigational site number #150
Investigational site number #251
Investigational site number #252
Investigational site number #254
Investigational site number #101
Investigational site number #255
Investigational site number #100


title: Efficacy and Safety of Riociguat (MK-4836) in Incipient Pulmonary Vascular Disease as an Indicator for Early Pulmonary Arterial Hypertension Double-blind, Randomized, Multicenter, Multinational, Placebo-controlled Phase IIa Study (ESRA)

acronym: ESRA

summary: This is a randomized, double-blind, placebo-controlled, multicenter, multinational study investigating the effect of riociguat (MK-4836) in patients with early pulmonary vascular disease.

ReferenceCitation: Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M. 2015 ESC/ERS Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension. Rev Esp Cardiol (Engl Ed). 2016 Feb;69(2):177. doi: 10.1016/j.rec.2016.01.002. No abstract available.

ReferenceCitation: Grunig E, Barner A, Bell M, Claussen M, Dandel M, Dumitrescu D, Gorenflo M, Holt S, Kovacs G, Ley S, Meyer JF, Pabst S, Riemekasten G, Saur J, Schwaiblmair M, Seck C, Sinn L, Sorichter S, Winkler J, Leuchte HH. [Non-invasive diagnosis of pulmonary hypertension: ESC/ERS Guidelines with commentary of the Cologne Consensus Conference 2010]. Dtsch Med Wochenschr. 2010 Oct;135 Suppl 3:S67-77. doi: 10.1055/s-0030-1263314. Epub 2010 Sep 22. German.

ReferenceCitation: Ghofrani HA, D'Armini AM, Grimminger F, Hoeper MM, Jansa P, Kim NH, Mayer E, Simonneau G, Wilkins MR, Fritsch A, Neuser D, Weimann G, Wang C; CHEST-1 Study Group. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl J Med. 2013 Jul 25;369(4):319-29. doi: 10.1056/NEJMoa1209657.

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Pan Z, Marra AM, Benjamin N, Eichstaedt CA, Blank N, Bossone E, Cittadini A, Coghlan G, Denton CP, Distler O, Egenlauf B, Fischer C, Harutyunova S, Xanthouli P, Lorenz HM, Grunig E. Early treatment with ambrisentan of mildly elevated mean pulmonary arterial pressure associated with systemic sclerosis: a randomized, controlled, double-blind, parallel group study (EDITA study). Arthritis Res Ther. 2019 Oct 26;21(1):217. doi: 10.1186/s13075-019-1981-0.

ReferenceCitation: Rubin LJ, Galie N, Grimminger F, Grunig E, Humbert M, Jing ZC, Keogh A, Langleben D, Fritsch A, Menezes F, Davie N, Ghofrani HA. Riociguat for the treatment of pulmonary arterial hypertension: a long-term extension study (PATENT-2). Eur Respir J. 2015 May;45(5):1303-13. doi: 10.1183/09031936.00090614. Epub 2015 Jan 22.

publisher_dissemination: European Respiratory Society

lead_sponsor: Heidelberg University

sponsor_collaborators:
Heidelberg University
Merck Sharp & Dohme LLC

location_country: Germany Italy Switzerland Austria France

location_facility: Universitätsspital Zürich Pulmonale Hypertonie, Klinik für Pneumologie

location_facility: Centre de référence des Maladies Auto-Immunes Systémiques rares du Nord et Nord-Ouest (CeRAINO) Service de Médecine Interne et Immunologie Clinique Hôpital Claude Huriez, CHU

location_facility: Università Degli Studi Di Napoli Federico II Scuola Di Medicina E Chirurgia

location_facility: Centre for Pulmonary Hypertension at the Thoraxklinik Heidelberg, Heidelberg University Hospital Heidelberg

location_facility: Carl Gustav Carus University Hospital at the TU Dresden, Medical Department I, Center for PH

location_facility: LKH-Univ. Klinikum Graz Universitätsklinik für Innere Medizin Klinische Abteilung für Pulmonologie


title: Desmoid Tumor and Pregnancy: Effect of Pregnancy on Disease Control and Effect of Diagnosis on Pregnancy History. An International Multicenter Retrospective Observational Study

summary:
Desmoid tumors (DT) are rare disease of intermediate malignancy with variable and often unpredictable clinical course. There is a growing interest in defining potential risk of recurrence or progression during or after pregnancy and in identifying potential obstetrical risks and infertility rate of desmoid patients.

Aim of the study:

to define the impact of pregnancy on diagnosis, progression and recurrence of DT;
to define the risks related to DT of obstetrical risks and decisions to interrupt or avoid pregnancy after the diagnosis of DT.

time_perspective: Retrospective

lead_sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

collaborators: Dana-Farber/Brigham and Women's Cancer Center

location_country:
United States
Italy
Canada
France

location_facility: Brigham and Women Hospital / Dana Farber Cancer Institute

intervention_type: Other


title: A Modular Phase I/II, Open-label, Dose Escalation and Expansion, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0466 as Monotherapy or in Combination With Anticancer Agents in Patients With Advanced Non-Hodgkin Lymphoma.

summary: This study evaluates the safety, tolerability, PK, and preliminary efficacy of AZD0466 as monotherapy or in combination with other anticancer agents in patients with advanced NHL

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.

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

lead_sponsor: AstraZeneca

location_country:
Italy
Portugal
Australia
United States
Korea, Republic of
Spain
France


title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, 36-Week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Maintain or Improve Symptom Control With Reduced Corticosteroid in Subjects With Myasthenia Gravis

summary: The efficacy and safety of CellCept (1g po, bid for 36 weeks) will be assessed in patients with myasthenia gravis receiving prednisone, or other corticosteroids. During the study, patients will undergo gradual corticosteroid dose reduction, if they respond to treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

ReferenceCitation: Sengupta M, Cheema A, Kaminski HJ, Kusner LL; Muscle Study Group. Serum metabolomic response of myasthenia gravis patients to chronic prednisone treatment. PLoS One. 2014 Jul 17;9(7):e102635. doi: 10.1371/journal.pone.0102635. eCollection 2014.

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Public Library of Science

lead_sponsor: Hoffmann-La Roche

sponsor_collaborators:
Hoffmann-La Roche
Aspreva Pharmaceuticals

location_country:
Germany
Former Serbia and Montenegro
Italy
India
Israel
United Kingdom
Netherlands
Mexico
United States
Spain
Canada
Ukraine
Russian Federation
France


title: Value-based Healthcare for Outcomes In Breast and Lung Cancer in Europe

acronym: VOICE

summary:
VOICE project aims to guide health services in their reorganization towards the provision of the highest value care for the patient at the best cost. VOICE is targeted to patients with breast and lung cancer. The purpose is to offer a new innovative strategic framework based on value-based healthcare model to these patients in Europe. VOICE Community consists of 13 hospitals across Europe working collaboratively to implement this approach.

The Community addresses what matters most to patients by measuring patient reported health outcomes in routine clinical practice on a systematic and long-term basis, by including patients´ perspective in clinical decision-making, improving patient empowerment and physician-patient communication, assessing the impact on costs of the processes implemented, identifying factors for a successful implementation of value-based healthcare and boosting knowledge generation and best practice exchange across Europe.

The VOICE ambition is to collect the health-related Quality of Life evidence from more than 1000 patients (patients with breast cancer and patients with lung cancer), by means of health related and patient reported questionnaires (ICHOM, International Consortium for Health Outcome Measurements, standard sets). Hospitals will go further by assessing the satisfaction, acceptability, relationship with professionals or decision-making process with patients.

The VOICE Community will benchmark health outcomes and related costs to improve care delivery of these patients.

primary_purpose: Health Services Research

lead_sponsor: Kronikgune

collaborators: Complejo Hospitalario de Especialidades Juan Ramón Jimenez

collaborators: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

collaborators: Instituto Portugues de Oncologia, Francisco Gentil, Porto

location_country: Italy Portugal Belgium Spain France

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Instituto Português de Oncologia do Porto

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori


title: An Open Label, Single-Arm, Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Biologic Activity of Pegcetacoplan in Pediatric Patients With Paroxysmal Nocturnal Hemoglobinuria

summary: The purpose of this study is to evaluate the safety, effectiveness, and biological activity (how the investigational medication is processed by the body) of pegcetacoplan in 12-17 year-olds (adolescents) who have paroxysmal nocturnal hemoglobinuria (PNH).

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
United Kingdom
Netherlands
United States
Spain
Thailand
Malaysia
Czechia
Serbia
France

location_facility: Phramongkutklao Hospital and College of Medicine


title: Outcomes of Endoscopically Resected High-risk Mucosal Adenocarcinoma and Low- and High-risk Submucosal Adenocarcinoma Arising in Barrett's Esophagus: an International Multicenter Retrospective Cohort Study

summary: The purpose of this study is to assess lymph node metastasis rate, distant metastasis rate, disease-specific mortality, and overall mortality in patients with Barrett's related T1b and high risk T1a esophageal adenocarcinoma (EAC) who underwent a diagnostic endoscopic resection.

lead_sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

location_country:
Germany
United Kingdom
Australia
Netherlands
Switzerland
Belgium
France

location_facility:
Barmherzige Brüder Regensburg
CHU Nantes
Erasmus MC - University Medical Center
MRI TUM
University Medical Center Groningen
Universitätsklinikum Augsburg
Westmead hospital
EVK Duesseldorf
Haga Medical Center
Amsterdam UMC, location VUmc
Isala Clinics
St. Antonius Hospital
UZ Gasthuisberg
University College London Hospital
Hirslanden private hospital group
Catharina Hospital


title: A Phase 2, Multicenter, Open-label, Active Comparator-controlled, Extension Trial To Evaluate The Long-term Safety And Efficacy Of Cp-690,550 In Renal Allograft Recipients

summary: This is a study that will follow transplant patients from Study A3921030 to monitor for long term safety, tolerability and efficacy for 5 additional years, except in Portugal where the study will follow transplant patients through Month 36 posttransplant. Patients will continue their study medications that were previously assigned.

lead_sponsor: Pfizer

location_country:
Germany
Italy
Poland
Portugal
Norway
Australia
Brazil
Netherlands
Belgium
United States
Korea, Republic of
Spain
Czechia
Canada
France

location_facility: Istituto di Clinica Chirurgica, Universita Cattolica del Sacro Cuore

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Asan Medical Center, Department of Surgery

location_facility: University of North Carolina, Department of Medicine/Nephrology

location_facility: CHRU de Nancy-Brabois - Service de Nephrologie

location_facility: Drexel University College of Medicine - Hahnemann University Hospital

location_facility: Hospitais da Universidade de Coimbra, EPE

location_facility: Investigational Drug Services (IDS) / UNC Healthcare

location_facility: Central Northern Adelaide Renal and Transplantation Service

location_facility: Medical University of South Carolina, Department of Transplantation Surgery

location_facility: Annette C. and Harold C. Simmons Transplant Institute at Baylor University Medical Center

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego we Wroclawiu

location_facility: Oslo universitetssykehus HF- Rikshospitalet

location_facility: Division of Pharmacotherapy, School of Pharmacy, University of North Carolina at Chapel Hill

location_facility: California Pacific Medical Center - Pacific Campus

location_facility: USCF Medical Center - Connie Frank Transplant Center

location_facility: Washington University School of Medicine

location_facility: Department of Surgery, Yonsei University College of Medicine Severance Hospital

location_facility: Westmead Hospital, Department of Renal Medicine

location_facility: Institut Klinicke a Experimentalni Mediciny

location_facility: UNC Department of Surgery/Abdominal Transplant Division

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi

location_facility: UNC Department of Surgery, Clinical Trials Consortium

location_facility: Ambulatorio Pos Transplante do Hospital do Rim a Hipertensao


title: A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment Course

acronym: ATAMS

summary: To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.

ReferenceCitation: Kappos L, Hartung HP, Freedman MS, Boyko A, Radu EW, Mikol DD, Lamarine M, Hyvert Y, Freudensprung U, Plitz T, van Beek J; ATAMS Study Group. Atacicept in multiple sclerosis (ATAMS): a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Neurol. 2014 Apr;13(4):353-63. doi: 10.1016/S1474-4422(14)70028-6. Epub 2014 Mar 6.

lead_sponsor: EMD Serono

location_country:
France
Germany
Lithuania
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
Lebanon
United States
Spain
Switzerland
Canada
Ukraine
Russian Federation
Czech Republic


title: Safety of Sports for Patients With Implantable Cardioverter-Defibrillators: A Multi-Center Registry

summary: The registry will obtain information to determine the safety of sports participation for patients with defibrillators (ICDs).

ReferenceCitation: Saarel EV, Law I, Berul CI, Ackerman MJ, Kanter RJ, Sanatani S, Cohen MI, Berger S, Fischbach PS, Burton DA, Dziura J, Brandt C, Simone L, Li F, Olshansky B, Cannom DS, Lampert RJ. Safety of Sports for Young Patients With Implantable Cardioverter-Defibrillators: Long-Term Results of the Multinational ICD Sports Registry. Circ Arrhythm Electrophysiol. 2018 Nov;11(11):e006305. doi: 10.1161/CIRCEP.118.006305.

lead_sponsor: Yale University

sponsor_collaborators:
Yale University
Medtronic
Abbott Medical Devices
Boston Scientific Corporation

location_country:
France
Germany
Poland
Israel
Norway
United Kingdom
Australia
Netherlands
Switzerland
Belgium
United States
Spain
Canada
Czech Republic

location_facility: Children's Hospital and Clinics of Minnesota

location_facility: The Ohio State University Research Foundation

location_facility: Midatlantic Cardiovascular Associates, PA

location_facility: Foundation for the Advancement of Cardiovascular Therapy

location_facility: Legacy Cllinical Research & Tech Center (Good Samaritan Hospital_

location_facility: Arizona Pediatric Cardiology Consultants

location_facility: London Health Sciences Centre University Hospital


title: A Randomized Discontinuation Study of Brivanib Alaninate (BMS-582664) Versus Placebo in Subjects With Advanced Tumors

summary: The purpose of this study is to determine if gastric/esophageal, lung, pancreatic, bladder and sarcoma patients show benefit from brivanib treatment. Patients who clearly do, stay on treatment. Those in which it is unclear will be randomized to continue or withdraw treatment to determine whether that benefit is related to brivanib

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Poland
United Kingdom
Argentina
Netherlands
Belgium
United States
Canada
France

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins


title: A Phase 2 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

summary: Study will evaluate the safety and potential benefit of recombinant human talactoferrin as an addition to the standard care of severe sepsis.

ReferenceCitation: Guntupalli K, Dean N, Morris PE, Bandi V, Margolis B, Rivers E, Levy M, Lodato RF, Ismail PM, Reese A, Schaumberg JP, Malik R, Dellinger RP; TLF LF-0801 Investigator Group. A phase 2 randomized, double-blind, placebo-controlled study of the safety and efficacy of talactoferrin in patients with severe sepsis. Crit Care Med. 2013 Mar;41(3):706-16. doi: 10.1097/CCM.0b013e3182741551. Erratum In: Crit Care Med. 2014 May;42(5):e390. multiple investigator names added.

lead_sponsor: Agennix

location_country:
Germany
United States
Spain
Canada
France

location_facility: The George Washington University Hospital

location_facility: Wake Forest University Baptist Medical Center

location_facility: Texas Tech University Health Sciences Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University of Pittsburgh Medical Center Presbyterian Hospital

location_facility: Floyd Memorial Hospital and Health Services

location_facility: University of Oklahoma Health Science Center


title: The Atrial High Rate Episodes (A-HIRATE) in Pacemaker Patients

summary: Prospective study assessing the incidence of atrial high rate episodes (AHRE) in pacemaker patients with and without previously diagnosed AT.

ReferenceCitation: Ghali JK, Orlov MV, Araghi-Niknam M, Sherfesee L, Hettrick DA. The influence of symptoms and device detected atrial tachyarrhythmias on medical management: insights from A-HIRATE. Pacing Clin Electrophysiol. 2007 Jul;30(7):850-7. doi: 10.1111/j.1540-8159.2007.00772.x.

ReferenceCitation: Orlov MV, Ghali JK, Araghi-Niknam M, Sherfesee L, Sahr D, Hettrick DA; Atrial High Rate Trial Investigators. Asymptomatic atrial fibrillation in pacemaker recipients: incidence, progression, and determinants based on the atrial high rate trial. Pacing Clin Electrophysiol. 2007 Mar;30(3):404-11. doi: 10.1111/j.1540-8159.2007.00682.x.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
United States
Australia
France


title: Prospective Epidemiological Study to Estimate the O-serotype Distribution of Extraintestinal Pathogenic Escherichia Coli (ExPEC) Isolated From Hospitalized Patients Aged 60 Years or Older With Invasive ExPEC Disease (IED) and to Evaluate the Clinical Case Definition and Risk Factors.

summary:
The purpose of this study is to collect information from study participants who are hospitalized with an invasive disease caused by Extraintestinal pathogenic E. coli (ExPEC). This information will be used to support the development of a new vaccine to prevent Extraintestinal pathogenic Escherichia coli (ExPEC). E. coli bacteria are a leading cause of serious infections. Especially adults older than 60 years have a higher risk of developing such infections. To date, there is no vaccine available to prevent E. coli infections. To support the development of a vaccine, more information about E. coli infections is first needed. This information will be collected in the current study, such as:

Medical information such as medical history, diagnosis, duration of hospitalization
Treatment and outcome of the Extraintestinal pathogenic Escherichia coli (ExPEC)
Laboratory information

lead_sponsor: UMC Utrecht

sponsor_collaborators:
UMC Utrecht
Janssen Research & Development, LLC
Innovative Medicines Initiative

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

location_facility: Andalusian Public Foundation for Health Research Management in Seville (FISEVI)


title: An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients With AL Amyloidosis Following at Least One Prior Line of Therapy

summary:
This is a phase 1/2 open label study of melphalan flufenamide (melflufen) in combination with dexamethasone for participants with Al amyloidosis following at least one prior line of therapy. Melflufen will be administered on Day 1 of each 28-day cycle in combination with dexamethasone on days 1 and 2.

In both phases, treatment of each individual participant will continue for up to 8 cycles or until any stopping events occur.

Approximately 46 participants will be enrolled.

The study was intended to be a Phase 1/2 trial but was early terminated and never moved forward to Phase 2.

lead_sponsor: Oncopeptides AB

sponsor_collaborators:
Oncopeptides AB
PRA Health Sciences

location_country:
Germany
Israel
Norway
United Kingdom
United States
Spain
Greece
Czechia
France

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Oslo University Hospital - Rikshospitalet

location_facility: University College London Hospitals NHS Foundation Trust


title: Pilot Study to Assess Success Factors and Barriers for Preparation of a Phase 3 Study With ExPEC10V in Adults Aged 60 Years or Older and in Stable Health

summary: The purpose of this study is to collect information from study participants who develop an invasive disease caused by Extraintestinal pathogenic E. coli (ExPEC) during a period of 12 months. This information will be used to support the development of a new vaccine to prevent ExPEC infections.

lead_sponsor: MJM Bonten

sponsor_collaborators:
MJM Bonten
Janssen Research & Development, LLC
Innovative Medicines Initiative

location_facility: - Andalusian Public Foundation for Health Research Management in Seville (FISEVI)


title: A Phase 1/2 Trial on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Exploratory Efficacy of DYN101 in Patients ≥ 16 Years of Age With Centronuclear Myopathies Caused by Mutations in DNM2 or MTM1.

acronym: Unite-CNM

summary:
There are no available treatments aside from supportive care for patients with Centronuclear myopathy (CNM). This trial will assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD)/preliminary efficacy of a new medicine called DYN101 in patients ≥ 16 years of age with CNM caused by mutations in Dynamin2 (DNM2) or Myotubularin1 (MTM1).

The trial will consist of a consent, a screening period, a run-in period (if applicable), a Single dose treatment part (SAD) with 4 weeks of follow-up after the drug administration and a washout period of at least 12 weeks (followed by follow-up phone calls), a Multiple dose treatment part (MAD) of 12 weeks of weekly dosing, and a Multiple dose extension part of 12 weeks. All subjects will participate in the SAD, MAD, and MAD extension parts, unless they withdraw. During this time, multiple test will be performed in order to better understand how the drug is distributed and then later removed from the body and whether there any signs of an effect.

As this trial is investigational, there is no defined, expected benefit for subjects who participate in this trial except a better knowledge of their disease.

lead_sponsor: Dynacure

location_country:
Germany
United Kingdom
Denmark
Netherlands
Belgium
France

location_facility: Rigshospitalet, Copenhagen Neuromuscular Center, Neurocentret

location_facility: Friedrich Baur Institut - Neurologische Klinik LMV, Klinikum Innenstadt

location_facility: MRC centre for Neuromuscular Disease, National Hospital for Neurology and Neurosurgery

location_facility: universitätsklinikum Essen, Kinderklinik I, Sozialpädiatrisches Zentrum


title: Post-Market Clinical Follow Up of Rotarex®S Catheter

summary: Post-Market Clinical Follow Up of the Rotarex®S Catheter

lead_sponsor: Straub Medical AG

location_country: Germany Italy Czechia Estonia France

location_facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen

location_facility: Kreiskrankenhaus Torgau "Johann Kentmann"

location_facility: Ospedale P. Pederzoli - Casa di Cura Privata Spa


title: Repositionable Lotus Edge™ Valve System - Post Market Evaluation of Real World Clinical Outcomes

acronym: RESPOND EDGE

summary: The purpose of the RESPOND EDGE post market study is to collect real world clinical and device performance outcomes data with the Lotus Edge™ Valve System used in routine clinical practice to demonstrate that the commercially available Lotus Edge Valve System is a safe and effective treatment for patients with severe calcific aortic stenosis.

lead_sponsor: Boston Scientific Corporation

location_country:
Finland
Ireland
Germany
Italy
United Kingdom
Denmark
Sweden
Netherlands
France

location_facility:
New Cross Hospital
Erasmus MC - Thorax Center
University Helsinki
University of Lund
The General Infirmary
Royal Sussex County Hospital
Galway University Hospital
Az Osp Univ Pisana
Clinique Pasteur
Herzzentrum Universität Leipzig
Oxford John Radcliffe Hospital
Royal Victoria Belfast
Rigshospitalet


title: Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With Opioid Induced Constipation.

acronym: NACASY

summary: This is a single-arm, open label, multinational, multicentre, prospective, real world observational study of Naloxegol in adult subjects with Opioid Induced Constipation (OIC) in patients receiving Naloxegol in routine clinical practice. Subjects who are receiving Naloxegol (prescribed by their physician according to the SmPC, which recommends that all currently used maintenance laxative therapy should be halted) during the enrolment period may be eligible for enrolment into the study.

lead_sponsor: Kyowa Kirin Pharmaceutical Development Ltd

location_country:
Finland
Germany
Italy
United Kingdom
Denmark
Sweden
Netherlands
Spain
Greece
France

location_facility: Paul Papin à Angers et site René Gauducheau


title: Evaluation of Safety Following Immune Tolerance Induction Treatment With Turoctocog Alfa in Patients With Haemophilia A Following Inhibitor Development in NN7170-4213 Trial

summary: This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to evaluate safety of immune tolerance induction (ITI) treatment with turoctocog alfa (a recombinant factor VIII) in patients who have developed neutralising antibodies against factor VIII after exposure to subcutaneous turoctocog alfa pegol during participation in NN7170-4213 (NCT02994407)

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

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
United Kingdom
Austria
Turkey
Bulgaria
Serbia
France