title: Direct Implantation of Rapamycin-Eluting Stents With Bio-Erodible Drug Carrier Technology Utilizing the Second Generation Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS)

acronym: DIRECT II

summary:
A prospective, randomized, active-control, multi-center clinical trial comparing the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) to that of the commercially available Resolute IntegrityTM Drug-Eluting Stent.

The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting Stent in patients with single, never previously treated coronary artery lesions

lead_sponsor: Svelte Medical Systems, Inc.

location_country: Sweden Switzerland Netherlands France Czechia Belgium Germany

location_facility: University Medical Center Utrecht, Department of Cardiology

location_facility: Medizinisches Verzorgungszentrum Prof. Mathey, Prof. Schofer

location_facility: University Medical Center Hamburg-Eppendorf


title: Neo Randomized Heart Failure Study

summary: The purpose of this portion of study NCT01471860 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in Canadian study participants implanted with the device.

study_start_date_type: Actual

status: Unknown status

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Müller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14.

family: Abraham

full_name: William T. Abraham

given: William T.

sequence: first

family: Zile

full_name: Michael R. Zile

given: Michael R.

sequence: additional

family: Weaver

full_name: Fred A. Weaver

given: Fred A.

family: Butter

full_name: Christian Butter

given: Christian

family: Ducharme

full_name: Anique Ducharme

given: Anique

family: Halbach

full_name: Marcel Halbach

given: Marcel

family: Klug

full_name: Didier Klug

given: Didier

family: Lovett

full_name: Eric G. Lovett

given: Eric G.

family: Müller-Ehmsen

full_name: Jochen Müller-Ehmsen

given: Jochen

family: Schafer

full_name: Jill E. Schafer

given: Jill E.

family: Senni

full_name: Michele Senni

given: Michele

family: Swarup

full_name: Vijay Swarup

given: Vijay

family: Wachter

full_name: Rolf Wachter

given: Rolf

family: Little

full_name: William C. Little

given: William C.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: JACC: Heart Failure

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceType: derived

ReferenceCitation: Halbach M, Abraham WT, Butter C, Ducharme A, Klug D, Little WC, Reuter H, Schafer JE, Senni M, Swarup V, Wachter R, Weaver FA, Wilks SJ, Zile MR, Müller-Ehmsen J. Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease. Int J Cardiol. 2018 Sep 1;266:187-192. doi: 10.1016/j.ijcard.2018.04.075. Epub 2018 Apr 21.

ReferenceCitation: Zile MR, Abraham WT, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Müller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy. Eur J Heart Fail. 2015 Oct;17(10):1066-74. doi: 10.1002/ejhf.299. Epub 2015 Jun 10.

name: Division of Cardiology, Department of Medicine Medical University of South Carolina  114 Doughty Street, Thurmond/Gazes, 323, Charleston, SC 29425, USA and Ralph H. Johnson Department of Veterans Affairs Medical Center Charleston SC USA

name: Division of Cardiovascular Medicine The Ohio State University  Columbus OH USA

name: Division of Vascular Surgery and Endovascular Therapy, Keck School of Medicine University of Southern California  Los Angeles CA USA

name: Department of Cardiology Immanuel Heart Center Bernau—Medical School Brandenburg  Bernau Germany

name: Montreal Heart Institute University of Montréal  Montreal Quebec Canada

name: Department of Internal Medicine III University Hospital of Cologne  Cologne Germany

name: Department of Cardiology A University Hospital  Lille France

name: Department of Research CVRx, Inc.  Minneapolis MN USA

name: Department of Medicine Asklepios Klinik Altona  Hamburg Germany

name: Department of Statistics NAMSA, Inc.  Minneapolis MN USA

name: Cardiovascular Department Ospedale Papa Giovanni XXIII  Bergamo Italy

name: Department of Electrophysiology Arizona Heart Hospital  Phoenix AZ USA

name: Clinic for Cardiology and Pneumology University Medicine Göttingen and German Cardiovascular Research Center (DZHK)  Göttingen Germany

name: Division of Cardiology University of Mississippi Medical Center  Jackson MS USA

location_facility: Azienda Ospedaliero Universitaria Opedali

location_facility: University Hospital of Schleswig-Holstein, Kiel Campus

location_facility: Azienda Ospedaliera Spedali Riuniti Di Bergamo

location_facility: Immanuel Hospital Bernau-Heart Center Brandenburg

location_facility: Azienda Ospedaliero - Universitaria Careggi


title: Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (The EFFORTLESS S-ICD Registry)

acronym: EFFORTLESS

summary: The EFFORTLESS ICD Registry is an observational, standard of care evaluation designed to demonstrate the early, mid and long-term clinical effectiveness the Boston Scientific S-ICD System. In addition, analysis of resource utilization and costs will be performed to document treatment costs for periods defined by Registry endpoints. Protocol 90904928 restricts enrolment to patients over 18 years of age while protocol 90904925 allows all patients to be included.

status: Active, not recruiting

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Boersma L, Barr C, Knops R, Theuns D, Eckardt L, Neuzil P, Scholten M, Hood M, Kuschyk J, Jones P, Duffy E, Husby M, Stein K, Lambiase PD; EFFORTLESS Investigator Group. Implant and Midterm Outcomes of the Subcutaneous Implantable Cardioverter-Defibrillator Registry: The EFFORTLESS Study. J Am Coll Cardiol. 2017 Aug 15;70(7):830-841. doi: 10.1016/j.jacc.2017.06.040.

family: Boersma

full_name: Lucas Boersma

given: Lucas

family: Barr

full_name: Craig Barr

given: Craig

family: Knops

full_name: Reinoud Knops

given: Reinoud

family: Theuns

full_name: Dominic Theuns

given: Dominic

family: Eckardt

full_name: Lars Eckardt

given: Lars

family: Neuzil

full_name: Petr Neuzil

given: Petr

family: Scholten

full_name: Marcoen Scholten

given: Marcoen

family: Hood

full_name: Margaret Hood

given: Margaret

family: Kuschyk

full_name: Juergen Kuschyk

given: Juergen

family: Jones

full_name: Paul Jones

given: Paul

family: Duffy

full_name: Elizabeth Duffy

given: Elizabeth

family: Husby

full_name: Michael Husby

given: Michael

family: Stein

full_name: Kenneth Stein

given: Kenneth

family: Lambiase

full_name: Pier D. Lambiase

given: Pier D.

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Burke MC, Gold MR, Knight BP, Barr CS, Theuns DAMJ, Boersma LVA, Knops RE, Weiss R, Leon AR, Herre JM, Husby M, Stein KM, Lambiase PD. Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry. J Am Coll Cardiol. 2015 Apr 28;65(16):1605-1615. doi: 10.1016/j.jacc.2015.02.047.

family: Burke

full_name: Martin C. Burke

given: Martin C.

family: Gold

full_name: Michael R. Gold

family: Knight

full_name: Bradley P. Knight

given: Bradley P.

full_name: Craig S. Barr

given: Craig S.

full_name: Dominic A.M.J. Theuns

given: Dominic A.M.J.

ReferenceCitation: Lambiase PD, Barr C, Theuns DA, Knops R, Neuzil P, Johansen JB, Hood M, Pedersen S, Kääb S, Murgatroyd F, Reeve HL, Carter N, Boersma L; EFFORTLESS Investigators. Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry. Eur Heart J. 2014 Jul 1;35(25):1657-65. doi: 10.1093/eurheartj/ehu112. Epub 2014 Mar 26.

name: Cardiology Department, The Heart Hospital, Institute of Cardiovascular Science, University College London, 16-18 Westmoreland Street, W1G 8PH London, UK

name: Cardiology Department, Russells Hall Hospital, Dudley, UK

name: Department of Clinical Electrophysiology, Erasmus Medical Center, Rotterdam, The Netherlands

name: Department of Cardiology and Electrophysiology, Academic Medical Center, Amsterdam, The Netherlands

name: Department of Cardiology, Homnolka Hospital, Prague, Czech Republic

name: Department of Cardiology, Electrophysiology Section, Odense University Hospital, Odense, Denmark

name: Auckland City Hospital, Auckland, New Zealand

name: Center of Research on Psychology in Somatic Diseases, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands

name: Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands

name: Division of Electrophysiology, Campus Grosshadern, University of Munich, Munich, Germany

name: Boston Scientific Corporation, St Paul MN, USA

name: St Antonius Ziekenhuis, Nieuwegein, The Netherlands

name: on behalf of the EFFORTLESS Investigators

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

location_country:
Italy
Netherlands
Spain
France
Czechia
New Zealand
Portugal
Denmark
Germany
United Kingdom

location_facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg

location_facility: Azienda Ospedaliero Universitaria Padova

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Ludwig-Maximilians-Universität München, Campus Großhadern


title: A Phase IIa Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 After 3 Weeks of Treatment in Patients With Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)

acronym: AVANT

summary: The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with peripheral neuropathic pain. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain.

status: Terminated

design_allocation: Randomized

enrollment_type: Anticipated

lead_sponsor: AstraZeneca

location_country:
Denmark
Canada
United Kingdom
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: International Report on Routine Practice of Sensor-enabled Pump Therapy

summary: The aim of the project is to document the international routine practice in sensor usage in patients treated with sensor-augmented pump therapy and to assess which variables (e.g. training of patients, frequency of sensor usage etc) are associated with an improvement in clinical outcome(s) from the start of the sensor use to the end of the follow-up period.

status: Completed

study_completion_date_type: Actual

ipd_sharing: Yes

ipd_sharing_description: Nørgaard K et al. Routine sensor-augmented pump therapy in type 1 diabetes: the INTERPRET study. Diabetes Technol Ther. 2013 Apr;15(4):273-80. doi: 10.1089/dia.2012.0288. Epub 2013 Feb 25.

lead_sponsor: Medtronic Diabetes

location_country: Italy Austria Sweden Serbia France Poland Lithuania Israel Slovakia Hungary Belgium Spain Denmark Slovenia

location_facility: LKH Salzburg/Universitätsklinikum der Paracelsus Med Privatuniversität/Innere Medizin I

location_facility: Klinika Chorób Dzieci Uniwersytecki Dzieciecy Szp

location_facility: Oddzial Kliniczny Kliniki Chorób Metabolicznych Sz

status_simplified: Completed


type: EudraCT Number

title: The Effects of Nitric Oxide for Inhalation on the Development of Chronic Lung Disease in Pre-term Infants

summary: The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to assess the long-term effects of the therapy on the development of these children over 7 years of clinical follow-up.

ReferenceCitation: Laube M, Amann E, Uhlig U, Yang Y, Fuchs HW, Zemlin M, Mercier JC, Maier RF, Hummler HD, Uhlig S, Thome UH. Inflammatory Mediators in Tracheal Aspirates of Preterm Infants Participating in a Randomized Trial of Inhaled Nitric Oxide. PLoS One. 2017 Jan 3;12(1):e0169352. doi: 10.1371/journal.pone.0169352. eCollection 2017.

apc_source: openAPC

family: Laube

full_name: Mandy Laube

given: Mandy

family: Amann

full_name: Elena Amann

given: Elena

family: Uhlig

full_name: Ulrike Uhlig

given: Ulrike

family: Yang

full_name: Yang Yang

given: Yang

family: Fuchs

full_name: Hans W. Fuchs

given: Hans W.

family: Zemlin

full_name: Michael Zemlin

family: Mercier

full_name: Jean-Christophe Mercier

given: Jean-Christophe

family: Maier

full_name: Rolf F. Maier

given: Rolf F.

family: Hummler

full_name: Helmut D. Hummler

given: Helmut D.

full_name: Stefan Uhlig

given: Stefan

family: Thome

full_name: Ulrich H. Thome

given: Ulrich H.

currency_apc_doaj: USD

journal_name: PLOS ONE

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: RWTH Aachen - RWTH Publications

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_institution:
PubMed Central - Europe PMC
RWTH Aachen - RWTH Publications

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

ReferenceCitation: Durrmeyer X, Hummler H, Sanchez-Luna M, Carnielli VP, Field D, Greenough A, Van Overmeire B, Jonsson B, Hallman M, Mercier JC, Marlow N, Johnson S, Baldassarre J; European Union Nitric Oxide Study Group. Two-year outcomes of a randomized controlled trial of inhaled nitric oxide in premature infants. Pediatrics. 2013 Sep;132(3):e695-703. doi: 10.1542/peds.2013-0007. Epub 2013 Aug 12.

family: Durrmeyer

full_name: X. Durrmeyer

given: X.

full_name: H. Hummler

name: for the European Union Nitric Oxide Study Group

title: Two-Year Outcomes of a Randomized Controlled Trial of Inhaled Nitric Oxide in Premature Infants

ReferenceCitation: Mercier JC, Hummler H, Durrmeyer X, Sanchez-Luna M, Carnielli V, Field D, Greenough A, Van Overmeire B, Jonsson B, Hallman M, Baldassarre J; EUNO Study Group. Inhaled nitric oxide for prevention of bronchopulmonary dysplasia in premature babies (EUNO): a randomised controlled trial. Lancet. 2010 Jul 31;376(9738):346-54. doi: 10.1016/S0140-6736(10)60664-2. Epub 2010 Jul 23.

ipd_sharing_description: Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT00551642) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

location_country:
Italy
Sweden
Netherlands
Finland
France
Belgium
Spain
Germany
United Kingdom

location_facility: Beatrix Children's Hospital, University Medical Center Groningen

location_facility: Astrid Lindgrens barnsjukjus, Karolinska Unviersritets sjukhuset-Solna

location_facility: Centre Hospitalier Intercommunal de Creteil


title: A Phase Ib, Multi-center, Open-label, Dose-escalation Study of Oral LBH589 When Administered in Combination With Oral Lenalidomide & Dexamethasone in Adult Patients With Multiple Myeloma

summary: This study will evaluate the safety of LBH589 given in combination with lenalidomide and dexamethasone in adult patients with multiple myeloma

design_allocation: Non-Randomized

ipd_sharing: Undecided

lead_sponsor: Novartis Pharmaceuticals

location_country:
United States
Australia
France
Spain

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept. of Winship Cancer Inst.

location_facility: St. Vincent's Comprehensive Cancer Center

intervention_type: Combination Product


title: A 5-Day, Double-Blind, Placebo-Controlled Multicenter Study of Oral YM087 (CI-1025) to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia

summary: Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia

lead_sponsor: Cumberland Pharmaceuticals

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


title: An Open Label Study of the Safety of First-line Treatment With Avastin in Combination With Cisplatin-gemcitabine or Carboplatin-paclitaxel in Patients With Advanced or Recurrent Squamous Non-small Cell Lung Cancer, Who Are Considered to be at High Risk of Pulmonary Haemorrhage

summary: This single arm study will assess the feasibility of using Avastin plus platinum-based chemotherapy (cisplatin-gemcitabine or carboplatin-paclitaxel) in patients with advanced or recurrent squamous non-small cell lung cancer who have not received prior chemotherapy. Patients will receive preventive radiation, followed by one cycle of chemotherapy alone and 5 cycles of chemotherapy in combination with Avastin (15mg/kg iv on day 1 of each 3 weekly cycle), followed by Avastin alone for a maximum total treatment period with Avastin of 12 months. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
France
Poland
Israel
Hungary
Belgium
Australia
Russian Federation
Spain
Czech Republic
Taiwan


title: A Multicentre, Stratified, Randomised, Double Blind, Parallel Group Trial to Evaluate Whether a Treatment Strategy Based on Aiming for Total Control Results in Better AHR Than a Treatment Strategy Based on Maintaining Well Control

summary: This double-blind, stratified, parallel group study is to determine whether aiming for 'Total control' results in better airway hyper-responsiveness than maintaining the treatment level at which 'Well-controlled' asthma was achieved. The primary endpoint is the mean change in PC20 methacholine. Well controlled subjects (as assessed after a 12 week run-in period) will enter a 24 week treatment period during which they will record PEF(Peak Expiratory Flow), symptoms, rescue beta2-agonist use over 24 hours, night time awakenings, asthma exacerbations, emergency visits due to asthma and Adverse Events. At every visit lung function measurements and airway hyper-responsiveness will be measured.

lead_sponsor: GlaxoSmithKline

location_country: Italy Sweden Netherlands Finland France Belgium Spain Estonia Germany Latvia


title: A Phase III, Multicenter, Open-Label Study To Evaluate the Control of Gastric Acid Secretion With Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome For 12 Months

summary: This research study will determine if esomeprazole, when administered twice daily at 40, 80, or 120 mg doses, can control excessive stomach acid secretion.

location_country:
United States
France


title: A Phase II/III Study of the Safety and Efficacy of NC-503 in Patients Suffering From Secondary (AA) Amyloidosis

summary: The main objective of this study is to evaluate the safety and efficacy of NC-503 compared to placebo in patients with secondary (AA) amyloidosis using a composite assessment of clinical improvement/worsening of both renal and gastrointestinal functions.

ReferenceType: background

ReferenceCitation: Safety, Tolerability and Pharmacokinetic Profile of FibrillexTM (Anti-AA Amyloid Agent) in Healthy and Renal Impaired Subjects. Garceau D., Gurbindo C., Laurin J. Neurochem Inc. Reference: Proceedings from the IXth International Symposium on Amyloidosis , 2001 (Budapest, Hungary)

ReferenceCitation: Dember LM, Hawkins PN, Hazenberg BP, Gorevic PD, Merlini G, Butrimiene I, Livneh A, Lesnyak O, Puéchal X, Lachmann HJ, Obici L, Balshaw R, Garceau D, Hauck W, Skinner M; Eprodisate for AA Amyloidosis Trial Group. Eprodisate for the treatment of renal disease in AA amyloidosis. N Engl J Med. 2007 Jun 7;356(23):2349-60.

lead_sponsor: Bellus Health Inc

location_country:
Italy
Netherlands
Finland
France
Poland
Lithuania
Israel
Russian Federation
Spain
Turkey
United States
United Kingdom

location_facility: Indiana University School of Medicine, Department of Pathology and Laboratory Medicine,

location_facility: Hospital Universitario Germans Trias I Pujol, Servicio de Reumatologia

location_facility: Italian Group for Systemic Amyloidosis, Biotechnology Research Laboratories, IRCCS Policlinico San Matteo, Internal Medicine and Medical Oncology

location_facility: Hospital Clinic I Provincial de Barcelona, Jefe del Departamento de Reumatologia

location_facility: Hôpital Cochin, Centre de Recherche et d'Explorations Fonctionnelles

location_facility: Istanbul Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology

location_facility: Okregowy Szpital Kolejowy, Zaklad Reumatologii

location_facility: Heller Institute of Medical Research, Sheba Medical Center

location_facility: Royal Free and University College Medical School, Department of Medicine, National Amyloidosis Centre

location_facility: Marmara University Medical School Hospital, Department of Rheumatology

location_facility: Hospital Clinico San Carlos de Madrid, Servicio de Reumatologia

location_facility: Hôpital Claude Huriez, Service de médecine Interne, Clinique Médicale A

location_facility: Ciutad Sanitària y Universitària de Bellvitge, Servicio de Reumatologia, Hospitalet de Llobregat

location_facility: Centre Hospitalier du Mans, Service de Rhumatologie

location_facility: University Hospital Groningen, Department of Medicine, Division of Rheumatology


title: Gemtuzumab Ozogamicin (CMA-676) Followed or Not by Intensive Chemotherapy as Initial Treatment for Elderly Patients With Acute Myeloid Leukemia: An EORTC-LG Pilot Phase II Study

summary:
RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy uses different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of gemtuzumab ozogamicin with or without chemotherapy in treating older patients who have acute myeloid leukemia.

ReferenceCitation: Seedhouse CH, Grundy M, White P, Li Y, Fisher J, Yakunina D, Moorman AV, Hoy T, Russell N, Burnett A, Pallis M; National Cancer Research Network. Sequential influences of leukemia-specific and genetic factors on p-glycoprotein expression in blasts from 817 patients entered into the National Cancer Research Network acute myeloid leukemia 14 and 15 trials. Clin Cancer Res. 2007 Dec 1;13(23):7059-66.

ReferenceCitation: Amadori S, Suciu S, Willemze R, et al.: Up-front window trial of gemtuzumab ozogamicin (GO) in previously untreated elderly patients with AML: an EORTC leukemia group study. [Abstract] Blood 104 (11): A-877, 2004.

ReferenceCitation: Amadori S, Suciu S, Willemze R, Mandelli F, Selleslag D, Stauder R, Ho A, Denzlinger C, Leone G, Fabris P, Muus P, Vignetti M, Hagemeijer A, Beeldens F, Anak O, De Witte T; EORTC leukemia group; GIMEMA leukemia group. Sequential administration of gemtuzumab ozogamicin and conventional chemotherapy as first line therapy in elderly patients with acute myeloid leukemia: a phase II study (AML-15) of the EORTC and GIMEMA leukemia groups. Haematologica. 2004 Aug;89(8):950-6.

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

location_country: Italy Austria Netherlands Croatia France Belgium Germany

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore


title: TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of the cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known which treatment regimen is more effective in treating melanoma.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have metastatic melanoma.

ReferenceCitation: Agarwala SS, Keilholz U, Gilles E, Bedikian AY, Wu J, Kay R, Stein CA, Itri LM, Suciu S, Eggermont AM. LDH correlation with survival in advanced melanoma from two large, randomised trials (Oblimersen GM301 and EORTC 18951). Eur J Cancer. 2009 Jul;45(10):1807-14. doi: 10.1016/j.ejca.2009.04.016. Epub 2009 May 4.

ReferenceCitation: Keilholz U, Suciu S, Bedikian AY, et al.: LDH is a prognostic factor in stage IV melanoma patients (pts) but is a predictive factor only for bcl2 antisense treatment efficacy: re-analysis of GM301 and EORTC18951 randomized trials. [Abstract] J Clin Oncol 25 (Suppl 18): A-8552, 485s, 2007.

ReferenceCitation: Keilholz U, Eggermont AM. The role of interleukin-2 in the management of stage IV melanoma: the EORTC melanoma cooperative group program. Cancer J Sci Am. 2000 Feb;6 Suppl 1:S99-103.

ReferenceCitation: Schmidt H, Suciu S, Punt CJ, Gore M, Kruit W, Patel P, Lienard D, von der Maase H, Eggermont AM, Keilholz U; American Joint Committee on Cancer Stage IV Melanoma; EORTC 18951. Pretreatment levels of peripheral neutrophils and leukocytes as independent predictors of overall survival in patients with American Joint Committee on Cancer Stage IV Melanoma: results of the EORTC 18951 Biochemotherapy Trial. J Clin Oncol. 2007 Apr 20;25(12):1562-9.

ReferenceCitation: Punt CJ, Suciu S, Gore MA, Koller J, Kruit WH, Thomas J, Patel P, Lienard D, Eggermont AM, Keilholz U. Chemoimmunotherapy with dacarbazine, cisplatin, interferon-alpha2b and interleukin-2 versus two cycles of dacarbazine followed by chemoimmunotherapy in patients with metastatic melanoma: a randomised phase II study of the European Organization for Research and Treatment of Cancer Melanoma Group. Eur J Cancer. 2006 Nov;42(17):2991-5. Epub 2006 Oct 4.

ReferenceCitation: Keilholz U, Punt CJ, Gore M, Kruit W, Patel P, Lienard D, Thomas J, Proebstle TM, Schmittel A, Schadendorf D, Velu T, Negrier S, Kleeberg U, Lehman F, Suciu S, Eggermont AM. Dacarbazine, cisplatin, and interferon-alfa-2b with or without interleukin-2 in metastatic melanoma: a randomized phase III trial (18951) of the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol. 2005 Sep 20;23(27):6747-55.

ReferenceCitation: Keilholz U, Punt CJ, Gore M, et al.: Dacarbazine, cisplatin and interferon alpha with or without interleukin-2 in advanced melanoma: interim analysis of EORTC trial 18951. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A2043, 530a, 1999.

location_country:
Italy
Austria
Switzerland
Netherlands
France
Belgium
Portugal
Germany
United Kingdom

location_facility: Instituto Portugues de Oncologia do Porto

location_facility: Centre Hospitalier Universitaire Vaudois


status: Suspended

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

location_country:
Italy
Brazil
South Africa
Switzerland
Mexico
France
Japan
Romania
Belgium
Argentina
Portugal
Turkey
Denmark
Germany
Ukraine

acronym: MORNINGSKY

location_facility: Tokyo Shinagawa Hospital Medical Corporation Association Tokyokyojuno-kai

location_facility: Dr. Victor Babes Clinical Hospital of Pneumophthisiology and Infectious Diseases

location_facility: PanAmerican Clinical Research, Querétaro

location_facility: Comprensorio Amedeo Di Savoia Birago Di Vische

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital #13" of Kharkiv City Council

location_facility: CNE Kyiv City Clinical Hospital#1 of Exec. Body

location_facility: Municipal Non-profit enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council

location_facility: Communal Non-Commercial Enterprise Vinnytsia City Clinical Hospital 1

location_facility: Ankara University Medical Faculty - PPDS

location_facility: Private Practice Dr Jean Benoit Martinot

location_facility: Public Non-Profit Enterprise "City Outpatient Clinic #9" of Kharkiv City Council

location_facility: ASST di Lecco - Presidio Ospedaliero A. Manzoni di Lecco

location_facility: Private Enterprise Private Manufacture Company "Acinus", diagnostic and treatment center

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital; Tesvikiye Caddesi No:20

location_facility: L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar

location_facility: National Hospital Organization Kasumigaura Medical Center

location_facility: Sanatorio Medico de Diagnostico Y Tratamiento

location_facility: Hospital Senhora da Oliveira - Guimaraes, E.P.E

location_facility: Kyiv Railway Clinical Hospital No2 of Branch Health Center of the JSC Ukrainian Rail

location_facility: Institute of Infectious Diseases Emilio Ribas

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council

location_facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Fujita Health University Banbuntane Hotokukai Hospital

location_facility: Prof. Dr. Matei Bals Institute of Infectious Diseases

location_facility: Sibiu Emergency Clinical County Hospital

location_facility: CNPE Ivano-Frankivsk Regional Centre of Phthisiology and Pulmonology of IFRC

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

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

location_facility: Karadeniz Technical University Faculty of Medicine

location_facility: Polyclinic of Center of Medical Service and Rehabilitation of State JSHC Artem

location_facility: Rigshospitalet Copenhagen University Hospital

location_facility: Panamerican Clinical Research S.A de C.V.

location_facility: Communal Non-Profit Enterprise City Hospital #7 of Zaporizhzhia City Council

location_facility: Hospital E Maternidade Celso Pierro PUCCAMP

source: euctr

title: A Multicenter, Phase III Randomized, Double-Blind, Placebo-Controlled, Outpatient Study to Evaluate the Efficacy, Safety, Antiviral Activity of RO7496998 (AT-527) in Patients With Mild or Moderate COVID-19

summary: This study will evaluate the efficacy, safety, antiviral activity, and pharmacokinetics of study drug RO7496998 (AT-527) compared to placebo in non-hospitalized adult and adolescent participants with mild to moderate coronavirus disease 2019 (COVID-19) in the outpatient setting.


title: A Randomized Double-Blind Phase IIA Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)

acronym: CROSSWALK-c

summary: This study is designed to evaluate the efficacy, safety and pharmacokinetics of crovalimab compared with placebo as adjunct therapy in the prevention of VOEs in participants with SCD.

study_start_date_type: Anticipated

status: Not yet recruiting

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

location_country:
Italy
Brazil
France
Spain
Turkey
United States

location_facility: Children's Hospital of Michigan; Pediatrics

location_facility: Mustafa Kemal University Medical Faculty; Infection

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Adana Acibadem Hospital; Pediatric Hematology

location_facility: East Carolina University; Brody School of Medicine

location_facility: CHU Henri Mondor; Service de médecine interne

location_facility: Northwell Health; Cohen Children's Medical Center

location_facility: Hospital Universitario Gregorio Marañón; Oncología y Hematología Pediátricas y del Adolescente

location_facility: Kosair Charities Pediactric Clinical Research Unit University of Louisville

location_facility: UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

location_facility: Università degli Studi della Campania Luigi Vanvitelli; UOC Ematologia ed oncologia pediatrica

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Hôpital Saint Eloi; Service de Médecine interne

location_facility: Hôpital Saint Eloi; Service de Pédiatrie

location_facility: Cukurova University Medical Faculty Balcali Hospital

location_facility: Hospital das Clínicas Faculdades Médicas de Ribeirão Preto

location_facility: Azienda Ospedaliera di Verona-Policlinico G.B. Rossi; Medicina Interna

location_facility: Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi

status_simplified: Ongoing


type: Other Identifier

type: Registry Identifier

title: A Randomized, Phase 3, Open-label Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Versus Intravenous Pembrolizumab, Administered With Platinum Doublet Chemotherapy, in the First-Line Treatment of Participants With Metastatic Squamous or Nonsquamous Non-Small-Cell Lung Cancer

summary:
The purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with standard-of-care chemotherapy. The primary hypothesis of the study is Pembrolizumab SC is noninferior to pembrolizumab intravenous (IV) for Cycle 1 Area Under Curve (AUC) and Cycle 6 minimal concentration (Ctrough) at steady state.

Participants who discontinue study treatment after receiving the first course of 35 administrations of pembrolizumab (approximately up to 2 years) for reasons other than disease progression or intolerability, may be eligible for a second course of pembrolizumab for up to approximately 1 additional year if they have experienced radiographic disease progression per RECIST 1.1 as assessed by BICR after stopping first course treatment.

status: Recruiting

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Guatemala
France
Japan
Poland
Hungary
Russian Federation
Spain
Turkey
United States
Taiwan
Ukraine

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1806)

location_facility: Saint-Petersburg Scientific-Practical Center of Specialized Kinds of Medical Care (o) ( Site 1424)

location_facility: Gulhane Egitim ve Arastirma Hastanesi ( Site 1704)

location_facility: Chang Gung Medical Foundation-Linkou Branch ( Site 2102)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1103)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1200)

location_facility: Hospital Universitario La Paz ( Site 1601)

location_facility: Medical Center Mriya Med-Service ( Site 1805)

location_facility: Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 1201)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1106)

location_facility: SPb SBHI City Clinical Oncological Dispensary ( Site 1409)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Okayama University Hospital ( Site 3012)

location_facility: Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 1707)

location_facility: Medical Center Asklepion LLC ( Site 1804)

location_facility: Clinica Privada Dr. Rixci Ramirez ( Site 0601)

location_facility: Kyiv City Clinical Oncology Centre ( Site 1809)

location_facility: Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 0100)

location_facility: Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1425)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 3001)

location_facility: Kansai Medical University Hospital ( Site 3016)

location_facility: Kanagawa Cardiovascular and Respiratory Center ( Site 3003)

location_facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1407)

location_facility: Hospital Juan Ramon Jimenez ( Site 1602)

location_facility: Hospital Universitario Lucus Augusti ( Site 1603)

location_facility: PIH Health Hematology Medical Oncology ( Site 0106)

location_facility: Juntendo University Hospital ( Site 3011)

location_facility: National Taiwan University Hospital Hsin-Chu Branch ( Site 2103)

location_facility: Institut Regional du Cancer de Montpellier - ICM ( Site 1003)

location_facility: Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0602)

location_facility: Millennium Physicians - Oncology ( Site 0097)

location_facility: Tokushima University Hospital ( Site 3019)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1701)

location_facility: Osaka Medical and Pharmaceutical University Hospital ( Site 3017)

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2107)

location_facility: Changhua Christian Hospital ( Site 2104)

location_facility: Ukrainian Center of Tomotherapy ( Site 1807)

location_facility: Montefiore Medical Center [Bronx, NY] ( Site 0040)

location_facility: National Cheng Kung University Hospital ( Site 2105)

location_facility: Centro Regional de Sub Especialidades Médicas SA ( Site 0600)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 3002)

location_facility: The University of Tennessee Medical Center ( Site 0050)

location_facility: Taipei Veterans General Hospital ( Site 2106)

location_facility: SPBU Clinic of Advanced medical technologies n.a. N. I. Pirogov ( Site 1406)

location_facility: National Hospital Organization Hokkaido Cancer Center ( Site 3014)

location_facility: St. Vincent Frontier Cancer Center ( Site 0058)

location_facility: Fujita Health University Hospital ( Site 3007)


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet Syndrome (DS)

summary:
The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of convulsive seizures in children and young adults with Dravet Syndrome.

Participants will receive their standard anti-seizure therapy, plus either a tablet of soticlestat or placebo for 16 weeks. A placebo looks just like soticlestat but will not have any medicine in it.

Participants may continue treatment in an extension study, based on the extension study's entry criteria. Those that want to stop treatment will have a gradual dose reduction during 1 week and then be followed up for 2 weeks.

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

lead_sponsor: Takeda

location_country:
Italy
United States
Serbia
Netherlands
Spain
France
Japan
Greece
Poland
Hungary
Belgium
Australia
Russian Federation
China
Canada
Latvia
Ukraine

location_facility: Kumamoto-Ezuko Medical Center for The Severely Disabled

location_facility: Communal Non-profit Enterprise City Childrens Clinical Hospital #5 of DCC

location_facility: CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSA

location_facility: SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of Ukr

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

location_facility: Stichting Epilepsie Instellingen Nederland

location_facility: University of California Benioff Children's Hospital

location_facility: Clinic for Neurology and Psychiatry for Children and Youth

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

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: University of Iowa Hospitals & Clinics - (CRS)

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

location_facility: Cook Children's Medical Center - Jane and John Justin Neurosciences Center

location_facility: ASST di Mantova - Azienda Ospedaliera Carlo Poma

location_facility: The Second Affiliated Hospital of Guangzhou Medical Univeristy

location_facility: Clinical Integrative Research Center of Atlanta

location_facility: Guangzhou Women And Children's Medical Center

location_facility: ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS

location_facility: National Center of Neurology and Psychiatry

location_facility: Children and Youth Health Care Institute of Vojvodina

location_facility: Hopital Universitaire des Enfants Reine Fabiola

location_facility: National Hospital Organization Nishi-Niigata Chuo National Hospital

location_facility: Children's Hospital of Chongqing Medical University

location_facility: Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy

location_facility: Municipal Institution Dnipropetrovsk Regional Children Clinical Hospital of DRC

location_facility: National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: Xiangya Hospital Central South University

location_facility: Communal Non-commercial Enterprise Iv-Frank Regional Childrens Clinical Hosp of Iv-Frank RC

location_facility: Beijing Children's Hospital,Capital Medical University

location_facility: Orszagos Mentalis, Ideggyogyaszati es Idegsebeszeti Intezet

location_facility: Childrens' Hospital of Athens 'P. and A. Kyriakou'

location_facility: Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego w Warszawie

location_facility: Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Adult Subjects With Lennox-Gastaut Syndrome (LGS)

summary:
The aims of the study are:

to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome.
to assess the safety profile of soticlestat when given in combination with other therapies.

Participants will receive their standard anti-seizure therapy, plus either tablets of soticlestat or placebo. A placebo looks just like soticlestat but will not have any medicine in it. Participants will take soticlestat or placebo for 16 weeks, followed by a gradual dose reduction for 1 week. Then, participants will be followed up for 2 weeks.

location_facility: Kumamoto-Ezuko Medical Center for The Severely Disabled

location_facility: Institute of Neurology and Neurosurgery at Saint Barnabas, LLC

location_facility: Communal Non-profit Enterprise City Childrens Clinical Hospital #5 of DCC

location_facility: CNPE Clinical Hospital Psychiatry of the Executive Body of the Kyiv City Council KCSA

location_facility: SI Ukr. Med. Rehabilitation Center For Children With Organic Injury of Nervous System of MoH of Ukr

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

location_facility: University of California Benioff Children's Hospital

location_facility: Stichting Epilepsie Instellingen Nederland

location_facility: Clinic for Neurology and Psychiatry for Children and Youth

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

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: University of Iowa Hospitals & Clinics - (CRS)

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Mother and Child Health Care Institute of Serbia Dr Vukan Cupic

location_facility: Cook Children's Medical Center - Jane and John Justin Neurosciences Center

location_facility: ASST di Mantova - Azienda Ospedaliera Carlo Poma

location_facility: The Second Affiliated Hospital of Guangzhou Medical Univeristy

location_facility: Guangzhou Women And Children's Medical Center

location_facility: Clinical Integrative Research Center of Atlanta

location_facility: University of Utah - Primary Children's Hospital - PPDS

location_facility: Medical University of South Carolina Children Hospital - PIN


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

summary: The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Brazil
Chile
Mexico
Spain
Finland
France
Czechia
Poland
Romania
Hungary
Argentina
Australia
Ireland
China
Russian Federation
United States
United Kingdom
Taiwan
Colombia

location_facility: Paramount Medical Research & Consulting, Llc

location_facility: Great Lakes Clinical Trials - West Wilson Avenue

location_facility: Arthritis Center of Lexington-Bluegrass Community Research, Inc.

intervention_type: Other


status: Enrolling by invitation

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

lead_sponsor: UCB Biopharma SRL

location_country:
United States
Germany
France
Bulgaria
Greece
Japan
Poland
Hungary
Australia
Spain
Canada

acronym: BE HEARD EXT

title: A Phase 3, Open-Label, Parallel Group, Multicenter, Extension Study Evaluating the Long-Term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

summary: The purpose of the study is to evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)


title: A Phase 2, Randomized, Open-Label Study of Trilaciclib Administered With First-Line Platinum-Based Chemotherapy and Avelumab Maintenance Therapy in Patients With Untreated, Locally Advanced or Metastatic Urothelial Carcinoma (PRESERVE 3)

summary: This is a Phase 2, multicenter, randomized, open-label study evaluating the safety and efficacy of trilaciclib administered with platinum-based chemotherapy followed by trilaciclib administered with avelumab maintenance therapy compared with platinum-based chemotherapy followed by avelumab maintenance therapy in patients receiving first-line treatment for advanced/metastatic bladder cancer.

ipd_sharing: No

lead_sponsor: G1 Therapeutics, Inc.

location_country:
France
Georgia
Hungary
Spain
United States

location_facility: Fundación Instituto Valenciano de Oncología

location_facility: The Harry and Jeanette Weinberg Cancer Institute

location_facility: Hospital Clinic de Barcelona - Servicio de Oncología Médica

location_facility: Hopitaux Universitaires de Strasbourg - Service Oncologie et Hématologie

location_facility: LTD "Multiprofile Clinic Consilium Medulla"

location_facility: National Center of Urology Named after Laur Managadze

location_facility: Medical Oncology Associates, PS (dba Summit Cancer Centers)

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint

location_facility: Institut Bergonié - Oncologie Médicale et Pédiatrique


ipd_sharing_description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
United States
Netherlands
Germany
France
Czechia
Poland
Norway
Australia
Spain
Canada

location_facility: Cityclinic Medical and Psychological Clinic Matusiak Partnership

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Dr. S. K. Siddha Medicine Professional Corporation

title: An Open-label, Long-term Extension Trial of Spesolimab Treatment in Adult Patients With Hidradenitis Suppurativa (HS)

summary:
This study is open to adults with hidradenitis suppurativa who took part in a previous clinical study of a medicine called spesolimab. Participants who completed treatment can join this study.

The purpose of this study is to find out how safe spesolimab is and whether it helps people with hidradenitis suppurativa in the long-term. Participants are in this study for about 2 years and 4 months. For 2 years, participants visit the study site every 2 weeks to get spesolimab injections under the skin. At study visits, doctors check the severity of participants' hidradenitis suppurativa and collect information on any health problems of the participants.


title: A 52-week Multicenter, Randomized, Double-masked, 2-arm Parallel Study to Compare Efficacy, Safety and Immunogenicity of SOK583A1 to Eylea®, Administered Intravitreally, in Patients With Neovascular Age-related Macular Degeneration

acronym: Mylight

summary:
Purpose and rationale: To demonstrate similar efficacy, safety and immunogenicity of SOK583A1 and Eylea EU as per Eylea approved treatment regimen in patients with nAMD.

The primary clinical question of interest is: Does SOK583A1 have similar efficacy as Eylea EU in terms of mean change in BCVA score in participants with nAMD who are anti-VEGF naive, without important protocol deviations and adherent to the treatment and completed the treatment to Week 8?

lead_sponsor: Sandoz

location_country:
Austria
Spain
France
Bulgaria
Japan
Israel
Lithuania
Poland
Hungary
Australia
Slovakia
Portugal
United States
Latvia

intervention_type: Biological


title: "A Phase 1, Multicenter, Open-label, Dose Finding Study of CC-96673 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma"

summary:
The purpose of this Phase 1 study is to evaluate the safety and tolerability of CC-96673 in adult participants with Relapsed or Refractory Non-Hodgkin's Lymphoma (R/R NHL).

The study will be conducted in 2 parts: Part A, monotherapy dose escalation and Part B, monotherapy dose expansion.

Parts A and B will consist of 3 periods: Screening, Treatment, and Follow-up.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_country:
United States
Canada
France
Spain

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: Universitario de Salamanca - Hospital Clinico


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging, Phase 2b Study to Evaluate Efficacy and Safety of Tezepelumab for the Treatment of Chronic Spontaneous Urticaria

acronym: INCEPTION

summary: The primary objective of this study is to evaluate the effect of tezepelumab on improvement in the Urticaria Activity Score over 7 days (UAS7).

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

lead_sponsor: Amgen

location_country:
Italy
United States
France
Japan
Greece
Korea, Republic of
Poland
Spain
Germany
Canada

location_facility: Clinique Spécialisée en Allergie de la Capitale

location_facility: David Fivenson MD Professional Liability Company

location_facility: Hospital General Universitario de Valencia

location_facility: Austin Institute for Clinical Research, Inc

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Washington University School of Medicine

location_facility: Attikon University General Hospital of Athens

location_facility: George Papageorgiou General Hospital of Thessaloniki

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Seoul National University Bundang Hospital

location_facility: Centre Hospitalier Universitaire Archet 2

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Hallym University Dongtan Sacred Heart Hospital

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: Cutis Wellness Dermatology and Dermatopathology, PLLC

location_facility: SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

location_facility: Fujita Health University Bantane Hospital

location_facility: Henry Ford Medical Center - New Center One

location_facility: Gordon Sussman Clinical Research Incorporated

location_facility: Dermatology Research Institute Incorporated

location_facility: Centre Hospitalier Universitaire de Brest - Hôpital Morvan

location_facility: Family Allergy and Asthma Research Institute

location_facility: Kliniczny Szpital Wojewodzki nr 1 im Fryderyka Chopina

location_facility: Dawes Fretzin Clinical Research Group, LLC


type: Other Grant/Funding Number

title: A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants

summary: The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of MK-1654 in healthy pre-term and full-term infants. It is hypothesized that MK-1654 will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to placebo.

primary_purpose: Prevention

ReferenceCitation: Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11.

family: Ginsburg

full_name: Amy Sarah Ginsburg

given: Amy Sarah

family: Srikantiah

full_name: Padmini Srikantiah

given: Padmini

journal_name: The Lancet Global Health

location_country:
Peru
Finland
Malaysia
Belgium
Denmark
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Philippines
United States
United Kingdom
Italy
Mexico
Israel
Turkey

location_facility: Clinica del Nino y la Madre ( Site 1005)

location_facility: Northwest Arkansas Pediatric Clinic ( Site 0050)

location_facility: Tribe Clinical Research, LLC ( Site 0015)

location_facility: Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0061)

location_facility: DCOL Center for Clinical Research ( Site 0042)

location_facility: Severance Hospital Yonsei University Health System ( Site 3201)

location_facility: Multicare Health System Institute for Research and Innovation ( Site 0025)

location_facility: St. Georges University Hospital NHS Foundation Trust ( Site 2601)

location_facility: Centrum Medyczne Pratia Warszawa ( Site 2438)

location_facility: Tottori University Hospital ( Site 3053)

location_facility: Sabah Womens & Childrens Hospital ( Site 3102)

location_facility: Midwest Children's Health Research Institute, LLC ( Site 0044)

location_facility: Gravita Diagnostyka i Leczenie Nieplodnosci ( Site 2423)

location_facility: St. Marianna University School of Medicine Hospital ( Site 3060)

location_facility: MTL Centrum Medyczne Puławska Społka zoo Sp K. ( Site 2426)

location_facility: Madera Family Medical Group ( Site 0046)

location_facility: Southeastern Pediatric Associates, P.A. ( Site 0008)

location_facility: Turun rokotetutkimusklinikka ( Site 2151)

location_facility: Seoul National University Hospital ( Site 3203)

location_facility: Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2435)

location_facility: Szpital Bielanski im. Ks. Jerzego Popiełuszki SPZOZ ( Site 2425)

location_facility: Szpital im. sw. Jadwigi Slaskiej w Trzebnicy ( Site 2409)

location_facility: Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 2157)

location_facility: Etela Helsingin rokotetutkimusklinikka ( Site 2159)

location_facility: UH Bristol Education Centre ( Site 2607)

location_facility: Hallym University Sacred Heart Hospital ( Site 3207)

location_facility: Hamilton Medical Research Group ( Site 0509)

location_facility: Tampereen yliopisto Seinajoen Rokotetutkimuskeskus ( Site 2155)

location_facility: Centre Hospitalier de Versailles ( Site 2206)

location_facility: Children's Hospital Colorado ( Site 0066)

location_facility: Shizuoka City Shimizu Hospital ( Site 3061)

location_facility: Children's National Hospital ( Site 0076)

location_facility: McGill University Health Centre - Vaccine Study Centre ( Site 0500)

location_facility: Instituto Nacional de Pediatria ( Site 1202)

location_facility: Optumcare Colorado Springs, LLC ( Site 0022)

location_facility: University Health System- San Antonio ( Site 0048)

location_facility: Acevedo Clinical Research Associates ( Site 0002)

location_facility: Oxford University Hospital NHS Foundation Trust ( Site 2604)

location_facility: Alergo-Med Specjalistyczna Przychodnia Lekarska SP ( Site 2403)

location_facility: Long Beach Memorial Medical Center ( Site 0014)

location_facility: Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 2160)

location_facility: Empilweni Services and Research Unit ( Site 2504)

location_facility: St.Luke's International Hospital ( Site 3062)

location_facility: JOHAS Yokohama Rosai Hospital ( Site 3058)

location_facility: Maebashi Red Cross Hospital ( Site 3057)

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2551)

location_facility: Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 2153)

location_facility: Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 2152)

location_facility: Multicare Institute For Research And Innovation ( Site 0045)

location_facility: Ageo Central General Hospital ( Site 3051)

location_facility: Seoul National University Bundang Hospital-Pediatrics ( Site 3204)

location_facility: Centro de Estudios en Infectologia Pediatrica SAS ( Site 1159)

location_facility: National Hospital Organization Beppu Medical Center ( Site 3063)

location_facility: Pusan National University Hospital ( Site 3206)

location_facility: Soroka University Medical Center Rahat Family health center ( Site 2355)

location_facility: Ohio Pediatric Research Association ( Site 0063)

location_facility: Aalborg Universitetshospital ( Site 2100)

location_facility: Facultad Medicina Universidad de Chile ( Site 1105)

location_facility: Policlinico Universitario Gemelli ( Site 2301)

location_facility: Regionshospitalet Nordjylland ( Site 2102)

location_facility: Red Cross War Memorial Children's Hospital ( Site 2502)

location_facility: Pediatric Research of Charlottesville, LLC ( Site 0073)

location_facility: Uniwersytecki Szpital Dzieciecy w Lublinie ( Site 2404)

location_facility: Next Phase Research Alliance, LLC ( Site 0071)

location_facility: University of Texas Medical Branch at Galveston ( Site 0059)

location_facility: Uniwersytecki Szpital Kliniczny-Klinika Pediatrii i Chorob Infekcyjnych ( Site 2440)

location_facility: MultiCare Rockwood Cheney Clinic ( Site 0068)

location_facility: Fukui-ken Saiseikai Hospital ( Site 3064)

location_facility: Soroka University Medical Center Ramot Family health center ( Site 2354)

location_facility: Far Eastern University - Nicanor Reyes Medical Foundation ( Site 3153)

location_facility: Uniwersyteckie Centrum Kliniczne ( Site 2437)

location_facility: Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 2154)

location_facility: Alder Hey Childrens NHS Foundation Trust Hospital ( Site 2606)

location_facility: Orange County Research Institute ( Site 0057)

location_facility: Hospital Militar Central Cir Mayor Cosme Argerich ( Site 1001)

location_facility: University of Calgary - Alberta Children Hospital ( Site 0504)

location_facility: Groupe Hospitalier Pellegrin ( Site 2218)

location_facility: Centre Hospitalier Universitaire Saint Pierre (Bruxelles) ( Site 2003)

location_facility: Clinica Peruano Americana S.A. ( Site 1253)

location_facility: Instytut Mikroekologii Sp. z.o.o. & Co. Sp. Komandytorowa ( Site 2412)

location_facility: Hospital Nacional Docente Madre - Nino San Bartolome ( Site 1251)

location_facility: Enhancing Care Foundation-DICRS ( Site 2506)

location_facility: Children's Clinic of Jonesboro, PA ( Site 0058)

location_facility: CAIMED Investigación en Salud S.A de C.V ( Site 1209)

location_facility: Steve Biko Academic Hospital ( Site 2505)

location_facility: Centenario Hospital Miguel Hidalgo ( Site 1204)

location_facility: Dartmouth-Hitchcock Medical Center ( Site 0031)


title: Randomized, Double-blind, Placebo-controlled, Study of Spesolimab in Patients With Moderate to Severe Hidradenitis Suppurativa

summary:
This study is open to adults with a chronic inflammatory skin disease called hidradenitis suppurativa. The purpose of this study is to find out whether a medicine called spesolimab helps people with moderate to severe hidradenitis suppurativa.

Participants are put into 2 groups by chance. One group takes spesolimab. The other group takes placebo. Every participant has twice the chance of being in the spesolimab group than in the placebo group. Participants get spesolimab or placebo as an infusion into a vein every week for the first 3 weeks. Afterwards, they get spesolimab or placebo as injections under the skin every 2 weeks. Placebo infusions and injections look like spesolimab infusions and injections but do not contain any medicine.

Participants are treated in the study for about 3 months. During this time, they visit the study site about 9 times. After completing this part of the study, participants are offered to join another clinical study in which all participants get spesolimab. Participants who cannot join the other study, stay in this study for about 4 more months. During this time, participants do not take spesolimab nor placebo but they visit the study site 2 times to have their health checked.

At study visits, doctors thoroughly check the skin of participants to count lumps (nodules) and boils (abscesses). The results between the spesolimab group and the placebo group are compared after 3 months of treatment. The doctors also regularly check the general health of the participants.

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

location_country:
Italy
United States
Netherlands
Germany
France
Czechia
Poland
Norway
Belgium
Australia
Spain
Canada

location_facility: Dr. S. K. Siddha Medicine Professional Corporation

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Cityclinic Medical and Psychological Clinic Matusiak Partnership

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Dawes Fretzin Clinical Research Group, LLC


title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-64304500 in Patients With Alopecia Areata

summary: The purpose of this study is to evaluate the clinical response of 22 weeks of study intervention with JNJ-64304500, compared with placebo, in participants with moderate to severe alopecia areata (AA).

status: Withdrawn

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
United States
Australia
France
Japan

location_facility: The Juntendo Tokyo Koto Geriatric Medical Center

location_facility: University of Pittsburgh Department of Dermatology

location_facility: St George Dermatology & Skin Cancer Centre


title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion

acronym: BALATON

summary: This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in participants with macular edema due to branch retinal vein occlusion (BRVO).

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Australia
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Korea, Republic of
Hong Kong
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
Spain

location_facility: Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: The 2nd Affiliated Hospital of Harbin Medical University

location_facility: Queen Mary Hospital; Department of Ophthalmology

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik

location_facility: Tan Tock Seng Hospital; Ophthalmology Department

location_facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: California Eye Specialists Medical group Inc.

location_facility: Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT

location_facility: Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia

location_facility: Eye Hospital, Wenzhou Medical University

location_facility: The Affiliated Eye Hospital of Nanjing Medical University

location_facility: Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

location_facility: Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde 3.B1.266

location_facility: Specjalistyczny Ośrodek Okulistyczny Oculomedica

location_facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

location_facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Chang Gung Medical Foundation - Linkou; Ophthalmology

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Retina-Vitreous Associates Medical Group

location_facility: National University Hospital; Ophthalmology Department

location_facility: Seoul National University Bundang Hospital

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Faculty Hospital Ostrava; Ophthalmology clinic

location_facility: Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic

location_facility: Retina Consultants of Southern Colorado PC

location_facility: "Intersec. Research and Technology Complex "Eye Microsurgery" n a Fyodorov Irkutsk branch

location_facility: Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

location_facility: Taipei Veterans General Hospital; Ophthalmology

location_facility: Bristol Eye Hospital;Retinal Treatment and Research Unit

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: Hospital dos de maig; servicio de oftalmologia

location_facility: National Taiwan University Hospital; Ophthalmology

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Changhua Christian Hospital; Department of Ophthalmology

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Centro Hospitalar Universitário do Porto - Hospital de Santo António; Servico de Oftalmologia

location_facility: Shiga University Of Medical Science Hospital

location_facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

location_facility: Zhongshan Ophthalmic Center, Sun Yat-sen University

location_facility: Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

location_facility: University Retina and Macula Associates, PC

intervention_type: Procedure


title: A Randomized, Open-Label, Parallel-Group, Multicentre, Phase II Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 mg With Anastrozole (ARIMIDEX™) 1 mg as First Line Hormonal Treatment for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer

acronym: FIRST

summary: The purpose of this study is to compare the efficacy and tolerability of Faslodex (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor positive advanced breast cancer.

lead_sponsor: AstraZeneca

location_country:
Italy
Brazil
France
Czechia
Bulgaria
Poland
Spain
United States
United Kingdom


location_country:
Finland
Greece
Romania
Belgium
Australia
Denmark
Croatia
France
Japan
Poland
Slovakia
Norway
Turkey
Sweden
Switzerland
Bulgaria
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Bosnia and Herzegovina
Serbia
Czechia
Spain
Estonia

acronym: DUET

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Padsevonil as Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy

summary: The purpose of the study is to evaluate the efficacy, safety and tolerability of the 3 selected dose regimens of padsevonil (PSL) administered concomitantly with up to 3 anti-epileptic drugs (AEDs) compared with placebo for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.


title: A Phase 2 Randomized, Multicenter, Double-blind, Vehicle Controlled, 90-Day, Safety, Efficacy & Systemic Exposure Study Followed by a 90-Day Open-label Extension of Trifarotene (CD5789) Cream HE1 in Adults and Adolescents With Autosomal Recessive Ichthyosis With Lamellar Scale

summary: This is a phase 2 randomized, multi-center, double-blind, vehicle controlled, 90 day, safety, efficacy, and systemic exposure study followed by a 90 day open-label extension of trifarotene cream in adults and adolescents with autosomal recessive ichthyosis with lamellar scale.

lead_sponsor: Mayne Pharma International Pty Ltd

location_country:
United States
Germany
France
Israel
Australia
Spain
Canada
United Kingdom
Ukraine

location_facility: Dnipropetrovsk State Hospital of Dermatovenerology

location_facility: Medical Center of Private Enterprise "Dzerkalo"

location_facility: Ternopil Regional Clinical Dermatovenereological Dispensary

location_facility: Royal London Hospital Barts Health Nhs Trust

location_facility: Community Institution "Zaporizhzhya Regional Dermatovenereology Clinical Hospital"

location_facility: Dawes Fretzin Clinical Research Group, LLC


title: A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer

summary: The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.

ReferenceCitation: Bachelot T, Garcia-Saenz JA, Verma S, Gutierrez M, Pivot X, Kozloff MF, Prady C, Huang X, Khosravan R, Wang Z, Cesari R, Tassell V, Kern KA, Blay JY, Lluch A. Sunitinib in combination with trastuzumab for the treatment of advanced breast cancer: activity and safety results from a phase II study. BMC Cancer. 2014 Mar 7;14:166. doi: 10.1186/1471-2407-14-166.

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Garcia-Saenz

full_name: Jose A Garcia-Saenz

given: Jose A

family: Verma

full_name: Sunil Verma

given: Sunil

family: Gutierrez

full_name: Maya Gutierrez

given: Maya

family: Pivot

full_name: Xavier Pivot

given: Xavier

family: Kozloff

full_name: Mark F Kozloff

given: Mark F

family: Prady

full_name: Catherine Prady

given: Catherine

family: Huang

full_name: Xin Huang

given: Xin

family: Khosravan

full_name: Reza Khosravan

given: Reza

family: Wang

full_name: Zhixiao Wang

given: Zhixiao

family: Cesari

full_name: Rossano Cesari

given: Rossano

family: Tassell

full_name: Vanessa Tassell

given: Vanessa

family: Kern

full_name: Kenneth A Kern

given: Kenneth A

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Lluch

full_name: Ana Lluch

given: Ana

currency_apc_doaj: GBP

journal_name: BMC Cancer

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Pfizer

location_country:
United States
France
Belgium
Spain
Canada


title: A Phase III, Multicentre, Randomized, Double-blind, Parallel-group Study to Evaluate the Safety of Once Daily Esomeprazole for the Treatment of Clinically Diagnosed Gastroesophageal Reflux Disease (GERD) in Pediatric and Adolescent Patients 12 to 17 Years of Age, Inclusive.

summary: This study is a phase III, multi-centre, randomized, double-blind study to assess the safety and tolerability of once daily treatment with esomeprazole 20 or 40 mg in pediatric and adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed GERD. The treatment period will be up to 8 weeks.

ReferenceCitation: Gunasekaran T, Tolia V, Colletti RB, Gold BD, Traxler B, Illueca M, Crawley JA. Effects of esomeprazole treatment for gastroesophageal reflux disease on quality of life in 12- to 17-year-old adolescents: an international health outcomes study. BMC Gastroenterol. 2009 Nov 18;9:84. doi: 10.1186/1471-230X-9-84.

family: Gunasekaran

full_name: Thirumazhisai Gunasekaran

given: Thirumazhisai

family: Tolia

full_name: Vasundhara Tolia

given: Vasundhara

family: Colletti

full_name: Richard B Colletti

given: Richard B

family: Gold

full_name: Benjamin D Gold

given: Benjamin D

family: Traxler

full_name: Barry Traxler

given: Barry

family: Illueca

full_name: Marta Illueca

given: Marta

family: Crawley

full_name: Joseph A Crawley

given: Joseph A

journal_name: BMC Gastroenterology

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

location_country:
Italy
United States
Canada
France


title: A Long-term, Multicenter, Single-arm, Open-label Extension of the SERENADE Study, to Assess the Safety and Efficacy of Macitentan in Subjects With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

acronym: SERENADE OL

summary: The aim of this open-label (OL) extension trial is to study the long-term safety and efficacy of macitentan in subjects with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease (PVD) beyond the treatment in the double-blind parent SERENADE study (AC-055G202, NCT03153111). Furthermore, this OL extension study will give eligible subjects of the main study (SERENADE/AC-055G202, NCT03153111) an opportunity to continue or start receiving macitentan.

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

lead_sponsor: Actelion

location_country:
Austria
Brazil
Sweden
Germany
France
Bulgaria
Poland
Israel
Romania
Hungary
Argentina
Russian Federation
Denmark
United States
United Kingdom

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: University Of Iowa - Hospitals & Clinics

location_facility: 4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ

location_facility: Washington University School of Medicine

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Maestri E Kormann Consultoria Médico- Científica Ltda

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Semmelweis Egyetem Városmajor Szív- és Érgyógyászati Klinika

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Krakowski Szpital Specjalityczny im. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn

location_facility: Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ

location_facility: Federal State Budget Scientific Institution


title: A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Either Persistent or Recurrent Following BCG Induction or That is Naïve to BCG Treatment (KEYNOTE-676)

summary: This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.

ReferenceCitation: Kamat AM, Shore N, Hahn N, Alanee S, Nishiyama H, Shariat S, Nam K, Kapadia E, Frenkl T, Steinberg G. KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC. Future Oncol. 2020 Apr;16(10):507-516. doi: 10.2217/fon-2019-0817. Epub 2020 Mar 12.

name: Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA

family: Kamat

full_name: Ashish M Kamat

given: Ashish M

name: Department of Urology, Carolina Urologic Research Center, Myrtle Beach, SC 29572, USA

family: Shore

full_name: Neal Shore

given: Neal

name: Department of Oncology & Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD 21287, USA

family: Hahn

full_name: Noah Hahn

given: Noah

name: Department of Urology, Henry Ford Hospital, Detroit, MI 48202, USA

family: Alanee

full_name: Shaheen Alanee

given: Shaheen

name: Department of Urology, University of Tsukuba, Tsukuba 305-8577, Japan

family: Nishiyama

full_name: Hiroyuki Nishiyama

given: Hiroyuki

name: Department of Urology, Medical University of Vienna, 1090 Vienna, Austria

family: Shariat

full_name: Shahrokh Shariat

given: Shahrokh

name: Department of Biostatistics and Research Decision Sciences, Merck & Co., Inc., Kenilworth, NJ 07033, USA

family: Nam

full_name: Kijoeng Nam

given: Kijoeng

name: Department of Oncology, Merck & Co., Inc., Kenilworth, NJ 07033, USA

family: Kapadia

full_name: Ekta Kapadia

given: Ekta

family: Frenkl

full_name: Tara Frenkl

given: Tara

name: Department of Urology, NYU Langone Health, New York, NY 10017, USA

family: Steinberg

full_name: Gary Steinberg

given: Gary

journal_name: Future Oncology

oa_colors: green other

evidence: open (via page says license)

repository_institution: University of Tsukuba - Terrestrial Environment Research Center

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

location_country:
Peru
Guatemala
Finland
Malaysia
Greece
Australia
Belgium
Costa Rica
France
Japan
Poland
Norway
Canada
Korea, Republic of
Switzerland
Netherlands
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Austria
Spain
Turkey

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0961)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0963)

location_facility: Hospital Universitario Quiron Madrid ( Site 0862)

location_facility: Urology Clinics of North Texas, PLLC ( Site 1064)

location_facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083)

location_facility: OHSU Knight Cancer Institute ( Site 1075)

location_facility: Urologica Praktyka Lekarska Adam Marcheluk ( Site 0654)

location_facility: Hospital Universitario La Paz ( Site 0866)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 1204)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1302)

location_facility: Princess Margaret Cancer Centre ( Site 0153)

location_facility: Maastricht University Medical Centre ( Site 0453)

location_facility: Nara Medical University Hospital ( Site 0411)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0353)

location_facility: Osp Generale Reg di Bolzano ( Site 0355)

location_facility: Akershus University Hospital ( Site 0553)

location_facility: Hirosaki University Hospital ( Site 0407)

location_facility: University Hospitals Cleveland Medical Center ( Site 1066)

location_facility: Tokyo Medical and Dental University Hospital ( Site 0409)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 0653)

location_facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 1353)

location_facility: Tampere University Hospital [Tampere Finland] ( Site 0201)

location_facility: Kitasato University Hospital ( Site 0403)

location_facility: Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0266)

location_facility: A.O.U. di Verona - Ospedale Civile Maggiore Borgo Trento ( Site 0356)

location_facility: University Malaya Medical Centre ( Site 1180)

location_facility: Northwell Health- Monter Cancer Center ( Site 1080)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0857)

location_facility: Exdeo Clinical Research Inc. ( Site 0165)

location_facility: Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0671)

location_facility: St. Peter's Hospital Cancer Care Center ( Site 1087)

location_facility: Arizona Institute of Urology (AIU) - Northwest ( Site 1096)

location_facility: Clinica Universitaria de Navarra ( Site 0863)

location_facility: Eskisehir Osmangazi Universitesi Hastanesi ( Site 0953)

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Urológiai Klinika ( Site 1303)

location_facility: University of Vermont Medical Center ( Site 1057)

location_facility: University of Tsukuba Hospital ( Site 0412)

location_facility: 2CA Braga. Centro Clinico Academico ( Site 0705)

location_facility: CHU UCL Namur Site de Godinne ( Site 0103)

location_facility: Osaka City University Hospital ( Site 0404)

location_facility: CHU de Quebec - Hotel-Dieu de Quebec ( Site 0151)

location_facility: UZA University Hospital Antwerp ( Site 0105)

location_facility: Grupo Medico Angeles-Grupo Medico Angeles ( Site 1453)

location_facility: Texas Oncology-Fort Worth Cancer Center ( Site 8003)

location_facility: University of California Irvine Medical Center ( Site 1061)

location_facility: Woodlands Medical Specialists, PA ( Site 8002)

location_facility: Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0708)

location_facility: Clinical Research Center Sp. z o.o. ( Site 0674)

location_facility: Policlinico Universitario A. Gemelli ( Site 0358)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 1074)

location_facility: General University Hospital of Patras ( Site 0302)

location_facility: Ospedale Clinicizzato Santissima Annunziata ( Site 0361)

location_facility: Carolina Urologic Research Center ( Site 1085)

location_facility: MD Anderson Cancer Center Madrid ( Site 0859)

location_facility: Ospedale Buccheri La Ferla Fatebenefratelli ( Site 0352)

location_facility: Sylvester Comprehensive Cancer Center ( Site 1056)

location_facility: Stavanger universitetssykehus ( Site 0555)

location_facility: Urology Associates [Nashville, TN] ( Site 1072)

location_facility: Hospital Universitario Lucus Augusti ( Site 0852)

location_facility: Osaka International Cancer Institute ( Site 0413)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0157)

location_facility: Pécsi Tudományegyetem Klinikai Központ-Urológiai Klinika ( Site 1304)

location_facility: Clinica Universitaria Navarra - Madrid ( Site 0860)

location_facility: Univ. Klinik f. Urologie Innsbruck ( Site 0051)

location_facility: Uniwesytecki Szpital Kliniczny we Wroclawiu ( Site 0669)

location_facility: Antikarkiniko Nosokomeio Thessalonikis THEAGENIO ( Site 0303)

location_facility: Istituto Tumori Giovanni Paolo II ( Site 0357)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 0601)

location_facility: Associated Medical Professionals of NY ( Site 1078)

location_facility: Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0455)

location_facility: Nasz Lekarz Przychodnie Medyczne ( Site 0679)

location_facility: Universitaetsklinik Salzburg ( Site 0053)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 1059)

location_facility: St Georges University Hospitals NHS Foundation Trust. ( Site 1005)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0164)

location_facility: Hospital Universitario Gregorio Maranon ( Site 0854)

location_facility: Inst. Portugues de Oncologia de Coimbra Francisco Gentil EPE ( Site 0704)

location_facility: Tri-State Urologic Services PSC, Inc. ( Site 1091)

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 0655)

location_facility: Korea University Anam Hospital ( Site 0801)

location_facility: Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 10

location_facility: Hôpital Foch-Urology department ( Site 1351)

location_facility: Krankenhaus der Barmherzigen Brüder Trier-Abteilung für Urologie und Kinderurologie ( Site 0262)

location_facility: Hospital Militar Central [Lima, Peru] ( Site 0604)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0701)

location_facility: Seoul National University Hospital ( Site 0802)

location_facility: University Of Texas Southwestern Medical Center ( Site 1053)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0052)

location_facility: Michigan Institute of Urology ( Site 1077)

location_facility: Universitaetsklinikum Wuerzburg ( Site 0265)

location_facility: University Hospital of Larissa ( Site 0301)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 0360)


title: Practical Utilisation of Octapharma FVIII Concentrates in Previously Untreated & Minimally Treated Haemophilia A Patients Entering Routine Clinical Treatment With Nuwiq, Octanate or Wilate - Efficacy & Safety Observational Study-Protect-NOW

acronym: Protect-NOW

summary: International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.

time_perspective: Other

lead_sponsor: Octapharma

location_country:
Italy
United States
Spain
Germany
France
Lithuania
Hungary
Belgium
Russian Federation
Turkey
Belarus
Estonia
Azerbaijan
United Kingdom
Canada

location_facility: Tallinn Childrenś Hospital Clinic of Paediatric Department of Haematology and Oncology

location_facility: Great Ormond Street Hospital for Children NHS Trust, Haemophilia Centre

location_facility: McMaster University, Division of Pediatric Hematology/Oncology Room 3N27

location_facility: CHU Hotel Dieu, Centre de Traitment de l'Hemophilie

location_facility: Moscow State Government-financed Public Healthcare Institution "Morozovskaya Children Clinical Hospital of Moscow Healthcare Department"

location_facility: Republican Scientific and Practical Centre of Children Oncology, Hematology and Immunology

location_facility: Department of Hematology Research Research Transition Facility

location_facility: Hospital Universitari Vall D'Hebrón, Unitat d'Hemofilia

location_facility: Institute of Experimental Haematology and Transfusion Medicine (IHT) University Clinic Bonn (AöR)

location_facility: Children's Hospital Affiliate of Vilnius Universtity Hospital Santaros Klinikos

location_facility: Hopital Simone Veil Groupement Hospitalier Eaubonne-Montmorency

location_facility: CHRU Hopital Nord, Secretariat de pediatre

location_facility: Birmingham Children's Hospital NHS Foundation Trust

location_facility: Cure 4 The Kids Foundation Children's Specialty Center

location_facility: University of Debrecen Department of Pediatrics

location_facility: John Radcliffe Hospital, Oxford University Hospitals, NHS Foundation Trust

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Republican Scientific Center for Radiation Medicine and Human Ecology

location_facility: Hospital General Universitario de Alicante Hematología y Hemoterapia

location_facility: Newcastle Haemophilia Comprehensive Care Centre, Royal Victoria Infirmary

location_facility: Hôpital Universitaire des Enfants Reine Fabiola

location_facility: Vivantes - Netzwerk für Gesundheit GmbH Klinikum im Friedrichshain

location_facility: Azerbaijan State Advanced Training Institute for Doctors Hematology Department Scientific-Research Center of Hemophilia

location_facility: Saint-Petersburg State Budget Healthcare Institution "City Out-patient Clinical # 37"