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

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
France
Japan
Belgium
Spain
Denmark
Canada
Korea, Republic of

ipd_sharing: Undecided

title: A Phase I/II Open-label, Single-arm, Multi-center Study of Ruxolitinib Added to Corticosteroids in Pediatric Patients With Grade II-IV Acute Graft vs. Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

summary: The study is an open-label, single-arm, Phase I/II multi-center study to investigate the PK, activity and safety of ruxolitinib added to the patient's immunosuppressive regimen in infants, children, and adolescents ages ≥28 days to <18 years old with either grade II-IV aGvHD or grade II-IV SR-aGvHD. This trial will utilize four age groups: Group 1 includes patients ≥12y to <18y, Group 2 includes patients ≥6y to <12y, Group 3 includes patients ≥2y to <6y, and Group 4 includes patients ≥28days to <2y.


title: Feature Assessment Study for Indications Based Programming

acronym: FASt-IBP

summary: The purpose of this evaluation is to assess the acceptance level of specific programming recommendations based on the patient's clinical needs and primary indications when using the feature 'Indications Based Programming' (IBP) available in the ZOOMVIEW Software Application for the TELIGEN DR / VR and COGNIS family of devices compared to daily life programming chosen by physicians.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Boston Scientific Corporation

location_country: Austria Switzerland Netherlands Spain France Greece Slovakia Belgium China Germany Latvia

location_facility: Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH

location_facility: Hartcentrum Hasselt - Dienst Cardiologie

location_facility: EHRU de Brest - Hospital de la Cavale Blanche

location_facility: KH der Barmherzigen Schwestern Ried/Innkreis

location_facility: Paul Stradina Clinical University Hospital

location_facility: Narodny ustav srdcvych a cievnych chorob

location_facility: Hospital Universitario Central de Asturias

location_facility: Praxis Schnabel der Praxisgemeinschaft Kardiologie Meissen

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: First International Randomized Trial in Locally Advanced and Metastatic Adrenocortical Carcinoma Treatment

summary: The purpose of this study is to determine whether treatment with etoposide, doxorubicin, cisplatin and mitotane (EDP/M) prolongs survival as compared to streptozotocin and mitotane (Sz/M) in patients with advanced adrenocortical carcinoma (ACC) whose disease is not amenable to complete surgical resection.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: result

ReferenceCitation: Fassnacht M, Terzolo M, Allolio B, Baudin E, Haak H, Berruti A, Welin S, Schade-Brittinger C, Lacroix A, Jarzab B, Sorbye H, Torpy DJ, Stepan V, Schteingart DE, Arlt W, Kroiss M, Leboulleux S, Sperone P, Sundin A, Hermsen I, Hahner S, Willenberg HS, Tabarin A, Quinkler M, de la Fouchardière C, Schlumberger M, Mantero F, Weismann D, Beuschlein F, Gelderblom H, Wilmink H, Sender M, Edgerly M, Kenn W, Fojo T, Müller HH, Skogseid B; FIRM-ACT Study Group. Combination chemotherapy in advanced adrenocortical carcinoma. N Engl J Med. 2012 Jun 7;366(23):2189-97. doi: 10.1056/NEJMoa1200966. Epub 2012 May 2.

family: Fassnacht

full_name: Martin Fassnacht

given: Martin

sequence: first

family: Terzolo

full_name: Massimo Terzolo

given: Massimo

sequence: additional

family: Allolio

full_name: Bruno Allolio

given: Bruno

family: Baudin

full_name: Eric Baudin

given: Eric

family: Haak

full_name: Harm Haak

given: Harm

family: Berruti

full_name: Alfredo Berruti

given: Alfredo

family: Welin

full_name: Staffan Welin

given: Staffan

family: Schade-Brittinger

full_name: Carmen Schade-Brittinger

given: Carmen

family: Lacroix

full_name: André Lacroix

given: André

family: Jarzab

full_name: Barbara Jarzab

given: Barbara

family: Sorbye

full_name: Halfdan Sorbye

given: Halfdan

family: Torpy

full_name: David J. Torpy

given: David J.

family: Stepan

full_name: Vinzenz Stepan

given: Vinzenz

family: Schteingart

full_name: David E. Schteingart

given: David E.

family: Arlt

full_name: Wiebke Arlt

given: Wiebke

family: Kroiss

full_name: Matthias Kroiss

given: Matthias

family: Leboulleux

full_name: Sophie Leboulleux

given: Sophie

family: Sperone

full_name: Paola Sperone

given: Paola

family: Sundin

full_name: Anders Sundin

given: Anders

family: Hermsen

full_name: Ilse Hermsen

given: Ilse

family: Hahner

full_name: Stefanie Hahner

given: Stefanie

family: Willenberg

full_name: Holger S. Willenberg

given: Holger S.

family: Tabarin

full_name: Antoine Tabarin

given: Antoine

family: Quinkler

repository_institution: Università degli Studi di Brescia - Institutional Research Information System

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

title: Combination Chemotherapy in Advanced Adrenocortical Carcinoma

lead_sponsor: Collaborative Group for Adrenocortical Carcinoma Treatment

location_country:
Italy
Austria
Sweden
Netherlands
Germany
France
Australia
United States

location_facility: University of Munich, Dept. of Internal Medicine (Innenstadt)

location_facility: Otto-von-Guericke University; Dept. of Endocrinology

location_facility: Dept of Surgery, Karolinska Hospital, Stockholm

location_facility: Academisch Medisch Centrum; Dept. of Endocrinology

location_facility: Uppsala University Hospital - Dept of Medical Sciences

location_facility: Maxima Medisch Centrum; Dept. of Internal Medicine

location_facility: University of Wuerzburg - Dept. of Medicine

location_facility: Endokrinologie Medizinische Hochschule Hannover

location_facility: University of Turin, Dept of Internal Medicine

location_facility: Zentrum für Innere Medizin - Endokrinologie des Universitätsklinikum Essen

location_facility: National Cancer Institute - Center for Cancer Research

location_facility: University Hospital Groningen; Dept. of Internal Medine

location_facility: Department of Medicine, The Jubileum Institute, Lund University

location_facility: University of Michigan, Department of Internal Medicine

location_facility: Department of Oncology, Linköping University Hospital

location_facility: Department of Oncology, Sahlgrenska University Hospital

location_facility: Clinica Endocrinologica, Università di Padova, Azienda Ospedaliera di Padova

location_facility: Charité-University, Dept. of Endocrinology; Campus Benjamin Franklin

location_facility: University of Duesseldorf, Dept. of Endocrrinology

location_facility: Charité-Universitätsmedizin Berlin - Campus Mitte


title: Diffuse Large B Cell And Peripheral T-Cell Non-Hodgkin's Lymphoma In The Frail Elderly. Progressive And Cautious Treatment Strategy In Poor Status Patients. A Phase II Trial With Emphasis On Geriatric Assessment And Quality Of Life

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older patients who have non-Hodgkin's lymphoma.

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

location_country:
Switzerland
Netherlands
France
Belgium
Egypt
Portugal
United Kingdom

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Centre Hospitalier Universitaire Brugmann

intervention_type: Radiation


type: Other Grant/Funding Number

title: Spironolactone In The Treatment of Heart Failure- A Double-blind, Randomized, Placebo-controlled, Parallel Group Interventional Phase III Study to Determine Efficacy and Safety of Spironolactone on the Composite Endpoint of Recurrent Heart Failure Hospitalizations and Cardiovascular Death in Patients With Heart Failure With Mid-range or Preserved Ejection Fraction

acronym: SPIRIT-HF

summary: The purpose of this study is to determine whether the treatment of patients with HFmrEF and HFpEF at high risk of cardiovascular events with the mineralocorticoid receptor antagonist (MRA) spironolactone reduces a composite of recurrent heart failure hospitalizations and cardiovascular mortality.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Charite University, Berlin, Germany

location_country: Austria Serbia Netherlands France Germany

location_facility: Clinical Hospital Center Dr. Dragisa Misovic

location_facility: Herz- und Diabeteszentrum NRW, Bad Oeynhausen

location_facility: University Medical Center Mannheim, Medical Faculty Mannheim, Heidelberg University

location_facility: Praxis Dr. Markus Knapp/Daniela Breuninger

location_facility: University Hospital Munich, Ludwig-Maximilians University

location_facility: Kardiologische Praxis Dr. Wolfgang Jungmair

location_facility: Insitute of Cardiovascular Diseases of Vojvodina

location_facility: University Hospital Schleswig-Holstein, University Heart Centre Lübeck

location_facility: German Heart Center Berlin, Clinic for Internal Medicine - Cardiology

location_facility: Kardiologische Praxis Am Park Sanssoucci

location_facility: Heart Center Dresden, Technical University of Dresden

location_facility: University Medical Center of Schleswig-Holstein, Campus Kiel

location_facility: Heart Center Leipzig-University Hospital

location_facility: University Hospital Klinikum rechts der Isar (TUM)

location_facility: Charité University of Medicine Berlin, CCM

location_facility: Zentrum für klinische Studien Südbrandenburg

location_facility: Groupe Hospitalier de la Rochelle-Ré-Aunis

intervention_type: Drug

lead_sponsor_type: academique

status_simplified: Ongoing


title: "Prognostic Role of Portal Hypertension Assessed by Non-invasive Methods to Stratify Surgical Risk in Compensated Advanced Chronic Liver Disease Patients Undergoing Elective Extrahepatic Surgery: ELASTOSURGERY STUDY."

summary: The ELASTO-SURGERY study aims to evaluate the prognostic role of portal hypertension evaluated by non-invasive methods in predicting post-operative morbidity (at 90 days) and mortality (at 365 days) in patients with advanced chronic liver disease undergoing elective extrahepatic surgery.

ReferenceType: background

ReferenceCitation: Uyei J, Taddei TH, Kaplan DE, Chapko M, Stevens ER, Braithwaite RS. Setting ambitious targets for surveillance and treatment rates among patients with hepatitis C related cirrhosis impacts the cost-effectiveness of hepatocellular cancer surveillance and substantially increases life expectancy: A modeling study. PLoS One. 2019 Aug 26;14(8):e0221614. doi: 10.1371/journal.pone.0221614. eCollection 2019.

ReferenceCitation: Newman KL, Johnson KM, Cornia PB, Wu P, Itani K, Ioannou GN. Perioperative Evaluation and Management of Patients With Cirrhosis: Risk Assessment, Surgical Outcomes, and Future Directions. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2398-2414.e3. doi: 10.1016/j.cgh.2019.07.051. Epub 2019 Jul 31. Review.

ReferenceCitation: Reverter E, Cirera I, Albillos A, Debernardi-Venon W, Abraldes JG, Llop E, Flores A, Martínez-Palli G, Blasi A, Martínez J, Turon F, García-Valdecasas JC, Berzigotti A, de Lacy AM, Fuster J, Hernández-Gea V, Bosch J, García-Pagán JC. The prognostic role of hepatic venous pressure gradient in cirrhotic patients undergoing elective extrahepatic surgery. J Hepatol. 2019 Nov;71(5):942-950. doi: 10.1016/j.jhep.2019.07.007. Epub 2019 Jul 19.

ReferenceCitation: Colecchia A, Ravaioli F, Marasco G, Colli A, Dajti E, Di Biase AR, Bacchi Reggiani ML, Berzigotti A, Pinzani M, Festi D. A combined model based on spleen stiffness measurement and Baveno VI criteria to rule out high-risk varices in advanced chronic liver disease. J Hepatol. 2018 Aug;69(2):308-317. doi: 10.1016/j.jhep.2018.04.023. Epub 2018 May 3.

ReferenceCitation: Colecchia A, Montrone L, Scaioli E, Bacchi-Reggiani ML, Colli A, Casazza G, Schiumerini R, Turco L, Di Biase AR, Mazzella G, Marzi L, Arena U, Pinzani M, Festi D. Measurement of spleen stiffness to evaluate portal hypertension and the presence of esophageal varices in patients with HCV-related cirrhosis. Gastroenterology. 2012 Sep;143(3):646-654. doi: 10.1053/j.gastro.2012.05.035. Epub 2012 May 27.

ReferenceCitation: Ma X, Wang L, Wu H, Feng Y, Han X, Bu H, Zhu Q. Spleen Stiffness Is Superior to Liver Stiffness for Predicting Esophageal Varices in Chronic Liver Disease: A Meta-Analysis. PLoS One. 2016 Nov 9;11(11):e0165786. doi: 10.1371/journal.pone.0165786. eCollection 2016.

ReferenceCitation: Cescon M, Colecchia A, Cucchetti A, Peri E, Montrone L, Ercolani G, Festi D, Pinna AD. Value of transient elastography measured with FibroScan in predicting the outcome of hepatic resection for hepatocellular carcinoma. Ann Surg. 2012 Nov;256(5):706-12; discussion 712-3. doi: 10.1097/SLA.0b013e3182724ce8.

ReferenceCitation: Marasco G, Colecchia A, Dajti E, Ravaioli F, Cucchetti A, Cescon M, Festi D. Prediction of posthepatectomy liver failure: Role of SSM and LSPS. J Surg Oncol. 2019 Mar;119(3):400-401. doi: 10.1002/jso.25345. Epub 2018 Dec 18.

ipd_sharing: No

lead_sponsor: Azienda Ospedaliera Universitaria Integrata Verona

location_country:
Italy
Austria
Hong Kong
Switzerland
Germany
France
Korea, Republic of
Spain
Denmark
United States
United Kingdom
Canada

location_facility: Gastroenterology Unit, University of Palermo

location_facility: Gastroenterology Unit - Azienda Ospedaliera Universitaria Sant'Orsola - Malpighi

location_facility: Barcelona Hepatic Hemodynamic Lab. Liver Unit. Hospital Clinic. Barcelona

location_facility: Room Nottingham Digestive Diseases Centre BRU

location_facility: Clinica di Gastroenterologia ed Epatologia Ancona

location_facility: hôpital Antoine-Béclère, Hôpitaux Universitaires Paris-Sud, Assistance Publique-Hôpitaux de Paris

location_facility: Hospices Civils de Lyon Hopital Hotel Dieu

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

location_facility: ASUGI Clinica Patologie del Fegato, Clinica Chirurgica

location_facility: Hospital Universitario Puerta de Hierro Majadahonda


type: EudraCT Number

title: A Two-Part, Randomized Phase III, Double-Blind, Multicenter Trial Assessing The Efficacy And Safety of Pertuzumab In Combination With Standard Chemotherapy Vs. Placebo Plus Standard Chemotherapy In Women With Recurrent Platinum-Resistant Epithelial Ovarian Cancer And Low HER3 mRNA Expression

summary: This two-part, multicenter study will evaluate the safety, tolerability and efficacy of pertuzumab in combination with standard chemotherapy in women with recurrent platinum-resistant epithelial ovarian cancer. In the non-randomized Part 1 safety run-in, participants will receive pertuzumab plus either topotecan or paclitaxel. In the randomized, double-blind Part 2 of the study, participants will receive either pertuzumab or placebo in combination with chemotherapy (topotecan, paclitaxel, or gemcitabine).

ReferenceType: derived

ReferenceCitation: Lorusso D, Hilpert F, González Martin A, Rau J, Ottevanger P, Greimel E, Lück HJ, Selle F, Colombo N, Kroep JR, Mirza MR, Berger R, Pardo B, Grischke EM, Berton-Rigaud D, Martinez-Garcia J, Vergote I, Redondo A, Cardona A, Bastière-Truchot L, du Bois A, Kurzeder C; PENELOPE trial investigators. Patient-reported outcomes and final overall survival results from the randomized phase 3 PENELOPE trial evaluating pertuzumab in low tumor human epidermal growth factor receptor 3 (HER3) mRNA-expressing platinum-resistant ovarian cancer. Int J Gynecol Cancer. 2019 Sep;29(7):1141-1147. doi: 10.1136/ijgc-2019-000370. Epub 2019 Aug 15.

family: Lorusso

full_name: Domenica Lorusso

given: Domenica

family: Hilpert

full_name: Felix Hilpert

given: Felix

family: González Martin

full_name: Antonio González Martin

given: Antonio

family: Rau

full_name: Joern Rau

given: Joern

family: Ottevanger

full_name: Petronella Ottevanger

given: Petronella

family: Greimel

full_name: Elfriede Greimel

given: Elfriede

family: Lück

full_name: Hans-Joachim Lück

given: Hans-Joachim

family: Selle

full_name: Frédéric Selle

given: Frédéric

family: Colombo

full_name: Nicoletta Colombo

given: Nicoletta

family: Kroep

full_name: Judith R Kroep

given: Judith R

family: Mirza

full_name: Mansoor R Mirza

given: Mansoor R

family: Berger

full_name: Regina Berger

given: Regina

family: Pardo

full_name: Beatriz Pardo

given: Beatriz

family: Grischke

full_name: Eva-Maria Grischke

given: Eva-Maria

family: Berton-Rigaud

full_name: Dominique Berton-Rigaud

given: Dominique

family: Martinez-Garcia

full_name: Jeronimo Martinez-Garcia

given: Jeronimo

family: Vergote

full_name: Ignace Vergote

given: Ignace

family: Redondo

full_name: Andrés Redondo

given: Andrés

family: Cardona

full_name: Andrés Cardona

family: Bastière-Truchot

full_name: Lydie Bastière-Truchot

given: Lydie

family: du Bois

full_name: Andreas du Bois

given: Andreas

family: Kurzeder

full_name: Christian Kurzeder

given: Christian

bso_classification: Medical research

datasource: user

genre: journal-article

journal_name: International Journal of Gynecologic Cancer

location_country: Italy Austria Sweden Netherlands France Norway Belgium Spain Denmark Germany

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: The Norvegian Radium Hospital Montebello; Dept of Oncology

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

location_facility: Ch Lyon Sud; Chir Onc Gyne Sct Jules Courmont

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie

location_facility: A.O.Spedali Civili; Ostetricia e Ginecologia

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

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

location_facility: Hospital Son Llatzer; Servicio de Oncologia

location_facility: UNI-Klinikum Campus Kiel Klinik f.Gynäkologie u.Geburtshilfe

location_facility: Clinique Armoricaine Radiologie; Hopital de Jour

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

location_facility: Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe

location_facility: Klinikum rechts der Isar der TU München; Frauenklinik & Poliklinik

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Istituto Tumori Napoli;Unità Operativa Oncologia Medica Uro-Ginecologica

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

location_facility: Academisch Ziekenhuis Leiden; Clinical Oncology

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Institut Gustave Roussy; Oncologie Medicale

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: A.O.U Pisana; Dipartimento di Ginecologia Oncologica

location_facility: Academ Ziekenhuis Groningen; Medical Oncology

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

location_facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

location_facility: Hämatologisch/Onkologische Praxis Dr. Herbrick - Zipp/Prof. Dr. Decker, Studienzentrum

location_facility: Evangelischen Krankenhauses Düsseldorf; Frauenklinik

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie

location_facility: Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum

location_facility: Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

location_facility: Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie

location_facility: Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica

location_facility: Istituto Regina Elena; Oncologia Medica A


ReferenceCitation: Macdougall IC. Comparison of different dosing regimens (once weekly vs. twice weekly, and once weekly vs. once every two weeks) with epoetin delta in patients with chronic kidney disease: a randomized controlled trial. Trials. 2007 Nov 13;8:35.

status: Terminated

lead_sponsor: Shire

location_country:
Italy
Austria
France
Belgium
Spain
Germany
United Kingdom

acronym: Dynepo Infrequent Dosing Study

location_facility: Universita' degli Studi di Napoli Federico II

location_facility: Nephrologische Gemeinschaftspraxis, Dialysezentrum Karlstrabe

location_facility: Richard Bright Renal Unit Southmead Hospital

location_facility: CH de Boulogne-sur-mer (Hopital de Dr Duchenne)

location_facility: CHU - Hopital Pellegrin, Nephrologie-Hemodialyse

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: CHU Hopital Civil, Nephrologie-Hemodialyse

location_facility: Gemeinschaftspraxis Prof. Mann/Prof. Heidenreich

location_facility: Clinique de Landy, Service de Nephrologie - Hemodialyse

location_facility: Med.Univ-Klinik/Klin. Abt.f.Nephrologie u. Hamodialyse

location_facility: UZ Gasthuisberg, Leuve, Dept of Nephrology

location_facility: Azienda Ospedaliera Universitaria Policlinico di Modena

location_facility: Hellig Hart Ziekenhuis, Campus Wilgenstraat

location_facility: KfH Nierenzentrum am Handr-Klinikum Stralsund

location_facility: Univ.-Klinik für Innere Medizin/Klin. Abt. für Nephrologie

source: euctr

title: An Open-Label, Phase IIIb, Multi-Centre, Randomised, Parallel-Group Study to Investigate the Efficacy and Safety of Three Dosing Schedules of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease Who Are Pre-Dialysis or Require Peritoneal Dialysis or Haemodialysis

summary: The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.

status_simplified: Unknown


type: U.S. NIH Grant/Contract

title: Outpatient Treatment of Low-risk Patients With Pulmonary Embolism: a Randomized-controlled Trial

acronym: OTPE

summary: The purpose of this randomized clinical trial is to determine whether outpatient treatment is as effective and safe as inpatient treatment among low-risk patients with pulmonary embolism.

primary_purpose: Health Services Research

ReferenceCitation: Aujesky D, Obrosky DS, Stone RA, Auble TE, Perrier A, Cornuz J, Roy PM, Fine MJ. Derivation and validation of a prognostic model for pulmonary embolism. Am J Respir Crit Care Med. 2005 Oct 15;172(8):1041-6. Epub 2005 Jul 14.

ReferenceCitation: Aujesky D, Roy PM, Le Manach CP, Verschuren F, Meyer G, Obrosky DS, Stone RA, Cornuz J, Fine MJ. Validation of a model to predict adverse outcomes in patients with pulmonary embolism. Eur Heart J. 2006 Feb;27(4):476-81. Epub 2005 Oct 5.

ReferenceCitation: Aujesky D, Roy PM, Verschuren F, Righini M, Osterwalder J, Egloff M, Renaud B, Verhamme P, Stone RA, Legall C, Sanchez O, Pugh NA, N'gako A, Cornuz J, Hugli O, Beer HJ, Perrier A, Fine MJ, Yealy DM. Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial. Lancet. 2011 Jul 2;378(9785):41-8. doi: 10.1016/S0140-6736(11)60824-6. Epub 2011 Jun 22.

family: Aujesky

full_name: Drahomir Aujesky

given: Drahomir

family: Roy

full_name: Pierre-Marie Roy

given: Pierre-Marie

family: Verschuren

full_name: Franck Verschuren

given: Franck

family: Righini

full_name: Marc Righini

given: Marc

family: Osterwalder

full_name: Joseph Osterwalder

given: Joseph

family: Egloff

full_name: Michael Egloff

given: Michael

family: Renaud

full_name: Bertrand Renaud

given: Bertrand

family: Verhamme

full_name: Peter Verhamme

given: Peter

family: Stone

full_name: Roslyn A Stone

given: Roslyn A

family: Legall

full_name: Catherine Legall

given: Catherine

family: Sanchez

full_name: Olivier Sanchez

given: Olivier

family: Pugh

full_name: Nathan A Pugh

given: Nathan A

family: N'gako

full_name: Alfred N'gako

given: Alfred

family: Cornuz

full_name: Jacques Cornuz

given: Jacques

family: Hugli

full_name: Olivier Hugli

family: Beer

full_name: Hans-Jürg Beer

given: Hans-Jürg

family: Perrier

full_name: Arnaud Perrier

given: Arnaud

family: Fine

full_name: Michael J Fine

given: Michael J

family: Yealy

full_name: Donald M Yealy

given: Donald M

genre_raw: journal-article

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: University of Lausanne Hospitals

location_country:
United States
Belgium
France
Switzerland

location_facility: University Hospital Saint-Luc, Université Catholique de Louvain

intervention_type: Other


title: A Multicenter, Randomized, Naturalistic, Open-Label Study Between Aripiprazole and Standard of Care in the Management of Community-Treated Schizophrenic Patients (Schizophrenia Trial of Aripiprazole - STAR)

summary: Aripiprazole will show improved effectiveness over the standard of care treatment with one of three atypical antipsychotics (olanzapine, quetiapine and risperidone).

ReferenceCitation: Hanssens L, L'Italien G, Loze JY, Marcus RN, Pans M, Kerselaers W. The effect of antipsychotic medication on sexual function and serum prolactin levels in community-treated schizophrenic patients: results from the Schizophrenia Trial of Aripiprazole (STAR) study (NCT00237913). BMC Psychiatry. 2008 Dec 22;8:95. doi: 10.1186/1471-244X-8-95.

family: Hanssens

full_name: Linda Hanssens

given: Linda

family: L'Italien

full_name: Gilbert L'Italien

given: Gilbert

family: Loze

full_name: Jean-Yves Loze

given: Jean-Yves

family: Marcus

full_name: Ronald N Marcus

given: Ronald N

family: Pans

full_name: Miranda Pans

given: Miranda

family: Kerselaers

full_name: Wendy Kerselaers

given: Wendy

currency_apc_doaj: GBP

journal_name: BMC Psychiatry

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Austria
Sweden
United Kingdom
Finland
France
Spain
Denmark
Germany
Czech Republic


title: A Multi-center, Double-blind, Double-dummy, Controlled, Randomized Study to Evaluate Cycle Control and Safety of a Four Phasic Oral Contraceptive (SH T00658ID) in Comparison to an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D 593 B) in Healthy Female Volunteers Aged Between 18 and 50 Years.

summary: The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC.

primary_purpose: Prevention

ReferenceCitation: Ahrendt HJ, Makalová D, Parke S, Mellinger U, Mansour D. Bleeding pattern and cycle control with an estradiol-based oral contraceptive: a seven-cycle, randomized comparative trial of estradiol valerate/dienogest and ethinyl estradiol/levonorgestrel. Contraception. 2009 Nov;80(5):436-44. doi: 10.1016/j.contraception.2009.03.018. Epub 2009 May 13.

family: Ahrendt

full_name: Hans-Joachim Ahrendt

given: Hans-Joachim

family: Makalová

full_name: Dagmar Makalová

given: Dagmar

family: Parke

full_name: Susanne Parke

given: Susanne

family: Mellinger

full_name: Uwe Mellinger

given: Uwe

family: Mansour

full_name: Diana Mansour

given: Diana

journal_name: Contraception

lead_sponsor: Bayer

location_country:
Germany
Czech Republic
France

location_facility: Provozorna Gynekologicka ordinace Dr. Tesar

location_facility: Frauenarztpraxis Dipl. med. Michael Stellmacher


title: First in Man Study With MEN1112, a CD157 Targeted Monoclonal Antibody, in Relapsed or Refractory Acute Myeloid Leukemia.

acronym: ARMY

summary: The purpose of this study is to assess the safety of MEN1112, given as intravenous infusion, in patients with relapsed or refractory AML. Pharmacokinetics, clinical activity and potential immunogenicity of MEN1112 will be evaluated as well.

lead_sponsor: Menarini Group

location_country: Italy France Belgium Spain Germany


title: A Parallel-Group, Randomized, Double-Blind, Multi-Center Dose Response Study To Evaluate The Efficacy And Safety Of PF-00885706, A 5-HT4 Receptor Partial Agonist, As Add-On Therapy To Esomeprazole For The Relief Of Symptoms In Subjects With Gastro-esophageal Reflux Disease (GERD) Who Have A Poor Response To Proton Pump Inhibitor (PPI) Treatment

summary: To understand the dose-response characteristics of PF-00885706 for efficacy in terms of symptomatic relief when used as add-on treatment to esomeprazole 20mg (standard proton pump inhibitor [PPI] treatment), in subjects with gastro-esophageal reflux (GERD) who have inadequate relief with PPIs.

lead_sponsor: Pfizer

location_country:
Brazil
France
Slovakia
Belgium
Spain
Germany
Korea, Republic of


title: Home CARE - Home Monitoring in CArdiac REsynchronisation Therapy

acronym: HomeCARE

summary: In spite of success in the management of heart failure, repetitive rehospitalisation and high mortality rate remain a serious problem. Recent studies, especially the COMPANION trial, have demonstrated that cardiac resynchronisation therapy (CRT) reduces mortality and rehospitalisation in heart failure patients. There is also evidence that telemonitoring of heart failure patients potentially reduces both mortality and morbidity. Recently, a Home Monitoring (HM) function has been integrated into BIOTRONIK CRT-defibrillators and CRT-pacemakers with a view of harnessing the powerful combination of CRT with close remote monitoring of heart failure patients. It is possible now to transmit predefined parameters on a daily basis from the implanted devices to a web-based platform accessible by patients' physicians. Our study evaluates clinical usefulness of Biotronik HM function in CRT-defibrillators and CRT-pacemakers.

ReferenceCitation: Ellery S, Pakrashi T, Paul V, Sack S. Predicting mortality and rehospitalization in heart failure patients with home monitoring--the Home CARE pilot study. Clin Res Cardiol. 2006;95 Suppl 3:III29-35. Review.

ReferenceCitation: Sack S, Wende CM, Nägele H, Katz A, Bauer WR, Barr CS, Malinowski K, Schwacke H, Leyva F, Proff J, Berdyshev S, Paul V. Potential value of automated daily screening of cardiac resynchronization therapy defibrillator diagnostics for prediction of major cardiovascular events: results from Home-CARE (Home Monitoring in Cardiac Resynchronization Therapy) study. Eur J Heart Fail. 2011 Sep;13(9):1019-27. doi: 10.1093/eurjhf/hfr089.

name: Cardiology Department; Universitätsklinikum Essen; Essen Germany

family: Sack

full_name: Stefan Sack

given: Stefan

family: Wende

full_name: Christian Michael Wende

given: Christian Michael

family: Nägele

full_name: Herbert Nägele

given: Herbert

name: Cardiology Department; Barzilai Medical Centre; Ashkelon Israel

family: Katz

full_name: Amos Katz

given: Amos

name: Cardiology Department; Universitätsklinikum Würzburg; Germany

family: Bauer

full_name: Wolfgang Rudolf Bauer

given: Wolfgang Rudolf

name: Cardiology Department; Russels Hall Hospital; Dudley UK

family: Barr

full_name: Craig Scott Barr

given: Craig Scott

name: Cardiology Department; Helios Klinikum Aue GmbH; Aue Germany

family: Malinowski

full_name: Klaus Malinowski

given: Klaus

name: Innere Abteilung, Allgemeines Krankenhaus Altona; Hamburg Germany

family: Schwacke

full_name: Harald Schwacke

given: Harald

family: Leyva

full_name: Francisco Leyva

given: Francisco

family: Proff

full_name: Jochen Proff

given: Jochen

family: Berdyshev

full_name: Sergey Berdyshev

given: Sergey

name: Cardiology Department; St. Peter's Hospital/St. George's; Chertsey UK

family: Paul

full_name: Vincent Paul

given: Vincent

journal_name: European Journal of Heart Failure

oa_colors: green other

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: Würzburg University - Online Publication Service of Würzburg University

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Biotronik SE & Co. KG

location_country:
Italy
Austria
United Kingdom
Netherlands
France
Israel
Latvia
Spain
Germany
Czech Republic

location_facility: CHRU Hôpital de Villeneuve, Cardiologie A

location_facility: Hadasit Medical Research Services & Development Ltd.

location_facility: Gemeinschaftpraxis für Kardiologie und Angiologie

location_facility: P. Stradina Clinical University Hospital

location_facility: Azienda Ospedaliera "Santi Antonio e Biagio e Cesare Arrigo

location_facility: Gemeinschaftspraxis Dr. Kroll/Dr. Rebeski

location_facility: CHRU Hôpital de Villeneuve, Cardiologie B

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Kardiologische Gemeinschaftspraxis Dr. Hoh u. Dr. Tamm


title: A Phase II, Open-label, Multicenter, International Study of Durvalumab Following Radiation Therapy in Patients With Stage III, Unresectable Non-Small Cell Lung Cancer Who Are Ineligible for Chemotherapy

acronym: DUART

summary: This is a Phase II open-label, single-arm, multicenter, international study to evaluate the clinical activity of durvalumab in patients with Stage III unresectable NSCLC who are deemed to be ineligible for chemotherapy per Investigator assessment. Patients will be enrolled into 2 cohorts according to radiotherapy pretreatment dose (Cohort A: standard radiation therapy [60 gray (Gy) ± 10% or hypofractionated bioequivalent dose (BED)]; Cohort B: palliative radiation therapy [40 to < 54 Gy or hypofractionated BED]).

ReferenceCitation: Filippi AR, Dziadziuszko R, García Campelo MR, Paoli JB, Sawyer W, Díaz Pérez IE. DUART: durvalumab after radiotherapy in patients with unresectable, stage III NSCLC who are ineligible for chemotherapy. Future Oncol. 2021 Nov 15. doi: 10.2217/fon-2021-0952. [Epub ahead of print]

name: Department of Radiation Oncology, Fondazione IRCCS Policlinico San Matteo & University of Pavia, Pavia 27100, Italy

family: Filippi

full_name: Andrea R Filippi

given: Andrea R

name: Department of Oncology & Radiotherapy, Medical University of Gdansk, Gdansk 80-210, Poland

family: Dziadziuszko

full_name: Rafał Dziadziuszko

given: Rafał

name: Medical Oncology Unit, University Hospital A Coruña, A Coruña 15006, Spain

family: García Campelo

full_name: Maria Rosario García Campelo

given: Maria Rosario

name: Service Radiothérapie, Hôpital Privé Clairval, Marseille 13009, France

family: Paoli

full_name: Jean-Baptiste Paoli

given: Jean-Baptiste

name: Global Medicines Development, AstraZeneca, Cambridge, CB2 0AA, UK

family: Sawyer

full_name: William Sawyer

given: William

name: Global Medical Affairs, AstraZeneca, Gaithersburg, MD 20878, USA

family: Díaz Pérez

full_name: Ignacio Esteban Díaz Pérez

given: Ignacio Esteban

journal_name: Future Oncology

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

ipd_sharing: Yes

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

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

lead_sponsor: AstraZeneca

location_country:
Italy
France
Poland
Russian Federation
Spain
United States


title: Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications

acronym: OPTI-MIND 2

summary: The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population.

location_country:
Italy
Netherlands
France
Slovakia
Belgium
Spain
Denmark
Germany
United Kingdom

location_facility: Service de cardiologie, CHU Nancy-Brabois

location_facility: The National Institute of Cardiovascular Diseases

location_facility: Ospedale "Misericordia e Dolce" - AZIENDA USL 4 PRATO

location_facility: Herz- und Diabeteszentrum Nordrhein-Westfalen

location_facility: Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari


title: Validation Study of RA-INF-Dx as a Multigene Molecular Test Intended to Aid in the Identification of Patients With Rheumatoid Arthritis Who Are Unlikely to Show an Initial Response to Infliximab and Methotrexate Combination Therapy

acronym: PRINT

summary:
Study Design & Objectives:

Multi-centre, non-interventional, open-label, non-comparative, prospective cohort study with a clinical follow-up between 12 and 14 weeks.

To determine the performances of the RA-INF-Dx blood test intended to aid in the identification of patients with rheumatoid arthritis who are unlikely to show an initial response to infliximab and methotrexate combination therapy evaluated according to EULAR response criteria.

Ancillary study objective:

To constitute a biocollection of samples associated with all clinical and biological data collected at inclusion and at the evaluation visit.

time_perspective: Cross-Sectional

lead_sponsor: TcLand Expression S.A.

location_country: Italy France Lithuania Slovakia Romania Hungary Spain Canada

location_facility:
Location n°16
Location n°9
Location n°39
Location n°37
Location n°25
Location n°28
Location n°14
Location n°40
Location n°17
Location n°10
Location n°15
Location n°7
Location n°36
Location n°11
Location n°21
Location n°20
Location n°27
Location n°3
Location n°13
Location n°24
Location n°38
Location n°6
Location n°34
Location n°41
Location n°31
Location n°23
Location n°35
Location n°26
Location n°18
Location n° 19
Location n°29
Location n°30
Location n°33
Location n°8
Location n°22
Location n°12
Location n°5


title: A Randomized, Double Blind, Parallel Group Study of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction and Their Female Partners Sexual Quality of Life. PARTNER II

summary: This trial is to provide additional important information on the impact of the treatment of the man its ED with vardenafil on partnership. This study is being run at up to 50 study centers in Europe and South Africa to evaluate the use of vardenafil in adult men with erectile dysfunction (often called impotence), and their female partner's sexual quality of life. Many men experience occasional erectile problems during their lives. However, when this becomes a continued problem, it can affect both the man and his female partner. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to 1) study the effectiveness and safety of vardenafil, and 2) show whether treating a man its erectile dysfunction with vardenafil will improve his female partner its sexual quality of life. The second part (week 12) of the study (Educational program) a subgroup of subjects/couples, approximately 50% of the randomized subjects, will receive an educational program concerning ED in the from of a DVD.

location_country:
Italy
South Africa
Netherlands
France
Belgium
Spain
Germany


title: A Multicentre, Randomised, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Different Concentrations of FK778 With Tacrolimus (FK506) and Steroids Versus a Standard Regimen of Tacrolimus, MMF and Steroids in Renal Transplant Patients

summary: A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients

lead_sponsor: Astellas Pharma Inc

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
United Kingdom
France
Poland
Belgium
Spain
Germany
Czech Republic


title: Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder

summary: The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.

ReferenceCitation: Perahia DG, Maina G, Thase ME, Spann ME, Wang F, Walker DJ, Detke MJ. Duloxetine in the prevention of depressive recurrences: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 May;70(5):706-16. Erratum in: J Clin Psychiatry. 2009 Dec;70(12):1729.

lead_sponsor: Eli Lilly and Company

location_country:
Italy
United States
Sweden
France
Russian Federation
Germany

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


type: Other Identifier

title: A Phase 1b Study of the MALT1 Inhibitor JNJ-67856633 and Ibrutinib in Combination in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

summary: The purpose of this study is to determine the safety and recommended Phase 2 dose (RP2D) of JNJ-67856633 and ibrutinib in combination in participants with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) in Part A (Dose Escalation) and to evaluate safety of JNJ-67856633 and ibrutinib in combination, at the RP2D regimen in Part B (Cohort Expansion).

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:
Italy
Sweden
France
Poland
Greece
Russian Federation
Spain
Denmark
United States
United Kingdom
Korea, Republic of

location_facility: Universitetssjukhuset Lund, Onkologiska Kliniken, Lund

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

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

location_facility: St.-Petersburg Clinical Research Institute of Hematology and Transfusiology

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Chonnam National University Hwasun Hospital

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: Nizhniy Novgorod Region Clinical Hospital


status: Active, not recruiting

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 Sciences Ireland UC

location_country:
Italy
France
Poland
Belgium
Spain
Germany
United Kingdom

location_facility: St George's, University of London and St George's University Hospitals NHS Foundation Trust

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska

location_facility: SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)

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

location_facility: Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1

location_facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy

location_facility: Azienda Ospedaliero Universitaria Pisana

title: A Randomized, Double Blind, Placebo-controlled Phase 2b Study to Evaluate Efficacy, Pharmacokinetics, and Safety of 48-week Study Intervention With JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

summary: The purpose of this study is to evaluate the efficacy of 48-week study intervention with JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by HBsAg levels. This study is part of HepB Wings Platform Trial (PLATFORMPAHPB2001).


title: A Phase I Study of the Anti-C5aR, IPH5401, in Combination With the Anti-PD-L1, Durvalumab, in Patients With Selected Advanced Solid Tumors

summary: This is a multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, antitumor activity of IPH5401 (anti C5aR) in combination with Durvalumab (MEDI4736) in Adult Subjects with selected advanced solid tumors.

design_allocation: Non-Randomized

lead_sponsor: Innate Pharma

location_country:
United States
France

location_facility: Centre Hospitalier Universitaire- Hôpital Nord Laennec

intervention_type: Biological


type: Registry Identifier

title: A Non-interventional, Post-authorization Safety Study of Patients With Relapsed or Refractory Mantle Cell Lymphoma to Further Investigate and Characterize the Association of Lenalidomide With Tumor Flare Reaction and High Tumor Burden

acronym: PASS MCL-005

summary:
This is a European multinational, retrospective, non-interventional study of patients with R/R MCL designed to further investigate the research objectives described below

The proposed study has two cohorts:

For Cohort 1, MCL patients in the Nordic countries (Denmark and Sweden) will be identified through electronic medical records (EMRs), enabling identification of R/R MCL patients. The cohort identified through EMRs at chosen hospitals will then be linked to the national health registries. Exposure to lenalidomide will be identified through prescription registers or medical chart review.

For Cohort 2, sites will be identified in other European countries where patients have been treated with lenalidomide for R/R MCL. Identification of sites will be completed through partnership with the European Mantle Cell Lymphoma (European MCL) Registry, Additional sites will be identified by Celgene and then assessed for feasibility and invited to participate in the R/R MCL PASS.

For both cohorts, only sites where lenalidomide treatment for R/R MCL is reimbursed will be selected for the study. All data will be collected retrospectively from identified patients following the first dose of lenalidomide treatment for up to 6 months including those patients who died within this data collection period.

time_perspective: Retrospective

lead_sponsor: Celgene

location_country: Italy Austria Netherlands France Greece Spain Germany

location_facility: Fondazione IRCCS Ca' Cranda, Ospedale Maggiore Policinico

location_facility: Private hospital "Iatriko Psychikou", Athens

location_facility: Theageneio General Hospital, Thessaloniki

location_facility: General University Hospital of Alexandroupolis

location_facility: Azienda Ospedaliero - Universiaria di Parma

location_facility: Praxis fuer Haematolgie, Onkologie und Palliativmedizin

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Arcispedale Santa Maria Nuova - AUSL Reggio Emilia

location_facility: LKH Graz Medizinische Universitätsklinik

location_facility: Ospedale di Busto Arsizio - ASST Valle Olona

location_facility: Policlinico Umberto I , Universita La Sapienza

location_facility: Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Universitaire Pitie Salpetriere (Hopital Pitie-Salpetriere)

location_facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III

location_facility: Klinikum Garmisch-Partenkirchen Gmbh - Zentrum Fuer Innere Medizin

location_facility: Salzburger Landeskliniken - Universitaetsklinikum Salzburg

location_facility: Amyloidosis Research & Treatment Center, Fondazione Irccs Policlinico San Matteo

location_facility: CHU de Caen, institut d'hematologie de basse Nomandie

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Ospedale Policlinico San Martino - IRCCS

location_facility: General University Hospital of Athens "LAIKO", Athens

location_facility: Centre Hospitalier de Versailles André Mignot

location_facility: Presidio Ospedaliero Molinette - A.O.U. Citta della Salute e della Scieza

location_facility: HagaZiekenhuis van Den Haag - Juliana Kinderziekenhuis (JKZ) - Leyweg

location_facility: Universita di Siena -Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte

location_facility: Hospital Clínico Universiatrio de Salamanca

location_facility: General Anti-Cancer Hospital "Agios Savvas"

location_facility: Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia


title: TachoSil® Versus Current Practice in Dura Sealing Techniques for the Prevention of Post-operative Cerebrospinal Fluid (CSF) Leaks in Patients Undergoing Skull Base Surgery: An Open Label, Randomised, Controlled, Multi-centre, Parallel Group Efficacy and Safety Trial.

summary:
The primary objective is to demonstrate superiority of TachoSil® compared to current practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be evaluated post-operatively. The secondary objective is to evaluate the safety of TachoSil® as an adjunct in sealing the dura mater.

The trial population will consist of 726 randomised (1:1) patients elected for skull base surgery. The trial duration consists of screening, surgery, efficacy follow-up after 7±1 weeks and safety follow-up 28±2 weeks after surgery.

lead_sponsor: Takeda

location_country:
Italy
Austria
Sweden
Netherlands
France
Poland
Greece
Belgium
Russian Federation
Spain
Germany

intervention_type: Procedure


title: Randomized Phase II Study of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects With Triple Negative (ER, PR, Her2 Negative) Locally Advanced Non-resectable and/or Metastatic Breast Cancer

summary: The purpose of this study was to estimate the response rate of ixabepilone monotherapy, and the combination of ixabepilone plus cetuximab as first-line treatment of female subjects with triple negative (estrogen receptor [ER], progesterone receptor [PR], Human Epidermal Growth Factor Receptor 2 [HER2] negative) locally advanced non-resectable and/or metastatic breast cancer

lead_sponsor: R-Pharm

location_country:
Italy
Austria
France
Poland
Greece
Spain
Czech Republic


title: A Blinded, Randomized, Placebo-controlled Trial in Genotype 1 Hepatitis C-Infected Subjects to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Repeated Doses of TMC435350, With or Without Peginterferon Alpha-2a and Ribavirin

summary: The purpose of this study is to investigate how efficient TMC435350 will work against the Hepatitis C virus genotype 1 (genotypes refer to the genetic constitution of the virus) and what the concentrations of TMC435350 in the blood are with or without pegylated interferon alpha-2a (PegIFNa-2a) or PegIFNa-2a plus ribavirin.

ReferenceCitation: Lenz O, de Bruijne J, Vijgen L, Verbinnen T, Weegink C, Van Marck H, Vandenbroucke I, Peeters M, Simmen K, Fanning G, Verloes R, Picchio G, Reesink H. Efficacy of re-treatment with TMC435 as combination therapy in hepatitis C virus-infected patients following TMC435 monotherapy. Gastroenterology. 2012 Nov;143(5):1176-1178.e6. doi: 10.1053/j.gastro.2012.07.117. Epub 2012 Aug 8.

family: Lenz

full_name: Oliver Lenz

given: Oliver

family: de Bruijne

full_name: Joep de Bruijne

given: Joep

family: Vijgen

full_name: Leen Vijgen

given: Leen

family: Verbinnen

full_name: Thierry Verbinnen

given: Thierry

family: Weegink

full_name: Christine Weegink

given: Christine

family: Van Marck

full_name: Herwig Van Marck

given: Herwig

family: Vandenbroucke

full_name: Ina Vandenbroucke

given: Ina

family: Peeters

full_name: Monika Peeters

given: Monika

family: Simmen

full_name: Kenneth Simmen

given: Kenneth

family: Fanning

full_name: Greg Fanning

given: Greg

family: Verloes

full_name: Rene Verloes

given: Rene

family: Picchio

full_name: Gaston Picchio

given: Gaston

family: Reesink

full_name: Hendrik Reesink

given: Hendrik

journal_name: Gastroenterology

title: Efficacy of Re-treatment With TMC435 as Combination Therapy in Hepatitis C Virus–Infected Patients Following TMC435 Monotherapy

ReferenceCitation: Manns M, Reesink H, Berg T, Dusheiko G, Flisiak R, Marcellin P, Moreno C, Lenz O, Meyvisch P, Peeters M, Sekar V, Simmen K, Verloes R. Rapid viral response of once-daily TMC435 plus pegylated interferon/ribavirin in hepatitis C genotype-1 patients: a randomized trial. Antivir Ther. 2011;16(7):1021-33. doi: 10.3851/IMP1894.

family: Manns

full_name: Michael Manns

given: Michael

full_name: Henk Reesink

given: Henk

family: Berg

full_name: Thomas Berg

given: Thomas

family: Dusheiko

full_name: Geoffrey Dusheiko

given: Geoffrey

family: Flisiak

full_name: Robert Flisiak

given: Robert

family: Marcellin

full_name: Patrick Marcellin

given: Patrick

family: Moreno

full_name: Christophe Moreno

given: Christophe

location_country:
Netherlands
Poland
France
Belgium
Germany
United Kingdom


title: A Randomised, Double-blind, Placebo-controlled, Multi-center Sequential Phase 2b and Phase 3 Study to Evaluate the Efficacy and Safety of AZD4831 Administered for Up to 48 Weeks in Participants With Heart Failure With Left Ventricular Ejection Fraction > 40%

acronym: ENDEAVOR

summary: This is a randomised, double-blind, placebo-controlled, multi-center sequential phase 2b and Phase 3 study to evaluate the efficacy and safety of AZD4831 administered for up to 48 Weeks in participants with heart failure with left ventricular ejection fraction > 40%. The study will consist of 2 separate parts, Part A and Part B, approximately 660 participants will be randomised in Part A, 825 in Part B.

location_country:
Brazil
Sweden
France
Czechia
Bulgaria
Israel
Japan
Poland
Slovakia
Russian Federation
Denmark
United States
Canada
Taiwan


title: A Randomized Non Comparative Phase II Study of Lacutamab With GemOx Versus GemOx Alone in Relapsed/Refractory Patients With Peripheral T-cell Lymphoma

summary:
This is an open-label multicenter randomized non comparative phase II study to evaluate the safety and efficacy of the monoclonal anti-KIR3DL2 antibody Lacutamab in patients with Refractory/Relapsing (R/R) KIR3DL2 positive Peripheral T Cell Lymphoma (PTCL) : Not Other Specified (NOS), PTCL-TFH (including Angioimmunoblastic T-cell Lymphoma (AITL), Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype), Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia/lymphoma (ATL), Hepatosplenic T-cell lymphoma (HSTL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T cell lymphoma (MEITL), NK-T cell lymphoma (NKT) and Aggressive NK-cell leukemia (ANKL).

The design is non comparative meaning that non comparison between arms will be performed as the control arm will ensure that the assumptions used for sample size calculation are verified. For that reason, randomization is unbalanced in favor of the experimental arm (2:1).

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Belgium France

location_facility: CHU de Poitiers - Hôpital de La Milétrie

location_facility: Cliniques Universitaires de Bruxelles - Hôpital Erasme

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole


title: Real World Effectiveness of Upadacitinib on Early and Sustained Pain Control in Radiographic Axial Spondylarthritis (UPSTAND)

acronym: UPSTAND

summary:
Axial spondyloarthritis (axSpA) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. The most frequent axSpA symptom is chronic, often inflammatory back pain (IBP) that might be difficult to distinguish from other causes of chronic back pain (CBP). Many participants report persistent pain, including back pain, which impacts disease activity and quality of life including creating burdens such as sleep disturbance, social isolation, loss of productivity, as well as anxiety and depression. Despite this, there is a lack of detailed data and knowledge on pain in radiographic-axial spondyloarthritis (r-axSpA), including pain types, how it is localized, and how these different facets of pain are impacted by treatment. This study will assess the real-world effectiveness of upadacitinib on early and sustained pain control, and the association between pain and clinical/patient-reported outcomes in radiographic axSpA participants.

Upadacitinib is being developed for the treatment of r-axSpA. Approximately 877 adult participants with activer-axSpA will be enrolled across approximately 19 countries in Europe, North America, South America, and Asia-Pacific.

Participants will receive oral upadacitinib tablets as prescribed by the physician prior to enrolling in this study in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. The overall duration of the study is approximately 30 months.

There may be a higher burden for participants in this study compared to usual standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.

lead_sponsor: AbbVie

location_country:
United Arab Emirates
Switzerland
Uruguay
France
Israel
Kuwait
Belgium
Argentina
Australia
Russian Federation
Canada

location_facility: CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 230947

location_facility: Orenburg State Medical University /ID# 233183

location_facility: Hadassah Medical Center-Hebrew University /ID# 241865

location_facility: CHU Lille - Hôpital Roger Salengro /ID# 228820

location_facility: Nebbiolo Clinical Research Center /ID# 231167

location_facility: Samara Regional Clinical Hospital n.a. V. D. Seredavin /ID# 231169

location_facility: Ulyanovsk Regional Clinical Hospital /ID# 238334

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 228829

location_facility: CHU Grenoble - Hopital Michallon /ID# 228792

location_facility: CHU de Besancon - Jean Minjoz /ID# 230528

location_facility: Nort-Western State Medical University n.a. Mechnikov /ID# 231172

location_facility: Dr. Sabeen Anwar Medicine Professional Corporation /ID# 241933

location_facility: Yaroslavl State Medicat University /ID# 231168

location_facility: AP-HM - Hopital Sainte Marguerite /ID# 241024

location_facility: Republican hospital named after V.A. Baranov /ID# 231173

location_facility: Mediclinic Airport Road Hospital /ID# 231227

location_facility: Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 231440

location_facility: ChUZ Clinical Hospital RZD-Medicine /ID# 233185

location_facility: Groupe de Recherche en Maladies Osseuses Inc /ID# 241111

location_facility: Rheumatologisches Versorgungszentrum Weinfelden /ID# 239435

location_facility: CHR Orleans - Hopital de la Source /ID# 234258

location_facility: The Chaim Sheba Medical Center /ID# 241305

location_facility: Clinical Rheumatologic Hospital No 25 /ID# 231171

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 230548

location_facility: Tel Aviv Sourasky Medical Center /ID# 241864

location_facility: CHU de Besancon - Jean Minjoz /ID# 242499

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 238961

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 228836

location_facility: Cabinet liberal - Compiegne - Dr Banse /ID# 242497

location_facility: AP-HP - Hopital Saint-Antoine /ID# 228795

location_facility: Clinic of Samara State Medical University /ID# 241166

location_facility: Regional Clinical Hospital of Kaliningrad region /ID# 238475

location_facility: CHU de Rennes - Hospital Sud /ID# 228842

location_facility: CHU Toulouse - Hopital Purpan /ID# 228818

location_facility: Hôpital d'instruction des armées Bégin /ID# 228793

location_facility: Military Medical Academy n.a. Kirov /ID# 242363

location_facility: Royal Prince Alfred Hospital /ID# 232417

location_facility: Barwon Rheumatology Services /ID# 230068

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 240980

location_facility: Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 232510

location_facility: Research Institute of Rheumatology named after V.A. Nasonova /ID# 238479


title: A 52-week, Randomised, Double-blind, Double-dummy, Parallel Group, Multi-centre, Non-inferiority Study Assessing Exacerbation Rate, Additional Measures of Asthma Control and Safety in Adult and Adolescent Severe Asthmatic Participants With an Eosinophilic Phenotype Treated With GSK3511294 Compared With Mepolizumab or Benralizumab

summary: This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype. Throughout the study, all participants will continue their non-biologic Baseline standard of care (SoC) asthma treatment.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Austria
United States
France
Japan
Poland
Australia
Spain
Canada
Taiwan


title: An Observational Retrospective Cohort Study of Systemic Therapies for Relapsed or Refractory Diffuse Large B Cell Lymphoma (R/R DLBCL), to Compare Outcomes to Those From Tafasitamab + Lenalidomide in the L-MIND Study

summary: To compare the efficacy outcomes of the L-MIND cohort with the effectiveness in a matched patient population treated with systemic NCCN/ESMO guideline listed regimens administered in routine clinical care.

lead_sponsor: MorphoSys AG

location_country:
Italy
Austria
United States
Germany
France
Australia
Spain
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan


title: Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guerin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

summary: The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease.

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

location_country:
Italy
United States
Netherlands
Spain
Germany
France
Japan
Greece
Belgium
Australia
Russian Federation
Portugal
Turkey
Canada
United Kingdom
Korea, Republic of
Ukraine

location_facility: FSBHI RSCRST n.a. Ac. Granov A.M. of MoH

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

location_facility: State Institution Academy Of Medical Sciences Of Ukraine

location_facility: Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino

location_facility: Pusan National University Yangsan Hospital

location_facility: General Hospital of Thessaloniki G. Gennimatas

location_facility: St.Marianna University School of Medicine

location_facility: Urological Associates of Southern Arizona, P.C.

location_facility: The Male/Female Health and Research Centre

location_facility: Istanbul Medeniyet University Goztepe Training and Research Hospital

location_facility: Attikon University General Hospital of Attica

location_facility: Centro Hospitalar de Trás os Montes e Alto-Douro

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil

location_facility: Kliniken Nordoberpfalz AG/Klinikum Weiden

location_facility: 'Papageorgiou' General Hospital of Thessaloniki

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: The Julius Center - Utrecht Science Park - Stratenum

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

location_facility: Polyclinique de Limoges - Francois Chenieux

location_facility: Studienpraxis Urologie Nürtingen - Germany

location_facility: Urologische Praxis am Wasserturm - Germany

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Cherkassy Regional Oncology Dispensary, Department of Hematology

location_facility: Institut de Cancérologie Strasbourg Europe (ICANS)

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

location_facility: N. N. Blokhin Russian Academy of Medical Sciences

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: A. Tsyb Medical Radiological Research Center

location_facility: BHI of Omsk region Clinical Oncology Dispensary

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Multifunctional clinical medical center 'Medical city'

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Chernihivskyi oblasnyi onkolohichnyi dyspanser

location_facility: Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital

location_facility: University of Texas Southwestern Medical Center

location_facility: Urologic Consultants of Southeastern Pennsylvania


title: A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma

summary: This is an open-label, randomized (1:1), multi-center trial of epcoritamab (GEN3013; DuoBody®-CD3xCD20) versus prespecified investigator's choice of chemotherapy in patients with relapsed, refractory diffuse large B-Cell Lymphoma

lead_sponsor: Genmab

location_country:
Austria
Sweden
Netherlands
Finland
France
Japan
Poland
Israel
Norway
Hungary
Australia
Belgium
Singapore
Spain
Turkey
Denmark
United States
United Kingdom
Korea, Republic of

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Tip Fakultesi

location_facility: Indiana Blood and Marrow Transplantation

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III der PMU

location_facility: Universitair Ziekenhuis gasthuisberg Leuven

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Oulu university hospital, Department of hematology

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: AZ Nikolaas- Verenigde Ziekenhuizen van Waas en Durme

location_facility: Szent Borbala Hospital, Hematology Department

location_facility: Kuopio University Hospital Cancer Center

location_facility: Royal Wolverhampton Nhs Trust, New Cross Hospital

location_facility: Aarhus University Hospital, Department of Hematology, Clinical Research Unit C116

location_facility: Royal Marsden NHS Foundation Trust (Sutton)

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

location_facility: Seoul National University Bundang Hospital

location_facility: Semmelweis Egyetem Belgyógyászati és Onkológiai Klinika

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: Belgyógyászati osztály Markhot Ferenc Kórház

location_facility: Semmelweis Egyetem, Belgyógyászati és Hematológiai Klinika

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Södra Älvsborgs Sjukhus, Hematolog dagvård

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Oslo University Hospital location Radium hospital

location_facility: Clinical Research Unit, KFE Herlev Hospital


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

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Peru
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Chile
Hong Kong
Netherlands
Singapore
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: CIUSSSS de l'Est-de-l'Ile-de-Montréal - Installation Hôpital Maisonneuve-Rosemont

location_facility: Erasmus MC - Daniel den Hoed Oncologisch Centrum

location_facility: Institut für Versorgungsforschung in der Onkologie

location_facility: The Sel of Centre dOncologie de Gentilly

location_facility: Mammazentrum HH am Krankenhaus Jerusalem

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Presidio Ospedaliero di Summa - Antonio Perrino

location_facility: Complejo Hospitalario Universitario A Coruña (CHUA)

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

location_facility: Japanese Foundation for Cancer Research (JFCR) - The Cancer Institute Hospital - Breast Oncology Center

location_facility: General Hospital of Athens Alexandra Clinic

location_facility: The 4th Hospital of Heibei Medical University

location_facility: Harzklinikum Dorothea Christiane Erxleben

location_facility: Algemeen Ziekenhuis AZ Klina - Borstkliniek

location_facility: Dept. OB/GYN Johanna Etienne Krankenhaus

location_facility: National Hospital Organization - Hokkaido Cancer Center

location_facility: Kliniken der Stadt Köln / Brustzentrum Holweide

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Kanagawa Cancer Center Hospital - Kanagawa Cancer Center (Kanagawa Cancer Centre Research Institute)

location_facility: Hospital MD Anderson Cancer Center Madrid

location_facility: A.O.U. Citta della Salute e della Scienza di Torino

location_facility: National Cancer Center Hospital East (NCCHE) - Kashiwa Campus

location_facility: Showa University Hospital - Breast Center

location_facility: Johannes Wesling Klinikum Minden, Hämatologie-Onkologie/Brustzentrum

location_facility: SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary

location_facility: Tennessee Oncology Nashville / Sarah Cannon

location_facility: Frauenklinik St. Louise - St. Vincenz- Krankenhaus GmbH

location_facility: Elmhurst Memorial Hospital- Nancy W. Knowles Cancer Center

location_facility: Universitätsklinikum Düsseldorf, Klinik für Frauenheilkunde & Geburtshilfe

location_facility: Clinica Oncologica, Ospedali Riuniti Umberto 1

location_facility: Sichuan University - West China Hospital

location_facility: Policlinico S.Orsola-Malpighi SSD Oncologia Medica Addarii

location_facility: General Hospital of Patras Agios Andreas

location_facility: Frankfurt University Department of Gynecology and Obstetrics

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Jilin University JLU - First Affiliated Hospital

location_facility: Union Hospital of Fujian Medical University

location_facility: Istituto Naz per la Ricerca sul Cancro (IST) Genov

location_facility: Nanjing Medical University NMU - Jiangsu Province Hospital

location_facility: Consultorio del Dr. Joaqun Gabriel Reinoso Toledo

location_facility: MedStar Franklin Square Cancer Center at Loch Raven Campus

location_facility: Austin Hospital- Olivia Newto-John Cancer and Wellness Centre

location_facility: MedStar Franklin Square Medical Center-Harry and Jeanette Weinberg Cancer Institute

location_facility: Chi Mei Medical Center CMMC - Yongkang Branch

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE

location_facility: St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC)

location_facility: Unifrauenklinik Köln - Studienzentrum Gynäkologie

location_facility: Department of Gyencology and Obstetrics, Saarland University Hospital

location_facility: Gemeinschaftspraxis Dres. Halder / Bangerter

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: University of Kentucky, Markey Cancer Center, Clinical Research Organization

location_facility: National Hospital Organization (NHO) - Shikoku Cancer Center

location_facility: Krankenhaus St. Elisabeth und St. Barbara Halle/Saale

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Regional Cancer Center at Indian Path Community Hospital

location_facility: The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH)

location_facility: State Budgetary Healthcare Institution Oncological Dispensary No. 2 of the Ministry of Health of Krasnodar Region

location_facility: Hospital da Senhora da Oliveira, Guimarães EPE

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: SRH Waldklinikum Gera, Brustzentrum Ostthüringen

location_facility: The University of Hong Kong (HKU) - Queen Mary Hospital (QMH)

location_facility: The Oncology Institute of Hope & Innovation

location_facility: IUC AP-HP. Sorbonne Université, Hôpital Tenon

location_facility: Ochsner Hematology Oncology North Shore - Covington (West Region)

location_facility: Richard A. Henson Cancer Institute Ocean Pines

location_facility: Instituto do Cancer do Estado de Sao Paulo (ICESP)

location_facility: Second Affiliated Hospital of Zhejiang University

location_facility: Klinikverbund Südwest Kliniken Böblingen Frauenklinik Böblingen

location_facility: Centro de Investigación Clinica Trujillo EIRL

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Hospital Clínico Universitario de Valencia

location_facility: National Hospital Organization - National Kyushu Cancer Center

location_facility: Gemeinschaftspraxis Frauenärzte am Bahnhofsplatz

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

location_facility: Fundación Instituto Valenciano de Oncologia (IVO)

location_facility: Istitutoperla Ricercaela Curadel Cancro IRCC

location_facility: Complejo Hospitalario Clínico Universitario de Santiago de Compostela (CHUS)

location_facility: Virginia Commonwealth University Massey Cancer Center

location_facility: St.-Johannes-Hospital Dortmund, Dept. of Obstetrics/Gynecology

location_facility: Reading Hospital, McGlinn Cancer Institute

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Kliniken Essen-Mitte, Klinik für Senologie/ Interdisziplinäres Brustzentrum

location_facility: Harbin Medical University Cancer Hospital

location_facility: LMU Klinikum/ Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

location_facility: Fundacao Pio XII-Hospital de Cancer de Barretos

location_facility: ALTHAIA, Xarxa Assistencial Universitària de Manresa F.P.

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Istanbul Medeniyet University Medical Faculty

location_facility: National Taiwan University Hospital NTUH

location_facility: University General Hospital of Heraklion

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Tohoku University Hospital (TUH) - Clinical Research, Innovation and Education Center (CRIETO)

location_facility: McGill University Health Centre - Cedars Cancer Centre

location_facility: Nanchang University - The First Affiliated Hospital

location_facility: Hospital Universitario Clínico San Cecilio

location_facility: Osaka International Cancer Institute (OICI)

location_facility: National Cancer Center (NCC) - Tsukiji Campus - National Cancer Center Hospital (NCCH)

location_facility: Royal United Hospital Bath NHS Trust - Royal United Hospital RUH

location_facility: CHA Bundang Medical Center CHA University

location_facility: Jewish General Hospital Segal Cancer Centre

location_facility: Pamela Youde Nethersole Eastern Hospital PYNEH

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: Hospital Universitario San Pedro de Alcantara

location_facility: Medzinische Fakultät Mannheim, Universität Heidelberg

location_facility: Instituto Nacional de Enfermedades Neoplasicas INEN

location_facility: Hospital Universitario HM Puerta del Sur

location_facility: MediOnko-Institut GbR, Praxisklinik Krebsheilkunde

location_facility: Colchester Hospital, East Suffolk & North Essex NHS Foundation Trust

location_facility: Clinique Tivoli Ducos - Centre dOncologie et de Radiotherapie a Bordeaux

location_facility: Centro di Riferimento Oncologico di Aviano - SOC Oncologia Medica e Prevenzione Oncologica

location_facility: Area Vasta Sud Est Sede Operativa Grosseto

location_facility: Medizinisches Versorgungszentrum für Hämatologie und Onkologie München MVZ GmbH

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta

location_facility: CHU de Quebec - Hopital du Saint-Sacrement

location_facility: IOB Institute Of Oncology-Hospital Quironsalud Barcelona

location_facility: National Hospital Organization - Osaka National Hospital (ONH)

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Unidade Local de Saúde de Matosinhos, EPE

location_facility: Wellmont Medical Associates Oncology & Hematology

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Schwarzwald - Baar Klinikum Frauenklinik

location_facility: Universitätsklinik Freiburg, Klinik für Frauenheilkunde

location_facility: MSCM Cancer Center and Institute of Oncology Department of Breast Cancer and Reconstructive Surgery

location_facility: Consorcio Hospitalario Provincial de Castelló

location_facility: Hospital Sirio-Libanes HSL - Centro de Oncologia - Brasilia

location_facility: Soon Chun Hyang Central Medical Center (SCHMC)

location_facility: Kindai University (Kinki University) - Faculty of Medicine (Kinki University School of Medicine (KUSM)) - Kindai University Hospital (Kinki University Hospital) - Cancer Center

location_facility: MultiCare Institute for Research & Innovation

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: State Budget Healthcare Institution of Stavropol Region

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE

location_facility: Complejo Asistencial Universitario de León

location_facility: Chongqing Medical University - The First Affiliated Hospital

location_facility: Frederick Health-James M Stockman Cancer Center

location_facility: Tokai University Hospital - Isehara Campus

title: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy (DESTINY-Breast05)

summary: Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy.


ipd_sharing_description:
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
Italy
Austria
Hong Kong
Finland
France
Czechia
Lithuania
Israel
Poland
Singapore
Hungary
Australia
Russian Federation
Spain
Turkey
Germany
United Kingdom
Korea, Republic of
Taiwan

location_facility: Tampereen yliopistollinen sairaala, keskussairaala

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka

location_facility: Centre de Lutte Contre le Cancer François Baclesse

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: Ankara Yildirim Beyazit Universitesi Tip Fakültesi

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Consorcio Hospitalario Provincial de Castellón

location_facility: IRCCS Centro di Riferimento Oncologico (CRO)

location_facility: Samara Regional Clinical Oncology Dispensary

location_facility: Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi

location_facility: Hospital Universitario Clinica Puerta de Hierro

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

location_facility: Centre Hospitalier Universitaire - Grenoble

location_facility: Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Institut Claudius Regaud - iUCT Oncopole

location_facility: Hadassah Hebrew University Hospital Ein Kerem

location_facility: Izmir Tepecik Egitim ve Arastirma Hastanesi

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie

location_facility: Seoul National University Bundang Hospital

location_facility: National Medical Research Radiology Center

location_facility: Uniwersytecki Szpital Kliniczny UM we Wroclawiu

location_facility: Szpital Grochowski im. dr.med. Rafala Masztaka

location_facility: Clinical Oncological Dispensary of Omsk Region

location_facility: Institut de Cancérologie de Lorraine - Alexis Vautrin

location_facility: The Hospital of Lithuanian University of Health SciencesLUHS

location_facility: Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has

location_facility: Tomsk National Research Medical Center of RAS

location_facility: Chelyabinsk Regional Oncology Dispensary

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi

location_facility: IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie

location_facility: A.O. Nazionale SS Antonio e Biagio e Cesare Arrigo

title: A Phase 4, Randomized, Open-label, Multicenter Efficacy and Safety Study of Standard Dose of Radium-223 Dichloride vs. Standard Doses of Novel Anti-hormonal Therapy (NAH) in Patients With Bone Dominant Metastatic Castration Resistant Prostate Cancer (mCRPC) Progressing on/After One Line of NAH

summary:
Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH therapy. Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone. The NAH drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of them are standard approved medications which are used in the treatment of advanced prostate cancer.

Participants in this study will receive either Radium-223 dichloride or a NAH therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain.