title: A Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in the Treatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis

summary: The purpose of the study is to further evaluate the safety and efficacy of EUR-1008 as compared to Kreon® in the treatment of exocrine pancreatic insufficiency associated with Cystic Fibrosis in subjects 12 years of age and older.

ReferenceCitation: Somaraju URR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Aug 5;8:CD008227. doi: 10.1002/14651858.CD008227.pub4.

ReferenceCitation: Taylor CJ, Thieroff-Ekerdt R, Shiff S, Magnus L, Fleming R, Gommoll C. Comparison of two pancreatic enzyme products for exocrine insufficiency in patients with cystic fibrosis. J Cyst Fibros. 2016 Sep;15(5):675-80. doi: 10.1016/j.jcf.2016.02.010. Epub 2016 Mar 21.

lead_sponsor: Forest Laboratories

location_country:
Poland
United Kingdom
Italy
France
Belgium
Germany
Bulgaria

location_facility: Wojewodzki Szpital Specjalistyczny im Kopernika

location_facility: University Federico II of Naples, Pediatrics Department

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino, Gastroenterologia Pediatrica E Fibrosi Cistica

location_facility: Istituto Azienda Ospedaliera Universitaria

location_facility: Clinica di Malattie dell'Apparato Respiratorio

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitaetsklinikum Essen gGmbH

location_facility: Azienda Ospedaliera Universitaria Integrata, Centro Fibrosi Cistica-Ospedale Civile Maggiore

location_facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy

location_facility: Universitatsklinikum Jena, Klinik fur Kinder und Jugendmedizin

location_facility: Universitaetsklinik für Kinder- und Jugendmedizin Tuebingen

location_facility: Specjalistyczny Zespot Opieki Zdrowotnej nad Matka i Dzieckiem Poradnia Leczenia Mukowiscydozy

location_facility: Centrum Pulmonologii i Alergologii w Karpaczu

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Universitätsklinikum Essen Zentrum f.Kinderheilkunde Klinik f.Kinderheilkunde III

location_facility: Bambino Gesu Hospital, Cystic Fibrosis Unit

location_facility: Clinic of Genetic and Paediatric Diseases at UMHAT Sveti Georgi

location_facility: Universita degli Studi di Roma La Sapienza, Azienda Policlinico Umberto I, Dipartimento di Pediatria, Centro Fibrosi Cistica Regione Lazio

location_facility: Sheffield Children's Hospital, The Academic Unit of Child Health

location_facility: Universitair Ziekenhuis Gent, Centrum voor Mucoviscidose

location_facility: Specialized Hospital for Active Treatment of Pulmological and Phtisiatric Disease

location_facility: NZOZ Podkarpacki Osrodek Pulmonologii i Alergologii

location_facility: University Hospital Antwerp - Universitair Ziekenhuis Antwerpen (UZA)

location_facility: Ruhr-Universitaet Bochum - St. Josef Hospital

location_facility: Multiprofile Clinic for Specialized Pediatric Clinic at MHAT Sveta Marina

location_facility: ALERGOTEST s.c Specjalistyczne Centrum Medyczne

location_facility: Clinic of Paediatric Diseases at UMHAT Dr Georgi Stranski

location_facility: Azienda Ospedaliero Universitaria, Ospedali Riuniti, Ospedale Pediatrico G. Salesi


type: EudraCT Number

type: Other Identifier

title: A Phase 2/3, Multicenter, Open-label Clinical Study to Assess the Safety and Efficacy of BAY86-6150 in Subjects With Hemophilia A or B With Inhibitors, Composed of 2 Parts (A & B). Part A: Sequential Cohorts of Four Dose Levels of the Modified rFVIIa BAY86-6150 Assessed in a Non-controlled Dose Response Design in Acutely Bleeding Subjects and for PK/ PD in an Intra-individual Crossover Design Compared With One Fixed Dose of Eptacog Alfa in Non-bleeding Subjects. Part B: Confirmatory Study to Further Investigate the Efficacy and Safety of BAY86-6150

summary:
Haemophilia is a disorder, usually genetic, affecting mostly male individuals, in which one of the proteins needed to form blood clots (FVIII) is missing or not present in sufficient levels. In a person with haemophilia, the clotting process is much slower and the person experiences bleeding episodes that can result in serious problems and potential disability.

The current haemophilia standard of care is to maintain FVIII activity level above 1%. Sometimes, patients can develop antibodies (so called "inhibitors") against FVIII and it is no longer effective at controlling bleeds. Bleeds in these patients are currently treated using other proteins involved in the clotting process.

The purpose of this study is to investigate how effectively BAY86-6150 may stop acute bleeds in "inhibitor" patients. This study consists of two parts, A and B. The purpose of part A is to find the most effective yet tolerable out of four doses of BAY86-6150 with regard to efficacy and safety (dose-finding part). Part A is expected to last 9 - 29 months. The purpose of part B is to confirm efficacy and safety of the dose found in part A in all participating patients (confirmatory part). Part B is expected to last 12-32 months.

Approximately 60 male subjects 12 to 62 years-of-age with moderate or severe haemophilia A or B, with inhibitors to FVIII or FIX, who have had 4 or more bleeding episodes in the last 6 months, will participate in this study.

Patient's bleeds will be treated with BAY86-6150 and with a rescue medication if no response is made to BAY86-6150. Patients will attend the treatment centre at regular intervals and be required to keep an electronic diary.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Bayer

location_country:
United Kingdom
Italy
Ukraine
United States
Romania
Japan
South Africa
Poland
Russian Federation
Australia
India
Israel
Turkey
Mexico
Singapore
Sweden
Brazil
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
New Zealand
Korea, Republic of
France
Chile
Colombia
Netherlands

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of Evolocumab (AMG145) on LDL-C in Subjects With Severe Familial Hypercholesterolemia

acronym: TAUSSIG

summary: A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.

study_start_date_type: Actual

ReferenceType: background

ReferenceCitation: Raal FJ, Hovingh GK, Blom D, Santos RD, Harada-Shiba M, Bruckert E, Couture P, Soran H, Watts GF, Kurtz C, Honarpour N, Tang L, Kasichayanula S, Wasserman SM, Stein EA. Long-term treatment with evolocumab added to conventional drug therapy, with or without apheresis, in patients with homozygous familial hypercholesterolaemia: an interim subset analysis of the open-label TAUSSIG study. Lancet Diabetes Endocrinol. 2017 Apr;5(4):280-290. doi: 10.1016/S2213-8587(17)30044-X. Epub 2017 Feb 16.

ReferenceCitation: Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7. Review.

ReferenceCitation: Santos RD, Stein EA, Hovingh GK, Blom DJ, Soran H, Watts GF, López JAG, Bray S, Kurtz CE, Hamer AW, Raal FJ. Long-Term Evolocumab in Patients With Familial Hypercholesterolemia. J Am Coll Cardiol. 2020 Feb 18;75(6):565-574. doi: 10.1016/j.jacc.2019.12.020.

ReferenceType: derived

ReferenceCitation: Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10:CD011748. doi: 10.1002/14651858.CD011748.pub3.

ReferenceCitation: Stein EA, Honarpour N, Wasserman SM, Xu F, Scott R, Raal FJ. Effect of the proprotein convertase subtilisin/kexin 9 monoclonal antibody, AMG 145, in homozygous familial hypercholesterolemia. Circulation. 2013 Nov 5;128(19):2113-20. doi: 10.1161/CIRCULATIONAHA.113.004678. Epub 2013 Sep 6.

lead_sponsor: Amgen

location_country:
Brazil
Hong Kong
Spain
Greece
Italy
Australia
Lebanon
Canada
New Zealand
United Kingdom
United States
France
Israel
South Africa
Belgium
Japan
Netherlands
Czechia

intervention_type: Biological


title: Comparison of Three Therapeutic Strategies for Treating Type 2 Diabetes Mellitus Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs

acronym: OSIRIS

summary:
Primary objectives :

To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin combined with 3 bolus of insulin glulisine (Arm 1), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs.
To show the non inferiority in terms of efficacy (HbA1c) of insulin glargine plus metformin combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 2) compared with insulin glargine plus metformin and insulin secretagogue (sulfonylurea or glinide) combined with 1 to 3 bolus of insulin glulisine introduced progressively (Arm 3), in type 2 diabetes mellitus patients poorly controlled on basal insulin therapy with oral antidiabetic drugs.

Secondary objectives :

To compare between the 3 treatment groups: evolution of HbA1c over time, percentage of subjects with HbA1c <= 7% at the end of the study, evolution of blood glucose profiles, incidence of hypoglycemia, insulin doses, evolution of body weight and treatment satisfaction.

design_allocation: Randomized

lead_sponsor: Sanofi

location_country:
Poland
Taiwan
Spain
Greece
Ireland
Italy
Mexico
Lithuania
Netherlands
Russian Federation
United Kingdom
Sweden
Hungary
Korea, Republic of
France
Turkey
Belgium
Germany


title: Phase 2 Study of Weekly Oxaliplatin and Capecitabine (XELOX) in Combination With Preoperative Radiotherapy in Patients With MRI Defined Locally Advanced Rectal Cancer

summary:
Primary objective:

Pathological complete response (ypT0N0) rate

Secondary objectives:

Histopathological R0 resection rate
Pathological downstaging (ypT0-T2N0) rate
One month surgical complication rate
Predictive value of pre-operative MRI for surgical, pathological and clinical outcomes
Safety
Local and distant recurrence rates
Progression-free survival
Overall survival

location_country:
Spain
Italy
United Kingdom
Netherlands
France
Belgium
Germany


title: Randomized Clinical Trial Comparing Surveillance and Selective Surgical Treatment for Abdominal Aortic Aneurysms Less Than 5.5 cm in Diameter Versus Early Endovascular Treatment

acronym: CAESAR

summary: Objective of the present study is to compare endovascular repair versus surveillance and, eventually delay treatment in patients with small abdominal aortic aneurysms (AAA), with respect to patient survival, AAA rupture and AAA related death risks.

status: Terminated

study_completion_date_type: Anticipated

ReferenceCitation: Alcorn HG, Wolfson SK Jr, Sutton-Tyrrell K, Kuller LH, O'Leary D. Risk factors for abdominal aortic aneurysms in older adults enrolled in The Cardiovascular Health Study. Arterioscler Thromb Vasc Biol. 1996 Aug;16(8):963-70.

ReferenceCitation: Scott RA, Wilson NM, Ashton HA, Kay DN. Is surgery necessary for abdominal aortic aneurysm less than 6 cm in diameter? Lancet. 1993 Dec 4;342(8884):1395-6.

ReferenceCitation: United Kingdom Small Aneurysm Trial Participants, Powell JT, Brady AR, Brown LC, Fowkes FG, Greenhalgh RM, Ruckley CV, Thompson SG. Long-term outcomes of immediate repair compared with surveillance of small abdominal aortic aneurysms. N Engl J Med. 2002 May 9;346(19):1445-52.

ReferenceCitation: Mortality results for randomised controlled trial of early elective surgery or ultrasonographic surveillance for small abdominal aortic aneurysms. The UK Small Aneurysm Trial Participants. Lancet. 1998 Nov 21;352(9141):1649-55.

ReferenceCitation: Lederle FA, Wilson SE, Johnson GR, Reinke DB, Littooy FN, Acher CW, Ballard DJ, Messina LM, Gordon IL, Chute EP, Krupski WC, Busuttil SJ, Barone GW, Sparks S, Graham LM, Rapp JH, Makaroun MS, Moneta GL, Cambria RA, Makhoul RG, Eton D, Ansel HJ, Freischlag JA, Bandyk D; Aneurysm Detection and Management Veterans Affairs Cooperative Study Group. Immediate repair compared with surveillance of small abdominal aortic aneurysms. N Engl J Med. 2002 May 9;346(19):1437-44.

ReferenceCitation: EVAR trial participants. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm (EVAR trial 1): randomised controlled trial. Lancet. 2005 Jun 25-Jul 1;365(9478):2179-86.

ReferenceCitation: De Rango P, Verzini F, Parlani G, Cieri E, Romano L, Loschi D, Cao P; Comparison of surveillance vs. Aortic Endografting for Small Aneurysm Repair (CAESAR) Investigators. Quality of life in patients with small abdominal aortic aneurysm: the effect of early endovascular repair versus surveillance in the CAESAR trial. Eur J Vasc Endovasc Surg. 2011 Mar;41(3):324-31. doi: 10.1016/j.ejvs.2010.11.005. Epub 2010 Dec 9.

ReferenceCitation: Cao P, De Rango P, Verzini F, Parlani G, Romano L, Cieri E; CAESAR Trial Group. Comparison of surveillance versus aortic endografting for small aneurysm repair (CAESAR): results from a randomised trial. Eur J Vasc Endovasc Surg. 2011 Jan;41(1):13-25. doi: 10.1016/j.ejvs.2010.08.026. Epub 2010 Sep 25.

lead_sponsor: University Of Perugia

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

location_facility: S.C. Chirurgia Vascolare - Università di Perugia

location_facility: Klinik Fuer Gefasschirurgie st.Franziskus Hospital

location_facility: Vitkovice Hospital Ostrava and University Hospital Ostrava - Poruba

location_facility: Chirurgia Vascolare Ospedale San Giovanni di Dio

location_facility: Chirurgia Vascolare, Ospedale San Donato

location_facility: Azienda Ospedaliera "Antonio Cardarelli"

location_facility: S.C. Chirurgia Vascolare Az Osp. S.Maria Nuova

location_facility: Policlinico Le Scotte - U.O. Chirurgia Vascolare

location_facility: Klinika Chirurgii ogolnej i Chorob Klatki Piersiowej Warsaw

location_facility: Institute of Cardiovascular Disease Hospital Clinic University of Barcelona

location_facility: Naczyniowej i Transplantacyjnej Akademii Medycznej

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Unknown


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

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

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

ReferenceType: result

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

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

location_country:
Poland
United Kingdom
Hungary
France
Belgium
Netherlands

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

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

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital


title: An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving HERCEPTIN-Containing Regimens

summary: This study was designed to determine the efficacy of an oral dual kinase inhibitor for the treatment of metastatic breast cancer tumors that are known to overexpress ErbB2 in a refractory patient population.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Argentina
United Kingdom
France


title: A Prospective Randomised Controlled Trial Of Hyperfractionated Versus Conventionally Fractionated Radiotherapy In Standard Risk Medulloblastoma

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy in different ways with combination chemotherapy may kill any remaining tumor cells following surgery. It is not yet known which radiation therapy regimen combined with combination chemotherapy is more effective in treating medulloblastoma.

PURPOSE: Randomized phase III trial to compare different radiation therapy regimens plus combination chemotherapy in treating children who have undergone surgery for medulloblastoma.

status: Unknown status

enrollment_type: Anticipated

lead_sponsor: University of Leicester

location_country:
Spain
Italy
United Kingdom
Netherlands
Sweden
France
Belgium
Germany

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Royal Liverpool Children's Hospital, Alder Hey

intervention_type: Radiation


title: A Multi-National Randomized Phase-III GCIG Intergroup-Study Comparing 1st-line Chemotherapy With Gemcitabine/Paclitaxel/Carboplatin vs Paclitaxel/Carboplatin In Previously Untreated Patients With Epithelial Ovarian Cancer FIGO Stages I-IV

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether carboplatin and paclitaxel combined with gemcitabine is more effective than carboplatin and paclitaxel alone in treating ovarian epithelial or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel combined with gemcitabine to see how well it works compared to paclitaxel and carboplatin alone in treating patients who have undergone surgery for ovarian epithelial or fallopian tube cancer.

ReferenceCitation: du Bois A, Herrstedt J, Hardy-Bessard AC, Müller HH, Harter P, Kristensen G, Joly F, Huober J, Avall-Lundqvist E, Weber B, Kurzeder C, Jelic S, Pujade-Lauraine E, Burges A, Pfisterer J, Gropp M, Staehle A, Wimberger P, Jackisch C, Sehouli J. Phase III trial of carboplatin plus paclitaxel with or without gemcitabine in first-line treatment of epithelial ovarian cancer. J Clin Oncol. 2010 Sep 20;28(27):4162-9. doi: 10.1200/JCO.2009.27.4696. Epub 2010 Aug 23.

ReferenceCitation: Machelon V, Gaudin F, Camilleri-Broët S, Nasreddine S, Bouchet-Delbos L, Pujade-Lauraine E, Alexandre J, Gladieff L, Arenzana-Seisdedos F, Emilie D, Prévot S, Broët P, Balabanian K. CXCL12 expression by healthy and malignant ovarian epithelial cells. BMC Cancer. 2011 Mar 16;11:97. doi: 10.1186/1471-2407-11-97.

lead_sponsor: AGO Study Group

location_country: Norway Denmark France Germany

location_facility: Herlev Hospital - University Hospital of Copenhagen

location_facility: University Hospital Schleswig-Holstein - Kiel Campus

location_facility: Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen

location_facility: Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

location_facility: Staedtische Kliniken Frankfurt am Main - Hoechst

location_facility: Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe - Universitaetsklinikum Muenster

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen


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

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

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

ReferenceCitation: Haas RL, Girinsky T. HOVON 47/EORTC 20013: chlorambucil vs 2x2 Gy involved field radiotherapy in stage III/IV previously untreated follicular lymphoma patients. Ann Hematol. 2003 Jul;82(7):458-62. Epub 2003 May 20.

lead_sponsor: Commissie Voor Klinisch Toegepast Onderzoek

location_country: Netherlands France Belgium

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


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

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

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

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

ReferenceCitation: Brada M, Baumert B. Focal fractionated conformal stereotactic boost following conventional radiotherapy of high-grade gliomas: a randomized phase III study. A joint study of the EORTC (22972) and the MRC (BR10). Front Radiat Ther Oncol. 1999;33:241-3.

location_country:
Spain
United Kingdom
Australia
Netherlands
Switzerland
France
Germany

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


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

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

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

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

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

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


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

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

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

location_country:
United Kingdom
Austria
Netherlands
Sweden
France
Norway
Germany

location_facility: Nijmegen Cancer Center at Radboud University Medical Center

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

location_facility: Velindre Cancer Center at Velinde Hospital


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

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

Aim of the study:

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

study_start_date_type: Anticipated

status: Not yet recruiting

study_type: Observational

time_perspective: Retrospective

ipd_sharing: No

lead_sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

location_country:
United States
Italy
Canada
France

location_facility: Brigham and Women Hospital / Dana Farber Cancer Institute

intervention_type: Other

status_simplified: Ongoing


title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

summary: The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are unresponsive or intolerant to treatment with anti-TNF-alpha agents.

ReferenceCitation: Aletaha D, Bingham CO 3rd, Tanaka Y, Agarwal P, Kurrasch R, Tak PP, Popik S. Efficacy and safety of sirukumab in patients with active rheumatoid arthritis refractory to anti-TNF therapy (SIRROUND-T): a randomised, double-blind, placebo-controlled, parallel-group, multinational, phase 3 study. Lancet. 2017 Mar 25;389(10075):1206-1217. doi: 10.1016/S0140-6736(17)30401-4. Epub 2017 Feb 16. Erratum in: Lancet. 2017 May 20;389(10083):1980.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Croatia
Spain
United Kingdom
Lithuania
United States
Belgium
Japan
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Mexico
Canada
Germany
Taiwan
New Zealand
Korea, Republic of
France
Netherlands


title: A Phase Ib Dose Escalation/Randomized Phase II, Multicenter, Open-label Study of BYL719 in Combination With Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

lead_sponsor: Novartis Pharmaceuticals

source: euctr

location_country:
Taiwan
Hong Kong
Australia
Canada
Korea, Republic of
United States
France
Singapore
Netherlands

summary:
This was a multi-center, open-label, Phase Ib dose escalation /Phase II study in recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) patients considered to be resistant, ineligible or intolerant to platinum-based chemotherapy. The Phase Ib included three arms. Three different methods of administration and two different BYL719 formulations were studied to determine the MTD and/or RP2D of BYL719 in combination with cetuximab:

Arm A - film-coated whole tablets were orally administered to patients who were able to swallow the tablets; Arm B - a drinkable suspension prepared from crushed film-coated tablets was administered orally to patients with swallowing dysfunction Arm C - a suspension from a dispersible tablet administered via G-tube, in patients with swallowing dysfunction. Arm C was used to investigate the pharmacokinetics (PK), compared to Arm A (film coated tablet), and safety of the dispersible tablet of the dispersible tablet formulation of BYL719.

The Phase II investigated the clinical efficacy of BYL719 and consisted of an open label, randomized Phase II part investigating BYL719 in combination with cetuximab compared to cetuximab alone in patients resistant or intolerant to platinum and naïve to cetuximab (Scheme 1: Arm 1 and Arm 2), and a non-randomized Phase II part Scheme 2: Arm 3. In addition, patients who experienced disease progression in Arm 2 (cetuximab) were allowed to switch to the combination regimen (cross-over, Arm 2B). The safety of the BYL719 in combination with cetuximab was also further characterized in Arms 1, 2B and 3.

Patients were treated until progression of disease), unacceptable toxicity, or withdrawal of informed consent, whichever occurred first (except for phase II Arm 2 had the opportunity to crossover to the combination treatment (Arm 2B). In the follow-up period all patients had to complete the safety follow-up assessments within 30 days after the last dose of the study treatment. Patients who did not have disease progression at the time of discontinuation of study treatment were radiologically followed for disease status until disease progression, initiation of subsequent anticancer therapies, or death, whichever occurred first. In addition, all patients enrolled in Phase II were followed for survival.


title: An Open-Label Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

summary: The purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in a follow-up randomized withdrawal study.

location_country:
Poland
Belgium
Serbia
Spain
Italy
Australia
Estonia
Canada
New Zealand
Ukraine
Hungary
Korea, Republic of
United States
France
South Africa
Colombia
Iceland
Singapore

location_facility:
Forest Investigative Site 067
Forest Investigative Site 226
Forest Investigative Site 124
Forest Investigative Site 001
Forest Investigative Site 075
Forest Investigative Site 177
Forest Investigative Site 276
Forest Investigative Site 804
Forest Investigative Site 070
Forest Investigative Site 580
Forest Investigative Site 577
Forest Investigative Site 228
Forest Investigative Site 728
Forest Investigative Site 116
Forest Investigative Site 704
Forest Investigative Site 114
Forest Investigative Site 132
Forest Investigative Site 703
Forest Investigative Site 069
Forest Investigative Site 098
Forest Investigative Site 202
Forest Investigative Site 106
Forest Investigative Site 056
Forest Investigative Site 107
Forest Investigative Site 115
Forest Investigative Site 077
Forest Investigative Site 101
Forest Investigative Site 378
Forest Investigative Site 023
Forest Investigative Site 080
Forest Investigative Site 576
Forest Investigative Site 123
Forest Investigative Site 021
Forest Investigative Site 051
Forest Investigative Site 118
Forest Investigative Site 096
Forest Investigative Site 078
Forest Investigative Site 453
Forest Investigative Site 381
Forest Investigative Site 028
Forest Investigative Site 026
Forest Investigative Site 452
Forest Investigative Site 084
Forest Investigative Site 141
Forest Investigative Site 109
Forest Investigative Site 117
Forest Investigative Site 102
Forest Investigative Site 061
Forest Investigative Site 062
Forest Investigative Site 729
Forest Investigative Site 086
Forest Investigative Site 801
Forest Investigative Site 029
Forest Investigative Site 072
Forest Investigative Site 125
Forest Investigative Site 074
Forest Investigative Site 204
Forest Investigative Site 052
Forest Investigative Site 802
Forest Investigative Site 055
Forest Investigative Site 702
Forest Investigative Site 651
Forest Investigative Site 057
Forest Investigative Site 326
Forest Investigative Site 081
Forest Investigative Site 090
Forest Investigative Site 066
Forest Investigative Site 104
Forest Investigative Site 063
Forest Investigative Site 059
Forest Investigative Site 329
Forest Investigative Site 627
Forest Investigative Site 401
Forest Investigative Site 005
Forest Investigative Site 676
Forest Investigative Site 578
Forest Investigative Site 119
Forest Investigative Site 113
Forest Investigative Site 379
Forest Investigative Site 127
Forest Investigative Site 097
Forest Investigative Site 068
Forest Investigative Site 002
Forest Investigative Site 019
Forest Investigative Site 730
Forest Investigative Site 092
Forest Investigative Site 380
Forest Investigative Site 053
Forest Investigative Site 803
Forest Investigative Site 131
Forest Investigative Site 807
Forest Investigative Site 105
Forest Investigative Site 108
Forest Investigative Site 626
Forest Investigative Site 201
Forest Investigative Site 628
Forest Investigative Site 091
Forest Investigative Site 155
Forest Investigative Site 100
Forest Investigative Site 065
Forest Investigative Site 526
Forest Investigative Site 382
Forest Investigative Site 082
Forest Investigative Site 579
Forest Investigative Site 203
Forest Investigative Site 085
Forest Investigative Site 629
Forest Investigative Site 701
Forest Investigative Site 727
Forest Investigative Site 073
Forest Investigative Site 071
Forest Investigative Site 376
Forest Investigative Site 054
Forest Investigative Site 130
Forest Investigative Site 064
Forest Investigative Site 095
Forest Investigative Site 227
Forest Investigative Site 136


title: SerUM Markers in MERkel Cell Carcinoma Patients: a Longitudinal moniTorIng Study for optiMization of European Guidelines

acronym: SUMMERTIME

summary: Merkel cell carcinoma (MCC) is a rare aggressive skin carcinoma. Approximately 80% of MCC are related to the Merkel Cell Polyomavirus (MCPyV). Although rates of relapse are high, the follow-up strategy lacks consensus. Patients are usually assessed clinically every 3 to 6 months for the first 2-3 years, and every 6 to 12 months thereafter. In the European guidelines, patients with early stages are monitored with clinical examination and ultrasonography of lymph nodes, while whole-body imaging is optional in patients with stage III disease, on a yearly basis for 5 years. Such strategy may prevent the diagnosis of infra-clinical recurrences, whereas patients could still be treated with surgery or radiation therapy. Until 2017, patients with advanced disease were treated with chemotherapies, with no long-term benefit. Immunotherapies with PD-1/PD-L1 inhibitors currently allow durable responses in 50% of such patients. This major change in the management of MCC patients argues for a follow-up strategy that would allow early diagnosis of infra-clinical metastases, when tumoral burden is still low. Given that all patients cannot be monitored by systematic regular imaging, additional non-invasive tools are needed. Blood-based biomarkers as a surrogate of tumor burden are advantageous as they can be repeated over time, providing guidance on when imaging is necessary. The study aims to assess two blood biomarkers, MCPyV T-Ag antibodies and cell-free miR-375, in a prospective fashion from baseline diagnosis, in a cohort of 150 European MCC patients

primary_purpose: Other

ReferenceCitation: Fan K, Ritter C, Nghiem P, Blom A, Verhaegen ME, Dlugosz A, Ødum N, Woetmann A, Tothill RW, Hicks RJ, Sand M, Schrama D, Schadendorf D, Ugurel S, Becker JC. Circulating Cell-Free miR-375 as Surrogate Marker of Tumor Burden in Merkel Cell Carcinoma. Clin Cancer Res. 2018 Dec 1;24(23):5873-5882. doi: 10.1158/1078-0432.CCR-18-1184. Epub 2018 Jul 30.

ReferenceCitation: Kervarrec T, Tallet A, Miquelestorena-Standley E, Houben R, Schrama D, Gambichler T, Berthon P, Le Corre Y, Hainaut-Wierzbicka E, Aubin F, Bens G, Tabareau-Delalande F, Beneton N, Fromont G, Arbion F, Leteurtre E, Touzé A, Samimi M, Guyétant S. Diagnostic accuracy of a panel of immunohistochemical and molecular markers to distinguish Merkel cell carcinoma from other neuroendocrine carcinomas. Mod Pathol. 2019 Apr;32(4):499-510. doi: 10.1038/s41379-018-0155-y. Epub 2018 Oct 22.

ReferenceCitation: Paulson KG, Lewis CW, Redman MW, Simonson WT, Lisberg A, Ritter D, Morishima C, Hutchinson K, Mudgistratova L, Blom A, Iyer J, Moshiri AS, Tarabadkar ES, Carter JJ, Bhatia S, Kawasumi M, Galloway DA, Wener MH, Nghiem P. Viral oncoprotein antibodies as a marker for recurrence of Merkel cell carcinoma: A prospective validation study. Cancer. 2017 Apr 15;123(8):1464-1474. doi: 10.1002/cncr.30475. Epub 2016 Dec 7.

ReferenceCitation: Samimi M, Molet L, Fleury M, Laude H, Carlotti A, Gardair C, Baudin M, Gouguet L, Maubec E, Avenel-Audran M, Esteve E, Wierzbicka-Hainaut E, Beneton N, Aubin F, Rozenberg F, Dupin N, Avril MF, Lorette G, Guyetant S, Coursaget P, Touzé A. Prognostic value of antibodies to Merkel cell polyomavirus T antigens and VP1 protein in patients with Merkel cell carcinoma. Br J Dermatol. 2016 Apr;174(4):813-22. doi: 10.1111/bjd.14313. Epub 2016 Feb 3.

lead_sponsor: University Hospital, Tours

location_country:
United Kingdom
Italy
Austria
Netherlands
Finland
Sweden
France
Turkey
Romania
Germany

location_facility: University Hospital of Helsinki, Finland

location_facility: Department of Dermatology, Başkent University Faculty of Medicine

location_facility: Skin Cancer and Surgery Center, Sahlgrenska University Hospital

location_facility: Department of Dermatology, Carol Davila University of Medicine and Pharmacy

location_facility: National Tumour Institute "Fondazione G. Pascale" Unit of Melanoma - Cancer Immunotherapy and Innovative therapy

location_facility: Dermatology Dept, Hospital University of Tours

location_facility: Department of Dermatology, Medical University of Vienna


title: Risk Factors and Treatment Options for Metachronic Brain Metastases After Esophagectomy for Esophageal Cancer: a Multicentric Retrospective Cohort Study (METABREC)

acronym: METABREC

summary:
Esophagectomy is the cornerstone of the curative treatment of esophageal carcinoma. Despite this treatment, patients can suffer from locoregional or distant metastatic disease and only a very selected group of patients can be cured: mostly those with recurrence in one single organ.

Brain metastases are rare after esophagectomy for cancer, but they have a serious impact on survival. Agressive treatment is often moren difficult for brain metastases compared to other metastases and some risk factors have been identified earlier.

There is an impression that the incidence of brain metastases in esophageal cancer patients has increased since the introduction of neoadjuvant treatment schemes. However, this is not clear yet. A potential explanation could be that chemotherapy disturbs the blood-brain-barrier, hereby facilitating the migration of tumor cells to the brain.

The purpose of this study is to retrospectively analyze the incidence and potential risk factors of brain metastases in patients who underwent esophagectomy for esophageal cancer. Patients treated between 2000 and 2019 will be included and outcome parameters are Odds Ratio for brain metastases (comparison between primary surgery and neoadjuvant treatment followed by surgery), time to recurrence and risk factors, number and characteristics of the brain metastases.

status: Recruiting

lead_sponsor: Universitaire Ziekenhuizen KU Leuven

location_country:
Ireland
Sweden
United States
France
Belgium
Netherlands

location_facility: Centre Hospitalier régional Universitaire de Lille


title: A Prospective Phase I/IIa, Open-label, Multicenter Trial to Evaluate the Safety and Efficacy of oNKord®, an Off-the-shelf, ex Vivo-cultured Allogeneic NK Cell Preparation, in Subjects With Acute Myeloid Leukemia Who Are in Morphologic Complete Remission With Measurable Residual Disease and Who Are Currently Not Proceeding to Allogeneic Hematopoietic Stem Cell Transplantation

lead_sponsor: Glycostem Therapeutics BV

location_country: Netherlands Switzerland France Belgium Germany

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: University Hospital Carl Gustav Carus Dresden

summary: WiNK is a Phase I/IIa trial to evaluate the safety and efficacy of oNKord® in 33 adults with acute myeloid leukemia (AML) who are in morphologic complete remission with residual measurable disease and who are currently not proceeding to allogeneic hematopoietic stem cell transplantation.


title: A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel With MORAb-004 in Metastatic Soft Tissue Sarcoma

acronym: SOURCE

summary: This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.

ReferenceCitation: Jones RL, Chawla SP, Attia S, Schöffski P, Gelderblom H, Chmielowski B, Le Cesne A, Van Tine BA, Trent JC, Patel S, Wagner AJ, Chugh R, Heyburn JW, Weil SC, Wang W, Viele K, Maki RG. A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb-004) in metastatic soft-tissue sarcomas. Cancer. 2019 Jul 15;125(14):2445-2454. doi: 10.1002/cncr.32084. Epub 2019 Apr 29.

lead_sponsor: Morphotek

location_country:
Italy
Australia
United States
France
Belgium
Netherlands

location_facility: The University of North Carolina at Chapel Hill

location_facility: Huntsman Cancer Institute at the University of Utah

location_facility: Sidney Kimmel Comprehensive Cancer Center at John Hopkins


title: A Twelve Week, Multicenter, Open Label Extension Study in Subjects With Schizophrenia

summary: This is a 12-week, multi-center, open-label extension study designed to evaluate the longer-term safety, tolerability and effectiveness of lurasidone for the treatment of subjects with schizophrenia.

lead_sponsor: Sunovion

location_country:
Serbia
Italy
Russian Federation
United States
France
South Africa
Slovakia

location_facility: St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)

location_facility: Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)

location_facility: California Neuropsychopharmacolgoy Clinical Research Insitute

location_facility: A.O.U. Santa Chiara, U.O di Psichiatria 1 building n.4

location_facility: Nemocnica s poliklinikou v Prievidzi so sidlom v Bojniciach, Psychiatricke oddelenie

location_facility: St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"

location_facility: Department of Psychiatry, University of Utah Health Sciences Center

location_facility: St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1

location_facility: Centre Hospitalier Spécialisé (CHS) du Jura - Centre Médico Psychiatrique (CMP)

location_facility: Specialized hospital for psychiatric diseases "Sveti Vracevi"

location_facility: Clinical Centre Kragujevac, Clinic for psychiatry

location_facility: Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'

location_facility: Neuropsychiatric Research Center of Orange County

location_facility: Research Unit, Department of Psychiatry Free State Psychiatric Complex

location_facility: Military Medical Academy, Clnic for Psychiatry

location_facility: Limited Liability Company (LLC) 'Research Center For Treatment and rehabilitation 'Phoenix'

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

location_facility: Clinical Centre Vojvodine, Clinic for Psychiatry

location_facility: Medical Research Group of Central Florida

location_facility: Clinical Centre Nis, Clinic for mental health protection

location_facility: PsychoLine s.r.o. Psychiatricka ambulancia


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

acronym: Unite-CNM

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

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

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

lead_sponsor: Dynacure

location_country:
Denmark
United Kingdom
Netherlands
France
Belgium
Germany

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

location_facility: Rigshospitalet, Copenhagen Neuromuscular Center, Neurocentret

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

location_facility: universitätsklinikum Essen, Kinderklinik I, Sozialpädiatrisches Zentrum


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

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

status: Active, not recruiting

time_perspective: Prospective

lead_sponsor: Straub Medical AG

location_country: Italy Estonia France Germany Czechia

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

location_facility: Kreiskrankenhaus Torgau "Johann Kentmann"

location_facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen

intervention_type: Device


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

acronym: RESPOND EDGE

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

lead_sponsor: Boston Scientific Corporation

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

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


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

acronym: NACASY

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

lead_sponsor: Kyowa Kirin Pharmaceutical Development Ltd

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

location_facility: Paul Papin à Angers et site René Gauducheau


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

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

ipd_sharing: Yes

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

lead_sponsor: Novo Nordisk A/S

location_country:
Serbia
United Kingdom
Austria
France
Turkey
Germany
Bulgaria


acronym: STRIVE-EU

title: Phase 3, Open-Label, Single-Arm, Single-Dose Gene Replacement Therapy Clinical Trial for Patients With Spinal Muscular Atrophy Type 1 With One or Two SMN2 Copies Delivering AVXS-101 by Intravenous Infusion

lead_sponsor: Novartis Gene Therapies

ReferenceCitation: Mercuri E, Muntoni F, Baranello G, Masson R, Boespflug-Tanguy O, Bruno C, Corti S, Daron A, Deconinck N, Servais L, Straub V, Ouyang H, Chand D, Tauscher-Wisniewski S, Mendonca N, Lavrov A; STR1VE-EU study group. Onasemnogene abeparvovec gene therapy for symptomatic infantile-onset spinal muscular atrophy type 1 (STR1VE-EU): an open-label, single-arm, multicentre, phase 3 trial. Lancet Neurol. 2021 Oct;20(10):832-841. doi: 10.1016/S1474-4422(21)00251-9.

ReferenceCitation: Day JW, Mendell JR, Mercuri E, Finkel RS, Strauss KA, Kleyn A, Tauscher-Wisniewski S, Tukov FF, Reyna SP, Chand DH. Clinical Trial and Postmarketing Safety of Onasemnogene Abeparvovec Therapy. Drug Saf. 2021 Oct;44(10):1109-1119. doi: 10.1007/s40264-021-01107-6. Epub 2021 Aug 12. Erratum in: Drug Saf. 2022 Feb;45(2):191-192.

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

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

location_country:
France
Italy
United Kingdom
Belgium

location_facility: University Hospital Ghent Neuromuscular reference center

location_facility: Great Ormond Street Hospital for Children

location_facility: The John Walton Muscular Dystrophy Research Centre MRC Centre for Neuromuscular Diseases at Newcastle

location_facility: Carlo Besta Neurological Research Institute

location_facility: Neuropédiatrie - Centre de Référence des Maladies Neuromusculaires

summary: Phase 3, open-label, single-arm, single-dose, trial of onasemnogene abeparvovec-xioi (gene replacement therapy) in patients with spinal muscular atrophy (SMA) Type 1 who meet enrollment criteria and are genetically defined by a biallelic pathogenic mutation of the survival motor neuron 1 gene (SMN1) with one or two copies of survival motor neuron 2 gene (SMN2). Up to 30 patients < 6 months (< 180 days) of age at the time of gene replacement therapy (Day 1) will be enrolled.


title: A Phase 3, Open-Label Study of ALXN1210 in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria (PNH)

lead_sponsor: Alexion Pharmaceuticals

publications_result: Kulagin A, Chonat S, Maschan A, Bartels M, Buechner J, Punzalan R, Richards M, Ogawa M, Hicks E, Yu J, Baruchel A, Kulasekararaj AG. Pharmacokinetics, pharmacodynamics, efficacy, and safety of ravulizumab in children and adolescents with paroxysmal nocturnal hemoglobinuria: interim analysis of a phase 3, open-label study. Presented at the European Hematology Association 2021 Virtual Congress, June 9-17, 2021.

location_country:
United Kingdom
Russian Federation
United States
France
Norway
Netherlands

summary: The purpose of this study was to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy of ravulizumab in pediatric participants with paroxysmal nocturnal hemoglobinuria (PNH).


title: An Open Label, 1-Year Trial, Including a Double-Blind Placebo-Controlled Withdrawal Period, of Setmelanotide (RM-493), a Melanocortin 4 Receptor (MC4R) Agonist, in Early Onset Leptin Receptor (LEPR) Deficiency Obesity Due to Bi-Allelic Loss-of-Function LEPR Genetic Mutation

lead_sponsor: Rhythm Pharmaceuticals, Inc.

ReferenceCitation: Clement K, van den Akker E, Argente J, Bahm A, Chung WK, Connors H, De Waele K, Farooqi IS, Gonneau-Lejeune J, Gordon G, Kohlsdorf K, Poitou C, Puder L, Swain J, Stewart M, Yuan G, Wabitsch M, Kuhnen P; Setmelanotide POMC and LEPR Phase 3 Trial Investigators. Efficacy and safety of setmelanotide, an MC4R agonist, in individuals with severe obesity due to LEPR or POMC deficiency: single-arm, open-label, multicentre, phase 3 trials. Lancet Diabetes Endocrinol. 2020 Dec;8(12):960-970. doi: 10.1016/S2213-8587(20)30364-8. Epub 2020 Oct 30.

location_country:
Réunion
United Kingdom
Netherlands
Canada
United States
France
Germany

location_facility: Institute of Cardiometabolism and Nutrition / Pitié-Salpêtrière Hospital

location_facility: University of Cambridge Metabolic Research Laboratories

summary: This study is assessing the effect of setmelanotide (RM-493) on weight and other factors in patients with Leptin Receptor (LEPR) deficiency obesity due to rare bi-allelic loss-of-function LEPR genetic mutation.


title: Endoscopic Management of Patients With T1bN0M0 Esophageal Adenocarcinoma: a Prospective Multicenter Registry.

summary: Aim of this prospective multicenter study is to evaluate the safety of an endoscopic follow-up strategy in patients treated with endoscopic resection (ER) for submucosal or high-risk mucosal esophageal adenocarcinoma (T1bN0M0 or HR T1aN0M0 EAC).

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

location_country:
United Kingdom
Australia
Netherlands
Switzerland
France
Belgium
Germany

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


title: An Observational Study Program to Investigate the Effectiveness of Intravitreal Aflibercept in Diabetic Macular Edema and/or Macular Edema Secondary to Retinal Vein Occlusion in a Real World Setting

acronym: AURIGA

summary:
AURIGA is designed to collect data from routine clinical practice on the effectiveness and utilization of intravitreal aflibercept in the treatment of visual impairment due to diabetic macular edema (DME) or macula edema secondary to retinal vein occlusion (RVO).

The primary objective of this observational study (OS) is to evaluate the effectiveness of intravitreal aflibercept in 4 cohorts (with/without prior treatment in DME or macular edema secondary to RVO) in each of the participating countries.

Additionally, utilization and treatment regimens in routine clinical practice will be described.

Health care resources and services as well as health out-comes related to vision loss will be evaluated based on information collected using the AURIGA patient questionnaires.

ipd_sharing: Undecided

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:
Kuwait
Taiwan
Saudi Arabia
Italy
Russian Federation
Lebanon
United Arab Emirates
France
China
Germany
Egypt


title: Post-Market Clinical Follow-up Study With the ASPIREX®S Endovascular System to Assess the Safety and Effectiveness in the Treatment of DVT Patients and Special Patient Groups

acronym: P-MAX

summary:
The ASPIREX®S Endovascular System is a rotating and aspirating catheter system. It is intended to be used for the percutaneous transluminal removal of fresh thrombotic or thromboembolic material from native blood vessels (or vessels fitted with stents, stent grafts or native or artificial bypasses) outside the cardiopulmonary, coronary and cerebral circulations.

CAPTUREX® , a catheter with a filter basket, is intended to be used for the filtering of emboli from blood vessels during potentially embolizing procedures on the patient.

ASPIREX®S and CAPTUREX® are CE-marked (Class III) medical devices. In this study the effectiveness and safety in the removal of thrombi in veins is assessed under real life setting.

location_country: Italy Austria Ireland France Germany

location_facility: Klinikum Arnsberg, Klinik für Angiologie

location_facility: Azienda Ospedaliera San Giovanni Addolorata

location_facility: Institut für Diagnostische und Interventionelle Radiologie, Universitätsklinik Rostock


acronym: ePHex

title: A Phase III Double-blind, Randomised Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria

lead_sponsor: OxThera

location_country:
Spain
United Kingdom
Tunisia
United States
France
Belgium
Germany

location_facility: Centre Hospitalier Universitaire de Liège

summary: This study will evaluate the efficacy and safety of OC5 in patients with PH.


title: Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation

acronym: READ-ASV

summary: Phase 1: The European ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in non-heart failure conditions. The purpose is to examine the effects of ASV on quality of life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient characteristics and to document adverse events related to therapy for a therapy safety analysis. A pilot phase will enrol at least 200 patients to test the feasibility of the registry. After the pilot phase will be completed and an intermediate data analysis had been performed, the registry will be expanded over several countries across Europe with the goal of enrolling up to 800 patients over a period of 5 years. Phase 2: The READ-ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in non-heart failure conditions. The purpose is to examine the effects of ASV on quality of life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient characteristics and to document adverse events related to therapy for a therapy safety analysis.

lead_sponsor: ResMed

location_country: Denmark Portugal Spain Switzerland France Germany

location_facility: Praxis für Pneumologie, Allergologie, Schlafmedizin Dr. med Christoph Stolpe

location_facility: Sjællands Universitetshospital/Zealand University Hospital Køge

location_facility: Klinik für Schlafmedizin Düsseldorf Grand Arc

location_facility: Centre d' investigation et de recherche sur le sommeil

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Klinik für Pneumologie, Schlaf- und Beatmungsmedizin


title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Polysomnography Study to Investigate Safety and Efficacy of the Rotigotine Transdermal Patch in Subjects With Restless Legs Syndrome and End-Stage Renal Disease Requiring Hemodialysis

summary:
This is a sleep laboratory study to evaluate the efficacy and safety of Rotigotine in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis.

The objectives are to demonstrate superiority of Rotigotine against Placebo as well as to investigate the effect of Rotigotine on quality of life and sleep.

lead_sponsor: UCB BIOSCIENCES GmbH

location_country:
Italy
Austria
Finland
United States
France
Germany


title: Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry

acronym: ANCHOR

summary:
The ANCHOR registry is a multi-center, post-market, non-interventional, non-randomized, prospective study.

Subjects must sign an ICF prior to obtaining any study specific information. Subjects are eligible to be consented up to 30 days post-procedure.

Enrolled subjects will be followed as per local 'standard of care' for up to 5 years post procedure. Study recommended follow-up is per SVS and ESVS guidance.

ReferenceCitation: Jordan WD Jr, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, Ouriel K, de Vries JP; Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry (ANCHOR) Workgroup Members. Results of the ANCHOR prospective, multicenter registry of EndoAnchors for type Ia endoleaks and endograft migration in patients with challenging anatomy. J Vasc Surg. 2014 Oct;60(4):885-92.e2. doi: 10.1016/j.jvs.2014.04.063. Epub 2014 Jul 31.

ReferenceCitation: Jordan WD Jr, Mehta M, Ouriel K, Arko FR, Varnagy D, Joye J, Moore WM Jr, de Vries JP. One-year results of the ANCHOR trial of EndoAnchors for the prevention and treatment of aortic neck complications after endovascular aneurysm repair. Vascular. 2016 Apr;24(2):177-86. doi: 10.1177/1708538115590727. Epub 2015 Jun 10.

ReferenceCitation: van Noort K, Vermeulen JJM, Goudeketting SR, Ouriel K, Jordan WD Jr, Panneton JM, Slump CH, de Vries JPM. Sustainability of Individual EndoAnchor Implants in Therapeutic Use to Treat Type Ia Endoleak After Endovascular Aneurysm Repair. J Endovasc Ther. 2019 Jun;26(3):369-377. doi: 10.1177/1526602819837753. Epub 2019 Mar 25.

ReferenceCitation: Arko FR 3rd, Stanley GA, Pearce BJ, Henretta JP, Fugate MW, Mehta M, Torsello G, Panneton JM, Garrett HE Jr. Endosuture aneurysm repair in patients treated with Endurant II/IIs in conjunction with Heli-FX EndoAnchor implants for short-neck abdominal aortic aneurysm. J Vasc Surg. 2019 Sep;70(3):732-740. doi: 10.1016/j.jvs.2018.11.033. Epub 2019 Mar 6.

ReferenceCitation: Muhs BE, Jordan W, Ouriel K, Rajaee S, de Vries JP. Matched cohort comparison of endovascular abdominal aortic aneurysm repair with and without EndoAnchors. J Vasc Surg. 2018 Jun;67(6):1699-1707. doi: 10.1016/j.jvs.2017.10.059. Epub 2017 Dec 18.

ReferenceCitation: Jordan WD Jr, de Vries JP, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, Henretta J. Midterm outcome of EndoAnchors for the prevention of endoleak and stent-graft migration in patients with challenging proximal aortic neck anatomy. J Endovasc Ther. 2015 Apr;22(2):163-70. doi: 10.1177/1526602815574685.

ReferenceCitation: Jordan WD Jr, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, de Vries JP; Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry ANCHOR; Aneurysm Treatment using the Heli-FX Aortic Securement System Global Registry ANCHOR. Outcome-based anatomic criteria for defining the hostile aortic neck. J Vasc Surg. 2015 Jun;61(6):1383-90.e1. doi: 10.1016/j.jvs.2014.12.063. Epub 2015 Feb 28.

ReferenceCitation: de Vries JP, Ouriel K, Mehta M, Varnagy D, Moore WM Jr, Arko FR, Joye J, Jordan WD Jr; Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry ANCHOR Trial. Analysis of EndoAnchors for endovascular aneurysm repair by indications for use. J Vasc Surg. 2014 Dec;60(6):1460-7.e1. doi: 10.1016/j.jvs.2014.08.089. Epub 2014 Oct 3.

lead_sponsor: Medtronic Cardiovascular

location_country:
Spain
Italy
Austria
Australia
Netherlands
New Zealand
United Kingdom
Switzerland
Sweden
United States
France
Germany
Slovakia

location_facility: University of California Irvine Medical Center

location_facility: Medical University of South Carolina (MUSC)

location_facility: Unihospital San Giovanni di Dio Ruggi d'Aragona

location_facility: A.ö. Landeskrankenhaus - Universitätskliniken Innsbruck

location_facility: Washington University School of Medicine, Barnes Jewish West County Hospital

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: New York University Langone Medical Center

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

location_facility: MedStar Georgetown University Hospital Vascular Surgery Dept.

location_facility: University of North Carolina (UNC) Memorial Hospital

location_facility: Kaiser Permanente Moanalua Medical Center and Clinic

location_facility: Allgemeines Krankenhaus - Universitätskliniken Wien

location_facility: The Royal Liverpool and NHS Broadgreen University Hospitals - Royal Liverpool University Hospital

location_facility: Narodny ustav srdcovych a cievnych chorob

location_facility: Harborview Medical Center, University of Washington

location_facility: John L McClellan Memorial Veterans Hospital

location_facility: Hospital Clínico Universitario de Valladolid


acronym: STEM

title: STEM: A Multicentre Phase 2 Study of SFX-01 Treatment and Evaluation in Patients With Estrogen Receptor (ER) Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer Progressing on Either an Aromatase Inhibitor (AI) or Tamoxifen or Fulvestrant

lead_sponsor: Evgen Pharma

location_country:
United Kingdom
France
Spain
Belgium

location_facility: Grand Hopital de Charleroi, Service D'Oncologie-Hematologie

location_facility: Royal Bournemouth & Christchurch Hospitals NHS

location_facility: University Hospitals Birmingham NHS Foundation

summary:
This is a Phase 2 study to demonstrate the safety and efficacy of SFX-01 when used in combination with aromatase inhibitors (AIs), tamoxifen and fulvestrant.

Patients will be enrolled into one of three study arms (SFX-01 in combination with AI, tamoxifen or fulvestrant) based on their current therapy.


title: Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases: Case-control

acronym: PRECISESADST

summary: Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known today are a group of chronic inflammatory conditions with autoimmune aetiology with few treatment options and difficult diagnosis.Brest team contribute to perform a new classification of the following systemic autoimmune diseases in a European Union's Seventh Framework Programme. The aim of this research is to constitute a Healthy Volunteers cohort to compare with systemic autoimmune diseases cohort into molecular clusters instead of clinical entities through the determination of molecular profiles using several "Omics" techniques.

lead_sponsor: Fundación Pública Andaluza Progreso y Salud

location_country: Portugal Spain Italy Austria Switzerland Hungary France Belgium Germany

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico (IRCCS)

location_facility: Deutsches Rheuma-Forschungszentrum Berlin (DRFZ)

location_facility: Hospital Universitario San Cecilio Servicio Andaluz de Salud

location_facility: Hospital Clinic I Provicia- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)

location_facility: Hospital Regional de Málaga Servicio Andaluz de Salud

location_facility: Hospital Universitario Marqués de Valdecilla, Servicio Cántabro de Salud

location_facility: Biobanco del Sistema Sanitario Público de Andalucía (SSPA)

location_facility: Hospital Universitario Reina Sofía Andaluz de Salud

location_facility: UZ Leuven - KU Leuven, Department of Rheumatology (KU LEUVEN)


title: Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases: Inception Cohort

acronym: PRECISESADSI

summary: Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known today are a group of chronic inflammatory conditions with autoimmune aetiology with few treatment options and difficult diagnosis.Brest team contribute to performe a new classification of the following systemic autoimmune diseases in a European Union's Seventh Framework Programme. The aim of this research consiteis to reclassify the individuals affected by SADs into molecular clusters instead of clinical entities through the determination of molecular profiles using several "Omics" techniques.

location_country: Spain Italy Switzerland France Belgium Germany

location_facility: Hospitaux Universitaires de Géneve (UNIGE)

location_facility: Université catholique de Louvain - Cliniques Universitaires Saint-Luc (UCL)


title: Prospective Multi-Center, Single Arm Study of the Shockwave Coronary Rx Lithoplasty® System in Coronary Arteries

summary: Prospective, multi-center, single arm study designed to evaluate the safety and performance of the Shockwave Coronary Rx Lithoplasty® System to treat calcified lesions in the coronary arteries for the purpose of enhancing the placement of stents and reducing the ultimate residual stenosis. Patients will be followed through discharge and at 30 and 180 days.

ReferenceCitation: Kereiakes DJ, Di Mario C, Riley RF, Fajadet J, Shlofmitz RA, Saito S, Ali ZA, Klein AJ, Price MJ, Hill JM, Stone GW. Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1337-1348. doi: 10.1016/j.jcin.2021.04.015. Epub 2021 May 3.

ReferenceCitation: Brinton TJ, Ali ZA, Hill JM, Meredith IT, Maehara A, Illindala U, Lansky A, Götberg M, Van Mieghem NM, Whitbourn R, Fajadet J, Di Mario C. Feasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of Calcified Coronary Stenoses. Circulation. 2019 Feb 5;139(6):834-836. doi: 10.1161/CIRCULATIONAHA.118.036531.

lead_sponsor: Shockwave Medical, Inc.

location_country:
United Kingdom
Australia
Sweden
France
Netherlands

location_facility:
St. Vincent's Hospital
Skane University Hospital- Lund
Royal Brompton Hospital
Monash Heart, Monash Health
Thoraxcenter, Erasmus MC
King's College Hospital
Clinic Pastuer


title: Transarterial Chemoembolization With Drug-Eluting Beads (Standard Arm) Versus Stereotactic Body Radiation Therapy (Experimental Arm) for Hepatocellular Carcinoma: A Multicenter Randomized Phase II Trial

acronym: TRENDY

summary:
Rationale:

This study will compare head to head in patients with hepatocellular carcinoma (HCC) ineligible for surgery or radiofrequency ablation, the standard treatment arm, transarterial chemoembolization with drug-eluting beads (TACE-DEB), with the experimental arm, stereotactic body radiation therapy (SBRT). The investigators hypothesis is that the time to progression is more favorable after SBRT than after TACE-DEB. The expected time to include the required patients for this trial will be four years.

To the best of the investigators knowledge this study will be the first in the world that will compare both techniques in a randomized trial.

Objective:

To assess the time to progression after TACE-DEB and after SBRT in a comparable population of patients diagnosed with HCC.

Study design:

Randomized, prospective, open-label, and phase II study.

Study population:

Patients diagnosed with HCC, Child-Pugh grade A, one to three tumors, cumulative diameter ≤ 6cm, and ≥ 18 years old.

Intervention:

Patients with HCC will be randomized to receive the standard treatment, TACE-DEB loaded with doxorubicin or the experimental arm, SBRT.

Main study parameters/endpoints:

The primary endpoint of this study will be time to progression, defined as time from randomization to radiological progression.

Secondary endpoints will be:

Time to local recurrence
Response rate (complete and partial response)
Overall survival
Toxicity
Quality of life.

lead_sponsor: Erasmus Medical Center

location_country: Netherlands France Belgium

location_facility:
UH Lille
Maastro
UMC Maastricht
UMC Utrecht
UH Leuven
AMC
UMC St Radboud
VU MC
LUMC
Erasmus MC
UH Antwerp


title: The EUROSCA Natural History Study

acronym: EUROSCA-NHS

summary: The key goals of EUROSCA-NHS is to determine and compare the rate of disease progression in SCA1, SCA2, SCA3 and SCA6 including determination of the order and occurrence of non-ataxia symptoms, assessment of activities of daily living (ADL) and quality of life (QoL), and identification of predictors of disease progression and survival.

ReferenceCitation: Diallo A, Jacobi H, Cook A, Labrum R, Durr A, Brice A, Charles P, Marelli C, Mariotti C, Nanetti L, Panzeri M, Rakowicz M, Sobanska A, Sulek A, Schmitz-Hübsch T, Schöls L, Hengel H, Melegh B, Filla A, Antenora A, Infante J, Berciano J, van de Warrenburg BP, Timmann D, Boesch S, Pandolfo M, Schulz JB, Bauer P, Giunti P, Kang JS, Klockgether T, Tezenas du Montcel S. Survival in patients with spinocerebellar ataxia types 1, 2, 3, and 6 (EUROSCA): a longitudinal cohort study. Lancet Neurol. 2018 Apr;17(4):327-334. doi: 10.1016/S1474-4422(18)30042-5. Epub 2018 Mar 13.

ReferenceCitation: Jacobi H, du Montcel ST, Bauer P, Giunti P, Cook A, Labrum R, Parkinson MH, Durr A, Brice A, Charles P, Marelli C, Mariotti C, Nanetti L, Panzeri M, Rakowicz M, Sulek A, Sobanska A, Schmitz-Hübsch T, Schöls L, Hengel H, Baliko L, Melegh B, Filla A, Antenora A, Infante J, Berciano J, van de Warrenburg BP, Timmann D, Szymanski S, Boesch S, Kang JS, Pandolfo M, Schulz JB, Molho S, Diallo A, Klockgether T. Long-term disease progression in spinocerebellar ataxia types 1, 2, 3, and 6: a longitudinal cohort study. Lancet Neurol. 2015 Nov;14(11):1101-8. doi: 10.1016/S1474-4422(15)00202-1. Epub 2015 Sep 13.

lead_sponsor: Ataxia Study Group

location_country:
Poland
Spain
Italy
Austria
Netherlands
United Kingdom
Hungary
France
Belgium
Germany

location_facility: Department of Neurology, University of Frankfurt

location_facility: Department of Neurology, University of Bonn

location_facility: Université Libre de Bruxelles (ULB), Neurology Service - ULB Hôpital Erasme, ULB Laboratory of Experimental Neurology

location_facility: Department of Neuroscience, Federico II University Naples

location_facility: University Hospital Marqués de Valdecilla (IDIVAL), University of Cantabria

location_facility: Radboud University Medical Center, Department of Neurology, Donders Institute for Brain, Cognition, and Behaviour

location_facility: Fondazione-IRCCS Istituto Neurologico Carlo Besta

location_facility: Department of Neurodegeneration and Hertie-Institute for Clinical Brain Research, University of Tübingen

location_facility: Department of Neurology, St. Josef Hospital, University Hospital of Bochum

location_facility: Department of Neurology, University Clinic Essen, University of Duisburg-Essen

location_facility: Department of Medical Genetics, University of Pecs

location_facility: Department of Neurology, Medical University, Innsbruck

location_facility: Department of Neurology, Zala County Hospital

location_facility: Hôpital de la Pitié-Salpêtrière, Département de Génétique


title: PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions - Small Vessel Sub-trial

acronym: PLATINUM SV

summary: The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions. The lesions can be located in vessels that are smaller than average-sized.

ReferenceCitation: Kelly CR, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Rabinowitz A, Carrié D, Pompili V, Bouchard A, Saito S, Allocco DJ, Dawkins KD, Stone GW. Long-Term Safety and Efficacy of Platinum Chromium Everolimus-Eluting Stents in Coronary Artery Disease: 5-Year Results From the PLATINUM Trial. JACC Cardiovasc Interv. 2017 Dec 11;10(23):2392-2400. doi: 10.1016/j.jcin.2017.06.070.

ReferenceCitation: Teirstein PS, Meredith IT, Feldman RL, Rabinowitz AC, Cannon LA, Lee TC, Dens J, Dubois CL, Mooney MR, Pompili VJ, Saito S, Allocco DJ, Dawkins KD, Stone GW. Two-year safety and effectiveness of the platinum chromium everolimus-eluting stent for the treatment of small vessels and longer lesions. Catheter Cardiovasc Interv. 2015 Feb 1;85(2):207-15. doi: 10.1002/ccd.25565. Epub 2014 Jul 4.

ipd_sharing_description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).

lead_sponsor: Boston Scientific Corporation

location_country:
Australia
New Zealand
United States
France
Belgium
Japan

location_facility: Oklahoma Foundation for Cardiovascular Research

location_facility: Ohio Health Research and Innovation Institute

location_facility: Lindner Center for Research and Education at The Christ Hospital

location_facility: Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation

location_facility: Mediquest Research at Munroe Regional Medical Center


title: A Long-term, Multicenter, Open-Label, Flexible Dose Continuation Study in Subjects Who Have Completed a Prior Lurasidone Study

summary: This is an open-label continuation study designed to monitor the safety, tolerability and effectiveness of lurasidone in subjects who have completed participation in a lurasidone extension study (NCT00868959 and NCT01566162) and who may benefit from continued treatment with lurasidone.

lead_sponsor: Sunovion

location_country:
Romania
Serbia
Russian Federation
Canada
Czech Republic
Lithuania
Ukraine
France
India
South Africa
Colombia
Slovakia

location_facility: Dnipropetrovsk Regional Clinical Hospital named Mechnikov

location_facility: St. Petersburg State Government Healthcare Institution "City Psychiatric Hospital #4" (St. Petersburg Insane Asylum Distributor)

location_facility: Crimean republican Clinical Psychiatric Hospital

location_facility: Hôpital Chalucet, Centre hospitalier intercommunal de Toulon la Seyne sur mer (CHITS)

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

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

location_facility: Brij Psychiatry Hospital & Muskaan Research Centre

location_facility: St. Petersburg State Healthcare Institution (SPbSHI) "City Psychiatric Hospital #6"

location_facility: Seskines Outpatient Clinic, Public Institution

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

location_facility: St. Petersburg State Budgetary Healthcare Institution 'City Psychoneurology Dispensary #7 (with In-Patient Department)', (SPb SBHI "CPNDD-7"), at Daycare Facility #1

location_facility: Spitalul Clinic de Neuropsihiatrie Craiova

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA Investigations

location_facility: Regional Clinical Psychiatric Hospital, Dept #11

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

location_facility: Mental Health Treatment Rehabililitation Foundation Dept. of Psychiatry

location_facility: Vijayawada Institute of Mental Health and Neurosciences

location_facility: Spitalul Clinic Judetean de Urgenta Cluj

location_facility: Regional Government Institution (RGI) 'Lipetsk Regional Psychoneurology Hospital'

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

location_facility: Institute of Neurology, Psychiatry and Narcology, NAMS of Ukraine

location_facility: Clinical Centre Nis, Clinic for mental health protection

location_facility: Brain Mind Behavior Neuroscience Research Institute

location_facility: PsychoLine s.r.o. Psychiatricka ambulancia


title: A Phase 1 Study of CC-486 as a Single Agent and in Combination With Carboplatin or ABI-007 in Subjects With Relapsed or Refractory Solid Tumors

summary: The purpose of the study is to evaluate the safety and to define the Maximal Tolerated Dose (MTD) or the Maximal Administered Dose (MAD) of oral azacitidine as a single agent and in combination with carboplatin (CBDCA) or paclitaxel protein bound particles (ABI-007,ABX) in subjects with relapsed or refractory solid tumors.

ReferenceCitation: LoRusso P, et al. A Phase Ib study of CC-486 (Oral Azacitidine) as a priming agent for carboplatin or NAB-paclitaxel in subjects with relapsed and refractory solid tumors . Presented at 25th AACR-NCI-EORTC Symposium on Molecular Targets and Cancer Therapeutics, October 19-23, 2013, Boston, MA. Abstract No. A120.

lead_sponsor: Celgene

location_country:
Netherlands
United States
Spain
France

location_facility: Scottsdale Healthcare Research Institute

location_facility: South Texas Accelerated Research Therapeutics

location_facility: The Netherlands Cancer Instiute Antoni Van Leeuwenhoekziekenhuis

location_facility: Hospital General Universitario Gregorio Maranon


title: Observational Study on the Incidence of NSF in Renal Impaired Patients Following Dotarem Administration

acronym: NSsaFe

summary: The main purpose of this study is to prospectively estimate the incidence of Nephrogenic Systemic Fibrosis (NSF) in patients with moderate to severe renal impairment after administration of Dotarem®

lead_sponsor: Guerbet

location_country:
Belgium
Spain
Italy
United Kingdom
Argentina
Korea, Republic of
United States
France
Turkey
Colombia
Germany

location_facility: IATM (Instituto de alta tecnologia Medica de Antoquia)

location_facility: Medeniyet University Goztepe Research and Training Hospital

location_facility: CRC Hospital Universitari Sant Joan de Reus

location_facility: Institute of Radiology and Neuroradiology

location_facility: University of Texas Health Science Center

location_facility: University Hospital of North Staffodshire


title: Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Lower Limb

acronym: PLUS

summary: The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.

lead_sponsor: Merz Pharmaceuticals GmbH

location_country:
Poland
Spain
Italy
Russian Federation
Canada
Czech Republic
United States
France
Germany

location_facility:
Merz Investigational Site #034027
Merz Investigational Site #049072
Merz Investigational Site #049022
Merz Investigational Site #048056
Merz Investigational Site #049303
Merz Investigational Site #001244
Merz Investigational Site #001208
Merz Investigational Site #048023
Merz Investigational Site #420024
Merz Investigational Site #034030
Merz Investigational Site #048022
Merz Investigational Site #039006
Merz Investigational Site #039012
Merz Investigational Site #048055
Merz Investigational Site #048053
Merz Investigational Site #420047
Merz Investigational Site #001206
Merz Investigational Site #048080
Merz Investigational Site #048044
Merz Investigational Site #048057
Merz Investigational Site #049304
Merz Investigational Site #049079
Merz Investigational Site #048054
Merz Investigational Site #034026
Merz Investigational Site #007011
Investigational site #001188
Merz Investigational Site #049148
Merz Investigational Site #001207
Merz Investigational Site #001210
Merz Investigational Site #001183
Merz Investigational Site #048081
Merz Investigational Site #007009
Merz Investigational Site #007010
Merz Investigational Site #420031
Merz Investigational Site #033018
Merz Investigational Site #001184
Merz Investigational Site #049302
Merz Investigational Site #420030
Merz Investigational Site #034028
Merz Investigational Site #001202
Merz Investigational Site #001009
Merz Investigational Site #048033
Merz Investigational Site #048031
Merz Investigational Site #049071
Merz Investigational Site #033024
Merz Investigational Site #001204
Merz Investigational Site #007012
Merz Investigational Site #039011
Merz Investigational Site #034029
Merz Investigational Site #001209
Merz Investigational Site # 001110
Merz Investigational Site #001198
Merz Investigational Site #048051


title: GAPP 1 Survey: Global Attitudes of Patients and Physicians in Insulin Therapy for Diabetes Mellitus

summary: This study is conducted in Asia, Europe and in the United States of America. The aim of this study is to examine patient and physician beliefs regarding insulin therapy and the degree to which patients adhere to their insulin regimens.

time_perspective: Cross-Sectional

ReferenceCitation: Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM. Insulin adherence behaviours and barriers in the multinational Global Attitudes of Patients and Physicians in Insulin Therapy study. Diabet Med. 2012 May;29(5):682-9. doi: 10.1111/j.1464-5491.2012.03605.x.

lead_sponsor: Novo Nordisk A/S

location_country:
Spain
United Kingdom
Russian Federation
India
United States
China
France
Turkey
Japan
Germany

intervention_type: Behavioral


title: A Phase 1b/2 Randomized Study of MEDI-573 in Combination With an Aromatase Inhibitor (AI) Versus AI Alone in Women With Metastatic Breast Cancer (MBC)

summary: Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative MBC.

lead_sponsor: MedImmune LLC

location_country:
Poland
Spain
United Kingdom
Canada
Hungary
United States
France
Israel
Belgium
Bahamas
Germany


title: Safety and Tolerability of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Extension Study to Study 3104001

summary: The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with castrate resistant prostate cancer.

ReferenceCitation: Shore ND, Tammela TL, Massard C, Bono P, Aspegren J, Mustonen M, Fizazi K. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naïve and CYP17 Inhibitor-naïve Patients: Follow-up from the ARADES and ARAFOR Trials. Eur Urol Focus. 2018 Jul;4(4):547-553. doi: 10.1016/j.euf.2017.01.015. Epub 2017 Feb 14.

ReferenceCitation: Fizazi K, Massard C, Bono P, Kataja V, James N, Tammela TL, Joensuu H, Aspegren J, Mustonen M. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Castration-resistant, CYP17 Inhibitor-naïve Prostate Cancer: Results from Extended Follow-up of the ARADES Trial. Eur Urol Focus. 2017 Dec;3(6):606-614. doi: 10.1016/j.euf.2017.01.010. Epub 2017 Feb 27.

ReferenceCitation: Fizazi K, Massard C, Bono P, Jones R, Kataja V, James N, Garcia JA, Protheroe A, Tammela TL, Elliott T, Mattila L, Aspegren J, Vuorela A, Langmuir P, Mustonen M; ARADES study group. Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial. Lancet Oncol. 2014 Aug;15(9):975-85. doi: 10.1016/S1470-2045(14)70240-2. Epub 2014 Jun 25.

lead_sponsor: Orion Corporation, Orion Pharma

location_country:
United Kingdom
Estonia
Finland
Czech Republic
United States
France

location_facility: Klinika onkologie a radioterapie LFUK a FN

location_facility: Eastern CT Hematology and Oncology Associates


title: A Prospective, Global Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the LUTONIX Drug Coated PTA Dilatation Catheter

summary: The registry will enroll patients with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects will be treated with the LUTONIX Drug Coated PTA Dilatation Catheter carrying the CE Mark per current Instructions for Use(IFU) and followed clinically for a minimum of 2 years.

ReferenceCitation: Thieme M, Von Bilderling P, Paetzel C, Karnabatidis D, Perez Delgado J, Lichtenberg M; Lutonix Global SFA Registry Investigators. The 24-Month Results of the Lutonix Global SFA Registry: Worldwide Experience With Lutonix Drug-Coated Balloon. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1682-1690. doi: 10.1016/j.jcin.2017.04.041. Epub 2017 Aug 2.

lead_sponsor: C. R. Bard

location_country:
Poland
Spain
Greece
Austria
Italy
United Kingdom
Switzerland
France
Belgium
Germany

location_facility: Azienda Ospedaliera della Valtellina e dalla Valchiavenna

location_facility: Szpital Kliniczny Przemienienia Panskiego


title: A Prospective, Randomized, Double-Blind Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus in Adult Patients With Type 2 Diabetes Mellitus: The ELEMENT 2 Study

acronym: ELEMENT 2

summary: The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus in controlling blood sugar levels in combination with two or more oral diabetes medications.

ReferenceCitation: Nishiyama H, Shingaki T, Suzuki Y, Ilag LL. Similar Intrapatient Blood Glucose Variability with LY2963016 and Lantus(®) Insulin Glargine in Patients with Type 1 (T1D) or Type 2 Diabetes, Including a Japanese T1D Subpopulation. Diabetes Ther. 2018 Aug;9(4):1469-1476. doi: 10.1007/s13300-018-0450-0. Epub 2018 May 31.

ReferenceCitation: Pollom RK, Costigan T, Lacaya LB, Ilag LL, Hollander PA. Similar Efficacy and Safety of Basaglar(®) and Lantus(®) in Patients with Type 2 Diabetes in Age Groups (< 65 Years, ≥ 65 Years): A Post Hoc Analysis from the ELEMENT-2 Study. Diabetes Ther. 2018 Apr;9(2):827-837. doi: 10.1007/s13300-018-0405-5. Epub 2018 Mar 14.

lead_sponsor: Eli Lilly and Company

location_country:
Poland
Taiwan
Spain
Greece
Czech Republic
Hungary
Korea, Republic of
United States
France
Puerto Rico
Mexico
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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: AN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1-3338-WW(B1801014)

lead_sponsor: Pfizer

ReferenceCitation: Foeldvari I, Constantin T, Vojinović J, Horneff G, Chasnyk V, Dehoorne J, Panaviene V, Sušić G, Stanevicha V, Kobusinska K, Zuber Z, Dobrzyniecka B, Nikishina I, Bader-Meunier B, Breda L, Doležalová P, Job-Deslandre C, Rumba-Rozenfelde I, Wulffraat N, Pedersen RD, Bukowski JF, Vlahos B, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial. Arthritis Res Ther. 2019 May 23;21(1):125. doi: 10.1186/s13075-019-1916-9.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Poland
Belgium
Serbia
Slovenia
Italy
Latvia
Australia
Mexico
Lithuania
Netherlands
Russian Federation
Spain
Hungary
France
Colombia
Norway
Germany
Slovakia
Czechia

location_facility: University Medical Centre Ljubljana, University Children's Hospital

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Klinika detskeho a dorostoveho lekarstvi 1. LF UK a VFN v Praze

location_facility: FGBNU Research Institute of Rheumatology n.a. V.A. Nasonovoy

location_facility: Instytut Reumatologii im. prof. dr hab. med. Eleonory Reicher, Klinika i

location_facility: Centro di Ricerca Clinica - Fondazione dell'Universita' degli Studi "G. D'Annunzio"

location_facility: Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie,

location_facility: Szpital Specjalistyczny im. A. Falkiewicza we Wroclawiu, Oddzial Pediatryczno - Reumatologiczny

location_facility: Children's Hospital at Vilnius University Hospital "Santaros klinikos"

location_facility: Fakultni nemocnice Brno - Detska nemocnice, Ambulance detske revmatologie

location_facility: Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego

location_facility: Asklepios Klinik Sankt Augustin GmbH, Zentrum fuer Kinder- und Jugendrheumatologie

location_facility: SBEI HPE Saint Petersburg State Pediatric Medical University

location_facility: Universitair Ziekenhuis Utrecht, Wilhelmina Kinderziekenhuis, Room number KC 03-063

summary: This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3 subtypes of Juvenile Idiopathic Arthritis (JIA) [extended oligoarticular JIA, enthestitis related arthritis (ERA), or psoriatic arthritis (PsA)] who have completed approximately 96 weeks of participation in study 0881A1-3338 (B1801014). The study contains an active treatment period, withdrawal/re-treatment period and a observational period (non-treatment).


title: Treatment of Patients With Posttransplant Lymphoproliferative Disorder (PTLD) With a Sequential Treatment Consisting of Anti-CD20 Antibody Rituximab and CHOP+GCSF Chemotherapy (PTLD-1/3)

summary: This phase-II trial will investigate the efficacy, safety and the tolerability of a sequential therapy consisting of 4 courses of single agent rituximab followed by 4 courses of R-CHOP chemotherapy in patients with CD20+ posttransplant lymphoproliferative disorders (PTLD). However, responders to rituximab achieving a CR after the first 4 applications of rituximab will go on with rituximab monotherapy and will not receive chemotherapy.

ReferenceCitation: Trappe RU, Dierickx D, Zimmermann H, Morschhauser F, Mollee P, Zaucha JM, Dreyling MH, Dührsen U, Reinke P, Verhoef G, Subklewe M, Hüttmann A, Tousseyn T, Salles G, Kliem V, Hauser IA, Tarella C, Van Den Neste E, Gheysens O, Anagnostopoulos I, Leblond V, Riess H, Choquet S. Response to Rituximab Induction Is a Predictive Marker in B-Cell Post-Transplant Lymphoproliferative Disorder and Allows Successful Stratification Into Rituximab or R-CHOP Consolidation in an International, Prospective, Multicenter Phase II Trial. J Clin Oncol. 2017 Feb 10;35(5):536-543. doi: 10.1200/JCO.2016.69.3564. Epub 2016 Dec 19.

lead_sponsor: Charite University, Berlin, Germany

location_country: Poland Italy Australia Sweden France Belgium Germany

location_facility: Div. Universitaria Ematologia e Terapie Cellulari, University of Torino

location_facility: Zakład Propedeutyki Onkologii, Gdańskiego Uniwersytetu Medycznego

location_facility: Hôpital Pitié-Salpétrière, Department of Hematology, 47-83 Boulevard de l'Hopital

location_facility: Princess Alexandra Hospital, Ipswich Rd, Woolloongabba, Qld 4102

location_facility: Sahlgrens hospital, Department of Hematology

location_facility: Catholic University of Leuven, Department of Hematology

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Department of Hematology and Oncology, Augustenburger Platz 1


title: Evaluation of the Safety and Effectiveness Performance of the Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissection Involving the Descending Thoracic Aorta

summary: The purpose of this study is to evaluate the safety and effectiveness performance of the Zenith® Dissection Endovascular System in the treatment of aortic dissections involving the descending thoracic aorta.

primary_purpose: Device Feasibility

ReferenceCitation: Lombardi JV, Cambria RP, Nienaber CA, Chiesa R, Mossop P, Haulon S, Zhou Q; STABLE I Investigators. Five-year results from the Study of Thoracic Aortic Type B Dissection Using Endoluminal Repair (STABLE I) study of endovascular treatment of complicated type B aortic dissection using a composite device design. J Vasc Surg. 2019 Oct;70(4):1072-1081.e2. doi: 10.1016/j.jvs.2019.01.089. Epub 2019 May 28.

lead_sponsor: William Cook Europe

location_country:
Italy
Australia
Czech Republic
France
Germany

location_facility: Clinic of Internal Medicine, University Hospital Rostock