title: Double Blind Placebo Controlled Dose Ranging Study of the Efficacy and Safety of SSR149744C 300 or 600 mg for the Conversion of Atrial Fibrillation / Flutter

acronym: CORYFEE

summary: Double blind study to assess versus placebo the efficacy of SSR149744C for the conversion of atrial fibrillation/flutter to sinus rhythm at the time of the planned electrical cardioversion.

ReferenceCitation: Khitri AR, Aliot EM, Capucci A, Connolly SJ, Crijns H, Hohnloser SH, Kulakowski P, Roy D, Radzik D, Kowey PR. Celivarone for maintenance of sinus rhythm and conversion of atrial fibrillation/flutter. J Cardiovasc Electrophysiol. 2012 May;23(5):462-72. doi: 10.1111/j.1540-8167.2011.02234.x. Epub 2011 Dec 15.

location_country:
Germany
Italy
Portugal
Hungary
Netherlands
United States
Canada
Czech Republic
France


acronym: WE

intervention_type: Drug

lead_sponsor: St. Olavs Hospital

summary: In Norway, about 60% of all children with cerebral palsy (CP) are being treated with botulinum toxin A (BoNT-A) at 6 years of age, mainly in the legs. Despite this widespread use of the drug, the evidence for a positive effect on walking is insufficient. Moreover, large variation in effect is seen by clinicians. The main objective of the present study is to investigate whether injections with BoNT-A in the calf muscles make walking easier in children with spastic CP within 6 months, reflected by reduced energy cost during walking.

ReferenceType: background

ReferenceCitation: Braendvik SM, Roeleveld K, Andersen GL, Raftemo AE, Ramstad K, Majkic-Tajsic J, Lamvik T, Lund B, Follestad T, Vik T. The WE-Study: does botulinum toxin A make walking easier in children with cerebral palsy?: Study protocol for a randomized controlled trial. Trials. 2017 Feb 6;18(1):58. doi: 10.1186/s13063-016-1772-8.

sponsor_collaborators: Norwegian University of Science and Technology

sponsor_collaborators: Mazowieckie Centrum Neuropsychiatrii, Warszawa

location_facility: Department of Orthopaedic Surgery, St. Olavs University Hospital

location_facility: Mazowieckie Centrum Neuropsychiatrii, Zagorze

status: Completed

title: Does Botulinum Toxin A Make Walking Easier in Children With Cerebral Palsy?

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country: Poland Norway France

study_type: Interventional

lead_sponsor_type: academique

status_simplified: Completed


title: Open Non-randomized Clinical Investigation to Evaluate the Safety and Effectiveness of the Nerve Capping Device to Prevent Neuroma Formation After Traumatic Nerve Section

summary: This study is conducted to clinically assess safety and performance of the Polyganics nerve capping device for the treatment of symptomatic neuroma. There is sufficient clinical experience with regard to the safety of the commercially available nerve guide, NEUROLAC®. This new nerve capping device is identical in material and manufacturing. The exception is in design, where NEUROLAC® has two open ends, the nerve capping device has one closed (sealed) end. This study will be conducted to obtain data on the clinical performance of the capping device's ability to isolate the nerve end, resulting in a reduction of pain of experienced from the symptomatic neuroma and prevention of the reoccurrence of a symptomatic neuroma.

study_start_date_type: Actual

ipd_sharing: Undecided

lead_sponsor: Polyganics BV

location_country: Netherlands France

location_facility:
UMCG
Albert Schweitzer Hospital
Martini Hospital Groningen
MC Groep
MUMC
Strasbourg University Hospitals
Haga Hospital

intervention_type: Device

lead_sponsor_type: industriel


title: Safety and Efficacy of Aliskiren When Added to Standardized Losartan and Optimal Antihypertensive Therapy in Patients With Hypertension, Type 2 Diabetes and Proteinuria

summary: Study of the efficacy and safety of aliskiren when added to losartan and optimal antihypertensive therapy in patients with hypertension, type 2 diabetes, and kidney disorders to monitor improvement in any of these conditions.

primary_purpose: Other

ReferenceType: derived

ReferenceCitation: Persson F, Lewis JB, Lewis EJ, Rossing P, Hollenberg NK, Parving HH; AVOID Study Investigators. Impact of baseline renal function on the efficacy and safety of aliskiren added to losartan in patients with type 2 diabetes and nephropathy. Diabetes Care. 2010 Nov;33(11):2304-9. doi: 10.2337/dc10-0833. Epub 2010 Aug 6.

ReferenceCitation: Parving HH, Persson F, Lewis JB, Lewis EJ, Hollenberg NK; AVOID Study Investigators. Aliskiren combined with losartan in type 2 diabetes and nephropathy. N Engl J Med. 2008 Jun 5;358(23):2433-46. doi: 10.1056/NEJMoa0708379.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
United Kingdom
Denmark
Romania
Netherlands
United States
Spain
Greece
Canada
Russian Federation
France

location_facility:
Novartis Pharmaceuticals
Investigative Site


title: A Phase II Efficacy And Safety Study Intravenous Edotecarin In Patients With Advanced Gastric Cancer That Has Progressed Or Recurred After Prior Fluropyrimidine-Based Chemotherapy

summary: This will be an international, multicenter, uncontrolled, 2-stage, phase II study in adult patients with advanced gastric cancer, reasonable performance status, good organ function, lack of serious concomitant medical conditions. Patients must have progressed or recurred after a fluoropyrimidine-containing regimen at anytime for primary metastatic disease or within 6 months of last dose of adjuvant therapy. Twenty-one evaluable patients will be enrolled in Stage 1. If at least 2 objective tumor responses are observed in the first 21 evaluable patients, the study will be expanded to enroll a total of 41 evaluable patients. Edotecarin will be administered at a starting dose of 13 mg/m2 as an IV infusion over 60 minutes in repeated 3-week cycles treatment.

design_allocation: Non-Randomized

lead_sponsor: Pfizer

location_country:
United Kingdom
Belgium
Spain
Taiwan
France


title: High Risk Neuroblastoma Study 1 Of Siop-Europe

summary:
RATIONALE: Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining isotretinoin and monoclonal antibodies may kill any remaining tumor cells following surgery. It is not yet known which treatment regimen is more effective in treating neuroblastoma.

PURPOSE: This randomized phase III trial is studying how well combination chemotherapy with or without filgrastim before surgery, high-dose chemotherapy, and radiation therapy followed by isotretinoin with or without monoclonal antibody work in treating patients with neuroblastoma.

status: Unknown status

enrollment_type: Anticipated

ReferenceType: result

ReferenceCitation: Ladenstein R, Valteau-Couanet D, Brock P, Yaniv I, Castel V, Laureys G, Malis J, Papadakis V, Lacerda A, Ruud E, Kogner P, Garami M, Balwierz W, Schroeder H, Beck-Popovic M, Schreier G, Machin D, Potschger U, Pearson A. Randomized Trial of prophylactic granulocyte colony-stimulating factor during rapid COJEC induction in pediatric patients with high-risk neuroblastoma: the European HR-NBL1/SIOPEN study. J Clin Oncol. 2010 Jul 20;28(21):3516-24. doi: 10.1200/JCO.2009.27.3524. Epub 2010 Jun 21.

ReferenceCitation: Veal GJ, Nguyen L, Paci A, Riggi M, Amiel M, Valteau-Couanet D, Brock P, Ladenstein R, Vassal G. Busulfan pharmacokinetics following intravenous and oral dosing regimens in children receiving high-dose myeloablative chemotherapy for high-risk neuroblastoma as part of the HR-NBL-1/SIOPEN trial. Eur J Cancer. 2012 Nov;48(16):3063-72. doi: 10.1016/j.ejca.2012.05.020. Epub 2012 Jun 26.

lead_sponsor: University of Leicester

location_country:
Ireland
Italy
Portugal
Israel
Norway
Denmark
United Kingdom
Sweden
Switzerland
Austria
Belgium
Spain
France

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Aarhus Universitetshospital - Aarhus Sygehus

location_facility: Royal Liverpool Children's Hospital, Alder Hey

location_facility: Great Ormond Street Hospital for Children

location_facility: Schneider Children's Medical Center of Israel

location_facility: Our Lady's Hospital for Sick Children Crumlin

location_facility: Royal Belfast Hospital for Sick Children

location_facility: Sir James Spence Institute of Child Health at Royal Victoria Infirmary

location_facility: Institute of Child Health at University of Bristol

location_facility: Fondazione Istituto Nazionale dei Tumori

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

status_simplified: Unknown


title: European Infant Neuroblastoma Study - Stage 2, 3, 4, and 4S; MYCN Amplified Tumors

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy given before surgery followed by peripheral stem cell or bone marrow transplantation in treating infants who have newly diagnosed neuroblastoma.

ReferenceCitation: Canete A, Gerrard M, Rubie H, Castel V, Di Cataldo A, Munzer C, Ladenstein R, Brichard B, Bermudez JD, Couturier J, de Bernardi B, Pearson AJ, Michon J. Poor survival for infants with MYCN-amplified metastatic neuroblastoma despite intensified treatment: the International Society of Paediatric Oncology European Neuroblastoma Experience. J Clin Oncol. 2009 Mar 1;27(7):1014-9. doi: 10.1200/JCO.2007.14.5839. Epub 2009 Jan 26.

lead_sponsor: European Infant Neuroblastoma Study Group - 1999

location_country:
Italy
Portugal
Norway
United Kingdom
Denmark
Sweden
Switzerland
Austria
Belgium
Spain
France

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.


title: European Infant Neuroblastoma Study - Stage 4 With Bone, Lung, Pleura or CNS Involvement; MYCN Not Amplified

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, and giving them before surgery, may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery in treating infants who have newly diagnosed neuroblastoma.

ReferenceCitation: De Bernardi B, Gerrard M, Boni L, Rubie H, Canete A, Di Cataldo A, Castel V, Forjaz de Lacerda A, Ladenstein R, Ruud E, Brichard B, Couturier J, Ellershaw C, Munzer C, Bruzzi P, Michon J, Pearson AD. Excellent outcome with reduced treatment for infants with disseminated neuroblastoma without MYCN gene amplification. J Clin Oncol. 2009 Mar 1;27(7):1034-40. doi: 10.1200/JCO.2008.17.5877. Epub 2009 Jan 26.

sponsor_collaborators: European Infant Neuroblastoma Study Group - 1999


title: European Infant Neuroblastoma Study - Stage 4S and Stage 4 (No Bone, Lung, Pleura or CNS); MYCN Not Amplified

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.

PURPOSE: Phase II trial to study the effectiveness of different combination chemotherapy regimens in treating infants who have newly diagnosed neuroblastoma.


title: European Infant Neuroblastoma Study - Unresectable Tumors (MYCN Not Amplified)

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery in treating infants who have newly diagnosed neuroblastoma.

ReferenceCitation: Rubie H, De Bernardi B, Gerrard M, Canete A, Ladenstein R, Couturier J, Ambros P, Munzer C, Pearson AD, Garaventa A, Brock P, Castel V, Valteau-Couanet D, Holmes K, Di Cataldo A, Brichard B, Mosseri V, Marquez C, Plantaz D, Boni L, Michon J. Excellent outcome with reduced treatment in infants with nonmetastatic and unresectable neuroblastoma without MYCN amplification: results of the prospective INES 99.1. J Clin Oncol. 2011 Feb 1;29(4):449-55. doi: 10.1200/JCO.2010.29.5196. Epub 2010 Dec 20.


title: Treatment Of Children Over The Age Of 1 Year With Unresectable Localized Neuroblastoma Without MYCN Amplification

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase III trial to determine the effectiveness of combination chemotherapy given before surgery in treating children who have localized neuroblastoma.

lead_sponsor: Societe Internationale d'Oncologie Pediatrique

location_country:
Germany
Italy
Portugal
Norway
United Kingdom
Denmark
Sweden
Switzerland
Austria
Belgium
Spain
France

location_facility: Southampton University Hospital NHS Trust


title: CPT-11 in Combination With Weekly 24 Hour Infusion 5-FU Plus Folinic Acid Relative to Weekly 24 Hour Infusion 5-FU Plus Folinic Acid Alone in Patients With Advanced Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether fluorouracil and leucovorin plus irinotecan is more effective than fluorouracil and leucovorin alone for colorectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil and leucovorin with or without irinotecan in treating patients who have metastatic colorectal cancer.

ReferenceCitation: Kohne CH, van Cutsem E, Wils J, Bokemeyer C, El-Serafi M, Lutz MP, Lorenz M, Reichardt P, Ruckle-Lanz H, Frickhofen N, Fuchs R, Mergenthaler HG, Langenbuch T, Vanhoefer U, Rougier P, Voigtmann R, Muller L, Genicot B, Anak O, Nordlinger B; European Organisation for Research and Treatment of Cancer Gastrointestinal Group. Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer: European Organisation for Research and Treatment of Cancer Gastrointestinal Group Study 40986. J Clin Oncol. 2005 Aug 1;23(22):4856-65. doi: 10.1200/JCO.2005.05.546. Epub 2005 Jun 6.

ReferenceCitation: Kohne CH, Van Custem E, Wils JA, et al.: Irinotecan improves the activity of the AIO regimen in metastatic colorectal cancer: results of EORTC GI Group study 40986. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1018, 2003.

ReferenceCitation: Kohne C, van Cutsem E, Wils J, et al.: Weekly high dose infusional 5-FU plus folinic acid (FA) with or without irinotecan (IRI) in metastatic colorectal cancer (MCRC): interim safety results of EORTC study 40986. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-532, 2002.

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

location_country:
Germany
Italy
Russian Federation
Netherlands
Austria
Belgium
South Africa
Egypt
France

location_facility: Krankenhaus Siloah - Medizinische Klinik II

location_facility: Kreiskrankenhaus Neustadt A. Rbge. des Landkreises Hannover

location_facility: St. Johannes Hospital - Medical Klinik II

location_facility: Harz-Klinikum Wernigerode GMBH - Medizinische Klinik

location_facility: Internistisch - Onkologische Gemeinschaftspraxis

location_facility: Universitaetsklinik und Strahlenklinik - Essen

location_facility: Medizinische Poliklinik, Universitaet Wuerzburg

location_facility: Russian Academy of Medical Sciences Cancer Research Center

location_facility: Hermann-Holthusen Institute for Radiotherapy

location_facility: Henriettenstiftung - Chirurgische Klinik

location_facility: Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet


title: Randomized Study With New Combination Chemotherapies in Advanced Non-Small Cell Lung Cancer

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 which combination chemotherapy regimen is more effective in treating advanced non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of three different combination chemotherapy regimens in treating patients who have advanced non-small cell lung cancer.

ReferenceCitation: Giaccone G. Gemcitabine plus taxane combinations in non-small cell lung cancer. Semin Oncol. 1999 Feb;26(1 Suppl 4):19-24.

ReferenceCitation: Efficace F, Bottomley A, Smit EF, Lianes P, Legrand C, Debruyne C, Schramel F, Smit HJ, Gaafar R, Biesma B, Manegold C, Coens C, Giaccone G, Van Meerbeeck J; EORTC Lung Cancer Group and Quality of Life Unit. Is a patient's self-reported health-related quality of life a prognostic factor for survival in non-small-cell lung cancer patients? A multivariate analysis of prognostic factors of EORTC study 08975. Ann Oncol. 2006 Nov;17(11):1698-704. doi: 10.1093/annonc/mdl183. Epub 2006 Sep 12.

ReferenceCitation: Smit EF, van Meerbeeck JP, Lianes P, Debruyne C, Legrand C, Schramel F, Smit H, Gaafar R, Biesma B, Manegold C, Neymark N, Giaccone G; European Organization for Research and Treatment of Cancer Lung Cancer Group. Three-arm randomized study of two cisplatin-based regimens and paclitaxel plus gemcitabine in advanced non-small-cell lung cancer: a phase III trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group--EORTC 08975. J Clin Oncol. 2003 Nov 1;21(21):3909-17. doi: 10.1200/JCO.2003.03.195.

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

location_country:
Germany
Italy
Poland
Netherlands
Switzerland
Belgium
Spain
Greece
South Africa
Czech Republic
Egypt
France

location_facility: Academisch Ziekenhuis der Vrije Universiteit

location_facility: University Hospital - Rotterdam Dijkzigt


title: A Randomized Phase III Trial for Evaluation of Usefulness of Pelvic Drains After Radical Hysterectomy and Node Dissection (RHND)

summary:
RATIONALE: The use of pelvic drains may help to prevent complications following radical hysterectomy and pelvic lymphadenectomy. It is not known whether receiving pelvic drains during surgery is more effective than receiving no pelvic drains during surgery in patients with uterine, cervical, or vaginal cancer.

PURPOSE: Randomized phase III trial to determine if the use of pelvic drains following radical hysterectomy and pelvic lymphadenectomy is effective in treating patients with uterine, cervical, or vaginal cancer.

primary_purpose: Supportive Care

ReferenceCitation: Franchi M, Trimbos JB, Zanaboni F, v d Velden J, Reed N, Coens C, Teodorovic I, Vergote I. Randomised trial of drains versus no drains following radical hysterectomy and pelvic lymph node dissection: a European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group (EORTC-GCG) study in 234 patients. Eur J Cancer. 2007 May;43(8):1265-8. doi: 10.1016/j.ejca.2007.03.011. Epub 2007 Apr 26.

location_country: Germany Italy Portugal Netherlands Austria Belgium Spain France

location_facility: University and I.R.C.C.S. Policlinico San Matteo

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori

intervention_type: Procedure


title: Mid to Long-term Quality of Life Effects Of imatiNIb Versus DASatinib in Chronic Myeloid Leukemia Patients (LEONIDAS)

summary: The broad goal of this study is to investigate if differences exist (and in which areas and of what magnitude) in QoL and symptoms of patients with CML being treated with first line therapy with dasatinib versus those receiving first line therapy with imatinib. Also, an additional objective is to characterize medication-taking behavior associated with imatinib or dasatinib.

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Cross-Sectional

ipd_sharing: No

lead_sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

collaborators:
European Leukemia Net
CML Advocates Network

location_country: Germany Italy Spain France

location_facility: U.O. di Ematologia - Casa Sollievo della Sofferenza

location_facility: U.O. Ematologia 1 - Centro Trapianti di Midollo - Ospedale Maggiore Milano

location_facility: Ematologia ed Immunologia Clinica - Università degli studi di Padova

location_facility: Divisione di Ematologia - Policlinico Careggi

location_facility: U.O di Ematologia d. U. - Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Department of Onco-Hematology - IRCCS; Centro di Riferimento Oncologico della Basilicata

location_facility: S.C. di Oncoematologia - A.O. "S. Maria"

location_facility: Clinica di Ematologia - Policlinico Umberto I- Università degli Studi "Sapienza"

location_facility: Divisione di Ematologia - A.O. Ospedali Riuniti di Reggio Calabria "Bianchi-Melacrino-Morelli"

location_facility: Onco-Ematologia - Ospedale S. Andrea- Vercelli

location_facility: U.O.C. Ematologia - A.O. SS Annunziata - P.O.S.G. Moscati

location_facility: Ematologia e CTMO - A.O.U. Università degli Studi di Parma

location_facility: Divisione Ematologia - Dipartimento di Medicina Interna -Policlinico Universitario di Messina

location_facility: Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza

location_facility: U.O. Ematologia con trapianto - Azienda Ospedaliero-Universitaria Policlinico di Bari

location_facility: Divisione di Ematologia - Ospedale S.Eugenio

location_facility: Divisione di Ematologia - Dip. Di Medicina Clinica e Sperimentale & BRMA - Università Piemonte Orientale "Amedeo Avogato"

location_facility: Ematologia Policlinico - Università degli Studi di Roma Tor Vergata (PTV)

location_facility: Dipartimento di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga

location_facility: Istituto di Ematologia "L. e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi

location_facility: Universität Heidelberg - III. Medizinische Klinik - Universitätsmedizin Mannheim

location_facility: Clinica Ematologica - Dipartimento di Medicina Interna - IRCCS San Martino - IST

location_facility: U.O.C. Ematologia e Trapianto cellule staminali - Pad Cesalpino- A.O. San Camillo Forlanini

location_facility: Divisione di Ematologia con trapianto di midollo - A.O.U. Policlinico "Paolo Giaccone"

location_facility: Clinica di Ematologia - Azienda Ospedaliera Regionale di Torrette

location_facility: U.O. Ematologia - Azienda USLL12 Veneziana - Ospedale dell'Angelo e Ospedale civile S. Giovanni e Paolo

location_facility: Dipartimento di Med. Clinica e Sperimentale- Area di Ematologia - Facoltà di Medicina e Chirurgia - Università degli Studi di Napoli "Federico II" -

location_facility: U.O.C. Ematologia - A.O. Ospedali Riuniti "Villa Sofia-Cervello"

location_facility: U.O. di Ematologia - Ente Ospedaliero San Giovanni Addolorata

location_facility: U.O. Ematologia Brindisi- Ospedale A. Perrino ASL BR

location_facility: Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto

location_facility: S. C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo

location_facility: XIX Divisione di Ematologia con trapianto - A.O.R.N. "A. Cardarelli"

location_facility: USD - Centro Trapianti Midollo Osseo Adulti - Cattedra di Ematologia - Azienda Spedali Civili - Brescia

location_facility: Department of Hematology, Hospital Universitario de la Princesa

location_facility: Clinica Ematologica ed Unità di Terapie Cellulari Carlo Melzi - A.O. Universitaria

location_facility: S.C.D.O. Ematologia II - A.O.U.S. San Giovanni Battista di Torino (Molinette)

location_facility: Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"

location_facility: Azienda Ospedaliera - Arcispedale S. Anna Sezione di Ematologia e Fisiopatologia delle Emostasi

location_facility: Department of Hematology and Oncology, Hôpital Mignot, Université Versailles Saint-Quentin-en-Yvelines

intervention_type: Other


title: Prospective, Multicenter, Randomized, Controlled Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Symptomatic Tricuspid Regurgitation (TR) - TRICAV Trial

acronym: TRICAV

summary: The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve implantation system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The TricValve® Transcatheter Bicaval Valves are pre-mounted into the TricValve® Delivery System which is used for percutaneous access and delivery of the TricValve® Transcatheter Bicaval Valve in the vena cava. The system is a single use, sterile device compatible with all the valve sizes. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system.

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceCitation: Estevez-Loureiro R, Sanchez-Recalde A, Amat-Santos IJ, Cruz-Gonzalez I, Baz JA, Pascual I, Mascherbauer J, Abdul-Jawad Altisent O, Nombela-Franco L, Pan M, Trillo R, Moreno R, Delle Karth G, Salido-Tahoces L, Santos-Martinez S, Nunez JC, Moris C, Goliasch G, Jimenez-Quevedo P, Ojeda S, Cid-Alvarez B, Santiago-Vacas E, Jimenez-Valero S, Serrador A, Martin-Moreiras J, Strouhal A, Hengstenberg C, Zamorano JL, Puri R, Iniguez-Romo A. 6-Month Outcomes of the TricValve System in Patients With Tricuspid Regurgitation: The TRICUS EURO Study. JACC Cardiovasc Interv. 2022 Jul 11;15(13):1366-1377. doi: 10.1016/j.jcin.2022.05.022. Epub 2022 May 17.

ReferenceCitation: Amat-Santos IJ, Estevez-Loureiro R, Sanchez-Recalde A, Cruz-Gonzalez I, Pascual I, Mascherbauer J, Abdul-Jawad Altisent O, Nombela-Franco L, Pan M, Trillo R, Moreno R, Delle Karth G, Blasco-Turrion S, Sanchez-Luna JP, Revilla-Orodoea A, Redondo A, Zamorano JL, Puri R, Iniguez-Romo A, San Roman A. Right heart remodelling after bicaval TricValve implantation in patients with severe tricuspid regurgitation. EuroIntervention. 2023 Aug 7;19(5):e450-e452. doi: 10.4244/EIJ-D-23-00077. No abstract available.

ReferenceCitation: Abdul-Jawad Altisent O, Codina P, Puri R, Bayes-Genis A. Transcatheter bi-caval valve implantation (CAVI) significantly improves cardiac output: mechanistic insights following CardioMEMS(R) and TricValve(R) implantation. Clin Res Cardiol. 2022 Aug;111(8):966-968. doi: 10.1007/s00392-022-02029-8. Epub 2022 May 2. No abstract available.

ReferenceCitation: Chandran K, Long A, Bishop J, Berman P, Matar F, Oliveira GH, Bezerra HG. First In-Man Experience With TricValve Transcatheter Bicaval Valve System in Left Ventricular Assist Device Heartmate II Patient for High-Risk Tricuspid Regurgitation. Circ Heart Fail. 2023 Jun;16(6):e010027. doi: 10.1161/CIRCHEARTFAILURE.122.010027. Epub 2023 Jun 6. No abstract available.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

ipd_sharing: Yes

ipd_sharing_description: The dataset generated during and/or analysed during the study will be available upon request from the Clinical Research Organization, Meditrial USA Inc. m.tocchi@meditrial.net Datasets will only be made available through publication, unless disclosure is mandated by law.

lead_sponsor: P+F Products + Features GmbH

sponsor_collaborators:
P+F Products + Features GmbH
Meditrial USA Inc.

location_country:
Germany
United Kingdom
Australia
Sweden
Belgium
United States
Spain
France

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: Department of Cardiology, Algemeen Stedelijk Ziekenhuis (ASZ)

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Hospital Clínico Universitario de Valladolid

status_simplified: Ongoing


title: An Observational Study Program to Investigate the Effectiveness of Aflibercept 8 mg Used in DME and nAMD in a Real-world Setting

summary:
This is an observational study in which only data are collected from people who have already been prescribed aflibercept 8 mg by their own doctors.

In this study, data from adults with visual impairment due to neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME) will be collected and studied.

Visual impairment is any degree of vision loss that affects a person's ability to perform daily activities. nAMD is an eye disorder that causes vision loss due to the growth of abnormal blood vessels that leak blood or retinal fluid into the macula (the central part of the retina). nAMD is a leading cause of vision loss for people aged 50 and older. DME is a diabetes-related eye disorder. In DME, the macula swells up due to fluid leakage from damaged blood vessels, resulting in vision problems.

Aflibercept 8 mg is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye.

Aflibercept 8 mg has been submitted for approval for the treatment of visual impairment due to nAMD and DME based on the results from 2 studies called PHOTON and PULSAR. This study will begin once approval is obtained. Currently, no real-world data are available for aflibercept 8 mg.

The main purpose of this study is to collect more information about how well aflibercept 8 mg injection works in people with nAMD and DME. This study will include participants who have not received any prior treatment for nAMD or DME and participants who have.

The main information that researchers will collect:

the change in vision test scores called the best corrected visual acuity (BCVA) after 12 months of treatment.

Data will be collected from February 2024 to September 2027 and will cover a period of up to 24 months per participant. The data will be collected using medical records and by interviewing the patients during regular visits that take place in routine practice.

Researchers will observe participants from the first injection of aflibercept 8 mg until the end of the observation.

In this study, only available data from regular visits will be collected. No visits or tests are required as part of this study.

time_perspective: Prospective

ipd_sharing_description: Availability of this study's data will later 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.vivli.org 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 member section of the portal.

lead_sponsor: Bayer

location_country:
Finland
Germany
Italy
Norway
United Kingdom
Denmark
Australia
Japan
Netherlands
Sweden
Switzerland
United Arab Emirates
Saudi Arabia
Canada
France


title: Phase I Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

summary: Study of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in Combination with Bortezomib and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma.

lead_sponsor: PharmaMar

location_country: Spain France

location_facility: Hospital Universitari i Politècnic la Fe

location_facility: Hospital Universitario Germans Trias I Pujol


title: A Phase 1/2 Study of TAS3351 in Patients With Advanced Non-Small Cell Lung Cancer and EGFR Mutations

summary: This is a first-in-human, open label, Phase 1/2 study to investigate the safety and efficacy of TAS3351 in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring an acquired C797S epidermal growth factor receptor (EGFR) mutation.

status: Recruiting

lead_sponsor: Taiho Oncology, Inc.

location_country:
Germany
Italy
United Kingdom
Japan
Netherlands
United States
Korea, Republic of
Spain
France

location_facility: University of Texas M. D. Anderson Cancer Center

location_facility: Georgetown University - Lombardi Comprehensive Cancer Center


type: Other Identifier

title: A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

summary: This is a multicenter, randomized (2:1), open-label, controlled Phase 3 trial of XL092 in combination with nivolumab versus sunitinib in subjects with unresectable, locally advanced or metastatic nccRCC who have not received prior systemic anticancer therapy.

lead_sponsor: Exelixis

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

location_facility:
Exelixis Clinical Site #14
Exelixis Clinical Site #9
Exelixis Clinical Site #11
Exelixis Clinical Site #3
Exelixis Clinical Site #10
Exelixis Clinical Site #4
Exelixis Clinical Site #13
Exelixis Clinical Site #7
Exelixis Clinical Site #15
Exelixis Clinical Site #5
Exelixis Clinical Site #12
Exelixis Clinical Site #8
Exelixis Clinical Site #2
Exelixis Clinical Site #6
Exelixis Clinical Site #16
Exelixis Clinical Site #1


acronym: B-Well 2

lead_sponsor: GlaxoSmithKline

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

title: Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment With Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B Virus (B-Well 2)

ipd_sharing_description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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


title: Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness

summary: The purpose of this study is to confirm the safety, performance and effectiveness of Stryker's PEEK Customized Implants when used for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton. The study is designed as a prospective, multi-center trial with a long-term follow-up (24 months) of study participants.

status: Enrolling by invitation

lead_sponsor: Stryker Craniomaxillofacial

sponsor_collaborators:
Stryker Craniomaxillofacial
Qmed Consulting A/S

location_country:
Germany
United Kingdom
Austria
United States
Spain
France

location_facility: University of Louisville 501 E. Broadway, Suite 210

location_facility: Klinik für Neurochirurgie Klinikum Dortmund Münsterstr. 240

location_facility: Servicio de Neurocirugía Hospital Universitario La Paz.

location_facility: St. Barbara-Klinik Hamm GmbH Hamm Heessen und St. Josef-Krankenhaus Hamm-Bockum-Hövel Am Heessener Wald 1 | 1263

location_facility: Universitätsklinik für Neurochirurgie Auenbruggerplatz 29

location_facility: Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9

location_facility: Neurosurgery, Emergency and Major Trauma (NET) Research | Division of Medicine | Imperial College Healthcare NHS Trust

location_facility: Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital

location_facility: Lewis Katz School of Medicine at Temple University, 3401 North Broad Street


title: European Sepsis Care Survey

summary: The objective of this survey is to investigate the current state of sepsis care around Europe. The study is aiming at hospital structure, emergency departments, wards, intensive care units and clinical diagnostic and microbiological service.

ipd_sharing_description: This study uses no patient data.

lead_sponsor: University Medicine Greifswald

collaborators: European Society of Anaesthesiology and Intensive Care

collaborators: European Society for Emergency Medicine (EUSEM) Research Network

collaborators: European Society of Clinical Microbiology and Infectious Diseases, ESGBIES Study Group

collaborators: European Society of Intensive Care Medicine

location_country:
Finland
Germany
Poland
Turkey
Czechia
France
Portugal
Denmark
Romania
Belgium
Moldova, Republic of
Italy
Norway
United Kingdom
Sweden
Netherlands
Spain
Greece
Russian Federation
Israel

location_facility: Faculty of Medicine, Department of Clinical Sciences Lund, Division of Infection Medicine, Lund University

location_facility: "Prof CC Iliescu" Emergency Institute for Cardiovascular Diseases, Bucharest

location_facility: Department of Emergency Medicine University of Southern Denmark

location_facility: Vladimir L. Vanevskii Department of Anaesthesiology and Reanimatology, North-Western State Medical University named after Ilya I. Mechnikov

location_facility: King's College London, Guy's and St Thomas' Foundation Hospital, Department of Critical Care, London

location_facility: Universidade do Porto Faculdade de Medicina: Porto

location_facility: Perioperative, Intensive Care and Pain Medicine Helsinki University Hospital

location_facility: Hopital Raymond Poncare Service de Reanimation Medicale

location_facility: Department of Anaesthesiology and Intensive Therapy Wroclaw Medical University

location_facility: Emergency Department Antwerp University Hospital

location_facility: Department of Anesthesiology and Intensive Care Medicine University Hospital of Ostrava

location_facility: National Institute for Antibiotic Resistance & Infection Control, Ministry of Health

location_facility: 4th Department of Internal Medicine ATTIKON University Hospital

location_facility: Corporació Sanitària Parc Taulí · critical care center, sabadell hospital, Corporació Sanitaria Universitaria Parc Tauli

location_facility: Hacettepe University, Department of Internal Medicine Sihhiye, Ankara

location_facility: State University of Medicine and Pharmaceutics "Nicolae Testemiţanu"


title: A Multicentre Surveillance Study to Evaluate the Long-term Safety in Participants Who Have Been Previously Treated With 177Lu-IPN01072 in an Ipsen-sponsored Clinical Study

summary: The purpose of the protocol is to evaluate the long-term safety of medicine 177Lu-satoreotide tetraxetan (also known as 177Lu-IPN01072 or 177Lu-OPS201) for patients who have previously received 177Lu-satoreotide tetraxetan in the clinical study OPS-C-001 / D-FR-01072-001.

status: Active, not recruiting

ipd_sharing_description:
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

lead_sponsor: Ipsen

location_country:
United Kingdom
Denmark
Australia
Switzerland
Austria
France

location_facility:
Royal Free Hospital London
University Hospital Basel
Peter Maccallum Cancer Center
Medical University of Vienna
Aarhus University Hospital
Hôtel Dieu de Nantes
Ramsay Hollywood Private Hospital


title: European Disease Registry on Retinopathy of Prematurity (ROP)

acronym: EU-ROP

summary:
The EU-ROP registry is a European wide multicenter non-interventional observational registry study intended to run open-ended in as many countries as possible including infants treated for retinopathy of prematurity irrespective of the used treatment modality. The registry is strictly observational; only clinical routine data is collected, no study-specific examinations or interventions are to be performed.

The aim of the EU-ROP registry is to collect information on as many patients as possible treated for ROP in Europe. Both the number of study centers as well as the number of patients to be included into the registry are not limited.

The primary objective is to describe the typical clinical features of infants with severe ROP, variations in phenotype, and the clinical progression of the disease over time (natural history) in different European countries as well as to study treatment patterns, follow-up patterns, as well as long-term outcomes.

time_perspective: Other

location_country: Germany Poland Switzerland Austria Spain Greece Turkey Ukraine Bulgaria Estonia Kosovo France

location_facility: Filatov Institute of Eye Diseases and Tissue Therapy Odessa

location_facility: Children's Memorial Health Institute Warsaw

location_facility: Hacettepe University Children's Hospital

location_facility: University and Polytechnic Hospital La Fe

location_facility: Etlik Zübeyde Hanim Women's Health Education and Research Hospital

location_facility: Department of Pediatric Ophthalmology and Eye Microsurgery Perinatal Center Kiev

location_facility: Medical University of Bialystok Children's Clinical Hospital


title: CoolSculpting® Elite: Multi-Country Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen, Flanks, Upper Arms, Inner Thighs, Outer Thighs and Submental Area

summary: This study aims to generate data that conveys participant's experiences such as their satisfaction with treatment delivered by the redesigned CoolSculpting® Elite system for non-invasive fat reduction in the midsection area (abdomen and flanks) in addition to optional body areas of upper arms, inner thighs, outer thighs and/or submental area. By doing this, the study will provide insights for doctors to better inform participants about the expected outcomes when one or more body areas are considered for treatment.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: Allergan

location_country:
Germany
France
Singapore
United States
Sweden

location_facility: Laser & Skin Surgery Medical group, Inc /ID# 239112

location_facility: Laser & Skin Surgery Center of New York /ID# 239113

location_facility: Centre Laser International de la Peau /ID# 239117


title: Cryoablation for Monomorphic Ventricular Tachycardia

acronym: CryoCure-VT

summary: A prospective, single-arm, multi-center, pre-market, clinical study designed to provide safety and performance data regarding the use of the Adagio Medical VT Cryoablation System in the treatment of ventricular tachycardia.

lead_sponsor: Adagio Medical

location_country: Germany Netherlands Belgium Czechia Canada France

location_facility: Herzzentrum Leipzig Universitätsklinik für Kardiologie

location_facility: CHU-Bordeaux, Pôle cardio-thoracique, Hôpital Haut-Lévêque


title: Balloon Expandable vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis. THE BASELINE TRIAL.

acronym: BASELINE

summary:
Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements is performed using a bioprosthesis1. Durability of surgical bioprostheses varies based on the patient's age at the moment of implantation, type and size etc2. TAVI has become the preferred treatment for degenerated aortic bioprostheses in elderly patients3. The median time since index surgical aortic valve replacement (SAVR) and for bioprosthetic valve degeneration is typically 8 - 10 years4-6. TAVI in this setting has proven to have equally favorable results as in native aortic valves7. Balloon expandable8 and self-expanding9 transcatheter heart valves (THV) can be used in a degenerated bioprosthesis and each have specific assets and limitations. TAVI in a failed bioprosthesis can cause coronary obstruction, THV migration, paravalvular leakage and prosthesis patient mismatch. The SAPIEN-3 / Ultra and EVOLUT R/Pro are the 2 most commonly used THV platforms in contemporary clinical practice including treatment of failing surgical aortic bioprostheses.

Objective: To compare TAVI with EVOLUT R/Pro vs. SAPIEN-3 / Ultra in terms of device success.

Study design: International multi-center randomized study with 1:1 randomization to TAVI with SAPIEN-3 / Ultra or Evolut R/Pro.

Study population: 440 patients with a failing surgical aortic bioprosthesis (aortic stenosis with or without aortic regurgitation) and selected for transfemoral TAVI by heart-team consensus.

Investigational intervention: Transfemoral TAVI with SAPIEN-3 / Ultra or Evolut R/PRO

Main study parameters/endpoints:

Primary endpoint is device success at 30 days

Defined by

Absence of procedural mortality AND
Correct positioning of a single prosthetic heart valve into the proper anatomical location AND
Intended performance of the prosthetic heart valve (no severe prosthesis- patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, AND no moderate or severe prosthetic valve regurgitation). Severe prosthesis patient mismatch is defined by effective orifice area (EOAi) ≤0.65 cm2/m2
Safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems.

lead_sponsor: Erasmus Medical Center

location_country:
Germany
Italy
Portugal
United Kingdom
Denmark
Netherlands
Austria
Switzerland
United States
Greece
Canada
France

location_facility: Division of Cardiology, Pulmonology, and Vascular Medicine, Heinrich Heine University Medical Center Dusseldorf, Dusseldorf, Germany

location_facility: Interventional Cardiology Unit, Cardiovascular Department, Fondazione Poliambulanza Institute, Brescia, Italy

location_facility: Department of Cardiology, Onassis Cardiac Surgery Center, Athens, Greece

location_facility: St Paul's and Vancouver General Hospital


title: A Phase II Study of Blincyto in Children With CD19+ Precursor B-lineage ALL and MRD-Positivity Before and/or Following First Allogeneic HSCT

summary:
A phase II trial of continuous intravenous infusion of Blincyto given over a 28-day cycle. Starting day for patients who are MRD-positive before HSCT is between day +60 and day +100 and for patients who become MRD-positive post HSCT it is between day +60 and day +360 post HSCT.

Patients will be evaluated for response at day +28 (+4 days) (bone marrow morphology and MRD analysis - defined by PCR/FLOW-techniques) after start of Blincyto-treatment at the end of first Blincyto infusion and at regular post-TX-checks (according to FORUM: days +28, +60, +100, +180 and +360 after HSCT).

The dose of Blincyto used in this trial will be 15 mcg/m2/day for 28 days

lead_sponsor: Prof. Christina Peters

sponsor_collaborators:
Prof. Christina Peters
Amgen

location_country: Italy Poland Slovakia Norway Denmark Austria Belgium Spain Greece Czechia France

location_facility: Nicolaus Copernicus University Collegium Medicum

location_facility: University Hospital Gasthuisberg (UZ Leuven)

location_facility: IRCCS Ospedale Pediatrico Bambino Gesù Roma


title: Rate of Progression of PCDH15-Related Retinal Degeneration in Usher

summary: The overall goal of this project, co-funded by the Foundation Fighting Blindness and the USHER 1F Collaborative is to characterize the natural history of disease progression in patients with PCDH15 mutations in order to accelerate the development of outcome measures for clinical trials.

ipd_sharing_description: A de-identified database is placed in the public domain on the FFB/Jaeb public website after the completion of each protocol and publication of the manuscript.

lead_sponsor: Jaeb Center for Health Research

sponsor_collaborators:
Jaeb Center for Health Research
Usher 1F Collaborative
Marjorie C. Adams Foundation

location_country:
Germany
France
Netherlands
Switzerland
United States
Canada
Israel

location_facility:
CHNO des Quinze-Vingts
University Hospital Basel
University of California, San Francisco
Haddassah Medical Center
The Johns Hopkins Wilmer Eye Institute
University of Tubingen
Hospital for Sick Children
Duke University, Duke Eye Center
Radboud University


title: An Open-Label, Multicenter, Phase 1 Study of RP3 as a Single Agent and in Combination With PD-1 Blockade in Patients With Solid Tumors

summary: This is a Phase 1, multicenter, open label, single agent dose escalation and combination treatment study of RP3 in adult participants with advanced solid tumors, to evaluate the safety and tolerability of RP3 both as a single agent and in combination with anti-PD1 therapy and to determine the recommended Phase 2 dose (RP2D) of RP3.

lead_sponsor: Replimune Inc.

sponsor_collaborators:
Replimune Inc.
Bristol-Myers Squibb

location_country:
United Kingdom
United States
Spain
Greece
France

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Vall d'Hebron Hospital Hospital Universitario Vall d´Hebron (Vall d'Hebron University Hospital)

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Laboratoire de Recherche Translationnelle en Immunotherapie (LRTI), Gustave Roussy

location_facility: START Madrid CIO Clara Campal, Hospital Universitario HM Sanchinarro Unidad de Ensayos Fase I Panta 3

intervention_type: Biological


title: A Phase 1/2 Ascending Dose Study to Evaluate the Safety and Effects on Progranulin Levels of LY3884963 in Patients With Fronto-Temporal Dementia With Progranulin Mutations (FTD-GRN)

acronym: PROCLAIM

summary: Study J4B-MC-OKAA is a Phase 1/2, multi-center, open-label ascending dose, first-in-human study that will evaluate the safety and effect of intra-cisternal LY3884963 administration on progranulin protein (PGRN) levels in patients with frontotemporal dementia with progranulin mutations (FTD-GRN). Two escalating dose (low dose and medium dose) cohorts are planned, as well as one bridging cohort which will allocate patients to receive either low or medium dose. The duration of the study is 5 years. During the first year, patients will be evaluated for the effect of LY3884963 on safety, tolerability, immunogenicity, biomarkers, and efficacy. Patients will follow up for an additional 4 years to monitor safety and changes on selected biomarkers and clinical outcomes.

lead_sponsor: Prevail Therapeutics

sponsor_collaborators:
Prevail Therapeutics
Eli Lilly and Company

location_country:
United Kingdom
Australia
Belgium
United States
Spain
France

location_facility: Bioclinica Orlando, 100 West Gore Street, Suite 202

location_facility: Hospital of the University of Pennsylvania, 3 West Gates Building, 3400 Spruce Street

location_facility: Royal Prince Alfred Hospital, Brain & Mind Research Institute, 94 Mallet Street

location_facility: Le Ber, Institut du Cerveau et de la Moelle Epinière

location_facility: Hospital Clinic de Barcelona, Villaroel 170 Servicio de Neurología

location_facility: University College London,Queen Square, Dementia Research Building, London,

location_facility: Hospital Universitario de Donostia, Servicio De Neurologia, Consultas Externas Neurologia, San Sebastian, Guipúzcoa


summary:
Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs.

Digital ulcers are frequent and have a major impact on the quality of life in patients with systemic sclerosis. The etiology of digital ulcers is complex and multifactorial and the principal mechanisms underlying the digital ulcers formation are ischemic, mechanic and inflammatory, alone or in combination, on the basis of the systemic sclerosis vasculopathy. Consequently, there are at least three types of DU: (i) those localized at the tips of the fingers and toes, mainly resulting from an ischemic process, (ii) those localized on the dorsal aspect of the fingers where the skin retraction due to fibrosis over bony prominences seems to be the main cause, and (iii) those evolving on a pitting scar or subcutaneous calcinosis due to a combined irritative-inflammatory mechanism. An early therapy to prevent or rapidly heal digital ulcers is today considered a mandatory approach to maintain quality of life and spare the enormous costs due to conventional digital ulcer management.

This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis.

Aim of this observational trial is:

To identify the best treatment combination for prevention of digital ulcers in patients with fulfilment of the new ACR/EULAR SSc criteria or the preliminary VEDOSS criteria for very early diagnosis of systemic sclerosis
To identify the best treatment associated with improved healing of digital ulcers in patients with fulfilment of the new ACR/EULAR SSc criteria

Thus, the observational trial consist of a prevention arm and a healing arm.

ReferenceCitation: Blagojevic J, Bellando-Randone S, Abignano G, Avouac J, Cometi L, Czirjak L, Denton CP, Distler O, Frerix M, Guiducci S, Huscher D, Jaeger VK, Lorand V, Maurer B, Nihtyanova S, Riemekasten G, Siegert E, Tarner IH, Vettori S, Walker UA, Allanore Y, Muller-Ladner U, Del Galdo F, Matucci-Cerinic M; EUSTAR co-workers. Classification, categorization and essential items for digital ulcer evaluation in systemic sclerosis: a DeSScipher/European Scleroderma Trials and Research group (EUSTAR) survey. Arthritis Res Ther. 2019 Jan 24;21(1):35. doi: 10.1186/s13075-019-1822-1.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_normalized: Zenodo

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

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
PubMed Central
UCL Discovery
Zenodo
eprints.whiterose.ac.uk

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: marco matucci cerinic

collaborators: University of Campania "Luigi Vanvitelli"

location_country:
Germany
Italy
Hungary
United Kingdom
Switzerland
France

location_facility: University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine

location_facility: The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital

location_facility: Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie

location_facility: Pecsi Tudomanyegyetem - University of Pecs

location_facility: Felix-Platter Spital, University of Basel

location_facility: Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology

location_facility: Centre for Pediatric Rheumatology, Klinikum Eilbek

location_facility: Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016

location_facility: University of Zurich, Department of Rheumatology

location_facility: Royal Free Hospital, University College London


title: A Two-part, Single- and Two Arm Randomized, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy (in Part 2 Only) of KRP203 in Patients Undergoing Stem Cell Transplant for Hematological Malignancies

summary: Two part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy (in Part 2 only) of KRP203 in patients undergoing allogeneic hemopoietic stem cell transplant for hematological malignancies

primary_purpose: Prevention

ReferenceCitation: Dertschnig S, Gergely P, Finke J, Schanz U, Holler E, Holtick U, Socie G, Medinger M, Passweg J, Teshima T, Stylianou C, Oehen S, Heim D, Bucher C. Mocravimod, a Selective Sphingosine-1-Phosphate Receptor Modulator, in Allogeneic Hematopoietic Stem Cell Transplantation for Malignancy. Transplant Cell Ther. 2023 Jan;29(1):41.e1-41.e9. doi: 10.1016/j.jtct.2022.10.029. Epub 2022 Nov 4.

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: University of Zurich - Zurich Open Repository and Archive

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country: Germany Switzerland France


summary:
Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the skin and all internal organs. Cardiac involvement, mainly characterised by small intramyocardial coronary artery involvement and myocardial fibrosis, can cause the development of impaired diastolic ventricular filling, cardiac blocks and ventricular arrhythmias, and can ensue in congestive heart failure and sudden death. Until now, no drug has been proven to have a therapeutic effect on SSc myocardial disease on an evidence-based level. Short-term trials and retrospective studies have suggested a favourable and protective effect of calcium channel blockers and angiotensin converting enzyme inhibitors in patients with myocardial involvement. However, no data are presently available on the prevention and treatment of severe heart disease.

This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis. Aim of this observational trial is to assess the efficacy and safety of calcium channel blockers and angiotensin converting enzyme inhibitors in asymptomatic SSc patients with cardiac involvement.

lead_sponsor: Gabriele Valentini

sponsor_collaborators:
Gabriele Valentini
European Union
University of Giessen
University of Zurich
University of Paris 5 - Rene Descartes
University of Florence
University of Basel
University College, London
Charite University, Berlin, Germany
University of Pecs
University of Leeds
Schoen Klinik Hamburg Eilbek


title: Clinical and Health Economic Evaluation of a New Baha® Abutment, With a Minimally Invasive Surgical Technique. An International Multicentre, Open, Randomised, Comparative, Parallel Group, Investigation. 1y Investigation, 2y Follow-up

summary:
To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction of inflammation/infection, overgrowth, pain and numbness at the site of implantation compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment).

To demonstrate that the minimally invasive surgical procedure in combination with the use of the Cochlear Baha BA400 abutment is associated with a reduction in direct medical costs, due to shorter surgical procedures, faster wound healing and less complications compared to the traditional surgical procedure in combination with the use of the standard Baha abutment (Cochlear Baha BA300 Abutment).

ReferenceCitation: van Hoof M, Wigren S, Ivarsson Blechert J, Molin M, Andersson H, Mateijsen DJM, Bom SJH, Calmels MN, van der Rijt AJM, Flynn MC, van Tongeren J, Hof JR, Brunings JW, Anteunis LJC, Marco Algarra J, Stokroos RJ, Joore MA. A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System-A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology. Front Neurol. 2020 Mar 13;11:106. doi: 10.3389/fneur.2020.00106. eCollection 2020.

repositories_concat: PubMed Central

publisher_dissemination: Frontiers

lead_sponsor: Cochlear Bone Anchored Solutions

location_country: Spain Sweden Netherlands France

location_facility: Otorhinolaryngology, Hospital Clinico Universitario De Valencia


acronym: IBUPROFEN LOZENGE IN ACUTE SORE THROAT PAIN

lead_sponsor: Pierre Fabre Medicament

summary: The purpose of this study is to evaluate the efficacy and safety of repeated doses of a low dosage of oromucosal Ibuprofen form (lozenge) versus placebo in patients suffering from acute sore throat pain.

ReferenceCitation: Bouroubi A, Donazzolo Y, Donath F, Eccles R, Russo M, Harambillet N, Gautier S, Montagne A. Pain relief of sore throat with a new anti-inflammatory throat lozenge, ibuprofen 25 mg: A randomised, double-blind, placebo-controlled, international phase III study. Int J Clin Pract. 2017 Sep;71(9). doi: 10.1111/ijcp.12961. Epub 2017 Sep 4.

oa_host_type: publisher

evidence: oa journal (via publisher name)

publisher_dissemination: Hindawi

title: Study of Efficacy and Safety of V0498 Versus Placebo in Acute Sore Throat Pain.

location_country:
Germany
Latvia
United Kingdom
France


title: Randomized ph. II Study to Explore Efficacy and Feasibility of Upfront Rotations Between SUNitinib and Everolimus vs Sequential Treatment of 1st lIne Sunitinib & 2nd Line EverolimuS Until Progression in Pats Met. Clear Cell Renal Cancer

acronym: SUNRISES

summary: The objective of this study is to assess the progression-free survival, of patients who receive rotations of sunitinib and everolimus versus patients who receive sunitinib as a first line treatment followed by everolimus when progression occurs.

status: Terminated

ReferenceCitation: Rodriguez-Vida A, Bamias A, Esteban E, Saez MI, Lopez-Brea M, Castellano D, Caballero C, Gonzalez-Larriba JL, Calvo E, Macia S, Ravaud A, Bellmunt J. Randomised Phase II study comparing alternating cycles of sunitinib and everolimus vs standard sequential administration in first-line metastatic renal carcinoma (SUNRISES study). BJU Int. 2020 Nov;126(5):559-567. doi: 10.1111/bju.15165. Epub 2020 Aug 2.

publisher_dissemination: Wiley

lead_sponsor: Associació per a la Recerca Oncologica, Spain

collaborators:
Novartis
Pivotal S.L.

location_country: Spain Greece France

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital General Universitario de Valencia


title: Post-Market Surveillance Registry for the NeoChord DS1000

summary: To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System

lead_sponsor: NeoChord

location_country: Germany Italy Lithuania Switzerland France

location_facility: Vilniaus Universiteto ligonines Santariskiu

location_facility: Bordeaux Heart University Hospital (CHU)


title: POLARIS: A Non-interventional Study in Patients With Diabetic Macular Edema (DME) With Central Involvement to Assess the Effectiveness of Existing Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment Regimens

acronym: POLARIS

summary: POLARIS : A non-interventional study in patients with diabetic macular edema (DME) with central involvement to assess the effectiveness of existing anti-vascular endothelial growth factor (anti-VEGF) treatment regimens.

lead_sponsor: Bayer

sponsor_collaborators:
Bayer
Regeneron Pharmaceuticals

location_country:
Germany
Portugal
Slovakia
United Kingdom
Spain
Greece
Russian Federation
France


summary: This is a prospective, randomised, open label, controlled pilot study to evaluate the safety and preliminary effectiveness of the ReCell Autologous Cell Harvesting Device (ReCell) for the management of chronic leg ulcers associated with venous insufficiency. Outcome will be compared between study participants receiving standard care (debridement, compression therapy) and participants receiving ReCell in addition to standard care.

lead_sponsor: Avita Medical

sponsor_collaborators:
Avita Medical
NAMSA

location_country:
United Kingdom
France

location_facility: University Hospital of South Manchester - Wythenshawe Hospital

location_facility: The Leeds Teaching Hospitals - James's University Hospital

location_facility: Cambridge University Hospitals - Addenbrooke's Hospital


title: Taste and Palatability of Orfadin Suspension. An Open, Non-controlled 3 Day Study in Pediatric Patients With Hereditary Tyrosinemia Type 1 Treated With Orfadin.

summary: The purpose of this study is to verify that pediatric patients, especially those who are not old enough to swallow capsules, accept the taste and palatability of a new suspension.

lead_sponsor: Swedish Orphan Biovitrum

location_country:
Germany
United Kingdom
France

location_facility: Evelina Children's Hospital, St Thomas' Hospital


title: Open-label, Single-arm, Multi-center Study of Intracerebral Administration of Adeno-associated Viral (AAV) Serotype rh.10 Carrying Human N-sulfoglucosamine Sulfohydrolase (SGSH) cDNA for Treatment of Mucopolysaccharidosis Type IIIA

acronym: AAVance

summary: MPS IIIA is predominantly a central nervous system disease causing cognitive disability, progressive loss of acquired skills, behavioral and sleep disturbance. LYS-SAF302 is a gene therapy which is intended to deliver a functional copy of the SGSH gene to the brain. This is a phase 2-3 study to assess the efficacy in improving or stabilizing the neurodevelopmental state of MPS IIIA patients.

ReferenceCitation: Tardieu M, Zerah M, Husson B, de Bournonville S, Deiva K, Adamsbaum C, Vincent F, Hocquemiller M, Broissand C, Furlan V, Ballabio A, Fraldi A, Crystal RG, Baugnon T, Roujeau T, Heard JM, Danos O. Intracerebral administration of adeno-associated viral vector serotype rh.10 carrying human SGSH and SUMF1 cDNAs in children with mucopolysaccharidosis type IIIA disease: results of a phase I/II trial. Hum Gene Ther. 2014 Jun;25(6):506-16. doi: 10.1089/hum.2013.238. Epub 2014 May 5.

lead_sponsor: LYSOGENE

location_country:
Germany
United Kingdom
Netherlands
United States
France

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Baylor college of medicine / Texas children's hospital


title: A Multicenter, Open Label, Sponsor Blinded, Randomized, Active Controlled, Parallel Group, Pivotal Study to Evaluate the Efficacy, Safety, and Tolerability of Murepavadin Given With Ertapenem Versus an Anti-pseudomonal-β-lactam-based Antibiotic in Adult Subjects With Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa

acronym: PRISM-UDR

summary: This is a phase 3, multicenter, open-label, sponsor blinded, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous murepavadin given with ertapenem versus an anti-pseudomonal β-lactam based antibiotic in the treatment of nosocomial pneumonia in adult subjects

lead_sponsor: Polyphor Ltd.

location_country:
United States
Czechia
Israel
France

location_facility:
Research site
Research Site


type: Registry Identifier

title: ATLAS-PPX: an Open-label, Multinational, Switching Study to Describe the Efficacy and Safety of Fitusiran Prophylaxis in Patients With Hemophilia A and B Previously Receiving Factor or Bypassing Agent Prophylaxis.

acronym: ATLAS-PPX

summary:
Primary Objective:

To characterize the frequency of bleeding episodes (BE) while receiving fitusiran treatment, relative to the frequency of bleeding episodes while receiving factor concentrate or bypassing agent (BPA) prophylaxis.

Secondary Objectives:

To characterize the following while receiving fitusiran treatment, relative to receiving factor or BPA prophylaxis:
the frequency of spontaneous bleeding episodes
the frequency of joint bleeding episodes
health related quality of life (HRQOL) in participants greater than or equal to (>=) 17 years of age
To characterize the frequency of bleeding episodes during the onset and treatment periods in participants receiving fitusiran.
To characterize the safety and tolerability of fitusiran.
To characterize the annualized weight-adjusted consumption of factor/BPA while receiving fitusiran treatment, relative to receiving factor or BPA prophylaxis.

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

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Ireland
Italy
Israel
United Kingdom
Denmark
Australia
Japan
Mexico
United States
China
Korea, Republic of
Malaysia
Turkey
Ukraine
France

location_facility:
Investigational Site Number 9005
Investigational Site Number 8104
Investigational Site Number 8204
Investigational Site Number 8202
Investigational site number 9013
Investigational Site Number 4407
Investigational Site Number 8201
Investigational Site Number 9001
Investigational Site Number 4402
Investigational Site Number 9006
Investigational Site Number 8002
Investigational Site Number 9004
Investigational Site Number 8101
Investigational Site Number 6003
Investigational Site Number 5301
Investigational Site Number 9003
Investigational Site Number 4401
Investigational Site Number 4403
Investigational Site Number 6002
Investigational Site Number 4501
Investigational Site Number 6004
Investigational Site Number 5201
Investigational Site Number 9008
Investigational Site Number 3902
Investigational Site Number 9002
Investigational Site Number 9010
Investigational Site Number 9009
Investigational Site Number 8003
Investigational Site Number 8109
Investigational Site Number 8604
Investigational Site Number 0139
Investigational Site Number 8102
Investigational Site Number 3303
Investigational Site Number 6104
Investigational Site Number 9701


title: Open Label, Two Cohort (With and Without Imiglucerase), Multicenter Study to Evaluate Pharmacokinetics, Safety, and Efficacy of Eliglustat in Pediatric Patients With Gaucher Disease Type 1 and Type 3

acronym: ELIKIDS

summary:
Primary Objective:

Evaluate the safety and pharmacokinetics of eliglustat in pediatric patients (≥2 to <18 years old).

Secondary Objective:

Evaluate the efficacy of eliglustat and quality of life in pediatric patients (≥2 to <18 years old).

lead_sponsor: Sanofi

location_country:
Italy
United Kingdom
Argentina
Japan
Sweden
Spain
Turkey
Canada
Russian Federation
France

location_facility:
Investigational Site Number : 3920002
Investigational Site Number : 3800002
Investigational Site Number : 1240001
Investigational Site Number : 7240002
Investigational Site Number : 3920001
Investigational Site Number : 7520001
Investigational Site Number : 6430004
Investigational Site Number : 0320001
Investigational Site Number : 6430005
Investigational Site Number : 7920002
Investigational Site Number : 7520002
Investigational Site Number : 6430001
Investigational Site Number : 1240002
Investigational Site Number : 8260002
Investigational Site Number : 2500002
Investigational Site Number : 7240003
Investigational Site Number : 7920003
Investigational Site Number : 6430002
Investigational Site Number : 7240001
Investigational Site Number : 1240003
Investigational Site Number : 7920004


title: Natural History Study of CEP290-Related Retinal Degeneration

summary: A prospective natural history study with systematic assessments and uniform follow-up to provide a high-quality dataset for assisting in the design of future clinical treatment trials involving patients with CEP290-related retinal degeneration caused by the common intron 26 mutation.

lead_sponsor: Editas Medicine, Inc.

location_country:
United States
Netherlands
Germany
France

location_facility: Universitaetsklinikum Giessen and Marburg GmbH


title: Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty. A Multicenter, Prospective, Non-controlled Post Market Clinical Follow-up Study

summary: This study is a multicenter, prospective, non-controlled post market clinical follow-up study. The objectives of this study are to confirm the safety and performance of the commercially available Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty.

lead_sponsor: Zimmer Biomet

location_country:
Finland
United Kingdom
Australia
Netherlands
Belgium
Spain
Canada
France

location_facility: Royal Liverpool and Broadgreen University Teaching Hospitals


title: Phase 1/1b Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 as Monotherapy and in Combination With AMG 404 in Subjects With Glioblastoma or Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII)

summary:
This is a Phase 1/1b Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 monotherapy or in combination with AMG 404 in Subjects with Glioblastoma or Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII).

This is a first in human (FIH), open-label, sequential-dose-escalation study in subjects with EGFRvIII-positive glioblastoma or malignant glioma. This study will enroll 2 groups of subjects according to disease stage, recurrent disease (Group 1) and maintenance treatment after SoC in newly diagnosed disease (Group 2).

ReferenceCitation: Sternjak A, Lee F, Thomas O, Balazs M, Wahl J, Lorenczewski G, Ullrich I, Muenz M, Rattel B, Bailis JM, Friedrich M. Preclinical Assessment of AMG 596, a Bispecific T-cell Engager (BiTE) Immunotherapy Targeting the Tumor-specific Antigen EGFRvIII. Mol Cancer Ther. 2021 May;20(5):925-933. doi: 10.1158/1535-7163.MCT-20-0508. Epub 2021 Feb 25.

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

lead_sponsor: Amgen

location_country:
Germany
Australia
Netherlands
United States
Spain
France

location_facility: UniversitÃ¤tsklinikum Carl Gustav Carus der Technischen UniversitÃ¤t Dresden

location_facility: Hospital Universitari Germans Trias i Pujol


title: Abiliti™ Treatment in Obese Subjects: A Randomized Post-Market Surveillance Multicenter Study

summary: The main objective of this post-market surveillance study is to compare the subject's weight loss and quality of life, and device safety performance of the abiliti System and the adjustable gastric banding therapies in obese to morbidly obese subjects.

ReferenceCitation: Morales-Conde S, Alarcon Del Agua I, Busetto L, Favretti F, Anselmino M, Rovera GM, Socas-Macias M, Barranco-Moreno A, Province-Azalde R, Torres AJ. Implanted Closed-Loop Gastric Electrical Stimulation (CLGES) System with Sensor-Based Feedback Safely Limits Weight Regain at 24 Months. Obes Surg. 2018 Jun;28(6):1766-1774. doi: 10.1007/s11695-017-3093-8.

ReferenceCitation: Busetto L, Torres AJ, Morales-Conde S, Alarcon Del Agua I, Moretto C, Fierabracci P, Rovera G, Segato G, Rubio MA, Favretti F. Impact of the feedback provided by a gastric electrical stimulation system on eating behavior and physical activity levels. Obesity (Silver Spring). 2017 Mar;25(3):514-521. doi: 10.1002/oby.21760. Epub 2017 Feb 6.

evidence: open (via free article)

unpaywall_oa_status: bronze

ReferenceCitation: Alarcon Del Agua I, Socas-Macias M, Busetto L, Torres-Garcia A, Barranco-Moreno A, Garcia de Luna PP, Morales-Conde S. Post-implant Analysis of Epidemiologic and Eating Behavior Data Related to Weight Loss Effectiveness in Obese Patients Treated with Gastric Electrical Stimulation. Obes Surg. 2017 Jun;27(6):1573-1580. doi: 10.1007/s11695-016-2495-3.

lead_sponsor: IntraPace, Inc

location_country:
Germany
Italy
United Kingdom
Switzerland
Spain
France

location_facility: Polyclinique de Rillieux, Clinique Lyon-Nord

location_facility: Complutense University of Madrid Hospital Clinico "San Carlos"


title: Automatic Acoustic Speech Analysis and REM Sleep Behaviour Disorder for Detecting Subjects at High Risk for Parkinson's Disease and Other Alpha-synucleinopathies

summary: Speech is an important indicator of motor function and movement coordination and can be extremely sensitive to involvement in the course of neurologic diseases. The aim of this project is to discover for the first time using simple speech recording and high end pattern analysis preclinical stages of disabling central nervous system disorders including Parkinson's disease and other alpha-synucleinopathies in "at high risk" patients with REM sleep behavior disorder and thus provide one essential prerequisite for trials on REM sleep behavior disorder with preventive therapy.

primary_purpose: Diagnostic

ReferenceCitation: Rusz J, Hlavnicka J, Tykalova T, Buskova J, Ulmanova O, Ruzicka E, Sonka K. Quantitative assessment of motor speech abnormalities in idiopathic rapid eye movement sleep behaviour disorder. Sleep Med. 2016 Mar;19:141-7. doi: 10.1016/j.sleep.2015.07.030. Epub 2015 Sep 14.

ReferenceCitation: Postuma RB, Lang AE, Gagnon JF, Pelletier A, Montplaisir JY. How does parkinsonism start? Prodromal parkinsonism motor changes in idiopathic REM sleep behaviour disorder. Brain. 2012 Jun;135(Pt 6):1860-70. doi: 10.1093/brain/aws093. Epub 2012 May 4.

ipd_sharing_description: De-identified clinical data (speech recordings and associated clinical scales) may be shared with the Michael J. Fox Foundation (the study funder). This data may be kept for storage at a central repository either hosted by the Michael J. Fox Foundation, its collaborators, or consultants.

lead_sponsor: Czech Technical University in Prague

collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre

collaborators: Philipps University Marburg Medical Center

location_country:
Germany
Italy
Austria
United States
Czechia
Canada
France

location_facility:
General University Hospital
McGill University Health Centre
Mayo Clinic
University of Marburg
Gui-de-Chauliac Hospital
Medical University of Innsbruck
San Raffaele Hospital


title: A Phase III, Multicentre, Double Blinded Study In Patients With Chronic Hepatitis C Who Are Non-Responders To Prior Peginterferon Alpha + Ribavirin Therapy Comparing Treatment With Thymosin Alpha 1 + Peginterferon Alpha-2a Plus Ribavirin With Peginterferon Alpha-2a + Ribavirin + Placebo

summary: The purpose of the study was to determine safety and efficacy of 48 weeks treatment with Thymosin alpha 1 (Talpha1) in combination with pegylated interferon (PEGIFN) alpha2a and ribavirin (RBV) in adult patients with chronic hepatitis C (CHC) already treated with, and not responding to previous courses of PEGIFN alpha plus RBV combination therapy, in comparison with a concurrent group treated with PEG IFN alpha2a in combination with RBV and placebo.

ReferenceCitation: Ciancio A, Andreone P, Kaiser S, Mangia A, Milella M, Sola R, Pol S, Tsianos E, De Rosa A, Camerini R, McBeath R, Rizzetto M. Thymosin alpha-1 with peginterferon alfa-2a/ribavirin for chronic hepatitis C not responsive to IFN/ribavirin: an adjuvant role? J Viral Hepat. 2012 Jan;19 Suppl 1:52-9. doi: 10.1111/j.1365-2893.2011.01524.x.

lead_sponsor: sigma-tau i.f.r. S.p.A.

sponsor_collaborators:
sigma-tau i.f.r. S.p.A.
SciClone Pharmaceuticals

location_country: Germany Italy Spain Greece France

location_facility: Dipartimento Medico Chirurgico delle Malattie dell'Apparato Digerente e della Nutrizione, Azienda Ospedaliera S Giovanni Battista


title: Performance of Acoustic Radiation Force Impulse-Imaging in Comparison to Transient Elastography for the Non-invasive Staging of Liver Fibrosis in Patients With Chronic Hepatitis C

summary: This study will evaluate the effectiveness of Acoustic Radiation Force Impulse (ARFI)- Imaging compared to Transient Elastography (FibroScan) in differentiating liver fibrosis in patients with chronic hepatitis C. Patients who are scheduled to have a liver biopsy will also undergo ARFI and FibroScan testing. The liver biopsy will be used as the reference method. The target sample size is 433.

lead_sponsor: Johann Wolfgang Goethe University Hospital

location_country: Germany Netherlands France

location_facility: Klinikum der Ludwig-Maximilians-Universität-Campus Großhadern


title: A Prospective, Double Blind Randomised Controlled Trial to Evaluate the Immunological Benefits and Clinical Effects of an Elimination Diet Using an Amino Acid Based Formula (AAF)

summary: The purpose of this study is to evaluate whether a new version of an amino acid based formula improves tolerance to milk in cow's milk allergic infants/young children.

ReferenceCitation: Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

oa_host_type: repository

unpaywall_oa_status: green

lead_sponsor: Nutricia Research

location_facility: Evelina Children's Hospital - St Thomas' Hospital

location_facility: David Hyde Allergy Clinic - St. Mary's hospital


lead_sponsor: Durect

summary: The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on the efficacy and safety of the product.

sponsor_collaborators: Durect Nycomed

title: An International, Randomised, Double Blinded, Multi-centre, Active- and Placebo-controlled Dose Response Trial to Evaluate the Efficacy and Safety of SABER-Bupivacaine for Postoperative Pain Control in Patients Undergoing Primary, Elective, Open, Abdominal Hysterectomy

location_country:
Germany
France
Hungary
United Kingdom
Latvia
Sweden


title: A Substudy of the IBCSG 24-02/ SOFT Trial to Investigate Estrogen Suppression for Patients Participating in Arms B and C of the IBCSG 24-02/ SOFT Trial

acronym: SOFT-EST

summary:
RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may help doctors learn how well triptorelin given together with tamoxifen citrate or exemestane works in lowering estrogen levels.

PURPOSE: This clinical trial is studying estrogen levels in premenopausal women who have undergone surgery for breast cancer and are receiving triptorelin and tamoxifen citrate or exemestane on clinical trial IBCSG-2402.

lead_sponsor: ETOP IBCSG Partners Foundation

location_country: Italy Portugal Hungary Sweden Switzerland Spain Peru France

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Sahlgrenska University Hospital Gothenburg

location_facility: Clinica Oncologica, Policlinico Univeritario

location_facility: Hospital Clinico Universitario de Valencia

location_facility: INEN (Instituto de Enfermedades Neoplasicas)


lead_sponsor: Pfizer

summary: Study to evaluate the safety and effectiveness of ReFacto AF for the treatment of severe hemophilia A in patients who have not yet received treatment for their hemophilia. Study subjects will be males less than 6 years old who have not taken any clotting factor or other blood products before the study. The safety and effectiveness of ReFacto AF will be determined in this study by tests and procedures done at the doctor's office.

location_facility: Klinikum Bremen-Mitte gGmbH, Professor Hess Kinderklinik

location_facility: Derzhavna ustanova "Instytut patolohii krovi ta transfuziinoi medytsyny Natsionalnoi akademii

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Agenzia per L'emofilia e Centro Regionale Riferimento Coagulopatie Congenite

title: AN OPEN-LABEL STUDY OF THE SAFETY AND EFFICACY OF REFACTO AF IN PREVIOUSLY UNTREATED PATIENTS IN USUAL CARE SETTINGS

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: Germany Italy Netherlands Spain Turkey Ukraine France


title: Phase II Efficacy and Safety Study of Dasatinib in Patients With Chronic and Accelerated Phase Chronic Myeloid Leukemia Relapsing After Allogeneic Blood or Bone Marrow Transplantation

acronym: Dasatinib

summary:
This is a phase II efficacy (indicates the capacity for beneficial change or therapeutic effect) and safety study of Dasatinib in patients with relapsed Chronic Myeloid Leukemia (CML) following a Stem Cell Transplant (SCT) and who are not benefiting from other treatment, such as imatinib therapy.

A relapse is when an illness that has seemed to be getting better, or to have been cured, comes back or gets worse again.

A total of 50 patients ≥18 years of age will be registered on the trial.

lead_sponsor: European Society for Blood and Marrow Transplantation

location_country:
Germany
United Kingdom
Switzerland
France

location_facility:
Stiftung Deutsche Klinik für Diagnostik
Uniklinik Leipzig
Hammersmith Hospital
E Herriot Hospital
Hopitaux Universitaires de Geneve
University Hospital


title: A Randomized, Open-label, Controlled, Multi-center Phase II Study to Evaluate the Efficacy and Safety of Adecatumumab Alone or Sequentially to FOLFOX Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases

summary: The purpose of this study is to determine the effect of adecatumumab alone or following FOLFOX in patients with R0 resected liver metastases from CRC (colorectal carcinoma) and to compare the effect to FOLFOX alone.

lead_sponsor: Amgen Research (Munich) GmbH

location_country: Germany France

location_facility: Klinikum am Bruderwald, Sozialstiftung Bamberg

location_facility: Universitätsklinikum der LMU Grosshadern

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: Klinikum der Johannes-Gutenberg Universität


lead_sponsor: CSL Behring

summary: This study is a continuation of the study ZLB06_001CR with the objective of assessing efficacy, tolerability, safety of IgPro, as well as long-term health-related quality of life in patients with PID.

ReferenceCitation: Jolles S, Borte M, Nelson RP Jr, Rojavin M, Bexon M, Lawo JP, Wasserman RL. Long-term efficacy, safety, and tolerability of Hizentra(R) for treatment of primary immunodeficiency disease. Clin Immunol. 2014 Feb;150(2):161-9. doi: 10.1016/j.clim.2013.10.008. Epub 2013 Oct 26.

repository_institution: Cardiff University - ORCA Online Research @Cardiff

version: acceptedVersion

title: A Multicenter Extension Study of the Efficacy, Tolerability, and Safety of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency (IgPro20 EU Extension Study)

location_country:
Germany
Poland
United Kingdom
Romania
Sweden
Switzerland
Spain
France


title: A Prospective, Non-comparative Study to Evaluate the Performance of the DePuy P.F.C. Sigma Rotating Platform TC3 Knee Prosthesis in Revision Knee Arthroplasty.

summary: The purpose of this study is to evaluate the long-term clinical and functional performance of the P.F.C. Sigma Rotating Platform TC3 knee system in revision knee surgery and to determine whether the implant design results in a longer-lasting knee replacement.

lead_sponsor: DePuy International

location_facility: Robert Jones & Agnes Hunt Orthopaedic Hospital


title: BIO|MASTER.Ilivia Family / Plexa

summary: Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right ventricular lead to fulfill requirements by the notified body and to support regulatory approval outside of the CE region

lead_sponsor: Biotronik SE & Co. KG

location_country: Germany Israel Singapore Denmark Australia Switzerland Austria Latvia Spain France

location_facility: Hospital Universitario Virgen de Macarena

location_facility: Pauls Stradins Clinical University Hospital


title: COSIMO Cancer Associated Thrombosis - Patient Reported Outcomes With Rivaroxaban. A Non-interventional Study on Patients Changing to Xarelto® for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer.

acronym: COSIMO

summary: This study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).

ReferenceCitation: Maraveyas A, Beyer-Westendorf J, Lee AY, Mantovani LG, De Sanctis Y, Abdelgawwad K, Fatoba S, Bach M, Cohen AT. Cancer-Associated ThrOmboSIs - Patient-Reported OutcoMes With RivarOxaban (COSIMO) - Baseline characteristics and clinical outcomes. Res Pract Thromb Haemost. 2021 Nov 30;5(8):e12604. doi: 10.1002/rth2.12604. eCollection 2021 Dec.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Cohen AT, Maraveyas A, Beyer-Westendorf J, Lee AYY, Mantovani LG, Bach M; COSIMO Investigators. COSIMO - patients with active cancer changing to rivaroxaban for the treatment and prevention of recurrent venous thromboembolism: a non-interventional study. Thromb J. 2018 Sep 4;16:21. doi: 10.1186/s12959-018-0176-2. eCollection 2018.

repository_institution: University of Milano-Bicocca - BOA - Bicocca Open Archive

lead_sponsor: Bayer

sponsor_collaborators:
Bayer
Janssen Research & Development, LLC

location_country:
Germany
Italy
United Kingdom
Denmark
Australia
Netherlands
Belgium
Spain
Canada
France


title: A Phase 4 Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, MultiCentre Study of Colesevelam as Add-on Therapy in Patients With Familial Hypercholesterolaemia

summary: This study is designed to assess whether colesevelam given as third line treatment added to a maximal tolerated and stable dose of a statin and ezetimibe is able to further decrease the level of LDL cholesterol in a safe and efficient manner in difficult to treat Familial Hypercholesterolaemia patients who are not at their target level of LDL cholesterol.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Germany
France
United Kingdom
Netherlands
Sweden

location_facility: Department of Medicine, University of Manchester

location_facility: Service d'Endocrinologie, Metabolisme Prevention des Maladies Cardio-Vasculaires


title: A Phase I/Ib, Open Label Study of LSZ102 Single Agent and LSZ102 in Combination With Either LEE011 (LSZ102 + LEE011) or BYL719 (LSZ102 + BYL719) in Patients With Advanced or Metastatic ER+ Breast Cancer Who Have Progressed After Endocrine Therapy

summary: To characterize the safety and tolerability, identify recommended doses and regimens for future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LSZ102 as a single agent and in combination with either LEE011 or BYL719 in adult patients with locally advanced or metastatic ER+ breast cancer who have progressed after endocrine therapy.

ReferenceCitation: Jhaveri K, Juric D, Yap YS, Cresta S, Layman RM, Duhoux FP, Terret C, Takahashi S, Huober J, Kundamal N, Sheng Q, Balbin A, Ji Y, He W, Crystal A, De Vita S, Curigliano G. A Phase I Study of LSZ102, an Oral Selective Estrogen Receptor Degrader, with or without Ribociclib or Alpelisib, in Patients with Estrogen Receptor-Positive Breast Cancer. Clin Cancer Res. 2021 Nov 1;27(21):5760-5770. doi: 10.1158/1078-0432.CCR-21-1095. Epub 2021 Aug 25.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repositories_concat: PubMed Central;air.unimi.it

publisher_dissemination: American Association for Cancer Research

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Singapore
Japan
Belgium
United States
France

location_facility: Massachusetts General Hospital Massachusetts General Hospital

location_facility: MD Anderson Cancer Center SC - LSZ102X2101


title: A Phase 1b Dose-Escalation and Cohort-Expansion Study of the Safety, Tolerability, and Efficacy of a Novel Transforming Growth Factor-β Receptor I Kinase Inhibitor (Galunisertib) Administered in Combination With the Anti-PD-L1 Antibody Durvalumab (MEDI4736) in Recurrent or Refractory Metastatic Pancreatic Cancer

summary: The main purpose of this study is to evaluate the safety and efficacy of the study drug known as galunisertib administered in combination with the anti-programmed cell death-ligand 1 (PD-L1) antibody durvalumab in participants with refractory metastatic pancreatic cancer.

ReferenceCitation: Melisi D, Oh DY, Hollebecque A, Calvo E, Varghese A, Borazanci E, Macarulla T, Merz V, Zecchetto C, Zhao Y, Gueorguieva I, Man M, Gandhi L, Estrem ST, Benhadji KA, Lanasa MC, Avsar E, Guba SC, Garcia-Carbonero R. Safety and activity of the TGFbeta receptor I kinase inhibitor galunisertib plus the anti-PD-L1 antibody durvalumab in metastatic pancreatic cancer. J Immunother Cancer. 2021 Mar;9(3):e002068. doi: 10.1136/jitc-2020-002068.

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: British Medical Journal

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
AstraZeneca

location_country:
Italy
United States
Korea, Republic of
Spain
France

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma


title: Randomised, Double-blind, Placebo-controlled Study of APD421 (Amisulpride for IV Injection) as Treatment of Established Post-operative Nausea and Vomiting, in Patients Who Have Had Prior Prophylaxis

summary: Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless, dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established PONV, in patients who have had prior PONV prophylaxis.

lead_sponsor: Acacia Pharma Ltd

location_country:
United States
Germany
France

location_facility: Wake Forest University School of Medicine