title: An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor Fluctuations

summary: A study of an investigational drug to see how it affects the people with Parkinson's Disease complicated by motor fluctuations ("OFF" Episodes) compared to an approved drug used to treat people with Parkinson's Disease complicated by motor fluctuations ("OFF" Episodes)

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

lead_sponsor: Sunovion

location_country:
Spain
Italy
Austria
United Kingdom
France
Germany

location_facility: Centre d'Investigation Clinique, CIC 43, CHU Purpan, Hopital Pierre-Paul Riquet, place du Dr. Baylac, Hall D, 2 eme etage -TSA

location_facility: St. Josef Hospital, Klnikum der Ruhr-Universitat-Bochum, Neurologische Klinik

location_facility: University Hospitals Plymouth NHS Trust-Derriford Hospital-The Lind Research Center, Level 5, Terence Lewis Building

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen

location_facility: Academic Neuroscience Department, C Floor, South Block, Nottingham University Hospitals NHS Trust Queens Medical Centre

location_facility: NHS Forth Valley, Pennine Actue NHS Trust, Fairfield General Hospital

location_facility: A.O.U. Universita degli Studi della Campania "Luigi Vanvitelli" Dipartamento di Scienze Mediche e Chirurgiche Avanzate

location_facility: Charite-University Medicine Berlin, Department of Neurology, Campus charite Mitte

location_facility: IRCCS San Raffaele Pisana-Clinical Trial Center

location_facility: St. Joseph Krankenhaus Berlin - Weissensee, Abteilung fur Neurologie

location_facility: Medical University Innsbruck, Neurolgy Dept

location_facility: Klinken Beelitz GmbH Neurologisches Fachkrankenhaus fur Bewegungsstorungen/Parkinson

location_facility: Hospital Universitario de Cruces, Neurology

location_facility: 10W, Imperial Memory/PD Research Unit, Imperial College Healthcare NHS Trust

location_facility: University Hospital Policlinico-Vittorio Emanuele, Department "G.F. Ingrassia", Section of Neurosciences

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Universitatsklinikum Carol Gustav Carus an der TU dDresden, Klinik umd Poliklinik fur Neurologie

location_facility: AOU San Giovanni di Dio e Ruggid'Aragona-CEMAND

location_facility: CINAC, Hospital Universitario HB Pueta del Sur

location_facility: Hospital de la Santa Creu i Sant Pau c/Mas de Casanovas 90

location_facility: Istituto Clinico Humanitas, Dipartmento di Neurologia 1

location_facility: Wilhelminenspital, Department of Neurology


ipd_sharing: Yes

status: Active, not recruiting

primary_purpose: Treatment

acronym: LemKids

intervention_type: Drug

title: A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT)

study_completion_date_type: Anticipated

lead_sponsor: Genzyme, a Sanofi Company

type: EudraCT Number

type: Other Identifier

source: euctr

study_start_date_type: Actual

study_type: Interventional

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

enrollment_type: Actual

location_country:
Poland
Portugal
United Kingdom
Italy
Austria
Russian Federation
France
Turkey
Belgium
Netherlands

location_facility:
Investigational Site Number :6200001
Investigational Site Number :6430001
Investigational Site Number :3800005
Investigational Site Number :6430005
Investigational Site Number :7920003
Investigational Site Number :7920004
Investigational Site Number :5280001
Investigational Site Number :3800001
Investigational Site Number :6430004
Investigational Site Number :0400001
Investigational Site Number :6160001
Investigational Site Number :2500002
Investigational Site Number :7920001
Investigational Site Number :3800004
Investigational Site Number :7920002
Investigational Site Number :0560001
Investigational Site Number :6160003
Investigational Site Number :2500001
Investigational Site Number :8260002
Investigational Site Number :6430002
Investigational Site Number :6160002

summary:
Primary Objective:

To evaluate the efficacy, safety, and tolerability of alemtuzumab intravenously (IV) in pediatric participants from 10 to less than (<) 18 years of age with Relapsing Remitting Multiple Sclerosis (RRMS) who have disease activity on prior DMT.

Secondary Objective:

To assess the pharmacokinetics (PK), pharmacodynamics (PD), anti-drug antibody (ADA) formation, and potential effects of alemtuzumab on other multiple sclerosis (MS) disease characteristics such as cognition and quality of life (QoL).

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Prospective Multi-Center, Single Arm Post-Market Study (PMS) of the Shockwave Medical, Inc. Coronary Lithoplasty® System in Coronary Arteries

summary: The objective of this post market study is to examine the safety and performance of the Shockwave Coronary Intravascular Lithotripsy System for the treatment of narrowed coronary arteries before the doctor places a stent.

status: Completed

study_completion_date_type: Actual

ReferenceType: derived

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

ReferenceCitation: Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Circ Cardiovasc Interv. 2019 Oct;12(10):e008434. doi: 10.1161/CIRCINTERVENTIONS.119.008434. Epub 2019 Sep 25.

ipd_sharing: No

lead_sponsor: Shockwave Medical, Inc.

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

location_facility: Oxford University Hospitals, John Radcliffe Hospital

location_facility: Universitaets-Herzzentrum Freiburg- Bad Krozingen

intervention_type: Device

status_simplified: Completed


title: Phase I Study of Intratumoral CV8102 in Patients With Advanced Melanoma, Squamous Cell Carcinoma of the Skin, Squamous Cell Carcinoma of the Head and Neck, or Adenoid Cystic Carcinoma

summary:
This study evaluates intratumoral administration of CV8102 in patients with advanced melanoma, squamous cell carcinoma of the skin, squamous cell carcinoma of the head and neck, or adenoid cystic carcinoma.

Patients will receive CV8102 as single agent or in combination with SoC anti-PD-1 therapy.

design_allocation: Non-Randomized

ReferenceCitation: Lutz J, Meister M, Habbeddine M, Fiedler K, Kowalczyk A, Heidenreich R. Local immunotherapy with the RNA-based immune stimulator CV8102 induces substantial anti-tumor responses and enhances checkpoint inhibitor activity. Cancer Immunol Immunother. 2022 Nov 2. doi: 10.1007/s00262-022-03311-4. [Epub ahead of print]

lead_sponsor: CureVac

location_country:
Spain
Austria
Russian Federation
France
Germany

location_facility: Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Allergologie und Venerologie

location_facility: Universitätsklinikum Münster, Klinik für Hautkrankheiten, ZiD- Zentrum für innovative Dermatologie

location_facility: Hospital Universitario Marqus de Valdecilla Santander

location_facility: Universitätsklinik für Dermatologie der Paracelsus medizinischen Privatuniversität Salzburg

location_facility: FSBI "National Medical Research Oncology Center n.a. N.N. Petrov

location_facility: Universitäts-Hautklinik, Abtl. Dermatologische Onkologie

location_facility: Center for Personalized Oncology, I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation

location_facility: Universitätsklinikum Erlangen,Hautklinik, Internistisches Zentrum (INZ)

location_facility: Medizinische Klinik III, Universitätsklinikum Bonn, Hämatologie, Immunonkologie und Rheumatologie

location_facility: FSBI "National Medical Research Center of Oncology n.a. N.N. Blokhin" of the Ministry of Healthcare of the Russian Federation

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg

location_facility: Hospital Duran i Reynals - Institut Catala dOncologia ICO

location_facility: Saint-Petersburg State University, Clinic of advanced medical technologies n. a. Nicolay I. Pirogov.

location_facility: Hospital Universitario Virgen de la Victoria

intervention_type: Biological


title: A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Study to Evaluate the Efficacy, Safety and Tolerability of Single Doses of BCX7353 as an Acute Attack Treatment in Subjects With Hereditary Angioedema

summary: This 3-part study will evaluate the efficacy and safety of an oral kallikrein inhibitor, BCX7353, in the treatment angioedema attacks in subjects with Type I or II hereditary angioedema (HAE). In each study part, subjects will treat 3 attacks with BCX7353 (2 attacks) or placebo (1 attack), in a randomly allocated order. In Part 1, the dose of 750mg will be assessed relative to placebo in up to 36 patients. If this is shown to be effective, then a further 12 patients will be enrolled at a 500mg dose (Part 1), followed by a further 12 (if efficacy still shown) at a dose of 250mg (Part 3) to determine the minimum effective dose of BCX7353 compared to placebo for treating HAE attacks. Efficacy will be determined by subject diary entries completed at pre-defined times post-dose.

design_allocation: Randomized

lead_sponsor: BioCryst Pharmaceuticals

location_country:
Denmark
Poland
United Kingdom
Italy
Austria
Switzerland
Hungary
North Macedonia
France
Israel
Romania
Germany

location_facility:
Study Center
Study center


title: Validation of the "Toronto Aortic Stenosis Quality of Life Questionnaire" in Patients Undergoing Surgical Aortic Valve Replacement or Transfemoral Transcatheter Aortic Valve Implantation The TASQ Registry

acronym: TASQ

summary: Prospective, multi-centre, multi-national registry with a follow-up of 3 months, in five European countries and Canada (Toronto), with elective patients undergoing TF-TAVI (n=120) and isolated SAVR (n=120), respectively and a control group of 50 patients receiving medical treatment only. All patient groups will fill in three different questionnaires to assess quality of life in 5 different languages (English, French, German, Italian and Spanish). One of these will be a new questionnaire, the Toronto Aortic Stenosis QoL (Quality of Life) questionnaire (TASQ).

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Frank D, Kennon S, Bonaros N, Romano M, Lefèvre T, Di Mario C, Stefàno P, Ribichini FL, Himbert D, Urena-Alcazar M, Salgado-Fernandez J, Cuenca Castillo JJ, Garcia B, Kurucova J, Thoenes M, Lüske C, Bramlage P, Styra R. Trial protocol for the validation of the 'Toronto Aortic Stenosis Quality of Life (TASQ) Questionnaire' in patients undergoing surgical aortic valve replacement (SAVR) or transfemoral (TF) transcatheter aortic valve implantation (TAVI): the TASQ registry. Open Heart. 2019 May 21;6(1):e001008. doi: 10.1136/openhrt-2019-001008. eCollection 2019.

ReferenceType: result

ReferenceCitation: Frank D, Kennon S, Bonaros N, Stastny L, Romano M, Lefèvre T, Di Mario C, Stefàno P, Ribichini F, Himbert D, Urena-Alcazar M, Salgado-Fernandez J, Castillo JJC, Garcia Del Blanco B, Deutsch C, Sykorova L, Kurucova J, Thoenes M, Lüske CM, Bramlage P, Styra R. Aortic valve replacement: validation of the Toronto Aortic Stenosis Quality of Life Questionnaire. ESC Heart Fail. 2021 Feb;8(1):270-279. doi: 10.1002/ehf2.12961. Epub 2020 Nov 18.

ReferenceCitation: Kennon S, Styra R, Bonaros N, Stastny L, Romano M, Lefèvre T, Di Mario C, Stefàno P, Ribichini FL, Himbert D, Urena-Alcazar M, Salgado-Fernandez J, Cuenca Castillo JJ, Garcia B, Deutsch C, Sykorova L, Kurucova J, Thoenes M, Lüske C, Bramlage P, Frank D. Quality of life after transcatheter or surgical aortic valve replacement using the Toronto Aortic Stenosis Quality of Life Questionnaire. Open Heart. 2021 Nov;8(2). pii: e001821. doi: 10.1136/openhrt-2021-001821.

lead_sponsor: Institut für Pharmakologie und Präventive Medizin

location_country:
Spain
Italy
Austria
United Kingdom
Canada
France
Germany

location_facility: UKSH University Clinical Center Schleswig-Holstein

location_facility: Department of Medicine, University of Verona

location_facility: Structual Interventional Cardiology, University Hospital Careggi

location_facility: University Health Network, Toronto General Hospital

intervention_type: Other


title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 2 Dose Regimens of Orally Administered SENS-111 (100 mg and 200 mg) Given During 4 Days in Patients Suffering From Acute Unilateral Vestibulopathy

summary: A multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 2 dose-regimens of orally administered SENS-111 (100mg and 200mg) given during 4 days in patients suffering from Acute Unilateral Vestibulopathy (AUV)

lead_sponsor: Sensorion

location_country:
Italy
Hungary
Korea, Republic of
United States
France
Israel
Germany
Czechia

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

location_facility: Bajcsy-Zsilinszky Kórház és Rendelőintézet

location_facility: Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ

location_facility: Pécsi Tudományegyetem, ÁOK Klinikai Központ

location_facility: Seoul National University Bundang Hospital


title: Efficacy and Safety of CD5024 1% in Acne Vulgaris

summary: Exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using intra-individual comparison involving subjects with acne vulgaris on face to evaluate the efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle.

primary_purpose: Other

lead_sponsor: Galderma R&D

location_country: Germany Canada France

location_facility:
Galderma Investigational Site (# 8060)
Galderma Investigational site
Galderma investigational site


status: Terminated

title: A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC

lead_sponsor: Samsung Bioepis Co., Ltd.

ReferenceCitation: Pivot X, Pegram M, Cortes J, Lüftner D, Lyman GH, Curigliano G, Bondarenko I, Yoon YC, Kim Y, Kim C. Three-year follow-up from a phase 3 study of SB3 (a trastuzumab biosimilar) versus reference trastuzumab in the neoadjuvant setting for human epidermal growth factor receptor 2-positive breast cancer. Eur J Cancer. 2019 Oct;120:1-9. doi: 10.1016/j.ejca.2019.07.015. Epub 2019 Aug 21.

location_country:
Poland
Russian Federation
Ukraine
France
Romania
Bulgaria
Czechia

location_facility: Vinnytsia Regional Clinical Oncological Dispensary

location_facility: SBI of Ryazan region "Regional Clinical Oncological Dispensary"

location_facility: Saint-Petersburg SBHI "City Clinical Oncology Dispensary"

location_facility: Communal Institution Zaporizhzhia Regional Clinical Oncological Dispensary of Zaporizhzhia Regional Council

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Spitalul Municipal Ploiesti, Sectia Oncologie Medicala

location_facility: Communal Institution of Kherson Regional Council Kherson Regional Oncological Dispensary

location_facility: Lviv State Oncological Regional Treatment and Diagnostic Center

location_facility: Bialostockie Centrum Onkologii im.M.Sklodowskiej-Curie w Bialymstoku

location_facility: SHBI of Yaroslavl Region "Regional Clinical Oncology Hospital"

location_facility: Uzhgorod Central City Clinical Hospital City Oncological Center

location_facility: Communal Institution Cherkasy Regional Oncological Dispensary of Cherkasy Regional Council

location_facility: Complex Oncological Center - Vratsa, EOOD

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

location_facility: SBHI "Saint-Petersburg Scientific and Practical Center of Specialized Methods of Medical Help (oncological)

location_facility: Samodzielny Publiczny ZOZ Opolskiego Centrum Onkologii w Opolu im. T. Koszarowskiego

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii I Radioterapii

location_facility: BHI of Omsk Region "Clinical Oncology Dispensary"

location_facility: Wielkopolskie Centrum Onkologii, im Marii Sklodowskiej-Curie

location_facility: Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways"

location_facility: Federal State Budgetary Institution "Federal Medical Research Center n.a. P.A Gertsen" of Ministry of healthcare of RF/3

location_facility: Centre Hospitalier de Belfort-Montbeliard

location_facility: SBHI "Leningrad Regional Oncology Dispensary"

location_facility: SC Centrul Medical Unirea SRL-Policlinica Baneasa, Specialitatea Oncologie Medicala

location_facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca

location_facility: S.I. Russian Oncological Research Center n.a. N.N. Blokhin

location_facility: Spitalul Clinic Filantropia, Compartimentul Oncologie Ginecologica

location_facility: Communal Institution Dnipropetrovsk City Multifield Clinical Hospital No.4 of Dnipropetrovsk Regional Council

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej

location_facility: SBHI of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Department

location_facility: Regional Communal Institution Sumy Regional Clinical Oncological Dispensary

location_facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare

location_facility: Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

location_facility: Communal Non-commercial Enterprise Regional Center of Oncology

location_facility: FSI "Scientific and Research Institution of Oncology n.a. N.N.Petrov" of Ministry of Healthcare and SD of RF

summary: A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC

status_simplified: Unknown


title: Prospective, Controlled, Double-Blind, Randomized Multicentric Study On The Efficacy And Safety Of An Early Target Controlled Plasma Volume Replacement Therapy With A Balanced Gelatine Solution vs A Balanced Electrolyte Solution In Patients With Severe Sepsis

acronym: GENIUS

summary: This prospective, double-blind randomized controlled trial evaluates the differences in terms of efficacy and safety of gelatin based resuscitation as compared to crystalloid based resuscitation in two parallel groups of patients with severe sepsis / septic shock.

ReferenceCitation: Marx G, Zacharowski K, Ichai C, Asehnoune K, Černý V, Dembinski R, Ferrer Roca R, Fries D, Molnar Z, Rosenberger P, Sanchez-Sanchez M, Schürholz T, Dehnhardt T, Schmier S, von Kleist E, Brauer U, Simon TP. Efficacy and safety of early target-controlled plasma volume replacement with a balanced gelatine solution versus a balanced electrolyte solution in patients with severe sepsis/septic shock: study protocol, design, and rationale of a prospective, randomized, controlled, double-blind, multicentric, international clinical trial : GENIUS-Gelatine use in ICU and sepsis. Trials. 2021 Jun 2;22(1):376. doi: 10.1186/s13063-021-05311-8.

lead_sponsor: B. Braun Melsungen AG

location_country: Spain Austria France Germany Czechia

location_facility: Universitätsinstitut - Johannes Wesling Klinikum MInden

location_facility: Masarykova nemocnice v Ústí nad Labem, o.z.


title: Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight

acronym: MIntS

summary:
The purpose of this study is to test whether the provision of ONS to malnourished children across Europe, in addition to standard counselling, will improve weight gain and other outcomes.

The hypothesis to be tested is:

• Supplementation with ONS in malnourished paediatric patients will lead to increased WFH gain, as well as less malnutrition related complications (e.g. infections).

Primary outcome • The change in BMI z-score over the intervention period of 3 months

Secondary outcomes

• The change in WFH-weight for height (z-scores) over the intervention period of 3 months

primary_purpose: Supportive Care

lead_sponsor: Dr. Michael Chourdakis

location_country:
Croatia
Poland
Greece
Russian Federation
Iran, Islamic Republic of
France
Turkey
Belgium
Norway

location_facility: Russian Medical Academy of Postgraduate Education

location_facility: Tehran University of Medical Sciences Tehrān, Children Medical Center

location_facility: Hospital Jeanne de Flandre, Pediatrics Department, CHRU

location_facility: 3rd Paediatric Dept, Hippokration Hospital, AUTH

location_facility: Aristotle University of Thessaloniki, School of Medicine

location_facility: The Children's Memorial Health Institute

location_facility: 1st Paediatric Dept, Hippokration Hospital, AUTH

location_facility: Department of Pediatrics, Women and Children's Division, Oslo University Hospital

intervention_type: Dietary Supplement


title: Safety and Tolerability of Single and Repeated Doses of ODM-203: An Open-label, Non-randomised, Uncontrolled, Dose Escalation, Multicentre, First-in-Human Study in Subjects With Advanced Solid Tumours

summary: The purpose of this first-in-human study is to evaluate the safety and tolerability of escalating doses of ODM-203 in subjects with advanced solid tumours and to determine the maximum tolerated dose and dose limiting toxicities.

ReferenceCitation: Bono P, Massard C, Peltola KJ, Azaro A, Italiano A, Kristeleit RS, Curigliano G, Lassen U, Arkenau HT, Hakulinen P, Garratt C, Ikonen T, Mustonen MVJ, Rodon JA. Phase I/IIa, open-label, multicentre study to evaluate the optimal dosing and safety of ODM-203 in patients with advanced or metastatic solid tumours. ESMO Open. 2020 Dec;5(6):e001081. doi: 10.1136/esmoopen-2020-001081.

lead_sponsor: Orion Corporation, Orion Pharma

location_country:
Denmark
Spain
Italy
United Kingdom
Finland
France

location_facility: Helsinki University Central Hospital, Department of Oncology


title: Study to Improve Outcomes in Aortic Stenosis. International, Multi-center, Prospective, Observation and Interventional Cohort Registry

acronym: IMPULSE

summary: The purpose of this study is to narrow the gap between patients being diagnosed with severe aortic stenosis and those being appropriately monitored and treated. For this purpose a prospective survey of current practice (3 months) will be conducted followed by a six month period of intervention during which a variety of quality improvements measures will be implemented. There will then be a 3 month follow-up period during which the legacy of this initiative will be monitored during which no intervention will be carried out.

ReferenceCitation: Steeds RP, Lutz M, Thambyrajah J, Serra A, Schulz E, Maly J, Aiello M, Rudolph TK, Lloyd G, Bortone AS, Hauptmann KE, Clerici A, Delle-Karth G, Rieber J, Indolfi C, Mancone M, Belle L, Lauten A, Arnold M, Bouma BJ, Deutsch C, Kurucova J, Thoenes M, Bramlage P, Frey N, Messika-Zeitoun D. Facilitated Data Relay and Effects on Treatment of Severe Aortic Stenosis in Europe. J Am Heart Assoc. 2019 Oct;8(19):e013160. doi: 10.1161/JAHA.119.013160. Epub 2019 Sep 24.

ReferenceCitation: Frey N, Steeds RP, Rudolph TK, Thambyrajah J, Serra A, Schulz E, Maly J, Aiello M, Lloyd G, Bortone AS, Hauptmann KE, Clerici A, Delle Karth G, Rieber J, Indorfi C, Mancone M, Belle L, Lauten A, Arnold M, Bouma BJ, Lutz M, Pohlmann C, Kurucova J, Thoenes M, Bramlage P, Messika-Zeitoun D; IMPULSE registry group. Symptoms, disease severity and treatment of adults with a new diagnosis of severe aortic stenosis. Heart. 2019 Nov;105(22):1709-1716. doi: 10.1136/heartjnl-2019-314940. Epub 2019 Jul 13.

ipd_sharing: Undecided

location_country:
Spain
Italy
Austria
Netherlands
United Kingdom
Switzerland
France
Germany
Czechia

location_facility: UKSK Campus Kiel, Klinik für Kardiologie und Angiologie

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: IKEM - Institute for Clinical and Experimental Medicine

location_facility: Università degli Studi di Bari Aldo Moro


title: The Eurocyst Initiative: Building a Reference Center Network Across EUROpe to Establish a Large-scale Longitudinal Observational Cohort of Autosomal Dominant polyCYSTic Kidney Disease (ADPKD) Patients

summary: EuroCYST initiative aims to build a large, well-characterized cohort of Autosomal Dominant polyCYSTic Kidney Disease (ADPKD) subjects who are followed in a longitudinal observational cohort study has the potential to identify progression factors and biomarkers, and to assess disease stage specific mortality, morbidity and health care costs.

status: Unknown status

enrollment_type: Anticipated

lead_sponsor: Andreas L. Serra

location_country:
Spain
Italy
United Kingdom
Netherlands
Czech Republic
Switzerland
France
Turkey
Belgium
Germany

location_facility: Istituto di Ricerche Farmacologiche "Mario Negri"

location_facility: Centre hospitalier universitaire de Brest

location_facility: University of Cambridge, Cambridge Cancer Center

location_facility: University of Sheffield Medical School Academic Unit of Nephrology Department of Infection and Immunity


title: A Phase I, Open Label, Multicenter, Dose-escalation Study of HDM201 in Adult Patients With Advanced Solid and Hematological Tumors Characterized by Wild-type TP53

summary: To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Taiwan
Spain
Netherlands
United States
France
Singapore
Japan
Germany

location_facility:
Memorial Sloan Kettering Onc. Dep
Novartis Investigative Site
Dana Farber Cancer Institute SC-6


acronym: POC

title: A Randomized, Multicenter, Phase II Study to Investigate Efficacy and Safety of ITF2984 in Acromegalic Patients

lead_sponsor: Italfarmaco

location_country:
Poland
Serbia
Spain
Italy
Czech Republic
Hungary
France
Romania
Netherlands

location_facility: Institutul de Endocrinologie C.I.Parhon, Sectia clinica de endocrinologie II

location_facility: University Children's Hospital of Cracow

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Klinika Endokrynologii Centrum Medycznego Kształcenia Podyplomowego

location_facility: Institutul de Endocrinologie C.I.Parhon, Sectia clinica de endocrinologie VI

summary: The purpose of this study is to investigate in acromegalic patients the effect of different doses of ITF2984 on GH and IGF-1 concentrations and to investigate safety and tolerability of three different doses of ITF2984.


title: Patient Registry of the European Friedreich's Ataxia Consortium for Translational Studies (EFACTS)

acronym: EFACTS

summary:
This is a multi-centre, multi-national, prospective, observational study of Friedreich's Ataxia (FRDA) with a control group to:

obtain natural history data on individuals affected by FRDA
relate clinical assessments and results from proteomic analyses
expedite identification and recruitment of participants for clinical trials
develop and validate sensitive and reliable outcome measures for detecting onset and change over the natural course of FRDA which may also be potential outcome measures for use in future clinical trials and clinical care
plan for future research studies

ReferenceCitation: Reetz K, Dogan I, Costa AS, Dafotakis M, Fedosov K, Giunti P, Parkinson MH, Sweeney MG, Mariotti C, Panzeri M, Nanetti L, Arpa J, Sanz-Gallego I, Durr A, Charles P, Boesch S, Nachbauer W, Klopstock T, Karin I, Depondt C, vom Hagen JM, Schöls L, Giordano IA, Klockgether T, Bürk K, Pandolfo M, Schulz JB. Biological and clinical characteristics of the European Friedreich's Ataxia Consortium for Translational Studies (EFACTS) cohort: a cross-sectional analysis of baseline data. Lancet Neurol. 2015 Feb;14(2):174-82. doi: 10.1016/S1474-4422(14)70321-7. Epub 2015 Jan 5.

ReferenceCitation: Reetz K, Dogan I, Hilgers RD, Giunti P, Parkinson MH, Mariotti C, Nanetti L, Durr A, Ewenczyk C, Boesch S, Nachbauer W, Klopstock T, Stendel C, Rodríguez de Rivera Garrido FJ, Rummey C, Schöls L, Hayer SN, Klockgether T, Giordano I, Didszun C, Rai M, Pandolfo M, Schulz JB; EFACTS study group. Progression characteristics of the European Friedreich's Ataxia Consortium for Translational Studies (EFACTS): a 4-year cohort study. Lancet Neurol. 2021 May;20(5):362-372. doi: 10.1016/S1474-4422(21)00027-2. Epub 2021 Mar 23.

ReferenceCitation: Indelicato E, Nachbauer W, Eigentler A, Amprosi M, Matteucci Gothe R, Giunti P, Mariotti C, Arpa J, Durr A, Klopstock T, Schöls L, Giordano I, Bürk K, Pandolfo M, Didszdun C, Schulz JB, Boesch S; EFACTS (European Friedreich's Ataxia Consortium for Translational Studies). Onset features and time to diagnosis in Friedreich's Ataxia. Orphanet J Rare Dis. 2020 Aug 3;15(1):198. doi: 10.1186/s13023-020-01475-9.

ReferenceCitation: Bonnechère B, Jansen B, Haack I, Omelina L, Feipel V, Van Sint Jan S, Pandolfo M. Automated functional upper limb evaluation of patients with Friedreich ataxia using serious games rehabilitation exercises. J Neuroeng Rehabil. 2018 Oct 4;15(1):87. doi: 10.1186/s12984-018-0430-7.

ReferenceCitation: Reetz K, Dogan I, Hohenfeld C, Didszun C, Giunti P, Mariotti C, Durr A, Boesch S, Klopstock T, Rodríguez de Rivera Garrido FJ, Schöls L, Giordano I, Bürk K, Pandolfo M, Schulz JB; EFACTS Study Group. Nonataxia symptoms in Friedreich Ataxia: Report from the Registry of the European Friedreich's Ataxia Consortium for Translational Studies (EFACTS). Neurology. 2018 Sep 4;91(10):e917-e930. doi: 10.1212/WNL.0000000000006121. Epub 2018 Aug 10.

ReferenceCitation: Tanguy Melac A, Mariotti C, Filipovic Pierucci A, Giunti P, Arpa J, Boesch S, Klopstock T, Müller Vom Hagen J, Klockgether T, Bürk K, Schulz JB, Reetz K, Pandolfo M, Durr A, Tezenas du Montcel S; EFACTS group. Friedreich and dominant ataxias: quantitative differences in cerebellar dysfunction measurements. J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):559-565. doi: 10.1136/jnnp-2017-316964. Epub 2017 Dec 26.

ReferenceCitation: Lad M, Parkinson MH, Rai M, Pandolfo M, Bogdanova-Mihaylova P, Walsh RA, Murphy S, Emmanuel A, Panicker J, Giunti P. Urinary, bowel and sexual symptoms in a cohort of patients with Friedreich's ataxia. Orphanet J Rare Dis. 2017 Sep 26;12(1):158. doi: 10.1186/s13023-017-0709-y.

ReferenceCitation: Reetz K, Dogan I, Hilgers RD, Giunti P, Mariotti C, Durr A, Boesch S, Klopstock T, de Rivera FJR, Schöls L, Klockgether T, Bürk K, Rai M, Pandolfo M, Schulz JB; EFACTS Study Group. Progression characteristics of the European Friedreich's Ataxia Consortium for Translational Studies (EFACTS): a 2 year cohort study. Lancet Neurol. 2016 Dec;15(13):1346-1354. doi: 10.1016/S1474-4422(16)30287-3. Erratum in: Lancet Neurol. 2017 Dec;16(12 ):954.

location_country:
Spain
Italy
Austria
United Kingdom
France
Belgium
Germany

location_facility: University Hospital Bonn, Dept. of Neurology

location_facility: University of Munich, Dept. of Neurology

location_facility: University Hospital Aachen, Dept. of Neurology

location_facility: Philipps University Marburg, Dept. of Neurology

location_facility: Hospital Universitario La Paz, Servicio de Neurologia

location_facility: University College of London, Institute of Neurology

location_facility: Hôptal de Hautepierre, Department of Neurology

location_facility: University of Tübingen, Dept. of Neurodegenerative Diseases, Hertie-Institute for Clinical Brain Research

location_facility: Medical University Innsbruck, Department of Neurology

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta


title: A Phase I, Open-label, Multi-arm, Multi-centre, Multi-dose, Dose Escalation Study of LTX-315 as Monotherapy or in Combination With Either Ipilimumab or Pembrolizumab in Patients With Transdermally Accessible Tumours

summary: The study will assess the safety, tolerability, PK and efficacy of different intra-tumoral dosing regimens of LTX-315; a lytic-peptide that induces long-term anti-cancer immune responses, as monotherapy or in combination with ipilimumab or pembrolizumab.

ReferenceCitation: Spicer J, Marabelle A, Baurain JF, Jebsen NL, Jossang DE, Awada A, Kristeleit R, Loirat D, Lazaridis G, Jungels C, Brunsvig P, Nicolaisen B, Saunders A, Patel H, Galon J, Hermitte F, Camilio KA, Mauseth B, Sundvold V, Sveinbjornsson B, Rekdal O. Safety, Antitumor Activity, and T-cell Responses in a Dose-Ranging Phase I Trial of the Oncolytic Peptide LTX-315 in Patients with Solid Tumors. Clin Cancer Res. 2021 May 15;27(10):2755-2763. doi: 10.1158/1078-0432.CCR-20-3435. Epub 2021 Feb 4.

ReferenceCitation: Jebsen NL, Apelseth TO, Haugland HK, Rekdal Ø, Patel H, Gjertsen BT, Jøssang DE. Enhanced T-lymphocyte infiltration in a desmoid tumor of the thoracic wall in a young woman treated with intratumoral injections of the oncolytic peptide LTX-315: a case report. J Med Case Rep. 2019 Jun 10;13(1):177. doi: 10.1186/s13256-019-2088-6.

lead_sponsor: Lytix Biopharma AS

location_country:
United Kingdom
Italy
France
Belgium
Norway

location_facility: Cliniques Universitaires St-Luc, Service d'oncologie médicale

location_facility: Oslo University Hospital Radiumhospitalet


title: A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Safety, Clinical Activity, and Pharmacokinetics of ALN-TTR02 in Patients With Familial Amyloidotic Polyneuropathy Who Have Previously Received ALN-TTR02

summary: The purpose of this study is to evaluate the safety and tolerability of long-term dosing with ALN-TTR02 (patisiran) in patients with transthyretin (TTR) mediated amyloidosis (ATTR).

ReferenceCitation: Coelho T, Adams D, Conceição I, Waddington-Cruz M, Schmidt HH, Buades J, Campistol J, Berk JL, Polydefkis M, Wang JJ, Chen J, Sweetser MT, Gollob J, Suhr OB. A phase II, open-label, extension study of long-term patisiran treatment in patients with hereditary transthyretin-mediated (hATTR) amyloidosis. Orphanet J Rare Dis. 2020 Jul 8;15(1):179. doi: 10.1186/s13023-020-01399-4.

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Brazil
Portugal
Spain
Sweden
United States
France
Germany


summary:
The objective of this survey is to establish the clinical course of vision loss and recovery in patients with a genetically confirmed diagnosis of Leber Hereditary Optic Neuropathy (LHON).

Visual acuity changes over time from onset of symptoms and from visual acuity nadir will be the main endpoint analysed.

The survey will collect historically documented visual acuity data for all patients at participating sites with a genetically confirmed diagnosis of LHON. No exclusion criteria apply. Patients are not required to attend the clinic for the survey.

Data will be collected in a completely anonymous manner. Ethical approvals and data release agreements will be obtained as required by local regulations.

time_perspective: Retrospective

lead_sponsor: Santhera Pharmaceuticals

location_country: Denmark Slovenia Italy France Belgium

location_facility: Glostrup Hospital/National Eye Clinic of the Kennedy Center/University of Copenhagen Department of Ophthalmology


acronym: Emollients in the management of AD

title: Emollients in the Management of Atopic Dermatitis in Children: Prevention of Flares.

lead_sponsor: Pierre Fabre Medicament

location_country: Poland Estonia Lithuania France Romania

summary: The purpose of this study is to confirm that emollients play a major role in the maintenance therapy after clearing of inflammatory lesions and can reduce occurrence of flares in children with atopic dermatitis.


title: A Phase IIIb/IV Randomized, Controlled, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy of Fidaxomicin to Vancomycin in the Sustained Clinical Cure of Clostridium Difficile Infection in Adults Receiving Immunosuppressive Therapy

acronym: FREEDOM

summary: The primary objective is to compare fidaxomicin versus vancomycin for the sustained clinical cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive therapy.

lead_sponsor: Astellas Pharma Europe Ltd.

location_country: Denmark Poland Spain Greece Austria France Germany

location_facility:
Laiko General Hospital
Klinik I für Innere Medizin
University Hospital of Crete
Univ. Klinik für Innere Medizi
Herlev University Hospital
Universitätsklinikum
H. U. de Bellvitge
Hospital 12 de Octubre
Universitätsklinikum Halle
Charité
Szpital Specjalistyczny w Brzo
H.U. Gregorio Maranon
Hôpital Necker
Metaxa Anticancer Hospital
General Hospital of Athens
Institut Curie


title: A Feasibility Study of the Mitralign Annuloplasty System for the Treatment of Chronic Functional Mitral Valve Regurgitation

acronym: ALIGN

summary: The purpose of this study is to test the safety and device performance of the Mitralign system ("MPAS") to treat functional mitral valve regurgitation.

lead_sponsor: Mitralign, Inc.

location_country: Poland France Paraguay Colombia

location_facility:
Sanatorio Italiano
Bordeaux Heart University Hospital
Centrum Medyczne HZP
Antonio Dager, MD
Clinica CardioVID
American Heart of Poland S.A.
Clinique Pasteur
Instytutem Kardiologii


summary: This study will evaluate the safety and efficacy of a carboxymethylcellulose based eye drop formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops (OPTIVE™) in subjects with dry eye disease.

lead_sponsor: Allergan

location_country:
Spain
Italy
Russian Federation
Australia
United Kingdom
France
Belgium
Germany


title: A Phase 2, Open-Label, Multi-Dose, Dose Escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusions of ALN-TTR02 in Patients With TTR Amyloidosis

summary: This was a multiple dose, dose escalation study designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of patisiran (ALN-TTR02) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).

ReferenceCitation: Suhr OB, Coelho T, Buades J, Pouget J, Conceicao I, Berk J, Schmidt H, Waddington-Cruz M, Campistol JM, Bettencourt BR, Vaishnaw A, Gollob J, Adams D. Efficacy and safety of patisiran for familial amyloidotic polyneuropathy: a phase II multi-dose study. Orphanet J Rare Dis. 2015 Sep 4;10:109. doi: 10.1186/s13023-015-0326-6.


title: Phase II Study of the BioVentrix PliCath HF™ System for the Treatment of Ischemic Cardiomyopathy

acronym: CONFIGURE-HF

summary: The purpose of this prospective, single-armed, multi-center clinical trial is to further establish the safety and feasibility of using the BioVentrix PliCath HF System for the treatment of left ventricular dysfunction in appropriate cohorts of humans suffering from heart failure.

ReferenceCitation: Wechsler AS, Sadowski J, Kapelak B, Bartus K, Kalinauskas G, Rucinskas K, Samalavicius R, Annest L. Durability of epicardial ventricular restoration without ventriculotomy. Eur J Cardiothorac Surg. 2013 Sep;44(3):e189-92; discussion e192. doi: 10.1093/ejcts/ezt292. Epub 2013 Jun 5.

lead_sponsor: BioVentrix

location_country:
Poland
Portugal
Spain
Italy
Austria
Greece
Latvia
Lithuania
United Kingdom
France
Czechia

location_facility: Hospital Clinic and University of Barcelona

location_facility: Hospital Pitie Sal Petirere Institute of Cardiology


title: A Multi-center, Open Label, Uncontrolled, Phase IIA Clinical Trial Evaluating the Safety and Efficacy of NOX A12 in Combination With a Background Therapy of Bortezomib and Dexamethasone (VD) in Previously Treated Patients With Multiple Myeloma (MM)

summary: The purpose of this study is to evaluate the safety and efficacy of NOX A12 alone and in combination with a background therapy of bortezomib and dexamethasone (VD) chemotherapy in previously treated patients with multiple myeloma (MM).

ReferenceCitation: Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. Review.

lead_sponsor: TME Pharma AG

location_country: Austria Germany France Italy

location_facility: Wilhelminenspital, Department of Medicine I, Center of Oncology and Hematology

location_facility: Sapienza University of Rome, Department of Hematology

location_facility: University Hospital Münster, Medizinische Klinik und Poliklinik A

location_facility: Niguarda Ca'Granda Hospital, Department of Hematology

location_facility: Hôpital Saint Antoine - Service des maladies du sang et de thérapie cellulaire

location_facility: University Hospital Ulm, Zentrum für Innere Medizin,

location_facility: University Hospital Salzburg, Department of Medicine III, Center of Oncology and Hematology

location_facility: Hôpital Huriez, Centre Hospitalier Régional Universitaire de Lille

location_facility: University Hospital San Martino, Department of Hematology and Oncology

location_facility: University Hospital Freiburg, Medizinische Universitätsklinik, Innere Medizin I, Haematologie und Onkologie


title: Neural Cardiac Therapy for Heart Failure Study

acronym: NECTAR-HF

summary: The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than 130 ms.

ReferenceCitation: De Ferrari GM, Tuinenburg AE, Ruble S, Brugada J, Klein H, Butter C, Wright DJ, Schubert B, Solomon S, Meyer S, Stein K, Ramuzat A, Zannad F. Rationale and study design of the NEuroCardiac TherApy foR Heart Failure Study: NECTAR-HF. Eur J Heart Fail. 2014 Jun;16(6):692-9. doi: 10.1002/ejhf.80. Epub 2014 May 20.

ReferenceCitation: Zannad F, De Ferrari GM, Tuinenburg AE, Wright D, Brugada J, Butter C, Klein H, Stolen C, Meyer S, Stein KM, Ramuzat A, Schubert B, Daum D, Neuzil P, Botman C, Castel MA, D'Onofrio A, Solomon SD, Wold N, Ruble SB. Chronic vagal stimulation for the treatment of low ejection fraction heart failure: results of the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) randomized controlled trial. Eur Heart J. 2015 Feb 14;36(7):425-33. doi: 10.1093/eurheartj/ehu345. Epub 2014 Aug 31.

ReferenceCitation: De Ferrari GM, Stolen C, Tuinenburg AE, Wright DJ, Brugada J, Butter C, Klein H, Neuzil P, Botman C, Castel MA, D'Onofrio A, de Borst GJ, Solomon S, Stein KM, Schubert B, Stalsberg K, Wold N, Ruble S, Zannad F. Long-term vagal stimulation for heart failure: Eighteen month results from the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) trial. Int J Cardiol. 2017 Oct 1;244:229-234. doi: 10.1016/j.ijcard.2017.06.036. Epub 2017 Jun 10.

lead_sponsor: Boston Scientific Corporation

location_country:
Spain
Italy
United Kingdom
Netherlands
France
Belgium
Germany
Czechia

location_facility: Imperial College Healthcare NHS Trust, St. Mary's Hospital

location_facility: Liverpool Heart and Chest Hospital, NHS Foundation Trust

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Clínica Universitaria de Navarra, Avenida Pio XII s/n

location_facility: University Hospitals Bristol, NHS Foundation Trust

location_facility: The Heart Hospital, University College London Hospitals, NHS Foundation Trust

location_facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg

location_facility: Centre d'Investigation Clinique Pierre Drouin, CHU de Nancy

location_facility: Universitäres Herzzentrum GmbH, Universitätsklinikum Hamburg-Eppendorf

intervention_type: Diagnostic Test


acronym: SBC-102 in Children with Growth Failure Due to Lysosomal Acid Lipase Deficiency

title: An Open Label, Multicenter, Dose Escalation Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of SBC-102 (Sebelipase Alfa) in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency

lead_sponsor: Alexion Pharmaceuticals

ReferenceCitation: Jones SA, Rojas-Caro S, Quinn AG, Friedman M, Marulkar S, Ezgu F, Zaki O, Gargus JJ, Hughes J, Plantaz D, Vara R, Eckert S, Arnoux JB, Brassier A, Le Quan Sang KH, Valayannopoulos V. Survival in infants treated with sebelipase Alfa for lysosomal acid lipase deficiency: an open-label, multicenter, dose-escalation study. Orphanet J Rare Dis. 2017 Feb 8;12(1):25. doi: 10.1186/s13023-017-0587-3.

location_country:
United Kingdom
Ireland
United States
France
Egypt

summary: This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency. Eligible participants received once-weekly (qw) infusions of sebelipase alfa for up to 5 years.


title: A Prospective Multicenter Randomized Study Comparing Photoselective Vaporization of the Prostate With the GreenLight XPS™ Laser System and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Hyperplasia

summary: The study compares procedural and post procedural outcomes for photoselective vaporization of the prostate (PVP) and transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction. The study requires use of the CE marked GreenLight XPS™ Laser System (GreenLight XPS) or a CE marked monopolar or bipolar loop TURP system for the treatment of benign prostatic hyperplasia (BPH).

ReferenceCitation: Thomas JA, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyère F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitán C, Knispel H, Bachmann A. A Multicenter Randomized Noninferiority Trial Comparing GreenLight-XPS Laser Vaporization of the Prostate and Transurethral Resection of the Prostate for the Treatment of Benign Prostatic Obstruction: Two-yr Outcomes of the GOLIATH Study. Eur Urol. 2016 Jan;69(1):94-102. doi: 10.1016/j.eururo.2015.07.054. Epub 2015 Aug 15.

ReferenceCitation: Bachmann A, Tubaro A, Barber N, d'Ancona F, Muir G, Witzsch U, Grimm MO, Benejam J, Stolzenburg JU, Riddick A, Pahernik S, Roelink H, Ameye F, Saussine C, Bruyère F, Loidl W, Larner T, Gogoi NK, Hindley R, Muschter R, Thorpe A, Shrotri N, Graham S, Hamann M, Miller K, Schostak M, Capitán C, Knispel H, Thomas JA. 180-W XPS GreenLight laser vaporisation versus transurethral resection of the prostate for the treatment of benign prostatic obstruction: 6-month safety and efficacy results of a European Multicentre Randomised Trial--the GOLIATH study. Eur Urol. 2014 May;65(5):931-42. doi: 10.1016/j.eururo.2013.10.040. Epub 2013 Nov 11.

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

location_facility: RadBound University Njmegen Medical Centre

location_facility: Diakoniekrankenhaus Rotenburg (W.) gGmbH

location_facility: Unita di chirurgia Urologica mininvasiva,Azienda Ospedatiera Sant'Andrea Hospital

location_facility: Basingstoke and North Hampshire NHS Foundation Trust

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: UroForshungs GmbH, im St. hedwig Krankenhaus

location_facility: Mid Yorkshire NHS Trust Dewsbury & District Hospital

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Hospital Iniversitario Fundacion Alcorcon

location_facility: Universitatsklinikum Schleswig-Holstein, Campus Kiel


title: A Phase I Open-Label Dose Escalation Study of the Focal Adhesion Kinase Inhibitor, GSK2256098, in Subjects With Solid Tumors

summary: This study is a Phase I dose escalation study in subjects with solid tumors. Part 1 will identify the maximum tolerated dose (MTD) using a dose-escalation procedure. Following identification of the MTD, enrollment into Parts 2, 3, 4 and 5 may be concurrent. Part 2 will explore further the safety, PK, tolerability, and anti-tumor activity of GSK2256098 in subjects with tumors known to overexpress focal adhesion kinase (FAK). Part 3 will characterize the range of biologically effective doses by assessing pharmacodynamic (PD) markers in hair, skin and tumor tissue at doses that will not go lower than 80 mg or above the MTD dose levels tested during the Phase 1 dose escalation. Part 4 will explore further the safety, PK, tolerability and anti-tumor activity of GSK2256098 in subjects with relapsed glioblastoma multiforme (GBM). The primary objective of this study is to determine the safety, tolerability, and MTD of GSK2256098. Secondary objectives are to characterize the pharmacokinetics (PK) of GSK2256098; to identify a range of biologically active doses; to explore the anti-tumor activity of GSK2256098, and to explore relationships between GSK2256098 PK, PD and clinical endpoints. Part 5 will investigate the time course, the extent of an apparent change in the PK of GSK2256098 following repeated dosing, and screen for potential CYP3A induction as a possible mechanism of reduced systemic exposure of GSK2256098 at Day 15 and later time points. The primary objective of this study is to determine the safety, tolerability, and MTD of GSK2256098.

ReferenceCitation: Brown NF, Williams M, Arkenau HT, Fleming RA, Tolson J, Yan L, Zhang J, Singh R, Auger KR, Lenox L, Cox D, Lewis Y, Plisson C, Searle G, Saleem A, Blagden S, Mulholland P. A study of the focal adhesion kinase inhibitor GSK2256098 in patients with recurrent glioblastoma with evaluation of tumor penetration of [11C]GSK2256098. Neuro Oncol. 2018 Nov 12;20(12):1634-1642. doi: 10.1093/neuonc/noy078. Erratum in: Neuro Oncol. 2020 Jun 9;22(6):894. Swartz, Lisa [removed].

lead_sponsor: GlaxoSmithKline

location_country:
Australia
France
United Kingdom


title: EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty

summary: The goal of the study is to identify the patients suffering from a mitral valve condition who benefit from the implantation of a Profile 3D annuloplasty ring in terms of acute and long-term relief of mitral valve regurgitation.

ReferenceCitation: Doll N, Sheytanov V, Labrousse L, Chu MWA, Stefàno P, Mokrácek A, Baron O, Li S, Günzinger R. Clinical performance of a three-dimensional saddle-shaped, rigid ring for mitral valve repair. Eur J Cardiothorac Surg. 2019 Feb 1;55(2):217-223. doi: 10.1093/ejcts/ezy215.

lead_sponsor: Medtronic Bakken Research Center

location_country: Italy Canada France Germany Czechia

location_facility: London Health Sciences Centre, University Hospital

location_facility: Hôpital Haut - Leveque - CHU Pessac Cedex Bordeaux

location_facility: Azienda Ospedaliero Universitaria Careggi


title: A Multicenter, Open Label, Phase I /Randomised Phase II Study to Evaluate Safety, Pharmacokinetics and Efficacy of BIBF 1120 in Comparison With Oral Sorafenib for Advanced Hepatocellular Carcinoma Patients.

summary: The study aim is to determine maximally tolerated dose (MTD) of BIBF 1120 in HCC (hepatocellular cancer) and compare efficacy of BIBF 1120 to Sorafenib in HCC patients

lead_sponsor: Boehringer Ingelheim

location_country:
Poland
United Kingdom
Austria
Netherlands
Hungary
France
Romania
Germany

location_facility: 1199.37.44008 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.44003 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.48002 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.49005 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.49008 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.40003 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.40002 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.49010 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.49001 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.43001 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.49004 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.49003 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.49006 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.44004 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.49009 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.33001 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.43002 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.49002 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.36001 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.44001 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.31002 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.44002 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.33002 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.44006 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.44005 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.48003 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.48001 Boehringer Ingelheim Investigational Site

location_facility: 1199.37.31001 Boehringer Ingelheim Investigational Site


title: An Open-Label, Multi-Center Phase I/II Study of the Safety and Tolerability of the Combination of Trastuzumab-MCC-DM1 (T-DM1) With Docetaxel, and Potentially Pertuzumab, for Treatment for Patients With Advanced Breast Cancer

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Martin M, Fumoleau P, Dewar JA, Albanell J, Limentani SA, Campone M, Chang JC, Patre M, Strasak A, de Haas SL, Xu J, Garcia-Saenz JA. Trastuzumab emtansine (T-DM1) plus docetaxel with or without pertuzumab in patients with HER2-positive locally advanced or metastatic breast cancer: results from a phase Ib/IIa study. Ann Oncol. 2016 Jul;27(7):1249-56. doi: 10.1093/annonc/mdw157. Epub 2016 Apr 6.

location_country:
United Kingdom
United States
Spain
France

summary: This is an open-label, multi-center, non-randomized study of the safety and tolerability of the combination of T-DM1 plus docetaxel for the treatment of participants with metastatic breast cancer (MBC) and of T-DM1 plus docetaxel with or without pertuzumab, for the treatment of participants with locally advanced breast cancer (LABC). The study comprises an initial dose finding (feasibility) part to determine the maximum tolerated dose (MTD) of T-DM1 and docetaxel, followed by an extension part aiming to consolidate the safety and efficacy of the recommended docetaxel/T-DM1 combination regimen.


title: A Prospective, Unmasked, Randomized Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-Angle Glaucoma

acronym: SL

summary: Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.

ReferenceCitation: Fea AM, Belda JI, Rękas M, Jünemann A, Chang L, Pablo L, Voskanyan L, Katz LJ. Prospective unmasked randomized evaluation of the iStent inject (®) versus two ocular hypotensive agents in patients with primary open-angle glaucoma. Clin Ophthalmol. 2014 May 7;8:875-82. doi: 10.2147/OPTH.S59932. eCollection 2014.

lead_sponsor: Glaukos Corporation

location_country:
Poland
Spain
Greece
Austria
Armenia
Italy
United Kingdom
France
Germany

location_facility: Azienda Ospedaliera S. Maria della Misericordia

location_facility: Universita' di Torino/Dipartimento di Fisiopatologia Clinica-Clinica Oculistica


title: A Phase I Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

summary: The purpose of this study is to determine the safety and tolerability of dasatinib with bortezomib in the treatment of relapsed or refractory multiple myeloma.

lead_sponsor: Bristol-Myers Squibb

location_country:
United States
Italy
Spain
France

location_facility: Orlando Health, Inc. M.D. Anderson Cancer Center Orlando

location_facility: Winship Cancer Institute, Emory University


title: A Phase III, Double-Blind, Multi-Centre, Randomised, Parallel Group Design, Placebo-Controlled, Flexible Dose Study of MCI-196 in Combination With a Ca-Based Phosphate Binder in CKD Stage V Subjects on Dialysis With Hyperphosphatemia.

summary: This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the treatment period, MCI-196 or placebo will be titrated every 3 weeks.

lead_sponsor: Mitsubishi Tanabe Pharma Corporation

location_country: Macedonia, The Former Yugoslav Republic of


title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment for 12 Weeks in Adolescent and Adult Patients (≥16 Years) With Genetically Ascertained Unverricht-Lundborg Disease

lead_sponsor: UCB Pharma SA

ReferenceCitation: Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.

ReferenceCitation: Kälviäinen R, Genton P, Andermann E, Andermann F, Magaudda A, Frucht SJ, Schlit AF, Gerard D, de la Loge C, von Rosenstiel P. Brivaracetam in Unverricht-Lundborg disease (EPM1): Results from two randomized, double-blind, placebo-controlled studies. Epilepsia. 2016 Feb;57(2):210-21. doi: 10.1111/epi.13275. Epub 2015 Dec 15.

location_country: Réunion Italy Finland Tunisia Sweden France Netherlands

summary: The study will compare the efficacy and safety of brivaracetam with placebo in patients with Unverricht-Lundborg disease.


title: Autologous Stem Cell Transplantation for Crohn's Disease: ASTIC

summary:
Transplant study for patients with relapsing Crohn's disease demonstrating clear intolerance or toxicity to conventional treatment.

The purpose of this study is to determine whether there is a potential clinical benefit of hematopoietic stem cell mobilisation followed by high dose immuno-ablation and autologous stem cell transplantation versus hematopoietic stem cell mobilisation only followed by best clinical practice.

ReferenceCitation: Lindsay JO, Allez M, Clark M, Labopin M, Ricart E, Rogler G, Rovira M, Satsangi J, Farge D, Hawkey CJ; ASTIC trial group; European Society for Blood and Marrow Transplantation Autoimmune Disease Working Party; European Crohn's and Colitis Organisation. Autologous stem-cell transplantation in treatment-refractory Crohn's disease: an analysis of pooled data from the ASTIC trial. Lancet Gastroenterol Hepatol. 2017 Jun;2(6):399-406. doi: 10.1016/S2468-1253(17)30056-0. Epub 2017 Apr 6.

ReferenceCitation: Hawkey CJ, Allez M, Clark MM, Labopin M, Lindsay JO, Ricart E, Rogler G, Rovira M, Satsangi J, Danese S, Russell N, Gribben J, Johnson P, Larghero J, Thieblemont C, Ardizzone S, Dierickx D, Ibatici A, Littlewood T, Onida F, Schanz U, Vermeire S, Colombel JF, Jouet JP, Clark E, Saccardi R, Tyndall A, Travis S, Farge D. Autologous Hematopoetic Stem Cell Transplantation for Refractory Crohn Disease: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2524-34. doi: 10.1001/jama.2015.16700.

location_country:
Spain
Italy
United Kingdom
Canada
Switzerland
France
Belgium

location_facility: Casa Sollievo Della Sofferenza IRCCS Hospital

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

location_facility: Dipatimento di Medicina Interna E Gastroenterologia

location_facility: Universita di Bologna Interna e Gastroenterologia Policlinico Saint Orsola

location_facility: Hospital Universitari Germans Trias I Pujol, Dept of Gastroenterology

intervention_type: Procedure


title: Randomized, Double-blind, Placebo-controlled, Parallel-group Pilot Study to Assess Efficacy, Safety and Pharmacokinetics of 2 Schedules of Reparixin in the Prevention of Delayed Graft Function After Kidney Transplant in High Risk Patients

summary: The chemokine CXCL8 plays a key role in the recruitment and activation of polymorphonuclear neutrophils in post-ischemia reperfusion injury after solid organ transplantation. Reparixin is a novel, specific inhibitor of CXCL8. This study is configured to explore the safety and efficacy of reparixin in preventing the delayed graft function (DGF) after kidney transplantation.

primary_purpose: Prevention

lead_sponsor: Dompé Farmaceutici S.p.A

location_facility: Division of Transplantation, Drexel University College of Medicine

location_facility: Divisione di Nefrologia e Dialisi, Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Divisione di Nefrologia e Dialisi, Ospedali Riuniti di Bergamo

location_facility: Transplant Center, University of Minnesota Medical School

location_facility: Service de Nephrologie et Transplantation, Hopital Lapeyronie, Centre Hospitalier Universitaire Montpellier

location_facility: Renal Transplant Unit, Hopital Clinic i Provincial de Barcelona

location_facility: Division of Nephrology, Institut Catala de la Salut, Ciutat Sanitaria i Universitaria de Bellvitge

location_facility: Università degli Studi di Padova, Clinica Chirurgica III

location_facility: Service de Transplantation et Soins Intensifs Nephrologiques, Hopital Necker


title: Phase II Study of Glivec (Imatinib) in Locally Advanced and/or Metastatic Soft Tissue Sarcomas Expressing the t(17;22)(q22;q13) Translocation Resulting in a COL1A1/PDGF-beta Fusion Protein i.e. DermatoFibroSarcoma Protuberans (DFSP) and Giant Cell Fibroblastoma (GCF)

summary:
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with locally advanced or metastatic dermatofibrosarcoma protuberans or giant cell fibroblastoma.

ReferenceCitation: Rutkowski P, Van Glabbeke M, Rankin CJ, Ruka W, Rubin BP, Debiec-Rychter M, Lazar A, Gelderblom H, Sciot R, Lopez-Terrada D, Hohenberger P, van Oosterom AT, Schuetze SM; European Organisation for Research and Treatment of Cancer Soft Tissue/Bone Sarcoma Group; Southwest Oncology Group. Imatinib mesylate in advanced dermatofibrosarcoma protuberans: pooled analysis of two phase II clinical trials. J Clin Oncol. 2010 Apr 1;28(10):1772-9. doi: 10.1200/JCO.2009.25.7899. Epub 2010 Mar 1.

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

location_country:
Netherlands
France
United Kingdom
Belgium

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital


title: A Study to Assess the Incidence of Deep Vein Thrombosis (DVT) Following Prophylactic Intravenous Administration of Recombinant Human Antithrombin(rhAT) to Hereditary Antithrombin (AT) Deficient Patients in High Risk Situations.

acronym: rhAT

summary: Patients with hereditary antithrombin (AT) deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial is focusing on patients with confirmed hereditary antithrombin deficiency who are undergoing a surgical procedure or induced/spontaneous labor and delivery. The study will test the safety and efficacy of recombinant human antithrombin (rhAT) by infusing rhAT prior to, during and following the period of risk or surgical procedure.

ReferenceCitation: DeJongh J, Frieling J, Lowry S, Drenth HJ. Pharmacokinetics of recombinant human antithrombin in delivery and surgery patients with hereditary antithrombin deficiency. Clin Appl Thromb Hemost. 2014 May;20(4):355-64. doi: 10.1177/1076029613516188. Epub 2013 Dec 11.

lead_sponsor: rEVO Biologics

location_country:
United Kingdom
Italy
Sweden
United States
France
Germany


title: Open Label Phase II Study on XR5000 Administered as a 5 Day Infusion 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.

PURPOSE: Phase II trial to study the effectiveness of acridine carboxamide in treating patients who have advanced non-small cell lung cancer that cannot be treated with surgery.

location_country: Denmark Spain Italy Austria France Germany

location_facility: Haemato-Onkologische Praxis und Tagesklinik

location_facility: Centre de Lute Contre le Cancer,Georges-Francois Leclerc

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

location_facility: Istituti Fisioterapici Ospitalieri - Roma


title: An Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

acronym: STARS extend

summary: The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.

status: Recruiting

lead_sponsor: VectivBio AG

location_country: Poland France Czechia Belgium

location_facility: Stadmedica, Non-Public Healthcare Facility

location_facility: M. Pirogow Provincial Specialized Hospital


title: A Phase 2 Open-Label Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Nedosiran in Pediatric Patients From Birth to 11Years of Age With Primary Hyperoxaluria and Relatively Intact Renal Function

summary: The aim of this study is to evaluate nedosiran in participants 11 years of age and younger who have Primary Hyperoxaluria with relatively intact renal function.

lead_sponsor: Dicerna Pharmaceuticals, Inc.

location_country:
Poland
Spain
Italy
United Kingdom
Lebanon
Canada
United States
France
Turkey
Japan
Germany
Morocco
United Arab Emirates

location_facility:
Clinical Trial Site
Clinical Research Site


title: AnaTomic Stenosis Severity Derived From Computed Tomography as a Prognostic Marker in Patients With Low-flow Low-gradient Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

acronym: ATLAS TAVI

summary: The ATLAS TAVI Registry is a retrospective, investigator-initiated, multicenter registry including patients, who underwent Transcatheter Aortic Valve Implantation (TAVI) for classical or paradoxical low-flow, low-gradient aortic stenosis (LFLG AS) with available non-contrast MSCT data on aortic valve calcification (AVC). The main objective of this study is the assessment of outcome after TAVI according to AVC density severity in patients with LFLG AS.

ReferenceCitation: Cueff C, Serfaty JM, Cimadevilla C, Laissy JP, Himbert D, Tubach F, Duval X, Iung B, Enriquez-Sarano M, Vahanian A, Messika-Zeitoun D. Measurement of aortic valve calcification using multislice computed tomography: correlation with haemodynamic severity of aortic stenosis and clinical implication for patients with low ejection fraction. Heart. 2011 May;97(9):721-6. doi: 10.1136/hrt.2010.198853. Epub 2010 Aug 18.

ReferenceCitation: Clavel MA, Messika-Zeitoun D, Pibarot P, Aggarwal SR, Malouf J, Araoz PA, Michelena HI, Cueff C, Larose E, Capoulade R, Vahanian A, Enriquez-Sarano M. The complex nature of discordant severe calcified aortic valve disease grading: new insights from combined Doppler echocardiographic and computed tomographic study. J Am Coll Cardiol. 2013 Dec 17;62(24):2329-38. doi: 10.1016/j.jacc.2013.08.1621. Epub 2013 Sep 24.

ReferenceCitation: Clavel MA, Pibarot P, Messika-Zeitoun D, Capoulade R, Malouf J, Aggarval S, Araoz PA, Michelena HI, Cueff C, Larose E, Miller JD, Vahanian A, Enriquez-Sarano M. Impact of aortic valve calcification, as measured by MDCT, on survival in patients with aortic stenosis: results of an international registry study. J Am Coll Cardiol. 2014 Sep 23;64(12):1202-13. doi: 10.1016/j.jacc.2014.05.066.

ReferenceCitation: Ludwig S, Goßling A, Waldschmidt L, Linder M, Bhadra OD, Voigtländer L, Schäfer A, Deuschl F, Schirmer J, Reichenspurner H, Blankenberg S, Schäfer U, Westermann D, Seiffert M, Conradi L, Schofer N. TAVR for low-flow, low-gradient aortic stenosis: Prognostic impact of aortic valve calcification. Am Heart J. 2020 Jul;225:138-148. doi: 10.1016/j.ahj.2020.03.013. Epub 2020 Apr 8.

ReferenceCitation: Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Muñoz D, Rosenhek R, Sjögren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017 Sep 21;38(36):2739-2791. doi: 10.1093/eurheartj/ehx391.

lead_sponsor: Universitätsklinikum Hamburg-Eppendorf

location_country:
Denmark
United Kingdom
Netherlands
Canada
Israel
France
Germany

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec, Université Laval

location_facility: University Heart and Vascular Center Hamburg

lead_sponsor_type: academique


title: A 104-Week, Multicenter, Single-Arm, Long-Term, Phase 3 Extension Trial Investigating the Safety and Efficacy of Glepaglutide in Adult Patients With Short Bowel Syndrome (SBS) Completing the EASE SBS 2 Trial

acronym: EASE SBS 3

summary: This trial is an extension trial to EASE SBS 2. The study looks at whether glepaglutide is a safe treatment for participants with Short Bowel Syndrome (SBS), as well as how well effectiveness is maintained during long term treatment. Participants in this trial will receive glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.) for approximately 2 years.

status: Enrolling by invitation

lead_sponsor: Zealand Pharma

location_country:
Denmark
Poland
United Kingdom
Netherlands
United States
France
Belgium
Germany

location_facility: Szpital Skawina sp. z o.o. im. Stanley Dudricka

location_facility: Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi


title: Annuloplasty Rings and Band Post-Market Clinical Follow-Up (ARB-PMCF) Study

acronym: ARB-PMCF

summary: ARB-PMCF is a multicenter, observational study of the safety and performance of Abbott annuloplasty devices used in surgical repair of mitral and tricuspid valve regurgitation. The devices included in this study are the SJM™ Rigid Saddle Ring and SJM Séguin Annuloplasty Ring, indicated for mitral valve repair, and the SJM Tailor™ Annuloplasty Ring and SJM Tailor Annuloplasty Band, indicated for mitral or tricuspid repair. Participants will be enrolled prior to undergoing mitral or tricuspid valve repair surgery including an Abbott annuloplasty implant and will complete annual follow-up visits through five years from implant. The study is being conducted to meet post-market clinical follow-up requirements of the European Union Medical Device Directives.

lead_sponsor: Abbott Medical Devices

location_country:
Spain
Italy
Estonia
Netherlands
United States
France
Germany

location_facility: Herzchirurgische Abteilung Klinikum Passau

location_facility: Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Herzzentrum-Bremen Klinikum Links der Weser

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Hopital Cardiovasculaire et Pneumologique Louis Pradel


title: A Multicenter, Open-label, Non-randomized, Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Subcutaneous Isatuximab in Adults With Warm Autoimmune Hemolytic Anemia

summary:
Primary Objectives:

Part A: To evaluate the safety and tolerability of subcutaneous injections of isatuximab in adults with wAIHA
Part B: To evaluate the efficacy of the selected dose in adults with wAIHA

Secondary Objectives:

Part A (Cohorts 2 and 3 only)
To evaluate the efficacy of isatuximab in adults with wAIHA
To evaluate the durability of response to isatuximab and time to response
To evaluate the impact of isatuximab treatment on fatigue

Part B

To evaluate the safety and tolerability of isatuximab in adults with wAIHA
To evaluate the durability of response to isatuximab and time to response
To evaluate the impact of isatuximab treatment on fatigue

Parts A (all Cohorts) and B

To evaluate the effect of isatuximab on markers of hemolysis
To characterize the pharmacokinetic profile of isatuximab in adults with wAIHA
To evaluate the immunogenicity of isatuximab

lead_sponsor: Sanofi

location_country:
United Kingdom
Italy
Netherlands
Hungary
United States
France
Belgium
Germany

location_facility: University of Southern California-Site Number:8400001

location_facility: Investigational Site Number :3480001 Egyetem ÁOK, Belgyógyászati és Onkológiai Klinika, Klinikai Farmakológiai Részleg

location_facility: Investigational Site Number :3800001 Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Via F. Sforza 35

location_facility: Investigational Site Number :2760001 Universitätsklinikum Essen Klinik für Hämatologie und Stammzellentransplantation

location_facility: Fox Chase Cancer Center-Site Number:8400004


title: Phase I/II, International, Multicentre, Open-label, Non-randomised, Non-comparative, Study Evaluating the Safety, Tolerability and Clinical Activity of Intravenously Administered S64315, a Selective Mcl-1 Inhibitor, in Combination With Azacitidine in Patients With Acute Myeloid Leukaemia (AML)

lead_sponsor: Institut de Recherches Internationales Servier

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH).

The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

location_country:
Australia
United States
Spain
France

location_facility: H. Universitario Valle de Hebrón Servicio de Hematología

location_facility: H. Universitario La Fe Servicio de Hematologia

location_facility: University of Texas MD Anderson Cancer Center Department of Leukemia, Division of Cancer Medicine

location_facility: The Alfred Hospital Malignant Haematology & Stem Cell Transplantation Services

summary: The purpose of this study is to assess the safety, tolerability and clinical activity of the combination S64315 with azacitidine in patients with acute myeloid leukaemia.


title: An Open-label, Randomized Study to Assess the Relative Bioavailability (BA) and Bioequivalence (BE) of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer

summary: The purpose of this study is to determine the relative bioavailability (rBA; Period 1) and bioequivalence (BE; Period 2 and 3) of various strengths and formulations of niraparib and abiraterone acetate (AA) at steady state under modified fasted conditions in participants with metastatic castration-resistant prostate cancer (mCRPC).

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Spain
United Kingdom
Georgia
Ukraine
Sweden
United States
France
Belgium
Netherlands
Moldova, Republic of

location_facility: Institut Bergonié, Centre de Lutte Contre le Cancer

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

location_facility: Sir Bobby Robson Unit, Northern Centre for Cancer Care


title: Fissure Closure With the AeriSeal System for CONVERTing Collateral Ventilation Status in Patients With Severe Emphysema; A Multicenter, Prospective Trial

acronym: CONVERT

summary:
This is a prospective, open-label, multi-center, single-arm study to be conducted at up to 20 investigational sites. The Study plans to enroll 140 subjects with severe emphysema and collateral ventilation in the target lobe. This protocol is designed to evaluate the utility of the AeriSeal System to occlude collateral air channels in a target lung lobe with collateral ventilation (CV) and convert the target lung lobe to having little to no collateral ventilation. Subjects can then receive Zephyr Valves to achieve atelectasis in the targeted lobe, once AeriSeal has converted the CV+ lobe to a CV- one. Therefore, the study will have two Stages:

• Stage 1 will address the closure of the lobar fissure gaps (or collateral air channels) to block collateral ventilation (CV) with the AeriSeal System; conversion of the CV+ target lobe to CV-. Conversion of collateral ventilation will be evaluated by Chartis after 45 days. In the case of unsuccessful conversion, a second treatment of AeriSeal may be attempted, provided that the total application volume from both the initial and the repeat treatments does not exceed 40 mL in up to three (3) segments.

Clinical Assessments post-AeriSeal will be conducted at 28 and 45 days after first treatment and repeated after the second treatment, if applicable. For the purpose of protocol follow-up, the Day 45 post-AeriSeal final treatment will equal Day 0 for Stage 2.

• Stage 2 will include successfully converted subjects; CV+ to CV- conversion in Stage 1. Converted CV- target lobes will follow standard of care and receive CE marked Zephyr Endobronchial valves per the Zephyr IFU to perform bronchoscopic lung volume reduction (BLVR).

Clinical assessments will be conducted at 45 Days, 3 and 6-months post-Zephyr Valve procedure.

lead_sponsor: Pulmonx Corporation

location_country:
United Kingdom
Italy
Australia
Netherlands
Switzerland
France
Belgium
Germany

location_facility: ASST Spedali Civili, University Hospital


title: Prospective, Open Label, Single Arm, First in Human (FIH) Clinical Study to Assess Safety and Efficacy of the CorNeat Keratoprosthesis for the Treatment of Corneal Blindness

summary: Prospective, open label, single arm, First in Human (FIH) clinical study to assess safety and efficacy of the CorNeat Keratoprosthesis, a synthetic cornea, for the treatment of corneal blindness

lead_sponsor: CorNeat Vision Ltd.

location_country:
Canada
United States
Israel
France
Netherlands

location_facility:
University of British Columbia
Rabin Medical Center - Beilinson
UHN - University Health Network
Hopital Fondation Adolphe de Rothschild
Cincinnati Eye Institute
Amsterdam UMC - Location AMC
Maastricht UMC+
CHU de Montpellier


title: A Phase 1b, Randomized, Double-blinded, Placebo-controlled Study of Hydroxychloroquine in Outpatient Adults With COVID-19

summary:
Primary Objective:

To assess the effect of hydroxychloroquine versus placebo on nasopharyngeal SARS-CoV-2 viral load in outpatient adults with COVID-19

Secondary Objectives:

To assess the effect of hydroxychloroquine versus placebo on clinical signs and symptoms and progression of disease in outpatient adults with COVID-19
To assess the safety and tolerability of hydroxychloroquine in outpatient adults with COVID-19

location_country:
Netherlands
United States
France
Belgium

location_facility:
Investigational Site Number 2501001
Investigational Site Number 2501002
Investigational Site Number 5281001
Investigational Site Number 5281002
Investigational Site Number 0561002
Investigational Site Number 8400001
Investigational Site Number 0561001


title: A Phase 1, First-in-Human, Multicenter, Open-label, Dose-escalation Study of IPH5201 as Monotherapy or in Combination With Durvalumab ± Oleclumab in Advanced Solid Tumors

summary: The purpose of this study is to assess the safety and tolerability and to determine the dose of IPH5201 that can be used as monotherapy or in combination with durvalumab +/- oleclumab in subjects with advanced solid tumors.

lead_sponsor: MedImmune LLC

location_country:
United States
Switzerland
Spain
France


title: A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts

acronym: TiGER

summary: Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.

lead_sponsor: Vascutek Ltd.

location_country:
Portugal
Spain
Italy
United Kingdom
Netherlands
Switzerland
United States
France
Belgium
Germany

location_facility: Hôpital Pneumologique et Cardiovasculaire Louis-Pradel

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Hospital Universitario Central de Asturias, Oviedo

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Hospital Universitari Valle Hebrón de Barcelona


title: A Phase I First Time in Human Open Label Study of GSK3745417 Administered With and Without Anticancer Agents in Participants With Advanced Solid Tumors

summary: This study aims to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of GSK3745417 administered alone (Part 1A) or co-administered (Part 2A) with dostarlimab in participants with refractory/relapsed solid tumors. Both parts will consist of a dose escalation phase.

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

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Australia
Canada
Korea, Republic of
United States
France
Japan
Netherlands


title: A Multicentre, Open-Label Phase I/II Study to Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2)

summary: This study consists of two phases. The phase I study is designed to investigate the safety and tolerability of Satoreotide tetraxetan following fractionated i.v. administrations in pre-treated subjects with locally advanced or metastatic cancers expressing sstr2 as identified by Satoreotide trizoxetan Positron Emission Tomography (PET/CT) scans. This phase will encompass both radioactivity escalation and peptide mass dose evaluation. Phase II will assess the efficacy of Satoreotide tetraxetan in subjects in selected indications, in a basket design.

lead_sponsor: Ipsen

location_country:
United Kingdom
Austria
Switzerland
United States
France
Belgium
Germany

location_facility:
Medical University of Innsbruck
Royal Marsden Hospital - Surrey
CHU de Marseille - Hôpital la Timone
Universitaetsklinikum Essen
CHU de Bordeaux - Hôpital Haut Lévêque
MD Anderson Cancer Center
University Hospital (UZ) Leuven
University Hospital Basel


title: A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Subepithelial Implantation of the Transform Corneal Allograft (TCA) for Improving Near Vision in Presbyopic Subjects

summary: The objective of this clinical study is to evaluate the safety and effectiveness of subepithelial implantation of the Allotex TransForm corneal allograft (TCA) for improving near vision in presbyopic subjects.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Allotex, Inc.

location_country:
United Kingdom
Ireland
Austria
Switzerland
France
Belgium

location_facility: Institute Laser Vision Noemie de Rothschild, Fondation Ophthalmolique Adolphe de Rothschild

location_facility: Corneo Plastic Unit and Eye Bank Queen Victoria Hospital


title: A Prospective Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Intrastromal Implant of the Transform Corneal Allograft (TCA) for Providing Near Vision in Presbyopic Subjects

summary: The objective of this clinical study is to evaluate the safety and effectiveness of intrastromal implantation of the Allotex TransForm corneal allograft (TCA) for improving near vision in presbyopic subjects.


title: A Prospective Multi Center Clinical Study to Evaluate the Safety And Effectiveness of the Transform™ Corneal Allograft (TCA) for Treatment of Hyperopia

summary:
The objective of this clinical study is to evaluate the safety and effectiveness of intrastromal implantation of the Allotex TCA for improving distance vision in hyperopic subjects.

The overall objective with respect to visual outcome is to provide improved vision without the requirement of additional visual aids.


title: A Phase I/IIA, Multi-Centre, Open-Label, Dose-Escalation Study With Expansion Arms to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CB-103 Administered Orally in Adult Patients With Locally Advanced or Metastatic Solid Tumours and Haematological Malignancies Characterised by Alterations of the NOTCH Signalling Pathway

summary: This is a phase I/II, non randomized, open-label, dose escalation study to investigate the safety, tolerability and preliminary efficacy of CB-103.

lead_sponsor: Cellestia Biotech AG

location_country:
Spain
Netherlands
Switzerland
Korea, Republic of
United States
France
Germany

location_facility: Severance Hospital - Yonsei Cancer Center

location_facility: Oncology Institute of Southern Switzerland

location_facility: Charite- Universitaetsmedizin Berlin- Campus Benjamin Franklin

location_facility: Vall d'Hebron Institute of Oncology (VHIO)

location_facility: Nationales Centrum für Tumorerkrankungen Heidelberg


title: Pragmatic, Prospective, Randomized, Controlled, Double-blind, Multi-centre, Multinational Study on the Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients

acronym: TETHYS

summary: The aim of the study is to investigate the safety of a 6% hydroxyethyl starch (HES) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in trauma patients.

ReferenceCitation: Palma CD, Mamba M, Geldenhuys J, Fadahun O, Rossaint R, Zacharowski K, Brand M, Díaz-Cambronero Ó, Belda J, Westphal M, Brauer U, Dormann D, Dehnhardt T, Hernandez-Gonzalez M, Schmier S, de Korte D, Plani F, Buhre W. PragmaTic, prospEctive, randomized, controlled, double-blind, mulTi-centre, multinational study on the safety and efficacy of a 6% HydroxYethyl Starch (HES) solution versus an electrolyte solution in trauma patients: study protocol for the TETHYS study. Trials. 2022 Jun 2;23(1):456. doi: 10.1186/s13063-022-06390-x.

ReferenceCitation: Chappell D, Jacob M. Should hydroxyethyl starch be banned? Lancet. 2018 Jul 14;392(10142):118. doi: 10.1016/S0140-6736(18)31174-7.

lead_sponsor: Fresenius Kabi

location_country:
Spain
Netherlands
France
South Africa
Belgium
Germany
Czechia

location_facility: Trident Clinical, Homestead Medical Centre

location_facility: University Hospital Schleswig-Holstein Campus Kiel

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Academic Medical Center (AMC) Anesthesiology

location_facility: University Medical Center (UMC) Maastricht

location_facility: Gama Research Centre Emergency Department, Leratong Hospital

location_facility: Hospital Universitari i Politecnic la Fe


title: A Multi-centre, Randomised Controlled Study, to Evaluate the Safety and Performance of The DIALIVE Liver Dialysis Device (LDD) in Patients With Acute on Chronic Liver Failure (ACLF) Versus Standard of Care (SOC)

acronym: DIALIVE _ACLF

summary: The First-In-Man study is a multi-centre, randomised, controlled, study to generate data for the evaluation of safety and performance of DIALIVE Liver Dialysis Device in 24 evaluable patients with Acute on Chronic Liver Failure (ACLF) versus standard of care (SOC).

primary_purpose: Device Feasibility

ReferenceCitation: Lee KC, Baker LA, Stanzani G, Alibhai H, Chang YM, Jimenez Palacios C, Leckie PJ, Giordano P, Priestnall SL, Antoine DJ, Jenkins RE, Goldring CE, Park BK, Andreola F, Agarwal B, Mookerjee RP, Davies NA, Jalan R. Extracorporeal liver assist device to exchange albumin and remove endotoxin in acute liver failure: Results of a pivotal pre-clinical study. J Hepatol. 2015 Sep;63(3):634-42. doi: 10.1016/j.jhep.2015.04.020. Epub 2015 May 1.

ipd_sharing_description: Only anonymized clinical data can be shared out of central database according to the H2020 project plan.

lead_sponsor: Yaqrit Ltd

location_country:
Denmark
Romania
Spain
United Kingdom
Austria
France
Belgium
Germany

location_facility:
Royal Free Hospital London NHS
Hospital Clinic Barcelona
University Hospital
university Hospital Graz
University Hospital Gregorio Maragnon
Queens Medical Centre
Hôpital Beaujon
university hospital BASILDON
University Hospital of Rostock
Paul Brousse Hospital
University Hospital Erasmus
Fundeni Clinical Institute


acronym: Mini-COMET

title: An Open-label Ascending Dose Cohort Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of Avalglucosidase Alfa (NeoGAA, GZ402666) in Patients With Infantile-onset Pompe Disease Treated With Alglucosidase Alfa Who Demonstrate Clinical Decline or Sub-optimal Clinical Response

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Taiwan
United Kingdom
United States
France
Japan

location_facility:
Investigational Site Number 3920001
Investigational Site Number 2500001
Investigational Site Number 8400005
Investigational Site Number 2500003
Investigational Site Number 8260002
Investigational Site Number 8400001
Investigational Site Number 8400002
Investigational Site Number 3920002
Investigational Site Number 1580001
Investigational Site Number 8260001

summary:
Primary Objective:

To evaluate the safety profile of avalglucosidase alfa in participants with infantile-onset Pompe disease previously treated with alglucosidase alfa.

Secondary Objective:

To characterize the pharmacokinetic profile of avalglucosidase alfa and to evaluate the preliminary efficacy of avalglucosidase alfa in comparison to alglucosidase alfa.


acronym: RSV F-021

title: An Observer-blind Study to Rank Different Formulations of GSK Biologicals' Investigational RSV Vaccine (GSK3003891A) Administered to Healthy Women

ReferenceCitation: Steff AM, Cadieux-Dion C, de Lannoy G, Prato MK, Czeszak X, André B, Ingels DC, Louckx M, Dewé W, Picciolato M, Maleux K, Fissette L, Dieussaert I. Hamster neogenin, a host-cell protein contained in a respiratory syncytial virus candidate vaccine, induces antibody responses in rabbits but not in clinical trial participants. Hum Vaccin Immunother. 2020 Jun 2;16(6):1327-1337. doi: 10.1080/21645515.2019.1693749. Epub 2020 Jan 17.

ReferenceCitation: Schwarz TF, McPhee RA, Launay O, Leroux-Roels G, Talli J, Picciolato M, Gao F, Cai R, Nguyen TL, Dieussaert I, Miller JM, Schmidt AC. Immunogenicity and Safety of 3 Formulations of a Respiratory Syncytial Virus Candidate Vaccine in Nonpregnant Women: A Phase 2, Randomized Trial. J Infect Dis. 2019 Oct 22;220(11):1816-1825. doi: 10.1093/infdis/jiz395.

location_country: Estonia France Germany Belgium

summary: The purpose of this study is to rank different RSV vaccine dosages of antigen (or formulations) based on safety/reactogenicity and immune response data. The formulations eliciting strong immune responses while maintaining an acceptable safety profile will be considered for further evaluation, including in studies vaccinating pregnant women.


title: Assessing Clinical Outcomes Using the EDWARDS INTUITY Elite Valve System in Isolated AVR Using Minimally InvaSive Surgery In a EurOpean Multi-ceNter, Active, Post-market Registry

acronym: MISSION

summary: The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a conventional valve within the MIS setting. The published dataset will used as a control group. Then to describe short term (30 days) and long term (6 months) clinical safety, to assess and compare hemodynamic data with EDWARDS INTUITY Elite to a conventional valve at discharge and at 6 months post AVR, to assess Quality of Life at baseline, and at 6 months post AVR to assess NYHA functional class at baseline, discharge, 1 month and at 6 months post AVR to assess Fitness for hospital discharge.

time_perspective: Other

ReferenceCitation: Laufer G, Strauch JT, Terp KA, Salinas M, Arribas JM, Massetti M, Andreas M, Young CP. Real-world 6-month outcomes of minimally invasive aortic valve replacement with the EDWARDS INTUITY Elite valve system. Interact Cardiovasc Thorac Surg. 2022 Jul 9;35(2). pii: ivac083. doi: 10.1093/icvts/ivac083.

lead_sponsor: Edwards Lifesciences

location_country:
Denmark
Luxembourg
Spain
Italy
Austria
Netherlands
United Kingdom
France
Germany

location_facility: Universitätsklinik für Herzchirurgie Medizinische Universität Innsbruck

location_facility: G. Pasquinucci Heart Hospital - "G.Monasterio" Foundation

location_facility: Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia"

location_facility: Università Cattolica del Sacro Cuore Policlinico

location_facility: Hôpital Cardiologique CHU Bordeaux Haut Leveque

location_facility: Institut National de Chirurgie Cardiaque et Cardiologie Interventionnelle (INCCI)

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Herz- und Gefäß-Klinik GmbH Bad Neustadt

location_facility: Klinisshe Abteiluing Für Herz-thoraxchirurgie

location_facility: Universitätsklinikum der Ruhr-Universität Bochum Klinik für Herz- und Thoraxchirurgie

location_facility: Complexo Hospitalario Universitario A Coruna


title: The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System

acronym: SPACER

summary: The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair/replacement.

location_country: Greece Canada Switzerland France Germany

location_facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite Laval

location_facility: St. Paul's Hospital, Providence Health Care Research Institute

location_facility: Munich University Clinic, Ludwig-Maximilian University