title: A Phase 2, Open-label Study to Investigate the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Subjects

acronym: COMMIT

summary: The purpose of this study is to determine the efficacy of a 12- or 24-week treatment regimen of simeprevir in combination with daclatasvir, as measured by sustain virologic response 12 (SVR12), in treatment-naive, chronic hepatitis C virus (HCV) genotype 1b-infected participants who have advanced fibrosis or compensated cirrhosis (METAVIR F3/F4).

ReferenceCitation: Hezode C, Almasio PL, Bourgeois S, Buggisch P, Brown A, Diago M, Horsmans Y, Serfaty L, Szalay F, Gaeta GB, Planas R, Schlag M, Lonjon-Domanec I, Omoruyi E, DeMasi R, Zeuzem S. Simeprevir and daclatasvir for 12 or 24 weeks in treatment-naive patients with hepatitis C virus genotype 1b and advanced liver disease. Liver Int. 2017 Sep;37(9):1304-1313. doi: 10.1111/liv.13376. Epub 2017 Mar 13.

lead_sponsor: Janssen-Cilag International NV

location_country:
Germany
Hungary
United Kingdom
Belgium
Spain
France


type: Registry Identifier

type: EudraCT Number

title: A First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Antitumor Activity of SAR408701 in Patients With Advanced Solid Tumors

summary:
Primary Objectives:

To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 2 weeks (with and without a loading dose at Cycle 1) to patients with advanced solid tumors (Main Escalation and Loading Dose Escalation Q2W).
To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 3 weeks to patients with advanced solid tumors (Escalation Q3W Cycle).
To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) (Expansion Phase) when SAR408701 is administered once every 2 weeks with or without a loading dose at Cycle 1.

Secondary Objectives:

To characterize the overall safety profile of SAR408701.
To characterize the pharmacokinetic (PK) profile of SAR408701 and of its potential circulating derivatives.
To identify the recommended phase 2 dose (RP2D) of SAR408701.
To assess the potential immunogenicity of SAR408701.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Yes

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

lead_sponsor: Sanofi

location_country:
United States
Spain
Korea, Republic of
Canada
France

location_facility: Dana Farber Cancer Institute Site Number : 840005

location_facility: Yale University School of Medicine Site Number : 840002

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


intervention_type: Biological

acronym: PRAME-AS15-MEL-001 (MET)

lead_sponsor: GlaxoSmithKline

summary: The purpose of this clinical study is to examine the safety, immunogenicity and clinical activity of the immunotherapeutic product GSK2302025A (also referred to as recPRAME + AS15 Antigen-Specific Cancer Immunotherapeutic [ASCI]) administered as a first line treatment in patients with unresectable and progressive metastatic cutaneous melanoma.

ReferenceType: derived

ReferenceCitation: Gutzmer R, Rivoltini L, Levchenko E, Testori A, Utikal J, Ascierto PA, Demidov L, Grob JJ, Ridolfi R, Schadendorf D, Queirolo P, Santoro A, Loquai C, Dreno B, Hauschild A, Schultz E, Lesimple TP, Vanhoutte N, Salaun B, Gillet M, Jarnjak S, De Sousa Alves PM, Louahed J, Brichard VG, Lehmann FF. Safety and immunogenicity of the PRAME cancer immunotherapeutic in metastatic melanoma: results of a phase I dose escalation study. ESMO Open. 2016 Aug 8;1(4):e000068. doi: 10.1136/esmoopen-2016-000068. eCollection 2016.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Elsevier

status: Completed

title: Study of GSK2302025A Antigen-Specific Cancer Immunotherapeutic in Patients With Metastatic Melanoma

source: euctr

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

study_completion_date_type: Actual

location_country:
Germany
Italy
Poland
Czechia
Russian Federation
France

status_simplified: Completed


title: Randomised, Double-blind, Placebo-controlled, Phase II Study to Assess the Safety and Efficacy of Different Doses of Intravenous APD405 for the Prevention of Post-operative Nausea and Vomiting

summary: To assess the efficacy and safety of different doses of APD405 in the prevention of post-operative nausea and vomiting (PONV) in adult patients at moderate to high-risk of PONV. Patients must be undergoing elective surgery under general anaesthesia (hysterectomy (any surgical technique), cholecystectomy (any surgical technique) or "other" elective surgery scheduled to last at least one hour from induction of anaesthesia), requiring at least one overnight stay in hospital, and have at least 2 of the following risk factors for PONV: Past history of PONV and/or motion sickness; Non-smoking status; Female gender; Planned opiate use for post-operative analgesia.

design_allocation: Randomized

primary_purpose: Prevention

ReferenceCitation: Kranke P, Rohm KD, Diemunsch P, Gan TJ, Apfel CC, Eberhart L, Minkowitz HS, Wallenborn J, Chassard D, Lebuffe G, Fox GM, Tramer MR. Intravenous buspirone for the prevention of postoperative nausea and vomiting. Eur J Clin Pharmacol. 2012 Nov;68(11):1465-72. doi: 10.1007/s00228-012-1284-8. Epub 2012 May 1.

lead_sponsor: Acacia Pharma Ltd

location_country:
United States
Switzerland
Germany
France

location_facility: Centre Hospitalier Universitaire Vaudois


lead_sponsor: Hoffmann-La Roche

summary: This sequential study will assess the efficacy and safety of multiple doses of intravenous (IV) methoxy polyethylene glycol-epoetin beta (MIRCERA), and will determine the optimum starting dose for maintenance treatment of anemia in children with chronic kidney disease on hemodialysis. Pediatric participants will remain on epoetin alfa, epoetin beta or darbepoetin alfa during the screening period, after which they will receive IV MIRCERA monthly, at a starting dose related to the previous weekly epoetin or darbepoetin alfa dose. Depending on the response achieved, another group may be selected to receive a higher or a lower dose.

location_facility: Chulalongkorn university Faculty of Medicine;Department of Pediatrics

location_facility: Hopital Armand Trousseau; Pediatrie Nephrologie

location_facility: Hôpital Robert Debré; Nephrologie pediatrique

location_facility: Wojewodzki Szpital Dzieciecy; Osrodek Chorob Nerek i Dializoterapii

location_facility: Hopital Femme Mere Enfant; Ped Nephrologie Rhumatologie

location_facility: Hopital Arnaud De Villeneuve; Pediatrie I

location_facility: Siriraj Hospital, Faculty of Medicine; Department of Pediatrics

location_facility: St. Maria Emergency Clinical Hospital for Children

location_facility: Kiev city childrens nephrological center of hospital #1; Nephrology and RRT

location_facility: Hospital Universitario la Fe; Servicio de Nefrologia Pediatrica

location_facility: Ospedale Pediatrico Bambino Gesu; U.O. Di Nefrologia E Dialisi

location_facility: Hopital Jeanne De Flandre; Cons Pediatrie

location_facility: Semmelweis University; 1st Department of Pediatrics, Pediatric Nephrology Center

location_facility: Instytut "Centrum Zdrowia Matki Polki; Klinika Nefrologii i Dializoterapii

location_facility: KfH-Nierenzentrum für Kinder und Jugendliche

location_facility: A.O. Di Padova; Dipartimento Di Pediatria U.O. Di Nefrologia Pediatrica, Dialisi e Trapianto

location_facility: Royal Children'S Hospital; Department of Nephrology

location_facility: SBIH Children City Hospital #1; Dialysis department

location_facility: Hopital Timone Enfants; Nephrologie Hemodialyse

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy

location_facility: Public Institution Zaporizhzhia City Multispecialty Children's Hospital #5; Allergologic

location_facility: Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego

location_facility: SPSZOZ Zdroje Oddzial Pediatrii; Nefrologii i Toksykologii ze Stacja Dializ

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica

location_facility: Akademia Medyczna im. Piastow Slaskich; Katedra i Klinika Nefrologii Pediatrycznej

location_facility: Dzieciecy Szpital Kliniczny; Klinika Nefrologii Dzieciecej

location_facility: Ospedale Infantile Regina Margherita; U.O. Autonoma di Nefrologia, Dialisi e Trapianto

location_facility: IRCCS G. Gaslini; U.O. Nefrologia, Dialisi e Trapianto

location_facility: Hospital Universitario La Paz: Nefrologia Pediatrica

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

location_facility: KfH-Nierenzentrum fur Kinder und Jugendliche

location_facility: DGCB St. Vladimir; Pediatric nephrologist

location_facility: KfH Nierenzentrum für Kinder und Jugendliche

title: An Open-Label Multi-center, Multiple Dose Study to Determine the Optimum Starting Dose of Intravenous MIRCERA for Maintenance Treatment of Anemia in Pediatric Participants With Chronic Kidney Disease on Hemodialysis

location_country:
Germany
Italy
Poland
Hungary
Romania
Australia
Belgium
Spain
Thailand
Ukraine
Russian Federation
France


title: A Randomized, Open Label Study to Evaluate the Effect of Subcutaneous Mircera, Versus no ESA Therapy, on Hemoglobin Levels in Chronic Kidney Disease Patients With Anemia After Kidney Transplant.

summary: This 2 arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera, versus no ESA therapy, in chronic kidney disease patients with anemia after kidney transplant, not currently treated with ESA. Patients will be randomized to receive a)subcutaneous Mircera at a recommended starting dose of 0.6 micrograms/kg every 2 weeks, switching to monthly treatment at week 16 or b)supportive treatment (eg. iron supplementation) for management of low hemoglobin concentrations. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

status: Terminated

location_country:
Germany
Italy
United Kingdom
Belgium
Spain
France

status_simplified: Unknown


title: A Randomized, Open-label Study Comparing the Anti-tumor Effect of Treatment With Tarceva Plus Avastin Versus Chemotherapy Plus Avastin in Patients With Advanced Non-small Cell Lung Cancer

summary: This 2 arm study will compare the efficacy and safety of Tarceva plus Avastin, and chemotherapy plus Avastin, in the first-line treatment of patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg p.o. daily plus Avastin 15mg/kg i.v. every 3 weeks, or standard platinum-based chemotherapy (4-6 cycles) plus Avastin. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

ReferenceCitation: Ciuleanu T, Tsai CM, Tsao CJ, Milanowski J, Amoroso D, Heo DS, Groen HJ, Szczesna A, Chung CY, Chao TY, Middleton G, Zeaiter A, Klingelschmitt G, Klughammer B, Thatcher N. A phase II study of erlotinib in combination with bevacizumab versus chemotherapy plus bevacizumab in the first-line treatment of advanced non-squamous non-small cell lung cancer. Lung Cancer. 2013 Nov;82(2):276-81. doi: 10.1016/j.lungcan.2013.08.002. Epub 2013 Aug 13.

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: closed

unpaywall_oa_status: hybrid

location_country:
Italy
Lithuania
Poland
United Kingdom
Singapore
Romania
Australia
Netherlands
Belgium
Korea, Republic of
Spain
Taiwan
France


type: Other Identifier

title: A Randomized, Controlled, Open-Label Study of the Long-Term Impact on Functioning Using Atomoxetine Hydrochloride Compared to Other Early Standard Care in the Treatment of Attention-Deficit/Hyperactivity Disorder in Treatment-Naïve Children and Adolescents

acronym: ADHD LIFE

summary: The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Attention-Deficit/Hyperactivity Disorder [ADHD]) on the long term functioning in approximately 400 children and adolescents with ADHD. Patients will be pharmacological naïve prior to entry into the study.

lead_sponsor: Eli Lilly and Company

location_country:
Ireland
Italy
Norway
United Kingdom
Mexico
Belgium
Spain
Turkey
France

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


title: A Phase IIIb Single Arm, Open-label, Multicentre Study of Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (SIERRA)

acronym: SIERRA

summary: This study will assess the safety and efficacy of Single Tremelimumab Regular Interval Durvalumab (STRIDE) as first-line therapy in participants with advanced unresectable HCC.

status: Recruiting

enrollment_type: Anticipated

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Germany
Italy
Hong Kong
Singapore
Japan
United States
Korea, Republic of
Spain
Vietnam
France


title: Subcutaneous Methotrexate, Oral Dexamethasone or Oral Montelukast for the Prevention of Infusion Related Reaction Associated With Amivantamab, an EGFR-MET Bispecific Antibody, Among Post-osimertinib Treated EGFRm NSCLC; SKIPPirr, a Phase 2 Study

summary: The purpose of the study is to separately assess the potential of dexamethasone, montelukast and methotrexate administration, prior to amivantamab infusion given through a needle in the vein, to decrease the incidence and/or severity of first-dose infusion related reactions.

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
United States
Spain
Korea, Republic of
Taiwan
France

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital


title: Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder

acronym: OPTIS

summary:
NMOSDCopilot is a digital tool developed for the self-assessment of Neuromyelitis Optica Spectrum Disorder symptoms that impact patients' functioning and quality of life. It has been co-designed with the help of patient advocacy groups, NMOSD patients and medical experts. It includes a smartphone-based application for patients, connected to a web portal developed for healthcare professionals (HCSPs). The patient application is composed of vision, walking, cognition, and dexterity e-active tests inspired by clinical standards, as well as e-questionnaires. The HCP web portal is a desktop-based software that allows HCPs to access the results generated via the patient application and facilitates remote monitoring of patients' symptoms.

The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone versus the standard in-clinic testing, as well as to evaluate the safety of use of the tool, its usability, and satisfaction towards the patient application among NMOSD patients, and the HCP web dashboard among HCPs.

primary_purpose: Other

ipd_sharing: No

lead_sponsor: Ad scientiam

location_country:
United States
France

location_facility: Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center)

intervention_type: Device


title: Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers

acronym: CALLIOPE

summary: The purpose of the clinical investigation is to document the safety and the performances of the remote monitoring functions of the ALIZEA, BOREA and CELEA pacemakers, i.e. the RAAT, the RVAT and the remote alerts.

study_type: Observational

time_perspective: Prospective

lead_sponsor: MicroPort CRM

location_country:
Germany
Portugal
United Kingdom
Netherlands
Austria
Belgium
Spain
France

location_facility: Hospital Professor Doutor Fernando Fonseca

location_facility: Kardiologische Praxis Dr. Trautwein & Dr. Placke


title: Controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to Stamaril in Adults

summary:
VYF03 is a phase II, randomized, parallel-group prevention study with 2 arms, active-controlled (Stamaril), observer-blind, multi-center study to assess the non-inferiority of the immune response, in terms of seroconversion rates of the investigational vaccine candidate vYF to the licensed Stamaril, in adults aged 18 years up to 60 years in Europe (EU).

The safety and immunogenicity profile of vYF in a cohort of Asian population of Chinese origin outside of China will also be described. The study will also assess the immunogenicity profiles and the safety profiles of vYF and Stamaril.

Participants will be randomized in a 2:1 ratio to receive a single subcutaneous injection of either the vYF vaccine (380 participants in EU and 80 participants of Chinese origin in Asia) or Stamaril (190 participants in EU and 40 participants of Chinese origin in Asia), on Day 01.

The duration of each participant's participation will be approximately 5 years.

lead_sponsor: Sanofi Pasteur, a Sanofi Company

location_country: Finland Germany Singapore Spain Thailand France

location_facility:
Investigational Site Number :2760004
Investigational Site Number :2460002
Investigational Site Number :7240001
Investigational Site Number :7020001
Investigational Site Number :7640001
Investigational Site Number :2500001
Investigational Site Number :2500008
Investigational Site Number :2500004
Investigational Site Number :2460003
Investigational Site Number :2500009
Investigational Site Number :7020003
Investigational Site Number :2460001
Investigational Site Number :2500006
Investigational Site Number :2500007
Investigational Site Number :7240002
Investigational Site Number :2760002
Investigational Site Number :2760001
Investigational Site Number :7640002
Investigational Site Number :7020002
Investigational Site Number :7240003
Investigational Site Number :2760003
Investigational Site Number :7640003
Investigational Site Number :7240004

lead_sponsor_type: academique


title: Influenza-associated Pulmonary Aspergillosis (IAPA) in ICU Patients With Severe Influenza: Incidence and Host- and Pathogen Related Risk Factors

acronym: IAPAFLU

summary: A prospective multi-center observational study to assess the incidence of influenza-associated pulmonary aspergillosis (IAPA) in ICU patients and to identify host- and pathogen related risk factors for IAPA in EORTC negative ICU patients with severe influenza.

ipd_sharing: Undecided

lead_sponsor: Radboud University Medical Center

location_country: Netherlands Belgium France

location_facility: Centre Hospitalier REgional Universitaire de Lille

location_facility: Hopital Pontchaillou, Centre Hospitalier Universitaire de Rennes

intervention_type: Other


title: Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating Single-agent MCLA-158 in Metastatic Colorectal Cancer and Other Advanced Solid Tumors

summary:
This is a Phase 1/2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the RP2D of MCLA-158 single agent in patients with mCRC.

The dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study. Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated.

The study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158.

lead_sponsor: Merus N.V.

location_country:
United Kingdom
Belgium
United States
Spain
France

location_facility: Cambridge University Hospitals NHS Foundation Trust


title: A Phase 2, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Standard of Care in Subjects With Previously Untreated and Advanced (Unresectable or Metastatic) Non-clear Cell Renal Cell Carcinoma (nccRCC)

summary: SUNNIFORECAST (Standard of Care vs. Nivolumab + Ipilimumab as First line treatment of renal cell cancer of non-clear cell subtypes) is a Phase II, randomized, open-label investigator initiated trial (IIT) of Nivolumab (BMS-936558) combined with Ipilimumab vs standard of care in subjects with previously untreated and advanced (unresectable or metastatic) non-clear cell renal cell carcinoma (nccRCC).

ReferenceType: background

ReferenceCitation: Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Choueiri TK, Gurney H, Donskov F, Bono P, Wagstaff J, Gauler TC, Ueda T, Tomita Y, Schutz FA, Kollmannsberger C, Larkin J, Ravaud A, Simon JS, Xu LA, Waxman IM, Sharma P; CheckMate 025 Investigators. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1803-13. doi: 10.1056/NEJMoa1510665. Epub 2015 Sep 25.

oa_colors: green other

evidence: open (via free article)

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Swansea University - Cronfa

version: acceptedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Armstrong AJ, Halabi S, Eisen T, Broderick S, Stadler WM, Jones RJ, Garcia JA, Vaishampayan UN, Picus J, Hawkins RE, Hainsworth JD, Kollmannsberger CK, Logan TF, Puzanov I, Pickering LM, Ryan CW, Protheroe A, Lusk CM, Oberg S, George DJ. Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial. Lancet Oncol. 2016 Mar;17(3):378-388. doi: 10.1016/S1470-2045(15)00515-X. Epub 2016 Jan 13.

ReferenceCitation: Vera-Badillo FE, Templeton AJ, Duran I, Ocana A, de Gouveia P, Aneja P, Knox JJ, Tannock IF, Escudier B, Amir E. Systemic therapy for non-clear cell renal cell carcinomas: a systematic review and meta-analysis. Eur Urol. 2015 Apr;67(4):740-9. doi: 10.1016/j.eururo.2014.05.010. Epub 2014 Jun 2.

ReferenceCitation: Ahrens M, Scheich S, Hartmann A, Bergmann L; IAG-N Interdisciplinary Working Group Kidney Cancer of the German Cancer Society. Non-Clear Cell Renal Cell Carcinoma - Pathology and Treatment Options. Oncol Res Treat. 2019;42(3):128-135. doi: 10.1159/000495366. Epub 2019 Feb 23.

ReferenceCitation: Motzer RJ, Tannir NM, McDermott DF, Aren Frontera O, Melichar B, Choueiri TK, Plimack ER, Barthelemy P, Porta C, George S, Powles T, Donskov F, Neiman V, Kollmannsberger CK, Salman P, Gurney H, Hawkins R, Ravaud A, Grimm MO, Bracarda S, Barrios CH, Tomita Y, Castellano D, Rini BI, Chen AC, Mekan S, McHenry MB, Wind-Rotolo M, Doan J, Sharma P, Hammers HJ, Escudier B; CheckMate 214 Investigators. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018 Apr 5;378(14):1277-1290. doi: 10.1056/NEJMoa1712126. Epub 2018 Mar 21.

repository_institution: Tampere University - Tampere University Institutional Repository

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

version: submittedVersion

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

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

lead_sponsor: Goethe University

location_country:
Germany
United Kingdom
Netherlands
Belgium
Spain
Czechia
France

location_facility: Nationales Zentrum für Tumorerkrankungen (NCT)

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Charite Berlin (Campus Virchow-Klinikum)

location_facility: Gent University Hospital (Universitair Ziekenhuis Gent)

location_facility: Les Hoptaux Universitaires de Strasbourg

location_facility: Centre Hospitalier Départemental de Vendée


title: Phase IIIb, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Previously Untreated Unresectable or Metastatic Melanoma

summary: This is a safety and efficacy study of different administration regimens of nivolumab plus Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.

lead_sponsor: Bristol-Myers Squibb

location_country: Italy Australia Spain France

location_facility: Istituto Nazionale Per La Ricerca Sul Cancro - Oncologia Med

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E Cura Tumori


title: An Open-Label, Multicenter, Phase 1b Study With an Expansion Cohort to Evaluate Safety and Efficacy of the Combination of Necitumumab With Pembrolizumab in Patients With Stage IV Non-Small Cell Lung Cancer

summary: The main purpose of this study is to evaluate the safety and efficacy of the combination of necitumumab with pembrolizumab in participants with stage IV non-small cell lung cancer (NSCLC).

sponsor_collaborators:
Eli Lilly and Company
Merck Sharp & Dohme LLC

location_country:
United States
Spain
Japan
France

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


title: Reporting Patterns and Results of Initial Antibiotic Treatment in Patients With Complicated Urinary Tract Infection,Complicated Intra-abdominal Infection and Nosocomial Pneumonia Including Ventilator-associated Pneumonia.

acronym: RECOMMEND

summary: Reporting patterns and results of initial antibiotic treatment in patients with complicated urinary tract infection (cUTI), complicated intra-abdominal infection (cIAI) and nosocomial pneumonia (NP) including ventilator-associated pneumonia (VAP) - RECOMMEND Study

time_perspective: Retrospective

ReferenceCitation: Ryan K, Karve S, Peeters P, Baelen E, Potter D, Rojas-Farreras S, Pascual E, Rodriguez-Bano J. The impact of initial antibiotic treatment failure: Real-world insights in healthcare-associated or nosocomial pneumonia. J Infect. 2018 Jul;77(1):9-17. doi: 10.1016/j.jinf.2018.04.002. Epub 2018 May 6.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Karve S, Ryan K, Peeters P, Baelen E, Rojas-Farreras S, Potter D, Rodriguez-Bano J. The impact of initial antibiotic treatment failure: Real-world insights in patients with complicated urinary tract infection. J Infect. 2018 Feb;76(2):121-131. doi: 10.1016/j.jinf.2017.11.001. Epub 2017 Nov 8.

oa_host_type: closed

lead_sponsor: Pfizer

location_country:
Italy
Brazil
Spain
Greece
Russian Federation
France


title: A Phase 2a, Randomized, Placebo Controlled, Proof of Mechanism Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Subjects With Primary Sjögren's Syndrome

summary: A Phase 2a study to evaluate the efficacy and safety of AMG 557/MEDI5872 in Primary Sjögren's Syndrome

lead_sponsor: MedImmune LLC

sponsor_collaborators:
MedImmune LLC
Amgen

location_country:
United States
United Kingdom
Sweden
France


acronym: Balise

summary: The primary purpose of this study is to compare the efficacy of the study drug LY2875358, given together with erlotinib, against erlotinib, alone. Participants will have Non-Small Cell Lung Cancer (NSCLC) that has advanced to Stage IV. Participants should not have been treated with drugs for Stage IV NSCLC, previously. All participants will get erlotinib alone, for approximately 8 weeks. Participants with radiographic disease control at the end of the erlotinib lead-in study period will be randomly assigned to receive LY2875358 plus erlotinib or erlotinib alone. Participants, who were chosen to receive erlotinib, alone, may cross over to the combination treatment at the time of progression.

title: A Randomized, Controlled Phase 2 Study Evaluating LY2875358 Plus Erlotinib Versus Erlotinib as First-Line Treatment in Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations Who Have Disease Control After an 8-Week Lead-In Treatment With Erlotinib

location_country:
Germany
Italy
United Kingdom
Denmark
Netherlands
Korea, Republic of
Spain
Taiwan
France


title: An Observational Study to Assess Persistence, Adherence, Quality of Life, and Treatment Satisfaction in Patients Beginning Therapy With the Avonex® PEN™.

acronym: PERSIST

summary: The primary objective of the study is to determine physician reported persistence with the Avonex PEN at Month 12/End of Study as well as determining factors associated with persistence. The secondary objectives for this study are as follows: To evaluate the tolerability for treatment administration of the Avonex PEN at Months 3, 6, and 12; To evaluate patient quality of life (QoL) while using the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate clarity of directions for use of the Avonex PEN at Month 3; To evaluate ease of use and the patient's assessment of the injection procedure with the Avonex PEN at Months 3, 6, and 12; To evaluate patient reported adherence at Months 6 and 12; To evaluate physician reported persistence at Month 6; To evaluate overall patient satisfaction with the use of the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate patient reported fear of injection at Months 3, 6, and 12; and To evaluate the percentage of patients switching from caregiver to self-injection at Months 3, 6, and 12.

ReferenceCitation: Hupperts R, Becker V, Friedrich J, Gobbi C, Salgado AV, Sperling B, You X. Multiple sclerosis patients treated with intramuscular IFN-beta-1a autoinjector in a real-world setting: prospective evaluation of treatment persistence, adherence, quality of life and satisfaction. Expert Opin Drug Deliv. 2015 Jan;12(1):15-25. doi: 10.1517/17425247.2015.989209. Epub 2014 Nov 28.

publisher_dissemination: Informa

lead_sponsor: Biogen

location_country:
Germany
Portugal
Slovakia
Norway
United Kingdom
Denmark
Sweden
Netherlands
Switzerland
France


lead_sponsor: Bayer

summary:
This study examines the efficacy and safety of the combination treatment BAY60-4552 plus vardenafil in patients with erectile dysfunction, who do not sufficiently respond to therapy with PDE5 (Phosphodiesterase 5) inhibitors.

Patients meeting the entry criteria, will receive vardenafil alone in the first four weeks of the study to assess the effect of PDE5 inhibitor therapy given alone.

Patients with an insufficient therapeutic response to vardenafil alone will enter the next part of the study, and will be randomly assigned to one of 3 treatments. There is a 1 in 3 chance of receiving either the combination BAY60-4552 plus vardenafil, or vardenafil alone, or placebo. Neither patient nor the treating physician will know which treatment is given (double-blinded design).This part of the study will last four weeks Patients will have to go to the clinic/hospital for 7 visits during the 8 weeks.

title: A Prospective, Randomized, Double-blind, Double-dummy, Placebo- and Active Controlled, Multicenter Study Assessing the Efficacy and Safety of the Combination BAY60-4552 / Vardenafil Compared to Vardenafil (20 mg) for the Treatment of Erectile Dysfunction Not Sufficiently Responsive to Standard Therapy With PDE5 (Phosphodiesterase 5) Inhibitors

location_country: Finland Italy Germany Sweden Netherlands Spain France


title: A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn's Disease.

summary: The study aims to evaluate the safety and clinical effect of daily oral treatment of Laquinimod capsules in active moderate to severe Crohn's disease. This study will assess Laquinimod doses of 0.5mg /day to 2 mg/day in sequential dose groups (cohorts). Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.

ReferenceCitation: D'Haens G, Sandborn WJ, Colombel JF, Rutgeerts P, Brown K, Barkay H, Sakov A, Haviv A, Feagan BG; Laquinimod for Crohn's Disease Investigators. A phase II study of laquinimod in Crohn's disease. Gut. 2015 Aug;64(8):1227-35. doi: 10.1136/gutjnl-2014-307118. Epub 2014 Oct 3.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: British Medical Journal

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
France
Italy
Poland
United Kingdom
Netherlands
Belgium
Spain
South Africa
Israel

location_facility:
Teva Investigational Site 3070
Teva Investigational Site 9017
Teva Investigational Site 3820
Teva Investigational Site 9013
Teva Investigational Site 5361
Teva Investigational Site 8046
Teva Investigational Site 3428
Teva Investigational Site 8049
Teva Investigational Site 8048
Teva Investigational Site 8047
Teva Investigational Site 3712
Teva Investigational Site 9009
Teva Investigational Site 5351
Teva Investigational Site 5355
Teva Investigational Site 5363
Teva Investigational Site 5354
Teva Investigational Site 5360
Teva Investigational Site 3160
Teva Investigational Site 3713
Teva Investigational Site 3430
Teva Investigational Site 3072
Teva Investigational Site 5352
Teva Investigational Site 5353
Teva Investigational Site 3429
Teva Investigational Site 3819
Teva Investigational Site 8051
Teva Investigational Site 3711
Teva Investigational Site 8050
Teva Investigational Site 5362
Teva Investigational Site 3164
Teva Investigational Site 5350
Teva Investigational Site 3158
Teva Investigational Site 3069
Teva Investigational Site 3432


title: A Phase II Study Of Su011248 In Patients With Recurrent And/Or Metastatic Squamous Head And Neck Carcinoma.

summary: Preclinical studies as well as phase I and II trials have demonstrated that SU11248 has antitumor activity in renal cell carcinoma, breast cancer, neuroendocrine tumor and GIST. So at the light of these pre-clinical and clinical data, it seems interesting and promising to test SU011248 in these poor prognosis patients.

lead_sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

location_country: Belgium France

location_facility: Clinique universiataire de Mont Godinnes UCL


title: A Multi-centre, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Investigate Efficacy and Safety of ONO-2506PO Compared to Placebo, in the Presence of Riluzole, to Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS), Who Have Had Onset of Muscle Weakness Within 14 Months of Randomization

summary: The purpose of this study is to determine if oral treatment with ONO-2506PO in patients diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization, could lead to the slowing of decline in respiratory function, functional status, muscle strength, quality of life and survival compared with placebo group.

lead_sponsor: Ono Pharmaceutical Co. Ltd

location_country:
Germany
Italy
United Kingdom
Netherlands
Austria
Belgium
Switzerland
France

location_facility: Dipartimento di Neuroscienze - Divisione di Neurologia II - Azienda Ospedaliera S. Giovanni Battista - Molinette

location_facility: Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic

location_facility: Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano

location_facility: Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik

location_facility: University of Sheffield - Academic Neurology Unit

location_facility: Martin-Luther-Universitat Halle-Wittenberg, Klinikum der Medizinischen Fakultat, Universitatsklinik und Poliklinik fur Neurologie

location_facility: Medizinische Hochschule Hannover, Neurologische Klinik

location_facility: Hopital Roger Salengro - Clinique Neurologique, Neurologie A

location_facility: L. Boltzmann Forschungsinstitut, Neurologische Abteilung, Kaiser Franz Josef Hospital, Wien

location_facility: Academic Medical Centre (AMC) Amsterdam - Dept of Neurology

location_facility: Interdisziplinares Zentrum fur Palliativmedizin

location_facility: Deutsche Klinik fur Diagnostik, Fachbereich Neurologie

location_facility: Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS

location_facility: Klinik und Poliklinik fur Neurologie der Universitat Ulm-Universitatsklinikum Ulm


title: First Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors, a Phase II Trial

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 temozolomide in treating patients with recurrent oligodendroglial tumors.

ReferenceCitation: Kouwenhoven MC, Kros JM, French PJ, Biemond-ter Stege EM, Graveland WJ, Taphoorn MJ, Brandes AA, van den Bent MJ. 1p/19q loss within oligodendroglioma is predictive for response to first line temozolomide but not to salvage treatment. Eur J Cancer. 2006 Oct;42(15):2499-503. doi: 10.1016/j.ejca.2006.05.021. Epub 2006 Aug 17.

ReferenceType: result

ReferenceCitation: van den Bent MJ, Taphoorn MJ, Brandes AA, Menten J, Stupp R, Frenay M, Chinot O, Kros JM, van der Rijt CC, Vecht ChJ, Allgeier A, Gorlia T; European Organization for Research and Treatment of Cancer Brain Tumor Group. Phase II study of first-line chemotherapy with temozolomide in recurrent oligodendroglial tumors: the European Organization for Research and Treatment of Cancer Brain Tumor Group Study 26971. J Clin Oncol. 2003 Jul 1;21(13):2525-8. doi: 10.1200/JCO.2003.12.015.

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

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

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: Instituto Portugues de Oncologia de Francisco Gentil


title: Open Label Extension Study to Investigate Long Term Safety, Tolerability and Efficacy of Tauroursodeoxycholic Acid in Patients With ALS Who Completed the TUDCA-ALS Study

acronym: TUDCA-ALS OLE

summary: This study will provide extended access to patients and assess longer-term outcomes on patients who have completed the TUDCA-ALS study.

lead_sponsor: Humanitas Mirasole SpA

sponsor_collaborators:
Humanitas Mirasole SpA
University of Ulm
University of Sheffield
University Hospital, Tours
KU Leuven
UMC Utrecht
University of Dublin, Trinity College
Bruschettini S.r.l.
Istituto Superiore di Sanità
Motor Neurone Disease Association

location_country:
Germany
Ireland
Italy
United Kingdom
Netherlands
Belgium
France

location_facility: NEuroMuscular Omnicentre. Fondazione Serena Onlus

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: AOU Università degli Studi della Campania "Luigi Vanvitelli"

location_facility: AOU Città della Salute e della Scienza di Torino

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Universitaire Limoges

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Regional Universitaire de Tours


title: A Multicentre, Single-arm Phase II Trial of Adagrasib in Patients With KRASG12C-mutant NSCLC, Including the Elderly (≥70 Years) or Patients With Poor Performance Status

acronym: ADEPPT

summary: ADEPPT is an international, multicentre, single-arm phase II trial. The protocol treatment consists of adagrasib, which is administered at a dose of 600 mg orally, twice daily until progression or unacceptable toxicity.The primary objective of this trial is to assess the clinical efficacy of adagrasib treatment, in terms of objective response, in patients with KRASG12C-mutant NSCLC, including the elderly (≥70 years) or patients with poor performance status (ECOG PS=2).

lead_sponsor: ETOP IBCSG Partners Foundation

sponsor_collaborators:
ETOP IBCSG Partners Foundation
Mirati Therapeutics Inc.

location_country:
Ireland
Italy
United Kingdom
Belgium
Spain
France

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: ICO Badalona - Hospital Germans Trias i Pujol

location_facility: Istituto Nazionale Tumori "Regina Elena"

location_facility: Complejo Hospitalario Universitario a Coruña

location_facility: Hospital General Universitario de Valencia (University Hospital Valencia)

location_facility: ICO Bellvitge -H. Duran i Reynals / H. Bellvitge


title: A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy of Asunercept for the Treatment of Hospitalized Patients With Moderate to Severe COVID 19 Disease

acronym: ASUCOV

summary:
This clincial trial is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase III trial in hospitalized patients with moderate to severe COVID-19 corresponding to score 5 or 6 on the WHO 10-point clinical progression scale (Grade 0-10).

The investigational drug (APG101; International Nonproprietary Name: asunercept) will be given at a dose of 100 mg intravenously (i.v.) once weekly for a period of 4 weeks (1 dose each on d1, d8, d15, and d22) in addition to the treatment recommended by international, national, or local treatment guidelines (SoC) and will be compared with the control arm (i.e., SoC + placebo).

lead_sponsor: Apogenix GmbH

location_country:
Germany
Italy
Poland
India
Austria
Spain
South Africa
Georgia
France

location_facility: Ltd "TSMU and Ingorokva High Medical Technology University Clinic"

location_facility: Ltd "Academician Vakhtang Bochorishvili Clinic"

location_facility: Govtl. Medical College and Hospital Aurangabad

location_facility: PCMC PGI Yashwantrao Chavan Memorial Hospital

location_facility: Victoria Hospital, BMCRI Bangalore Medical College & Research Institute

location_facility: Synapta Clinical Research, 704 Durban Medical Centre

location_facility: Complejo Asistencial Universitario de Salamanca

location_facility: KLES Dr. Prabhakar Kore Hospital & Medical Research Center

location_facility: Complejo Hospitalario Universitario de Vigo - Hospital Álvaro Cunqueiro

location_facility: Azienda Ospedaliere Universitaria Federico I

location_facility: Atharva Multispecialty Hospital and Research Center

location_facility: Dubois Hospital, Service de médecine intensive Réanimation

location_facility: Azienda Ospedaliera Universitaria L. Vanvitelli

location_facility: Uniklinik Köln - Klinik I für Innere Medizin

location_facility: CHU Amiens - Site Sud, Centre de Recherche Clinique

location_facility: Hospital General Universitario de Alicante Dr. Balmis

location_facility: Ltd "Academician Nikoloz Kipshidze Central University Clinic"


acronym: CARE

lead_sponsor: Intercept Pharmaceuticals

summary: This is a Phase 2, multicenter, open-label, single dose and multi-dose, dose-finding study with an optional open-label extension (OLE) to assess the safety, tolerability, and pharmacokinetics of obeticholic acid (OCA) in pediatric subjects with biliary atresia with successful hepatoportoenterostomy (HPE, also known as a Kasai portoenterosomy). The OLE will continue to evaluate safety, tolerability, pharmacodynamics, and efficacy of OCA. In addition, a change in vitamin A and D levels, and where possible the degree of change in liver stiffness, will be assessed during the OLE.

location_facility: CHU de Toulouse Purpan-Hopital des Enfants

location_facility: University Medical Center Gröningen-Beatrix, children's Hospital

location_facility: Hannover Medical School, Children's Hospital, Paediatric Gastroenterology and Hepatology,

title: A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study, With an Optional Open-Label Extension to Assess the Safety, Tolerability, and Pharmacokinetics of Obeticholic Acid in Pediatric Subjects With Biliary Atresia

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


title: A Case-control Study on Risk Factors, Timing, and PCR Use, for Pneumocystis Pneumonia (PcP) After Allogeneic HSCT

summary:
The fungus Pneumocystis jirovecii is responsible for pneumocystosis (PcP), a life threatening pneumonia in patients undergoing HSCT. The spontaneous attack rate of 16% within the first 6 months following allogeneic HSCT reported in the 1980's has considerably decreased with prophylaxis. However, PcP still remains a concern in the transplant ward with an incidence rate up to 2.5% in allo- and 1.4% in autologous HSCT but up to 7.2% on low dose of Dapsone. The mortality of PcP is especially high in HSCT recipients. One of the main factors of PcP after HSCT seems to be either the lack of TMP-SMX prophylaxis (all the other prophylactic drugs being inferior to TMP-SMX), or poor compliance to prophylaxis. Due to the rarity of the disease after HSCT, it is impossible to study it in monocenter studies, except on very long periods of time which may not reflect current practice. Several questions deserve investigations in a multicenter study, about timing, risk factors, and outcome.

Moreover, some European laboratories involved in the diagnosis of PcP have already given up to classical diagnostic methods and switched to qPCR. This implies that lower fungal burden can be detected and the clinical pertinence of such a diagnostic strategy deserves to be assessed.

lead_sponsor: European Society for Blood and Marrow Transplantation

location_country: Germany France Hungary Norway Belgium Israel

location_facility: Oslo University Hospital, Rikshospitalet

location_facility: United St. Istvan and St. Laszlo Hospital


title: Biomarker- Guided Intervention to Prevent Acute Kidney Injury After Major Surgery. A Prospective Randomized Controlled Multicenter Trial (BigpAK-2)

summary:
There is no specific therapy for acute kidney injury. It is presumed that supportive measures improve the care and outcome of patients with acute kidney injury. The investigators hypothesize that the implementation of a bundle of supportive measures adapted to patients undergoing major surgery reduces the occurrence of AKI.

This randomized prospective multicenter trial is needed to investigator whether the implementation of the bundle of measures is effective to prevent AKI in high risk patients undergoing major surgery.

primary_purpose: Supportive Care

lead_sponsor: University Hospital Muenster

sponsor_collaborators:
University Hospital Muenster
BioMérieux

location_country:
Germany
Italy
United Kingdom
Netherlands
Switzerland
Belgium
Spain
France

location_facility: Department of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital

location_facility: Department of Anesthesiology and Intensive Care, San Bortolo Hospital

location_facility: Department of Anaesthesiology and Intensive Care Medicine, Parc de Salut Mar

location_facility: Department of Anesthesia, Hospital Juan Ramon Jimenez

location_facility: Department of Anesthesiology, Department of Anesthesiology and Critical Care, Franziskus Hospital Münster

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Servicio de Anestesiologia, Hospital Universitario y Politécnico La Fe

location_facility: Adult Intensive Care Unit, Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Department of Anesthesiology and Intensive Care Medicine, Philipps-University

location_facility: Department of Health Sciences, Section of Anesthesiology, Intensive Care and Pain Medicine, University of Florence; Department of Anesthesia and Intensive Care, Section of Oncological Anesthesia and Intensive care, Azienda Ospedaliero Careggi

location_facility: Department of Anesthesiology, University Hospital Düsseldorf, Heinrich-Heine-University Duesseldorf

location_facility: Department of Anesthesiology, Heidelberg University Hospital

location_facility: Department of Anesthesiology and Intensive Care Medicine, University Hospital Bonn

location_facility: Department of Anaesthesiology and Surgical Critical Care, Hospital Universitario Marqués de Valdecilla

location_facility: Service d´Anesthésie-Réanimation, Hôpital Edouard Herriot, Hospices Civils de Lyon

location_facility: Department of Anesthetics, King's College Hospital, Denmark Hill

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

location_facility: Department of Anesthesiology and Intensive Care Medicine, University Hospital Essen, University Duisburg-Essen

location_facility: Department of Anesthesiology, University Medical Center, Georg-August-University

location_facility: Santa Chiara Regional Hospital, APSS Trento

location_facility: Department of Nephrology, Heidelberg University Hospital

location_facility: Department of Anesthesiology, Hospital Universitario Ramón y Cajal

location_facility: Centre Hospitalier Universitaire de Reims

location_facility: Servicio de Anestesiologia y Reanimación, Hosp. Universitario de La Princesa

location_facility: Department of Translational Medicine and for Romagna, St. Anne's Archbishop Hospital, University of Ferrara

location_facility: Department of Anesthesiology and Intensive Care Medicine, Medical Faculty and University Hospital Cologne, University of Cologne

location_facility: Department of Anesthesiology and Intensive Care, IRCCS Humanitas Clinical and Research Hospital

location_facility: Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Knappschaftskrankenhaus, Ruhr University Bochum

location_facility: Department of Anesthesiology and Critical Care, University Hospital Vall d'Hebron

location_facility: Department of Anaesthesiology and Intensive Care Medicine, Klinikum Bayreuth GmbH

location_facility: Department of Anesthesiology and Intensive Care Medicine, University Hospital "Carl Gustav Carus", Technische Universität Dresden

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna

location_facility: Department of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen, Eberhard Karls University Tübingen

location_facility: Clinical Research Department, Centre Hospitalier Universitaire Brugmann

location_facility: Intensive Care Unit, Royal Liverpool University Hospital

location_facility: Department of Anesthesia and Perioperative Care, Infanta Leonor University Hospital

location_facility: Department of Anaesthetics and Critical Care, Harefield Hospital

location_facility: Centre for Experimental Medicine, School of Medicine, Dentistry, and Biomedical Sciences, Queen's University Belfast

location_facility: Intensive Care Unit, Royal Surrey County Hospital

location_facility: Department of Anesthesiology, Intensive Care and Pain Medicine, Klinikum Dortmund

location_facility: Department of Anaesthesiology, Laboratory of Experimental Intensive Care and Anaesthesiology (L.E.I.C.A.), Amsterdam UMC, Location Academic Medical Centre (AMC), Amsterdam, University of Amsterdam

location_facility: Centre Hospitalier Universitaire de Angers

location_facility: Department of Anesthesiology and Intensive Care Medicine, University Hospital Augsburg


title: Open-label, Non-randomized Phase 1, Multicenter Study to Assess Radium-223 Biodistribution in Participants With Bone Metastatic Castration Resistant Prostate Cancer (CRPC) Receiving Radium-223 Dichloride Treatment.

summary: In this study researcher want to gain more information on how the study drug (radium-223) is distributed in the bone, particularly in the tumor free bone in participants with prostate cancer. The study plans to enroll 60 patients with the age of at least 18 years and suffering from prostate cancer which has spread to the bones. Researcher will divide the study participants into 2 groups. Patients in Group 1 should have up to 6 bone metastases and patients for group 2 should have more than 6 bone metastases. The study medication will be given as injection into a vein every 4 weeks up to a maximum of 6 times. To study how radium distributes in the body and particularly in the bones, participants will undergo after study medication intake MRI or CT Scans (imaging techniques).

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

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

location_country:
France
Lithuania
Italy
United Kingdom
Austria
Israel

location_facility: Institut de Cancérologie de l'Ouest - Saint Herblain

location_facility: Institut Claudius Regaud - iUCT Oncopole

location_facility: Uniklinikum Salzburg - Landeskrankenhaus

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

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Guy's and St. Thomas' NHS Trust, St. Thomas' Hospital

location_facility: University College London Hospitals NHS Foundation Trust


lead_sponsor: 4SC AG

summary: This phase II trial studies how well domatinostat (4SC-202) works in combination with avelumab in adult patients with advanced unresectable and/or metastatic Merkel Cell Carcinoma that have progressed on a previous therapy with an anti-PD-(L)1 antibody

location_facility: Hôpital Ambroise Paré - Boulogne-Billancourt

location_facility: Instituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck

location_facility: Istituto Nazionale Tumori Fondazione G.Pascale

title: A Phase II, Open Label Study to Investigate the Efficacy and Safety of Domatinostat in Combination With Avelumab in Patients With Advanced Unresectable/Metastatic Merkel Cell Carcinoma Progressing on Anti-PD-(L)1 Antibody Therapy

location_country: Germany Italy Netherlands Belgium Spain France


title: Outcome of COVID-19 Patients After Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome: A Multicenter European Study

summary: This study aims to investigate outcomes and predictors of outcome after extracorporeal membrane oxygenation (ECMO) therapy for severe acute respiratory syndrome (ARDS) in COVID-19 patients.

ReferenceCitation: Biancari F, Mariscalco G, Dalen M, Settembre N, Welp H, Perrotti A, Wiebe K, Leo E, Loforte A, Chocron S, Pacini D, Juvonen T, Broman LM, Perna DD, Yusuff H, Harvey C, Mongardon N, Maureira JP, Levy B, Falk L, Ruggieri VG, Zipfel S, Folliguet T, Fiore A. Six-Month Survival After Extracorporeal Membrane Oxygenation for Severe COVID-19. J Cardiothorac Vasc Anesth. 2021 Jul;35(7):1999-2006. doi: 10.1053/j.jvca.2021.01.027. Epub 2021 Jan 19.

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repository_institution: University of Turku - UTUPub

repository_institution: University of Oulu - University of Oulu Repository - Jultika

lead_sponsor: Helsinki University Central Hospital

location_country:
Finland
Italy
Germany
France
United Kingdom
Sweden

location_facility:
Nancy University Hospital
Lecco Hospital
Henri Mondon Unoversity Hospital
Robert Debré University Hospital
Hamburg University Heart Center
Karolinska University Hospital
Münster University Hospital
Helsinki University Hospital
University Hospitals of Leicester
S. Orsola Hospital
University Hospital Jean Minjoz


title: Response to CFTR-modulators in Intestinal Organoids of Patients With CF Having at Least One R334W Mutation

summary: In contrary to what is seen in FRT cells, rectal organoids of patients with a R334W mutation do respond to CFTR modulators ivacaftor and lumacaftor. The present study will investigate the response to modulators in organoids of 30 patients with CF and a R334W mutation, to allow further stratificaton for a future clinical trial assessing the clinical effect of ivacaftor/tezacaftor in patients with CF and a R334W mutation.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Universitaire Ziekenhuizen KU Leuven

sponsor_collaborators:
Universitaire Ziekenhuizen KU Leuven
Vertex Pharmaceuticals Incorporated
KU Leuven
University of Lisbon

location_country: Italy Portugal Belgium Spain France

location_facility: Fondazione Ospedale Maggiore Policlinico

location_facility: Sapienza university - Centra Fibrosi Cistica Regione Lazio

location_facility: Azieda Ospedaliera Universitaria Integrata

location_facility: Centre Hospitalier Régional Universitaire Montpellier

intervention_type: Procedure


title: A Post-Authorisation Safety Study Patient Registry of Patients With High-risk Neuroblastoma Being Treated With the Monoclonal Antibody Dinutuximab Beta

summary: This is a non-interventional, multi-national, observational, prospective patient registry to further evaluate the effectiveness and safety of dinutuximab beta - a monoclonal immunoglobulin G 1 (IgG1) antibody, to obtain information on survival, pain severity and incidence of neuro-toxicity, visual impairment, capillary leak syndrome, cardiovascular events, hypersensitivity reactions and long-term safety.

lead_sponsor: EusaPharma (UK) Limited

sponsor_collaborators:
EusaPharma (UK) Limited
United BioSource, LLC

location_country:
Germany
Italy
Poland
United Kingdom
Austria
Spain
France

location_facility: Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Hôpital de la Timone, Hôpital des Enfants


title: Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO

acronym: PROOF

summary: Percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.

lead_sponsor: Occlutech International AB

location_country: Germany Italy Canada France

location_facility: Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden

location_facility: Institut de Cardiologie,groupe hospitalier pitié salpêtrière


acronym: TUDCA-ALS

summary: This is a Phase III, multi-centre, randomized, double-blind, placebo-controlled, parallel-group study to evaluate Safety and Efficacy of Tauroursodeoxycholic (TUDCA) as add-on Treatment in Patients Affected by Amyotrophic Lateral Sclerosis (ALS).

ReferenceCitation: Albanese A, Ludolph AC, McDermott CJ, Corcia P, Van Damme P, Van den Berg LH, Hardiman O, Rinaldi G, Vanacore N, Dickie B; TUDCA-ALS Study Group. Tauroursodeoxycholic acid in patients with amyotrophic lateral sclerosis: The TUDCA-ALS trial protocol. Front Neurol. 2022 Sep 27;13:1009113. doi: 10.3389/fneur.2022.1009113. eCollection 2022.

sponsor_collaborators:
Humanitas Mirasole SpA
University of Ulm
University of Sheffield
University Hospital, Tours
KU Leuven
UMC Utrecht
University of Dublin, Trinity College
Bruschettini S.r.l.
Istituto Superiore di Sanità
Motor Neurone Disease Association
European Commission

location_facility: NEuroMuscular Omnicentre. Fondazione Serena Onlus

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: AOU Università degli Studi della Campania "Luigi Vanvitelli"

location_facility: AOU Città della Salute e della Scienza di Torino

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Centre Hospitalier Universitaire Limoges

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Centre Hospitalier Regional Universitaire de Tours

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust

type: Other Grant/Funding Number

ipd_sharing_description:
Once the dataset has been analysed, a complete, cleaned, anonymized copy of the final data used in conducting the final analyses will be made available to be used in further studies by the research partners or by other research groups and clinicians.

To prevent misuse and misinterpretation, relevant study metadata (such as the study protocol, case report forms, documentation providing information about the methodology and procedures used to collect the data, definition of variables and statistical code) will be shared in a data repository with a stable URL. Patient anonymity and legal compliance will be assured throughout all the steps of data transfer.


title: A Prospective Multinational European Study on Evaluation of Practices and Prognostic Factors of Percutaneous Coronary Interventions (PCI) of Calcified Complex Lesions Using Rotational Atherectomy Device.

acronym: Eurotaclub

summary:
In spite of technological advances, PCI of complex calcified coronary lesions remain a challenge.

Observational studies demonstrate that moderate or severe calcifications in lesions to treat are associated with an increase in mortality, in myocardial infarctions, in stent thrombosis, and in complementary revascularizations. Rotational atherectomy is now part of therapeutic armamentarium of interventional cardiologists for the treatment of some complex calcified coronary lesions. Last recommendations of the European Society of Cardiology about revascularizations indicate that rotational atherectomy should be used for "the preparation of calcified or massive fibrotic lesions that cannot be crossed by a balloon or for an optimal dilatation before stenting". However, this technique is not frequently used and limited to high-volume PCI centers. Even though rotational atherectomy demonstrated an improvement in immediate success of complex lesions, the longterm reduction of cardiovascular events after active stenting has not been proved. In observational studies, the results are not consistent because of many selection biases that influence the choice of an angioplasty with rotational atherectomy device (calcifications, severity of the disease). Furthermore, this technique needs operators with a certain amount of experience. The fundamentals of an optimal use of rotational atherectomy remain to be defined (duration and speed of burr, anti-platelet treatments...).

lead_sponsor: University Hospital, Toulouse

location_country:
Germany
Italy
Poland
Austria
Spain
Greece
Russian Federation
France

location_facility: Hospital Universitario Central de la Defensa "Gomez Ulla"

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: Interventional Cardiology Clinic, Jagiellonina University


lead_sponsor: RECORDATI GROUP

summary: Study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Rec 0/0438 in subjects with neurogenic detrusor overactivity due to spinal cord injury

location_facility: Department of Urology, Academic hospital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Pierre et Marie Curie Medical School, Sorbonne Universités

location_facility: Centre Hospitalier Lyon Sud Unité de Pharmacie Clinique Oncologique (essai clinique) Pavillon Marcel Bérard - Bât. 1G

title: Effects of Two Different Doses of Rec 0/0438 Administered by Intravesical Instillation in Patients With Neurogenic Detrusor Overactivity Due to Spinal Cord Injury: a Repeated Doses, Double-blind, Placebo Controlled Study

location_country: Czechia Poland Portugal France


title: Validation of Fenestrations Positioning by Numerical Simulation in Fenestrated Endovascular Repair of Abdominal Aortic Aneurysms

acronym: FenSim

summary: Fenestrated endovascular repair (FEVAR) is nowadays a recognized option to treat juxtarenal, pararenal or suprarenal abdominal aortic aneurysms in patients at high risk for conventional repair. The technique consists in deploying a custom-made stent-graft (SG) inside the patient aorta. Part of the customization involves cauterizing a hole in SG fabric and reinforcing it with a Nitinol stent ring, thereby creating a fenestration for each corresponding collateral artery. For this reason, preoperative planning is crucial to determine adequate positions of fenestrations, in order to obtain perfect alignment with the collateral arteries of the patient. Inadequate positioning may result in failure to catheterize a collateral artery and subsequent organ damage, increased catheterizing time, increased irradiation dose, endoleaks… The current process of fenestrations positioning for fenestrated anacondaTM SG involves: (i) anatomical measurements on patient preoperative CT-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with CAD software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a SG prototype deployed inside a transparent anatomy model (3D-printed model of patient aorta and collateral arteries). The main limitations of this process are the costs and long SG delivery time.

lead_sponsor: Centre Hospitalier Universitaire de Saint Etienne

location_country:
Germany
United Kingdom
Netherlands
Austria
France

location_facility: University Hospital, Campus Benjamin Franklin


title: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure: the SWISS-APERO Randomized Clinical Trial

acronym: SWISS-APERO

summary: Left atrial appendage closure (LAAC) is an emerging therapeutic option in non-valvular atrial fibrillation (NVAF) patients with high thromboembolic and bleeding risks. In Europe the devices most frequently utilized for LAAC are Amplatzer Amulet (St. Jude Medical-Abbott) and Watchman (Boston Scientific) system. However there are currently no randomized controlled trials assessing the degree of LAA closure between the two devices. The main purpose of this trial is to evaluate the feasibility and the efficacy of the devices in terms of LAA complete occlusion with a non-invasive imaging technique such as cardiac computed tomography angiography (CCTA).

ReferenceCitation: Galea R, De Marco F, Aminian A, Meneveau N, Anselme F, Grani C, Huber AT, Teiger E, Iriart X, Angelillis M, Brugger N, Spirito A, Corpataux N, Franzone A, Vranckx P, Fischer U, Pedrazzini G, Bedogni F, Windecker S, Raber L, Valgimigli M. Design and Rationale of the Swiss-Apero Randomized Clinical Trial: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure. J Cardiovasc Transl Res. 2021 Oct;14(5):930-940. doi: 10.1007/s12265-020-10095-4. Epub 2021 Apr 21.

ReferenceCitation: Galea R, De Marco F, Meneveau N, Aminian A, Anselme F, Grani C, Huber AT, Teiger E, Iriart X, Babongo Bosombo F, Heg D, Franzone A, Vranckx P, Fischer U, Pedrazzini G, Bedogni F, Raber L, Valgimigli M. Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: Primary Results of the SWISS-APERO Randomized Clinical Trial. Circulation. 2022 Mar 8;145(10):724-738. doi: 10.1161/CIRCULATIONAHA.121.057859. Epub 2021 Nov 6.

evidence: open (via free pdf)

repository_institution: University of Bern - Bern Open Repository and Information System

repository_institution: UHasselt - Document Server@UHasselt

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Insel Gruppe AG, University Hospital Bern

location_country: Italy Switzerland Belgium France

location_facility: Centre Hospitalier Universitaire Hôpitaux De Rouen

location_facility: Centre Hospitalier Universitaire de Charleroi

location_facility: Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz

location_facility: Department of Cardiology, Cardiocentro Ticino

location_facility: Hopital cardiologique Haut Lévêque CHU de Bordeaux

location_facility: Hôpital Hôpitaux Universitaires Henri-Mondor


title: Safety and Efficacy Comparison Of Two TAVI Systems in a Prospective Randomized Evaluation II: A Randomized, Controlled, Non-inferiority Trial Evaluating Safety and Clinical Efficacy of the Symetis ACURATE Neo Compared to the Medtronic Evolut R Bioprosthesis in Transfemoral Transcatheter Aortic Valve Implantation

acronym: SCOPE II

summary: Current care randomized clinical trial comparing the CE marked Symetis ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System with the CE marked Medtronic CoreValve Evolut R TAVI system (or any future CE-marked CoreValve versions).

ReferenceCitation: Tamburino C, Bleiziffer S, Thiele H, Scholtz S, Hildick-Smith D, Cunnington M, Wolf A, Barbanti M, Tchetche D, Garot P, Pagnotta P, Gilard M, Bedogni F, Van Belle E, Vasa-Nicotera M, Chieffo A, Deutsch O, Kempfert J, Sondergaard L, Butter C, Trillo-Nouche R, Lotfi S, Mollmann H, Joner M, Abdel-Wahab M, Bogaerts K, Hengstenberg C, Capodanno D. Comparison of Self-Expanding Bioprostheses for Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis: SCOPE 2 Randomized Clinical Trial. Circulation. 2020 Dec 22;142(25):2431-2442. doi: 10.1161/CIRCULATIONAHA.120.051547. Epub 2020 Oct 15.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_institution:
KU Leuven - Lirias
UHasselt - Document Server@UHasselt

lead_sponsor: Ceric Sàrl

sponsor_collaborators:
Ceric Sàrl
Symetis SA

location_country:
Germany
Italy
United Kingdom
Denmark
Spain
France

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: Herzzentrum Leipzig - Universitätsklinik

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Klinik für Herz- & Kreislauferkrankungen - Deutsches Herzzentrum München

location_facility: Heart Center, Rigshospitalet, University of Copenhagen

location_facility: Herzzentrum Brandenburg, Immanuel Klinikum Bernau

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: University of Catania, Ferrarotto Hospital

location_facility: Brighton and sussex University hospital NHS trust


acronym: Safety and Efficacy of Nemolizumab in PN

lead_sponsor: Galderma R&D

summary: The aim of this study is to assess the safety and efficacy of nemolizumab in subjects with prurigo nodularis.

ReferenceCitation: Stander S, Yosipovitch G, Legat FJ, Lacour JP, Paul C, Narbutt J, Bieber T, Misery L, Wollenberg A, Reich A, Ahmad F, Piketty C. Trial of Nemolizumab in Moderate-to-Severe Prurigo Nodularis. N Engl J Med. 2020 Feb 20;382(8):706-716. doi: 10.1056/NEJMoa1908316.

location_facility: Klinikum Der Universität München - Campus Innenstadt - Dermatologie und Allergologie

location_facility: Dermoklinika Centrum Medyczne s.c. M.Kierstan, J.Narbutt, A.Lesiak

location_facility: Centre-Hospitalier Universitaire (CHU) - Hopital Morvan - Br

location_facility: Charite - Campus Charite Mitte (CCM) - Dermatologie & Allergologie - Dermatologie & Allergologie

location_facility: Eberhard-Karls Universitaet Tuebingen - Universitaets Hautkl

location_facility: Centre Hospitalier Universitaire De Toulouse

location_facility: Kliniczny Szpital Wojew. nr 1 im. F.Chopina w Rzeszowie

location_facility: Klinikum der Johann-Wolfgang Goethe-Universität

title: A Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis (PN)

location_country: Germany Poland Austria France


acronym: LUX-Lung-IO

lead_sponsor: Boehringer Ingelheim

summary:
The main objective is to assess the efficacy of afatinib in combination with pembrolizumab, as measured by objective response (OR) in patients with locally advanced or metastatic squamous NSCLC who progressed during or after first line platinum-based treatment.

The secondary objectives are to confirm the RP2D, assess the safety profile, and the secondary measures of clinical efficacy including disease control (DC), duration of objective response (DoR), progression-free survival (PFS), overall survival (OS), and tumour shrinkage.

ReferenceCitation: Levy B, Barlesi F, Paz-Ares L, Bennouna J, Erman M, Felip E, Isla D, Ryun Kim H, Kim SW, Madelaine J, Molinier O, Ozguroglu M, Rodriguez Abreu D, Adeniji A, Lorence RM, Voccia I, Chisamore MJ, Riess JW. Phase II study of afatinib plus pembrolizumab in patients with squamous cell carcinoma of the lung following progression during or after first-line chemotherapy (LUX-Lung-IO). Lung Cancer. 2022 Apr;166:107-113. doi: 10.1016/j.lungcan.2022.01.023. Epub 2022 Feb 3.

oa_host_type: repository

repository_institution: Yonsei University Medical Library - YUHSpace

unpaywall_oa_status: green

ReferenceCitation: Levy B, Paz-Ares L, Bennouna J, Felip E, Abreu DR, Isla D, Barlesi F, Molinier O, Madelaine J, Audigier-Valette C, Kim SW, Kim HR, Ozguroglu M, Erman M, Badin FB, Mekhail TM, Scheff R, Chisamore MJ, Sadrolhefazi B, Riess JW. Afatinib With Pembrolizumab for Treatment of Patients With Locally Advanced/Metastatic Squamous Cell Carcinoma of the Lung: The LUX-Lung IO/KEYNOTE 497 Study Protocol. Clin Lung Cancer. 2019 May;20(3):e407-e412. doi: 10.1016/j.cllc.2018.12.022. Epub 2019 Jan 4.

location_facility: Complejo Hospitalario Universitario Insular - Materno Infantil

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Hacettepe Universitesi Tip Fakultesi, Onkoloji ABD

location_facility: Hospital Clínico Universitario Lozano Blesa

title: LUX-Lung IO: A Phase II, Open Label, Non-randomised Study of Afatinib in Combination With Pembrolizumab in Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Lung

location_country:
United States
Spain
Korea, Republic of
Turkey
France


title: Phase I Dose-escalation Study of Oral Administration of the Selective Bcl2 Inhibitor S 55746 in Patients With Refractory or Relapsed Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma

summary: The purpose of this study is to determine the safety profile and tolerability of S 55746 in patients with CLL, B-Cell NHL and MM, in terms of Dose-Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) through safety profile (DLT, MTD), PK profile, PD profile and preliminary efficacy.

ipd_sharing_description:
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Germany
Poland
Hungary
Singapore
United Kingdom
Australia
Korea, Republic of
France

location_facility: National University Cancer Institute Singapore

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


title: A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of AZD9291 on the Pharmacokinetics of Rosuvastatin (a Sensitive BCRP Substrate) in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI

summary:
This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase inhibitor (TKI) agent.

Part A will assess the effect of AZD9291 on the pharmacokinetic (PK) parameters of rosuvastatin, following multiple oral dosing of AZD9291 in the fasted state.

Part B will allow patients further access to AZD9291 after the PK phase (Part A) and will provide for additional safety data collection. All patients from Part A who completed treatment may continue to receive AZD9291 80 mg once daily as a single agent until: disease progression; they are no longer deriving clinical benefit; or any other reason.

ReferenceCitation: Harvey RD, Aransay NR, Isambert N, Lee JS, Arkenau T, Vansteenkiste J, Dickinson PA, Bui K, Weilert D, So K, Thomas K, Vishwanathan K. Effect of multiple-dose osimertinib on the pharmacokinetics of simvastatin and rosuvastatin. Br J Clin Pharmacol. 2018 Dec;84(12):2877-2888. doi: 10.1111/bcp.13753. Epub 2018 Oct 10.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
LIRIAS (KU Leuven)
PubMed Central
UCL Discovery

repositories_concat: LIRIAS (KU Leuven);PubMed Central;UCL Discovery

publisher_dissemination: Wiley

lead_sponsor: AstraZeneca

location_country:
United States
Spain
United Kingdom
France


title: Phase IB, Open-Label, Multicenter, Dose-Escalation Study Followed by an Extension Phase to Evaluate the Safety, Pharmacokinetics and Activity of RO5479599, a Glycoengineered Antibody Against HER3, Administered in Combination With Pertuzumab and Paclitaxel in Patients With Metastatic Breast Cancer Expressing HER3 & HER2 Protein

summary: This multicenter, open-label dose-escalation study with an extension phase will evaluate the safety and pharmacokinetics of lumretuzumab in combination with pertuzumab and paclitaxel in participants with metastatic breast cancer expressing HER3 and HER2 protein. Cohorts of participants will receive escalating doses of lumretuzumab intravenously (IV) every three weeks (Q3W) in combination with pertuzumab 840 milligrams (mg) IV initial dose followed by 420 mg IV Q3W and paclitaxel 80 milligrams per square meter (mg/m^2) IV weekly. After completion of dose-limiting toxicity period (21 days), the study will be conducted in two extension phase cohorts: Cohort 1 and Cohort 2. Enrollment in Extension Phase Cohort 2 will occur only upon completion of Extension Phase Cohort 1. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

ReferenceCitation: Schneeweiss A, Park-Simon TW, Albanell J, Lassen U, Cortes J, Dieras V, May M, Schindler C, Marme F, Cejalvo JM, Martinez-Garcia M, Gonzalez I, Lopez-Martin J, Welt A, Levy C, Joly F, Michielin F, Jacob W, Adessi C, Moisan A, Meneses-Lorente G, Racek T, James I, Ceppi M, Hasmann M, Weisser M, Cervantes A. Phase Ib study evaluating safety and clinical activity of the anti-HER3 antibody lumretuzumab combined with the anti-HER2 antibody pertuzumab and paclitaxel in HER3-positive, HER2-low metastatic breast cancer. Invest New Drugs. 2018 Oct;36(5):848-859. doi: 10.1007/s10637-018-0562-4. Epub 2018 Jan 19.

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repositories:
PubMed Central
Pure (Denmark)
dnet
repositori.upf.edu

repositories_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

publisher_dissemination: Springer-Nature

lead_sponsor: Hoffmann-La Roche

location_country: Germany Denmark Spain France

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

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

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

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Universitaetsklinikum Essen; Westdeutsches Tumorzentrum; Innere Klinik (Tumorforschung)

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


title: A Controlled, Prospective, Non-Inferiority, Parallel-Group, Randomised, Interventional, Open, Blinded Outcome Assessment (PROBE-Design), Multi-centre Trial, Comparing Efficacy and Safety of Isolation of the PVs With a Cryoballoon Catheter vs a Radiofrequency Ablation With a ThermoCool Catheter in Patients With PAF

summary: Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation.

ReferenceCitation: Furnkranz A, Brugada J, Albenque JP, Tondo C, Bestehorn K, Wegscheider K, Ouyang F, Kuck KH. Rationale and Design of FIRE AND ICE: A multicenter randomized trial comparing efficacy and safety of pulmonary vein isolation using a cryoballoon versus radiofrequency ablation with 3D-reconstruction. J Cardiovasc Electrophysiol. 2014 Dec;25(12):1314-20. doi: 10.1111/jce.12529. Epub 2014 Nov 12.

ReferenceCitation: Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

ReferenceCitation: Kuck KH, Brugada J, Furnkranz A, Chun KRJ, Metzner A, Ouyang F, Schluter M, Elvan A, Braegelmann KM, Kueffer FJ, Arentz T, Albenque JP, Kuhne M, Sticherling C, Tondo C; FIRE AND ICE Investigators. Impact of Female Sex on Clinical Outcomes in the FIRE AND ICE Trial of Catheter Ablation for Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2018 May;11(5):e006204. doi: 10.1161/CIRCEP.118.006204.

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

ReferenceCitation: Chun KRJ, Brugada J, Elvan A, Geller L, Busch M, Barrera A, Schilling RJ, Reynolds MR, Hokanson RB, Holbrook R, Brown B, Schluter M, Kuck KH; FIRE AND ICE Investigators. The Impact of Cryoballoon Versus Radiofrequency Ablation for Paroxysmal Atrial Fibrillation on Healthcare Utilization and Costs: An Economic Analysis From the FIRE AND ICE Trial. J Am Heart Assoc. 2017 Jul 27;6(8):e006043. doi: 10.1161/JAHA.117.006043. Erratum In: J Am Heart Assoc. 2017 Sep 15;6(9):

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

repository_institution: Semmelweis University - Semmelweis University Repository

evidence: oa repository (semantic scholar lookup)

ReferenceCitation: Kuck KH, Furnkranz A, Chun KR, Metzner A, Ouyang F, Schluter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kuhne M, Sticherling C, Brugada J; FIRE AND ICE Investigators. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016 Oct 7;37(38):2858-2865. doi: 10.1093/eurheartj/ehw285. Epub 2016 Jul 5.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: Consorci de Serveis Universitaris de Catalunya - RECERCAT

ReferenceCitation: Luik A, Radzewitz A, Kieser M, Walter M, Bramlage P, Hormann P, Schmidt K, Horn N, Brinkmeier-Theofanopoulou M, Kunzmann K, Riexinger T, Schymik G, Merkel M, Schmitt C. Cryoballoon Versus Open Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: The Prospective, Randomized, Controlled, Noninferiority FreezeAF Study. Circulation. 2015 Oct 6;132(14):1311-9. doi: 10.1161/CIRCULATIONAHA.115.016871. Epub 2015 Aug 17.

sponsor_collaborators:
Medtronic Atrial Fibrillation Solutions
Medtronic

location_country: Germany Italy Hungary Netherlands Switzerland Spain Czechia France

location_facility: Hospital Henri Mondor CHU, Service de Cardiologie

location_facility: Isala Klinieken loc. Weezenlanden Diagram Clinical Resarch

location_facility: CHU Lyon, Départment de Rythmologie, Hospital Cardiologique Pradel

location_facility: Klinik für Kardiologie II mit interventioneller Elektrophysiologie

location_facility: Hospital Clinico Universtitario, Cardiology Department Arrhythmia Unit

location_facility: Hospital Clinic, University of Barcelona

location_facility: Cardiac Arrhythmia Research Centre Department of Cardiovascular Medicine Centro Cardiologico Monzino University of Milan

location_facility: Universitätsspital Basel, Elektrophysiologie/ Kardiologie

location_facility: Arrhythmia Unit Hospital Clinico San Carlos

location_facility: La Clinique Pasteur, 45 Avenue de Lombez

location_facility: Hospital Universitario Virgen de la Victoria, Department of Cardiology, Campus Teatinos sn

location_facility: Semmelweis University of Medicine, Kardiovaskuläres Zentrum

location_facility: Cardioangiologisches Centrum Bethanien - CCB


lead_sponsor: CSL Behring

summary: The primary objective of the study is to assess the safety of IV administration of rIX-FP. Safety will be evaluated by adverse events and laboratory changes over time. The secondary objective of the study is to evaluate the pharmacokinetics parameters, following a single intravenous dose of rIX-FP.

ReferenceCitation: Santagostino E, Negrier C, Klamroth R, Tiede A, Pabinger-Fasching I, Voigt C, Jacobs I, Morfini M. Safety and pharmacokinetics of a novel recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in hemophilia B patients. Blood. 2012 Sep 20;120(12):2405-11. doi: 10.1182/blood-2012-05-429688. Epub 2012 Aug 2.

location_facility:
Study site
Study Site

title: An Open-label, Multicenter, Dose-Escalation Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B

location_country: Germany Italy France Austria Spain Israel


title: PERCEVAL Pivotal Trial

summary: The clinical investigation is designed as a prospective and non-randomised study on a maximum of 150 patients. This study will be conducted at Investigational Centres in the European Community. A minimum number of 8 European Centres will be involved in the clinical investigation. A minimum of 15 patients will be enrolled at each Investigational Centre. The clinical follow-up requires evaluations at discharge (or 30 days if the patient is still hospitalized), 3-6 and 12 months following the procedure.The primary objective of this clinical investigation is to assess the performance of the Perceval S valve at 3-6 months after implantation in high surgical risk patients, who require a surgical intervention to replace the aortic valve.

lead_sponsor: Corcym S.r.l

location_country: Germany Switzerland Belgium France

location_facility:
UZ Leuven
Hopital Guillaume et René Laennec
Institut Mutualiste Montsouris
Ruhr Universität Bochum
CHRU de Lille
Inselspital Bern
Westdeutsches Herzzentrum
Medizinische Hochschule Hannover
Hôpital Cardiologique du Haut-Lévêque


title: Transfemoral Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (EUROPE)

summary: A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), its transfemoral delivery system, and crimper accessories. The trial includes a premarket confirmatory cohort to evaluate the system performance as well as a Post Market Clinical Follow-up phase involving expanded enrollment and long-term follow-up of all patients to evaluate valve performance out to 5 years.

lead_sponsor: Edwards Lifesciences

location_country:
Germany
United Kingdom
Belgium
France

location_facility: Ornze Lieve Vrouwziekenhuis (OLVZ) Aalst

location_facility: Hamburg University Cardiovascular Center


title: Multi-Center, Open Label Study to Assess Early Response to Abatacept With Background Methotrexate Using Power Doppler Ultrasonography in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

summary: The purpose of the study is to assess early signs of response to abatacept+methotrexate in metacarpophalangeal joints in both hands using power Doppler ultrasonography in patients with active rheumatoid arthritis.

ReferenceCitation: D'Agostino MA, Boers M, Wakefield RJ, Berner Hammer H, Vittecoq O, Filippou G, Balint P, Moller I, Iagnocco A, Naredo E, Ostergaard M, Gaillez C, Le Bars M. Exploring a new ultrasound score as a clinical predictive tool in patients with rheumatoid arthritis starting abatacept: results from the APPRAISE study. RMD Open. 2016 May 5;2(1):e000237. doi: 10.1136/rmdopen-2015-000237. eCollection 2016.

repository_institution: PubMed Central - Europe PMC

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

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

repositories_institution: University of Copenhagen - Research at the University of Copenhagen

ReferenceCitation: Golinski ML, Vandhuick T, Derambure C, Freret M, Lecuyer M, Guillou C, Hiron M, Boyer O, Le Loet X, Vittecoq O, Lequerre T. Dysregulation of RasGRP1 in rheumatoid arthritis and modulation of RasGRP3 as a biomarker of TNFalpha inhibitors. Arthritis Res Ther. 2015 Dec 26;17:382. doi: 10.1186/s13075-015-0894-9.

ReferenceCitation: D'Agostino MA, Wakefield RJ, Berner-Hammer H, Vittecoq O, Filippou G, Balint P, Moller I, Iagnocco A, Naredo E, Ostergaard M, Boers M, Gaillez C, Van Holder K, Le Bars M; OMERACT-EULAR-Ultrasound Task Force. Value of ultrasonography as a marker of early response to abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: results from the APPRAISE study. Ann Rheum Dis. 2016 Oct;75(10):1763-9. doi: 10.1136/annrheumdis-2015-207709. Epub 2015 Nov 20.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

location_country:
Germany
Italy
Hungary
Norway
Denmark
United Kingdom
Spain
France


title: Vascular-Targeted Photodynamic Therapy Using WST 11 in Patients With Localized Prostate Cancer

summary:
The aim of this clinical study is to determine the optimal treatment conditions to achieve prostate cancer tumor ablation and to assess the effects of WST11 mediated VTP treatment in patients with localized prostate cancer.

The secondary objectives is to evaluate safety and quality of life ; to assess the pharmacokinetic parameters and to model the relationship between concentration and effects; and to assess the effects, the safety and quality of life of a second WST11 VTP treatment in patients with persistent or recurrent localized prostate cancer after a first VTP;

ReferenceCitation: Moore CM, Azzouzi AR, Barret E, Villers A, Muir GH, Barber NJ, Bott S, Trachtenberg J, Arumainayagam N, Gaillac B, Allen C, Schertz A, Emberton M. Determination of optimal drug dose and light dose index to achieve minimally invasive focal ablation of localised prostate cancer using WST11-vascular-targeted photodynamic (VTP) therapy. BJU Int. 2015 Dec;116(6):888-96. doi: 10.1111/bju.12816. Epub 2015 Apr 21.

repositories_concat: UCL Discovery

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Azzouzi AR, Lebdai S, Benzaghou F, Stief C. Vascular-targeted photodynamic therapy with TOOKAD(R) Soluble in localized prostate cancer: standardization of the procedure. World J Urol. 2015 Jul;33(7):937-44. doi: 10.1007/s00345-015-1535-2. Epub 2015 Mar 19.

ReferenceCitation: Azzouzi AR, Barret E, Bennet J, Moore C, Taneja S, Muir G, Villers A, Coleman J, Allen C, Scherz A, Emberton M. TOOKAD(R) Soluble focal therapy: pooled analysis of three phase II studies assessing the minimally invasive ablation of localized prostate cancer. World J Urol. 2015 Jul;33(7):945-53. doi: 10.1007/s00345-015-1505-8. Epub 2015 Feb 25.

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

ReferenceCitation: Lebdai S, Villers A, Barret E, Nedelcu C, Bigot P, Azzouzi AR. Feasibility, safety, and efficacy of salvage radical prostatectomy after Tookad(R) Soluble focal treatment for localized prostate cancer. World J Urol. 2015 Jul;33(7):965-71. doi: 10.1007/s00345-015-1493-8. Epub 2015 Jan 23.

ReferenceCitation: Colin P, Estevez JP, Betrouni N, Ouzzane A, Puech P, Leroy X, Biserte J, Villers A, Mordon S. [Photodynamic therapy and prostate cancer]. Prog Urol. 2011 Feb;21(2):85-92. doi: 10.1016/j.purol.2010.07.018. Epub 2010 Sep 17. French.

ipd_sharing_description: The data are available in case report form for each patient

lead_sponsor: Steba Biotech S.A.

location_country:
United Kingdom
Canada
France

location_facility: University Health Network-Princess Margaret Hospital


title: Comparison of Basal Bolus Treatment With Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes Mellitus

summary: This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.

ReferenceCitation: Ligthelm RJ, Mouritzen U, Lynggaard H, Landin-Olsson M, Fox C, le Devehat C, Romero E, Liebl A. Biphasic insulin aspart given thrice daily is as efficacious as a basal-bolus insulin regimen with four daily injections: a randomised open-label parallel group four months comparison in patients with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Oct;114(9):511-9. doi: 10.1055/s-2006-924424.

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
Poland
United Kingdom
Hong Kong
Romania
Singapore
Sweden
Netherlands
Spain
Malaysia
Croatia
Russian Federation
France


acronym: SAKK 56/07 (DaFLiG)

lead_sponsor: Swiss Group for Clinical Cancer Research

summary:
RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works as first-line therapy in treating patients with gastrointestinal stromal tumors.

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hopital Cantonal Universitaire de Geneve

title: Dasatinib First-Line Treatment in Gastrointestinal Stromal Tumors. A Multi Center Phase II Trial

location_country: Finland Switzerland Germany France


title: An Evaluation of a Doppler-Guided Uterine Artery Occlusion Device as Treatment for the Reduction of Fibroid-Associated Bleeding

summary: The primary objective of this study is to evaluate the safety and effectiveness of Doppler guided Uterine Artery Occlusion (D-UAO) as treatment for the reduction of fibroid-associated symptoms.

lead_sponsor: Ethicon, Inc.

location_country:
Germany
Norway
United Kingdom
Denmark
Netherlands
Switzerland
France

location_facility: CHRU de Lille, Hopital Jeanne de Flandre

location_facility: Hull and East Yorkshire Women & Children Hospital

location_facility: Service de Gynecologie Obsterique, Hopital Antoine Beclere

location_facility: Queen Elizabeth the Queen Mother Hospital


title: Comparing Efficacy and Safety of Tacrolimus With Steroids or Monoclonal Anti-IL2R Antibody in HCV Positive in Liver Transplantation

acronym: CHASE

summary: This is an exploratory study to evaluate the impact of eliminating steroid administration upon viral HCV load at 12 months measured by quantitative serum HCV-RNA determination in patients transplanted for HCV cirrhosis.

lead_sponsor: Astellas Pharma Inc

location_country:
Germany
Italy
Poland
United Kingdom
Sweden
Spain
Czech Republic
France