acronym: ENDURE-CML-IX

lead_sponsor: Philipps University Marburg Medical Center

summary: A randomized, open-label assessor blinded, multi-center, controlled phase III Trial to evaluate the efficacy of AOP2014 administered bi-weekly subcutaneously (s.c.) in preventing molecular relapse (loss of MMR) in CML patients, who discontinue ABL tyrosine kinase inhibitor therapy (TKI) in deep molecular remission of MR4 or better (MR4.5, or MR5).

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oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

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sponsor_collaborators: Philipps University Marburg Medical Center

sponsor_collaborators: Deutsche Krebshilfe e.V., Bonn (Germany)

location_facility: 10 Technische Universität München (TUM) Klinikum rechts der Isar, III. Medizinische Klinik und Poliklinik

location_facility: 14 Johannes-Gutenberg-Universität III. Medizinische Klinik

location_facility: 19 Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III

location_facility: 04 Universitätsmedizin Mannheim, III. Medizinische Klinik

location_facility: 03 Universitätsklinikum Aachen, Hämatologie/Onkologie

location_facility: 13 Universitätsklinikum Leipzig, Abteilung für Hämatologie u. Internistische Onkologie

location_facility: 07 Universitätsklinikum Erlangen, Medizinische Klinik 5

location_facility: 23 Evangelische Krankenhaus Hamm gGmbH, Klinik für Hämatologie, Onkologie und Palliativmedizin

location_facility: 20 Universitätsklinikum Essen, Klinik für Hämatologie

location_facility: 09 Universitätsklinikum Tübingen, Medizinische Klinik

location_facility: 06 Universitätsmedizin Berlin Charite- Campus Virchow Klinikum, Klinik für Hämatologie und Onkologie

location_facility: 16 Klinikum Bremen Mitte, Medizinische Klinik I

location_facility: 24 Institut für Versorgungsforschung in der Onkologie GbR

location_facility: 02 Universitätsklinikum Jena, linik für Innere Medizin II Abt. für Hämatologie und Internistische Onkologie

location_facility: 05 Universitätsklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie

location_facility: 22 BAG / Onkologische Gemeinschaftspraxis

location_facility: 15 Universitätsklinikum Würzburg, Zentrum für Innere Medizin

location_facility: 17 Klinikum der Goethe Universität, Medizinische Klinik II

location_facility: 01 Universitätsklinikum Gießen und Marburg GmbH, Standort Marburg, Klinik für Hämatologie, Onkologie und Immunologie

location_facility: 08 Universitätsklinikum Münster, Medizinische Klinik, Innere Medizin A

location_facility: 21 Universitätsklinikum Hamburg Eppendorf, Klinik für Onkologie, Hämatologie und KMT

location_facility: 12 Universitätsklinikum Ulm, Klinik für Innere Medizin III

title: Efficacy and Safety of Pegylated Proline Interferon Alpha 2b (AOP2014) in Maintaining Deep Molecular Remissions in Patients With Chronic Myeloid Leukemia (CML) Who Discontinue ABL-Kinase Inhibitor Therapy - a Randomized Phase III, Multicenter Trial With Post-study Follow-up

primary_purpose: Prevention

location_country: Germany France

collaborators: Deutsche Krebshilfe e.V., Bonn (Germany)


title: A Pivotal Phase III, Open-label, Randomized, Controlled Multi-center Study of the Efficacy of L19IL2/L19TNF Neoadjuvant Intratumoral Treatment Followed by Surgery Versus Surgery Alone in Clinical Stage III B/C Melanoma Patients

acronym: Pivotal

summary: Phase III, open-label, randomized, controlled multi-center study of the efficacy of L19IL2/L19TNF neoadjuvant intratumoral treatment in Stage III B/C melanoma patients.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Philogen S.p.A.

location_country: Germany Italy Poland France

location_facility: Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie Warszawa

location_facility: Klinik und Polyklinik für Dermatologie, Universitätsklinikum Regensburg

location_facility: Klinik für Dermatologie, Medizinische Fakultät Universitätsklinikum Essen

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Klinik für Dermatologie und Allergologie, Universitätsklinikum Augsburg

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 1, Open-label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CC-90011 in Subjects With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas

summary: Study CC-90011-ST-001 is an open-label, Phase 1, dose escalation and expansion, First-In-Human (FIH) clinical study of CC-90011 in subjects with advanced unresectable solid tumors (enriched for grade 2 NENs, grade 2 NETs and NECs) and R/R NHL (MZL, including extranodal MZL [EMZL], splenic MZL [SMZL], nodal MZL [NMZL], and histologic transformation of MZL). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-90011 to estimate the maximum tolerated dose (MTD) of CC-90011. The expansion part (Part B) will further evaluate the safety and efficacy of CC-90011 administered at or below the MTD in 3 selected expansion cohorts of approximately 10-20 evaluable subjects each, in order to further define the RP2D.

status: Active, not recruiting

design_allocation: Non-Randomized

ReferenceType: background

ReferenceCitation: Hollebecque A, Salvagni S, Plummer R, Isambert N, Niccoli P, Capdevila J, Curigliano G, Moreno V, Martin-Romano P, Baudin E, Arias M, Mora S, de Alvaro J, Di Martino J, Parra-Palau JL, Sanchez-Perez T, Aronchik I, Filvaroff EH, Lamba M, Nikolova Z, de Bono JS. Phase I Study of Lysine-Specific Demethylase 1 Inhibitor, CC-90011, in Patients with Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin Lymphoma. Clin Cancer Res. 2021 Jan 15;27(2):438-446. doi: 10.1158/1078-0432.CCR-20-2380. Epub 2020 Oct 12.

ReferenceType: derived

ReferenceCitation: Hollebecque A, Salvagni S, Plummer R, Niccoli P, Capdevila J, Curigliano G, Moreno V, de Braud F, de Villambrosia SG, Martin-Romano P, Baudin E, Arias M, de Alvaro J, Parra-Palau JL, Sanchez-Perez T, Aronchik I, Filvaroff EH, Lamba M, Nikolova Z, de Bono JS. Clinical activity of CC-90011, an oral, potent, and reversible LSD1 inhibitor, in advanced malignancies. Cancer. 2022 Sep 1;128(17):3185-3195. doi: 10.1002/cncr.34366. Epub 2022 Jun 23.

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

version: publishedVersion

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

lead_sponsor: Celgene

location_country:
Italy
United Kingdom
Japan
Spain
France

location_facility:
Local Institution - 102
Local Institution - 502
Local Institution - 200
Local Institution - 501
Local Institution - 402
Local Institution - 500
Local Institution - 301
Local Institution - 400
Local Institution - 401
Local Institution - 100
Local Institution - 300
Local Institution - 101
Local Institution - 404
Local Institution - 202
Local Institution - 201


title: Safety and Efficacy Evaluation of Hairstetics Hair Implant in Subjects Affected With Hair Loss - a Clinical Study

summary:
This is a prospective, single-arm, multi-center, international, open-label, non-randomized, clinical study.

The aim of the study is to assess the safety and efficacy of the use of the Hairstetics hair implant device in subjects affected with hair loss.

status: Unknown status

primary_purpose: Other

lead_sponsor: Hairstetics

location_country:
Romania
India
United Kingdom
France

location_facility:
Egoclinic
Revere clinic
Fortis Hospital
Metropolitan hospital
Cabinet du Dr G. Beilin
Paras hospital
Georges Mandel Office Surgery Clinic
Cabinet médical du Dr Jack Smadja

intervention_type: Device

status_simplified: Unknown


type: EudraCT Number

title: A Phase 1/2, Single-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Study of Subcutaneously Administered ALN-GO1 in Healthy Adult Subjects, and Patients With Primary Hyperoxaluria Type 1

summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of lumasiran in healthy adult volunteers and subjects with primary hyperoxaluria type 1 (PH1). In Part A, single ascending dose (SAD) part, healthy adults were dosed with lumasiran or placebo once. In Part B, multiple ascending doses (MAD) part, patients with primary hyperoxaluria type 1 (PH1) were dosed with lumasiran or placebo. All patients that initially received placebo received lumasiran after completing placebo dosing.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceCitation: Frishberg Y, Deschenes G, Groothoff JW, Hulton SA, Magen D, Harambat J, Van't Hoff WG, Lorch U, Milliner DS, Lieske JC, Haslett P, Garg PP, Vaishnaw AK, Talamudupula S, Lu J, Habtemariam BA, Erbe DV, McGregor TL, Cochat P; study collaborators. Phase 1/2 Study of Lumasiran for Treatment of Primary Hyperoxaluria Type 1: A Placebo-Controlled Randomized Clinical Trial. Clin J Am Soc Nephrol. 2021 Jul;16(7):1025-1036. doi: 10.2215/CJN.14730920. Epub 2021 May 13.

oa_host_type: publisher;repository

host_type: publisher

publisher_dissemination: Wolters Kluwer Health

ipd_sharing: Undecided

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Germany
France
United Kingdom
Netherlands
Israel

status_simplified: Completed


title: Phase II, Single Arm, Non-randomized and Multicenter Clinical Trial of Regorafenib as a Single Agent in the First-line Setting for Patients With Metastatic and/or Unresectable KIT/PDGFR Wild Type GIST

acronym: REGISTRI

summary: Evaluate the treatment with regorafenib in patients with metastatic and/or unresectable KIT/PDGFR wild type GIST in the first line setting.

ipd_sharing: No

lead_sponsor: Grupo Espanol de Investigacion en Sarcomas

location_country: Italy Spain France

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Fondazione IRCCS Istituto Dei Tumori di Milano

location_facility: Policlinico Universitario Campus Bio-Medico


lead_sponsor: UCB Celltech

summary:
This is a Phase 2, multicenter, double-blind, placebo-controlled, 12-week proof-of-concept study to assess the efficacy, safety, and tolerability of UCB5857 in subjects with primary Sjögren's Syndrome (pSS).

The primary objective of this study is to evaluate the efficacy on overall disease activity and safety of UCB5857 added to current treatment relative to placebo in subjects with pSS.

ReferenceType: result

ReferenceCitation: Juarez M, Diaz N, Johnston GI, Nayar S, Payne A, Helmer E, Cain D, Williams P, Devauchelle-Pensec V, Fisher BA, Giacomelli R, Gottenberg JE, Guggino G, Kvarnstrom M, Mariette X, Ng WF, Rosas J, Sanchez Burson J, Triolo G, Barone F, Bowman SJ. A phase 2 randomized, double-blind, placebo-controlled, proof-of-concept study of oral seletalisib in primary Sjogren's syndrome. Rheumatology (Oxford). 2021 Mar 2;60(3):1364-1375. doi: 10.1093/rheumatology/keaa410.

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

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

version: submittedVersion

repositories_concat: Pure (Denmark)

publisher_dissemination: Oxford University Press

sponsor_collaborators:
UCB Celltech
PRA Health Sciences

status: Terminated

title: A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy of UCB5857 Over 12 Weeks in Subjects With Primary Sjögren's Syndrome

source: euctr

location_country:
France
Italy
United Kingdom
Spain
Sweden


title: A Dose Escalation Study to Evaluate Safety, Tolerability Dosimetry, Pharmacokinetics and Preliminary Efficacy of 131I-Tenatumomab Treatment in Tenascin-C Positive Cancer Patients

acronym: Tenatumomab

summary: Tenatumomab is a Sigma-Tau developed new anti-Tenascin antibody. It is a murine monoclonal antibody directed towards Tenascin-C. By means of this antibody, Tenascin-C expression was studied on a commercial tissue array slides each carrying malignant breast, colorectal, lung, ovarian or B and T cell Non-Hodgkin Limphoma tissue sections. All these cancers type showed positivity to Tenascin-C between the 64% and 13.3%. Consequently, Sigma-tau is exploring the use of the 131I-labeled Tenatumomab for anti-cancer radioimmunotherapy.

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

sponsor_collaborators:
sigma-tau i.f.r. S.p.A.
Medpace, Inc.

location_country: Italy France

location_facility: Istituto Nazionale Dei Tumori Irccs - Fondazione "G. Pascale"

intervention_type: Combination Product


type: Registry Identifier

title: A Dose Escalation, Safety, Pharmacokinetic, Pharmacodynamic and Preliminary Efficacy Study of SAR650984 (Isatuximab) Administered Intravenously in Combination With Bortezomib - Based Regimens in Adult Patients With Newly Diagnosed Multiple Myeloma Non Eligible for Transplantation or No Intent for Immediate Transplantation

summary:
Primary Objectives:

VCDI cohort:

To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR650984 isatuximab when administered in combination with bortezomib (Velcade®) , cyclophosphamide, and dexamethasone (VCDI) based on the dose-limiting toxicity(ies) (DLTs) observed in patients with newly diagnosed multiple myeloma non-eligible for transplantation
To evaluate safety and preliminary efficacy (overall response rate and complete response rate) of isatuximab administered at the selected dose in combination with bortezomib based regimin VCDI according to IMWG criteria.

VRDI Part A cohort and Part B cohort:

To evaluate the preliminary efficacy (complete response [CR] rate) of isatuximab administered at the selected dose in combination with bortezomib based regimen: VRDI, (bortezomib, lenalidomide, dexamethasone) according to IMWG criteria in adult patients with newly diagnosed MM non eligible for transplantation or no intent for immediate transplantation.

Secondary Objectives:

VCDI cohort:

To characterize the overall safety profile of SAR650984 in combination with VCD regimen, including cumulative toxicities.
To characterize the pharmacokinetic (PK) profile of SAR650984/isatuximab and each combination drug in VCDI regimen.
To evaluate the immunogenicity of SAR650984 in combination treatments.
To evaluate the preliminary efficacy of VCDI regimen in terms of duration of response and progression-free survival.
To assess the relationship between clinical effects (adverse event [AE] and/or tumor response) and CD38 receptor density.

VRDI Part A cohort and Part B cohort:

To characterize the overall safety profile of isatuximab in combination with VRD regimen.
To evaluate the infusion duration (only applicable for VRDI Part B cohort)
To characterize the PK profile of isatuximab and each combination drug in VRDI regimen.
To evaluate the immunogenicity of isatuximab in combination treatments.
To evaluate the preliminary efficacy of VRDI regimen in terms of ORR, DOR, and PFS.
To evaluate the impact of M protein measurement without isatuximab interference (via the SEBIA HYDRASHIFT 2/4 isatuximab IFE test) on CR and BOR assessment.
To assess the relationship between clinical effects (AE and/or tumor response) and CD38 receptor density (only applicable for VRDI Part A cohort).
To assess MRD negativity rate in patients achieving a CR or VGPR and explore correlation with clinical outcome.

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: Germany Italy Spain France

location_facility:
Investigational Site Number : 380003
Investigational Site Number : 724002
Investigational Site Number : 276003
Investigational Site Number : 276002
Investigational Site Number : 250003
Investigational Site Number : 724004
Investigational Site Number : 724001
Investigational Site Number : 724003
Investigational Site Number : 250002
Investigational Site Number : 380001
Investigational Site Number : 250001
Investigational Site Number : 380002


title: Multicenter Randomized Study of the MiStent Sirolimus Eluting Absorbable Polymer Stent System (MiStent SES) for Revascularization of Coronary Arteries

acronym: DESSOLVE III

summary: The primary objective of this study is to compare the performance of MISTENT to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events.

ReferenceCitation: de Winter RJ, Katagiri Y, Asano T, Milewski KP, Lurz P, Buszman P, Jessurun GAJ, Koch KT, Troquay RPT, Hamer BJB, Ophuis TO, Wohrle J, Wyderka R, Cayla G, Hofma SH, Levesque S, Zurakowski A, Fischer D, Kosmider M, Goube P, Arkenbout EK, Noutsias M, Ferrari MW, Onuma Y, Wijns W, Serruys PW. A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial. Lancet. 2018 Feb 3;391(10119):431-440. doi: 10.1016/S0140-6736(17)33103-3. Epub 2017 Dec 5.

ReferenceCitation: Wang R, Kawashima H, Hara H, Gao C, Ono M, Takahashi K, Tu S, Soliman O, Garg S, van Geuns RJ, Tao L, Wijns W, Onuma Y, Serruys PW. Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials. Circ Cardiovasc Qual Outcomes. 2021 Nov;14(11):e008055. doi: 10.1161/CIRCOUTCOMES.121.008055. Epub 2021 Oct 20.

oa_host_type: publisher

repositories_concat: closed

ReferenceCitation: Katagiri Y, Andreini D, Miyazaki Y, Takahashi K, Komiyama H, Mushtaq S, Sonck J, Schoors D, Maisano F, Kaufman PA, Leal I, Lindeboom W, Piek JJ, Wykrzykowska JJ, Morel MA, Bartorelli AL, Onuma Y, Serruys PW; SYNTAX III REVOLUTION Investigators. Site vs. core laboratory variability in computed tomographic angiography-derived SYNTAX scores in the SYNTAX III trial. Eur Heart J Cardiovasc Imaging. 2021 Aug 14;22(9):1063-1071. doi: 10.1093/ehjci/jeaa172.

oa_host_type: closed

ReferenceCitation: Takahashi K, Serruys PW, Kogame N, Buszman P, Lurz P, Jessurun GAJ, Koch KT, Troquay RPT, Hamer BJB, Oude Ophuis T, Milewski KP, Hofma SH, Wykrzykowska JJ, Onuma Y, de Winter RJ, Wijns W. Final 3-Year Outcomes of MiStent Biodegradable Polymer Crystalline Sirolimus-Eluting Stent Versus Xience Permanent Polymer Everolimus-Eluting Stent: Insights From the DESSOLVE III All-Comers Randomized Trial. Circ Cardiovasc Interv. 2020 Jun;13(6):e008737. doi: 10.1161/CIRCINTERVENTIONS.119.008737. Epub 2020 May 29.

license: public-domain

license_normalized: public-domain

unpaywall_oa_status: hybrid

lead_sponsor: ECRI bv

collaborators:
Micell Technologies
Stentys

sponsor_collaborators:
ECRI bv
Micell Technologies
Stentys

location_country: Germany Poland Netherlands France

location_facility:
Research Center Leeuwarden
Tergooi
Research center Chrzanow
Research Center Munster
Research Center Venlo
Research Center Tychy
Research Center Zgierz
Research Center Amersfoort
Research Center Bielsko-Biala
Research Center Wiesbaden
Research Center Emmen
Research Center Jena
Research Center Amsterdam
Research Center Ulm
Research Center Corbeil
Research Center Leipzig
Research Center Nijmegen
Research Center Belchatow
Research Center Poitiers
Research Center Nimes


title: Neoadjuvant Treatment With the Combination of Vemurafenib, Cobimetinib and Atezolizumab in Limited Metastasis of Malignant Melanoma (AJCC Stage IIIC/IV) and Integrated Biomarker Study: a Single Armed, Two Cohort, Phase II EADO Trial NEO-VC

acronym: NEO-VC

summary: Evaluation of the efficacy, safety and biologic effects of neo-adjuvant treatment with vemurafenib + cobimetinib + atezolizumab in patients with limited metastasis of melanoma in stage IIIC/IV melanoma.

lead_sponsor: University Hospital Tuebingen

location_facility: Department of Dermatology, Elbe Hospital

location_facility: Department of Dermatology, University Hospital of Nantes

location_facility: Department of Dermatology & Skin Cancer University Hospital La Timone, Aix-Marseille University

location_facility: Hopital Saint-Louis Hopitaux Universitaires Saint-Louis Laboisiere Fernand-Widal

lead_sponsor_type: academique


title: Study 110933: Albiglutide Versus Placebo in Insulin-treated Subjects With New-onset Type 1 Diabetes Mellitus

summary: This is a Phase II, randomized, double-blind, parallel group, placebo controlled, multicentre study of 52 weeks treatment duration. The primary objective is to evaluate the efficacy(on endogenous insulin secretion), safety and tolerability of weekly albiglutide (a glucagon-like peptide-1 receptor (GLP-1R) agonist) versus placebo when added to insulin therapy in subjects with new-onset type 1 diabetes mellitus (NOT1DM) and residual insulin production.. Approximately 68 eligible subjects will be randomised in a 3:1 ratio such that 51 subjects receive albiglutide 30 milligram (mg) once weekly (with increase to 50 mg once weekly at Week 6 if the 30-mg weekly dose is tolerated) added-on to insulin therapy and 17 subjects receive placebo once weekly added-on to insulin therapy. The total duration of a subject's participation will be approximately 72 weeks (up to 8 weeks of Screening, 52 weeks of treatment and 12 weeks of Post-treatment Follow-up)

ReferenceCitation: Pozzilli P, Bosi E, Cirkel D, Harris J, Leech N, Tinahones FJ, Vantyghem MC, Vlasakakis G, Ziegler AG, Janmohamed S. Randomized 52-week Phase 2 Trial of Albiglutide Versus Placebo in Adult Patients With Newly Diagnosed Type 1 Diabetes. J Clin Endocrinol Metab. 2020 Jun 1;105(6):dgaa149. doi: 10.1210/clinem/dgaa149.

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

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
United Kingdom
Spain
France

intervention_type: Biological


title: A Noninterventional Study of Vimpat® (Lacosamide) as Adjunctive Antiepileptic Drug Therapy in Patients With Brain Tumor-related Epilepsy

acronym: VIBES

summary: This study is being conducted to find out whether lacosamide (a drug to treat epilepsy) is effective in routine clinical practice for patients with epilepsy caused by a brain tumor.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Ruda R, Houillier C, Maschio M, Reijneveld JC, Hellot S, De Backer M, Chan J, Joeres L, Leunikava I, Glas M, Grant R. Effectiveness and tolerability of lacosamide as add-on therapy in patients with brain tumor-related epilepsy: Results from a prospective, noninterventional study in European clinical practice (VIBES). Epilepsia. 2020 Apr;61(4):647-656. doi: 10.1111/epi.16486.

lead_sponsor: UCB BIOSCIENCES GmbH

sponsor_collaborators:
UCB BIOSCIENCES GmbH
PRA Health Sciences

location_country:
Germany
Italy
United Kingdom
Netherlands
Spain
France


title: A Multi-center Noninterventional Study to Evaluate the Effectiveness of Neupro® (Rotigotine Transdermal Patch) and Levodopa Combination Therapy in Patients With Parkinson's Disease (NEUPART)

acronym: NEUPART

summary: This study aims to evaluate the effectiveness of Rotigotine and Levodopa combination therapy for younger and older patients with Parkinson's Disease under real life conditions. Effects on ability to perform activities of daily living, sleep, medication dose and other factors will be assessed.

lead_sponsor: UCB Biopharma S.P.R.L.

sponsor_collaborators:
UCB Biopharma S.P.R.L.
PRA Health Sciences


title: An Open-label, Randomised, Phase I, Study to Determine the Effect of Food on the Pharmacokinetics of Single Oral Doses of AZD9291 in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI

summary:
This is a 2-part study in patients with epidermal growth factor receptor mutation positive (EGFRm+) non-small cell lung cancer (NSCLC) whose disease has progressed on treatment with an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI): Part A will determine the effect of food on the pharmacokinetics (PK) of AZD9291; Part B will allow patients further access to AZD9291 and will provide for additional safety data collection.

Part A is a randomised, open-label, 2 treatment period crossover study in which patients will each receive a single oral dose of AZD9291 (1 x 80 mg tablet) at breakfast time (approximately 0800) in each of 2 treatment periods (once immediately following a high fat meal [fed], and once in the fasted state [fasted]), with a washout period of 9 days between doses.

Approximately 38 patients are planned to be enrolled and dosed; at least 30 evaluable patients will be required to complete Part A (ie, the last PK sample in Treatment Period 2 [TP 2] has been collected). Additional patients may be enrolled to allow for at least 30 evaluable patients

ReferenceCitation: Vishwanathan K, Dickinson PA, Bui K, Cassier PA, Greystoke A, Lisbon E, Moreno V, So K, Thomas K, Weilert D, Yap TA, Plummer R. The Effect of Food or Omeprazole on the Pharmacokinetics of Osimertinib in Patients With Non-Small-Cell Lung Cancer and in Healthy Volunteers. J Clin Pharmacol. 2018 Apr;58(4):474-484. doi: 10.1002/jcph.1035. Epub 2017 Nov 26.

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

lead_sponsor: AstraZeneca

location_country:
Korea, Republic of
Spain
United Kingdom
France


title: Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™

acronym: PREVENT

summary:
The TriCinch System™ is intended for percutaneous treatment of tricuspid regurgitation.

It is a percutaneous catheter-based device designed for tricuspid valve repair in order to decrease effective cross-sectional area and relieve symptoms in patients with tricuspid valve regurgitation.

lead_sponsor: 4Tech Cardio Ltd.

location_country: Germany Italy Netherlands France

location_facility: Fondazione Toscana G. Monasterio Ospedale del Cuore G. Pasquinucci


title: A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During Transcatheter Aortic Valve Implantation

acronym: TAVI

summary: A randomized evaluation of the TriGuard™ HDH embolic deflection device during transcatheter aortic valve implantation.

lead_sponsor: Keystone Heart

location_country:
Germany
Italy
France
United Kingdom
Netherlands
Israel

location_facility:
Leeds General Infirmary
Universitäts-Herzzentrum Freiburg
Chru-Lille
Rambam Medical Center
Shaarey Tzedek
Ferrarotto hospital
Clinique chez APHM
Städtische Kliniken Neuss
UMC Utrecht
Royal Sussex County Hospital
Hôpital de la Cavale Blanche
Bristol Heart Institute
Medical Care Center
Praxisklinik Herz Und Gefässe


title: Prospective, Randomized, Multicentre, Open-label, Phase II / III Study to Assess Efficacy and Safety of Ranibizumab 0.5 mg Intravitreal Injections Plus Panretinal Photocoagulation (PRP) Versus PRP in Monotherapy in the Treatment of Subjects With High Risk Proliferative Diabetic Retinopathy. (PROTEUS)

acronym: PROTEUS

summary:
This study is a prospective, randomized, multicentre, open label study that intents to compare the efficacy and safety of ranibizumab 0.5 mg Intravitreal (ITV) injections plus Panretinal Photocoagulation versus Panretinal Photocoagulation alone in the regression of the neovascularization area in patients with High Risk Proliferative Diabetic Retinopathy over a 12-month treatment period.

One of the major complications of the diabetes mellitus is Diabetic Retinopathy (DR), one of the leading causes of visual impairment in working age in industrialized countries. Longer diabetes duration and poor glycaemic and blood pressure control are strongly associated with Diabetic Retinopathy. The overall prevalence of any form of Diabetic Retinopathy is 34.4% and 6.96% corresponds to Proliferative Diabetic Retinopathy (PDR). Therefore, approximately 93 million people have Diabetic Retinopathy and 17 million of them have Proliferative Diabetic Retinopathy.

It has been shown that treatment with repeated injections of ranibizumab can improve visual acuity in patients with PDR. Further, , the standard PRP treatment of PDR remains unsatisfactory. The knowledge of the mechanisms of this retinal complication is incomplete and, therefore, efforts should be done to understand and characterize patients' eyes response to combined treatments.

Therefore, the purpose of this study is to compare the standard treatment for PDR (i.e. Panretinal Photocoagulation) with Panretinal Photocoagulation treatment combined with ITV injections of ranibizumab since it is expected that anti-vascular endothelial growth factor (VEGF) treatment with ITV injections will increase the rate of success of Panretinal Photocoagulation in regression of neovascularization with improved final visual acuity.

collaborators: European Vision Institute Clinical Research Network

location_country:
Italy
Portugal
United Kingdom
France

location_facility: Centre d'Investigation Clinique - Centre National d'Ophtalmologie des Quinze-Vingts

location_facility: Centre for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image

location_facility: Department of Ophthalmology, University Vita Salute - Scientific Institute of San Raffael

location_facility: Ophthalmology Clinical Trials Unit Frimley Park Hospital Foundation Trust

location_facility: Clinical Trial Unit, Dep. Ophth., Gloucestershire Hospitals NHS Foundation Trust

location_facility: Serviço de Oftalmologia,Hospital de Vila Franca de Xira

location_facility: Department of Ophthalmology, University Hospital, CHU Dijon

location_facility: Centre for Clinical Trials, Department of Ophthalmology, University of Padova

location_facility: Department of Ophthalmology, Lariboisière Hospital

location_facility: Laser and Retinal Research Unit, King's Health Partners

intervention_type: Procedure


title: Atlas of Human Milk Nutrients

summary:
The main objective of this clinical trial is to collect human milk samples from 0 to 4 months after delivery in order to characterize human milk components. The secondary objectives of this study are:

To assess whether there is a correlation between human milk composition and mothers' diet
To assess whether there is a correlation between human milk composition and maternal clinical parameters
To assess whether there is a correlation between human milk composition and mother and infant clinical parameters

ReferenceCitation: Raymond F, Lefebvre G, Texari L, Pruvost S, Metairon S, Cottenet G, Zollinger A, Mateescu B, Billeaud C, Picaud JC, Silva-Zolezzi I, Descombes P, Bosco N. Longitudinal Human Milk miRNA Composition over the First 3 mo of Lactation in a Cohort of Healthy Mothers Delivering Term Infants. J Nutr. 2022 Jan 11;152(1):94-106. doi: 10.1093/jn/nxab282.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

publisher_dissemination: Elsevier

ReferenceCitation: Binia A, Lavalle L, Chen C, Austin S, Agosti M, Al-Jashi I, Pereira AB, Costeira MJ, Silva MG, Marchini G, Martinez-Costa C, Stiris T, Stoicescu SM, Vanpee M, Rakza T, Billeaud C, Picaud JC, Domellof M, Adams R, Castaneda-Gutierrez E, Sprenger N. Human milk oligosaccharides, infant growth, and adiposity over the first 4 months of lactation. Pediatr Res. 2021 Sep;90(3):684-693. doi: 10.1038/s41390-020-01328-y. Epub 2021 Jan 14.

publisher_dissemination: Springer-Nature

lead_sponsor: Société des Produits Nestlé (SPN)

location_country: Italy Portugal Norway Romania Sweden Spain France

location_facility: Centro Hospitalar do Alto Ave Guimarães Hospital

location_facility: Department of Woman and Child Health, Karolinska University Hospital

location_facility: Hospital Clínico Universitario de Valencia


title: Effect of Starter Formula With Synbiotics on Prevention of Gastro-intestinal Infections and All Infections With Fever in Full Term Infants

summary: The aim of this trial is to test the efficacy of an infant formula containing synbiotics on the prevention of gastro-intestinal infections.

location_country: Germany Netherlands France

location_facility: Universitätsklinikum Gießen und Marburg, Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: Hôpital de la Croix Rousse, Service de réanimation néonatale

location_facility: Maternité régionale de Nancy, Service de Néonatologie

location_facility: Hôpital Arnaud de Villeneuve, Service de pédiatrie 2

location_facility: Vrije Universiteit Medisch Centrum, Afdeling Kindergeneeskunde

location_facility: Klinikum Ernest von Bergmann, Klinik für Kinder- und Jugendmedizin

location_facility: Charité Campus Virchow-Klinikum, Klinik für Geburtsmedizin

intervention_type: Other


title: Open, Blindly Evaluated, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Standard of Care in Accelerating the Wound Healing of Split-Thickness Skin Graft Donor Sites

summary: The main purpose of this phase III clinical trial was to show safety and efficacy of Oleogel-S10 in accelerating the wound healing of Split-Thickness Skin Graft (STSG) donor sites.

ReferenceCitation: Barret JP, Podmelle F, Lipovy B, Rennekampff HO, Schumann H, Schwieger-Briel A, Zahn TR, Metelmann HR; BSH-12 and BSG-12 study groups. Accelerated re-epithelialization of partial-thickness skin wounds by a topical betulin gel: Results of a randomized phase III clinical trials program. Burns. 2017 Sep;43(6):1284-1294. doi: 10.1016/j.burns.2017.03.005. Epub 2017 Apr 8.

lead_sponsor: Birken AG

location_country: Latvia Greece Spain France

location_facility: National University, "Andreas Syggros" Skin & Venereal Diseases Hospital

location_facility: Riga East University Hospital, Microsurgery Center

location_facility: Riga East University Hospital, State Burn Center


title: Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin)

acronym: FIZZ

summary: 90Y Ibritumomab tiuxetan (zevalin) has demonstrated consistently high response rates in patients who have received previous treatment for lymphoma. More than two-thirds of the patients who achieve CR go on to experience durable remissions lasting for years. Despite these highly promising clinical results with radioimmunotherapy (RIT) in relapsed follicular lymphoma there is very little data using RIT in previously untreated follicular lymphoma. The objective of this trial is to evaluate the safety and efficacy of two fractions of Zevalin in patients with previously untreated follicular lymphoma in a Phase II study.

ReferenceCitation: Illidge TM, Mayes S, Pettengell R, Bates AT, Bayne M, Radford JA, Ryder WD, Le Gouill S, Jardin F, Tipping J, Zivanovic M, Kraeber-Bodere F, Bardies M, Bodet-Milin C, Malek E, Huglo D, Morschhauser F. Fractionated (9)(0)Y-ibritumomab tiuxetan radioimmunotherapy as an initial therapy of follicular lymphoma: an international phase II study in patients requiring treatment according to GELF/BNLI criteria. J Clin Oncol. 2014 Jan 20;32(3):212-8. doi: 10.1200/JCO.2013.50.3110. Epub 2013 Dec 2.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: The Christie NHS Foundation Trust

sponsor_collaborators:
The Christie NHS Foundation Trust
Bayer

location_country:
United Kingdom
France

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Lille


title: Feasibility Study of the PneumRx, Inc. Lung Volume Reduction Coil for the Treatment of Emphysema

summary: This is a multicenter single arm open label study. The primary objective is to evaluate the safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of patients with emphysema in multiple centers.

ReferenceCitation: Hartman JE, Klooster K, Gortzak K, ten Hacken NH, Slebos DJ. Long-term follow-up after bronchoscopic lung volume reduction treatment with coils in patients with severe emphysema. Respirology. 2015 Feb;20(2):319-26. doi: 10.1111/resp.12435. Epub 2014 Nov 23.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repositories_concat: PubMed Central;pure.rug.nl

ReferenceCitation: Deslee G, Klooster K, Hetzel M, Stanzel F, Kessler R, Marquette CH, Witt C, Blaas S, Gesierich W, Herth FJ, Hetzel J, van Rikxoort EM, Slebos DJ. Lung volume reduction coil treatment for patients with severe emphysema: a European multicentre trial. Thorax. 2014 Nov;69(11):980-6. doi: 10.1136/thoraxjnl-2014-205221. Epub 2014 Jun 2.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Oxford - Oxford Academic Notes & Queries

publisher_dissemination: British Medical Journal

lead_sponsor: Boston Scientific Corporation

sponsor_collaborators:
Boston Scientific Corporation
PneumRx, Inc.

location_facility:
Campus Charite Mitte
University Medical Center Groningen
Gaetan Deslee
Lungenklinik
Klinikum Donaustauf
Thoraxklinik
Krankenhaus von Roten Kreuz
CHU de Nice - Hospital Pasteur
Asklepios
CHRU de Strasbourg-NHC
UKT University Hospital


title: Observational Sentinel Sites Study in Infants Younger Than 12 Months Who Are Prescribed Treatment With Keppra® (Levetiracetam) Oral Solution in Usual Clinical Practice

summary: The purpose of this observational study is to broaden the knowledge of the known safety and efficacy profile of Keppra® (Levetiracetam) oral solution in epileptic infants younger than 12 months when treated according to routine clinical practice. Their data will be collected until they reach the age of 13 months.

lead_sponsor: UCB Pharma

location_country:
Germany
Italy
Poland
United Kingdom
Spain
Greece
France


title: A Single Arm 48-Week Follow-on Safety Study to the Core Study (A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa)

summary: This is a 48-week extension study to CMA-0631-PR-0010 Core Study. Patients who have a positive culture for P. aeruginosa at visit 4 of the first 8-week core study period and/or if deemed appropriate by the Investigators will be able to be included in the 48-week follow-on period (Extension Study) to continue the treatment only with Bramitob® (tobramycin nebuliser solution, 300 mg twice daily in 4 mL unit dose vials).

ReferenceCitation: Wine JJ. Cystic fibrosis: How do CFTR mutations cause cystic fibrosis? Curr Biol. 1995 Dec 1;5(12):1357-9. doi: 10.1016/s0960-9822(95)00269-7. No abstract available.

ReferenceCitation: Lewis PA. The epidemiology of cystic fibrosis. In: Hodson ME, Geddes DM. Cystic Fibrosis 2nd edition, Arnold, London 2000; 1a: 2-12.

ReferenceCitation: Dodge JA, Morison S, Lewis PA, Coles EC, Geddes D, Russell G, Littlewood JM, Scott MT. Incidence, population, and survival of cystic fibrosis in the UK, 1968-95. UK Cystic Fibrosis Survey Management Committee. Arch Dis Child. 1997 Dec;77(6):493-6. doi: 10.1136/adc.77.6.493.

ReferenceCitation: Lucotte G, Hazout S, De Braekeleer M. Complete map of cystic fibrosis mutation DF508 frequencies in Western Europe and correlation between mutation frequencies and incidence of disease. Hum Biol. 1995 Oct;67(5):797-803.

ReferenceCitation: Bossi A, Battistini F, Braggion C, Magno EC, Cosimi A, de Candussio G, Gagliardini R, Giglio L, Giunta A, Grzincich GL, La Rosa M, Lombardo M, Lucidi V, Manca A, Mastella G, Moretti P, Padoan R, Pardo F, Quattrucci S, Raia V, Romano L, Salvatore D, Taccetti G, Zanda M. [Italian Cystic Fibrosis Registry: 10 years of activity]. Epidemiol Prev. 1999 Jan-Mar;23(1):5-16. Italian.

ReferenceCitation: Yamashiro Y, Shimizu T, Oguchi S, Shioya T, Nagata S, Ohtsuka Y. The estimated incidence of cystic fibrosis in Japan. J Pediatr Gastroenterol Nutr. 1997 May;24(5):544-7. doi: 10.1097/00005176-199705000-00010.

ReferenceCitation: Imaizumi Y. Incidence and mortality rates of cystic fibrosis in Japan, 1969-1992. Am J Med Genet. 1995 Aug 28;58(2):161-8. doi: 10.1002/ajmg.1320580215.

ReferenceCitation: Boat TF, Welsh MJ, Beaudet AL. Cystic fibrosis, in the metabolic basis of inherited disease (7th edn). McGraw-Hill, New York,1995.

ReferenceCitation: Wood RE, Boat TF, Doershuk CF. Cystic fibrosis. Am Rev Respir Dis. 1976 Jun;113(6):833-78. doi: 10.1164/arrd.1976.113.6.833. No abstract available.

ReferenceCitation: Rommens JM, Iannuzzi MC, Kerem B, Drumm ML, Melmer G, Dean M, Rozmahel R, Cole JL, Kennedy D, Hidaka N, et al. Identification of the cystic fibrosis gene: chromosome walking and jumping. Science. 1989 Sep 8;245(4922):1059-65. doi: 10.1126/science.2772657.

ReferenceCitation: Riordan JR, Rommens JM, Kerem B, Alon N, Rozmahel R, Grzelczak Z, Zielenski J, Lok S, Plavsic N, Chou JL, et al. Identification of the cystic fibrosis gene: cloning and characterization of complementary DNA. Science. 1989 Sep 8;245(4922):1066-73. doi: 10.1126/science.2475911. Erratum In: Science 1989 Sep 29;245(4925):1437.

ReferenceCitation: Anderson MP, Gregory RJ, Thompson S, Souza DW, Paul S, Mulligan RC, Smith AE, Welsh MJ. Demonstration that CFTR is a chloride channel by alteration of its anion selectivity. Science. 1991 Jul 12;253(5016):202-5. doi: 10.1126/science.1712984.

ReferenceCitation: Trapnell BC, Chu CS, Paakko PK, Banks TC, Yoshimura K, Ferrans VJ, Chernick MS, Crystal RG. Expression of the cystic fibrosis transmembrane conductance regulator gene in the respiratory tract of normal individuals and individuals with cystic fibrosis. Proc Natl Acad Sci U S A. 1991 Aug 1;88(15):6565-9. doi: 10.1073/pnas.88.15.6565.

ReferenceCitation: Høiby N. Microbiology of lung infections in cystic fibrosis patients. Acta Paediatr Scand 1982; 301: 33-54.

ReferenceCitation: Moss RB, Babin S, Hsu YP, Blessing-Moore J, Lewiston NJ. Allergy to semisynthetic penicillins in cystic fibrosis. J Pediatr. 1984 Mar;104(3):460-6. doi: 10.1016/s0022-3476(84)81117-8.

ReferenceCitation: Hodson ME, Gallagher CG, Govan JR. A randomised clinical trial of nebulised tobramycin or colistin in cystic fibrosis. Eur Respir J. 2002 Sep;20(3):658-64. doi: 10.1183/09031936.02.00248102.

ReferenceCitation: Ramsey BW, Dorkin HL, Eisenberg JD, Gibson RL, Harwood IR, Kravitz RM, Schidlow DV, Wilmott RW, Astley SJ, McBurnie MA, et al. Efficacy of aerosolized tobramycin in patients with cystic fibrosis. N Engl J Med. 1993 Jun 17;328(24):1740-6. doi: 10.1056/NEJM199306173282403.

ReferenceCitation: Ramsey BW, Pepe MS, Quan JM, Otto KL, Montgomery AB, Williams-Warren J, Vasiljev-K M, Borowitz D, Bowman CM, Marshall BC, Marshall S, Smith AL. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. Cystic Fibrosis Inhaled Tobramycin Study Group. N Engl J Med. 1999 Jan 7;340(1):23-30. doi: 10.1056/NEJM199901073400104.

ReferenceCitation: Gilligan PH. Microbiology of airway disease in patients with cystic fibrosis. Clin Microbiol Rev. 1991 Jan;4(1):35-51. doi: 10.1128/CMR.4.1.35.

ReferenceCitation: Ramsey BW, Schaeffler BL, Montgomery AB, et al. Survival and lung function during two years of treatment with intermittent tobramycin solution for inhalation in CF patients. Presented at European Cystic Fibrosis Conference (June 1999), The Hague, The Netherlands.

ReferenceCitation: Van Dalfsen JM, Lin L, Burns JL, et al. Microbiology effect of 18 months of intermittent inhaled tobramycin in patients with CF. Presented at European Cystic Fibrosis Conference (June 1999), The Hague, The Netherlands.

ReferenceCitation: Lenoir G, Aryayev N, et al. Highly concentrated aerosolized Tobramycin in the treatment of patients with cystic fibrosis and Pseudomonas aeruginosa infection. Eur. Respir. J 2005:26 (suppl. 49) 620s.

ReferenceCitation: Chuchalin A, Gyurkovics K, et al. Long term administration of aerosolised tobramycin, in patients with cystic fibrosis. Eur. Respir. J.2005: 26 (suppl 49) 3942s.

ReferenceCitation: Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault JC. Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J Suppl. 1993 Mar;16:5-40. No abstract available.

ReferenceCitation: Pin I, Gibson PG, Kolendowicz R, Girgis-Gabardo A, Denburg JA, Hargreave FE, Dolovich J. Use of induced sputum cell counts to investigate airway inflammation in asthma. Thorax. 1992 Jan;47(1):25-9. doi: 10.1136/thx.47.1.25.

ReferenceCitation: Henry DA, Campbell ME, LiPuma JJ, Speert DP. Identification of Burkholderia cepacia isolates from patients with cystic fibrosis and use of a simple new selective medium. J Clin Microbiol. 1997 Mar;35(3):614-9. doi: 10.1128/jcm.35.3.614-619.1997. Erratum In: J Clin Microbiol 1999 Apr;37(4):1237.

ReferenceCitation: Bauernfeind A, Rotter K, Weisslein-Pfister C. Selective procedure to isolate haemophilus influenzae from sputa with large quantities of Pseudomonas aeruginosa. Infection. 1987 Jul-Aug;15(4):278-80. doi: 10.1007/BF01644138.

ReferenceCitation: Johansen HK, Hoiby N. Seasonal onset of initial colonisation and chronic infection with Pseudomonas aeruginosa in patients with cystic fibrosis in Denmark. Thorax. 1992 Feb;47(2):109-11. doi: 10.1136/thx.47.2.109.

ReferenceCitation: Mazurek H, Chiron R, Kucerova T, Geidel C, Bolbas K, Chuchalin A, Blanco-Aparicio M, Santoro D, Varoli G, Zibellini M, Cicirello HG, Antipkin YG. Long-term efficacy and safety of aerosolized tobramycin 300 mg/4 ml in cystic fibrosis. Pediatr Pulmonol. 2014 Nov;49(11):1076-89. doi: 10.1002/ppul.22989. Epub 2014 Jan 24.

lead_sponsor: Chiesi Farmaceutici S.p.A.

location_country: Poland Ukraine France

location_facility: Donetsk Regional Children Clinical Hospital

location_facility: Oddzial Kliniczny Interny Dzieciecej i Alergologii, Wojewodzki Szpital Specjalistyczny

location_facility: Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj

location_facility: Klinika Pediatrii Instytut Matki I Dziecka

location_facility: Lviv Regional Children Specialized Clinical Hospital

location_facility: Dzieciecy Szpital Kliniczny Akademii Medycznej, Klinika Chorob Pluc I Reumatologii

location_facility: Dnipropetrovsk City Children Clinical Hospital # 2

location_facility: Zaporizhya Regional Clinical Children Hospital

location_facility: Odesa Regional Children Clinical Hospital

location_facility: I Oddzial Chorob Dzieciecych, Wojewodzki Specjalistyczny Szpital Dzieciecy

location_facility: Institute of Phthysiology and Pulmonology n.a., F.G.Yanovskiy of the Academy of Medical Science of Ukraine

location_facility: Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of Ukraine

location_facility: Specjalistyczny ZOZ nad Matka i Dzieckiem, Poradnia Leczenia Mukowiscydozy

location_facility: Simferopol Central District Clinical Hospital

location_facility: Klinika Pneumonologii, Alergologii Dzieciecej i Immunologii Klinicznej Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu

location_facility: Hopital Arnaud de Villeneuve, Clinique des maladies respiratoires

location_facility: Poradnia Mukowiscydozy Wojewodzkiej, Przychodni Specjalistycznej dla Dzieci, Szpitala Wojewodzkiego Nr 2


title: A Prospective Study of the NUVANCE Facial Rejuvenation System for Mid-Face, Neck and Jowl Rejuvenation Procedures

summary: The objective of this study is to evaluate the clinical tolerability of the NUVANCE™ Facial Rejuvenation System for correcting neck, mid-face and/or jowl ptosis.

ipd_sharing_description: Not an applicable trial, product manufactured outside of US and all study sites outside US.

lead_sponsor: Ethicon, Inc.

location_country:
Germany
Israel
United Kingdom
France

location_facility:
Catherine Bergeret-Galley
Bernard Mole
Rotes Kreuz Krankenhous Kassel
Chirurgie Praxisklinik Kaiserplatz
Springfield Hospital
Rambam Medical Center
Rabin Medical Center
Martin-Luther-Krankenhaus
Benjamin Ascher


title: Intra-articular Treatment With MEN16132 in Patients With Symptomatic Primary Osteoarthritis of the Knee: A Randomized, Multi-centre, Double Blind, Placebo Controlled, Five Parallel Group, Dose Finding Study

acronym: ALBATROSS

summary: The purpose of this study is to determine whether intra-articular (knee joint) administration of MEN16132 is effective reducing the pain from knee osteoarthritis.

lead_sponsor: Menarini Group

location_facility: Istituto di Reumatologia, "Policlinico Le Scotte" Università degli Studi di Siena

location_facility: Dipartimento di Biomedicina - SOD Reumatologia - Azienda Ospedaliera Universitaria Careggi

location_facility: Servicio de Reumatologia, Hospital de Basurto

location_facility: Klinik für Rheumatologie und Klinische Immunologie, Charité - Campus Charité Mitte

location_facility: Servizio di Reumatologia, Ospedale Privato Accreditato Nigrisoli

location_facility: Centre Hospitalier Régional - Hôpital Porte Madeleine

location_facility: Servicio de Reumatologia, Corporacio Sanitaria Parc Tauli, Hospital de Sabadell

location_facility: ClinPharm International, Prüfzentrum Dresden

location_facility: Servicio de Reumatologia, Hospital Universitario La Paz

location_facility: Dipartimento di Medicina Interna Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara Pisa

location_facility: ClinPharm International, Prüfzentrum Bochum

location_facility: Rheumatologie/Immunologie - Rheumazentrum, Krankenhaus Doberan

location_facility: Department of Rheumatology, Purpan University Hospital

location_facility: ClinPharm International, Prüfzentrum Leipzig

location_facility: Servicio de Reumatologia, Hospital Universitario Virgen Macarena

location_facility: Medizinische Klinik 3, Universität Erlangen-Nürnberg


title: A Multicenter, Prospective, Single-Blind, Randomized, Controlled Study of the Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair

acronym: StAR

summary: The objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive Tissue Matrix (TM) and those managed by standard repair. It is hypothesized that the use of Strattice(TM) TM to reinforce the repair will reduce the incidence of these post-repair complications.

ReferenceCitation: Van Geldere D. One hundred years of abdominal wound dehiscence and nothing has changed. Hernia 2000; 4:302-4.

ReferenceCitation: van't RM, De Vos Van Steenwijk PJ, Bonjer HJ, Steyerberg EW, Jeekel J. Incisional hernia after repair of wound dehiscence: incidence and risk factors. Am Surg. 2004 Apr;70(4):281-6.

ReferenceCitation: Murugappan K, Gomes F, Waxman B. Abdominal wound dehiscence - who is really at risk? ANZ J Surg 2009; 79(S1):A25

ReferenceCitation: Gislason H, Viste A. Closure of burst abdomen after major gastrointestinal operations--comparison of different surgical techniques and later development of incisional hernia. Eur J Surg. 1999 Oct;165(10):958-61. doi: 10.1080/110241599750008071.

ReferenceCitation: Webster C, Neumayer L, Smout R, Horn S, Daley J, Henderson W, Khuri S; National Veterans Affairs Surgical Quality Improvement Program. Prognostic models of abdominal wound dehiscence after laparotomy. J Surg Res. 2003 Feb;109(2):130-7. doi: 10.1016/s0022-4804(02)00097-5.

lead_sponsor: LifeCell

location_facility: Krankenhaus Salem der Evang. Stadtmission Heidelberg

location_facility: Klinikum und Fachbereich Medizin der Johann Wolfgang Goethe Universitat

location_facility: Universitätsklinikum Giessen und Marburg GmbH

location_facility: Technischen Universität München - Klinikum rechts der Isar


title: Mastering Hospital Antibiotic Resistance, a Cluster Randomized Intervention Study in Intensive Care Units Throughout Europe (Work Package 3)

acronym: MOSAR-ICU

summary:
Colonization of patients with Antimicrobial Resistant Bacteria (AMRB) like Methicillin Resistant Staphylococcus Aureus (MRSA), Vancomycin-Resistant Enterococcus (VRE) and Extended-Spectrum Beta-Lactamases (ESBL) enterobacteriaceae leads to infections; and ultimately to adverse outcomes (eg prolonged hospital stay, death). This is an urgent problem in Europe, especially in Intensive Care Units (ICUs).

In this trial, colonization of patients with these AMRB will be assessed in the baseline period (6m). In phase 2 the effect of a Hygiene Improvement Program, including Chlorhexidine body washings and a Hand Hygiene training program, will be assessed (6m). In phase 3 units will be randomized to either Active Surveillance with Chromagar based tests or a Molecular based tests.

Study Hypothesis: the abovementioned interventions will reduce ICU-acquired colonization rates with MRSA, VRE and ESBL.

primary_purpose: Screening

ReferenceCitation: Derde LPG, Cooper BS, Goossens H, Malhotra-Kumar S, Willems RJL, Gniadkowski M, Hryniewicz W, Empel J, Dautzenberg MJD, Annane D, Aragao I, Chalfine A, Dumpis U, Esteves F, Giamarellou H, Muzlovic I, Nardi G, Petrikkos GL, Tomic V, Marti AT, Stammet P, Brun-Buisson C, Bonten MJM; MOSAR WP3 Study Team. Interventions to reduce colonisation and transmission of antimicrobial-resistant bacteria in intensive care units: an interrupted time series study and cluster randomised trial. Lancet Infect Dis. 2014 Jan;14(1):31-39. doi: 10.1016/S1473-3099(13)70295-0. Epub 2013 Oct 23. Erratum In: Lancet Infect Dis. 2014 Jan;14(1):11.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

lead_sponsor: UMC Utrecht

location_country: Slovenia Italy Portugal Latvia Spain Luxembourg Greece France

location_facility: University Clinic of Respiratory and Allergic Diseases


title: Vascular-Targeted Photodynamic Therapy Using WST11 in Patients With Localized Prostate Cancer

summary:
The aim of this trial is to determine the optimal treatment conditions to achieve prostate cancer tumour ablation and to assess the effects of WST11-mediated Vascular-Targeted Photodynamic therapy (VTP) treatment in patients with localized prostate cancer.

The secondary objectives are to assess the safety and quality of life following WST11-mediated VTP treatment,to assess the effects,safety and quality of life following a second WST11-mediated VTP treatment; and to explore optimisation techniques to reduce the duration of the VTP procedure.

ReferenceCitation: Azzouzi AR, Barret E, Moore CM, Villers A, Allen C, Scherz A, Muir G, de Wildt M, Barber NJ, Lebdai S, Emberton M. TOOKAD((R)) Soluble vascular-targeted photodynamic (VTP) therapy: determination of optimal treatment conditions and assessment of effects in patients with localised prostate cancer. BJU Int. 2013 Oct;112(6):766-74. doi: 10.1111/bju.12265.

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.

license: cc-by

license_normalized: cc-by

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.

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

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.

lead_sponsor: Steba Biotech S.A.

location_country:
United Kingdom
Netherlands
France

location_facility: University College London Hospital (UCLH)


title: A Randomized, Double-blind, Placebo Controlled, Multi-centre, Exploratory, Pilot, Phase II Trial of 150mg Atacicept Given Subcutaneously in Combination With Rituximab in Subjects With Rheumatoid Arthritis.

acronym: August III

summary: The primary objective of this study is to assess the safety and tolerability of combined treatment with atacicept and rituximab in subjects with active rheumatoid arthritis (RA) receiving re-treatment with rituximab.

ReferenceCitation: van Vollenhoven RF, Wax S, Li Y, Tak PP. Safety and efficacy of atacicept in combination with rituximab for reducing the signs and symptoms of rheumatoid arthritis: a phase II, randomized, double-blind, placebo-controlled pilot trial. Arthritis Rheumatol. 2015 Nov;67(11):2828-36. doi: 10.1002/art.39262.

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country:
United Kingdom
Sweden
Netherlands
France


acronym: NT crow's feet

lead_sponsor: Merz Pharmaceuticals GmbH

summary: To investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in comparison to placebo in the treatment of moderate to severe lateral periorbital wrinkles at maximum smile and to compare two different application schemes of Xeomin. Each subject will be treated on the right and left eye area, using the same dose but different application schemes (i.e. 3 or 4 injection sites).

title: A Prospective, Randomized, Double-Blind, Multicenter Trial to Investigate the Efficacy and Safety of NT 201 in Comparison to Placebo and to Compare Two Different Application Schemes of NT 201 in the Treatment of Lateral Periorbital Wrinkles

location_country:
Germany
Italy
United Kingdom
France


title: A Multicenter, Open, Single Sequence Crossover Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Stable Liver Transplant Patients Converted From a Prograf® Based Immunosuppressive Regimen

summary: Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable liver transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.

lead_sponsor: Astellas Pharma Inc

location_country:
Germany
Ireland
Poland
United Kingdom
Spain
France


title: A Randomized, Single Blinded, Placebo-controlled, Multi-centre, Phase II Study of Lapatinib in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

summary: This is a study comparing the activity of lapatinib versus placebo followed by chemoradiation. This study is designed to explore the effects of lapatinib monotherapy on apoptosis/necrosis, in pre-treatment and post-treatment tumour tissue samples in subjects with locally advanced squamous cell carcinoma of head and neck.

lead_sponsor: GlaxoSmithKline

location_country: India Spain Greece Peru France


title: An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Unresectable Hepatocellular Carcinoma

summary: The study will consist of two parts. In Part 1 the study will start enrolling 38 patients and then further 25 patients up to a total of 63 eligible patients. If the study gives good results it can be expanded to a total of 160 patients. SU011248 will be administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg [milligrams] with provision for dose reduction based on tolerability. All patients will receive repeated cycles of SU011248 until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival

ReferenceCitation: Harmon CS, DePrimo SE, Raymond E, Cheng AL, Boucher E, Douillard JY, Lim HY, Kim JS, Lechuga MJ, Lanzalone S, Lin X, Faivre S. Mechanism-related circulating proteins as biomarkers for clinical outcome in patients with unresectable hepatocellular carcinoma receiving sunitinib. J Transl Med. 2011 Jul 25;9:120. doi: 10.1186/1479-5876-9-120.

ReferenceCitation: Faivre S, Zappa M, Vilgrain V, Boucher E, Douillard JY, Lim HY, Kim JS, Im SA, Kang YK, Bouattour M, Dokmak S, Dreyer C, Sablin MP, Serrate C, Cheng AL, Lanzalone S, Lin X, Lechuga MJ, Raymond E. Changes in tumor density in patients with advanced hepatocellular carcinoma treated with sunitinib. Clin Cancer Res. 2011 Jul 1;17(13):4504-12. doi: 10.1158/1078-0432.CCR-10-1708. Epub 2011 Apr 29.

ReferenceCitation: Faivre S, Raymond E, Boucher E, Douillard J, Lim HY, Kim JS, Zappa M, Lanzalone S, Lin X, Deprimo S, Harmon C, Ruiz-Garcia A, Lechuga MJ, Cheng AL. Safety and efficacy of sunitinib in patients with advanced hepatocellular carcinoma: an open-label, multicentre, phase II study. Lancet Oncol. 2009 Aug;10(8):794-800. doi: 10.1016/S1470-2045(09)70171-8. Epub 2009 Jul 6.

lead_sponsor: Pfizer

location_country:
Korea, Republic of
Taiwan
France


title: A Phase II, Multi-Centre, Randomised, Double-blind, Dose-Ranging Study Comparing the Efficacy and Safety of a Single Treatment With 15, 30 or 45 Units (Per Eye) of Dysport to Placebo in the Symptomatic Treatment of Lateral Canthal Lines (Crow's Feet)

summary: Despite the wealth of information in the literature regarding the cosmetic applications of botulinum type A toxin (BoNT-A), and the widespread use of the BoNT-A for cosmetic applications, the number of randomised, controlled clinical trials is small. Much of the published information is based on open-label studies or anecdotal data. Of the robust trial data that is available, the vast majority relates to the treatment of glabellar lines, and there is little data available regarding the use of BoNT-A in lateral canthal lines. This study aims to determine the optimum dose for the use of BoNT-A in this area.

lead_sponsor: Ipsen

location_country:
Germany
United Kingdom
France

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Dermatologie, Stadt. Klinikum Dresden-Friedrichstadt


title: Phase III Study of Usefulness of Near Infrared Spectroscopy to Optimize Tissues Perfusion and Oxygenation in Severe Sepsis

acronym: OTO-STS

summary: The purpose of this study is to evaluate the usefulness of an optimization of muscle perfusion and oxygenation, as assessed by the NIRS technique, in critically ill patients with sepsis.

ReferenceCitation: Nardi O, Zavala E, Martin C, Nanas S, Scheeren T, Polito A, Borrat X, Annane D. Targeting skeletal muscle tissue oxygenation (StO2) in adults with severe sepsis and septic shock: a randomised controlled trial (OTO-StS Study). BMJ Open. 2018 Mar 19;8(3):e017581. doi: 10.1136/bmjopen-2017-017581.

oa_colors: green gold

evidence: oa journal (via doaj)

repositories_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

unpaywall_oa_status: gold

lead_sponsor: University of Versailles

sponsor_collaborators:
University of Versailles
Hutchinson Technology Inc
Assistance Publique - Hôpitaux de Paris

location_country: Germany Spain Greece France

location_facility:
GERLACH Herwig
Raymond Poincaré Hospital
EZAVALA Elizabeth
Hôpital Nord AP HM
CHU Tours
NANAS Serafeim
University Hospital Rostock


summary: The overall purpose of this study is to determine the efficacy, safety and tolerability of indisulam in combination with irinotecan as a treatment for patients with metastatic colorectalcancer previously treated with 5-fluorouracil/leucovorin and oxaliplatin (FOLFOX).

lead_sponsor: Eisai Limited

location_facility:
Beatson Oncology Centre
Aberdeen Royal Infirmary
Hôpitaux Civils de Colmar
Centre Antoine Lacassagne
Leicester Royal Infirmary
Cookridge Hospital
CRLC Val d'Aurelle


title: Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

summary: The purpose of this clinical research study is to learn if irbesartan is superior to hydrochlorothiazide relative to effects on insulin sensitivity and glucose metabolism in hypertensive patients with metabolic syndrome.

ReferenceCitation: Parhofer KG, Birkeland KI, DeFronzo R, Del Prato S, Bhaumik A, Ptaszynska A. Irbesartan has no short-term effect on insulin resistance in hypertensive patients with additional cardiometabolic risk factors (i-RESPOND). Int J Clin Pract. 2010 Jan;64(2):160-8. doi: 10.1111/j.1742-1241.2009.02246.x. Epub 2009 Nov 19.

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Sanofi

location_country:
Germany
Italy
Norway
Spain
Russian Federation
France


title: A Retrospective PMCF Study Evaluating the Safety and Clinical Performance of the S.M.A.R.T. Flex Stent Iliac, S.M.A.R.T. Flex SFA/PP, S.M.A.R.T. Control Nitinol Stent, S.M.A.R.T. Nitinol Stent, PALMAZ Blue .018 Peripheral Stent on Slalom, PALMAZ Genesis .035 Peripheral Stent on Opta Pro, SABER OTW PTA Catheter, SABERX PTA Dilatation Catheter and PowerFlex Pro PTA Catheter for the Endovascular Interventions in the Ilio-femoropopliteal Vessels

summary: The rationale of this study is to confirm and support the clinical safety and performance of the products in a real-word population of 350 patients who underwent an endovascular intervention within standard-of-care (SOC) of the ilio-femoropopliteal artery, using at least 1 of the products (named above) from Cordis US Corp.

time_perspective: Retrospective

lead_sponsor: Cordis Corporation

collaborators: FCRE (Foundation for Cardiovascular Research and Education)

location_country: Netherlands Austria France

location_facility: The Public Hospital, Centre Hospitalier Universitaire de Toulouse

location_facility: Medizinische Universität WienMedizinische Universität Wien

location_facility: Universitätsklinikum St. Pölten - Lilienfeld

location_facility: Public health establishment, Arras Hospital


title: A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia

acronym: CML

summary: The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.

lead_sponsor: Enliven Therapeutics

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

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin, Servicio Canario de Salud (SCS)

location_facility: Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

location_facility: CHRU de Lille - Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille

location_facility: Medizinische Universitatsklinik Mannheim der Universitat Heidelberg

location_facility: Chonnam National University Hwasun Hospital

location_facility: Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: Oregon Health & Science University-Knight Cardiovascular Institute

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Uniklinik RWTH Aachen Medizinische Klinik III


title: Expanded Access Use of Zanidatamab for the Treatment of HER2-Positive Advanced Solid Tumor

summary: This is an intermediate-size Expanded Access Protocol (EAP) for use of zanidatamab (ZW25) in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced biliary tract cancer (BTC) who are not eligible for other zanidatamab clinical trials, and who in the opinion of the treating oncologist, would potentially benefit from treatment with zanidatamab.

status: Available

study_type: Expanded Access

lead_sponsor: Jazz Pharmaceuticals

location_country:
Italy
United Kingdom
United States
Spain
France

location_facility: UCLH Cancer Institute (Meera Desai, Pharmacist)

location_facility: Washington University School of Medicine

location_facility: Salinas Valley Memorial Healthcare System

location_facility: Fundacion Jimenez Diaz University Hospital - Autonomous University of Madrid

location_facility: The Princess Alexandra Hospital NHS Trust (Joanne Kwa, Pharmacist)


title: A Prospective, Multi-Center, Single Arm Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke: The EvaQ Study

acronym: EvaQ

summary: Assess the safety and efficacy of the Q Revascularization System to remove thrombi and emboli from the neurovasculature in patients experiencing an acute ischemic stroke

lead_sponsor: MIVI Neuroscience, Inc.

location_country:
United States
France

location_facility:
CHU Urbains
Hôpital Purpan
University at Buffalo Neurosurgery
Baptist Memorial Hospital
CHU Bicetre Paris
CHU Pellegrin
Cooper University Health Care
University of South Florida


title: Evaluation of the Evolution of Biological and Imaging Markers of Bone and Cartilage Degradation in Patients With Knee Osteoarthritis Receiving Intra-articular Injections of a Hyaluronan Derivative HYMOVIS®

acronym: MOKHA

summary: This pilot study MOKHA is aimed to evaluate the beneficial effect of HYMOVIS® on cartilage of patients suffering of knee osteoarthritis as revealed by using scientifically sound, objective measurements of biological and MRI-based imaging markers.

lead_sponsor: Fidia Farmaceutici s.p.a.

location_country: Belgium France

location_facility: Service de Rhumatologie CHU Dinant-Godinne (Site Godinne)

location_facility: Service de Rhumatologie CHR Metz Thionville Hôpital Bel Air

location_facility: Service de rhumatologie,RDC Hôpital Lariboisière


title: A Phase 1 Study of BOS172738 in Patients With Advanced Solid Tumors With RET Gene Alterations Including Non-Small Cell Lung Cancer (NSCLC) and Medullary Thyroid Cancer (MTC)

summary: This study will be conducted to assess the safety and tolerability of BOS172738 when administered to patients with advanced solid tumors with rearranged during transfection (RET) gene alterations and also to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of BOS172738.

lead_sponsor: Boston Pharmaceuticals

location_country:
Hong Kong
Belgium
United States
Korea, Republic of
Spain
Taiwan
France

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Severance Hospital, Yonsei University College of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: START MADRID-FJD, Hospital Fundación Jiménez Díaz


title: An Open Label, Multicenter, Dose Escalation and Expansion, Phase 1 Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7121661, a PD-1/TIM-3 Bispecific Antibody, in Patients With Advanced and/or Metastatic Solid Tumors

summary: This is a first-in-human, open-label, multicenter, Phase I multiple-ascending dose (MAD) study of single agent lomvastomig (RO7121661), an anti PD-1 (programmed death-1) and TIM-3 (T-cell immunoglobulin and mucin domain 3) bispecific antibody, for participants with advanced and/or metastatic solid tumors. The study consists of 2 parts: Dose Escalation (Part A) and Expansion (Parts B1, B2, B3, B4, and B5). The Dose Escalation part will be conducted first to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) based on safety, tolerability, pharmacokinetic, and/or the pharmacodynamic profile of escalating doses of lomvastomig. The Expansion part will enroll tumor-specific cohorts to evaluate anti-tumor activity of the MTD and/or RDE of lomvastomig from Part A (Q2W) and to confirm safety and tolerability in participants with selected tumor types.

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
New Zealand
Denmark
United States
Korea, Republic of
Spain
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Auckland City Hospital; Clinical Oncology

location_facility: CHU Timone; Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM)

location_facility: Centre Leon Berard; Service Oncologie Medicale

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: Vall d?Hebron Institute of Oncology (VHIO), Barcelona

location_facility: Clinica Universitaria de Navarra; Servicio de oncología

location_facility: START Madrid-FJD, Hospital Fundacion Jimenez Diaz