title: A Randomised, Comparative, Multicentre Clinical Trial of the Immunogenicity and Safety of Tdap-IPV Vaccine and a Tetanus Monovalent Vaccine in Healthy Adults 18 Years of Age and Older

summary: The purpose of this study is to demonstrate that a combined adult Tdap-IPV vaccine (REPEVAX®) will provide similar rapid antibody responses against tetanus toxoid as a tetanus toxoid vaccine alone in healthy adults.

ReferenceCitation: Laurichesse H, Zimmermann U, Galtier F, Launay O, Duval X, Richard P, Sadorge C, Soubeyrand B. Immunogenicity and safety results from a randomized multicenter trial comparing a Tdap-IPV vaccine (REPEVAX®) and a tetanus monovalent vaccine in healthy adults: new considerations for the management of patients with tetanus-prone injuries. Hum Vaccin Immunother. 2012 Dec 1;8(12):1875-81. doi: 10.4161/hv.22083. Epub 2012 Oct 2.

lead_sponsor: Sanofi Pasteur, a Sanofi Company

location_facility: Hôpital Gabriel Montpied - CHU Clermont-Ferrand

location_facility: Groupe Hospitalier Cochin - Saint-Vincent de Paul


status: Completed

primary_purpose: Treatment

acronym: SEQUENTIAL

intervention_type: Drug

title: Efficacy and Safety of Velcade Plus Dexamethasone (VD), VD+Cyclophosphamide or VD Plus Lenalidomide in MMY Patients Who Are Refractory or Have Relapsed After Their Primary Therapy for MMY and Have Achieved Stable Disease After 4 Cycles of VD

study_completion_date_type: Actual

lead_sponsor: Janssen-Cilag International NV

type: Other Identifier

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Dimopoulos MA, Orlowski RZ, Facon T, Sonneveld P, Anderson KC, Beksac M, Benboubker L, Roddie H, Potamianou A, Couturier C, Feng H, Ataman O, van de Velde H, Richardson PG. Retrospective matched-pairs analysis of bortezomib plus dexamethasone versus bortezomib monotherapy in relapsed multiple myeloma. Haematologica. 2015 Jan;100(1):100-6. doi: 10.3324/haematol.2014.112037. Epub 2014 Sep 26.

enrollment_type: Actual

location_country:
Poland
Serbia
Spain
Greece
United Kingdom
Lithuania
Hungary
France
Turkey
Germany

summary: The purpose of this study is to test the effectiveness and safety of adding cyclophosphamide or lenalidomide to the VD combination in the treatment of patients with multiple myeloma that have achieved a stable response after 4 initial cycles of treatment with VD. Multiple myeloma is the second most common cancer of the blood. Bortezomib disrupts the life cycle of the cell, affecting numerous biologic pathways, including those related to growth and survival of cancer cells.

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Active Controlled, Double-blind, Study to Compare the Safety and Reduction in Disease Activity With the Combination of Rituximab (MabThera®)and Tocilizumab (RoActemra®) Versus Tocilizumab in Patients With Active Rheumatoid Arthritis With an Incomplete Response to Methotrexate

summary:
This 2 part study will investigate the safety, tolerability and efficacy of MabT hera in combination with RoActemra in patients with active rheumatoid arthritis despite a stable dose of methotrexate. In Part 1 of the study, patients will be randomized to receive either MabThera 0.5g iv or placebo on days 1 and 15, follo wed by RoActemra at one of the ascending doses between 2mg/kg and 8mg/kg at week s 4, 8 and 12 (MabThera arm) or 8mg/kg (placebo arm). In Part 2, additional pati ents will be randomized to one of 2 groups to receive MabThera 0.5g on days 1 an d 15 followed by the selected dose (from Part 1)of RoActemra at weeks 4, 8 and 1 2, or placebo on days 1 and 15 followed by RoActemra 8mg/kg at weeks 4,8 and 12.

All patients will then be eligible to receive extension treatment withRoActemra every 4 weeks. The anticipated time on study treatment is 12 months, and the tar get sample size is <100 individuals.

status: Terminated

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Spain
Greece
United Kingdom
Netherlands
Switzerland
France
Germany

status_simplified: Unknown


title: An Open-label, Dose-escalation Study With Extension to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO4987655, a MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors

summary: This study will determine the maximum tolerated dose and the dose-limiting toxicities of RO4987655 in patients with advanced and/or metastatic solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending oral doses of RO4987655 daily for 28 days. The starting dose of 1mg daily will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with metastatic or advanced malignant melanoma, or any other responsive tumor type, will be randomized to receive either the maximum tolerated dose or the optimal biological dose of RO4987655 daily. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

design_allocation: Non-Randomized

location_country:
Spain
United Kingdom
Netherlands
France
Germany


title: Pilot, Prospective, Multicenter, Open and Non-randomised Study: Definition of an Index of Anti Xa Value at the End of Hemodialysis Treatment.

acronym: RHODES

summary: The current clinical study aims at defining an index of Anti Xa, which is the marker to evaluate the activity of heparin, at the end of the dialysis treatment and so showing the possibility to decrease heparin doses during hemodialysis when using Evodial hemodialyzer. Actually, an elevated value of AntiXa at the end of the dialysis treatment increases the risk of bleeding for patients with diabetic retinopathy, or for instance in case of fall at home.

ReferenceType: background

ReferenceCitation: Lavaud S, Canivet E, Wuillai A, Maheut H, Randoux C, Bonnet JM, Renaux JL, Chanard J. Optimal anticoagulation strategy in haemodialysis with heparin-coated polyacrylonitrile membrane. Nephrol Dial Transplant. 2003 Oct;18(10):2097-104.

ReferenceCitation: Chanard J, Lavaud S, Maheut H, Kazes I, Vitry F, Rieu P. The clinical evaluation of low-dose heparin in haemodialysis: a prospective study using the heparin-coated AN69 ST membrane. Nephrol Dial Transplant. 2008 Jun;23(6):2003-9. Epub 2007 Dec 21.

ReferenceCitation: Kessler M, Gangemi C, Gutierrez Martones A, Lacombe JL, Krier-Coudert MJ, Galland R, Kielstein JT, Moureau F, Loughraieb N. Heparin-grafted dialysis membrane allows minimal systemic anticoagulation in regular hemodialysis patients: a prospective proof-of-concept study. Hemodial Int. 2013 Apr;17(2):282-93. doi: 10.1111/j.1542-4758.2012.00733.x. Epub 2012 Aug 23.

lead_sponsor: Baxter Healthcare Corporation

location_country: Germany Sweden France Italy

location_facility:
Borgo Trento Hospital
Clinique St Exupéry
Medizinische Hochschule
ALTIR Dialysis center
Hopital Brabois
Calydial dialysis unit
Karolinska Hospital

intervention_type: Device


title: Evaluation of the Safety of Sepraspray in Open Abdominal Surgery

summary:
This study will examine the Performance of Sepraspray in Patients undergoing open abdominal surgery

NOTE regarding reason for study termination:

A patient death reported during the trial warranted temporary suspension for review by the independent data review committee. Although the committee recommended continuing enrollment, enrollment was electively terminated by the sponsor.

A preliminary analysis did not identify any new risk that was not listed on the investigational labeling for this product. A full analysis of the results is expected to allow characterization of the risk/benefit and clinical utility of the product in the exposed patient population.

lead_sponsor: Genzyme, a Sanofi Company

location_country: Sweden France

location_facility:
Karolinska University Hospital
University Hospital
Akademiska Sjukhuset
Hopital de la Croix Rousse
CHRU de Lille, Hopital Huriez
Hopital Lariboisiere
Chu Hotel Dieu


title: A Single Arm, Multicenter Single Stage Phase II Trial of RAD001 as Monotherapy in the Treatment of Metastatic Non Syndromic Neuro-endocrine Tumors

summary: To evaluate the preliminary efficacy and safety of RAD001 as monotherapy for first-line treatment of patients with metastatic papillary carcinoma of the kidney.

study_start_date_type: Actual

lead_sponsor: Novartis Pharmaceuticals

location_country:
Poland
Spain
Italy
United Kingdom
Netherlands
Sweden
France
Germany


title: Phase II Trial of Pemetrexed in Second Line Advanced/Metastatic Osteosarcomas

summary:
The primary purpose of your participation in this study is to help answer the following research questions, and not to provide you treatment for your condition.

To assess how well treatment with pemetrexed works for patients with your type of cancer
To assess for any side effects that might be associated with pemetrexed.
To look at the characteristics and levels of certain of your genes and proteins to learn more about osteosarcoma and how pemetrexed works in your body.

lead_sponsor: Eli Lilly and Company

location_country:
United Kingdom
Spain
Italy
France
Germany

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


title: An Open-Label Phase 2 Trial of Pegylated Liposomal Doxorubicin and rIL-21 in Ovarian Cancer Patients With Persistent or Progressive Disease After, or Relapse Within One Year of, Completion of Standard First Line Therapy

lead_sponsor: Novo Nordisk A/S

location_country: Germany France

summary: This trial is conducted in Europe. The aim of this trial is to investigate the efficacy of rIL-21 and Caelyx in cancer patients who have relapsed after, or have persistent disease after, first line therapy. Patients will be treated for 6 months.


intervention_type: Genetic

title: Master Protocol for Mantle Cell Lymphoma A Multicenter Phase II Trial Testing Everolimus (RAD001) for the Treatment of Patients With Relapsed or Therapy Resistant Mantle Cell Lymphoma

lead_sponsor: Swiss Group for Clinical Cancer Research

ReferenceType: result

ReferenceCitation: Renner C, Zinzani PL, Gressin R, Klingbiel D, Dietrich PY, Hitz F, Bargetzi M, Mingrone W, Martinelli G, Trojan A, Bouabdallah K, Lohri A, Gyan E, Biaggi C, Cogliatti S, Bertoni F, Ghielmini M, Brauchli P, Ketterer N; Swiss SAKK and French GOELAMS group from European Mantle Cell Lymphoma Network. A multicenter phase II trial (SAKK 36/06) of single-agent everolimus (RAD001) in patients with relapsed or refractory mantle cell lymphoma. Haematologica. 2012 Jul;97(7):1085-91. doi: 10.3324/haematol.2011.053173. Epub 2012 Feb 7.

location_country: France Switzerland Italy

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Istituto Oncologico della Svizzera Italiana

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

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with relapsed or refractory mantle cell lymphoma.


title: A Phase II, Multi-center, Open-label, Uncontrolled Study to Evaluate the Efficacy and Safety of BAY 43-9006 Given Daily in Combination With Repeated 21-Day Cycles of Dacarbazine (DTIC) Chemotherapy in Subjects With Advanced Metastatic Melanoma.

summary: The purpose of this study is to see whether a new type of anti-cancer drug, known as BAY 43-9006, can be given safely and with good effect in combination with dacarbazine (DTIC). DTIC is the current standard chemotherapy drug given for melanoma that has spread through the body. Although this drug can be effective on its own and is generally well tolerated, not all patients will benefit, so there is a need to test new drugs and drug combinations for treating melanoma.

ReferenceCitation: Eisen T, Marais R, Affolter A, Lorigan P, Robert C, Corrie P, Ottensmeier C, Chevreau C, Chao D, Nathan PD, Jouary T, Harries M, Negrier S, Montegriffo E, Ahmad T, Gibbens I, James MG, Strauss UP, Prendergast S, Gore ME. Sorafenib and dacarbazine as first-line therapy for advanced melanoma: phase I and open-label phase II studies. Br J Cancer. 2011 Jul 26;105(3):353-9. doi: 10.1038/bjc.2011.257. Epub 2011 Jul 12.

lead_sponsor: Bayer

location_country:
France
United Kingdom


title: Randomized Phase II Study of Ixabepilone Plus Trastuzumab vs. Docetaxel Plus Trastuzumab in Female Subjects With Her2+ Locally Advanced and/or Metastatic Breast Cancer

summary: The purpose of this randomized, Phase 2 open-label study was to assess the response rate of participants with Human Epidermal Growth Factor Receptor 2 (Her2+) locally advanced and/or metastatic breast cancer (not previously treated with chemotherapy or trastuzumab) to treatment with ixabepilone plus trastuzumab and/or docetaxel plus trastuzumab.

lead_sponsor: R-Pharm

location_country: Spain Italy Greece Turkey France


ipd_sharing: Yes

title: A Randomized, Double-Blind, Phase II Trial of Fulvestrant Plus Enzastaurin Versus Fulvestrant Plus Placebo in Aromatase Inhibitor-Resistant Metastatic Breast Cancer

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country: Spain Italy Netherlands France Germany

summary: The primary purpose of this study is to help answer the following research question: whether enzastaurin given together with fulvestrant can help participants who have breast cancer and make the tumor smaller or disappear and for how long.


title: International, Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) to Restore Absolute Lymphocyte Counts (ALC) in Patients With Sepsis

summary:
This phase II randomized study will assess the effect of receiving IV recombinant human IL-7 (CYT107) versus placebo in lymphopenic sepsis patients

The aim is to confirm the immune cell reconstitution observed in other studies and other patient populations among which the IRIS-7 A&B study which was conducted in the same patient population.

ReferenceCitation: Francois B, Jeannet R, Daix T, Walton AH, Shotwell MS, Unsinger J, Monneret G, Rimmelé T, Blood T, Morre M, Gregoire A, Mayo GA, Blood J, Durum SK, Sherwood ER, Hotchkiss RS. Interleukin-7 restores lymphocytes in septic shock: the IRIS-7 randomized clinical trial. JCI Insight. 2018 Mar 8;3(5). pii: 98960. doi: 10.1172/jci.insight.98960.

ipd_sharing: No

ipd_sharing_description: Study results will be published Individual data can't be shared and are protected by the new GDPR rule

lead_sponsor: Revimmune

location_country:
United States
France

location_facility: Washington University School of Medicine

intervention_type: Biological


status: Active, not recruiting

acronym: BEAT-meso

title: A Multicentre Randomised Phase III Trial Comparing Atezolizumab Plus Bevacizumab and Standard Chemotherapy Versus Bevacizumab and Standard Chemotherapy as First-line Treatment for Advanced Malignant Pleural Mesothelioma

study_completion_date_type: Anticipated

lead_sponsor: ETOP IBCSG Partners Foundation

ReferenceCitation: Vogelzang NJ, Rusthoven JJ, Symanowski J, Denham C, Kaukel E, Ruffie P, Gatzemeier U, Boyer M, Emri S, Manegold C, Niyikiza C, Paoletti P. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol. 2003 Jul 15;21(14):2636-44.

ReferenceCitation: Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Rivière F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-1414. doi: 10.1016/S0140-6736(15)01238-6. Epub 2015 Dec 21. Erratum in: Lancet. 2016 Apr 2;387(10026):e24.

ReferenceCitation: Ceresoli GL, Zucali PA, Mencoboni M, Botta M, Grossi F, Cortinovis D, Zilembo N, Ripa C, Tiseo M, Favaretto AG, Soto-Parra H, De Vincenzo F, Bruzzone A, Lorenzi E, Gianoncelli L, Ercoli B, Giordano L, Santoro A. Phase II study of pemetrexed and carboplatin plus bevacizumab as first-line therapy in malignant pleural mesothelioma. Br J Cancer. 2013 Aug 6;109(3):552-8. doi: 10.1038/bjc.2013.368. Epub 2013 Jul 16.

ReferenceCitation: Melero I, Berman DM, Aznar MA, Korman AJ, Pérez Gracia JL, Haanen J. Evolving synergistic combinations of targeted immunotherapies to combat cancer. Nat Rev Cancer. 2015 Aug;15(8):457-72. doi: 10.1038/nrc3973. Review.

ReferenceCitation: Soto-Ortiz L, Finley SD. A cancer treatment based on synergy between anti-angiogenic and immune cell therapies. J Theor Biol. 2016 Apr 7;394:197-211. doi: 10.1016/j.jtbi.2016.01.026. Epub 2016 Jan 27.

ReferenceCitation: Wallin JJ, Bendell JC, Funke R, Sznol M, Korski K, Jones S, Hernandez G, Mier J, He X, Hodi FS, Denker M, Leveque V, Cañamero M, Babitski G, Koeppen H, Ziai J, Sharma N, Gaire F, Chen DS, Waterkamp D, Hegde PS, McDermott DF. Atezolizumab in combination with bevacizumab enhances antigen-specific T-cell migration in metastatic renal cell carcinoma. Nat Commun. 2016 Aug 30;7:12624. doi: 10.1038/ncomms12624.

ReferenceCitation: Tsiouris A, Walesby RK. Malignant pleural mesothelioma: current concepts in treatment. Nat Clin Pract Oncol. 2007 Jun;4(6):344-52. Review.

ReferenceCitation: Fennell DA, Gaudino G, O'Byrne KJ, Mutti L, van Meerbeeck J. Advances in the systemic therapy of malignant pleural mesothelioma. Nat Clin Pract Oncol. 2008 Mar;5(3):136-47. doi: 10.1038/ncponc1039. Review.

ReferenceCitation: Nowak AK. Chemotherapy for malignant pleural mesothelioma: a review of current management and a look to the future. Ann Cardiothorac Surg. 2012 Nov;1(4):508-15. doi: 10.3978/j.issn.2225-319X.2012.10.05.

ReferenceCitation: Armato SG 3rd, Nowak AK. Revised Modified Response Evaluation Criteria in Solid Tumors for Assessment of Response in Malignant Pleural Mesothelioma (Version 1.1). J Thorac Oncol. 2018 Jul;13(7):1012-1021. doi: 10.1016/j.jtho.2018.04.034. Epub 2018 May 9. Erratum in: J Thorac Oncol. 2019 Mar;14(3):560.

ReferenceCitation: Uprety D. CheckMate 743: A Glimmer of Hope for Malignant Pleural Mesothelioma. Clin Lung Cancer. 2021 Mar;22(2):71-73. doi: 10.1016/j.cllc.2020.11.009. Epub 2020 Dec 2.

location_country:
Spain
Italy
United Kingdom
Switzerland
France
Belgium

location_facility: Istituto Oncologica della Svizzera Italiana

location_facility: Vall Hebron University Hospital/Vall Hebron Institue Oncology

location_facility: IRCCS Instituto Tumori Giovanni Paolo II

location_facility: Fondazione IRCCS Istituto Nazionale die Tumori

location_facility: Complexo Hospitalario Universitario de Vigo

location_facility: SS Antonio e Biagio e Cesare Arrigo Hospital

summary: The aim of this clinical trial is to assess the effect of treatment with a monoclonal antibody called atezolizumab in patients diagnosed with a type of lung cancer called malignant pleural mesothelioma. The efficacy (whether the treatment works), safety and tolerability (side effects of treatment) of atezolizumab plus bevacizumab in combination with standard chemotherapy versus bevacizumab in combination with standard chemotherapy will be investigated.

status_simplified: Ongoing


title: Evaluation of the Effectiveness of the Belatacept (Nulojix®) Patient Alert Cards in Patients Following Renal Transplantation in European Economic Area Countries

summary: The purpose of the study is to determine a) if the implementation of belatacept patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.

study_type: Observational

time_perspective: Cross-Sectional

lead_sponsor: Bristol-Myers Squibb

location_country: Austria Germany France Sweden

location_facility:
CHU Tours Hopital Bretonneau
CHU Clemont Ferrand
APHP Hopital Henri Mondor
CHU Toulouse Hopital Rangueli
CHU Bordeaux Hopital Pellegrin
UK Mannheim
Local Institution
CHU Brest Hopital La Cavale Blanche


title: A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma

acronym: HIJAK

summary: Phase II study to assess the efficacy of 6 cycles of oral JAK1/2 inhibitor ruxolitinib in patients with advanced Hodgkin's lymphoma for whom no curative option is available.

ReferenceCitation: Van Den Neste E, André M, Gastinne T, Stamatoullas A, Haioun C, Belhabri A, Reman O, Casasnovas O, Ghesquieres H, Verhoef G, Claessen MJ, Poirel HA, Copin MC, Dubois R, Vandenberghe P, Stoian IA, Cottereau AS, Bailly S, Knoops L, Morschhauser F. A phase II study of the oral JAK1/JAK2 inhibitor ruxolitinib in advanced relapsed/refractory Hodgkin lymphoma. Haematologica. 2018 May;103(5):840-848. doi: 10.3324/haematol.2017.180554. Epub 2018 Jan 19.

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: France Belgium

location_facility: Université Catholique de Louvain Mont Godinne


acronym: PREMYA

summary:
This is a multi-center, prospective, non-interventional study of patients who have been diagnosed with moderate to severe symptoms of uterine fibroids and are initiating a pre-operative treatment with ESMYA.

The objectives of the study are to characterize and describe treatment with ESMYA and to evaluate the safety, effectiveness, and HRQL outcomes in this population

status: Unknown status

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceCitation: Fernandez H, Descamps P, Koskas M, Lopès P, Brun JL, Darai E, Agostini A. Real-world data of 197 patients treated with ulipristal acetate for uterine fibroids: PREMYA study French population main outcomes. J Gynecol Obstet Hum Reprod. 2017 Sep;46(7):559-564. doi: 10.1016/j.jogoh.2017.06.006. Epub 2017 Jul 1.

lead_sponsor: PregLem SA

location_country:
Poland
Portugal
Spain
Italy
Austria
United Kingdom
Hungary
France
Romania
Germany

location_facility: Semmelweis University Faculty of Medicine

location_facility: Fachaerzte fuer Frauenheilkunde und Geburtshilfe

location_facility: IRCCS ospedale maggiore policlinico mangiagalli e regina elena di milano

location_facility: North Cumbria University Hospitals NHS Trust

location_facility: Gravida Specjalistyczny Osrodek Ginekologii i Poloznictwa

location_facility: Gynaekologische Praxisklinik Harburger Ring

location_facility: Nottingham University Hospital NHS trust

location_facility: Azienda Ospedaliera-universitaria di Ferrar-Arcispedale Sant'Anna

location_facility: Spitalul Clinic de Urgenta Militar Central

location_facility: Medizinisches Zentrum Bonn Friedensplatz

location_facility: University Hospitals of Leicester NHS Trust

location_facility: Epsom & St Helier University Hospitals NHS Trust

location_facility: Klinikum der Universitaet Muenchen - Klinik und Poliklinik für Frauenheilkunde

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola-Malpighi

location_facility: Clinica ospedale san martino e cliniche universitarie convenzionate di genova


title: A Prospective, Multinational Study of Real-Life Current Standards of Care in Patients With Relapsed and/or Refractory Multiple Myeloma

acronym: MoMMent

summary: The purpose of this study is to assess in real-life clinical practice, over a 24-month period, the effectiveness and safety of current standard of care (SOC) antimyeloma treatments in participants with previously treated relapsed and/or refractory multiple myeloma.

status: Recruiting

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Spain
Italy
United Kingdom
Netherlands
France
Belgium
Germany

location_facility: Universitatsklinikum Carl Gustvav Carus Dresden an der Technischen Universitat Dresden

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS

location_facility: U.O. Ematologia Istituto Tumori Giovanni Paolo II

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Nottingham University Hospitals NHS Trust

location_facility: IRCCS Azienda Ospedaliera San Martino - IST

location_facility: Universitätsklinik Hamburg-Eppendorf - Orthopädische Universitätsklinik und Poliklinik

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Universita degli Studi di Padova - Azienda Ospedaliera di Pa

location_facility: Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany

location_facility: Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

intervention_type: Other


acronym: EMPIRE

title: Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn's Disease and Complex Perianal Fistula

lead_sponsor: Takeda

type: Registry Identifier

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country: Spain Austria France Israel Germany Czechia

location_facility: CHRU de Lille - Hopital Claude Huriez - Gastroenterologie

location_facility: Hospital Universitario Nuestra Senora de la Candelaria

location_facility: Klinikum Dresden, University Hospital Dresden

location_facility: CHRU Hopital de Pontchaillou - Maladies De L'Appareil Digesti

location_facility: Centre Hospitalier Lyon Sud - Gastroenterology

location_facility: CHU de Nice - Hopital de l'Archet II - Gastro-Enterologie, Hepatologi

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem

summary: The main aim is to check the long term side effects of a repeat treatment of darvadstrocel and to see if that treatment improves symptoms of Crohn's disease and complex perianal fistula. Participants will attend 8 clinic visits and will receive 1 treatment of darvadstrocel at the third visit. A magnetic resonance imaging (MRI) will be performed several times during the study.


title: Transvenous Approach for the Treatment of Cerebral Arteriovenous Malformations (TATAM): A Randomized Controlled Trial and Registry

acronym: TATAM

summary:
A new endovascular route for the treatment of brain AVMs may be possible in some cases: Trans-Venous Embolization (TVE). The technique uses microcatheters to navigate to the draining veins of AVM, to reach and then fill the AVM nidus retrogradely with liquid embolic agents until the lesion is occluded. This technique has the potential to improve on some of the problems with the arterial approach to AVM embolization, such as a low overall occlusion rate. However, by occluding the vein first, and filling the lesion with the embolic agent in a retrograde fashion, the method transgresses a widely held dogma in the surgical or endovascular treatment of AVMs: to preserve the draining vein until all afferent vessels have been occluded. Nevertheless, the initial case series have shown promising results, with high occlusion rates, and few technical complications.

The method is increasingly used in an increasing number of centers, but there is currently no research protocol to guide the use of this promising but still experimental treatment in a prudent fashion. Care trials can be designed to offer such an experimental treatment, taking into account the best medical interests of patients, in the presence of rapidly evolving indications and techniques.

ReferenceCitation: van Beijnum J, van der Worp HB, Buis DR, Al-Shahi Salman R, Kappelle LJ, Rinkel GJ, van der Sprenkel JW, Vandertop WP, Algra A, Klijn CJ. Treatment of brain arteriovenous malformations: a systematic review and meta-analysis. JAMA. 2011 Nov 9;306(18):2011-9. doi: 10.1001/jama.2011.1632. Review.

ReferenceCitation: Iosif C, Mendes GA, Saleme S, Ponomarjova S, Silveira EP, Caire F, Mounayer C. Endovascular transvenous cure for ruptured brain arteriovenous malformations in complex cases with high Spetzler-Martin grades. J Neurosurg. 2015 May;122(5):1229-38. doi: 10.3171/2014.9.JNS141714. Epub 2015 Mar 20.

ReferenceCitation: Kessler I, Riva R, Ruggiero M, Manisor M, Al-Khawaldeh M, Mounayer C. Successful transvenous embolization of brain arteriovenous malformations using Onyx in five consecutive patients. Neurosurgery. 2011 Jul;69(1):184-93; discussion 193. doi: 10.1227/NEU.0b013e318212bb34.

ReferenceCitation: Mendes GAC, Kalani MYS, Iosif C, Lucena AF, Carvalho R, Saleme S, Mounayer C. Transvenous Curative Embolization of Cerebral Arteriovenous Malformations: A Prospective Cohort Study. Neurosurgery. 2018 Nov 1;83(5):957-964. doi: 10.1093/neuros/nyx581.

ReferenceCitation: Zhang G, Zhu S, Wu P, Xu S, Shi H. The transvenous pressure cooker technique: A treatment for brain arteriovenous malformations. Interv Neuroradiol. 2017 Apr;23(2):194-199. doi: 10.1177/1591019916682357. Epub 2016 Dec 5.

ReferenceCitation: Raymond J, Darsaut TE, Altman DG. Pragmatic trials can be designed as optimal medical care: principles and methods of care trials. J Clin Epidemiol. 2014 Oct;67(10):1150-6. doi: 10.1016/j.jclinepi.2014.04.010. Epub 2014 Jul 16.

ReferenceCitation: Raymond J, Fahed R, Darsaut TE. Randomize the first patient. J Neuroradiol. 2017 Sep;44(5):291-294. doi: 10.1016/j.neurad.2017.03.004. Epub 2017 May 3.

ReferenceCitation: Fahed R, Darsaut TE, Mounayer C, Chapot R, Piotin M, Blanc R, Mendes Pereira V, Abud DG, Iancu D, Weill A, Roy D, Nico L, Nolet S, Gevry G, Raymond J. Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM): Study protocol of a randomised controlled trial. Interv Neuroradiol. 2019 Jun;25(3):305-309. doi: 10.1177/1591019918821738. Epub 2019 Feb 4.

lead_sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

location_country: Canada France

location_facility: Centre hospitalier régional universitaire de Brest

location_facility: Centre Hospitalier de l'Université de Montréal

location_facility: Centre hospitalier universitaire Limoges

location_facility: Hôpital Forndation Adolphe de Rothschild

location_facility: Centre hospitalier universitaire de Rouen Normandie

location_facility: Centre hospitalier universitaire de Bordeaux

location_facility: Centre hospitalier universitaire de la Réunion

location_facility: Centre hospitalier universitaire de Grenoble

intervention_type: Procedure

lead_sponsor_type: academique


title: A Multi-centre Proof-of-performance Clinical Study to Validate Blood-based Biomarker Candidates for the Diagnosis of Alzheimer's Disease

acronym: ADDIA

summary:
The objective of the ADDIA clinical Proof-of-Performance study is to validate the performance of ADDIA' blood biomarkers for diagnosis of Alzheimer's disease (AD).

ADDIA clinical study is a multi-centre, non-interventional, prospective, proof-of-performance study with only one visit.

About 800 well-characterized subjects will be recruited into 3 groups in 2:1:1 ratio, namely patients with Alzheimer's disease (AD), patients with non-AD neurodegenerative disease (NAD) and 200 control subjects (healthy as compared to their age).

400 patients with Alzheimer's disease (AD): 200 patients with mild AD, 200 patients with moderate-to-severe AD,
200 patients with non-Alzheimer's neurodegenerative diseases (NAD),
200 controls (healthy as compared to their age).

lead_sponsor: Amoneta Diagnostics SAS

location_country: Italy Switzerland Turkey France Belgium

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: APHP-Hôpitaux Universitaires Pitié Salpêtrière

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Hôpitaux Civils (Hopital Louis Pasteur) de Colmar

location_facility: IRCCS Centro San Giovanni di Dio Fatenenefratelli

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Besançon


title: Multicenter, Open-Label, Single-Arm Study to Evaluate Long-Term Safety, Tolerability, and Effectiveness of 10 mg/kg BID Olesoxime in Patients With Spinal Muscular Atrophy

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
United Kingdom
Italy
Netherlands
France
Belgium
Germany

location_facility: National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases

location_facility: Policlinico Agostino Gemelli; Dipartimento di Neuropsichiatria Infantile

location_facility: Uniklinikum Freiburg Zentrum für Kinder- und Jugendmedizin; Neuropädiatrie und Muskelerkrankungen

location_facility: Hopital des Enfants; Unite de Neurologie Pediatrique

location_facility: Newcastle University & The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Hopital Jeanne De Flandre; CIC pediatrique

location_facility: CHRU de Montpellier, Hopital Gui de Chauliac; Service de Neuropediatrie

location_facility: Hôpital Raymond Poincare; Serv. Neurologie et Réanimation pédiatriques - Centre réf. neuromusculaire

location_facility: Hopital Armand Trousseau; centre reference Maladies Neuro-musculaires Est parisien Neuropediatrie

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA;NEMO (NEuroMuscular Omnicentre);Centro clinico - Fonda

location_facility: Hopital Femme Mere Enfant; Medecine Physique et Readaptation Pediatrique - L'ESCALE

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie; Klinika Neurologii

location_facility: I.R.C.C.S. Cà Granda - Ospedale Maggiore Policlinico; Dip. di Salute Mentale

location_facility: Ospedale Pediatrico Bambino Gesù; Dip. Neuroscienze e Salute Mentale

location_facility: IRCCS Istituto G. Gaslini; UOC Neurologia Pediatrica e Malattie Muscolari

location_facility: UMC Utrecht; Polkliniek Neuromusculaire ziekten

location_facility: Azienda Ospedaliera Universitaria Policlinico G.Martino; Dip. Neurologia e Malattie neuromuscolari

location_facility: Hopital la Timone Enfants; Service de Pediatrie et Neurologie Pediatrique

summary: The purpose of this open-label, single arm study is to further evaluate long-term tolerability, safety and efficacy outcomes of olesoxime in participants with Spinal Muscular Atrophy (SMA) who previously participated in one of the following two clinical studies: TRO19622 CL E Q 1115-1 (open-label Phase Ib, multicenter, single- and multiple- dose study) or TRO19622 CL E Q 1275-1 (NCT01302600, Phase II/III, adaptive, parallel-group, double blind, randomized, placebo-controlled, multicenter, multinational study).


title: Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3 (BRAVO 2/3)

acronym: BRAVO 2/3

summary: The objective of this study is to assess the safety and efficacy of using bivalirudin instead of unfractionated heparin (UFH) in transcatheter aortic valve replacements (TAVR). The primary hypothesis of BRAVO 3 was that bivalirudin would reduce major bleeding compared with heparin in TAVR procedures. Results for all participants enrolled into the randomized trial (BRAVO 3) are presented.

ReferenceCitation: Van Belle E, Hengstenberg C, Lefevre T, Kupatt C, Debry N, Husser O, Pontana F, Kuchcinski G, Deliargyris EN, Mehran R, Bernstein D, Anthopoulos P, Dangas GD; BRAVO-3 MRI Study Investigators. Cerebral Embolism During Transcatheter Aortic Valve Replacement: The BRAVO-3 MRI Study. J Am Coll Cardiol. 2016 Aug 9;68(6):589-599. doi: 10.1016/j.jacc.2016.05.006. Epub 2016 May 18.

ReferenceCitation: Dangas GD, Lefèvre T, Kupatt C, Tchetche D, Schäfer U, Dumonteil N, Webb JG, Colombo A, Windecker S, Ten Berg JM, Hildick-Smith D, Mehran R, Boekstegers P, Linke A, Tron C, Van Belle E, Asgar AW, Fach A, Jeger R, Sardella G, Hink HU, Husser O, Grube E, Deliargyris EN, Lechthaler I, Bernstein D, Wijngaard P, Anthopoulos P, Hengstenberg C; BRAVO-3 Investigators. Bivalirudin Versus Heparin Anticoagulation in Transcatheter Aortic Valve Replacement: The Randomized BRAVO-3 Trial. J Am Coll Cardiol. 2015 Dec 29;66(25):2860-2868. doi: 10.1016/j.jacc.2015.10.003. Epub 2015 Oct 15.

lead_sponsor: The Medicines Company

location_country:
United Kingdom
Italy
Netherlands
Canada
Switzerland
France
Germany

location_facility: Ospedale San Raffaele U.O. Cardiologia Interventistica

location_facility: University Heart Centre, Clinic of Inner Medicine 1 Cardiology

location_facility: Clinique Pasteur, Unité de Cardiologie Interventionnelle

location_facility: LMU Munich, Klinikum der Universität München

location_facility: Ferraroto Hospital, University of Catania

location_facility: Azienda Ospedaliera San Camillo-Forlanini

location_facility: St. Paul´s Hospital Providence Health Care

location_facility: Universitätsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: Service de Cardiologie, Centre Hospitalo-Universitaire, Hôpital Charles-Nicolle

location_facility: Policlinico Umberto I, Università La Sapienza


acronym: LUNA

title: Multicenter 3-arm Trial to Evaluate the Efficacy and Safety of Pasireotide LAR or Everolimus Alone or in Combination in Patients With Well Differentiated Neuroendocrine Carcinoma of the Lung and Thymus - LUNA Trial

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Ferolla P, Brizzi MP, Meyer T, Mansoor W, Mazieres J, Do Cao C, Léna H, Berruti A, Damiano V, Buikhuisen W, Grønbæk H, Lombard-Bohas C, Grohé C, Minotti V, Tiseo M, De Castro J, Reed N, Gislimberti G, Singh N, Stankovic M, Öberg K, Baudin E. Efficacy and safety of long-acting pasireotide or everolimus alone or in combination in patients with advanced carcinoids of the lung and thymus (LUNA): an open-label, multicentre, randomised, phase 2 trial. Lancet Oncol. 2017 Dec;18(12):1652-1664. doi: 10.1016/S1470-2045(17)30681-2. Epub 2017 Oct 23.

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

This trial data availability is according to the criteria and process described on

https://www.clinicalstudydatarequest.com/

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

summary: This was a multicenter, randomized, phase II study evaluating Everolimus or Pasireotide LAR alone or in combination in adult patients with advanced (unresectable or metastatic) neuroendocrine carcinoma of the lung and thymus


title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel-group Phase II Study on the Efficacy and Safety of Debio 025 Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients

lead_sponsor: Debiopharm International SA

ReferenceCitation: Paeshuyse J, Kaul A, De Clercq E, Rosenwirth B, Dumont JM, Scalfaro P, Bartenschlager R, Neyts J. The non-immunosuppressive cyclosporin DEBIO-025 is a potent inhibitor of hepatitis C virus replication in vitro. Hepatology. 2006 Apr;43(4):761-70.

ReferenceCitation: Inoue K, Umehara T, Ruegg UT, Yasui F, Watanabe T, Yasuda H, Dumont JM, Scalfaro P, Yoshiba M, Kohara M. Evaluation of a cyclophilin inhibitor in hepatitis C virus-infected chimeric mice in vivo. Hepatology. 2007 Apr;45(4):921-8.

ReferenceCitation: Flisiak R, Horban A, Gallay P, Bobardt M, Selvarajah S, Wiercinska-Drapalo A, Siwak E, Cielniak I, Higersberger J, Kierkus J, Aeschlimann C, Grosgurin P, Nicolas-Métral V, Dumont JM, Porchet H, Crabbé R, Scalfaro P. The cyclophilin inhibitor Debio-025 shows potent anti-hepatitis C effect in patients coinfected with hepatitis C and human immunodeficiency virus. Hepatology. 2008 Mar;47(3):817-26. doi: 10.1002/hep.22131.

ReferenceCitation: Reesink HW, Zeuzem S, Weegink CJ, Forestier N, van Vliet A, van de Wetering de Rooij J, McNair L, Purdy S, Kauffman R, Alam J, Jansen PL. Rapid decline of viral RNA in hepatitis C patients treated with VX-950: a phase Ib, placebo-controlled, randomized study. Gastroenterology. 2006 Oct;131(4):997-1002.

ReferenceCitation: Pawlotsky JM. Treatment of hepatitis C: don't put all your eggs in one basket! Gastroenterology. 2007 Apr;132(4):1611-5.

ReferenceCitation: Dienstag JL, McHutchison JG. American Gastroenterological Association technical review on the management of hepatitis C. Gastroenterology. 2006 Jan;130(1):231-64; quiz 214-7. Review.

ReferenceCitation: Zeuzem S, Buti M, Ferenci P, Sperl J, Horsmans Y, Cianciara J, Ibranyi E, Weiland O, Noviello S, Brass C, Albrecht J. Efficacy of 24 weeks treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C infected with genotype 1 and low pretreatment viremia. J Hepatol. 2006 Jan;44(1):97-103. Epub 2005 Nov 7.

ReferenceCitation: Watashi K, Hijikata M, Hosaka M, Yamaji M, Shimotohno K. Cyclosporin A suppresses replication of hepatitis C virus genome in cultured hepatocytes. Hepatology. 2003 Nov;38(5):1282-8.

ReferenceCitation: Watashi K, Ishii N, Hijikata M, Inoue D, Murata T, Miyanari Y, Shimotohno K. Cyclophilin B is a functional regulator of hepatitis C virus RNA polymerase. Mol Cell. 2005 Jul 1;19(1):111-22.

ReferenceCitation: Rice CM, You S. Treating hepatitis C: can you teach old dogs new tricks? Hepatology. 2005 Dec;42(6):1455-8.

ReferenceCitation: Ishii N, Watashi K, Hishiki T, Goto K, Inoue D, Hijikata M, Wakita T, Kato N, Shimotohno K. Diverse effects of cyclosporine on hepatitis C virus strain replication. J Virol. 2006 May;80(9):4510-20.

ReferenceCitation: Yang F, Robotham JM, Nelson HB, Irsigler A, Kenworthy R, Tang H. Cyclophilin A is an essential cofactor for hepatitis C virus infection and the principal mediator of cyclosporine resistance in vitro. J Virol. 2008 Jun;82(11):5269-78. doi: 10.1128/JVI.02614-07. Epub 2008 Apr 2.

location_country: Poland Romania Spain Italy France Belgium Germany

location_facility: Centrul de Diagnostic si Tratament Dr. Victor Babe

location_facility: Seconda Università di Napoli- Secondo Policlinico

location_facility: Az. Osp. Universitaria S. Giovanni Battista

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla I

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Wojewódzki Szpital Specjalstyczny im. Wl. Biegansk

location_facility: Wojewódzki Szpital Obserwacyjno-Zakazny im. Tadeus

location_facility: "Policlinico ""Paolo Giaccone"" dell'Università di

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Woj

location_facility: "Spitalul Clinic de Urgenta ""Prof. dr. Octavian F

location_facility: Institutul de Gastroenterologie si Hepatologie

location_facility: Hôpital du Haut-Levêque - C.H.U de Bordeaux

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Wojewódzki Szpital Specjalistyczny im. K. Dluskieg

location_facility: Center for HIV and Hepatogastroenterology

summary: The purpose of this study is to compare several Debio 025 (alisporivir)/peg-IFNα2a/ribavirin triple therapies with the current standard of care (SOC) in treatment naïve chronic hepatitis C genotype 1 patients.


title: Maintenance of Effect of Duloxetine 60 mg Once Daily in Patients With Diabetic Peripheral Neuropathic Pain

summary: To determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from Diabetic Neuropathy.

ReferenceCitation: Skljarevski V, Desaiah D, Zhang Q, Chappell AS, Detke MJ, Gross JL, Ziegler D. Evaluating the maintenance of effect of duloxetine in patients with diabetic peripheral neuropathic pain. Diabetes Metab Res Rev. 2009 Oct;25(7):623-31. doi: 10.1002/dmrr.1000.

ReferenceCitation: Hall JA, Wang F, Oakes TM, Utterback BG, Crucitti A, Acharya N. Safety and tolerability of duloxetine in the acute management of diabetic peripheral neuropathic pain: analysis of pooled data from three placebo-controlled clinical trials. Expert Opin Drug Saf. 2010 Jul;9(4):525-37. doi: 10.1517/14740338.2010.484418.

lead_sponsor: Eli Lilly and Company

location_country: Germany France Brazil Italy

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: Prospective Randomised Study of Doxorubicin in the Treatment of Hepatocellular Carcinoma by Drug-Eluting Bead Embolisation (PRECISION V)

acronym: PRECISIONV

summary: The objective of this study is to assess the safety and efficacy of DC Bead™ delivered by intra-arterial embolisation for the treatment of Hepatocellular Carcinoma

ReferenceCitation: Vogl TJ, Lammer J, Lencioni R, Malagari K, Watkinson A, Pilleul F, Denys A, Lee C. Liver, gastrointestinal, and cardiac toxicity in intermediate hepatocellular carcinoma treated with PRECISION TACE with drug-eluting beads: results from the PRECISION V randomized trial. AJR Am J Roentgenol. 2011 Oct;197(4):W562-70. doi: 10.2214/AJR.10.4379.

lead_sponsor: Boston Scientific Corporation

location_country: Austria Germany France Switzerland

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Fakultat fur Klinische Medizin Mannheim Universitat


title: Phase II Study Of NX 211 (Liposomal Lurtotecan) Given As An IV Bolus Injection On Days 1 and 8 Every 3 Weeks In Patients With Metastatic Or Loco-Regional Recurrent Squamous Cell Carcinoma Of The Head and Neck With Target Lesions Within Previously Irradiated Fields Or Outside Previously Irradiated Fields

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 liposomal lurtotecan in treating patients who have metastatic or locally recurrent head and neck cancer.

ReferenceCitation: Duffaud F, Borner M, Chollet P, Vermorken JB, Bloch J, Degardin M, Rolland F, Dittrich C, Baron B, Lacombe D, Fumoleau P; EORTC-New Drug Development Group/New Drug Development Program. Phase II study of OSI-211 (liposomal lurtotecan) in patients with metastatic or loco-regional recurrent squamous cell carcinoma of the head and neck. An EORTC New Drug Development Group study. Eur J Cancer. 2004 Dec;40(18):2748-52.

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

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

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

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

location_facility: Istituti Fisioterapici Ospitalieri - Roma

location_facility: Instituto Portugues de Oncologia de Francisco Gentil-Centro de Lisboa


title: An Open Label Trial of BI 765063 in Combination With BI 754091 (Ezabenlimab) Alone or With BI 836880, Chemotherapy, or Cetuximab, in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) or Hepatocellular Carcinoma (HCC)

summary:
This study is open to adults with head and neck cancer or liver cancer. This is a study for people for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out whether combining different medicines make tumours shrink in people with head and neck cancer or liver cancer. The tested medicines in this study are antibodies that act in different ways against cancer.

BI 765063 and ezabenlimab may help the immune system fight cancer (checkpoint inhibitors). Cetuximab blocks growth signals and may prevent the tumour from growing. BI 836880 blocks the formation of new blood vessels that the tumour needs to grow. All participants get BI 765063 and ezabenlimab. One group gets no additional medicine. The other groups get either BI 836880, cetuximab, or chemotherapy. BI 765063, ezabenlimab, and BI 836880 are given as infusions into veins every 3 weeks. Cetuximab is given as an infusion every 1 or 2 weeks.

Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors monitor the size of the tumour. The doctors also regularly check participants' health and take note of any unwanted effects.

ipd_sharing_description:
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

studies in products where Boehringer Ingelheim is not the license holder;
studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

lead_sponsor: Boehringer Ingelheim

location_country:
Spain
Italy
United Kingdom
Thailand
United States
France
Mexico
Japan
Malaysia

location_facility: Washington University School of Medicine

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V.


acronym: Storytime

title: A PHASE 1, MULTICENTRE, OPEN-LABEL, DOSE-ESCALATION AND COHORT EXPANSION STUDY OF NIRAPARIB AND DOSTARLIMAB IN PAEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMOURS

lead_sponsor: GlaxoSmithKline

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

location_country:
Spain
United Kingdom
Hungary
France
Germany
Czechia

summary: This study will evaluate the combination of a poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor, niraparib, with the programmed cell death protein 1 (PD-1) inhibitor, dostarlimab in the pediatric population. This study will be conducted to determine the recommended Phase 2 dose (RP2D) and evaluate the pharmacokinetics (PK), safety, and efficacy of niraparib in combination with dostarlimab in pediatric participants with recurrent or refractory solid tumors.


acronym: Pain study

title: A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide 100mg Once Daily, as add-on Therapy, in Idiopathic Parkinson's Disease (PD) Patients With Motor Fluctuations and PD Related Chronic Pain

lead_sponsor: Zambon SpA

location_country: Spain Italy Austria France Germany

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Azienda Ospedaliera Universitaria OO.RR. San Giovanni di Dio Ruggi d'Aragona

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Centro per la Malattia di Parkinson e i Disturbi del Movimento

location_facility: Centre Hospitalier Universitaire de Nimes

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: Institut für Neuroimmunologische und Neurodegenerative Erkrankungen

location_facility: Istituto Neurologico Mediterraneo Neuromed

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: C.A.U de Burgos - Hospital Universitario de Burgos

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Ospedale San Giovanni Battista - ACISMOM

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

summary:
This is a Phase IV, international, multicentre, randomised, double-blind, placebo controlled study in IPD patients, experiencing motor fluctuations and PD related chronic pain while on stable doses of levodopa (L-Dopa).

Participants will be randomized 2:1 to receive either active or placebo


title: Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy

summary: stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy

ReferenceCitation: Koole S, van Stein R, Sikorska K, Barton D, Perrin L, Brennan D, Zivanovic O, Mosgaard BJ, Fagotti A, Colombo PE, Sonke G, Driel WJV; OVHIPEC-2 Steering Committee and the Dutch OVHIPEC group. Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) for FIGO stage III epithelial ovarian cancer: OVHIPEC-2, a phase III randomized clinical trial. Int J Gynecol Cancer. 2020 Jun;30(6):888-892. doi: 10.1136/ijgc-2020-001231. Epub 2020 Mar 23.

lead_sponsor: The Netherlands Cancer Institute

location_country:
Denmark
Italy
Ireland
Sweden
United States
France
Netherlands

location_facility: Mater Misericordiae University Hospital, Dublin

location_facility: Oncopole, Institute Universitaire du Cancer de Toulouse (IUCT Toulouse)

location_facility: Institut de Cancerologie de l'Ouest, ICO Nantes)


title: European Prevention of Alzheimer's Dementia (EPAD) Longitudinal Cohort Study (LCS)

acronym: EPAD-LCS

summary:
Brain changes associated with Alzheimer's disease may precede symptoms of Alzheimer's Dementia by over 20 years. The Investigators hope to be able to identify Alzheimer's disease at its very earliest stages when in theory treatments are most likely to be successful in preventing further spread of the disease in the brain and causing dementia. The aim of EPAD programme is to develop new treatments more quickly to prevent Alzheimer's dementia. A major component of the EPAD programme is the EPAD Longitudinal Cohort Study which can provide subjects for the EPAD trial as well as data to improve understanding of disease before dementia develops.

The Investigators will approach a broad range of people over the age of 50 who have previously taken part in various research studies and consented to being recontacted for further research. Participants will be asked questions to assess their memory and other cognitive function. The participants will also undertake a brain scan, provide a sample of spinal fluid, blood, urine and saliva to look at markers in these bodily fluids that may change in Alzheimer's disease. The Investigators will then follow these participants until December 2019 repeating these tests annually. This will be called the EPAD Longitudinal Cohort Study (EPAD LCS). The main reasons for EPAD developing a cohort are to help the Investigators understand more about what happens to people before dementia develops, and to help recruit people more quickly into the EPAD trials of new medications or other interventions expected to prevent dementia.

People in the EPAD LCS may be invited to take part in the EPAD Proof of Concept prevention studies to see if interventions can modify the probability of developing dementia or cognitive problems (this will be subject to separate ethics approval and consent). Together EPAD LCS and EPAD PoC make up the full EPAD Programme.

ReferenceCitation: Vermunt L, Muniz-Terrera G, Ter Meulen L, Veal C, Blennow K, Campbell A, Carrié I, Delrieu J, Fauria K, Huesa Rodríguez G, Ingala S, Jenkins N, Molinuevo JL, Ousset PJ, Porteous D, Prins ND, Solomon A, Tom BD, Zetterberg H, Zwan M, Ritchie CW, Scheltens P, Luscan G, Brookes AJ, Visser PJ; IMI-EPAD collaborators. Prescreening for European Prevention of Alzheimer Dementia (EPAD) trial-ready cohort: impact of AD risk factors and recruitment settings. Alzheimers Res Ther. 2020 Jan 6;12(1):8. doi: 10.1186/s13195-019-0576-y.

ReferenceCitation: Solomon A, Kivipelto M, Molinuevo JL, Tom B, Ritchie CW; EPAD Consortium. European Prevention of Alzheimer's Dementia Longitudinal Cohort Study (EPAD LCS): study protocol. BMJ Open. 2019 Feb 19;8(12):e021017. doi: 10.1136/bmjopen-2017-021017.

ipd_sharing_description: EPAD is an Innovative Medicines Initiative (IMI) project with open access to data.

lead_sponsor: University of Edinburgh

location_country:
Spain
Italy
Greece
United Kingdom
Switzerland
Sweden
France
Belgium
Netherlands

location_facility: Centre Leenaards de la memoire- CHUV, Department of Neurosciences cliniques

location_facility: Neuropsychiatric Research Unit, Sahlgrenska University Hoospital

location_facility: University of Oxford, Department of Psychiatry

location_facility: CMRR du CHRU de Lille Hôpital Roger Salengro

location_facility: Cliniques Universitaires Saint-Luc ASBL, Neurology Department

location_facility: Unidade Deterioro Cognitivo, Servicio de Neurologia, Hospital Universitario

location_facility: Glasgow Clinical Research Facility; NHS Greater Glasgow and Clyde

location_facility: Hôpital Universitaire de la Pitié Salpêtrière

location_facility: Greater Manchester Clinical Research Network

location_facility: National and Kapodistran, University of Athens, 1st Department of Neurology, Aeginition Hospital

location_facility: Univerita di Perugia, Centro Disturbi della Memoria, Clinica Neurologica

location_facility: IRCCS San Giovanni di Dio - Fatebenefratelli

location_facility: University of Cambridge; Department of Clinical Neurosciences

location_facility: CMRR- Hôpital Laënnec Nord - CIC Neurologie / CHU de Nantes

location_facility: Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal

location_facility: University of Edinburgh, Centre for Dementia Prevention

location_facility: Fundacion CITA-alzheimer Fundazioa, Center for Research and Advanced Therapies

location_facility: Fundacion ACE, Institut Catala de Neurocienies Aplicades

location_facility: CHU Gui de Chauliac Département de Neurologie

location_facility: VUmc Alzheimer Center and Alzheimer Research Center

location_facility: Toulouse University Hospital / Gérontopôle-Research Clinical Center


title: The European Bifurcation Club Left Main Study: A Randomised Comparison of Single Versus Dual Stent Implantation for Distal Left Main True Coronary Bifurcation Lesions

acronym: EBC MAIN

summary: The objective of the study is to investigate clinical outcomes following single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions.

ReferenceCitation: Hildick-Smith D, Egred M, Banning A, Brunel P, Ferenc M, Hovasse T, Wlodarczak A, Pan M, Schmitz T, Silvestri M, Erglis A, Kretov E, Lassen JF, Chieffo A, Lefèvre T, Burzotta F, Cockburn J, Darremont O, Stankovic G, Morice MC, Louvard Y. The European bifurcation club Left Main Coronary Stent study: a randomized comparison of stepwise provisional vs. systematic dual stenting strategies (EBC MAIN). Eur Heart J. 2021 Oct 1;42(37):3829-3839. doi: 10.1093/eurheartj/ehab283.

lead_sponsor: European Cardiovascular Research Center

location_country:
Denmark
Serbia
Spain
Latvia
Italy
United Kingdom
France
Germany

location_facility: Rigshospitalet Copenhagen University Hospital

location_facility: University of Catania - Ferrarotto Hospital

location_facility: Pauls Stradins Clinical University Hospital


title: An Open-label, Multi-center, Dose Escalation Phase I Study of Single Agent RO5520985 (Vanucizumab), and in Combination With Atezolizumab, Administered as an Intravenous Infusion in Patients With Locally Advanced or Metastatic Solid Tumors

summary: This multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of vanucizumab as a single agent or in combination with atezolizumab in participants with locally advanced or metastatic solid tumors. Cohorts of participants will receive escalating doses of vanucizumab, fixed dose of vanucizumab (MTD and/or recommended phase two dose [RP2D]), and fixed dose of vanucizumab in combination with atezolizumab, intravenously every 2 weeks.

location_country: France Spain Belgium

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

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

location_facility: Centre Leon Berard; Departement Oncologie Medicale

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

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia


title: Phase II, Multicenter, Randomized, Adaptive, Double-blind, Placebo Controlled Study to Assess Safety and Efficacy of Olesoxime (TRO19622) in 3-25 Year Old Spinal Muscular Atrophy (SMA) Patients.

ReferenceCitation: Bertini E, Dessaud E, Mercuri E, Muntoni F, Kirschner J, Reid C, Lusakowska A, Comi GP, Cuisset JM, Abitbol JL, Scherrer B, Ducray PS, Buchbjerg J, Vianna E, van der Pol WL, Vuillerot C, Blaettler T, Fontoura P; Olesoxime SMA Phase 2 Study Investigators. Safety and efficacy of olesoxime in patients with type 2 or non-ambulatory type 3 spinal muscular atrophy: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol. 2017 Jul;16(7):513-522. doi: 10.1016/S1474-4422(17)30085-6. Epub 2017 Apr 28. Erratum in: Lancet Neurol. 2017 Aug;16(8):584.

location_facility: CHU de Montpellier, Hôpital Gui de Chauliac

location_facility: Bambino Gesu' Research Children's Hospital

location_facility: Policlinico Universitario "Agostino Gemelli",

summary: Assess the efficacy and the safety of olesoxime in SMA type 2 or type 3 non ambulant patients aged 3-25 years


title: A Phase II Multi-centre, Extension Study to Investigate the Long Term Safety of ONO-2506PO in Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS)

summary: The objective of this study is to investigate the long term safety of ALS patients taking ONO-2506PO.

lead_sponsor: Ono Pharmaceutical Co. Ltd

location_country:
United Kingdom
Italy
Netherlands
Switzerland
France
Belgium
Germany

location_facility: Prof Gian Domenico Borasio, Interdisziplinares Zentrum fur Palliativmedizin

location_facility: Prof. Claude Desnuelle, Hopital 1-Archet 1

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

location_facility: Prof. Vincenzo Silani, Dipartimento di Neurologia e Laboratorio di Neuroscienze - Universita di Milano - IRCCS - Istituto Auxologico Italiano

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

location_facility: Dr. Chris McDermott, Royal Hallamshire Hospital

location_facility: Prof. Reinhard Dengler, Medizinische Hochschule Hannover, Neurologische Klinik

location_facility: Prof. Vincent Meininger, Hopital LaPitie Salpetriere

location_facility: Prof. Albert Ludolph, Klinik und Poliklinikfur Neurologie der Universitat Ulm-Univeritatsklinikum Ulm

location_facility: Prof. Torsten Grehl, Neurologische Ambulanz Universitatsklinik Bergmannsheil

location_facility: Prof. Nigel Leigh, Academic Neuroscience Centre

location_facility: Dr. Gabriele Mora, Divisione di Neuroriabilitazione II - Fondazione Salvatore Maugeri - IRCCS

location_facility: Professor Dieter Heuss, Poliklinik der Universitat Erlangen-Nurnberg, Neurologische Klinik

location_facility: Dr. Thomas Meyer, Charite Campus Virchow, ALS Ambulanz

location_facility: Prof. Leonard H Van Den Berg, University Medical Center Utrecht

location_facility: Prof. Philippe Couratier, Hopital Duruytren

location_facility: Dr. Berthold Schrank, Deutsche Klinik fur Diagnostik, Fachbereich Neurologie

location_facility: Prof. Alain Destee, Hopital Roger Salengro - Clinique Neurologique, Neurologie A

location_facility: Prof. Douglas Mitchell, Royal Preston Hospital

location_facility: Dr. Markus Weber, Kantonsspital St. Gallen, Muskelzentrum/ALS Clinic

location_facility: Prof Marianne de Visser, Academic Medical Centre (AMC) Amsterdam - Dept of Neurology


title: Open Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus

summary: Is oral therapy with Repaglinide equivalent to insulin therapy with three daily injections with respect to blood glucose control, weight and pulmonary function over 2 years in patients with cystic fibrosis and secondary diabetes mellitus? That is the question examined in the phase III trial.

ReferenceCitation: Onady GM, Stolfi A. Drug treatments for managing cystic fibrosis-related diabetes. Cochrane Database Syst Rev. 2020 Oct 19;10:CD004730. doi: 10.1002/14651858.CD004730.pub5.

ReferenceCitation: Ballmann M, Hubert D, Assael BM, Staab D, Hebestreit A, Naehrlich L, Nickolay T, Prinz N, Holl RW; CFRD Study Group. Repaglinide versus insulin for newly diagnosed diabetes in patients with cystic fibrosis: a multicentre, open-label, randomised trial. Lancet Diabetes Endocrinol. 2018 Feb;6(2):114-121. doi: 10.1016/S2213-8587(17)30400-X. Epub 2017 Dec 5. Erratum in: Lancet Diabetes Endocrinol. 2019 Apr;7(4):e4.

ReferenceCitation: Ballmann M, Hubert D, Assael BM, Kronfeld K, Honer M, Holl RW; CFRD Study group. Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus. BMC Pediatr. 2014 Mar 11;14:70. doi: 10.1186/1471-2431-14-70.

ReferenceCitation: Schmid K, Fink K, Holl RW, Hebestreit H, Ballmann M. Predictors for future cystic fibrosis-related diabetes by oral glucose tolerance test. J Cyst Fibros. 2014 Jan;13(1):80-5. doi: 10.1016/j.jcf.2013.06.001. Epub 2013 Jun 25.

lead_sponsor: Mukoviszidose Institut gGmbH

location_country: Austria Germany France Italy

location_facility: Kinderklinik Dritter Orden, Sozialpädiatrisches Zentrum

location_facility: CRCM adultes, Centre Hospitalier Lyon Sud

location_facility: Universitätsklinik für Kinder- und Jugendheilkunde

location_facility: Medizinische Hochschule Hannover, CF-Ambulanz f. Erwachsene

location_facility: Klinik und Poliklinik für allgemeine Kinderheilkunde

location_facility: Klinik für Kinder und Jugendliche Erlangen

location_facility: Klinik und Poliklinik für Kinder- und Jugendmedizin

location_facility: APHP, CRCM pediatrique, Hopital Robert Debre

location_facility: Medizinische Hochschule Hannover, Abt. Kinderheilkunde

location_facility: Med. Klinik II, Allergologie und Pneumologie

location_facility: Klikum der Universität Heidelberg, Kinderklinik

location_facility: Universitätsklinik für Kinder- und Jugendmedizin


title: A Phase III, Observer-blind, Randomised Study to Evaluate the Safety and Immunogenicity of One and Two Administrations of Pandemic Monovalent (H5N1) Influenza Vaccine (Adjuvanted Split Virus Formulation) in Adults Aged 18 Years and Older

summary: Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule. This study is designed to test in healthy adults aged above 18 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus.

primary_purpose: Prevention

ReferenceCitation: Rümke HC, Bayas JM, de Juanes JR, Caso C, Richardus JH, Campins M, Rombo L, Duval X, Romanenko V, Schwarz TF, Fassakhov R, Abad-Santos F, von Sonnenburg F, Dramé M, Sänger R, Ballou WR. Safety and reactogenicity profile of an adjuvanted H5N1 pandemic candidate vaccine in adults within a phase III safety trial. Vaccine. 2008 May 2;26(19):2378-88. doi: 10.1016/j.vaccine.2008.02.068. Epub 2008 Mar 27.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
Spain
Russian Federation
Estonia
Netherlands
Sweden
France
Germany


title: Randomized, Open Phase II Study of Immunization With the Recombinant MAGE-3 Protein Combined With Adjuvant AS02B or AS15 in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma

summary:
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This randomized phase II trial is studying two different regimens of vaccine therapy and comparing them to see how well they work in treating patients with stage III or stage IV melanoma that cannot be removed with surgery.

ReferenceCitation: Kruit WH, Suciu S, Dreno B, et al.: Immunization with recombinant MAGE-A3 protein combined with adjuvant systems AS15 or AS02B in patients with unresectable and progressive metastatic cutaneous melanoma: A randomized open-label phase II study of the EORTC Melanoma Group (16032- 18031). [Abstract] J Clin Oncol 26 (Suppl 15): A-9065, 2008.

ReferenceCitation: Louahed J, Gruselle O, Gaulis S, et al.: Expression of defined genes identified by pretreatment tumor profiling: association with clinical responses to the GSK MAGE- A3 immunotherapeutic in metastatic melanoma patients (EORTC 16032-18031). [Abstract] J Clin Oncol 26 (Suppl 15): A-9045, 2008.

ReferenceCitation: Kruit WH, Suciu S, Dreno B, Mortier L, Robert C, Chiarion-Sileni V, Maio M, Testori A, Dorval T, Grob JJ, Becker JC, Spatz A, Eggermont AM, Louahed J, Lehmann FF, Brichard VG, Keilholz U. Selection of immunostimulant AS15 for active immunization with MAGE-A3 protein: results of a randomized phase II study of the European Organisation for Research and Treatment of Cancer Melanoma Group in Metastatic Melanoma. J Clin Oncol. 2013 Jul 1;31(19):2413-20. doi: 10.1200/JCO.2012.43.7111. Epub 2013 May 28.

ReferenceCitation: Ulloa-Montoya F, Louahed J, Dizier B, Gruselle O, Spiessens B, Lehmann FF, Suciu S, Kruit WH, Eggermont AM, Vansteenkiste J, Brichard VG. Predictive gene signature in MAGE-A3 antigen-specific cancer immunotherapy. J Clin Oncol. 2013 Jul 1;31(19):2388-95. doi: 10.1200/JCO.2012.44.3762. Epub 2013 May 28.

location_country:
Spain
Italy
United Kingdom
Netherlands
France
Belgium
Germany

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Centre Hospitalier Regional et Universitaire de Lille

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

location_facility: Centro di Riferimento Oncologico - Aviano


title: Phase II Study Of Iressa (ZD 1839) In Locally Advanced And/Or Metastatic Synovial Sarcoma Expressing HER1/EGFR1

summary:
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of synovial sarcoma.

PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic synovial sarcoma.

ReferenceCitation: Ray-Coquard I, Le Cesne A, Whelan JS, Schoffski P, Bui BN, Verweij J, Marreaud S, van Glabbeke M, Hogendoorn P, Blay JY. A phase II study of gefitinib for patients with advanced HER-1 expressing synovial sarcoma refractory to doxorubicin-containing regimens. Oncologist. 2008 Apr;13(4):467-73. doi: 10.1634/theoncologist.2008-0065.

location_country:
Netherlands
France
United Kingdom
Belgium

location_facility: Nijmegen Cancer Center at Radboud University Medical Center

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

location_facility: Meyerstein Institute of Oncology at University College of London Hospitals

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Royal Marsden NHS Foundation Trust - London


title: A Phase II Study of Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Patients With Percutaneously Accessible Lesions With Advanced Melanoma Refractory to Pembrolizumab

summary: ATLAS-IT-05 is an open-label, single-arm study in patients with advanced melanoma accessible for injections (cutaneous, subcutaneous, lymph node, or intramuscular tumors) and who have either exhausted treatment options or are not eligible for, suitable for, or willing to undergo such treatments.

ReferenceCitation: Camilio KA, Rekdal O, Sveinbjornsson B. LTX-315 (Oncopore): A short synthetic anticancer peptide and novel immunotherapeutic agent. Oncoimmunology. 2014 Jun 25;3:e29181. doi: 10.4161/onci.29181. eCollection 2014.

ReferenceCitation: Sveinbjornsson B, Camilio KA, Haug BE, Rekdal O. LTX-315: a first-in-class oncolytic peptide that reprograms the tumor microenvironment. Future Med Chem. 2017 Aug;9(12):1339-1344. doi: 10.4155/fmc-2017-0088. Epub 2017 May 11.

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

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

lead_sponsor: Lytix Biopharma AS

location_country:
Norway
United States
Spain
France

location_facility:
Icahn School of Medicine at Mount Sinai
Clínica Universidad de Navarra
Akershus University Hospital
Hospital Lyon Sud
MD Anderson Cancer Centre

intervention_type: Combination Product


title: Risk Stratification of Patients With Suspected COVID-19 Presenting to the ED (EUROCOV Study)

acronym: EUROCOV

summary: This project is an unfunded collaboration of approximately 30 emergency departments across Europe led by the EUSEM research network. It involves collection of data in relation to determining the epidemiology and outcome of adult patients who present to emergency departments with a suspected Covid infection.

status: Enrolling by invitation

time_perspective: Retrospective

ReferenceCitation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648.

ReferenceCitation: Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11. Erratum in: Lancet. 2020 Mar 28;395(10229):1038. Lancet. 2020 Mar 28;395(10229):1038.

ReferenceCitation: Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum in: JAMA Intern Med. 2020 Jul 1;180(7):1031.

ReferenceCitation: Young BE, Ong SWX, Kalimuddin S, Low JG, Tan SY, Loh J, Ng OT, Marimuthu K, Ang LW, Mak TM, Lau SK, Anderson DE, Chan KS, Tan TY, Ng TY, Cui L, Said Z, Kurupatham L, Chen MI, Chan M, Vasoo S, Wang LF, Tan BH, Lin RTP, Lee VJM, Leo YS, Lye DC; Singapore 2019 Novel Coronavirus Outbreak Research Team. Epidemiologic Features and Clinical Course of Patients Infected With SARS-CoV-2 in Singapore. JAMA. 2020 Apr 21;323(15):1488-1494. doi: 10.1001/jama.2020.3204. Erratum in: JAMA. 2020 Apr 21;323(15):1510.

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

location_country: Croatia Italy Greece Finland France


title: JuggerStitch™ for Meniscal Repair Post Market Clinical Follow-up Study

summary: This study is a post-market follow-up study. The data collected from this study will serve the purpose of confirming the safety and performance of the JuggerStitch Device used for meniscal repair according to the product labelling (Instruction For Use).

lead_sponsor: Zimmer Biomet

location_country:
Japan
Germany
United States
France

location_facility: Medizinische Fakultät der Otto-von-Guericke-Universität Magdeburg

location_facility: Ramsay General de Sante - Hôpital Privé Jean Mermoz - Centre Orthopédique Santy

location_facility: Tokyo Medical and Dental University Hospital of Medicine


title: Wright Foot & Ankle Post-Market Observational Study

summary: WRIGHT FOOT & ANKLE POST-MARKET OBSERVATIONAL STUDY, Multi-Year, Multi-Site, Multi-Device, Post-Market Observational Study, 10 sites, a minimum of 40 patients per device

ipd_sharing: Undecided

lead_sponsor: Stryker Trauma GmbH

location_country:
Germany
United States
United Kingdom
France

location_facility: Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust


title: ULTRA Study: a Feasibility, Prospective, Multicenter, Single-arm Trial of the AblaCare Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualisation in Women With Polycystic Ovary Syndrome (PCOS)

summary: The objective of this study is to provide preliminary evidence for the safety and effectiveness of the AblaCare Kit in transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome.

primary_purpose: Device Feasibility

lead_sponsor: AblaCare

location_country:
France
United Kingdom
Belgium

location_facility:
CHU Saint-Pierre
Royal Hallamshire Hospital
CU Saint-Luc
Royal Derby Hospital
Bicetre Hospital


title: Open Label, Multicenter Phase I Study of IPH4102, a Humanized Anti-KIR3DL2 Monoclonal Antibody, in Patients With Relapsed/Refractory Cutaneous T-cell Lymphomas (CTCL)

summary: The primary objective of this first in human study is to assess the safety and tolerability of increasing intravenous (IV) doses of single agent IPH4102 administered to patients with relapsed/refractory CTCL to characterize the dose limiting toxicities (DLT) and identify a Maximum Tolerated Dose (MTD).

ReferenceCitation: Bagot M, Porcu P, Marie-Cardine A, Battistella M, William BM, Vermeer M, Whittaker S, Rotolo F, Ram-Wolff C, Khodadoust MS, Bensussan A, Paturel C, Bonnafous C, Sicard H, Azim HA Jr, Kim YH. IPH4102, a first-in-class anti-KIR3DL2 monoclonal antibody, in patients with relapsed or refractory cutaneous T-cell lymphoma: an international, first-in-human, open-label, phase 1 trial. Lancet Oncol. 2019 Aug;20(8):1160-1170. doi: 10.1016/S1470-2045(19)30320-1. Epub 2019 Jun 25.

lead_sponsor: Innate Pharma

location_country:
Netherlands
United States
United Kingdom
France

location_facility:
Ohio State University
Guy's Hospital
Hôpital Saint-Louis
Leiden University Medical Center
Stanford Cancer Center


title: A 12-week, Open-label, Dose-escalating, Phase 2 Study to Evaluate the Effects of MBX-8025 in Patients With Homozygous Familial Hypercholesterolemia (HoFH)

lead_sponsor: CymaBay Therapeutics, Inc.

location_country: Norway Netherlands Canada France

location_facility: Endocrinologie metabolisme et prevention cardiovasulaire, Institut E3M et IHU cardiometabolique (ICAN), Hôpital Pitié Salpêtrière

summary: A 12-week, open-label, dose-escalating, phase 2 study to evaluate the effects of MBX-8025 in patients with Homozygous Familial Hypercholesterolemia (HoFH).


title: Study to Evaluate Physician Knowledge of Safety and Safe Use Information for Diane-35 and Its Generics in Europe: An Observational Post-Authorisation Safety Study

summary:
The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians with recent experience in prescribing Diane-35 or its generics in a total of five European countries. The primary objective of this study is to measure physician knowledge and understanding of the key information contained in the Diane-35 educational material: Patient information card, and Prescribers' Checklist.

Specifically, the following objectives will be addressed:

Investigate whether physicians have received any educational material related to Diane-35 or its generics
Assess physicians' knowledge and understanding of key safety information pertaining to the patient information card
Assess physicians' knowledge and understanding of key safety information pertaining to the following areas:
Contraindications relevant to thromboembolism
Risk factors for thromboembolism
Signs and symptoms of thromboembolism

time_perspective: Other

lead_sponsor: Bayer

location_country:
Spain
Austria
Czech Republic
France
Netherlands


title: A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing

acronym: CHRA

summary: This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral replacement.

lead_sponsor: Smith & Nephew, Inc.

location_country:
Australia
France
United Kingdom
Sweden

location_facility:
Barwon Health
Institut Nices
Danderyd Hospital
Brisbane Hand & Upper Limb Clinic
Wrightington Hospital


title: A Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Biological Activity of ATYR1940 in Adult Patients With Molecularly Defined Genetic Muscular Dystrophies

summary: The purpose of this study is to assess the safety and tolerability profile of ATYR1940 in the treatment of adult participants with molecularly defined genetic muscular dystrophies

lead_sponsor: aTyr Pharma, Inc.

location_country:
Netherlands
United States
Italy
France


title: A Phase I Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma, Transformed Follicular Lymphoma, Other Non-Hodgkin's Lymphomas, Solid Tumors and Multiple Myeloma

summary: This is an open-label, multicenter, 2-part study to determine the recommended Phase 2 dose (RP2D) for GSK2816126 given twice weekly by intravenous (IV) infusion. Part 1 will be conducted in adult subjects with relapsed/refractory diffuse large B cell lymphoma (DLBCL), transformed follicular lymphoma (tFL), other Non-Hodgkin's lymphomas (NHL), solid tumors (including castrate resistant prostate cancer) and multiple myeloma (MM) to determine the safety and tolerability of GSK2816126. Expansion cohorts (Part 2) are planned to further explore clinical activity of GSK2816126 at the RP2D in subjects with Enhancer of Zeste 2 (EZH2) wild type and EZH2 mutant positive germinal center B-cell like diffuse large B cell lymphoma (GCB-DLBCL), tFL and MM.

ReferenceCitation: Yap TA, Winter JN, Giulino-Roth L, Longley J, Lopez J, Michot JM, Leonard JP, Ribrag V, McCabe MT, Creasy CL, Stern M, Pene Dumitrescu T, Wang X, Frey S, Carver J, Horner T, Oh C, Khaled A, Dhar A, Johnson PWM. Phase I Study of the Novel Enhancer of Zeste Homolog 2 (EZH2) Inhibitor GSK2816126 in Patients with Advanced Hematologic and Solid Tumors. Clin Cancer Res. 2019 Dec 15;25(24):7331-7339. doi: 10.1158/1078-0432.CCR-18-4121. Epub 2019 Aug 30.

lead_sponsor: GlaxoSmithKline

location_country:
United States
United Kingdom
France


title: A Phase Ib Open Label Dose Finding Study of BYL719 in Combination With Paclitaxel in Advanced Solid Tumors Followed by Two Expansion Phases in Locally Advanced/Metastatic Chemotherapy Naive HER2 Negative Breast Cancer Patients (HER2- mBC) and in Recurrent and Metastatic Head-and-neck Squamous Cell Carcinoma Patients (HNSCC) Pre-treated With Platinum Based Therapy

summary: Dose escalation part:to determine the highest dose of BYL719 administered on a daily basis when given in combination with weekly paclitaxel Dose escalation part: to confirm the safety and tolerability of the BYL719 and paclitaxel combination

ReferenceCitation: Rodon J, Curigliano G, Delord JP, Harb W, Azaro A, Han Y, Wilke C, Donnet V, Sellami D, Beck T. A Phase Ib, open-label, dose-finding study of alpelisib in combination with paclitaxel in patients with advanced solid tumors. Oncotarget. 2018 Aug 3;9(60):31709-31718. doi: 10.18632/oncotarget.25854. eCollection 2018 Aug 3.

lead_sponsor: Novartis Pharmaceuticals

location_country:
United States
Italy
Spain
France

location_facility:
Highlands Oncology Group
Novartis Investigative Site
Horizon Oncology Center BioAdvance


acronym: Determination of MTD of volasertib  in paediatric patients with advanced cancer

title: Open, Non-controlled, Dose Escalating Phase I Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, Tolerability and Toxicity of Volasertib in Paediatric Patients From 2 Years to Less Than 18 Years of Age With Acute Leukaemia or Advanced Solid Tumour, for Whom no Effective Treatment is Known

lead_sponsor: Boehringer Ingelheim

location_country: Italy France Belgium Germany Czechia

location_facility:
UNIV UZ Gent
Osp. Pediatrico Bambin Gesù
Universitätsklinikum Köln (AöR)
University Hospital Motol
INS Curie

summary: The present trial will be performed according to an open design to determine the maximum tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less than 18 years. A further objective is to collect data on safety, tolerability, toxicity, efficacy (preliminary activity), pharmacokinetics and pharmacodynamics of volasertib in paediatric cancer patients


title: A Phase 1 Study of AEB071, an Oral Protein Kinase C Inhibitor, in Patients With Metastatic Uveal Melanoma

summary: This study has two parts, dose escalation and dose expansion. For dose escalation, the primary objective is to estimate the maximum tolerated dose (MTD) of AEB071 in patients with uveal melanoma. For dose expansion, the primary objective is to characterize the safety and tolerability of the MTD of AEB071 in patients with uveal melanoma.

location_facility: Dana Farber Cancer Institute DFCI - Brookline


title: Dose Escalation, Safety and Pharmacokinetic, First in Man Study, of SAR566658 Administered as a Single Agent by Intravenous Infusion in Adult Patients With CA6-Positive and Refractory Solid Tumors

summary:
Primary Objective:

To determine the maximum tolerated dose (MTD) of SAR566658

Secondary Objectives:

To characterize the safety profile of SAR566658
To evaluate the pharmacokinetic profile of SAR566658
To assess the potential immunogenicity of SAR566658
To assess preliminary antitumor activity
To assess the effect of SAR566658 at recommended dose on CYP3A enzyme activity using midazolam
To assess safety in the alternative schedules of SAR566658 administration

lead_sponsor: Sanofi

location_country:
United States
Spain
France

location_facility:
Investigational Site Number 840002
Investigational Site Number 840001
Investigational Site Number 724001
Investigational Site Number 724002
Investigational Site Number 250001


title: A Randomized, Double Blind, Placebo Controlled, 2-Way Crossover Methodology Study Designed To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing (QST) In Patients With Neuropathic Pain Treated With Pregabalin Vs Placebo

summary: Conventional pain efficacy measures such as Visual Analogue Scores (VAS) are often unable to detect treatment efficacy in small-scale clinical trials. Combining conventional pain efficacy measures with quantitative sensory testing (QST) may provide more sensitive and informative outcome measures in clinical trials.

primary_purpose: Other

lead_sponsor: Pfizer

location_country:
Austria
France
United Kingdom
Belgium


title: Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or Prostacyclines

lead_sponsor: Idorsia Pharmaceuticals Ltd.

location_country:
United States
Switzerland
France

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: University Hospital of Basel, Clinic of Pneumology

location_facility: Washington University School of Medicine


title: Vibration Response Imaging (VRI) in Patients That Are Undergoing Pulmonary Interventional Procedure

summary:
Vibration response imaging (VRI) technology, provides a radiation-free dynamic image of the lung, by visualizing vibration energy emitted during the respiration cycle (lung sounds). Airflow in the lungs during the respiration cycle creates vibrations that propagate through the lung tissue; these vibrations are affected by the structural properties of the lungs and may vary in space, time and frequency. Moreover, any structural alteration, such as a bronchial obstruction or space occupying infiltration, is reflected in a corresponding modification of the vibration response.

As obstructions that occur in airways alter airflow, the VRI may provide additional lung function information prior to treatment for airway obstruction and during follow-up. Moreover, the VRI may provide the physician immediate evaluation of the improvement of air flow distribution, quantitative and qualitative measurements. Furthermore, the VRI is a non-invasive, radiation free procedure which is simple and doesn't require the level of patient effort required for lung function test and other evaluation.

ReferenceCitation: Dellinger RP, Parrillo JE, Kushnir A, Rossi M, Kushnir I. Dynamic visualization of lung sounds with a vibration response device: a case series. Respiration. 2008;75(1):60-72. Epub 2007 Jun 4.

ReferenceCitation: Ernst A, Feller-Kopman D, Becker HD, Mehta AC. Central airway obstruction. Am J Respir Crit Care Med. 2004 Jun 15;169(12):1278-97. Review.

lead_sponsor: Deep Breeze

location_facility: National Jewish Medical and Research Center


title: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Trial Using CD133 Enriched Bone Marrow Cells Following Primary Angioplasty for Acute Myocardial Infarction

acronym: SELECT-AMI

summary: An international, multi-centre, double-blind, randomised, placebo-controlled clinical trial with central core lab analyses to determine the safety of intra-coronary infusion of enriched CD133+, bone marrow-derived, autologous progenitor cells in patients 5-10 days after acute percutaneous coronary revascularization (primary PCI) for ST-segment elevation myocardial infarction (STEMI).

lead_sponsor: Jozef Bartunek

location_country:
Netherlands
France
United Kingdom
Belgium

location_facility:
Hôpital Cardiologique
CHU ST-Pierre
OLVZ Aalst
Catharina Ziekenhuis
King's College University Hospital


title: The DESTINY Trial: a Prospective Randomized Multicenter Trial Comparing the Implant of a Drug Eluting Stent (XIENCE V, Abbott Vascular) vs. a Bare Metal Stent (MULTILINK VISION, Abbott Vascular) in the Critically Ischemic Lower Leg

acronym: DESTINY

summary: The Destiny trial compares the use of bare metal stent systems with drug eluting stent systems in the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia. It will be investigated whether there is a difference in 12 month angiographic patency of the stented area using the 2 different stent systems.

ReferenceCitation: Bosiers M, Scheinert D, Peeters P, Torsello G, Zeller T, Deloose K, Schmidt A, Tessarek J, Vinck E, Schwartz LB. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012 Feb;55(2):390-8. doi: 10.1016/j.jvs.2011.07.099. Epub 2011 Dec 14.

lead_sponsor: Flanders Medical Research Program

location_country: Germany France Belgium

location_facility:
Herzzentrum
Polyclinique Les Fleurs
AZ Sint-Blasius
Imelda Hospital
Herz-zentrum Bad Krozingen


title: Long-term Treatment of Scalp Psoriasis With Calcipotriol Plus Betamethasone Dipropionate Gel

summary:
The purpose of the trial is to study the safety and efficacy of long term use of once daily applications, as needed, of calcipotriol plus betamethasone dipropionate gel, as compared to calcipotriol alone in the same gel.

The primary response criteria will be the incidence of adverse drug reactions of any type, and the incidence of adverse events of concern associated with long-term corticosteroid use on the scalp.

lead_sponsor: LEO Pharma

location_country:
Denmark
United Kingdom
Canada
France
Germany

location_facility: Monklands Hospital, Department of Dermatology

location_facility: Hørsholm Hospital, Dermatological Department

location_facility: Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten


title: A Phase I Multicenter, Dose Escalation Study of AMN107 in Combination With Imatinib on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant Gastrointestinal Stromal Tumors (GIST)

summary: This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination.

location_country:
Germany
United States
Italy
France


title: The Nosology and Etiology of Leukodystrophies of Unknown Cause

summary:
Leukodystrophy is a disease of the white matter of the brain. White matter is the portion of the brain responsible for conducting electrical impulses from one area of the brain to the other. Insulating cells called myelin cover the brain and nerve cells in the white matter. If myelin becomes damaged electrical information cannot be transferred properly.

Many patients suffering from leukodystrophies do not fit the description of any of the defined types of leukodystrophies and are therefore considered to have a leukodystrophy of unknown cause.

The purpose of this study is to define groups of patients with leukodystrophies and to work toward finding the cause of the disorders. In order to do this, researchers will analyze patients with leukodystrophies of unknown causes. Patients will undergo clinical, neurophysiologic, biochemical, and genetic examinations and tests.

Researchers believe that by studying these patients and their disorders they will be able to better understand the causes of myelin destruction, and eventually lead to effective treatments for these disorders.

ReferenceCitation: Aicardi J. The inherited leukodystrophies: a clinical overview. J Inherit Metab Dis. 1993;16(4):733-43. Review.

ReferenceCitation: Schiffmann R, Moller JR, Trapp BD, Shih HH, Farrer RG, Katz DA, Alger JR, Parker CC, Hauer PE, Kaneski CR, et al. Childhood ataxia with diffuse central nervous system hypomyelination. Ann Neurol. 1994 Mar;35(3):331-40.

ReferenceCitation: Schiffmann R, Tedeschi G, Kinkel RP, Trapp BD, Frank JA, Kaneski CR, Brady RO, Barton NW, Nelson L, Yanovski JA. Leukodystrophy in patients with ovarian dysgenesis. Ann Neurol. 1997 May;41(5):654-61.

ReferenceCitation: McNeill N, Nasca A, Reyes A, Lemoine B, Cantarel B, Vanderver A, Schiffmann R, Ghezzi D. Functionally pathogenic EARS2 variants in vitro may not manifest a phenotype in vivo. Neurol Genet. 2017 Jul 14;3(4):e162. doi: 10.1212/NXG.0000000000000162. eCollection 2017 Aug.

lead_sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

location_country:
Netherlands
United States
Israel
France

location_facility: Institut National de la Sante' et de la Recherche Medicale

location_facility: Academiseh Ziuekenhuis Vrije Universiteit