title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis

acronym: OCTAVE

summary: The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.

ReferenceCitation: Lichtenstein GR, Bressler B, Francisconi C, Vermeire S, Lawendy N, Salese L, Sawyerr G, Shi H, Su C, Judd DT, Jones T, Loftus EV. Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):27-41. doi: 10.1093/ibd/izac084.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

ReferenceCitation: Hudesman DP, Torres J, Salese L, Woolcott JC, Mundayat R, Su C, Mosli MH, Allegretti JR. Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program. Patient. 2023 Mar;16(2):95-103. doi: 10.1007/s40271-022-00603-w. Epub 2022 Nov 7.

ReferenceCitation: Winthrop KL, Vermeire S, Long MD, Panes J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2023 Jan 5;29(1):85-96. doi: 10.1093/ibd/izac063.

ReferenceCitation: Vavricka SR, Greuter T, Cohen BL, Reinisch W, Steinwurz F, Fellmann M, Guo X, Lawendy N, Paulissen J, Peyrin-Biroulet L. Corticosteroid-free efficacy and safety outcomes in patients receiving tofacitinib in the OCTAVE Sustain maintenance study. Therap Adv Gastroenterol. 2022 May 10;15:17562848221090834. doi: 10.1177/17562848221090834. eCollection 2022.

ReferenceCitation: Mukherjee A, Tsuchiwata S, Nicholas T, Cook JA, Modesto I, Su C, D'Haens GR, Sandborn WJ. Exposure-Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies. Clin Pharmacol Ther. 2022 Jul;112(1):90-100. doi: 10.1002/cpt.2601. Epub 2022 Apr 27.

ReferenceCitation: Feagan BG, Khanna R, Sandborn WJ, Vermeire S, Reinisch W, Su C, Salese L, Fan H, Paulissen J, Woodworth DA, Niezychowski W, Sands BE. Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1442-1453. doi: 10.1111/apt.16626. Epub 2021 Oct 6.

ReferenceCitation: Farraye FA, Qazi T, Kotze PG, Moore GT, Mundayat R, Lawendy N, Sharma PP, Judd DT. The impact of body mass index on efficacy and safety in the tofacitinib OCTAVE ulcerative colitis clinical programme. Aliment Pharmacol Ther. 2021 Aug;54(4):429-440. doi: 10.1111/apt.16439. Epub 2021 Jun 24.

ReferenceCitation: Rubin DT, Reinisch W, Greuter T, Kotze PG, Pinheiro M, Mundayat R, Maller E, Fellmann M, Lawendy N, Modesto I, Vavricka SR, Lichtenstein GR. Extraintestinal manifestations at baseline, and the effect of tofacitinib, in patients with moderate to severe ulcerative colitis. Therap Adv Gastroenterol. 2021 May 16;14:17562848211005708. doi: 10.1177/17562848211005708. eCollection 2021.

ReferenceCitation: Panes J, Vermeire S, Dubinsky MC, Loftus EV, Lawendy N, Wang W, Salese L, Su C, Modesto I, Guo X, Colombel JF. Efficacy and Safety of Tofacitinib Re-treatment for Ulcerative Colitis After Treatment Interruption: Results from the OCTAVE Clinical Trials. J Crohns Colitis. 2021 Nov 8;15(11):1852-1863. doi: 10.1093/ecco-jcc/jjab065.

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2022 Mar;20(3):591-601.e8. doi: 10.1016/j.cgh.2021.02.043. Epub 2021 Mar 6.

ReferenceCitation: Vong C, Martin SW, Deng C, Xie R, Ito K, Su C, Sandborn WJ, Mukherjee A. Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis. Clin Pharmacol Drug Dev. 2021 Mar;10(3):229-240. doi: 10.1002/cpdd.899. Epub 2021 Jan 29.

ReferenceCitation: Curtis JR, Regueiro M, Yun H, Su C, DiBonaventura M, Lawendy N, Nduaka CI, Koram N, Cappelleri JC, Chan G, Modesto I, Lichtenstein GR. Tofacitinib Treatment Safety in Moderate to Severe Ulcerative Colitis: Comparison of Observational Population Cohort Data From the IBM MarketScan(R) Administrative Claims Database With Tofacitinib Trial Data. Inflamm Bowel Dis. 2021 Aug 19;27(9):1394-1408. doi: 10.1093/ibd/izaa289.

ReferenceCitation: Colombel JF, Osterman MT, Thorpe AJ, Salese L, Nduaka CI, Zhang H, Lawendy N, Friedman GS, Quirk D, Su C, Reinisch W. Maintenance of Remission With Tofacitinib Therapy in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Jan;20(1):116-125.e5. doi: 10.1016/j.cgh.2020.10.004. Epub 2020 Oct 9.

ReferenceCitation: Sands BE, Colombel JF, Ha C, Farnier M, Armuzzi A, Quirk D, Friedman GS, Kwok K, Salese L, Su C, Taub PR. Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management. Inflamm Bowel Dis. 2021 May 17;27(6):797-808. doi: 10.1093/ibd/izaa227.

repositories_institution: California Digital Library - eScholarship

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:

repository_institution: Newcastle Univesity - Newcastle University ePrints

repositories_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Lichtenstein GR, Rogler G, Ciorba MA, Su C, Chan G, Pedersen RD, Lawendy N, Quirk D, Nduaka CI, Thorpe AJ, Panes J. Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2021 May 17;27(6):816-825. doi: 10.1093/ibd/izaa199.

repository_institution: Washington University School of Medicine - Digital Commons@Becker

ReferenceCitation: Sandborn WJ, Panes J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.

ReferenceCitation: Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.

ReferenceCitation: Sandborn WJ, Panes J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.

ReferenceCitation: Winthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.

repositories:
LIRIAS (KU Leuven)
PubMed Central
pdfs.semanticscholar.org

repositories_concat: LIRIAS (KU Leuven);PubMed Central;pdfs.semanticscholar.org

ReferenceCitation: Motoya S, Watanabe M, Kim HJ, Kim YH, Han DS, Yuasa H, Tabira J, Isogawa N, Arai S, Kawaguchi I, Hibi T. Tofacitinib induction and maintenance therapy in East Asian patients with active ulcerative colitis: subgroup analyses from three phase 3 multinational studies. Intest Res. 2018 Apr;16(2):233-245. doi: 10.5217/ir.2018.16.2.233. Epub 2018 Apr 30. Erratum In: Intest Res. 2018 Jul;16(3):499-501.

publisher_dissemination: Korean Association for the Study of Intestinal Diseases

ReferenceCitation: Panes J, Vermeire S, Lindsay JO, Sands BE, Su C, Friedman G, Zhang H, Yarlas A, Bayliss M, Maher S, Cappelleri JC, Bushmakin AG, Rubin DT. Tofacitinib in Patients with Ulcerative Colitis: Health-Related Quality of Life in Phase 3 Randomised Controlled Induction and Maintenance Studies. J Crohns Colitis. 2018 Jan 24;12(2):145-156. doi: 10.1093/ecco-jcc/jjx133. Erratum In: J Crohns Colitis. 2019 Jan 1;13(1):139-140.

ReferenceCitation: Sandborn WJ, Su C, Sands BE, D'Haens GR, Vermeire S, Schreiber S, Danese S, Feagan BG, Reinisch W, Niezychowski W, Friedman G, Lawendy N, Yu D, Woodworth D, Mukherjee A, Zhang H, Healey P, Panes J; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2017 May 4;376(18):1723-1736. doi: 10.1056/NEJMoa1606910.

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Japan
Croatia
Canada
Serbia
France
Czech Republic
Colombia
Slovakia
Hungary
Denmark
United States
Latvia
Ukraine
Romania
Belgium
Estonia
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet Gasztroenterologiai Tanszek

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Bekes Megyei Pandy Kalman Korhaz III. Gasztroenterologiai Osztaly

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

location_facility: Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III

location_facility: University of Alberta - Zeidler Ledcor Centre

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,

location_facility: Regional Gastroenterology Associates of Lancaster, Ltd.

location_facility: Baylor College of Medicine (Baylor Medical Center)

location_facility: North Florida Gastroenterology Research, LLC

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: X-Ray Department, Clinic Linezers (radiology only)

location_facility: ECG Unit of West Tallinn Central Hospital

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: Hopital Saint Antoine - Service de Gastroenterologie

location_facility: Addenbrooke's Hospital-Cambridge University Hospitals NHS Foundation Trust

location_facility: Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology

location_facility: Oddzial Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital

location_facility: X- Ray Department of West Tallinn Central Hospital

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: East Ann Arbor Health and Geriatrics Center - UMHS

location_facility: Non-State Healthcare Institution "Road Clinical Hospital at the station Samara"

location_facility: Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology

location_facility: X-Ray Department of West Tallinn Central Hospital

location_facility: Limited Liability Company Medical Company "Hepatolog"

location_facility: Samara Diagnostic center, X-ray Department

location_facility: X-Ray Unit, East Tallinn Central Hospital

location_facility: McGovern Medical School -The University of Texas Health Science Center at Houston

location_facility: Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. Sz. Belgyogyaszati Klinika

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: ECG Unit, Innomedica OU and Qualitas AS (ECG Only)

location_facility: Hospital de Clinicas de Porto Alegre - HCPA

location_facility: Hospital Universitari de Bellvitge, Servicio de Digestivo

location_facility: VCU Health System Digestive Health Center

location_facility: SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,

location_facility: Spitalul Universitar de Urgenta Bucharest

location_facility: Federal state Institution "Sibirian regional Medical centre of Federal Medicobiologic Agency",

location_facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"

location_facility: Connecticut Clinical Research Foundation

location_facility: The Hospital of Hyogo College of Medicine

location_facility: National Hospital Organization Mito Medical Center

location_facility: NYU Langone Nassau Gastroenterology Associates

location_facility: The North West London Hospitals NHS Trust

location_facility: Federal State Budgetary Institution "Scientific Research Institute of Physiology and Fundamental

location_facility: Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2,

location_facility: University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre

location_facility: Hopital Saint Louis - Service d'hepato-gastoenterologie

location_facility: Professional Quality Research, Inc.- Austin Gastroenterology PA

location_facility: Nemocnice Strakonice, a.s., Interni oddeleni

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: ECG room Clinic Linezers (ECG only) Riga East University Hospital

location_facility: Cotton-O'Neal Clinical Research Center Digestive Health

location_facility: Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.

location_facility: Saint Joseph Mercy Hospital - Inpatient Pharmacy

location_facility: Municipal Budget Institution of Healthcare of Novosibirsk " City Clinical Hospital No 12"

location_facility: Baylor College of Medicine - Baylor Medical Center (Drug Storage)

location_facility: Peterfy Sandor Utcai Korhaz Rendelointezet es Baleseti Kozpont

location_facility: Federal state budget institution "State scientific centre of coloproctology"

location_facility: Medical Science Research Building 1 - UMHS

location_facility: Internal Medicine Center of Crimean Republic Institution"Clinical Territorial Medical Community"

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine

location_facility: Carolina Research, Carolina Digestive Diseases

location_facility: Cabinet Particular Policlinic Algomed Srl

location_facility: Regional Municipal Institution Chernivtsi Regional Clinical Hospital,

location_facility: Municipal Institution "Odesa Regional Clinical Hospital"

location_facility: Department of Gastroenterology, Old Building

location_facility: State Institution "National L.T. Malaya Therapy Institute of National Academy of

location_facility: Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,

location_facility: UCSD Health System - Investigational Drug Pharmacy - Moores Cancer Center

location_facility: Municipal Institution "City Hospital #7", Zaporizhzhia State Medical University

location_facility: Chris Hani Baragwanath Academic Hospital

location_facility: The Private Practice of Simon Lichtiger, MD

location_facility: Shiga University of Medical Science Hospital

location_facility: Citrus Surgery & Endoscopy Center (colonoscopy)

location_facility: Municipal Institution of Healthcare City Clinical Hospital 12,

location_facility: Saint Joseph Mercy Hospital Outpatient Laboratory

location_facility: AOU Mater Domini - U.O. Fisiopatologia Digestiva

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: National Hospital Organization Sendai Medical Center

location_facility: University Medical Center Groningen (UMCG)

location_facility: Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych, Szpital Uniwersytecki nr 2 im

location_facility: Houston Hospital for Specialized Surgery (Endoscopy only)

location_facility: London Health Sciences Centre - University Hospital

location_facility: East Tallinn Central Hospital Internal Medical Clinic

location_facility: Klinika Chorob Wewnetrznych i Gastroenterologii z

location_facility: Kyiv Municipal Clinical Hospital #18, Proctology Department

location_facility: Springhill Memorial Hospital (Endoscopy Only)

location_facility: SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI "Uzhgorod Nat.

location_facility: UZ Leuven (University Hospital Leuven), Campus Gasthuisberg

location_facility: Clinical Centre of Vojvodina, Emergency Internal Medicine Division

location_facility: State Budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.

location_facility: Minicipal Institution City Hospital 7, Therapevtic Department,

location_facility: State Budget Educational Institution of Higher Professional Education

location_facility: Dr Rethy Pal Korhaz-Rendelointezet, III Belgyogyaszat

location_facility: State Institution "Institute of Gastroenterology of the National Academy of Medical Sciences of

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital

location_facility: State budget institution of healthcare of Yaroslavl region Regional clinical hospital


title: Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer

acronym: LAPC

summary: The purpose of this study is to determine whether patients with locally advanced pancreatic cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
France
Germany
Ireland
Italy
Poland
Hungary
United Kingdom
Romania
Australia
Austria
Belgium
United States
Canada
Russian Federation
Czech Republic

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis on Background of Cyclophosphamide or Rituximab Treatment

summary: The aim of this trial is to optimize the treatment to induce remission for patients with non-life-threatening anti-neutrophil cytoplasmic antibody vasculitis (AAV). The intent is to reduce the toxicity of induction therapy by reducing the overall exposure to or eliminating entirely the use of systemic corticosteroids during the induction period with an inhibitor of the complement C5a receptor plus cyclophosphamide or rituximab.

ReferenceType: derived

ReferenceCitation: Cravedi P, Leventhal J, Lakhani P, Ward SC, Donovan MJ, Heeger PS. Immune cell-derived C3a and C5a costimulate human T cell alloimmunity. Am J Transplant. 2013 Oct;13(10):2530-9. doi: 10.1111/ajt.12405. Epub 2013 Sep 6.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Elsevier

lead_sponsor: ChemoCentryx

location_country:
Germany
Poland
Hungary
United Kingdom
Sweden
Netherlands
Austria
Belgium
Czechia
France


type: Other Identifier

title: A Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)

summary: This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of MABT5102A in patients with mild to moderate Alzheimer's Disease.

study_start_date_type: Actual

ReferenceCitation: Yoshida K, Moein A, Bittner T, Ostrowitzki S, Lin H, Honigberg L, Jin JY, Quartino A. Pharmacokinetics and pharmacodynamic effect of crenezumab on plasma and cerebrospinal fluid beta-amyloid in patients with mild-to-moderate Alzheimer's disease. Alzheimers Res Ther. 2020 Jan 22;12(1):16. doi: 10.1186/s13195-020-0580-2.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

lead_sponsor: Genentech, Inc.

location_country:
Germany
United Kingdom
United States
Spain
Canada
France

location_facility: Camden Mews Day Hospital; Camden and Islington

location_facility: Universitätsklinik Tübingen; Psychiatrie und Psychotherapie

location_facility: Villa Sauer, Praxis für; Neurologie und Psychiatrie

location_facility: Clinica Ruber, 4 planta; Servicio de Neurologia

location_facility: IU Healthy Partners Adult Neurology Clinic

location_facility: University of California Davis Medical System

location_facility: Toronto Memory Program (Neurology Research Inc.)

location_facility: Hospital Universitario Virgen de la Macarena;

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: Providence Care Centre; Mental Health Site

location_facility: Miami Jewish Health Systems; Clinical Research

location_facility: University of Rochester Medical Center; Monroe Community Hospital

location_facility: CHU de Rouen Hopital; Service de Neurologie

location_facility: University of British Columbia Hospital; Division of Neurology

location_facility: Hopital Hautepierre; Centre dInvestigation Clinique

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Royal Sussex County Hospital, CIRU Level 5

location_facility: The National Hospital for Neurology & Neurosurgery; Dementia Research Center

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Moorgreen Hospital; Memory Assessment & Rsch Ctr

location_facility: Studienambulanz emovis GmbH; St. Joseph Krankenhaus

location_facility: Univ Berlin; Klin fur Psychi & Psycho Charite

location_facility: Univ of CA San Diego; Neurosciences Comp.Alzheimer's

location_facility: Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine

location_facility: West London Research Unit; Brentford Lodge

location_facility: Great Western Hosp.; Kingshill Research Ctr

location_facility: Florida Atlantic University; College of Medicine

location_facility: McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric

location_facility: Clinical Neuroscience Research Associates, Inc.

location_facility: Zentralinstitut fuer Seelische Gesundheit

location_facility: Investigational Drug Service; Univ of Rochester Medical Ctr


type: EudraCT Number

title: A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Dacarbazine in Subjects With Soft Tissue Sarcoma

summary: This is a randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin with dacarbazine in subjects with advanced soft tissue sarcoma who have disease progression within 6 months prior to study enrolment following standard therapies which must have included an anthracycline, unless contraindicated and then at least one additional regimen after failure of the anthracycline.

ReferenceCitation: Schoffski P, Chawla S, Maki RG, Italiano A, Gelderblom H, Choy E, Grignani G, Camargo V, Bauer S, Rha SY, Blay JY, Hohenberger P, D'Adamo D, Guo M, Chmielowski B, Le Cesne A, Demetri GD, Patel SR. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016 Apr 16;387(10028):1629-37. doi: 10.1016/S0140-6736(15)01283-0. Epub 2016 Feb 10.

repositories_concat: LIRIAS (KU Leuven)

lead_sponsor: Eisai Inc.

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Thailand
Czechia
Canada
France
Denmark
United States
Romania
Belgium
Italy
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
Russian Federation
Israel


title: A Phase III, Randomized, Double-blind, Placebo-controlled, Parallel Group Safety and Efficacy Study of BI 10773 (10 mg and 25 mg Administered Orally Once Daily) During 52 Weeks in Patients With Type 2 Diabetes Mellitus and Insufficient Glycemic Control on MDI Insulin Regimen Alone or With Metformin

summary: This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.

ReferenceCitation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

oa_colors: green other

evidence: open (via free pdf)

evidence: oa repository (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

version: submittedVersion

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: University of Illinois at Chicago - INDIGO

repositories_institution: University College London - UCL Discovery

repositories_institution: University of Illinois at Chicago - INDIGO

unpaywall_oa_status: bronze

publisher_dissemination: American Diabetes Association

ReferenceCitation: Rosenstock J, Jelaska A, Frappin G, Salsali A, Kim G, Woerle HJ, Broedl UC; EMPA-REG MDI Trial Investigators. Improved glucose control with weight loss, lower insulin doses, and no increased hypoglycemia with empagliflozin added to titrated multiple daily injections of insulin in obese inadequately controlled type 2 diabetes. Diabetes Care. 2014 Jul;37(7):1815-23. doi: 10.2337/dc13-3055. Epub 2014 Jun 14.

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: closed

unpaywall_oa_status: hybrid

lead_sponsor: Boehringer Ingelheim

sponsor_collaborators:
Boehringer Ingelheim
Eli Lilly and Company

location_country:
Finland
France
Germany
Colombia
Guatemala
Mexico
Belgium
United States
Spain
Peru
Bulgaria
Ukraine
Russian Federation
Czech Republic

location_facility: 1245.49.52006 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10006 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.42010 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.75014 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10024 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33008 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.42012 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.49002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.57003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34043 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10019 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.75013 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.42011 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.49005 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10023 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.59001 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10011 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.51001 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.57005 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.51006 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33004 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.50204 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10013 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52009 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.50202 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34016 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10004 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.51009 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52001 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10001 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52011 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33012 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.70009 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10020 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10009 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10016 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10025 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33007 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10015 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.49101 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10026 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10032 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.75015 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52008 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34047 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.32012 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.42013 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.32010 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.32013 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.51002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.72003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.57006 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34041 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.70008 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.57004 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.50203 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34039 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.70010 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52012 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10005 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34045 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.51008 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34038 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.49013 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.32014 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.42009 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.32002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.50205 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.59003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.49104 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.72002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52010 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33009 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.75007 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10030 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.72001 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.75016 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.51010 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10022 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10007 Boehringer Ingelheim Investigational Site

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location_facility: 1245.49.49102 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.42003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33011 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.59004 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.34044 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10033 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33001 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.50201 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52004 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10021 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52005 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.70006 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.52003 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.57002 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.33010 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.32007 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10031 Boehringer Ingelheim Investigational Site

location_facility: 1245.49.10014 Boehringer Ingelheim Investigational Site


title: A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease

summary: This is a randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A as compared to placebo over 12 weeks in adult subjects with moderately-to-severely active Crohn's disease. Efficacy will be assessed by proportion of subjects achieving response, defined as a decrease in Crohn's Disease Activity Index (CDAI) score of at least 100 points (clinical response). Clinical remission (CDAI score less than 150 points) will be evaluated as a key secondary endpoint. Safety will be assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram (ECG). Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form-36 version 2 (SF-36v2), EQ-5D and Work Productivity and Activity Impairment-CD (WPAI-CD) and receipt of disability.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Poland
New Zealand
Australia
Japan
Czechia
Canada
France
Slovakia
Hungary
Denmark
United States
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Israel


title: A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance, Safety, and Tolerability of SAR110894D at the Doses of 0.5 mg, 2 mg, and 5 mg/Day for 24 Weeks in Patients With Mild to Moderate Alzheimer's Disease on Stable Donepezil Therapy

summary:
Primary Objective:

- To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) in comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's disease (AD) while on stable donepezil therapy

Secondary Objectives:

To explore the effect of SAR110894 on functional impairment, global clinical status and behavioral disturbances;
To assess the safety/tolerability of SAR110894;
To assess pharmacokinetic (PK) of SAR110894 and concentrations of donepezil;
To explore caregiver time consumption and distress changes.

ReferenceCitation: McCleery J, Sharpley AL. Pharmacotherapies for sleep disturbances in dementia. Cochrane Database Syst Rev. 2020 Nov 15;11(11):CD009178. doi: 10.1002/14651858.CD009178.pub4.

publisher_dissemination: Wiley

ReferenceCitation: Leger D, Elbaz M, Dubois A, Rio S, Mezghiche H, Carita P, Stemmelin J, Strauss M. Alzheimer's Disease Severity is Not Significantly Associated with Short Sleep: Survey by Actigraphy on 208 Mild and Moderate Alzheimer's Disease Patients. J Alzheimers Dis. 2017;55(1):321-331. doi: 10.3233/JAD-160754.

oa_host_type: closed

publisher_dissemination: IOS Press

lead_sponsor: Sanofi

location_country:
Germany
Italy
Poland
Portugal
Australia
United States
Spain
Canada
France

location_facility:
Investigational Site Number 840012
Investigational Site Number 250008
Investigational Site Number 036005
Investigational Site Number 036002
Investigational Site Number 380003
Investigational Site Number 724008
Investigational Site Number 124006
Investigational Site Number 840003
Investigational Site Number 724001
Investigational Site Number 250009
Investigational Site Number 840038
Investigational Site Number 840018
Investigational Site Number 124013
Investigational Site Number 616003
Investigational Site Number 840013
Investigational Site Number 250007
Investigational Site Number 250002
Investigational Site Number 036008
Investigational Site Number 840002
Investigational Site Number 840001
Investigational Site Number 840037
Investigational Site Number 840014
Investigational Site Number 724007
Investigational Site Number 840039
Investigational Site Number 840025
Investigational Site Number 840040
Investigational Site Number 036003
Investigational Site Number 124002
Investigational Site Number 616006
Investigational Site Number 276008
Investigational Site Number 124003
Investigational Site Number 616002
Investigational Site Number 724003
Investigational Site Number 840024
Investigational Site Number 380006
Investigational Site Number 840021
Investigational Site Number 840041
Investigational Site Number 124010
Investigational Site Number 124004
Investigational Site Number 620001
Investigational Site Number 840026
Investigational Site Number 840009
Investigational Site Number 250004
Investigational Site Number 840030
Investigational Site Number 840032
Investigational Site Number 620002
Investigational Site Number 036009
Investigational Site Number 250005
Investigational Site Number 124014
Investigational Site Number 036004
Investigational Site Number 124008
Investigational Site Number 840006
Investigational Site Number 276007
Investigational Site Number 616005
Investigational Site Number 276001
Investigational Site Number 276011
Investigational Site Number 036001
Investigational Site Number 840008
Investigational Site Number 124011
Investigational Site Number 250003
Investigational Site Number 380005
Investigational Site Number 124015
Investigational Site Number 840004
Investigational Site Number 276009
Investigational Site Number 724002
Investigational Site Number 124009
Investigational Site Number 616004
Investigational Site Number 250006
Investigational Site Number 616001
Investigational Site Number 276012
Investigational Site Number 840034
Investigational Site Number 250001
Investigational Site Number 036006
Investigational Site Number 124001
Investigational Site Number 380001
Investigational Site Number 380004
Investigational Site Number 840031
Investigational Site Number 036007
Investigational Site Number 380002
Investigational Site Number 840011
Investigational Site Number 840005
Investigational Site Number 840015


title: A Phase 3 Randomized, Open Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors to Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) Fixed-dose Regimen in Virologically Suppressed, HIV-1 Infected Patients

summary:
The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment option to patients who wish to simplify dosing by reducing pill burden or to improve the tolerability of their treatment.

Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which participants will switch treatment regimens at the start of the study, and the Stay on Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their baseline regimen during the first 24 weeks of the study (designed to provide an initial active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit.

After the 48-week study analysis period, participants may continue to receive the FTC/RPV/TDF STR per protocol before switching to a commercially available source.

lead_sponsor: Gilead Sciences

location_country:
Germany
Italy
United Kingdom
Austria
Belgium
United States
Spain
Canada
Puerto Rico
France

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: 2.Interne Lungenabteilung Otto Wagner Spital

location_facility: Center for HIV and Hepatogastroenterology

location_facility: Department of Infectious Diseases, Saint-Louis hospital

location_facility: AIDS Healthcare Foundation-Research Center

location_facility: University of South Florida - HIV Clinical Research Unit

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Azienda Ospedaliera San Paolo, Mallattie Infettive e Tropicali

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: University of Bonn, Dep. of Internal Medicine I, HIV-Outpatient Clinic

location_facility: Infectious Disease Specialists of Atlanta (IDSA)

location_facility: National Institute for Infectious Diseases "L. Spallanzani" IRCCS

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Tarrant County Infectious Diseases Associates

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: Infectiologie - 7ème Ouest - CHU HOTEL DIEU

location_facility: Clinical Alliance for Research & Education-Infectious Diseases, LLC (CARE-ID)

location_facility: Hôpital Saint Antoine, Servuce de Maladies Infectieuses

location_facility: University of Cologne, Department of Internal Medicine

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive

location_facility: Downtown Infectious Disease Clinic - Univ of BC

location_facility: University Medical Center Hamburg - Eppendorf

location_facility: La Playa Medical Group and Clinical Research

location_facility: Johns Hopkins University School of Medicine

location_facility: Chelsea and Westminster Hospital Foundation Trust

location_facility: Archet 1 CHU de Nice - 6ème Niveau - Infectiology

location_facility: Dept. of Dermatology, Div. of Immunology,


title: AXITINIB IN ADVANCED / METASTATIC RENAL CELL CARCINOMA - A NON-INTERVENTIONAL STUDY OF REAL WORLD TREATMENT OUTCOMES IN PATIENTS RECEIVING 2ND LINE AXITINIB AFTER 1ST LINE SUNITINIB (ADONIS)

acronym: ADONIS

summary: This is an international, multi-centre, prospective (partly retrospective), observational study to evaluate treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated with sunitinib in first line and/or receiving axitinib in second line post sunitinib. The study is designed to enroll approximately 750 patients over the course of an enrollment period of approximately 36 months.

study_type: Observational

time_perspective: Other

ipd_sharing: No

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Italy
United Kingdom
Netherlands
Austria
Belgium
Spain
Greece
France

location_facility: Hopital de Hautepierre-Service Oncologie at Hematologie

location_facility: Centre Hospitalier De Bourg En Bresse - Hopital Fleyriat

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: C.H.G. Antoine Gayraud, Medecine Interne

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Krankenhaus der Barmherzigen Schwestern Linz Abteilung fuer Urologie

location_facility: Institut Sainte Catherine, Department Oncologie, Medecine Interene

location_facility: Istituto Nazionale Tumori, Oncologia Medica B

location_facility: AKH - Universitaetsklinik fuer Innere Medizin I

location_facility: Cl Armoricaine Radiologie / Radiotherapie

location_facility: Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta

location_facility: AKH-Universitat Klinik fur Innere Medizin I

location_facility: Istituto per lo Studio e la Cura dei Tumori Fondazione Pascale

location_facility: Royal Marsden Hospital, Royal Marsden NHS Foundation Trust

location_facility: Algemeen Ziekenhuis Sint-Lucas, Dienst Oncologie

location_facility: Hospital General Universitario de Alicante

location_facility: Centro Sanitario Hospital Universitario y Politecnico La Fe

location_facility: Hopital Jean BERNARD - Tours - 7eme etage

location_facility: General Hospital of Chest Diseases of Athens "Sotiria"

location_facility: Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera

location_facility: H. U. de Vigo- Hospital Álvaro Cunqueiro/Servicio de Oncologia Medica

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centre d'Oncologie et de Radiotherapie du pays Basque

location_facility: Divisione di Oncologia Medica, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Divisione di Oncologia, AORN Antonio Cardarelli

location_facility: Groupe Hospitalier Intercommunal le Raincy Montfermeil

location_facility: Universitasklinik für Urologie und Andrologie

location_facility: Centre Rene Gauducheau - Service Oncologie Medicale

location_facility: Centre Antoine Lacassagne, Service d'Oncologie

location_facility: Centre Hospitalier Lyon Sud - Service d oncologie medicale

intervention_type: Other


title: A Randomized, Open-Label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

summary: The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.

ReferenceCitation: Sarrazin C, Dierynck I, Cloherty G, Ghys A, Janssen K, Luo D, Witek J, Buti M, Picchio G, De Meyer S. An OPTIMIZE study retrospective analysis for management of telaprevir-treated hepatitis C virus (HCV)-infected patients by use of the Abbott RealTime HCV RNA assay. J Clin Microbiol. 2015 Apr;53(4):1264-9. doi: 10.1128/JCM.03030-14. Epub 2015 Feb 4.

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Buti M, Agarwal K, Horsmans Y, Sievert W, Janczewska E, Zeuzem S, Nyberg L, Brown RS Jr, Hezode C, Rizzetto M, Parana R, De Meyer S, De Masi R, Luo D, Bertelsen K, Witek J. Telaprevir twice daily is noninferior to telaprevir every 8 hours for patients with chronic hepatitis C. Gastroenterology. 2014 Mar;146(3):744-753.e3. doi: 10.1053/j.gastro.2013.11.047. Epub 2013 Dec 4.

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

lead_sponsor: Janssen Infectious Diseases BVBA

sponsor_collaborators:
Janssen Infectious Diseases BVBA
Vertex Pharmaceuticals Incorporated

location_country:
Germany
Ireland
Poland
United Kingdom
Australia
Brazil
Sweden
Austria
Belgium
Mexico
United States
Spain
France


title: A Placebo Controlled, Multicenter, Randomized Double Blind Trial to Evaluate the Safety and Effectiveness of IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction

summary: The primary objective is to evaluate the safety and effectiveness of the IK-5001 device for the prevention of ventricular remodeling and congestive heart failure when administered to subjects who had successful percutaneous coronary intervention with stent placement after ST segment elevation MI (STEMI).

primary_purpose: Prevention

ReferenceCitation: Wei X, Chen S, Xie T, Chen H, Jin X, Yang J, Sahar S, Huang H, Zhu S, Liu N, Yu C, Zhu P, Wang W, Zhang W. An MMP-degradable and conductive hydrogel to stabilize HIF-1alpha for recovering cardiac functions. Theranostics. 2022 Jan 1;12(1):127-142. doi: 10.7150/thno.63481. eCollection 2022.

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: Ivyspring International Publisher

ReferenceCitation: Rao SV, Zeymer U, Douglas PS, Al-Khalidi H, White JA, Liu J, Levy H, Guetta V, Gibson CM, Tanguay JF, Vermeersch P, Roncalli J, Kasprzak JD, Henry TD, Frey N, Kracoff O, Traverse JH, Chew DP, Lopez-Sendon J, Heyrman R, Krucoff MW. Bioabsorbable Intracoronary Matrix for Prevention of Ventricular Remodeling After Myocardial Infarction. J Am Coll Cardiol. 2016 Aug 16;68(7):715-23. doi: 10.1016/j.jacc.2016.05.053.

ReferenceCitation: Frey N, Linke A, Suselbeck T, Muller-Ehmsen J, Vermeersch P, Schoors D, Rosenberg M, Bea F, Tuvia S, Leor J. Intracoronary delivery of injectable bioabsorbable scaffold (IK-5001) to treat left ventricular remodeling after ST-elevation myocardial infarction: a first-in-man study. Circ Cardiovasc Interv. 2014 Dec;7(6):806-12. doi: 10.1161/CIRCINTERVENTIONS.114.001478. Epub 2014 Oct 28.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Bellerophon BCM LLC

location_country:
Germany
Poland
Israel
Australia
Belgium
United States
Spain
Canada
France

location_facility: I Klinika Kardiologii i Elektrokardiologii lnterwencyjnej oraz Nadcisnienia Tetniczego CM UJ

location_facility: Royal Perth Hospital - Dept. of Cardiology

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM w Szczecinie

location_facility: Vivantes Netzwerk fur Gesundheit GmbH, Kinikum Neukolln

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Queen Elizabeth II Health Science Centre

location_facility: Hospital Clinico de Santiago de Compostela

location_facility: Samodzileny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Klinik fur Kardiologie and Angiologie Universitatsklinikum

location_facility: Montefiore Medical Center Weiler Division

location_facility: Carl and Edyth Lindner Center for Research and Education @ Christ Hospital

location_facility: Centrum Interwencyjnego Leczenia Chorob Serca i Naczyn z Pododdzialem Kardiologii Interwencyjnej

location_facility: Hadassah University Medical Center Jerusalem-Cardiology

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: Universitatsklinikum Jena, Klinik fur Innere Medizin, Kardiologie

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Centre Hospitalier Universitaire de Nice Hopital Pasteur

location_facility: Stadtische Kliniken Neuss - Lukaskrankenhaus

location_facility: Oddzial Kardiologiczny Wojewodzki Specjalistyczny Szpital im. Bieganskiego w Lodzi

location_facility: Krankenhaus Barmherzige Brüder Abt.Kardiologie und Pneumologie

intervention_type: Device


acronym: PACE

lead_sponsor: Ariad Pharmaceuticals

summary: The purpose of this study is to determine the efficacy of ponatinib in patients with chronic myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or intolerant to either dasatinib or nilotinib, or have the (T)hreonine-315-(I)soleucine (T315I) mutation.

ReferenceType: result

ReferenceCitation: Cortes JE, Kim DW, Pinilla-Ibarz J, le Coutre PD, Paquette R, Chuah C, Nicolini FE, Apperley JF, Khoury HJ, Talpaz M, DeAngelo DJ, Abruzzese E, Rea D, Baccarani M, Muller MC, Gambacorti-Passerini C, Lustgarten S, Rivera VM, Haluska FG, Guilhot F, Deininger MW, Hochhaus A, Hughes TP, Shah NP, Kantarjian HM. Ponatinib efficacy and safety in Philadelphia chromosome-positive leukemia: final 5-year results of the phase 2 PACE trial. Blood. 2018 Jul 26;132(4):393-404. doi: 10.1182/blood-2016-09-739086. Epub 2018 Mar 22.

evidence: open (via free article)

repository_institution: Imperial College London - Spiral

repositories_concat: PubMed Central;spiral.imperial.ac.uk

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

publisher_dissemination: American Society of Hematology

ReferenceCitation: Januzzi JL, Garasic JM, Kasner SE, McDonald V, Petrie MC, Seltzer J, Mauro M, Croce K, Berman E, Deininger M, Hochhaus A, Pinilla-Ibarz J, Nicolini F, Kim DW, DeAngelo DJ, Kantarjian H, Xu J, Hall T, Srivastava S, Naranjo D, Cortes J. Retrospective analysis of arterial occlusive events in the PACE trial by an independent adjudication committee. J Hematol Oncol. 2022 Jan 6;15(1):1. doi: 10.1186/s13045-021-01221-z. Erratum In: J Hematol Oncol. 2022 Mar 23;15(1):33.

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_concat: PubMed Central;eprints.gla.ac.uk

ReferenceCitation: Cortes JE, Kim DW, Pinilla-Ibarz J, le Coutre P, Paquette R, Chuah C, Nicolini FE, Apperley JF, Khoury HJ, Talpaz M, DiPersio J, DeAngelo DJ, Abruzzese E, Rea D, Baccarani M, Muller MC, Gambacorti-Passerini C, Wong S, Lustgarten S, Rivera VM, Clackson T, Turner CD, Haluska FG, Guilhot F, Deininger MW, Hochhaus A, Hughes T, Goldman JM, Shah NP, Kantarjian H; PACE Investigators. A phase 2 trial of ponatinib in Philadelphia chromosome-positive leukemias. N Engl J Med. 2013 Nov 7;369(19):1783-96. doi: 10.1056/NEJMoa1306494. Epub 2013 Nov 1.

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;escholarship.org

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: O'Hare T, Zabriskie MS, Eiring AM, Deininger MW. Pushing the limits of targeted therapy in chronic myeloid leukaemia. Nat Rev Cancer. 2012 Jul 24;12(8):513-26. doi: 10.1038/nrc3317. Erratum In: Nat Rev Cancer. 2012 Dec;12(12):886.

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

title: A Pivotal Phase 2 Trial of Ponatinib (AP24534) in Patients With Refractory Chronic Myeloid Leukemia and Ph+ Acute Lymphoblastic Leukemia

source: euctr

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.

design_allocation: Non-Randomized

location_country:
Germany
Italy
United Kingdom
Singapore
Australia
Sweden
Netherlands
Belgium
Korea, Republic of
Spain
France

ipd_sharing: Yes


intervention_type: Biological

acronym: FLU D-QIV-003

summary: This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to describe safety and immunogenicity of the GSK Biologicals' investigational vaccine GSK2321138A in children aged 6 to 35 months.

ReferenceCitation: Domachowske JB, Pankow-Culot H, Bautista M, Feng Y, Claeys C, Peeters M, Innis BL, Jain V. A randomized trial of candidate inactivated quadrivalent influenza vaccine versus trivalent influenza vaccines in children aged 3-17 years. J Infect Dis. 2013 Jun 15;207(12):1878-87. doi: 10.1093/infdis/jit091. Epub 2013 Mar 7.

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Oxford University Press

title: Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2321138A When Administered in Children

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:
Germany
United States
Czechia
Philippines
France


title: A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR)

acronym: VALOR

summary: This study compared treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine.

ReferenceCitation: Ravandi F, Ritchie EK, Sayar H, Lancet JE, Craig MD, Vey N, Strickland SA, Schiller GJ, Jabbour E, Erba HP, Pigneux A, Horst HA, Recher C, Klimek VM, Cortes J, Roboz GJ, Odenike O, Thomas X, Havelange V, Maertens J, Derigs HG, Heuser M, Damon L, Powell BL, Gaidano G, Carella AM, Wei A, Hogge D, Craig AR, Fox JA, Ward R, Smith JA, Acton G, Mehta C, Stuart RK, Kantarjian HM. Vosaroxin plus cytarabine versus placebo plus cytarabine in patients with first relapsed or refractory acute myeloid leukaemia (VALOR): a randomised, controlled, double-blind, multinational, phase 3 study. Lancet Oncol. 2015 Sep;16(9):1025-1036. doi: 10.1016/S1470-2045(15)00201-6. Epub 2015 Jul 30.

repositories_institution: University of California - eScholarship University of California

ipd_sharing_description: De-identified data of individual participants experiencing Serious Adverse Events

lead_sponsor: Sunesis Pharmaceuticals

location_country:
Germany
Italy
Poland
New Zealand
Hungary
United Kingdom
Australia
Austria
Belgium
United States
Korea, Republic of
Spain
Czechia
Canada
France

location_facility: Haematology Department, Gosford Hospital

location_facility: Division of Hematology, Vancouver General Hospital

location_facility: Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust

location_facility: Centro Oncologico MD Anderson International Espana

location_facility: HCA HealthONE - Rocky Mountain Blood and Marrow Transplant Program

location_facility: University Health Network, Princess Margaret Hospital

location_facility: SLK-Kliniken Heilbronn GmbH, Medizinische Klinik

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Klinikum St. Georg gGmbH; Klinik fur Internistische Onkologie/Hamatologie

location_facility: Department of Haematology, Royal Liverpool University Hospital

location_facility: The University of Texas, M.D. Anderson Cancer Center, Department of Leukemia

location_facility: Department of Clinical Haematology and BMT Service, Royal Melbourne Hospital

location_facility: AORN "A. Cardarelli", U.O.S.C. Ematologia con TMO

location_facility: Universitatsklinik Graz, Universitatsklinik fur Innere Medizin, Abteilung fur Hamatologie

location_facility: CHU Nantes Hotel Dieu, Service d'hematologie clinique

location_facility: North Shore Long Island Jewish Health System

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen lll, Medizinische Klinik

location_facility: Hospital Universitari Politecnic la Fe Hematology Department

location_facility: Universitatsklinikum Hamburg-Eppendorf; ll. Medizinische Klinik und Poliklinik; Onkologie, Hamatologie und Knochenmarktransplantation

location_facility: CHU Angers, Service des maladies du sang

location_facility: Landeskrankenhaus Salzburg, Universitaetsklinik fur innere Medizin lll, Universitaetsklinikum der PMU

location_facility: Ospedale "A. Perrino", U.O. Compessa di Ematologia

location_facility: kaposi Mor Oktato Korhaz Belgyogyaszati Osztaly

location_facility: Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

location_facility: Ospedaliera Universitaria San Martino di Genova

location_facility: University Hospital for Internal Medicine V, Innsbruck Medical University

location_facility: Fakultni nemocnice Hradec Kralove, 2. Interni klinika-oddeleni klinicke hematologie

location_facility: Azienda Ospedaliero-Universitaria Maggiore Della Carita, Struttura Complessa Direzione Universitaria Ematologia

location_facility: Staedtisches Krankenhaus Kiel GmbH, Infektionsambulanz der 2. Medizinischen Klinik

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: St. Francis Medical Group Oncology and Hematology Specialists

location_facility: CHU de Bordeaux- Hopital Haut-Leveque, Centre Francois Magendle

location_facility: Regional Cancer Treatment Service, Palmerston North Hospital

location_facility: Service d'hematologie- Hopital Purpan- CHU de Toulouse

location_facility: Klinika Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego, Szpital Kliniczny Przemiemienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: UT Southwestern Medical Center at Dallas

location_facility: AKH Wien / MedUniWien Universtatsklinik fur Innere Medizin 1

location_facility: Centre Hospitalier Lyon Sud - Service d'Hematologie - Pavillon Marcel Berard - Bat. 1G - 1er etage, 165 Chemin du grand Revoyet

location_facility: Fakultni nemocnice Kralovske Vinohrady, Oddeleni klinicke hematologie

location_facility: Ellis Fischel Cancer Center, University of Missouri Health Care

location_facility: Klinikum Frankfurt am Main-Hochst, Department of Hematology and Oncology, Klinikum Frankfurt Academic Hospital of the University of Frankfurt

location_facility: Medizinische Hochschule Hannover, Abteilung Hamatologie

location_facility: Rush University Medical Center, Division of Hematology/Oncology

location_facility: Fakultni nemocnice Brno, Interni hematoonkologicka klinika

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: University of Debrecen Medical and Health Sciences Center

location_facility: Szegedi Tudomanyegyetem, 11. Belgyogyaszati Klinika

location_facility: CHU Lille, Service des maladies du sang, Hopital Huriez

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Fondazione IRCCS, Policlinico S. Matteo - Dipartimento di Ematologia

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: New York Medical College, Division of Oncology/Hematology

location_facility: Department of Haematology, Guy's Hospital

location_facility: ZNA Stuivenberg, Lange Beeldekensstraat 267

location_facility: Department of Medicine Section of Hematology/Oncology, West Virginia University Hospitals, Mary Babb Randolph Cancer Center, West Virginia University

location_facility: UZ Leuven, campus Gasthuisberg, Department of Haematology

location_facility: Department of Haematology, University Hospital of Wales

location_facility: Haematology Research, Auckland District Health Board, Auckland City Hospital

location_facility: Azienda Ospedaliero-Universitaria Sant'Anna, Sezione di Ematologia, Dipartmento di Science Biomediche e Terapie Avanzate

location_facility: University of Iowa Hospitals and Clinics

location_facility: George Washington University-Medical Faculty Associates

location_facility: Andrew Love Cancer Center, Geelong Hospital, Barwon Health

location_facility: Central Manchester University Hospitals NHS Trust, Manchester Royal Infirmary

location_facility: Dept. of Hematology, Asan Medical Center

location_facility: Queen's Centre for Oncology and Hematology, Castle Hill Hospital

location_facility: Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital

location_facility: Hopital Avicenne- Departement Onco-hematologie

location_facility: Department of Haematology, Waikato Hospital

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital

location_facility: Leicester Royal Infirmary, University Hospitals of Leicester, NHS Trust


summary: This is a randomized, Phase II, double-blind, multicenter, placebo-controlled trial designed to preliminarily estimate the efficacy and evaluate the safety and tolerability of onartuzumab (MetMAb) + bevacizumab + paclitaxel and onartuzumab + placebo + paclitaxel versus placebo + bevacizumab + paclitaxel in participants with metastatic or locally recurrent, triple-negative breast cancer who either have not received treatment (first-line) or have progressed after one conventional cytotoxic chemotherapy regimen (second-line).

ReferenceCitation: Dieras V, Campone M, Yardley DA, Romieu G, Valero V, Isakoff SJ, Koeppen H, Wilson TR, Xiao Y, Shames DS, Mocci S, Chen M, Schmid P. Randomized, phase II, placebo-controlled trial of onartuzumab and/or bevacizumab in combination with weekly paclitaxel in patients with metastatic triple-negative breast cancer. Ann Oncol. 2015 Sep;26(9):1904-1910. doi: 10.1093/annonc/mdv263. Epub 2015 Jul 22.

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

sponsor_collaborators:
Genentech, Inc.
Hoffmann-La Roche

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Klinikum rechts der Isar der TU München; Frauenklinik

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Mount Vernon Hospital; Centre For Cancer Treatment

location_facility: Can Care Assoc Med Group Inc; Beach Cities Offices

location_facility: St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr

location_facility: The Clatterbridge Cancer Ctr For Oncolgy

location_facility: Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: Hospital Universitario Puerta del Mar; Servicio de Oncologia

location_facility: Instituto Catalán de Oncología; Servicio de Farmacia

location_facility: Centre Francois Baclesse; Gastro-Enterologie

location_facility: Sharp Healthcare; Oncology Research Program

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

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

title: A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Onartuzumab And/or Bevacizumab in Combination With Paclitaxel in Patients With Metastatic, Triple-Negative Breast Cancer

location_country:
Germany
United Kingdom
Belgium
United States
Spain
France


title: A Double-blind, Randomized, Placebo-controlled Trial Evaluating The Safety And Efficacy Of Early Treatment With Eplerenone In Patients With Acute Myocardial Infarction

acronym: REMINDER

summary: Administration of eplerenone within 24 hours of onset of symptoms of myocardial infarction, in patients without heart failure, reduces cardiovascular mortality / morbidity.

ReferenceCitation: Montalescot G, Pitt B, Lopez de Sa E, Hamm CW, Flather M, Verheugt F, Shi H, Turgonyi E, Orri M, Vincent J, Zannad F; REMINDER Investigators; REMINDER Investigators. Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: the Randomized Double-Blind Reminder Study. Eur Heart J. 2014 Sep 7;35(34):2295-302. doi: 10.1093/eurheartj/ehu164. Epub 2014 Apr 29.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Institut Pasteur

repository_normalized: HAL

repositories_concat: HAL

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Germany
Poland
Slovakia
Hungary
United Kingdom
Netherlands
Spain
Greece
Czechia
Canada
France

location_facility: Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ w Oswiecimiu G.V.M CARINT Sp. zo.o.

location_facility: Chu Rangueil Service de Cardiologie, A - Bat H1

location_facility: Staedtisches Klinikum Muenchen GmbH Klinikum Neuperlach

location_facility: Narodny ustav srdcovych a cievnych chorob, a.s.

location_facility: Nemocnice Na Homolce - kardiologicke oddeleni

location_facility: Service Cardiologie, Centre Hospitalier de Cannes

location_facility: HOSPITAL CLINICO SAN CARLOS- Universidad Complutense de Madrid

location_facility: Blackpool Victoria Hospital NHS Trust , Cardiac Research ,Lancashire Cardiac Centre

location_facility: Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Centre de Sante et de Services Sociaux de Chicoutimi (CSSSC) (Complexe Hospitalier de la Sagamie)

location_facility: Vancouver General Hospital, Vancouver Coastal Health Authority

location_facility: Josa Andras Oktato Korhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Kardiologia

location_facility: Vancouver General Hospital - Centennial Pavilion

location_facility: Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny We Wroclawiu

location_facility: Hospital Del Sas de Jerez de La Frontera

location_facility: Clinical Trials Unit, Morriston Hospital

location_facility: Hôpital Henri Mondor - Pysiologie explorations fonctionnelles

location_facility: Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleurimont

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: The Queens Medical Research Institute- University of Edinburgh

location_facility: Georg-August-Universitaet Goettingen, Zentrum f. Innere Medizin / Kardiologie u. Pneumologie

location_facility: ECOGENE-21 / Centre de sante et de services sociaux de Chicoutimi

location_facility: General Hospital of Athens "Georgios Gennimatas"

location_facility: Walter C Mackenzie Health Sciences Centre (WCM)

location_facility: I.Interni klinika-kardiologie FN Olomouc

location_facility: Service Cardiologie Hopital Robert Boulin

location_facility: I. Interni klinika - kardiologie FN Olomouc

location_facility: Sankt Johannes Hospital Medizinische Klinik I

location_facility: Universitaets-Herzzentrum Freiburg Bad Krozingen

location_facility: Onze Lieve Vrouwe Gasthuis, Locatie Oosterpark

location_facility: Hospital General Universitario de Valencia

location_facility: University Hospitals Coventry and Warwickshire NHS Trust

location_facility: Stredoslovensky ustav srdcovych a cievnych chorob, a.s.

location_facility: Petz Aladar Megyei Oktato Korhaz, Kardiologiai Osztaly

location_facility: Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

location_facility: Katedra i Klinika Kardiologii i Chorob Wewnetrznych

location_facility: University Hospital of Leicester (UHL) NHS Trust

location_facility: "Hospital Clinic i Provincial de Barcelona,Instituto Clinic del Torax


acronym: RETAIN

lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment regimen.

ReferenceCitation: Prunte C, Fajnkuchen F, Mahmood S, Ricci F, Hatz K, Studnicka J, Bezlyak V, Parikh S, Stubbings WJ, Wenzel A, Figueira J; RETAIN Study Group. Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study. Br J Ophthalmol. 2016 Jun;100(6):787-95. doi: 10.1136/bjophthalmol-2015-307249. Epub 2015 Oct 9.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

publisher_dissemination: British Medical Journal

title: A 2 Year Randomized, Single-masked, Multicenter, Controlled Phase IIIb Trial Assessing the Efficacy and Safety of 0.5 mg Ranibizumab in Two "Treat and Extend" Treatment Algorithms vs. 0.5 mg Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus

location_country:
Ireland
Italy
Poland
Portugal
Hungary
United Kingdom
Netherlands
Switzerland
Belgium
Spain
Greece
Czech Republic
France


title: Sub-cutaneous Rituximab-miniCHOP Versus Sub-cutaneous Rituximab-miniCHOP + Lenalidomide (R2-miniCHOP) in Diffuse Large B Cell Lymphoma for Patients of 80 Years Old or More. A Multicentric Phase III Study of the LYSA Association

summary: The purpose of this study is to compare the efficacy of R2-miniCHOP (Sub-cutaneous Rituximab-miniCHOP + lenalidomide) and R-miniCHOP (Sub-cutaneous Rituximab-miniCHOP) in patients aged 80 years old or more with not previously treated cluster of differentiation antigen 20 positive (CD20+) diffuse large B-cell lymphoma as measured by the overall survival (OS).The SENIOR trial will evaluate the tolerance and efficacy of the combination of the R2-miniCHOP regimen and compare this experimental arm to the standard R-miniCHOP regimen.The statistical plan is based on the hypothesis of an increase by 15% of the 2y-OS in favor of the experimental arm, as compared to the reference arm (R-miniCHOP).

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Belgium France

location_facility: Université Catholique de Louvain Saint Luc


title: A Long-term Follow up Study to Evaluate the Safety and Efficacy in Transplant Recipients Treated With Modified Release Tacrolimus, FK506E (MR4), Based Immunosuppression Regimen

summary: The purpose of this study was to offer patients who had participated in one of the phase II PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until commercial availability of the drug and to record long term efficacy and safety data.

ipd_sharing_description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

lead_sponsor: Astellas Pharma Europe Ltd.

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Australia
Brazil
Czechia
Canada
France
Hungary
Denmark
Switzerland
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
South Africa
Sweden

location_facility: Unita Operativa Trapianto di Fegato e Multiorgano

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"

location_facility: Univ. Klinik und Poliklinik fuer Urologie

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Instituto Mexicano de Transplantes Cuernava

location_facility: University of Stellenbosch, Tygerberg Hospital

location_facility: Azienda Ospedaliera Ospedale Maggiore di Milano

location_facility: Vancouver Hospital & Health Sciences Centre

location_facility: Azienda Ospedaliera Policlinico di Modena

location_facility: Unita Operativa Complessa di Chirurgia dei Trapianti

location_facility: Hospital General Universitario Gregorio Maranón


title: Phase 3B, Randomized Trail of Revlimid® (Lenalidomide) Versus Placebo Maintenance Therapy Following Melphalan Prednisone Velcade (Bortezomib) Induction Therapy In Newly Diagnosed Multiple Myeloma

acronym: ARUMM

summary:
The purpose of this study is to compare the safety and efficacy of Lenalidomide versus Placebo maintenance following melphalan, prednisone and velcade induction therapy in newly diagnosed multiple myeloma.

After the study is unblinded, subjects in treatment Arm A (Len 10 mg) will remain on study therapy at the Investigator's discretion and subjects in treatment Arm B (placebo), will be discontinued from study treatment. Subjects who discontinued from study treatment for any reason will enter the LTFU Phase.

ReferenceType: background

ReferenceCitation: Ailawadhi S, Jacobus S, Sexton R, Stewart AK, Dispenzieri A, Hussein MA, Zonder JA, Crowley J, Hoering A, Barlogie B, Orlowski RZ, Rajkumar SV. Disease and outcome disparities in multiple myeloma: exploring the role of race/ethnicity in the Cooperative Group clinical trials. Blood Cancer J. 2018 Jul 6;8(7):67. doi: 10.1038/s41408-018-0102-7.

ReferenceCitation: Dumontet C, Hulin C, Dimopoulos MA, Belch A, Dispenzieri A, Ludwig H, Rodon P, Van Droogenbroeck J, Qiu L, Cavo M, Van de Velde A, Lahuerta JJ, Allangba O, Lee JH, Boyle E, Perrot A, Moreau P, Manier S, Attal M, Roussel M, Mohty M, Mary JY, Civet A, Costa B, Tinel A, Gaston-Mathe Y, Facon T. A predictive model for risk of early grade >/= 3 infection in patients with multiple myeloma not eligible for transplant: analysis of the FIRST trial. Leukemia. 2018 Jun;32(6):1404-1413. doi: 10.1038/s41375-018-0133-x. Epub 2018 Apr 26.

ReferenceCitation: Jain T, Sonbol MB, Firwana B, Kolla KR, Almader-Douglas D, Palmer J, Fonseca R. High-Dose Chemotherapy with Early Autologous Stem Cell Transplantation Compared to Standard Dose Chemotherapy or Delayed Transplantation in Patients with Newly Diagnosed Multiple Myeloma: A Systematic Review and Meta-Analysis. Biol Blood Marrow Transplant. 2019 Feb;25(2):239-247. doi: 10.1016/j.bbmt.2018.09.021. Epub 2018 Sep 20.

ReferenceCitation: Gambella M, Omede P, Spada S, Muccio VE, Gilestro M, Saraci E, Grammatico S, Larocca A, Conticello C, Bernardini A, Gamberi B, Troia R, Liberati AM, Offidani M, Rocci A, Palumbo A, Cavo M, Sonneveld P, Boccadoro M, Oliva S. Minimal residual disease by flow cytometry and allelic-specific oligonucleotide real-time quantitative polymerase chain reaction in patients with myeloma receiving lenalidomide maintenance: A pooled analysis. Cancer. 2019 Mar 1;125(5):750-760. doi: 10.1002/cncr.31854. Epub 2018 Dec 18.

ReferenceCitation: Pegourie B, Karlin L, Benboubker L, Orsini-Piocelle F, Tiab M, Auger-Quittet S, Rodon P, Royer B, Leleu X, Bareau B, Cliquennois M, Fuzibet JG, Voog E, Belhadj-Merzoug K, Decaux O, Rey P, Slama B, Leyronnas C, Zarnitsky C, Boyle E, Bosson JL, Pernod G; IFM Group. Apixaban for the prevention of thromboembolism in immunomodulatory-treated myeloma patients: Myelaxat, a phase 2 pilot study. Am J Hematol. 2019 Jun;94(6):635-640. doi: 10.1002/ajh.25459. Epub 2019 Apr 1.

lead_sponsor: Celgene

location_country: Italy Belgium Spain Greece France

location_facility: Centre Hospitalier EpiCURA - Clinique Louis Caty de Baudour

location_facility: Institut Universitaire du Cancer IUCT - Oncopole

location_facility: Policlinico San Matteo Universita Di Pavia

location_facility: Unità Operativa di Oncoematologia, Ospedale di Matera

location_facility: Dipartimento Medicina ed Oncologia Sperimentale - Divisione Universitaria di Ematologia Azienda Ospe

location_facility: Centre Hospitalier Regional Metz-Thionville Hopital de Mercy

location_facility: Clinica Ematologica, A.O.U. San Martino di Genova

location_facility: U.O. di Ematologia e Trapianto di Midollo Osseo

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: Centre Hospitalier Sud Francilien - Site Gilles de Corbeil

location_facility: Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce

location_facility: Theagenio Anticancer Hospital of Thessaloniki

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Centre Hospitalier de la Region d'Annecy


title: Treatment of Brain AVMs (TOBAS) Study: A Randomized Controlled Trial and Registry

acronym: TOBAS

summary:
The objectives of this study and registry are to offer the best management possible for patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of long-term outcomes, despite the presence of uncertainty. Management may include interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or in combination) or conservative management.

The trial has been designed to test a) whether medical management or interventional therapy will reduce the risk of death or debilitating stroke (due to hemorrhage or infarction) by an absolute magnitude of about 15% (over 10 years) for unruptured AVMs (from 30% to 15%); and, b) to test if endovascular treatment can improve the safety and efficacy of surgery or radiation therapy by at least 10% (80% to 90%).

As for the nested trial on the role of embolization in the treatment of Brain AVMs by other means: the pre-surgical or pre-radiosurgery embolization of cerebral AVMs can decrease the number of treatment failures from 20% to 10%. In addition,embolization of cerebral AVMs can be accomplished with an acceptable risk, defined as permanent disabling neurological complications of 8%.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Fleetwood IG, Steinberg GK. Arteriovenous malformations. Lancet. 2002 Mar 9;359(9309):863-73. doi: 10.1016/S0140-6736(02)07946-1.

ReferenceCitation: Wedderburn CJ, van Beijnum J, Bhattacharya JJ, Counsell CE, Papanastassiou V, Ritchie V, Roberts RC, Sellar RJ, Warlow CP, Al-Shahi Salman R; SIVMS Collaborators. Outcome after interventional or conservative management of unruptured brain arteriovenous malformations: a prospective, population-based cohort study. Lancet Neurol. 2008 Mar;7(3):223-30. doi: 10.1016/S1474-4422(08)70026-7. Epub 2008 Feb 1.

ReferenceCitation: Brown RD Jr, Wiebers DO, Torner JC, O'Fallon WM. Frequency of intracranial hemorrhage as a presenting symptom and subtype analysis: a population-based study of intracranial vascular malformations in Olmsted Country, Minnesota. J Neurosurg. 1996 Jul;85(1):29-32. doi: 10.3171/jns.1996.85.1.0029.

ReferenceCitation: Brown RD Jr, Wiebers DO, Forbes G, O'Fallon WM, Piepgras DG, Marsh WR, Maciunas RJ. The natural history of unruptured intracranial arteriovenous malformations. J Neurosurg. 1988 Mar;68(3):352-7. doi: 10.3171/jns.1988.68.3.0352.

ReferenceCitation: Wilkins RH. Natural history of intracranial vascular malformations: a review. Neurosurgery. 1985 Mar;16(3):421-30. doi: 10.1227/00006123-198503000-00026.

ReferenceCitation: da Costa L, Wallace MC, Ter Brugge KG, O'Kelly C, Willinsky RA, Tymianski M. The natural history and predictive features of hemorrhage from brain arteriovenous malformations. Stroke. 2009 Jan;40(1):100-5. doi: 10.1161/STROKEAHA.108.524678. Epub 2008 Nov 13.

ReferenceCitation: Gross BA, Du R. Natural history of cerebral arteriovenous malformations: a meta-analysis. J Neurosurg. 2013 Feb;118(2):437-43. doi: 10.3171/2012.10.JNS121280. Epub 2012 Nov 30.

ReferenceCitation: Hernesniemi JA, Dashti R, Juvela S, Vaart K, Niemela M, Laakso A. Natural history of brain arteriovenous malformations: a long-term follow-up study of risk of hemorrhage in 238 patients. Neurosurgery. 2008 Nov;63(5):823-9; discussion 829-31. doi: 10.1227/01.NEU.0000330401.82582.5E.

ReferenceCitation: Hartmann A, Mast H, Mohr JP, Koennecke HC, Osipov A, Pile-Spellman J, Duong DH, Young WL. Morbidity of intracranial hemorrhage in patients with cerebral arteriovenous malformation. Stroke. 1998 May;29(5):931-4. doi: 10.1161/01.str.29.5.931.

ReferenceCitation: Hartmann A, Mast H, Mohr JP, Pile-Spellman J, Connolly ES, Sciacca RR, Khaw A, Stapf C. Determinants of staged endovascular and surgical treatment outcome of brain arteriovenous malformations. Stroke. 2005 Nov;36(11):2431-5. doi: 10.1161/01.STR.0000185723.98111.75. Epub 2005 Oct 13.

ReferenceCitation: Hartmann A, Stapf C, Hofmeister C, Mohr JP, Sciacca RR, Stein BM, Faulstich A, Mast H. Determinants of neurological outcome after surgery for brain arteriovenous malformation. Stroke. 2000 Oct;31(10):2361-4. doi: 10.1161/01.str.31.10.2361.

ReferenceCitation: Cockroft KM, Chang KE, Lehman EB, Harbaugh RE. AVM Management Equipoise Survey: physician opinions regarding the management of brain arteriovenous malformations. J Neurointerv Surg. 2014 Dec;6(10):748-53. doi: 10.1136/neurintsurg-2013-011030. Epub 2013 Dec 6.

ReferenceCitation: Cockroft KM. Unruptured brain arteriovenous malformations should be treated conservatively: no. Stroke. 2007 Dec;38(12):3310-1. doi: 10.1161/STROKEAHA.107.504613. Epub 2007 Oct 25. No abstract available.

ReferenceCitation: Stapf C, Mohr JP. Unruptured brain arteriovenous malformations should be treated conservatively: yes. Stroke. 2007 Dec;38(12):3308-9. doi: 10.1161/STROKEAHA.107.504605. Epub 2007 Oct 25. No abstract available.

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.

ReferenceCitation: Davies JM, Yanamadala V, Lawton MT. Comparative effectiveness of treatments for cerebral arteriovenous malformations: trends in nationwide outcomes from 2000 to 2009. Neurosurg Focus. 2012 Jul;33(1):E11. doi: 10.3171/2012.5.FOCUS12107.

ReferenceCitation: Morgan MK, Davidson AS, Koustais S, Simons M, Ritson EA. The failure of preoperative ethylene-vinyl alcohol copolymer embolization to improve outcomes in arteriovenous malformation management: case series. J Neurosurg. 2013 May;118(5):969-77. doi: 10.3171/2012.11.JNS112064. Epub 2013 Jan 25.

ReferenceCitation: Pierot L, Fiehler J, Cognard C, Soderman M, Spelle L. Will a randomized trial of unruptured brain arteriovenous malformations change our clinical practice? AJNR Am J Neuroradiol. 2014 Mar;35(3):416-7. doi: 10.3174/ajnr.A3867. Epub 2014 Jan 16. No abstract available.

ReferenceCitation: Raymond J; TEAM collaborative group. Reflections on the TEAM trial: why clinical care and research should be reconciled. Can J Neurol Sci. 2011 Mar;38(2):198-202. doi: 10.1017/s0317167100011343.

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ReferenceCitation: Darsaut TE, Magro E, Bojanowski MW, Chaalala C, Nico L, Bacchus E, Klink R, Iancu D, Weill A, Roy D, Sabatier JF, Cognard C, Januel AC, Pelissou-Guyotat I, Eker O, Roche PH, Graillon T, Brunel H, Proust F, Beaujeux R, Aldea S, Piotin M, Cornu P, Shotar E, Gaberel T, Barbier C, Corre ML, Costalat V, Jecko V, Barreau X, Morandi X, Gauvrit JY, Derrey S, Papagiannaki C, Nguyen TN, Abdalkader M, Tawk RG, Huynh T, Viard G, Gevry G, Gentric JC, Raymond J; TOBAS Collaborative Group; List of participating TOBAS centers and physicians. Surgical treatment of brain arteriovenous malformations: clinical outcomes of patients included in the registry of a pragmatic randomized trial. J Neurosurg. 2022 Sep 9;138(4):891-899. doi: 10.3171/2022.7.JNS22813. Print 2023 Apr 1.

publisher_dissemination: American Association of Neurological Surgeons

ReferenceCitation: Magro E, Gentric JC, Batista AL, Kotowski M, Chaalala C, Roberge D, Weill A, Stapf C, Roy D, Bojanowski MW, Darsaut TE, Klink R, Raymond J. The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research. J Neurosurg. 2018 Jun;128(6):1823-1829. doi: 10.3171/2017.2.JNS162751. Epub 2017 Sep 1.

ReferenceCitation: Magro E, Gentric JC, Darsaut TE, Batista AL, Chaalala C, Roberge D, Weill A, Roy D, Bojanowski MW, Raymond J. [Treatment of brain AVMS (TOBAS): A randomized controlled trial and registry]. Neurochirurgie. 2016 Aug;62(4):197-202. doi: 10.1016/j.neuchi.2015.12.008. Epub 2016 May 25. French.

ReferenceCitation: Darsaut TE, Magro E, Gentric JC, Batista AL, Chaalala C, Roberge D, Bojanowski MW, Weill A, Roy D, Raymond J. Treatment of Brain AVMs (TOBAS): study protocol for a pragmatic randomized controlled trial. Trials. 2015 Nov 4;16:497. doi: 10.1186/s13063-015-1019-0.

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

collaborators: Centre Hospitalier Régional et Universitaire de Brest

location_country:
Colombia
Brazil
United States
Chile
Canada
France

location_facility: CHRU de Brest (Brest University Hospital)

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Régional Universitaire de Tours

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire de Lyon

location_facility: Les Hôpitaux Universitaires de Strasbourg

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: University of New Mexico Health Sciences Center

location_facility: Centre Hospit Régional Universitaire de Besançon

location_facility: Centre Hospitalier Régional Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Universitaire Hôpitaux de Rouen

location_facility: Assistance Publique - Hôpitaux de Marseille

location_facility: Centre Hospitalier Universitaire de Montpellier

intervention_type: Procedure

lead_sponsor_type: academique

status_simplified: Ongoing


title: An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease

acronym: STAR Extension

summary: To evaluate the long-term safety and tolerability of idalopirdine (Lu AE58054) as adjunctive therapy to donepezil in patients with mild-moderate Alzheimer's Disease (AD).

lead_sponsor: H. Lundbeck A/S

location_country:
Finland
Germany
Poland
Argentina
Brazil
Croatia
Chile
Czechia
Canada
France
Lithuania
Portugal
Hungary
Denmark
United States
Ukraine
Romania
Belgium
Estonia
Italy
United Kingdom
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Israel


title: Evaluation of an Immunomodulatory Maintenance Treatment in Patients With Metastatic Colorectal Cancer With Tumor Reduction During Induction Treatment

acronym: IMPALA

summary: The purpose of this this trial is to prove the efficacy and safety of MGN1703 as a maintenance therapy after first-line chemotherapeutic treatment of metastatic colorectal cancer.

status: Unknown status

lead_sponsor: Mologen AG

location_country:
Germany
Italy
United Kingdom
Austria
Belgium
Spain
Estonia
France

location_facility: DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH

location_facility: The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: Klinikum Mittelbaden Medizinische Klinik II

location_facility: Clinique Saint Anne, Strasbourg Oncologie Liberale

location_facility: Ospedale Civile SS Annunziata, U.O.C. Oncologia Medica

location_facility: Universitätsklinikum Gießen und Marburg, Standort Gießen

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

location_facility: Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin

location_facility: Medizinisches Versorgungszentrum Osthessen GmbH

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Ospedale Infermi di Rimini, U.O. Oncologia

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

location_facility: Hospital Universitario Arnau de Vilanova

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: HELIOS Klinikum Wuppertal Medizinische Klinik I

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Onkologie Dreiländereck - Onkologische Schwerpunktpraxis Lörrach

location_facility: St. Josef-Hospital im Katholischen Klinikum Bochum

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: York Teaching Hospitals NHS Fondation Trust, Research and Development department

location_facility: Hôpital Européen Georges Pompidou (HEGP)

location_facility: Medizinisches Versorgungszentrum Ärzteforum Seestrasse

status_simplified: Unknown