ReferenceCitation: Mahlangu J, Oldenburg J, Paz-Priel I, Negrier C, Niggli M, Mancuso ME, Schmitt C, Jiménez-Yuste V, Kempton C, Dhalluin C, Callaghan MU, Bujan W, Shima M, Adamkewicz JI, Asikanius E, Levy GG, Kruse-Jarres R. Emicizumab Prophylaxis in Patients Who Have Hemophilia A without Inhibitors. N Engl J Med. 2018 Aug 30;379(9):811-822. doi: 10.1056/NEJMoa1803550.

name: From the Haemophilia Comprehensive Care Centre, Faculty of Health Sciences, University of the Witwatersrand and National Health Laboratory Service, Johannesburg (J.M.); Universitätsklinikum Bonn, Bonn, Germany (J.O.); Genentech, South San Francisco, CA (I.P.-P., J.I.A., G.G.L.); Louis Pradel University Hospital, Lyon, France (C.N.); F. Hoffmann–La Roche, Basel, Switzerland (M.N., C.S., C.D., E.A.); Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca’ Granda, Ospedale Maggiore...

family: Mahlangu

full_name: Johnny Mahlangu

given: Johnny

family: Oldenburg

full_name: Johannes Oldenburg

given: Johannes

family: Paz-Priel

full_name: Ido Paz-Priel

given: Ido

family: Negrier

full_name: Claude Negrier

given: Claude

family: Niggli

full_name: Markus Niggli

given: Markus

family: Mancuso

full_name: M. Elisa Mancuso

given: M. Elisa

family: Schmitt

full_name: Christophe Schmitt

given: Christophe

family: Jiménez-Yuste

full_name: Victor Jiménez-Yuste

given: Victor

family: Kempton

full_name: Christine Kempton

given: Christine

family: Dhalluin

full_name: Christophe Dhalluin

family: Callaghan

full_name: Michael U. Callaghan

given: Michael U.

family: Bujan

full_name: Willem Bujan

given: Willem

family: Shima

full_name: Midori Shima

given: Midori

family: Adamkewicz

full_name: Joanne I. Adamkewicz

given: Joanne I.

family: Asikanius

full_name: Elina Asikanius

given: Elina

family: Levy

full_name: Gallia G. Levy

given: Gallia G.

family: Kruse-Jarres

full_name: Rebecca Kruse-Jarres

given: Rebecca

journal_name: New England Journal of Medicine

evidence: open (via free article)

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
South Africa
Costa Rica
France
Japan
Poland
Ireland
Australia
Spain
Germany
United Kingdom
Korea, Republic of
Taiwan

acronym: HAVEN 3

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: ALVAMED Lekarskie Gabinety Specjalistyczne

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Children's Hospital of Michigan; Pediatrics

location_facility: The Alfred Hospital, Melbourne; Thrombosis and Haemostasis Unit

location_facility: Bloodworks Northwest (formerly Puget Sound Blood Center); Hemophilia

location_facility: Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych

location_facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico; Centro Emofilia e Trombosi "Angelo Bianchi e Bonomi"

location_facility: CH de Bicetre; Centre de Traitement d' Hemophilie

location_facility: Dana-Farber Cancer Institute; Brigham and Women's Cancer Center

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Cornell Univ Medical College; Hematology-Oncolog

location_facility: Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Hopital Cardio-vasculaire Louis Pradel; Hemostase clinique

location_facility: Universitätsklinikum Bonn; Institut für Experimentelle Hämatologie und Transfusionsmedizin

location_facility: Georgetown Uni Medical Center; Lombardi Cancer Center

title: A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Patients Without Inhibitors

summary: This is a randomized, global, multicenter, open-label, Phase 3 clinical study in participants with severe hemophilia A without inhibitors against Factor VIII (FVIII) who are 12 years or older. The study evaluates two prophylactic emicizumab regimens versus no prophylaxis in this population with emphasis on efficacy, safety, and pharmacokinetics.


title: Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC).

summary: The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95.

ReferenceCitation: Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.

ReferenceCitation: Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbalý V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.

family: Stupp

full_name: Roger Stupp

given: Roger

sequence: first

family: Wong

full_name: Eric T. Wong

given: Eric T.

sequence: additional

family: Kanner

full_name: Andrew A. Kanner

given: Andrew A.

family: Steinberg

full_name: David Steinberg

given: David

family: Engelhard

full_name: Herbert Engelhard

given: Herbert

family: Heidecke

full_name: Volkmar Heidecke

given: Volkmar

family: Kirson

full_name: Eilon D. Kirson

given: Eilon D.

family: Taillibert

full_name: Sophie Taillibert

given: Sophie

family: Liebermann

full_name: Frank Liebermann

given: Frank

family: Dbalý

full_name: Vladimir Dbalý

given: Vladimir

family: Ram

full_name: Zvi Ram

given: Zvi

family: Villano

full_name: J. Lee Villano

given: J. Lee

family: Rainov

full_name: Nikolai Rainov

given: Nikolai

family: Weinberg

full_name: Uri Weinberg

given: Uri

family: Schiff

full_name: David Schiff

family: Kunschner

full_name: Lara Kunschner

given: Lara

family: Raizer

full_name: Jeffrey Raizer

given: Jeffrey

family: Honnorat

full_name: Jerome Honnorat

given: Jerome

family: Sloan

full_name: Andrew Sloan

given: Andrew

family: Malkin

full_name: Mark Malkin

given: Mark

family: Landolfi

full_name: Joseph C. Landolfi

given: Joseph C.

family: Payer

full_name: Franz Payer

given: Franz

family: Mehdorn

full_name: Maximilian Mehdorn

given: Maximilian

title: NovoTTF-100A versus physician’s choice chemotherapy in recurrent glioblastoma: A randomised phase III trial of a novel treatment modality

ReferenceCitation: Giladi M, Schneiderman RS, Voloshin T, Porat Y, Munster M, Blat R, Sherbo S, Bomzon Z, Urman N, Itzhaki A, Cahal S, Shteingauz A, Chaudhry A, Kirson ED, Weinberg U, Palti Y. Mitotic Spindle Disruption by Alternating Electric Fields Leads to Improper Chromosome Segregation and Mitotic Catastrophe in Cancer Cells. Sci Rep. 2015 Dec 11;5:18046. doi: 10.1038/srep18046.

ReferenceCitation: Giladi M, Weinberg U, Schneiderman RS, Porat Y, Munster M, Voloshin T, Blatt R, Cahal S, Itzhaki A, Onn A, Kirson ED, Palti Y. Alternating electric fields (tumor-treating fields therapy) can improve chemotherapy treatment efficacy in non-small cell lung cancer both in vitro and in vivo. Semin Oncol. 2014 Oct;41 Suppl 6:S35-41. doi: 10.1053/j.seminoncol.2014.09.006. Epub 2014 Sep 8.

ReferenceCitation: Kirson ED, Dbalý V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. Epub 2007 Jun 5.

ReferenceCitation: Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.

name: University Hospital Zurich and University of Zurich, Zurich, Switzerland2Lausanne University Hospital (CHUV), Lausanne, Switzerland

name: Assistance Publique des Hôpitaux de Paris, La Pitié-Salpétrière-University Hospital, Pierre and Marie Curie University, Paris, France

name: Tel Aviv Sourasky Medical Center, Tel Aviv University, Tel Aviv, Israel

name: Geisinger Health System, Danville, Pennsylvania

name: Tufts Medical Center, Boston, Massachusetts

name: University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

name: Istituto Nazionale Neurologico Carlo Besta, Milan, Italy

name: Cleveland Clinic Foundation, Cleveland, Ohio

name: Baylor University Medical Center, Dallas, Texas13University of Texas Health Science Center, Houston

name: Swedish Neuroscience Institute, Seattle, Washington

name: University of Southern California, Los Angeles

name: Washington University Barnes-Jewish Hospital, St Louis, Missouri

name: Na Homolce Hospital, Prague, Czech Republic

name: New Jersey Neuroscience Institute, Edison

name: Fondazione Ospedale Maggiore Policlinico, Milan, Italy

name: Houston Methodist Hospital, Houston, Texas

name: Hospices Civils de Lyon, University Claude Bernard Lyon 1, Lyon, France

ReferenceCitation: Pless M, Droege C, von Moos R, Salzberg M, Betticher D. A phase I/II trial of Tumor Treating Fields (TTFields) therapy in combination with pemetrexed for advanced non-small cell lung cancer. Lung Cancer. 2013 Sep;81(3):445-450. doi: 10.1016/j.lungcan.2013.06.025. Epub 2013 Jul 23.

ReferenceCitation: Lin NU, Lee EQ, Aoyama H, Barani IJ, Barboriak DP, Baumert BG, Bendszus M, Brown PD, Camidge DR, Chang SM, Dancey J, de Vries EG, Gaspar LE, Harris GJ, Hodi FS, Kalkanis SN, Linskey ME, Macdonald DR, Margolin K, Mehta MP, Schiff D, Soffietti R, Suh JH, van den Bent MJ, Vogelbaum MA, Wen PY; Response Assessment in Neuro-Oncology (RANO) group. Response assessment criteria for brain metastases: proposal from the RANO group. Lancet Oncol. 2015 Jun;16(6):e270-8. doi: 10.1016/S1470-2045(15)70057-4. Epub 2015 May 27. Review.

ReferenceCitation: Brozova H, Lucas A, Salmaggi A, Vymazal J. COMET: A phase II randomized study of TTFields versus supportive care in non-small cell lung cancer patients with 1-5 brain metastases - initial safety results. Neuro Oncol. 2015 Nov; 17 (suppl 5): v46. doi:10.1093/neuonc/nov208.6

location_country:
Italy
Austria
Serbia
Hong Kong
Spain
Germany
Croatia
Bulgaria
France
Israel
Poland
Hungary
China
United States
Canada

location_facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: UNC - Lineberger Comprehensive Cancer Center

location_facility: Baylor Scott & White Medical Center - Temple

location_facility: Memorial Health University Medical Center

location_facility: University of Mississippi Medical Center

location_facility: University of Louisville-James Graham Brown Cancer Center

location_facility: The First Affiliated Hospital of Guangdong Pharmaceutical University

location_facility: Ellis Fischel Cancer Center, University of Missouri Healthcare

location_facility: (CHUS) Centre Hospitalier Universitaire de Sherbrooke, Service de Neurochirurgie

location_facility: Onkologiai Osztaly, Balassa Janos Korhaz

location_facility: Walter Reed National Military Medical Center

location_facility: The Second Affiliated Hospital Of Xingtai Medical College

location_facility: Azienda Socio Sanitaria Territoriale di Lecco

location_facility: University Multiprofile Hospital for Active Treatment Sofiamed, Department of Medical Oncology

location_facility: Center for Neuro-oncology, Neurosurgery Clinic, Clinical Center of Serbia

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

location_facility: Mischer Neuroscience Associates - Texas Medical Center

location_facility: Abbott Northwestern Hospital - Givens Brain Tumor Center

location_facility: The First Affiliated Hospital of Soochow University

location_facility: A.O.S.G. Moscati Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità

location_facility: UMHAT Sv. Ivan Rilski EAD, Department of Medical Oncology

location_facility: The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange

location_facility: Klinik für Radioonkologie und Strahlentherapie der Charité Universitätsmedizin Berlin Campus Charité Virchow-Klinikum

location_facility: Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

location_facility: University of Alabama at Birmingham Comprehensive Cancer Center

location_facility: Le CIUSSS de I'Est-de-L'ile de Montreal - Hopital Moaisonneuve Rosemont

location_facility: Geza Hetenyi Hospital-Clinic of Jasz-Nagykun-Szolnok County

location_facility: Grandview Medical Center - Cancer Center

location_facility: Dr. Senckenbergisches Institut für Neuroonkologie, Zentrum der Neurologie und Neurochirurgie

location_facility: University Hospital of Messina AOU Policlinico "G. Martino"

location_facility: John Nasseff Neuroscience Institute ANW Brain Tumor Center

location_facility: A.O.U Città della Salute e della Scienza di Torino

location_facility: Medical University of South Carolina- Hollings Cancer Center

location_facility: Marek Harat Private Practice, Neurosurgery and Radiation Oncology

location_facility: Universitätsklinikum Halle (Saale), Klinik für Innere Medizin IV, Hämatologie / Onkologie

location_facility: University of Minnesota Medical Center (UMMC) - Fairview - Masonic Cancer Clinic


ReferenceCitation: Cahn P, Madero JS, Arribas JR, Antinori A, Ortiz R, Clarke AE, Hung CC, Rockstroh JK, Girard PM, Sievers J, Man C, Currie A, Underwood M, Tenorio AR, Pappa K, Wynne B, Fettiplace A, Gartland M, Aboud M, Smith K; GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019 Jan 12;393(10167):143-155. doi: 10.1016/S0140-6736(18)32462-0. Epub 2018 Nov 9. Erratum in: Lancet. 2018 Nov 28;:.

intervention_type: Drug

status: Active, not recruiting

study_start_date_type: Actual

lead_sponsor: ViiV Healthcare

enrollment_type: Actual

location_country:
Italy
United States
Peru
Switzerland
Mexico
Spain
Germany
France
Poland
Romania
Belgium
Argentina
Australia
Portugal
Russian Federation
Canada
United Kingdom
Taiwan

acronym: Gemini 2

type: EudraCT Number

source: euctr

title: A Phase III, Randomised, Double-blind, Multicentre, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Dolutegravir Plus Lamivudine Compared to Dolutegravir Plus Tenofovir/Emtricitabine in HIV-1-infected Treatment-naïve Adults

summary: This study will compare safety, efficacy, and tolerability of a two drug regimen of dolutegravir (DTG) plus (+) lamivudine (3TC) administered once daily with DTG plus two nucleoside reverse transcriptase inhibitors (tenofovir disoproxil fumarate [TDF]/emtricitabine [FTC] fixed dose combination [FDC]) administered once daily in human immunodeficiency virus (HIV) 1 infected adult subjects that have not previously received antiretroviral therapy. The study is designed to demonstrate the non inferior antiviral activity of DTG + 3TC regimen to that of DTG + TDF/FTC FDC and will characterise the long term antiviral activity, tolerability and safety of DTG plus 3TC through Week 148. Approximately, 700 subjects will be randomised 1:1 to receive DTG + 3TC or DTG + TDF/FTC FDC. Subjects will be stratified by screening HIV 1 ribonucleotide nucleic acid (RNA) levels and by screening CD4+ (cluster of differentiation 4) cell count.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: An Open Label, Phase I Study to Assess the Effect of Itraconazole (CYP3A4 and P-gp Inhibitor) on the Pharmacokinetics of Anetumab Ravtansine and to Assess the ECG Effects, Safety and Immunogenicity of Anetumab Ravtansine Given as a Single Agent and Together With Itraconazole in Subjects With Mesothelin-expressing Advanced Solid Cancers

summary: Characterize the safety, tolerability, ECG effects, pharmacokinetics and immunogenicity of anetumab ravtansine given as single agent and after inhibition of CYP3A4 and P-gp by concomitant administration of itraconazole in subjects with mesothelin-expressing advanced solid cancers

status: Completed

study_completion_date_type: Actual

ipd_sharing: Undecided

ipd_sharing_description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
Netherlands
France
Belgium
Australia
Spain
United States

location_facility: Washington University School of Medicine

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: University Hospitals Cleveland Medical Center

location_facility: Fundacion Jimenez Diaz (Clinica de la Concepcion)

location_facility: Universitair Medisch Centrum St. Radboud

status_simplified: Completed


ReferenceType: derived

ReferenceCitation: Korobelnik JF, Larsen M, Eter N, Bailey C, Wolf S, Schmelter T, Allmeier H, Chaudhary V. Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend for Macular Edema in Central Retinal Vein Occlusion: the CENTERA Study. Am J Ophthalmol. 2021 Jul;227:106-115. doi: 10.1016/j.ajo.2021.01.027. Epub 2021 Feb 6.

family: Korobelnik

full_name: Jean-François Korobelnik

given: Jean-François

family: Larsen

full_name: Michael Larsen

given: Michael

family: Eter

full_name: Nicole Eter

given: Nicole

family: Bailey

full_name: Clare Bailey

given: Clare

family: Wolf

full_name: Sebastian Wolf

given: Sebastian

family: Schmelter

full_name: Thomas Schmelter

given: Thomas

family: Allmeier

full_name: Helmut Allmeier

given: Helmut

family: Chaudhary

full_name: Varun Chaudhary

given: Varun

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: American Journal of Ophthalmology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repository_institution: Universite de Bordeaux - Oskar-Bordeaux

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_normalized: HAL

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

location_country:
Italy
Germany
France
Australia
Spain
Denmark
Canada
United Kingdom

acronym: CENTERA

title: A Multi-center, Single-arm, Interventional Phase 4 Study to Evaluate a Treat and Extend Regimen of Intravitreal Aflibercept for Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion

summary:
Central retinal vein occlusion (CRVO) occurs when the main blood vessel that transports blood away from the retina (the very back portion of the eye) becomes blocked, causing the leakage of fluid into the retina and thereby causing a swelling of the macula (the portion of the retina responsible for fine vision). This swelling is called macular edema. When the macula swells with fluid, central vision becomes blurry. The study drug aflibercept has been shown to reduce the amount of fluid and blood leaked into the retina. It can help to stabilize, and in many cases, improve the vision loss related to CRVO. Aflibercept has been approved for the treatment of macular edema secondary to CRVO in the United States (US), European Union (EU), Japan, and other countries.

The study was considered research because, although the study drug was already on the market for macular edema secondary to CRVO, there were no studies available that addressed the questions of what were useful intervals for treating and assessing patients, how did they differ among patients, and how were criteria applied for retreatment. The purpose of this study was to evaluate the effectiveness, treatment interval, and safety of the treatment regimen (pattern for administering treatment) in subjects with macular edema secondary to CRVO. In addition, this study explored new imaging methods for assessing the affected eye.


ReferenceCitation: Young G, Liesner R, Chang T, Sidonio R, Oldenburg J, Jiménez-Yuste V, Mahlangu J, Kruse-Jarres R, Wang M, Uguen M, Doral MY, Wright LY, Schmitt C, Levy GG, Shima M, Mancuso ME. A multicenter, open-label phase 3 study of emicizumab prophylaxis in children with hemophilia A with inhibitors. Blood. 2019 Dec 12;134(24):2127-2138. doi: 10.1182/blood.2019001869.

name: Children’s Hospital Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, CA;

family: Young

full_name: Guy Young

given: Guy

name: Great Ormond Street Hospital, London, United Kingdom;

family: Liesner

full_name: Ri Liesner

given: Ri

name: Genentech, Inc, South San Francisco, CA;

family: Chang

full_name: Tiffany Chang

given: Tiffany

name: Children’s Healthcare of Atlanta, Emory University, Atlanta, GA;

family: Sidonio

full_name: Robert Sidonio

given: Robert

suffix: Jr

name: Institute of Experimental Hematology and Transfusion Medicine, University of Bonn, Bonn, Germany;

family: Oldenburg

full_name: Johannes Oldenburg

given: Johannes

name: Hospital Universitario La Paz, Autónoma University, Madrid, Spain;

family: Jiménez-Yuste

full_name: Victor Jiménez-Yuste

given: Victor

name: National Health Laboratory Service (NHLS), Charlotte Maxeke Johannesburg Academic Hospital, University of the Witwatersrand, Johannesburg, South Africa;

family: Mahlangu

full_name: Johnny Mahlangu

given: Johnny

family: Kruse-Jarres

full_name: Rebecca Kruse-Jarres

given: Rebecca

name: School of Medicine Hemophilia and Thrombosis Center, Anschutz Medical Campus, University of Colorado, Aurora, CO;

family: Wang

full_name: Michael Wang

name: F. Hoffmann–La Roche Ltd, Basel, Switzerland;

family: Uguen

full_name: Marianne Uguen

given: Marianne

family: Doral

full_name: Michelle Y. Doral

given: Michelle Y.

family: Wright

full_name: Lilyan Y. Wright

given: Lilyan Y.

family: Schmitt

full_name: Christophe Schmitt

given: Christophe

family: Levy

full_name: Gallia G. Levy

given: Gallia G.

name: Department of Pediatrics, Nara Medical University, Kashihara, Japan; and

family: Shima

full_name: Midori Shima

given: Midori

name: Angelo Bianchi Bonomi Hemophilia and Thrombosis Centre, Ospedale Maggiore Policlinico, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Ca’ Granda, Milan, Italy

family: Mancuso

full_name: Maria Elisa Mancuso

given: Maria Elisa

journal_name: Blood

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

design_allocation: Non-Randomized

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

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

location_country:
Italy
United States
South Africa
Costa Rica
France
Japan
Spain
Turkey
Germany
United Kingdom

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Hospital of the University of Occupational and Environmental Health,Japan

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Children's Hospital of Michigan; Pediatrics

location_facility: Oregon Health & Science Uni ; Dept of Pediatrics

location_facility: Bloodworks Northwest (formerly Puget Sound Blood Center); Hemophilia

location_facility: Adana Acibadem Hospital; Pediatric Hematology

location_facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico; Centro Emofilia e Trombosi "Angelo Bianchi e Bonomi"

location_facility: CH de Bicetre; Centre de Traitement d' Hemophilie

location_facility: Istanbul University, Cerrahpasa Medical Faculty; Pediatrics Department

location_facility: Charlotte Maxeke Johannesburg Hospital; Haemophilia Comprehensive Care Center

location_facility: Hospital Universitario la Fe; Servicio de Hematologia

location_facility: North Shore/Long Island Jewish PRIME; Pediatric Hematology/Oncology & Stem Cell Transplantation

location_facility: Ege University, School of Medicine; Pediatrics Department

location_facility: Great Ormond street Hospital for Children NHS Foundation Trust; Haemophilia Centre

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: University of Colorado Denver, Children's Hospital

location_facility: Hopital Cardio-vasculaire Louis Pradel; Hemostase clinique

location_facility: Universitätsklinikum Bonn; Institut für Experimentelle Hämatologie und Transfusionsmedizin

title: A Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Administration of Emicizumab in Hemophilia A Pediatric Patients With Inhibitors

summary: This non-randomized, multicenter, open-label, Phase III clinical study will evaluate the efficacy, safety, and pharmacokinetics of emicizumab administered subcutaneously initially once weekly (QW) in pediatric participants with hemophilia A with FVIII inhibitors. This study will open two additional non-randomized cohorts to investigate once every 2 weeks (Q2W) and once every 4 weeks (Q4W) regimens in pediatric participants.


title: A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Subjects With Solid Tumors and Non-Hodgkin's Lymphoma

acronym: Meteor 1

summary: This first time in human (FTIH) open-label, dose escalation study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in participants with advanced or recurrent solid tumors, as well as clinical activity in participants with a subset of solid tumors and non-Hodgkin's lymphoma (NHL).

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
United States
Canada
France
Netherlands


ReferenceCitation: Pujol JL, Vansteenkiste J, Paz-Ares Rodríguez L, Gregorc V, Mazieres J, Awad M, Jänne PA, Chisamore M, Hossain AM, Chen Y, Beck JT. Abemaciclib in Combination With Pembrolizumab for Stage IV KRAS-Mutant or Squamous NSCLC: A Phase 1b Study. JTO Clin Res Rep. 2021 Sep 25;2(11):100234. doi: 10.1016/j.jtocrr.2021.100234. eCollection 2021 Nov.

family: Pujol

full_name: J.-L. Pujol

family: Vansteenkiste

full_name: J. Vansteenkiste

given: J.

family: Paz-Ares Rodríguez

full_name: L. Paz-Ares Rodríguez

given: L.

family: Gregorc

full_name: V. Gregorc

given: V.

family: Mazieres

full_name: J. Mazieres

family: Awad

full_name: M. Awad

given: M.

family: Jänne

full_name: P.A. Jänne

family: Chisamore

full_name: M. Chisamore

family: Hossain

full_name: A.M. Hossain

family: Chen

full_name: Y. Chen

given: Y.

family: Beck

full_name: J.T. Beck

currency_apc_doaj: USD

journal_name: JTO Clinical and Research Reports

oa_host_type: publisher

evidence: oa journal (via doaj)

title: Abemaciclib in Combination With Pembrolizumab for Stage IV KRAS-Mutant or Squamous Non-Small Cell Lung Cancer: A Phase 1B Study

lead_sponsor: Eli Lilly and Company

location_country:
Italy
France
Belgium
Spain
Turkey
United States
Taiwan

location_facility: Centre Hospitalier Universitaire Sart Tilman

location_facility: University of Colorado School of Medicine

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori

location_facility: CHU de Montpellier-Hopital Arnaud de Villeneuve

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Taipei Medical University- Shuang Ho Hospital

type: Other Identifier

title: A Phase 1b Study of Abemaciclib in Combination With Pembrolizumab for Patients With Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer

summary: The main purpose of this study is to evaluate the safety and efficacy of abemaciclib in combination with pembrolizumab in participants with advanced non-small cell lung cancer (NSCLC) or hormone receptor positive (HR+), human epidermal growth factor receptor negative (HER2-) breast cancer.


title: Risk, Predictors, Impact and Outcome of Anticoagulation-associated Abnormal Menstrual Bleeding in Female Patients With VTE

acronym: TEAM-VTE

summary: This study is an international, multicenter, academically sponsored, observational study, that focusses on fertile female patients with proven symptomatic deep vein thrombosis of the legs (DVT) or acute pulmonary embolism (PE). The incidence and severity of abnormal menstrual bleeding will be assessed for each menstrual period and correlated to quality of life. Causes of abnormal menstrual bleeding other than active anticoagulant treatment will be assessed. Treatment of abnormal menstrual bleeding (all within routine clinical care) will be evaluated for efficacy and safety.

status: Terminated

study_type: Observational

time_perspective: Prospective

ipd_sharing_description: Undecided

lead_sponsor: Leiden University Medical Center

location_country:
Austria
Switzerland
Netherlands
France
Germany
United Kingdom

location_facility:
Hôpital de la Cavale Blanche
Leiden University Medical Center
Medical University Hospital
University Medical Centre Mannheim
Geneva University Hospital
CHU Saint-Etienne
Guy's & St Thomas' Hospital

lead_sponsor_type: academique

status_simplified: Unknown


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

acronym: TiGER

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

lead_sponsor: Vascutek Ltd.

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

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Hospital Universitario Central de Asturias, Oviedo

location_facility: Hospital Universitari Valle Hebrón de Barcelona

location_facility: Hôpital Pneumologique et Cardiovasculaire Louis-Pradel

location_facility: Hospital Clinic i Provincial de Barcelona

intervention_type: Device


title: A Phase 2, Fast Real Time Assessment of Combination Therapies in Immuno-Oncology Study in Subjects With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung)

acronym: FRACTION-Lung

summary: The purpose of this study is to determine whether Nivolumab, in combination with other therapies, is effective in patients with advanced Non-Small Cell lung cancer

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
United States
Switzerland
France
Australia
Spain
Canada

location_facility: University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Ce

location_facility: Washington University, The Center for Advanced Medicine

location_facility: The West Clinic, P.C. d/b/a West Cancer Center

location_facility: University of Maryland - Marlene and Stewart Greenebaum Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: University of Californa, Los Angeles (UCLA)

location_facility: Sidney Kimmel Comprehensive Cancer Center

location_facility: Juravinski Cancer Centre, Hamilton Health Sciences-Mcmaster Univeristy's Faculty Of Health Sciences

location_facility: University Of Ottawa - The Ottawa Hospital Cancer centre

location_facility: University of Washington-Seattle Cancer Care Alliance


title: An Open-label, Non-randomized Study on Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of LNP023 in Two Patient Populations With C3 Glomerulopathy

summary: The study is an open-label, two cohort non-randomized study evaluating the efficacy, safety, and pharmacokinetics of LNP023 in patients with C3G (Cohort A) and patients who have undergone kidney transplant and have C3G recurrence (Cohort B).

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

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United States
France
Spain
Germany
United Kingdom


title: Long Term Follow-up of the Tendril STS and Isoflex Leads in Conjunction With the Assurity MRI™ and Endurity MRI™ Pacemakers Within the 3T MRI Environment (Brady 3T MRI PMCF)

summary: The objective of this post-market, clinical follow up (PMCF) study, is to confirm the long-term safety of the Tendril STS and Isoflex leads, implanted with the Assurity MRI™ or Endurity MRI™ pacemakers, in patients undergoing a clinically indicated 3T MRI (3 Tesla Magnetic Resonance Imaging) scan.

lead_sponsor: Abbott Medical Devices

location_country: Italy India Netherlands France Estonia

location_facility: Hopital Cardiovasculaire et Pneumologique Louis Pradel

location_facility: AOU Federico II - Università degli Studi di Napoli

intervention_type: Radiation


ReferenceCitation: Van Cutsem E, Danielewicz I, Saunders MP, Pfeiffer P, Argilés G, Borg C, Glynne-Jones R, Punt CJA, Van de Wouw AJ, Fedyanin M, Stroyakovskiy D, Kroening H, Garcia-Alfonso P, Wasan H, Falcone A, Kanehisa A, Egorov A, Aubel P, Amellal N, Moiseenko V. Trifluridine/tipiracil plus bevacizumab in patients with untreated metastatic colorectal cancer ineligible for intensive therapy: the randomized TASCO1 study. Ann Oncol. 2020 Sep;31(9):1160-1168. doi: 10.1016/j.annonc.2020.05.024. Epub 2020 Jun 1.

family: Van Cutsem

full_name: E. Van Cutsem

given: E.

family: Danielewicz

full_name: I. Danielewicz

given: I.

family: Saunders

full_name: M.P. Saunders

family: Pfeiffer

full_name: P. Pfeiffer

given: P.

family: Argilés

full_name: G. Argilés

given: G.

family: Borg

full_name: C. Borg

given: C.

family: Glynne-Jones

full_name: R. Glynne-Jones

given: R.

family: Punt

full_name: C.J.A. Punt

family: Van de Wouw

full_name: A.J. Van de Wouw

family: Fedyanin

full_name: M. Fedyanin

family: Stroyakovskiy

full_name: D. Stroyakovskiy

given: D.

family: Kroening

full_name: H. Kroening

given: H.

family: Garcia-Alfonso

full_name: P. Garcia-Alfonso

family: Wasan

full_name: H. Wasan

family: Falcone

full_name: A. Falcone

given: A.

family: Kanehisa

full_name: A. Kanehisa

family: Egorov

full_name: A. Egorov

family: Aubel

full_name: P. Aubel

family: Amellal

full_name: N. Amellal

given: N.

family: Moiseenko

full_name: V. Moiseenko

journal_name: Annals of Oncology

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

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

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

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

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

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
Italy
Brazil
Netherlands
France
Poland
Belgium
Australia
Russian Federation
Spain
Denmark
Germany
United Kingdom

location_facility: AMC Academisch Medisch Centrum Medische Oncologie

location_facility: Hôpital Saint Antoine, oncology department

location_facility: Odense Universitetshospital - Department of Oncology

location_facility: Centro de Pesquisa Hospital de Caridade de Ijuí

location_facility: Leicester Royal Infirmary, The HOPE Clinical Trials Unit

location_facility: A.O. Ospedale Niguarda Ca' Granda-Milano, Department of Onco-Haematology- Onoclogia Falck

location_facility: Amphia Ziekenhuis, Interne Geneeskunde/Oncologie, Langendijk 75

location_facility: Centralny Szpital Kliniczny MSW Klinika Onkologii i Hematologii

location_facility: Centre René Gauducheau, Oncologie Médicale

location_facility: Hospital do Câncer de Barretos - Fundação Pio XII

location_facility: Scientific Centre for Specialized Medical Care (oncological)

location_facility: VieCurie Medisch Centrum, Interne Geneeskunde, Tegelseweg 210

location_facility: Instituto Nacional do Câncer - INCA Unidade de Pesquisa ClínicaInstituto Nacional do Câncer - INCA Unidade de Pesquisa Clínica

location_facility: Hospital Universitario Reina Sofia, Deparatmento Oncología Médica

location_facility: Imperial healthcare NHS Trust Charing Cross Hospital

location_facility: Mount Vernon Hospital Department of Oncology

location_facility: Complejo Hospitalario de Navarra, Oncología Médica

location_facility: Hospital General Universitario, Oncología Médica

location_facility: The Beatson West of Scotland Cancer Centre GI cancers

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii

location_facility: Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii

location_facility: Fondazione Poliambulanza Istituto Ospedaliero, Clinical Oncology

location_facility: Russian Cancer Research Center n.a. NN Blokhin, Department of Research for New Antitumour Medicines

location_facility: Zuyderland Medisch Centrum Interne Geneeskunde

location_facility: H. Universitario La Paz Oncología Médica

location_facility: NZOZ MAGODENT Oddzial Onkologii Klinicznej / Chemioterapii

location_facility: Seconda Università degli Studi di Napoli, U.O.C. di Oncologia Medica ed Ematologia

location_facility: The Queen Elizabeth Hospital Haematology and Oncology Unit

location_facility: CHU Jean Minjoz, Service d'oncologie médicale

location_facility: Austin Hospital Olivia Newton-John Cancer & Wellness Centre

location_facility: Tergooi Hilversum, Medische Oncologie, Van Riebeeckweg 212

location_facility: Hospital Ramón y Cajal, Oncología Médica

location_facility: Isala Klinieken, Medische oncologie, Dokter Van Heeweg 2

location_facility: .O.U. Pisana-Ospedale Santa Chiara, U.O. di Oncologia Medica 2

location_facility: Martini Ziekenhuizen, Interne Geneeskunde/Oncologie, Van Swietenplein 1

location_facility: Christie Hospital NHS Foundation Trust, GI & Endocrine

location_facility: Städtisches Krankenhaus München Neuperlach, Klinik für Onkologie und Hämatologie

location_facility: A.O.U. SanMartino-IST, Unità Operativa Oncologia Medica 1

location_facility: Sint Antonius Ziekenhuis Interne Geneeskunde/Oncologie

location_facility: Grand Hôpital de Charleroi Oncologie-Hématologie

location_facility: Hospital de Base, Centro Intergrado de Pesquisa

location_facility: Moscow City Oncology Hospital # 62, Chemotherapy

location_facility: Instituto Catalan De Oncología, Hospitalet de Llobregat

location_facility: Instituto do Câncer do Estado de São Paulo - ICESP, Núcleo de Pesquisa

location_facility: UZ Leuven Campus Gasthuisberg Digestieve Oncologie

location_facility: Schwerpunktpraxis für Hämatologie und Onkologie

location_facility: Catharina Ziekenhuis, Interne Geneeskunde/Oncologie

location_facility: Hospital Valle de Hebrón, Servicio de Oncología

title: An Open-label, Randomised, Non-comparative Phase 2 Study Evaluating S 95005 (TAS-102) Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Metastatic COlorectal Cancer Who Are Non-eligible for Intensive Therapy (TASCO1 Study).

summary: The main purpose of this study is to evaluate the progression-free survival (PFS) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy.


intervention_type: Other

ipd_sharing_description: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants/study sites, …).

lead_sponsor: Shire

location_country:
Italy
Finland
France
United Kingdom

location_facility: Great Ormond Street Hospital for Children

location_facility: Groupe Hospitalier Pellegrin - Hôpital des Enfants

ipd_sharing: No

title: A Randomized, Open-label, 24-Week Safety, Efficacy, and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome Who Are Dependent on Parenteral Support

summary: The purpose of the study is to evaluate the safety, efficacy/pharmacodynamics (PD) and pharmacokinetics (PK) of teduglutide treatment in infants with short bowel syndrome (SBS) dependent on parenteral (PN) support.


title: A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects With Narcolepsy

summary: The purpose of this study is to determine whether once-nightly FT218 is safe and effective for the treatment of excessive daytime sleepiness and cataplexy in subjects with narcolepsy.

lead_sponsor: Avadel

location_country:
United States
Germany
France
Czechia
Australia
Canada

location_facility: University Hospitals Case Medical Center

location_facility: Sleep Management Institute Intrepid Research

location_facility: OSF Healthcare Saint Francis Medical Center

location_facility: Baptist Health Center for Clinical Research

location_facility: Florida Pulmonary Research Institute LLC

location_facility: Sleep Medicine Specialist of South Florida

location_facility: NHMRC CEntre for Translational Sleep and Circadian Neurobiology

location_facility: INSERM - Centre d'Investigation Clinque Hopital Robert Debre

location_facility: Yale-New Haven Hospital's Sleep Medicine Center

location_facility: NeuroMedical Research Institute/Global Research Holdings, LLC

location_facility: CIUSS de Nord-de-I'ile-de- Montreal- Hopital de Sacre-Coeur de Montreal

location_facility: Medical University of South Carolina - Institute of Psychiatry


lead_sponsor: H. Lundbeck A/S

location_country:
Italy
South Africa
Serbia
United Kingdom
Mexico
Germany
France
Bulgaria
Korea, Republic of
Poland
Hungary
Russian Federation
Spain
Estonia
United States
Latvia
Canada
Colombia
Ukraine

location_facility: RS1006 Clinic of Neurology and Psychiatry for Children and Adolescents

location_facility: US1385 Ericksen Research And Development

title: Interventional, Randomised, Double-blind, Placebo-controlled, Active Reference (Fluoxetine), Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years, With Major Depressive Disorder (MDD)

summary: Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD).


location_country:
Italy
South Africa
Serbia
Mexico
Germany
France
Bulgaria
Korea, Republic of
Israel
Poland
Hungary
Russian Federation
Spain
Estonia
United States
Latvia
Canada
Colombia
Ukraine

location_facility: State Budgetary Healthcare Institution of Sverdlovsk Region Â¿Sverdlovsk Regional Clinical Psychi...

location_facility: Centro Investigacion Medico Biologica Y Terapia Avanzada

location_facility: Filip Rybakowski Specjalistyczna Praktyka Lekarska

location_facility: E.S.E. Hospital Mental de Antioquia HOMO

location_facility: Scientific Institute Fondazione Stella Maris

location_facility: Ukrainian Research Institute Of Social, Forensic Psychiatry And Drug Abuse, Kiev City Psychoneuro...

location_facility: State Budgetary Healthcare Institution (SBHI) Specialized Clinical Psychiatric Hospital 1 of the ...

location_facility: Guz Saratov Regional Psychiatric Hospital St. Sofii

location_facility: Ternopil Regional Clinical Municipal Psycho-Neurological Hospital, Ternopil State Medical Univers...

location_facility: St. Charles Psychiatric Associates - Midwest Research Group

location_facility: ICARO Investigaciones en Medicina S.A. de C.V.

location_facility: Centrum Badan Klinicznych PI-House Sp. z o.o.

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Centro de investigaciones del Sistema Nervioso SAS Grupo CISNE SAS

location_facility: Children's National Medical Center Merge

location_facility: Alliance for Wellness dba Alliance for Research

location_facility: City Psychiatric Hospital # 3 named after I.I. Skvortsov-Stepanov

location_facility: Child and Adolescent Neurology and Psychiatry Clinic

location_facility: Diagnostic Consultative Center Mladost-M Varna OOD

location_facility: Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)

location_facility: Clinical Center of Vojvodina - Clinic of Psychiatry

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA LTDA IPS.

location_facility: The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital

location_facility: Specjalistyczny Szpital im. dra A. Sokolowskiego w Walbrzychu

location_facility: Odessa Regional Medical Centre of Mental Health

location_facility: Rheinhessen-Fachklinik Mainz, Kinder und Jugendpsychiatri

location_facility: LLC City Neurological Center Sibneuromed

location_facility: Kansas University School of Medicine-Wichita

location_facility: Spectrum Centrum Psychiatrii Specjalistyczny Gabinet Psychiatryczny

location_facility: Yaroslavl Regional Clinical Psychiatry Hospital

location_facility: Arkhangelsk Regional Clinical Mental Hospital

location_facility: Stavropol Region Psychiatric Hospital #2

location_facility: Medical Research Group of Central Florida

location_facility: Unidad de Salud Mental Infanto-Juvenil (USMI-J) Edificio de Consultas Externas. Hospital MarAtimo

location_facility: Daily Hospital for Children and Adolescents

location_facility: CRI Centro Regiomontano de Investigacion SC

location_facility: Medicorehabilitation Research Center Phoenix

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

location_facility: Rostov State Medical University of the Minzdravsotsrazvitiya of Russia

location_facility: Maltsev Poltava Regional Clinical Psychiatric Hospital, Higher State Educational Institution Of U...

location_facility: University Hospital Cleveland Medical Center Division of Child and Adolescent Psychiatry

location_facility: Przychodnia Syntonia Poradnia Zdrowia Psychicznego

title: Interventional, Randomised, Double-blind, Placebo-controlled, Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years With Major Depressive Disorder (MDD)

summary: Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric patients (age 7 to 11 years)


title: A Randomized, Controlled, Double Blind, Parallel Group, Multi-country Study to Investigate the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth, Safety and Tolerance in Healthy Term Infants

acronym: TENUTO

summary:
It is universally accepted that the best nutrition for a new-born infant is breast milk. Breast milk provides a complete set of nutrients to support growth and development of children in early life, including components that have a beneficial effect on gut health and the body's ability to defend itself against infectious organisms and other invaders (immune system).However, it may occur that a mother is unable to breastfeed her child, or chooses not to breastfeed. In such cases, an infant formula inspired by breast milk is the best alternative. Research is done to optimize milk formula for infants. One of these formulas contains 'partially hydrolyzed' proteins instead of intact proteins, meaning the proteins in this formula are broken down into smaller pieces. These smaller pieces of protein make the milk more suitable for consumption by infants at risk of developing cow's milk allergy. These types of partially hydrolyzed protein formulas have been on the market for several years, in particular for children with a family risk of allergy. So far, no safety related issues have been reported. It is also known that weight gain of infants receiving partially hydrolyzed proteins in general is appropriate according to the World Health Organisation growth standards.

The main purpose of the TENUTO study is to demonstrate that infants who receive a specific partially hydrolyzed protein infant formula for the first 4 months of life have a similar weight gain compared to infants receiving standard infant formula with intact proteins. A group of infants who receive breast milk only is also included for comparison.

primary_purpose: Prevention

lead_sponsor: Nutricia Research

location_country: Netherlands Finland Poland France Spain Germany

location_facility: Specjalistyczna Poradnia Medyczna Przylądek Zdrowia

location_facility: Groupement des Hopitaux de l'institut Catholique de Lille

location_facility: Vivantes Klinik für Geburtsmedizin, Klinikum Neukölln

location_facility: Hospital Universitari de Tarragona Joan XXIII

location_facility: NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska

location_facility: Hospital Universitari Sant Joan de Reus (IISPV)

location_facility: Poliklinika Ginekologiczno-Poloznicza Sp. z o.o. Sp.k

location_facility: University of Turku Children's Allergy and Asthma Clinic


title: A Phase 2, Open-label, Multiple Cohort, Single-arm, Multi-center Trial to Determine the Safety, Feasibility and Efficacy of JCAR015 in Adult Subjects With B-cell Acute Lymphoblastic Leukemia.

acronym: ORBIT

summary: This is a single-arm, multi-center, open-label, Phase 2 study to determine the efficacy and safety of JCAR015 in adult subjects with B-cell ALL. The study is divided into two sequential parts, Part A and Part B; subjects will be screened and will provide informed consent before initiating any study procedures in Part A of the study.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Celgene

location_country:
Italy
Switzerland
France
Belgium
Spain
Germany
United Kingdom

location_facility: USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden

location_facility: Istituto Clinico Humanitas - Istituti di Ricovero E Cura A Carattere Scientifico (IRCSS)

location_facility: Bristol Royal Infirmary, University of Bristol Foundation Trust


title: Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement

summary:
The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.

The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.

ReferenceCitation: Lanz J, Reardon MJ, Pilgrim T, Stortecky S, Deeb GM, Chetcuti S, Yakubov SJ, Gleason TG, Huang J, Windecker S. Incidence and Outcomes of Infective Endocarditis After Transcatheter or Surgical Aortic Valve Replacement. J Am Heart Assoc. 2021 Oct 5;10(19):e020368. doi: 10.1161/JAHA.120.020368. Epub 2021 Sep 28.

name: Department of Cardiology InselspitalBern University Hospital Bern Switzerland

family: Lanz

full_name: Jonas Lanz

given: Jonas

name: Methodist DeBakey Heart & Vascular Center Houston TX

family: Reardon

full_name: Michael J. Reardon

given: Michael J.

family: Pilgrim

full_name: Thomas Pilgrim

given: Thomas

family: Stortecky

full_name: Stefan Stortecky

given: Stefan

name: University of Michigan Medical Center Ann Arbor MI

family: Deeb

full_name: G. Michael Deeb

given: G. Michael

family: Chetcuti

full_name: Stanley Chetcuti

given: Stanley

name: Riverside Methodist Hospital Columbus OH

family: Yakubov

full_name: Steven J. Yakubov

given: Steven J.

name: Division of Cardiac Surgery, Brigham & Women's Hospital & Harvard Medical School Boston MA

family: Gleason

full_name: Thomas G. Gleason

given: Thomas G.

name: Department of Statistics Medtronic, plc Minneapolis MN

family: Huang

full_name: Jian Huang

given: Jian

family: Windecker

full_name: Stephan Windecker

given: Stephan

journal_name: Journal of the American Heart Association

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Blanke P, Leipsic JA, Popma JJ, Yakubov SJ, Deeb GM, Gada H, Mumtaz M, Ramlawi B, Kleiman NS, Sorajja P, Askew J, Meduri CU, Kauten J, Melnitchouk S, Inglessis I, Huang J, Boulware M, Reardon MJ; Evolut Low Risk LTI Substudy Investigators. Bioprosthetic Aortic Valve Leaflet Thickening in the Evolut Low Risk Sub-Study. J Am Coll Cardiol. 2020 May 19;75(19):2430-2442. doi: 10.1016/j.jacc.2020.03.022. Epub 2020 Mar 28.

family: Blanke

full_name: Philipp Blanke

given: Philipp

family: Leipsic

full_name: Jonathon A. Leipsic

given: Jonathon A.

family: Popma

full_name: Jeffrey J. Popma

given: Jeffrey J.

family: Gada

full_name: Hemal Gada

given: Hemal

family: Mumtaz

full_name: Mubashir Mumtaz

given: Mubashir

family: Ramlawi

full_name: Basel Ramlawi

given: Basel

family: Kleiman

full_name: Neal S. Kleiman

given: Neal S.

family: Sorajja

full_name: Paul Sorajja

journal_name: Journal of the American College of Cardiology

ReferenceCitation: Popma JJ, Deeb GM, Yakubov SJ, Mumtaz M, Gada H, O'Hair D, Bajwa T, Heiser JC, Merhi W, Kleiman NS, Askew J, Sorajja P, Rovin J, Chetcuti SJ, Adams DH, Teirstein PS, Zorn GL 3rd, Forrest JK, Tchétché D, Resar J, Walton A, Piazza N, Ramlawi B, Robinson N, Petrossian G, Gleason TG, Oh JK, Boulware MJ, Qiao H, Mugglin AS, Reardon MJ; Evolut Low Risk Trial Investigators. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715. doi: 10.1056/NEJMoa1816885. Epub 2019 Mar 16.

name: From Beth Israel Deaconess Medical Center, Boston (J.J.P.); University of Michigan Hospitals, Ann Arbor (G.M.D., S.J.C.), and Spectrum Health Hospitals, Grand Rapids (J.C.H., W.M.) — both in Michigan; Riverside Methodist–Ohio Health, Columbus (S.J.Y.); University of Pittsburgh Medical Center Pinnacle Health, Harrisburg (M.M., H.G.), and the University of Pittsburgh, Pittsburgh (T.G.G.) — both in Pennsylvania; Aurora–Saint Luke’s Medical Center, Milwaukee (D.O., T.B.); Houston Methodist Debakey Heart and...

ReferenceCitation: Leipsic J, Bax JJ, Webb JG, Martin R, Blanke P. Trials Testing the Value of Imaging Use in Valve Disease and in Transcatheter Valvular Interventions. JACC Cardiovasc Imaging. 2017 Mar;10(3):286-295. doi: 10.1016/j.jcmg.2016.09.031. Review.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

location_country:
United States
Netherlands
France
Japan
Australia
New Zealand
Canada

location_facility: Baylor Jack and Jane Hamilton Heart and Vascular Hospital

location_facility: University of Pittsburgh Medical Center UPMC Presbyterian

location_facility: University of Southern California University Hospital

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: The University of Vermont Medical Center

location_facility: National Cerebral and Cardiovasclular Center

location_facility: University Hospitals Case Medical Center


lead_sponsor: Vifor Fresenius Medical Care Renal Pharma

location_country:
United States
Poland
France
Lithuania
Romania
Russian Federation
Germany

location_facility: Uniwersytecki Szpital Dzieciecy w Krakowie - Prokocimiu

location_facility: Hospital Of Lithuanian University Of Health Sciences Kaunas Clinics

location_facility: Washington University School of Medicine in St. Louis

location_facility: Texas Children's Hospital - Texas Children's Feigin Center

location_facility: St. Vladimir Children's City Clinical Hospital

location_facility: Oregon Health and Science University, Doernbecher Children's Hospital

location_facility: Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku

location_facility: Service de Néphrologie et Endocrinologie pédiatriques

location_facility: University of Iowa Hospitals and Clinics

location_facility: The University of Texas Southwestern Medical Center

location_facility: University of Miami - Miller School of Medicine

location_facility: Instytut "Pomnik - Centrum Zdrowia Dziecka"

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: The University of Texas Medical School at Houston

location_facility: St. Petersburg GBUZ "Children's City Hospital No. 1"

location_facility: Spitalul Clinic de Urgenţă pentru copii "Maria Sklodowska Curie"

location_facility: Children's Hospital, Affiliate of Vilnius University Hospital Santariskiu Klinikos

location_facility: University of Alabama at Birmingham School of Medicine

title: An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients With Hyperphosphataemia

summary: This is a Phase 3, Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients with Hyperphosphataemia. The aim of this Phase 3 clinical study is to demonstrate similar efficacy of PA21 (Velphoro) in paediatric and adolescent patients with CKD, and to provide safety and dosing information for this patient population. The Phoslyra (comparator) group provides information for a descriptive comparison of PA21 against a commonly used calcium-based phosphate binder (calcium acetate).


location_country:
Jordan
Finland
Russian Federation
Taiwan
India
Croatia
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
South Africa
Saudi Arabia
Switzerland
Bulgaria
Singapore
Hungary
China
Portugal
United States
Germany
Italy
Austria
Lebanon
Czechia
Israel
Spain
Turkey

title: Multicenter, Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCZ696 Followed by a 52-week Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared With Enalapril in Pediatric Patients From 1 Month to < 18 Years of Age With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction

summary:
This study consist of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study.

The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in pediatric heart failure patients over 52 weeks of treatment.


title: An Open Label Multi-Center Extension Study to Evaluate the Long-term Safety of Zorblisa™ (SD-101-6.0) in Patients With Epidermolysis Bullosa

summary: The study aimed to assess the long-term safety of topical use of Zorblisa (SD-101-6.0) in participants with Epidermolysis Bullosa (EB).

lead_sponsor: Scioderm, Inc.

location_country:
Austria
Serbia
Netherlands
Germany
France
Poland
Lithuania
Israel
Australia
Spain
United States
United Kingdom


lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
Canada
France

location_facility:
Dana Farber Cancer Institute
MD Anderson Cancer Center
University of Alberta Hospital
CHU de Bordeaux
UC Davis; Comprehensive Cancer Center
Princess Margaret Cancer Center
Hopital Avicenne, Paris
Universita di Roma
Univ of Calif, San Francisco
Presidio san salvatore muraglia
Weill Cornell Medical College
University of Colorado
Wake Forest Baptist Medical Center
Jewish General Hospital
Institut Paoli Calmettes
University of Bologna
USC Norris Cancer Center

title: A Phase IB Multi-Arm Study With Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy

summary: The primary objective for this study is to assess the safety and tolerability as well as preliminary efficacy of venetoclax in combination with cobimetinib, and venetoclax in combination with idasanutlin in patients with relapsed or refractory acute myeloid leukemia (R/R) AML who are not eligible for cytotoxic therapy.


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

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Italy
Austria
United States
Mexico
Netherlands
Germany
France
Czechia
Norway
Hungary
Argentina
Belgium
Ireland
Spain
Canada
United Kingdom
Colombia

acronym: PDUS

title: A 52-week, Multicenter Study to Assess the Time Course of Response to Secukinumab on Joint Inflammation Using Power Doppler Ultrasonography in Patients With Active Psoriatic Arthritis

summary: This study was designed to leverage the sensitivity of ultrasonography available in clinical practice setting to better describe the time course of response to secukinumab (150 mg and 300 mg) on joint synovitis and enthesitis in PsA patients with an inadequate response to non-biologic DMARDs. PDUS changes in joint synovitis will be assessed using the global Outcome Measures in Rheumatology (OMERACT)-European League against Rheumatism (EULAR) synovitis score (GLOESS) and changes in joint enthesitis were assessed using the OMERACT enthesitis score.


ReferenceCitation: Blom DJ, Chen J, Yuan Z, Borges JLC, Monsalvo ML, Wang N, Hamer AW, Ge J. Effects of evolocumab therapy and low LDL-C levels on vitamin E and steroid hormones in Chinese and global patients with type 2 diabetes. Endocrinol Diabetes Metab. 2020 Mar 6;3(2):e00123. doi: 10.1002/edm2.123. eCollection 2020 Apr.

name: University of Cape Town Cape Town South Africa

family: Blom

full_name: Dirk J. Blom

given: Dirk J.

name: Guangdong Cardiovascular Institute Guangdong General Hospital Guangzhou China

family: Chen

full_name: Jiyan Chen

given: Jiyan

name: First Affiliated Hospital of Xi’an Jiaotong University Xi’an China

family: Yuan

full_name: Zuyi Yuan

given: Zuyi

name: Universidade Catolica de Brasilia Brasilia Brazil

family: Borges

full_name: Joao L. C. Borges

given: Joao L. C.

family: Monsalvo

full_name: Maria L. Monsalvo

given: Maria L.

family: Wang

full_name: Nan Wang

family: Hamer

full_name: Andrew W. Hamer

given: Andrew W.

name: Zhongshan Hospital Fudan University Shanghai China

family: Ge

full_name: Junbo Ge

given: Junbo

journal_name: Endocrinology, Diabetes & Metabolism

oa_colors: green gold

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Effects of evolocumab therapy and low LDL‐C levels on vitamin E and steroid hormones in Chinese and global patients with type 2 diabetes

ReferenceCitation: Chen Y, Yuan Z, Lu J, Eliaschewitz FG, Lorenzatti AJ, Monsalvo ML, Wang N, Hamer AW, Ge J. Randomized study of evolocumab in patients with type 2 diabetes and dyslipidaemia on background statin: Pre-specified analysis of the Chinese population from the BERSON clinical trial. Diabetes Obes Metab. 2019 Jun;21(6):1464-1473. doi: 10.1111/dom.13700. Epub 2019 Apr 14.

name: Department of CardiologyChinese People's Liberation Army General Hospital Beijing China

full_name: Yundai Chen

given: Yundai

name: First Affiliated Hospital of Xi'an Jiaotong University Shaanxi China

name: Department of EndocrinologyChinese People's Liberation Army General Hospital Beijing China

family: Lu

full_name: Juming Lu

given: Juming

name: CPCLIN/DASA ‐ Centro de Pesquisas Clínicas São Paulo Brazil

family: Eliaschewitz

full_name: Freddy G. Eliaschewitz

given: Freddy G.

name: Clinical Research and Cardiology, Instituto Medico DAMIC / Fundación Rusculleda Córdoba Argentina

family: Lorenzatti

full_name: Alberto J. Lorenzatti

given: Alberto J.

name: Clinical Development, Amgen Inc. Thousand Oaks California

full_name: Maria Laura Monsalvo

given: Maria Laura

name: Department of Cardiology, Shanghai Institute of Cardiovascular DiseasesZhongshan Hospital, Fudan University Shanghai China

title: Randomized study of evolocumab in patients with type 2 diabetes and dyslipidaemia on background statin: Pre‐specified analysis of the Chinese population from the BERSON clinical trial

location_country:
Brazil
United States
France
Argentina
Russian Federation
China
Turkey
Canada
Korea, Republic of
Colombia

title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety and Efficacy of Evolocumab (AMG 145) in Combination With Statin Therapy in Diabetic Subjects With Hyperlipidemia or Mixed Dyslipidemia (BERSON)

summary: The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in diabetic adults with hyperlipidemia or mixed dyslipidemia.


title: Peptide Receptor Radionuclide Therapy (PRRT) in Combination With Lanreotide Autogel: A Retrospective Study in Progressive Digestive and Bronchopulmonary Neuroendocrine Neuroendocrine Tumours

acronym: PRELUDE

summary: The objective of the PRELUDE study is to describe the use of lanreotide Autogel® (LAN ATG) combined with Peptide Receptor Radionuclide Therapy (PRRT) in the treatment of progressive neuroendocrine tumours located in the lung or in the digestive system as there is currently limited data on these treatments used together for these types of neuroendocrine tumours.

time_perspective: Retrospective

ReferenceCitation: Prasad V, Srirajaskanthan R, Toumpanakis C, Grana CM, Baldari S, Shah T, Lamarca A, Courbon F, Scheidhauer K, Baudin E, Truong Thanh XM, Houchard A, Dromain C, Bodei L. Lessons from a multicentre retrospective study of peptide receptor radionuclide therapy combined with lanreotide for neuroendocrine tumours: a need for standardised practice. Eur J Nucl Med Mol Imaging. 2020 Sep;47(10):2358-2371. doi: 10.1007/s00259-020-04712-2. Epub 2020 Feb 15.

family: Prasad

full_name: Vikas Prasad

given: Vikas

family: Srirajaskanthan

full_name: Raj Srirajaskanthan

given: Raj

family: Toumpanakis

full_name: Christos Toumpanakis

given: Christos

family: Grana

full_name: Chiara Maria Grana

given: Chiara Maria

family: Baldari

full_name: Sergio Baldari

given: Sergio

family: Shah

full_name: Tahir Shah

given: Tahir

family: Lamarca

full_name: Angela Lamarca

given: Angela

family: Courbon

full_name: Frédéric Courbon

given: Frédéric

family: Scheidhauer

full_name: Klemens Scheidhauer

given: Klemens

family: Baudin

full_name: Eric Baudin

given: Eric

family: Truong Thanh

full_name: Xuan-Mai Truong Thanh

given: Xuan-Mai

family: Houchard

full_name: Aude Houchard

given: Aude

family: Dromain

full_name: Clarisse Dromain

given: Clarisse

family: Bodei

full_name: Lisa Bodei

given: Lisa

journal_name: European Journal of Nuclear Medicine and Molecular Imaging

license: cc-by

license_normalized: cc-by

repository_institution: Technische Universität München - mediaTUM Gesamtbestand

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Ipsen

location_country:
Italy
France
Australia
Germany
United Kingdom

location_facility:
Peter MacCallum Cancer Centre
Queen Elizabeth Hospital Birmingham
Royal Free Hospital London
IEO Institutio Europeo di Oncologia
IUCT Oncopole
Klinikum rechts der Usar
Unversità degli Studi di Messina
The Christie NHS Foundation Trust
Institut Gustave Roussy
Charité
Kings College Hospital
Zentralklinil Bad Berka


title: An Exploratory Phase II Study to Demonstrate the Safety and Efficacy of A4250 in Children With Cholestatic Pruritus

summary: This study will evaluate A4250 (IBATinhibitor) as a treatment option in pediatric patients with chronic cholestasis with main emphasis on safety evaluation and on effects on pruritus

lead_sponsor: Albireo

location_country:
Sweden
France
Denmark
Germany
United Kingdom

location_facility: Pediatric Gastroenterology and Hepatology, Pediatric Surgery, Hannover

location_facility: Department of Pediatric Gastroenterology Hepatology-Nutrition, Necker-Enfants maladies hospital

location_facility: Department of Pediatric and Adolescent Medicine Rigshospitalet

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Pediatric Hepatology and Liver Transplantation, University Hospitals of Paris-Sud

location_facility: Gastroenterology/Hepatology, University Hospital for Children and Adolescents


ReferenceCitation: Harrington KJ, Kong A, Mach N, Chesney JA, Fernandez BC, Rischin D, Cohen EEW, Radcliffe HS, Gumuscu B, Cheng J, Snyder W, Siu LL. Talimogene Laherparepvec and Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (MASTERKEY-232): A Multicenter, Phase 1b Study. Clin Cancer Res. 2020 Oct 1;26(19):5153-5161. doi: 10.1158/1078-0432.CCR-20-1170. Epub 2020 Jul 15.

family: Harrington

full_name: Kevin J. Harrington

given: Kevin J.

family: Kong

full_name: Anthony Kong

given: Anthony

family: Mach

full_name: Nicolas Mach

given: Nicolas

family: Chesney

full_name: Jason A. Chesney

given: Jason A.

family: Fernandez

full_name: Beatriz Castelo Fernandez

given: Beatriz Castelo

family: Rischin

full_name: Danny Rischin

given: Danny

family: Cohen

full_name: Ezra E.W. Cohen

given: Ezra E.W.

family: Radcliffe

full_name: Hoi-Shen Radcliffe

given: Hoi-Shen

family: Gumuscu

full_name: Burak Gumuscu

given: Burak

family: Cheng

full_name: Jonathan Cheng

given: Jonathan

family: Snyder

full_name: Wendy Snyder

given: Wendy

family: Siu

full_name: Lillian L. Siu

given: Lillian L.

journal_name: Clinical Cancer Research

evidence: open (via free pdf)

publisher: American Association for Cancer Research (AACR)

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Italy
Austria
United States
Switzerland
France
Greece
Australia
Belgium
Spain
Canada
United Kingdom

title: A Phase 1b/3 Multicenter, Randomized, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab for the Treatment of Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

summary: The primary objective of this study was to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).


type: Registry Identifier

title: Deep Brain Stimulation (DBS) of the Globus Pallidus (GP) in Huntington's Disease (HD): A Prospective, Randomised, Controlled, International, Multi-centre Study

acronym: HD-DBS

summary: The aim of the study is to prove the efficacy and safety of pallidal DBS in HD patients and to show superiority of DBS on motor function in the stimulation group compared to stimulation-off group

ReferenceCitation: Moro E, Lang AE, Strafella AP, Poon YY, Arango PM, Dagher A, Hutchison WD, Lozano AM. Bilateral globus pallidus stimulation for Huntington's disease. Ann Neurol. 2004 Aug;56(2):290-4.

ReferenceCitation: Groiss SJ WL, Suedmeyer, M, Ploner M, Reck C, Voges J, SturmV, Timmermann L, Schnitzler A. Effect of bilateral pallidal deep brain stimulation in Huntington's disease: A case report. Mov Disord, Volume 21, Issue S15. Tenth International Congress of Parkinson's Disease and Movement Disorders. Kyoto 2006.

ReferenceCitation: Fasano A, Cadeddu F, Guidubaldi A, Piano C, Soleti F, Zinzi P, Bentivoglio AR. The long-term effect of tetrabenazine in the management of Huntington disease. Clin Neuropharmacol. 2008 Nov-Dec;31(6):313-8. doi: 10.1097/WNF.0b013e318166da60.

ReferenceCitation: Wojtecki L, Groiss SJ, Ferrea S, Elben S, Hartmann CJ, Dunnett SB, Rosser A, Saft C, Südmeyer M, Ohmann C, Schnitzler A, Vesper J; Surgical Approaches Working Group of the European Huntington's Disease Network (EHDN). A Prospective Pilot Trial for Pallidal Deep Brain Stimulation in Huntington's Disease. Front Neurol. 2015 Aug 18;6:177. doi: 10.3389/fneur.2015.00177. eCollection 2015.

ReferenceCitation: Wojtecki L, Groiss SJ, Hartmann CJ, Elben S, Omlor S, Schnitzler A, Vesper J. Deep Brain Stimulation in Huntington's Disease-Preliminary Evidence on Pathophysiology, Efficacy and Safety. Brain Sci. 2016 Aug 30;6(3). pii: E38. doi: 10.3390/brainsci6030038. Review.

ReferenceCitation: Rodrigues FB, Ferreira JJ, Wild EJ. Huntington's Disease Clinical Trials Corner: June 2019. J Huntingtons Dis. 2019;8(3):363-371. doi: 10.3233/JHD-199003.

name: UCL Huntington’s Disease Centre, UCL Queen Square Institute of Neurology, University College London, London, UK

name: Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal

name: Instituto de Medicina Molecular, Lisbon, Portugal

family: Rodrigues

full_name: Filipe B. Rodrigues

given: Filipe B.

name: CNS - Campus Neurológico Sénior, Torres Vedras, Portugal

family: Ferreira

full_name: Joaquim J. Ferreira

given: Joaquim J.

family: Wild

full_name: Edward J. Wild

given: Edward J.

journal_name: Journal of Huntington's Disease

oa_colors: green other

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

publisher: IOS Press

publisher_dissemination: IOS Press

publisher_group: IOS Press

publisher_normalized: IOS Press

title: Huntington’s Disease Clinical Trials Corner: June 2019

ReferenceCitation: Hartmann CJ, Groiss SJ, Vesper J, Schnitzler A, Wojtecki L. Brain stimulation in Huntington's disease. Neurodegener Dis Manag. 2016 Jun;6(3):223-36. doi: 10.2217/nmt-2016-0007. Epub 2016 May 27. Review.

name: Department of Neurology, Medical Faculty, Heinrich-Heine University Düsseldorf, Moorenstrasse 5, 40225 Düsseldorf, Germany

name: Institute of Clinical Neuroscience & Medical Psychology, Medical Faculty, Heinrich-Heine University Düsseldorf, Germany

family: Hartmann

full_name: Christian Johannes Hartmann

given: Christian Johannes

family: Groiss

full_name: Stefan Jun Groiss

given: Stefan Jun

name: Department of Neurosurgery, Medical Faculty, Heinrich-Heine University Düsseldorf, Germany

family: Vesper

full_name: Jan Vesper

given: Jan

family: Schnitzler

full_name: Alfons Schnitzler

given: Alfons

family: Wojtecki

full_name: Lars Wojtecki

given: Lars

journal_name: Neurodegenerative Disease Management

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

ipd_sharing_description: After the study the data will be provided to the CHDI. The Foundation may use, and make available for use by the Foundation Collaborators, the Study Data for the following purposes: (A) to design and guide future research studies and clinical trials and (B) to support and enable the following scientific discussion and research: (1) to better understand HD or other diseases being studied, (2) that furthers the development of treatments for HD or other diseases or (3) that furthers biomedical research.

lead_sponsor: Heinrich-Heine University, Duesseldorf

location_country: Austria Germany France Switzerland

location_facility: CHU Amiens Hôpital nord, Department of neurosurgery and Department of neurology

location_facility: Hôpital Roger Salengro, Service de Neurologie et Pathologie du mouvement

location_facility: University hospital Heinrich Heine University Düsseldorf