title: Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT)

acronym: FORMaT

summary: Mycobacterium abscessus (MABS) is a group of rapid-growing, multi-drug resistant non-tuberculous mycobacteria (NTM) causing infections in humans. MABS pulmonary disease (MABS-PD) can result in significant morbidity, increased healthcare utilisation, accelerated lung function decline, impaired quality of life, more challenging lung transplantation, and increased mortality. While the overall numbers affected is small, the prevalence of infections is increasing worldwide. The Finding the Optimal Regimen for Mycobacterium abscessus Treatment (FORMaT) trial aims to produce high quality evidence for the best treatment regimens to maximise health outcomes and minimise toxicity and treatment burden, as well as developing biomarkers (serology, gene expression signatures, and radiology) to guide decisions for starting treatment and measuring disease severity in patients with MABS PD.

ipd_sharing_description: All de-identified raw data measured during the trial will be made available.

lead_sponsor: The University of Queensland

collaborators: Australian Government Department of Health and Ageing

collaborators: South Australian Health and Medical Research Institute

collaborators: James Cook University, Queensland, Australia

location_country:
Ireland
New Zealand
United Kingdom
Singapore
Denmark
Australia
Netherlands
Canada
France

location_facility:
Royal Hobart Hospital
Mater Adult Hospital
Skejby University Hospital
St Michaels Hospital
Sir Charles Gardiner Hospital
Sydney Children's Hospital
Gladstone Hospital
The Prince Charles Hospital
Gold Coast University Hospital
Greenslopes Private Hospital,
John Hunter Hospital
Erasmus MC Sophia Children's Hospital
Royal Brompton Hosptial
The Children's Hospital at Westmead
Westmead Hospital
Princess Alexandra Hospital
Nottingham Children's Hosptial
The Hospital for Sick Kids
Perth Children's Hospital
Cairns Base Hospital
St George's Hospital
Tan Tock Seng Hospital Pte Ltd
Starship Children's Hosptial
Sunshine Coast University Hospital
St Vincent's University Hospital
Concord Repatriation Hospital
Monash Children's Hospital
Queensland Children's Hospital
Rigshospitalet
Royal Prince Alfred Hospital
Royal Brisbane & Women's Hospital
Hospital Cochin
Royal Adelaide Hospital
Rockhampton Hospital
The Alfred
Townsville Hospital
Mackay base Hospital
Monash Medical Centre


title: Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive

summary:
Approximately one fourth of cases of endometrial cancer (EC) are diagnosed in premenopausal women, of whom approximately 40% wish to preserve their fertility. When arising in young women, EC usually presents with favorable prognostic features, as a focal, well differentiated endometrioid tumor, with minimal or absent myometrial invasion. This profile corresponds to the Type 1 EC, which correlates with the estrogen/progesterone receptor positive (ER+/PR+) pattern. On the other hand, these patients frequently present with clinical signs of a hyperestrogenism (chronic anovulation, infertility, obesity). Primary progestin therapy has been demonstrated to be effective in early well differentiated tumors and in poor operative candidates with response rates ranging from 58-100%.Currently, the therapeutic approach to an early stage EC consists of a staging laparotomy/laparoscopy, including a total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH-BSO), peritoneal washings, and lymphadenectomy (pelvic and aortic), depending on the pathological risk profile pre- and intraoperatively determined. Therefore, the current standard of surgical approach is preclusive of fertility.

The worldwide experience and data on conservative management of EC are, however, still limited. Most of reports based on cases retrospectively collected, harboring potential methodological bias, using different treatments and drugs, and with insufficient follow-up.

Some systematic reviews have been published in the last decade, trying to summarize the literature data. Therapeutic results seem to be promising with a regression rate of approximately 75% and relapse occurring in 25-40% of cases, with anecdotical reports of deaths of disease (DOD). The fertility outcome was, however, not satisfying with about 30% pregnancy rate in patients attempting to conceive, and an overall low rate of assisted reproductive techniques (ART) despite the subfertile clinical profile.Therefore, there is a need for a prospective, multicentre cooperative project able to systematically collect data from consecutive patients treated according to defined (not necessarily identical) protocols, concerning the oncological, as well as, the obstetrical outcomes. Moreover, this project could represent the "template" in which a pretreatment fertility counseling, psychological support, and definitive surgery are routinely included according to shared criteria.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: Data generated are property of all investigators and will be object of publication after general agreement.

lead_sponsor: National Cancer Institute, Naples

location_country:
Germany
Ireland
Italy
United Kingdom
Denmark
Australia
Japan
Netherlands
Austria
Belgium
United States
China
Korea, Republic of
Spain
Canada
France

location_facility: SGCTG (Scottish Gynaecological Cancer Trials Group)

location_facility: NOGGO (Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie)

location_facility: KGOG - Korean Gynecologic Oncology Group

location_facility: GEICO - Grupo Espanol de Investigacion en Cancer de Ovario

location_facility: GINECO - Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens

location_facility: ANZGOG - Australia and New Zealand Gynecological Oncology Group

location_facility: PMHC (Princess Margaret Hospital Consortium)

location_facility: SGOG (Shanghai Gynecologic Oncology Group)

location_facility: GOTIC - Gynecologic Oncology Trial and Investigation Consortium

location_facility: JGOG - Japanese Gynecologic Oncology Group

location_facility: ICORG - Ireland Cooperative Oncology Research Group

location_facility: NCIC Clinical Trials Group (Canadian Cancer Society Research Institute)

location_facility: EORTC - European Organization for Research and Treatment of Cancer

location_facility: AGO-AUST Arbeitsgemeinschaft Gynaekologische Onkologie

location_facility: AGO-De Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom

location_facility: MITO (Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies)

location_facility: NSGO (Nordic Society of Gynecologic Oncology)

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Ongoing


acronym: FRESH

intervention_type: Drug

lead_sponsor: Quantum Genomics SA

summary: This is a double-blind, placebo-controlled, multicenter, efficacy and safety study of firibastat (QGC001) administered po bid over 12 weeks in male and female subjects ≥18 years of age at Screening, with uncontrolled primary HTN. Subjects will be randomized 1:1 to investigational product (IP) and will receive either firibastat (QGC001) or matching placebo on top of their current chronic antihypertensive treatments.

ReferenceType: derived

ReferenceCitation: Khosla J, Aronow WS, Frishman WH. Firibastat: An Oral First-in-Class Brain Aminopeptidase A Inhibitor for Systemic Hypertension. Cardiol Rev. 2022 Jan-Feb 01;30(1):50-55. doi: 10.1097/CRD.0000000000000360.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wolters Kluwer Health

location_facility: Universitätsklinikum Schleswig-Holstein - Campus Kiel

location_facility: Les Hôpitaux Universitaires de Strasbourg

location_facility: Jacksonville Center for Clinical Research

location_facility: Sterling Research Group - Cincinnati / Mount Auburn

status: Completed

title: A Phase 3, Double-blind, Placebo-controlled, Efficacy and Safety Study of Firibastat (QGC001) Administered Orally, Twice Daily, Over 12 Weeks in Difficult-to-treat/Resistant Hypertensive Subjects

primary_purpose: Treatment

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Poland
United States
Spain
Czechia
France

study_type: Interventional

ipd_sharing: No

status_simplified: Completed


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)

summary: This study is an open-label extension to evaluate the safety and tolerability of long-term dosing of Losmapimod in patients with FSHD1 who participated in the ReDux4 study.

status: Active, not recruiting

ReferenceType: background

ReferenceCitation: Barbour AM, Sarov-Blat L, Cai G, Fossler MJ, Sprecher DL, Graggaber J, McGeoch AT, Maison J, Cheriyan J. Safety, tolerability, pharmacokinetics and pharmacodynamics of losmapimod following a single intravenous or oral dose in healthy volunteers. Br J Clin Pharmacol. 2013 Jul;76(1):99-106. doi: 10.1111/bcp.12063.

ReferenceCitation: Cheriyan J, Webb AJ, Sarov-Blat L, Elkhawad M, Wallace SM, Maki-Petaja KM, Collier DJ, Morgan J, Fang Z, Willette RN, Lepore JJ, Cockcroft JR, Sprecher DL, Wilkinson IB. Inhibition of p38 mitogen-activated protein kinase improves nitric oxide-mediated vasodilatation and reduces inflammation in hypercholesterolemia. Circulation. 2011 Feb 8;123(5):515-23. doi: 10.1161/CIRCULATIONAHA.110.971986. Epub 2011 Jan 24.

ReferenceCitation: de Greef JC, Lemmers RJ, van Engelen BG, Sacconi S, Venance SL, Frants RR, Tawil R, van der Maarel SM. Common epigenetic changes of D4Z4 in contraction-dependent and contraction-independent FSHD. Hum Mutat. 2009 Oct;30(10):1449-59. doi: 10.1002/humu.21091.

ReferenceCitation: Han JJ, Kurillo G, Abresch RT, de Bie E, Nicorici A, Bajcsy R. Reachable workspace in facioscapulohumeral muscular dystrophy (FSHD) by Kinect. Muscle Nerve. 2015 Feb;51(2):168-75. doi: 10.1002/mus.24287. Epub 2014 Nov 19.

ReferenceCitation: Jagannathan S, Shadle SC, Resnick R, Snider L, Tawil RN, van der Maarel SM, Bradley RK, Tapscott SJ. Model systems of DUX4 expression recapitulate the transcriptional profile of FSHD cells. Hum Mol Genet. 2016 Oct 15;25(20):4419-4431. doi: 10.1093/hmg/ddw271.

ReferenceCitation: Statland JM, Tawil R. Risk of functional impairment in Facioscapulohumeral muscular dystrophy. Muscle Nerve. 2014 Apr;49(4):520-7. doi: 10.1002/mus.23949. Epub 2014 Feb 10.

ReferenceCitation: Wang LH, Friedman SD, Shaw D, Snider L, Wong CJ, Budech CB, Poliachik SL, Gove NE, Lewis LM, Campbell AE, Lemmers RJFL, Maarel SM, Tapscott SJ, Tawil RN. MRI-informed muscle biopsies correlate MRI with pathology and DUX4 target gene expression in FSHD. Hum Mol Genet. 2019 Feb 1;28(3):476-486. doi: 10.1093/hmg/ddy364.

lead_sponsor: Fulcrum Therapeutics

location_country:
United States
Spain
Canada
France

location_facility: University of California Los Angeles (UCLA)

location_facility: Montreal Neurological Institute and Hospital

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Washington University School of Medicine


title: A Phase 1 Study of SEA-TGT (SGN-TGT) in Subjects With Advanced Malignancies

summary:
This trial will look at a drug called SEA-TGT (also known as SGN-TGT) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SEA-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SEA-TGT works to treat solid tumors and lymphomas.

The study will have four parts. Part A of the study will find out how much SEA-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SEA-TGT is and if it works to treat solid tumors and lymphomas. Part C will study how well SEA-TGT with sasanlimab works to treat solid tumors. Part D will study how well SEA-TGT with brentuximab vedotin works to treat classical Hodgkin lymphoma (cHL).

design_allocation: Non-Randomized

lead_sponsor: Seagen Inc.

location_country:
Italy
United Kingdom
United States
Spain
Canada
France

location_facility: Carbone Cancer Center / University of Wisconsin

location_facility: University of Alberta / Cross Cancer Institute

location_facility: University of Cincinnati Cancer Institute

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: University of California at San Francisco

location_facility: Texas Oncology - Baylor Sammons Cancer Center

location_facility: University Health Network, Princess Margaret Hospital

location_facility: University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center

location_facility: Wake Forest Baptist Medical Center / Wake Forest University

location_facility: HM Centro Integral Oncologico Clara Campal

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care

location_facility: University of Mississippi Medical Center

location_facility: University of Michigan Comprehensive Cancer Center


lead_sponsor: Eli Lilly and Company

summary: The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.

location_facility: Private Practice - Dr. Korczowski Bartosz

location_facility: Transcarpathian Regional Hospital im.Andriya Novak

location_facility: Synexus Polska Sp. z o.o. Oddzial w Poznaniu

location_facility: Okayama Saiseikai Outpatient Center Hospital

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"

location_facility: SR Kalla Memorial Gastro & General Hospital

location_facility: Xiangya Hospital Central South University

location_facility: North Shore Gastroenterology & Endoscopy Centers

location_facility: Institut Klinicke a Experimentalni Mediciny

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Tokushukai Sapporo Higashi Tokushukai Hospital

location_facility: CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição

location_facility: Synexus Polska Sp. z o.o. Oddział w Gdyni

location_facility: Medical Center of Limited Liability Company "Medical Center "Consilium Medical"

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Woodholme Gastroenterology Associates - Glen Burnie

location_facility: University Hospitals Cleveland Medical Center

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Gastroenterology and internal medicine research institute

location_facility: The Third Xiangya Hospital of Central South University

location_facility: The University of Oklahoma Health Sciences Center

location_facility: Centro de Alta Especialidad en Reumatologia e Investigación del Potosi,S.C

location_facility: Research Institute of Physiology and Fundamental Medicine

location_facility: Shengjing Hospital of China Medical University

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Saint Petersburg State Budgetary Healthcare Institution City Clinical Hospital No.31

location_facility: Gastroenterology Associates of Pensacola, PA

location_facility: MNGI Digestive Health - Plymouth Endoscopy Center & Clinic

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

location_facility: Indiana University Health University Hospital

location_facility: Gujarat Hospital - Gastro & Vascular Centre

location_facility: Medical Clinical Investigational Center of Medical Center Health Clinic

location_facility: Midland Florida Clinical Research Center, LLC

location_facility: The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university

location_facility: Centro Multidisciplinar de Estudos Clinicos

location_facility: Tidewater Physicians Multispecialty Group Clinical Research

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Tokyo Medical And Dental University Medical Hospital

location_facility: L2IP - Instituto de Pesquisas Clínicas - FC072920211954380192

location_facility: Núcleo de Pesquisa Clínica do Rio Grande do Sul

location_facility: Instituto de Assist├ncia M├dica ao Servidor P

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Univerzitná nemocnica Bratislava - Nemocnica Ružinov

location_facility: University Hospital,Kyoto Prefectural University of Medicine

location_facility: Nizhny Novgorod Regional Hospital N.A. Semashko

location_facility: Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrainian Railway

location_facility: Gastroenterology Associates of Orangeburg

location_facility: Arizona Arthritis & Rheumatology Associates

location_facility: Karelia Republican Hospital V.A. Baranova

location_facility: Synexus Leipzig Clinical Research Centre

location_facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital

location_facility: Private Practice - Dr. Stephane M. Gauthier

location_facility: Jiangsu Province Hospital of Chinese Medicine

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

location_facility: Poliklinika Agmu "Konsul'tativno-Diagnosticheskiy Tsentr"

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: First Pavlov State Medical University of Saint Petersburg

location_facility: Tongji Hospital Tongji Medical,Science & Technology

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Pauls Stradins Clinical Univeristy Hospital

location_facility: Scientific Centre of Reconstructive and Restorative Surgery

location_facility: The Digestive Health Center of Michigan (DHCMI)

location_facility: Carolina Digestive Diseases and Endoscopy Center

location_facility: Clinical Research of West Florida, Inc. (Clearwater)

location_facility: The Sixth Affiliated Hospital of Sun Yat-sen University

location_facility: West China Hospital of Sichuan University

location_facility: Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej

location_facility: Gastroenterologische Praxis Balsiger, Seibold & Partner

location_facility: The First Affiliated Hospital Of Fujian Medical University

location_facility: Private Healthcare Institution "Clinical Hospital "RZhD-Medicina" City Samara"

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Université Libre de Bruxelles - Hôpital Erasme

location_facility: Zhongshan Hospital Affiliated to Xiamen University

title: A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's Disease

type: Other Identifier

type: EudraCT Number

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

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Croatia
Czechia
Canada
Serbia
France
Lithuania
Slovakia
Hungary
Switzerland
United States
Latvia
Ukraine
India
Romania
Belgium
China
Italy
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Russian Federation
Israel


lead_sponsor: UCB Biopharma SRL

summary: The purpose of this study is to demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment and assess safety and tolerability of rozanolixizumab in adult study participants with primary immune thrombocytopenia (ITP).

status: Terminated

title: A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

location_country:
Germany
Poland
United Kingdom
United States
China
Spain
Taiwan
Bulgaria
Ukraine
Russian Federation
France

status_simplified: Unknown


acronym: AMETHIST

lead_sponsor: Genzyme, a Sanofi Company

summary:
Primary Objectives:

Primary population (adult participants with late-onset GM2 gangliosidosis): To assess the efficacy and pharmacodynamics (PD) of daily oral dosing of venglustat when administered over a 104-week period

Secondary population (participants with juvenile/adolescent late-onset GM2 gangliosidosis, GM1 gangliosidosis, saposin C deficiency, sialidosis type 1 or juvenile/adult galactosialidosis): To assess PD response (plasma and CSF GL-1 biomarker and disease specific biomarkers) of venglustat when administered once daily over a 104-week period

Secondary Objectives:

Primary population:

To assess the PD of daily oral dosing of venglustat and the effect of venglustat on selected performance test and scale over a 104-week period
To determine the safety and tolerability of venglustat when administered orally once daily over a 104-week period
To assess the pharmacokinetics (PK) of venglustat in plasma and cerebrospinal fluid (CSF)

Secondary population:

To assess the effect of venglustat on selected performance tests and scale over a 104-week period
To determine the safety and tolerability of venglustat when administered once daily over a 104-week period
To assess the PK of venglustat in plasma and CSF
To assess the acceptability and palatability of the venglustat tablet

ReferenceCitation: Nicoli ER, Annunziata I, d'Azzo A, Platt FM, Tifft CJ, Stepien KM. GM1 Gangliosidosis-A Mini-Review. Front Genet. 2021 Sep 3;12:734878. doi: 10.3389/fgene.2021.734878. eCollection 2021.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Frontiers

location_facility: Hospital de Clinicas de Porto Alegre _investigational site number 0760001

location_facility: Emory Genetics - Investigational site number 8400006

location_facility: Ataxia Center and HD Center of Excellence, 300 UCLA Med Plaza, Suite B200 - Investigational site number 8400004

location_facility: NYU Langone - 550 First Avenue-Investigational site number 8400001

location_facility: Hospital Clínico Universitario de Santiago-CHUS. Travesia de Chopuana, s/n_investigational site number 7240002

location_facility: Clínica Universitaria Reina Fabiola Córdoba_investigational site number 0320001

location_facility: Hospital Universitario Austral Pilar, Buenos Aires_Unidad de Investigación Clínica_investigational site number 0320002

location_facility: Vseobecna Fakultni Nemocnice V Praze Metabolicke centrum U Nemocnice 2_investigational site number 2030001

location_facility: NIH National Human Genome Research Institute - 10 Center Dr - Bldg. 10 CRC3-2551 MSC 1205 - Investigational site number 8400005

location_facility: Cambridge University Hospitals NHS Foundation Trust Addenbrookes Hospital Hills Road_investigational site number 8260001

location_facility: Japanese Red Cross Akita Hospital 222-1 Nawashirosawa, Kamikitatesaruta_investigational site number 3920001

location_facility: Massachusetts General Hospital - Charles River Plaza 175 Cambridge St. Ste 340 - Investigational site number 8400002

location_facility: Centro Hospitalar Universitário Lisboa Norte- Hospital Santa Maria Avenida Professor Egas Moniz_investigational site number 6200002

location_facility: Salford Royal NHS Foundation Trust Salford Royal Hospital Stott Lane_investigational site number 8260002

location_facility: Hospital Maternoinfantil Sant Joan de Déu Paseo de Sant Joan de Déu, 2_investigational site number 7240001

location_facility: Universitätsklinikum der Justus-Liebig-Universität Gießen Zentrum für Kinderheilkunde und Jugendmedizin Feulgenstraße 10-12_investigational site number 2760001

location_facility: Research Center Of Neurology 80, Volokolamskoye shosse_investigational site number 6430001

location_facility: Hospital Universitari de Bellvitge. Feixa Llarga, S / N_investigational site number 7240004

location_facility: Tohoku Medical and Pharmaceutical University Hospital_investigation site number 3920002

location_facility: APHP - Centre Hospitalier la Pitié Salpetrière, Service de Neurologie, 47-83 Boulevard De l'Hôpital_Investigational site number 2500001

location_facility: Gazi Universitesi Tip Fakultesi Emniyet Street Mevlana Blv Besevler Yenimahalle_investigational site number 7920001

title: A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Venglustat in Late-onset GM2 Gangliosidosis (Tay-Sachs Disease and Sandhoff Disease) Together With a Separate Basket for Juvenile/Adolescent Late-onset GM2 Gangliosidosis and Ultra-rare Diseases Within the Same and Similar Glucosylceramide-based Sphingolipid Pathway

type: Registry Identifier

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

location_country:
Germany
Italy
Portugal
United Kingdom
Argentina
Japan
Brazil
United States
Spain
Turkey
Czechia
Russian Federation
France


acronym: HOPE Kids 2

lead_sponsor: Pfizer

summary: This study is a Phase 3, randomized, double-blind, placebo-controlled study of voxelotor in pediatric participants, aged ≥ 2 to < 15 years old, with Sickle Cell Disease. The primary objective is to evaluate the effect of voxelotor on the TCD (Transcranial Doppler Ultrasound) measurements in SCD participants in this age range.

location_facility: Kemri/Crdr,Siaya,Kemri Clinical Research Annex

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Boston Children's Hospital - Clinical Research Pharmacy

location_facility: Abu El Rich Hospital, Cairo University Hospital

location_facility: Alexandria Clinical Research Center, Faculty of Medicine, Alexandria University

location_facility: Medical University of South Carolina: Shawn Jenkins Women's and Children's Hospital

location_facility: Barau Dikko Teaching/Kaduna State University

location_facility: Medical University of South Carolina: Investigational Drug Services

location_facility: Texas Children's Hospital- Wallace Tower

location_facility: Children's Healthcare of Atlanta: Scottish Rite

location_facility: Egyptian Thalassemia Association (satellite site)

location_facility: Azienda Ospedaliera Universitaria Meyer "A.O.U. Meyer" - SOC "Oncologia, Ematologia e TCSE"

location_facility: St. Jude Children's Research Hospital - Pharmaceutical Services

location_facility: Azienda Ospedaliera Universita' (AOU) Padova

location_facility: Children's Healthcare of Atlanta: Hughes Spalding

location_facility: Washington University School of Medicine

location_facility: Texas Children's Hospital - Investigational Pharmacy

location_facility: Children's Healthcare of Atlanta AFLAC Center

location_facility: Boston Childien's Hospital - Clinical Research Pharmacy

location_facility: Department of Child Health, University of Ghana Medical School, College of Health Sciences, Korle-Bu

location_facility: King's College Hospital NHS Foundation Trust

location_facility: University of Mississippi Medical Center

location_facility: Ain Shams University Hospital- Clinical Research Center (MASRI)

location_facility: Azienda Ospedaliera Universitaria (A.O.U.) "Luigi Vanvitelli"

location_facility: College of Medicine, University of Ibadan

location_facility: King Abdullah International Medical Research Center (KAIMRC), Ministry of National Guard - Health

location_facility: Azienda Ospedaliera Universita' (AOU ) Padova

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Voxelotor (GBT440) in Pediatric Participants With Sickle Cell Disease (HOPE Kids 2)

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.

location_country:
Italy
United Kingdom
Nigeria
United States
Saudi Arabia
Oman
Kenya
Ghana
Egypt
France


title: Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF

acronym: PULSED AF

summary: The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelect™ PFA System for the treatment of atrial fibrillation (AF). The study will also provide first in human insights into clinical safety and device function of the PulseSelect PFA System for pulmonary vein isolation (PVI) as a treatment for AF. To this end, the clinical study has been designed into phases (Pilot and Pivotal), with each phase comprising a separate data set that will be analyzed and reported on per the below objectives.

ReferenceType: result

ReferenceCitation: Verma A, Haines DE, Boersma LV, Sood N, Natale A, Marchlinski FE, Calkins H, Sanders P, Packer DL, Kuck KH, Hindricks G, Onal B, Cerkvenik J, Tada H, DeLurgio DB; PULSED AF Investigators. Pulsed Field Ablation for the Treatment of Atrial Fibrillation: PULSED AF Pivotal Trial. Circulation. 2023 May 9;147(19):1422-1432. doi: 10.1161/CIRCULATIONAHA.123.063988. Epub 2023 Mar 6.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

ReferenceCitation: Verma A, Boersma L, Haines DE, Natale A, Marchlinski FE, Sanders P, Calkins H, Packer DL, Hummel J, Onal B, Rosen S, Kuck KH, Hindricks G, Wilsmore B. First-in-Human Experience and Acute Procedural Outcomes Using a Novel Pulsed Field Ablation System: The PULSED AF Pilot Trial. Circ Arrhythm Electrophysiol. 2022 Jan;15(1):e010168. doi: 10.1161/CIRCEP.121.010168. Epub 2021 Dec 29.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Australia
Japan
Netherlands
Austria
Belgium
United States
Spain
Canada
France

location_facility: Northwell Health - North Shore University Hospital

location_facility: NYU Langone Health - Heart Rhythm Center

location_facility: Tokyo Medical and Dental University, Medical Hospital

location_facility: The Ohio State University Wexner Medical Center

location_facility: Ordensklinikum Linz GmbH / Elisabethinen

location_facility: Saint Luke's Mid America Heart Institute

location_facility: University of Pittsburgh Medical Center- UPMC Presbyterian

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital of the University of Pennsylvania

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

intervention_type: Device


title: Boston Scientific Double-J PLUS Ureteral Stent Postmarket Patient Registry

summary: A multi-center global registry to obtain post-market safety and efficacy data on Boston Scientific Ureteral and Urinary Diversion Stents

lead_sponsor: Boston Scientific Corporation

location_country:
United States
Canada
Japan
France

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Northwestern University-Department of Urology

location_facility: New York Presbyterian Hospital-Columbia University Medical Center


title: Evaluating Oral Peri-operative Acetylsalicylic Acid in Subjects Undergoing Endovascular Coiling-only of Unruptured Brain Aneurysms(EVOLVE): A Phase 3 Multicenter Randomized Study

acronym: EVOLVE

summary: This trial is a is a prospective, randomized (1:1) placebo-controlled, clinical trial with blinded endpoint assessment of 440 participants with unruptured brain aneurysm planned for endovascular treatment using coiling-only approach (primary coiling or using balloon-assistance but not stenting) to test if oral acetylsalicylic acid (325 mg/ day for a total of 5 days) is superior placebo in preventing clinical and silent strokes. The primary outcome is a clinical or silent stroke at the time of discharge assessed by clinical examination and MRI brain. Participants will return to the clinic or be contacted by phone for the end of study procedures on Day 90 to collect functional outcome data.

primary_purpose: Prevention

lead_sponsor: University of Calgary

location_country: Canada France

location_facility: Centre Hospitalier Régional Universitaire de Tours

lead_sponsor_type: academique


acronym: PRIME

lead_sponsor: Sanofi

summary:
Primary Objective:

To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapies or when those therapies are not advisable.

Secondary Objectives:

To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with PN, inadequately controlled on topical prescription therapies or when those therapies are not advisable.

To demonstrate efficacy of dupilumab on skin lesions of PN. To demonstrate the improvement in health-related quality of life. To evaluate safety outcome measures. To evaluate immunogenicity of dupilumab.

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_facility:
Investigational Site Number :8400018
Investigational Site Number :4840001
Investigational Site Number :4100001
Investigational Site Number :8400002
Investigational Site Number :8400022
Investigational Site Number :8400007
Investigational Site Number :4840005
Investigational Site Number :6430009
Investigational Site Number :0320003
Investigational Site Number :8400017
Investigational Site Number :4840006
Investigational Site Number :6430007
Investigational Site Number :2500005
Investigational Site Number :8400009
Investigational Site Number :8400004
Investigational Site Number :6430010
Investigational Site Number :8400011
Investigational Site Number :8400006
Investigational Site Number :4100004
Investigational Site Number :1560001
Investigational Site Number :8400026
Investigational Site Number :4100003
Investigational Site Number :0320004
Investigational Site Number :4100002
Investigational Site Number :8400019
Investigational Site Number :8400003
Investigational Site Number :8400015
Investigational Site Number :8400016
Investigational Site Number :8400001
Investigational Site Number :0320009
Investigational Site Number :3920010
Investigational Site Number :3920006
Investigational Site Number :4100007
Investigational Site Number :8400014
Investigational Site Number :0320002
Investigational Site Number :0320001
Investigational Site Number :6430001
Investigational Site Number :1560004
Investigational Site Number :8400024
Investigational Site Number :0320007
Investigational Site Number :3920009
Investigational Site Number :3920004
Investigational Site Number :3920001
Investigational Site Number :8400005
Investigational Site Number :0320006
Investigational Site Number :6430008
Investigational Site Number :3920005
Investigational Site Number :3920007
Investigational Site Number :6430006
Investigational Site Number :3920002
Investigational Site Number :0320008
Investigational Site Number :4840003
Investigational Site Number :1560002
Investigational Site Number :4840002
Investigational Site Number :0320005
Investigational Site Number :8400010
Investigational Site Number :8400025
Investigational Site Number :1560003
Investigational Site Number :6430005
Investigational Site Number :3920003
Investigational Site Number :4100005
Investigational Site Number :8400013
Investigational Site Number :6430002

title: A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable

location_country:
Argentina
Japan
Mexico
United States
China
Korea, Republic of
Russian Federation
France


acronym: SELUNE

lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this trial is to evaluate the efficacy and safety of subcutaneous secukinumab 300 mg compared to placebo, in combination with standard of care therapy (SoC), in subjects with active lupus nephritis (ISN/RPS Class III or IV, with or without co-existing class V features).

title: A Two-year, Phase III Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Safety, Efficacy, and Tolerability of 300 mg s.c. Secukinumab Versus Placebo, in Combination With SoC Therapy, in Patients With Active Lupus Nephritis

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:
Germany
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Croatia
Chile
Czechia
Canada
France
Colombia
Portugal
Slovakia
Denmark
Switzerland
United States
India
Romania
China
Peru
Philippines
Italy
Guatemala
Norway
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Sweden


lead_sponsor: Hoffmann-La Roche

summary: This study will evaluate the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Nottingham University Hospitals NHS Trust

location_facility: FSAI Treatment and rehabilitation Centre Ministry of Health; Clinical research and chemotherapy.

location_facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

location_facility: Prince of Wales Hospital; Department of Clinical Onocology

location_facility: Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Memorial Cancer Institute at Memorial West

location_facility: KYS Sadesairaala; Syopatautien poliklinikka

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: MI Kyiv Regional Council Kyiv Regional Oncological Dispensary; Department of Mammology

location_facility: St. Joseph Mercy Hospital; Cancer Care Center.

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

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

location_facility: Municipal Institution Odesa Regional Clinical Hospital

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Centro Integral Oncologico Clara Campal; Servicio de Oncología

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: IRCCS Istituto Clinico Humanitas; Oncologia

location_facility: Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia

location_facility: Wellington Regional Hospital; Clinical Trials Unit

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Sahyadri Super Specialty Hospital Hadapsar

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Unidad de Investigación Oncologica; Hospital Nacional Daniel Alcides Carrion

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: China Medical University Hospital; Surgery

location_facility: Kyungpook National University Medical Center

location_facility: Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF

location_facility: Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Fraser Valley Centre British Columbia Cancer Agency

location_facility: Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

location_facility: SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department

location_facility: BEATSON WEST OF SCOTLAND CANCER CENTRE; Clinical Research Unit ? Level 1

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Nancy N. and J.C. Lewis Cancer & Research Pavillion -St. Josephs / Candler Health System-CCD PRIME

location_facility: Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi

location_facility: Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: Memorial Healthcare System - Memorial Regional Hospital

location_facility: Instituto Regional de Enfermedades Neoplasicas

location_facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA

location_facility: Royal North Shore Hospital; Department of Medical Oncology

location_facility: St John of God Hospital; Bendat Cancer Centre

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council; Chemotherapy Department

location_facility: VAASAN KESKUSSAIRAALA; Onkologian poliklinikka

location_facility: Hospital Beatriz Angelo; Departamento de Oncologia

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

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

location_facility: National Cancer Centre; Medical Oncology

location_facility: Wake Forest University Baptist Medical Center

location_facility: Ospedale Civile; Unita Operativa Di Oncologia Medica

location_facility: ASU FC S. M. DELLA MISERICORDIA; Oncologia

location_facility: Universitätsspital Zürich Gynäkologische Klinik; Klinik für Gynäkologie

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e

location_facility: Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej

location_facility: Regional Oncology Center; Department of Mammology

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie

location_facility: Medipol University Medical Faculty; Oncology Department

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Kaiser Permanente-SCPMG; Oncology Research

title: A Phase III, Double-blind, Placebo-controlled, Randomized Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data 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 the Sharing of Clinical 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:
Finland
Poland
New Zealand
Argentina
Australia
Brazil
Costa Rica
Japan
Thailand
Turkey
Czechia
Canada
France
Colombia
Portugal
Hong Kong
Denmark
Switzerland
United States
Ukraine
India
Romania
Belgium
Peru
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


acronym: LLSAT

lead_sponsor: GlaxoSmithKline

summary: This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 [NCT01899703], 201000 GLIMMER [NCT02966834] (group 1) or 212620 GLISTEN [NCT00210418]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study's end or until linerixibat can be lawfully made available to participants. However, the total duration of study participation will vary by participant depending upon the time of entry relative to study end in their respective country.

title: Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis

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

location_country:
Germany
Poland
Argentina
Japan
Brazil
Czechia
Canada
France
Switzerland
United States
Belgium
China
Italy
United Kingdom
Mexico
Spain
Greece
Bulgaria
Russian Federation
Israel


acronym: SYNERGY-NASH

summary: The purpose of this study is to see if the study drug, tirzepatide administered once weekly, is safe and effective as a treatment for Nonalcoholic Steatohepatitis (NASH).

location_facility: Groupe Hospitalier Mutualiste Les Portes du Sud

location_facility: Synexus North East Clinical Research Centre

location_facility: University of Alabama-The Kirklin Clinic

location_facility: Synexus Manchester Clinical Research Centre

location_facility: The National Diabetes & Obesity Research Institute

location_facility: Synexus North Teesside Clinical Research Centre

location_facility: Iowa Diabetes and Endocrinology Research Center

location_facility: University Hospital,Kyoto Prefectural University of Medicine

location_facility: Alliance for Multispecialty Research, LLC

location_facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie

location_facility: Synexus Midlands Clinical Research Centre

location_facility: Synexus Clinical Research Centre - Lancashire

location_facility: Aintree University Hospital NHS Foundation Trust

location_facility: Diabetes & Endocrinology Consultants, PC

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Accel Research Sites - Maitland Clinical Research Unit

location_facility: National Hospital Organization Yokohama Medical Center

location_facility: Research Centers of America ( Hollywood )

location_facility: Harborview Medical Center/University of Washington

location_facility: Buffalo Clinical and Translational Research Center

location_facility: Southern Therapy and Advanced Research (STAR) LLC

location_facility: Velocity Clinical Research, Panorama City

location_facility: American Research Corporation at Texas Liver Institute

location_facility: National Research Institute - Huntington Park

title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)

location_country:
Italy
Poland
United Kingdom
Japan
Mexico
United States
Spain
France


type: U.S. NIH Grant/Contract

title: Alzheimer's Clinical Trial Consortium for Down Syndrome (ACTC-DS) Trial-Ready Cohort - Down Syndrome (TRC-DS)

acronym: TRC-DS

summary:
The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort (TRC), and up to 250 participants in total including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study. Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression.

To learn more about the study and participating sites, visit our study website at: https://www.trcds.org/.

TRC-DS is collaborating with the Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) to allow study participants to be concurrently enrolled in both ABC-DS and TRC-DS, referred to as "co-enrollment". ABC-DS is a longitudinal, observational research study that is overseen at University of Pittsburgh Coordinating Center. ABC-DS participants who express interest in potentially joining a clinical trial in the future and who meet TRC-DS eligibility criteria, may choose to co-enroll in TRC-DS at an ABC-DS Site. Co-enrolled participants will adhere to the ABC-DS protocol and schedule of activities, but agree to share their data with the TRC-DS team and to receive invitations for future participation in clinical trials. Fore more information on ABC-DS please visit https://www.nia.nih.gov/research/abc-ds or http://abcds.pitt.edu/.

ReferenceCitation: Hardy J. The discovery of Alzheimer-causing mutations in the APP gene and the formulation of the "amyloid cascade hypothesis". FEBS J. 2017 Apr;284(7):1040-1044. doi: 10.1111/febs.14004.

ReferenceCitation: Selkoe DJ, Hardy J. The amyloid hypothesis of Alzheimer's disease at 25 years. EMBO Mol Med. 2016 Jun 1;8(6):595-608. doi: 10.15252/emmm.201606210. Print 2016 Jun.

ReferenceCitation: Handen BL, Cohen AD, Channamalappa U, Bulova P, Cannon SA, Cohen WI, Mathis CA, Price JC, Klunk WE. Imaging brain amyloid in nondemented young adults with Down syndrome using Pittsburgh compound B. Alzheimers Dement. 2012 Nov;8(6):496-501. doi: 10.1016/j.jalz.2011.09.229.

ReferenceCitation: Rafii MS, Wishnek H, Brewer JB, Donohue MC, Ness S, Mobley WC, Aisen PS, Rissman RA. The down syndrome biomarker initiative (DSBI) pilot: proof of concept for deep phenotyping of Alzheimer's disease biomarkers in down syndrome. Front Behav Neurosci. 2015 Sep 14;9:239. doi: 10.3389/fnbeh.2015.00239. eCollection 2015.

ReferenceCitation: Lao PJ, Betthauser TJ, Hillmer AT, Price JC, Klunk WE, Mihaila I, Higgins AT, Bulova PD, Hartley SL, Hardison R, Tumuluru RV, Murali D, Mathis CA, Cohen AD, Barnhart TE, Devenny DA, Mailick MR, Johnson SC, Handen BL, Christian BT. The effects of normal aging on amyloid-beta deposition in nondemented adults with Down syndrome as imaged by carbon 11-labeled Pittsburgh compound B. Alzheimers Dement. 2016 Apr;12(4):380-90. doi: 10.1016/j.jalz.2015.05.013. Epub 2015 Jun 13.

ReferenceCitation: Rafii MS, Lukic AS, Andrews RD, Brewer J, Rissman RA, Strother SC, Wernick MN, Pennington C, Mobley WC, Ness S, Matthews DC; Down Syndrome Biomarker Initiative and the Alzheimer's Disease Neuroimaging Initiative. PET Imaging of Tau Pathology and Relationship to Amyloid, Longitudinal MRI, and Cognitive Change in Down Syndrome: Results from the Down Syndrome Biomarker Initiative (DSBI). J Alzheimers Dis. 2017;60(2):439-450. doi: 10.3233/JAD-170390.

ReferenceCitation: McCarron M, McCallion P, Reilly E, Dunne P, Carroll R, Mulryan N. A prospective 20-year longitudinal follow-up of dementia in persons with Down syndrome. J Intellect Disabil Res. 2017 Sep;61(9):843-852. doi: 10.1111/jir.12390. Epub 2017 Jun 29.

ReferenceCitation: Firth NC, Startin CM, Hithersay R, Hamburg S, Wijeratne PA, Mok KY, Hardy J, Alexander DC; LonDownS Consortium; Strydom A. Aging related cognitive changes associated with Alzheimer's disease in Down syndrome. Ann Clin Transl Neurol. 2018 May 20;5(6):741-751. doi: 10.1002/acn3.571. eCollection 2018 Jun.

ReferenceCitation: Startin CM, Hamburg S, Hithersay R, Al-Janabi T, Mok KY, Hardy J; LonDownS Consortium; Strydom A. Cognitive markers of preclinical and prodromal Alzheimer's disease in Down syndrome. Alzheimers Dement. 2019 Feb;15(2):245-257. doi: 10.1016/j.jalz.2018.08.009. Epub 2018 Nov 28.

ReferenceCitation: Hithersay R, Startin CM, Hamburg S, Mok KY, Hardy J, Fisher EMC, Tybulewicz VLJ, Nizetic D, Strydom A. Association of Dementia With Mortality Among Adults With Down Syndrome Older Than 35 Years. JAMA Neurol. 2019 Feb 1;76(2):152-160. doi: 10.1001/jamaneurol.2018.3616.

lead_sponsor: University of Southern California

collaborators: Alzheimer's Therapeutic Research Institute

location_country:
Ireland
United Kingdom
United States
Spain
France

location_facility: New York State Institute for Basic Research in Developmental Disabilities (SIBRDD), Co-Enrolling through ABC-DS Only

location_facility: Linda Crnic Institute for Down Syndrome, University of Colorado

location_facility: University of Pittsburgh, Co-Enrolling through ABC-DS Only

location_facility: University of Texas Health San Antonio, Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases

location_facility: Vanderbilt University Medical Center Center for Cognitive Medicine

location_facility: King's College London, Institute of Psychiatry, Psychology & Neuroscience

location_facility: Sant Pau Biomedical Research Institute (IIB Sant Pau)

location_facility: Massachusetts General Hospital, Co-Enrolling through ABC-DS Only

location_facility: University of Wisconsin - Madison, Waisman Center, Co-Enrolling through ABC-DS Only

location_facility: University of Kentucky, Co-Enrolling through ABC-DS Only

location_facility: Institute of Memory and Cognition, Tallaght University Hospital

location_facility: University of California, Irvine School of Medicine, Co-Enrolling through ABC-DS Only


summary: This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory desmoplastic small round cell tumor (DSRCT) in children and young adults. This trial is part of the CAMPFIRE master protocol (NCT05999994) which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Lee Health- Golisano Children's hosptial of southwest Florida

location_facility: Children's Healthcare of Atlanta - Egleston Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Riley Hospital for Children at Indiana University Health

location_facility: Children's Hospital of Philadelphia (CHOP)

location_facility: Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

location_facility: Princess Máxima Center for Pediatric Oncology

title: A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults With Relapsed, Recurrent, or Refractory Desmoplastic Small Round Cell Tumor

location_country:
Italy
United Kingdom
Australia
Japan
Netherlands
Belgium
United States
Spain
France


title: An Open-Label, Multicenter Phase 1/1b Study of Intratumorally Administered STING Agonist E7766 in Subjects With Advanced Solid Tumors or Lymphomas - INSTAL-101

summary: This is an open label, multicenter, phase 1/1b study to assess safety/tolerability and preliminary clinical activity of E7766 as a single agent administered intratumorally in participants with advanced solid tumors or lymphomas.

ipd_sharing_description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

lead_sponsor: Eisai Inc.

sponsor_collaborators:
Eisai Inc.
H3 Biomedicine Inc.

location_country:
United Kingdom
United States
Spain
Korea, Republic of
France

location_facility: INCLIVA Hospital Clínico Universitario de Valencia

location_facility: University of Pittsburgh Medical Center and Hillman Cancer Center

location_facility: Massachusetts General Hospital Cancer Center

location_facility: University of Miami Hospital Sylvester Comprehensive Cancer Center


title: PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib

acronym: ON-TRK

summary: In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.

ReferenceCitation: Yang JCH, Brose MS, Castro G, Kim ES, Lassen UN, Leyvraz S, Pappo A, Lopez-Rios F, Reeves JA, Fellous M, Penault-Llorca F, Rudzinski ER, Tabatabai G, Vassal G, Drilon A, Trent J. Rationale and design of ON-TRK: a novel prospective non-interventional study in patients with TRK fusion cancer treated with larotrectinib. BMC Cancer. 2022 Jun 7;22(1):625. doi: 10.1186/s12885-022-09687-x.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: Springer-Nature

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

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

lead_sponsor: Bayer

location_country:
Finland
Germany
Ireland
Argentina
Australia
Brazil
Japan
Luxembourg
Canada
France
Denmark
Switzerland
United States
Belgium
China
Italy
Norway
Singapore
United Kingdom
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Sweden

location_facility: Atlantic Hem Onc / Morristown Medical Center

location_facility: UCSF Benioff Children's Hospital Oakland

location_facility: Stanford Univ Med Ctr. / Lucile Packard Children's Hosp

location_facility: Frederick Health-James M Stockman Cancer Institute

location_facility: East Carolina University / Vidant Health

location_facility: UT Southwestern Medical Center / Children's Health

location_facility: Intermountain Healthcare - Intermountain Medical Center

location_facility: Intermountain Healthcare - Dixie Regional Medical Center

location_facility: Ohio State Comp. Cancer Ctr. / James Cancer Hospital

location_facility: Providence Health System - Southern California

location_facility: SSM Health Cancer Center - Dean Medical Group

location_facility: USC / Norris Comprehensive Cancer Center

location_facility: Memorial Sloan Kettering Children's Cancer Center

location_facility: Univ. of Maryland / Greenebaum Comp. Cancer Ctr.

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

location_facility: Johns Hopkins / Sidney Kimmel Cancer Center

location_facility: Staten Island Univ. Hospital (Northwell Health)


title: A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

summary:
The primary objective of this study is:

• To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

status: Enrolling by invitation

lead_sponsor: Rigel Pharmaceuticals

location_country:
Germany
Belarus
Italy
Norway
United Kingdom
Australia
Netherlands
Austria
Belgium
United States
Spain
Czechia
Ukraine
Bulgaria
Georgia
Serbia
Russian Federation
France

location_facility: Vitebsk Regional Clinical Oncology Dispensary

location_facility: Fakultni nemocnice Ostrava Klinika hematoonkologie

location_facility: Kyiv City Clinical Hospital №9, hematology department №1

location_facility: State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory

location_facility: City Clinical Hospital № 4, Hematology Center

location_facility: LTD Multiprofile Clinic Consilium Medulla

location_facility: Clinical Centre of Vojvodina, Clinic for Hematology

location_facility: Specialized Hospital for Active Treatment of Hematological Disease EAD,

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Ematologia

location_facility: CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses

location_facility: University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Varna, Clinic of Clinical Haematology

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD, Plovdiv, Clinic of Medical oncology

location_facility: SCDU Ematologia AOU "Maggiore della Carità"

location_facility: University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Laboratory

location_facility: American Oncology Network Vista Oncology Division

location_facility: Universitätsklinik f. Innere Medizin I - Klin. Abt. f. Hämatologie u. Hämostaseologie

location_facility: Princess Alexandra Hospital - Cancer Trials Unit

location_facility: Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika

location_facility: Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia

location_facility: Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust


title: Rate of Progression in EYS Related Retinal Degeneration (Pro-EYS)

acronym: Pro-EYS

summary: The overall goal of this project funded by the Foundation Fighting Blindness is to characterize the natural history of disease progression in patients with EYS mutations in order to accelerate the development of outcome measures for clinical trials.

ipd_sharing_description: A de-identified database is placed in the public domain on the FFB/Jaeb public website after the completion of each protocol and publication of the manuscript.

lead_sponsor: Jaeb Center for Health Research

sponsor_collaborators:
Jaeb Center for Health Research
Foundation Fighting Blindness

location_country:
Germany
Finland
Israel
Netherlands
United States
Canada
France

location_facility: Oregon Health Science University Casey Eye Institute

location_facility: University of Miami: Neuro-ophthalmology Department

location_facility: Kellogg Eye Center, University of Michigan

location_facility: Centre hospitalier National d'Ophtalmologie des Quinze-Vingts

location_facility: University of Wisconsin-Madison: McPherson Eye Research Institute


title: Darolutamide Observational Study in Non-metastatic Castration-resistant Prostate Cancer Patients

acronym: DAROL

summary: The purpose of this study is to find out in the real-world setting, if darolutamide is safe and effective for patients diagnosed with prostate cancer that has not spread to other parts of the body. When a patient is enrolled to the study, his/her physician would have already made the decision to treat patient with darolutamide per local standard practice.

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.

location_country:
Finland
Germany
Ireland
Argentina
Australia
Brazil
Japan
Turkey
Canada
France
Colombia
Slovakia
Hong Kong
Denmark
United States
India
Belgium
China
Italy
Norway
United Kingdom
Netherlands
Austria
Mexico
Spain
Greece
Taiwan
Russian Federation
Sweden

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: Genesis Comprehensive Prostate Cancer Center

location_facility: Baylor Scott & White Medical Center - Temple

location_facility: Dukes Cancer Intitute Center for Prostate and Urologic Cancers

location_facility: MultiCare Institute for Research & Innovation


lead_sponsor: Emalex Biosciences Inc.

summary: This study was an international, multicenter, open-label, long term extension study evaluating the safety of ecopipam tablets for the treatment of children and adolescent subjects with Tourette Syndrome.

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis

location_facility: University Hospitals Cleveland Medical Center

location_facility: Pharmakologisches Studienzentrum Chemnitz GmbH

location_facility: Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie

location_facility: St. Charles Psychiatric Associates dba Midwest Research Group

location_facility: Helen DeVos Children's Hospital / Spectrum Health Medical Group

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

location_facility: Center for Psychiatry and Behavioral Medicine Inc.

location_facility: Northwest Florida Clinical Research Group, LLC

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: Pediatric Epilepsy and Neurology Specialists

location_facility: Eastside Therapeutic Resource Inc dba Core Clinical Research

title: A Multicenter, Open-Label, Extension Study Intended to Evaluate the Long-term Safety of Ecopipam Tablets in Children and Adolescent Subjects With Tourette's Syndrome

location_country:
Germany
Poland
United States
Canada
France


title: Global Prospective Case Series Using a Single-Use Duodenoscope

summary: Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures

primary_purpose: Other

location_country:
Germany
Italy
India
Hong Kong
Singapore
Australia
Netherlands
United States
South Africa
Canada
France

location_facility: Erasmus University Medical Center of Rotterdam

location_facility: Metro North Hospital and Health Services

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: University of California Los Angeles Medical Center


title: Non-Contrast CT vs CTP or MRI Selection vs Medical Management in Late Presentation of Large Vessel Occlusion Stroke, 6-24 Hours. A Multicenter Retrospective Study

acronym: CLEAR

summary:
The objective of this multicenter, retrospective, cross-sectional, chart review study is to compare outcomes (disability, complications and mortality) of patients with large vessel occlusion stroke presenting at late time window selected by either Non-Contrast CT (NCCT) only, advanced imaging with CTP (Computed Tomography Perfusion), MRI (Magnetic Resonance Imaging), or medical management.

Boston Medical Center (BMC) will serve as the main data coordinating site. Fifteen additional sites will seek local IRB approval or ethics approval. The aggregated de-identified data will be analyzed comparing types of interventions and outcomes by type of imaging or medical management.

time_perspective: Retrospective

ReferenceCitation: Nguyen TN, Abdalkader M, Nagel S, Qureshi MM, Ribo M, Caparros F, Haussen DC, Mohammaden MH, Sheth SA, Ortega-Gutierrez S, Siegler JE, Zaidi S, Olive-Gadea M, Henon H, Mohlenbruch MA, Castonguay AC, Nannoni S, Kaesmacher J, Puri AS, Seker F, Farooqui M, Salazar-Marioni S, Kuhn AL, Kaliaev A, Farzin B, Boisseau W, Masoud HE, Lopez CY, Rana A, Kareem SA, Sathya A, Klein P, Kassem MW, Ringleb PA, Cordonnier C, Gralla J, Fischer U, Michel P, Jovin TG, Raymond J, Zaidat OO, Nogueira RG. Noncontrast Computed Tomography vs Computed Tomography Perfusion or Magnetic Resonance Imaging Selection in Late Presentation of Stroke With Large-Vessel Occlusion. JAMA Neurol. 2022 Jan 1;79(1):22-31. doi: 10.1001/jamaneurol.2021.4082. Erratum In: JAMA Neurol. 2022 Jan 1;79(1):93.

evidence: open (via free pdf)

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

repository_institution: University of Massachusetts Medical School - eScholarship@UMMS

publisher_dissemination: American Medical Association

ReferenceCitation: Seker F, Qureshi MM, Mohlenbruch MA, Nogueira RG, Abdalkader M, Ribo M, Caparros F, Haussen DC, Mohammaden MH, Sheth SA, Ortega-Gutierrez S, Siegler JE, Zaidi SF, Olive-Gadea M, Henon H, Castonguay AC, Nannoni S, Kaesmacher J, Puri AS, Farooqui M, Salazar-Marioni S, Kuhn AL, Kiley NL, Farzin B, Boisseau W, Masoud HE, Lopez CY, Rana A, Abdul Kareem S, Sathya A, Klein P, Kassem MW, Cordonnier C, Gralla J, Fischer U, Michel P, Strambo D, Jovin TG, Raymond J, Zaidat OO, Ringleb PA, Nguyen TN, Nagel S. Reperfusion Without Functional Independence in Late Presentation of Stroke With Large Vessel Occlusion. Stroke. 2022 Dec;53(12):3594-3604. doi: 10.1161/STROKEAHA.122.039476. Epub 2022 Oct 14.

oa_host_type: publisher

unpaywall_oa_status: bronze

ReferenceCitation: Siegler JE, Qureshi MM, Nogueira RG, Tanaka K, Nagel S, Michel P, Vigilante N, Ribo M, Yamagami H, Yoshimura S, Abdalkader M, Haussen DC, Mohammaden MH, Nannoni S, Mohlenbruch MA, Henon H, Sheth SA, Ortega-Gutierrez S, Olive-Gadea M, Caparros F, Seker F, Zaidi S, Castonguay AC, Uchida K, Sakai N, Puri AS, Farooqui M, Toyoda K, Salazar-Marioni S, Takeuchi M, Farzin B, Masoud HE, Kuhn AL, Rana A, Morimoto M, Shibata M, Nonaka T, Klein P, Sathya A, Kiley NL, Cordonnier C, Strambo D, Demeestere J, Ringleb PA, Roy D, Zaidat OO, Jovin TG, Kaesmacher J, Fischer U, Raymond J, Nguyen TN. Endovascular vs Medical Management for Late Anterior Large Vessel Occlusion With Prestroke Disability: Analysis of CLEAR and RESCUE-Japan. Neurology. 2023 Feb 14;100(7):e751-e763. doi: 10.1212/WNL.0000000000201543. Epub 2022 Nov 4.

oa_host_type: repository

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

repositories_concat: PubMed Central;boris.unibe.ch

unpaywall_oa_status: green

lead_sponsor: Boston Medical Center

collaborators: Society of Vascular and Interventional Neurology

location_country:
Finland
Germany
Portugal
Japan
Switzerland
Belgium
United States
Spain
Canada
France

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Grady Health; Marcus Stroke & Neuroscience Center

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: National Cerebral and Cardiovascular Center


acronym: OAK

lead_sponsor: Theravance Biopharma

summary: A Phase 3, multi-center, open-label study to evaluate the safety and tolerability of ampreloxetine in subjects with primary autonomic failures (MSA, PD, and PAF) and symptomatic nOH over 182 weeks.

location_facility: Limited Liability Company City Neurological Center Sibneiromed

location_facility: Concord Hospital, Neurosciences Department

location_facility: Fondazione PTV - Policlinico Tor Vergata I U.0.C. Neurologia

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS / Istituto di Neurologia - Ambulatorio Disturbi del Movimento

location_facility: Universitätsklinikum Tulln Abteilung fur Neurologie

location_facility: CNE Acad O.I. Yushchenko Vinnytsia Reg Psychoneurological Hospital of Vinnytsia Regional Council, Department of Neurology

location_facility: MHATNP Sv. Naum EAD Clinic of Neurological Diseases for Locomotor Disorders

location_facility: Oregon Health & Science University (OHSU)

location_facility: Federal State Budgetary Institution Federal Sibirian Scientific and Clinical Center of Federal Medico-Biological Agency

location_facility: UO Farmacia Centralizzata OM (SC) Ospedale Maggiore

location_facility: SBEI APE Russian Medical Academy of Postgraduate Education of the MoH of the RF

location_facility: Municipal Instituion of Health: Kharkiv Public Outpatient Clinic 9, Kharkiv Medical Academy of Post-Graduate Education, Department of General Practice - Family Medicine

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: Clinical Trials Centre, Level 3 Monash Health Translational Precinct Building Monash Medical Centre

location_facility: State Budgetary Institution of Healthcare of Novosibirsk region City Clinical Hospital No. 34

location_facility: Instytut Zdrowia Dr Boczarska-Jedynak SP. Z 0.0., SP. K.

location_facility: Perron Institute for Neurological and Translational Science

location_facility: FSBI "National Medical Research Centre of psychiatry and neurology named after V.M. Bekhterev" of the MOH of the Russian Federation

location_facility: Colorado Springs Neurological Associates

location_facility: Specjalistyczna Praktyka Lekarska prof.Grzegorz Opala

location_facility: Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej

location_facility: Charite - Campus Virchow- Klinikum, Klinik fur Neurologie

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: Montreal Neurological Institute & Hospital

location_facility: AOU San Giovanni di Dio e Ruggi d'Aragona

location_facility: University of Cincinnati Medical Center (UCGNI)

location_facility: University of Texas Southwestern Medical Center

location_facility: Fondazione IRCCS CA Granda Ospedale Maggiore Pliclinico - U.O. Neurologia

location_facility: Universita di Bologna-Clinica Neurologica-Dipartimento di Scienze Neurologiche Ospedale Bellaria

title: A Phase 3, 182-week, Open-Label, Extension Study to Investigate the Safety and Tolerability of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension (Symptomatic nOH) in Subjects With Primary Autonomic Failure

ipd_sharing_description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

location_country:
Germany
Italy
Poland
Portugal
New Zealand
Israel
United Kingdom
Denmark
Australia
Estonia
Austria
United States
Spain
Ukraine
Bulgaria
Canada
Russian Federation
France


title: A Phase 1, Randomized, Dose and Schedule Evaluation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Belantamab Mafodotin Administered in Combination With Standard of Care in Participants With Newly Diagnosed Multiple Myeloma

acronym: DREAMM 9

summary: This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide), dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per dosing schedule. Participants will receive belantamab mafodotin on a schedule that is dependent on the cohort to which they are assigned. Belantamab mafodotin will be administered in combination with VRd every 3 weeks (Q3W), every 6 weeks (Q6W), or every 9 weeks (Q9W) to Cycle 8, and then in combination with Rd every 4 weeks (Q4W), every 8 weeks (Q8W), or every 12 weeks (Q12W) thereafter. Participants will complete an End of Treatment (EOT) visit at the point of study treatment discontinuation, followed by a Safety Follow-up visit 70 days after EOT.

location_country:
Germany
Italy
Poland
United Kingdom
Australia
United States
Korea, Republic of
Spain
Canada
France


title: Medtronic Cardiac Surgery Post Market Clinical Follow-up Registry

summary: This registry is being conducted to support ongoing post-market surveillance activities.

time_perspective: Other

lead_sponsor: Medtronic Cardiac Surgery

location_country:
Germany
Italy
Netherlands
Austria
Belgium
Switzerland
United States
Spain
Greece
France

location_facility: Deutsches Herzzentrum München Klinik an der TU München

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: Hospital Regional Universitario Carlos Haya Málaga - Hospital General

location_facility: University of Pittsburgh Medical Center UPMC Presbyterian

location_facility: Allgemeines Krankenhaus - Universitätskliniken Wien


title: A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

summary:
Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of SNDX-5613 in participants with acute leukemia.

In Phase 2, participants will be enrolled in 3 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of SNDX-5613.

ReferenceCitation: Sasca D, Guezguez B, Kuhn MWM. Next generation epigenetic modulators to target myeloid neoplasms. Curr Opin Hematol. 2021 Sep 1;28(5):356-363. doi: 10.1097/MOH.0000000000000673.

ReferenceCitation: Jimenez JA, Apfelbaum AA, Hawkins AG, Svoboda LK, Kumar A, Ruiz RO, Garcia AX, Haarer E, Nwosu ZC, Bradin J, Purohit T, Chen D, Cierpicki T, Grembecka J, Lyssiotis CA, Lawlor ER. EWS-FLI1 and Menin Converge to Regulate ATF4 Activity in Ewing Sarcoma. Mol Cancer Res. 2021 Jul;19(7):1182-1195. doi: 10.1158/1541-7786.MCR-20-0679. Epub 2021 Mar 19.

oa_colors: green other

version: acceptedVersion

repository_institution: University of Illinois at Chicago - INDIGO

version: submittedVersion

repositories_concat: PubMed Central;figshare.com

publisher_dissemination: American Association for Cancer Research

lead_sponsor: Syndax Pharmaceuticals

location_country:
Germany
Italy
Lithuania
Israel
Australia
Netherlands
United States
Spain
Canada
France

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Princess Maxima Center for Pediatric Oncology

location_facility: Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals

location_facility: Florida Cancer Specialists and Research Institute

location_facility: Washington University in St. Louis School of Medicine

location_facility: Huntsman Cancer Institute at the University of Utah

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: IRCCS Azienda Ospedaliero Universitaria di Bologna

location_facility: The University of Chicago Medical Center

location_facility: Istituto Romagnolo Per Lo Studio dei tumori Dino Amadori

location_facility: City of Hope Comprehensive Cancer Center


lead_sponsor: UCB Biopharma SRL

summary: The purpose of the study is to assess long-term safety and tolerability of weekly doses of rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

title: An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

location_country:
Germany
United Kingdom
Denmark
Netherlands
Belgium
United States
Spain
France


title: A Phase 1 Study of SGN-CD228A in Select Advanced Solid Tumors

summary: This trial will study SGN-CD228A to find out whether it is an effective treatment for different kinds of cancer. It will also look at what side effects (unwanted effects) may occur. The study will have two parts. Part 1 of the study will find out how much SGN-CD228A should be given for treatment and how often. Part 2 of the study will use the dose found in Part 1 and look at how safe and effective the treatment is.

lead_sponsor: Seagen Inc.

location_country:
Italy
United Kingdom
United States
Spain
France

location_facility: South Texas Accelerated Research Therapeutics

location_facility: The Angeles Clinic and Research Institute

location_facility: Case Western Reserve University / University Hospitals Cleveland Medical Center

location_facility: University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center

location_facility: Wake Forest Baptist Medical Center / Wake Forest University

location_facility: MD Anderson Cancer Center / University of Texas


intervention_type: Biological

acronym: not applicable

lead_sponsor: Novartis Gene Therapies

summary: This is a long-term follow-up safety and efficacy study of participants in clinical trials for spinal muscular atrophy (SMA) who were treated with onasemnogene abeparvovec-xioi. Participants will roll over from their respective previous (parent) study into this long-term study for continuous monitoring of safety as well as monitoring of continued efficacy and durability of response to onasemnogene abeparvovec-xioi treatment.

ReferenceCitation: Day JW, Mendell JR, Mercuri E, Finkel RS, Strauss KA, Kleyn A, Tauscher-Wisniewski S, Tukov FF, Reyna SP, Chand DH. Clinical Trial and Postmarketing Safety of Onasemnogene Abeparvovec Therapy. Drug Saf. 2021 Oct;44(10):1109-1119. doi: 10.1007/s40264-021-01107-6. Epub 2021 Aug 12. Erratum In: Drug Saf. 2022 Feb;45(2):191-192.

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: American Medical Association - The Journal of the American Medical Association (JAMA) Network

repositories_institution: University of Massachusetts Medical School - eScholarship@UMMS

location_facility: Children's Hospital of The King's Daughters

location_facility: Spectrum Health Hospitals Helen DeVos Children's Hospital

location_facility: John Hopkins Hospital - David M. Rubenstein Child Health Building

location_facility: Ann Robert H. Lurie Children's Hospital of Chicago

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Centre de Référence des Maladies Neuromusculaires

location_facility: Children's Health Specialty Center Dallas Campus

location_facility: Washington Unviersity School of Medicine in Saint Louis

location_facility: Children's Hospital of Eastern Ontario Research Institute

location_facility: Great Ormond Street Hospital for Children NHS Foundation Trust

location_facility: Tokyo Women's Medical University Hospital

title: A Long-term Follow-up Study of Patients in the Clinical Trials for Spinal Muscular Atrophy Receiving AVXS-101

location_country:
Italy
United Kingdom
Australia
Japan
Belgium
United States
Taiwan
Canada
France


title: An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis

acronym: POETYK PSO-LTE

summary: The main purpose of this study is to characterize the long-term safety and efficacy of the drug Deucravacitinib (BMS-986165) in patients who have been previously enrolled in an applicable Phase 3 psoriasis study.

lead_sponsor: Bristol-Myers Squibb

location_country:
Finland
Germany
Poland
New Zealand
Australia
Japan
Czechia
Canada
France
Hungary
United States
China
Puerto Rico
United Kingdom
Sweden
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: Krajska zdravotni - Masarykova nemocnice v Usti nad Labem

location_facility: Synexus - Merseyside Clinical Research Centre

location_facility: University of California San Diego Health Systems

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato - Debrecen Affiliated Site

location_facility: Clinical Research Advantage - Evansville - South Kenmore Drive

location_facility: Austin Institute for Clinical Research - Pflugerville

location_facility: Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus

location_facility: Total Skin and Beauty Dermatology Center

location_facility: Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

location_facility: Center for Clinical Studies - Texas Medical Center

location_facility: Synexus - Lancashire Clinical Research Centre

location_facility: Interspond - Houston Center for Clinical Research

location_facility: Qualiclinic Egeszsegugyi Szolgaltato es Kutatasszervezo Kft.

location_facility: First OC Dermatology & Belle-Aimee Skincare Clinic Fountain Valley

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Alliance Dermatology and Mohs Center - Phoenix

location_facility: Dermatology Clinical Research Center of San Antonio

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Washington University School of Medicine - West County Dermatology

location_facility: St. George Dermatology & Skin Care Centre

location_facility: Josa Andras Oktatokorhaza - Szabolcs Szatmar-Bereg Megyei Onkormanyzat

location_facility: ZDROWIE OSTEO-MEDIC s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Associated Skin Care Specialists - Minnesota Clinical Study Center

location_facility: Coastal Carolina Research Center - Mount Pleasant

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato - Gyula

location_facility: Clinical Research Consortium - Las Vegas

location_facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato - Zalaegerszeg

location_facility: Centre Hospitalier Universitaire de Nice Hopital lArchet

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej MED-LASER

location_facility: Dermatology Research Associates - Los Angeles

location_facility: Guys and Saint Thomas NHS Foundation Trust

location_facility: Clinical Research Center of the Carolinas

location_facility: Northwest Arkansas Clinical Trials Center, PLLC

location_facility: Synexus - Manchester Clinical Research Centre

location_facility: Japan Community Health Care Organization Tokyo Yamate Medical Center

location_facility: Treasure Valley Dermatology & Skin Cancer Center


lead_sponsor: Ra Pharmaceuticals

summary: The purpose of the study is to evaluate the safety and efficacy of zilucoplan in patients with Immune-Mediated Necrotizing Myopathy (IMNM). Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or matching placebo for 8 weeks.

location_facility: University of Florida Health Jacksonville

location_facility: Washington University School of Medicine in Saint Louis

location_facility: Salford Royal NHS Barnes Clinical Research Facility

location_facility: The University of Texas Health Science Center at Houston

location_facility: University College London Hospitals NHS Foundation Trust

title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Immune-Mediated Necrotizing Myopathy

location_country:
United States
United Kingdom
Netherlands
France


title: Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study for Patients With Nonalcoholic Steatohepatitis

acronym: iLEAD

summary: The objective of this study is: (1) to investigate the correlation of ultrasound parameters (SW speed, Dispersion slope, Attenuation value, Normalized Local Variance, Liver / Kidney Intensity Ratio) with the pathological parameters (fibrosis, intralobular inflammation, ballooning degeneration and steatosis); (2) to evaluate the diagnostic performance of SW speed for liver fibrosis, Dispersion slope for intralobular inflammation and Attenuation value for steatosis by comparison with the tissue diagnosis by liver biopsy.

time_perspective: Cross-Sectional

lead_sponsor: Tokyo Medical University

location_country:
Germany
Italy
United Kingdom
Japan
United States
China
Korea, Republic of
France

location_facility: Policlinico Umberto I, Univ. La Sapienza

location_facility: Charing Cross Hospital / Imperial College London

intervention_type: Diagnostic Test


title: AURORAX-0087A: Glycosaminoglycan Scores for Surveillance of Recurrence in Leibovich Points ≥5 Non-metastatic Clear Cell Renal Cell Carcinoma

summary: AUR87A is an observational prospective multicenter diagnostics test cohort study for detection of renal cell carcinoma recurrence as determined by the reference standard, which is imaging using computed tomography (CT) of the chest and abdomen at defined intervals after primary surgery.

ipd_sharing_description: Unidentified clinical and biochemical data will become available to the research community along with the publication of a scientific article related to the present investigation.

lead_sponsor: Elypta

location_country:
Finland
Italy
Portugal
United Kingdom
Denmark
Sweden
United States
Spain
Canada
France

location_facility:
Salford Royal NHS Foundation Trust
Zealand University Hospital
AOU San Orsola Malpighi
Emory University School of Medicine
Odense University Hospital
Hospital Universitario Cabueñes
Royal Berkshire Hospital
Norfolk & Norwich University Hospital
Frimley Park Hospital
Addenbrooke's Hospital
Careggi University Hospital
Royal Free Hospital
Memorial Sloan Kettering Cancer Center
Prostate Cancer Centre
AOU Integrata Verona
Helsinki University Central Hospital
Guys & St Thomas Hospital
Hospital da Luz Coimbra
Hôpital Henri Mondor
Sahlgrenska University Hospital
MD Anderson Cancer Center
Istituto Nazionale Tumori Regina Elena
Aarhus University Hospital
AOU San Luigi Gonzaga
Western General Hospital
San Raffaele Hospital