title: A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)

summary: To investigate if Riociguat is effective in the treatment of systemic sclerosis

ReferenceCitation: Distler O, Pope J, Denton C, Allanore Y, Matucci-Cerinic M, de Oliveira Pena J, Khanna D. RISE-SSc: Riociguat in diffuse cutaneous systemic sclerosis. Respir Med. 2017 Jan;122 Suppl 1:S14-S17. doi: 10.1016/j.rmed.2016.09.011. Epub 2016 Sep 28.

lead_sponsor: Bayer

location_country:
Italy
United States
Switzerland
Netherlands
Germany
France
Czechia
Japan
Hungary
Belgium
Australia
New Zealand
Turkey
Canada
United Kingdom

location_facility: Medical University of South Carolina Medical Center

location_facility: Centre Hospitalier Universitaire - Grenoble

location_facility: Universitair Medisch Centrum St. Radboud

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Institute of Rheumatology Tokyo Women's Medical University

location_facility: Cukurova Univ. Tip. Fak. Balcali Hastanesi

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Rutgers Robert Wood Johnson Medical School


ReferenceType: background

ReferenceCitation: Busse WW, Brusselle GG, Korn S, Kuna P, Magnan A, Cohen D, Bowen K, Piechowiak T, Wang MM, Colice G. Tralokinumab did not demonstrate oral corticosteroid-sparing effects in severe asthma. Eur Respir J. 2019 Jan 31;53(2). pii: 1800948. doi: 10.1183/13993003.00948-2018. Print 2019 Feb.

ReferenceType: derived

ReferenceCitation: Panettieri RA Jr, Wang M, Braddock M, Bowen K, Colice G. Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program. Immunotherapy. 2018 Mar 1;10(6):473-490. doi: 10.2217/imt-2017-0191. Epub 2018 Mar 14. Review.

name: Rutgers Institute for Translational Medicine & Science, Rutgers, The State University of New Jersey, NJ 08901, USA

family: Panettieri Jr

full_name: Reynold A Panettieri Jr

given: Reynold A

sequence: first

name: Global Medicines Development, AstraZeneca, Cambridge, UK

family: Wang

full_name: Millie Wang

given: Millie

sequence: additional

family: Braddock

full_name: Martin Braddock

given: Martin

name: Global Medicines Development, AstraZeneca, Gaithersburg, MD 20878, USA

family: Bowen

full_name: Karin Bowen

given: Karin

family: Colice

full_name: Gene Colice

given: Gene

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Immunotherapy

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

design_allocation: Randomized

intervention_type: Other

status: Completed

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: AstraZeneca

enrollment_type: Actual

primary_purpose: Treatment

location_country:
United States
Netherlands
France
Poland
Belgium
Germany
Ukraine

acronym: TROPOS

study_completion_date_type: Actual

source: euctr

title: A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid Use in Adults and Adolescents With Oral Corticosteroid Dependent Asthma (TROPOS)

summary: A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid dependent Asthma.

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

type: Registry Identifier

title: A Phase-2 Study To Determine Efficacy and Safety of Luspatercept in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis and Anemia With or Without Red Blood Cell-Transfusion Dependence

summary: This is a Phase 2, multicenter, open-label study to evaluate the efficacy and safety of luspatercept in subjects with MPN-associated myelofibrosis and anemia with and without RBC-transfusion dependence. The study is divided into a Screening Period, a Treatment Period (consisting of a Primary Phase, a Day 169 Disease Response Assessment, and an Extension Phase), followed by a Posttreatment Follow-up Period.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Celgene

location_country:
Italy
United States
United Kingdom
France

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Mid Florida Hematology and Oncology Centers, PA

location_facility: Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: MD Anderson Cancer Center The University of Texas

intervention_type: Drug

status_simplified: Ongoing


title: A Multicenter, Double-Blind, Randomized, Comparative Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of CF-301 vs. Placebo in Addition to Standard-of-Care Antibacterial Therapy for the Treatment of Adult Patients With Staphylococcus Aureus Bloodstream Infections (Bacteremia) Including Endocarditis

summary:
The purpose of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of CF-301 in addition to background standard of care (SOC) antibacterial therapy for the treatment of Staphylococcus aureus (S. aureus) bloodstream infections (bacteremia), including endocarditis in adults. Patients will be randomized to receive a single intravenous dose of CF-301 or placebo in addition to SOC antibacterial therapy. Patients will be prescribed standard of care antibiotics selected by the investigators based on their professional experience, practice guidelines and local antibiotic susceptibility information for the treatment of S. aureus bacteremia.

CF-301 is a lysin and member of a new class of targeted protein-based antimicrobials that has demonstrated activity against S. aureus in laboratory (in vitro) and animal studies, alone and in addition to conventional antibiotics.

ReferenceCitation: Fowler VG Jr, Das AF, Lipka-Diamond J, Schuch R, Pomerantz R, Jáuregui-Peredo L, Bressler A, Evans D, Moran GJ, Rupp ME, Wise R, Corey GR, Zervos M, Douglas PS, Cassino C. Exebacase for patients with Staphylococcus aureus bloodstream infection and endocarditis. J Clin Invest. 2020 Jul 1;130(7):3750-3760. doi: 10.1172/JCI136577.

family: Fowler

full_name: Vance G. Fowler

given: Vance G.

suffix: Jr.

family: Das

full_name: Anita F. Das

given: Anita F.

family: Lipka-Diamond

full_name: Joy Lipka-Diamond

given: Joy

family: Schuch

full_name: Raymond Schuch

given: Raymond

family: Pomerantz

full_name: Roger Pomerantz

given: Roger

family: Jáuregui-Peredo

full_name: Luis Jáuregui-Peredo

given: Luis

family: Bressler

full_name: Adam Bressler

given: Adam

family: Evans

full_name: David Evans

given: David

family: Moran

full_name: Gregory J. Moran

given: Gregory J.

family: Rupp

full_name: Mark E. Rupp

given: Mark E.

family: Wise

full_name: Robert Wise

given: Robert

family: Corey

full_name: G. Ralph Corey

given: G. Ralph

family: Zervos

full_name: Marcus Zervos

given: Marcus

family: Douglas

full_name: Pamela S. Douglas

given: Pamela S.

family: Cassino

full_name: Cara Cassino

given: Cara

journal_name: Journal of Clinical Investigation

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

license_normalized: no license

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

publisher: American Society for Clinical Investigation

lead_sponsor: ContraFect

location_country:
Italy
Chile
Guatemala
Germany
France
Czechia
Bulgaria
Greece
Israel
Belgium
Russian Federation
Spain
United States
United Kingdom

location_facility:
CF-301-102 Study Site #2
CF301-102 Study Site #3
CF301-102 Study site
CF301-102 Study Site
Study Site #2
CF-301-102 Study Site
Cf301-102
CF301-102 Study Site #2
Cf-301-102
CF0301-102 Study Site
CF-301 Study Site


title: An International, Multi-centre Prospective Pharmacokinetic Evaluation of Antifungal Drug Exposure in Intensive Care Unit Patients Receiving Conventional Dosing Regimens

acronym: SAFE-ICU

summary:
Adequate antifungal therapy is a critical determinant of survival in patients admitted to an Intensive Care Unit (ICU) with suspected or proven fungal infections. Critical illness can alter the way human body handles antifungal agents, i.e. how the drugs are distributed in the body and removed from the body. Consequently, these changes can increase the risk of inappropriate antifungal exposure that may lead to adverse consequence on patients' outcome. Developing an evidence-based antifungal dosing guideline is of global significance and should be considered a priority to improving clinical outcomes for patients receiving antifungal agents

The aim of the SAFE-ICU Study is to develop optimised antibiotic dosing guidelines for ICU patients with life-threatening infections that account for patient characteristics. This will be achieved through completion of the following aims:

i) Describe detailed demographic, clinical and plasma antibiotic concentration-time data in a large ICU patient cohort; ii) Perform a robust statistical analysis of the data collected in Aim 1 to develop an enhanced preliminary prediction algorithm for antifungal dosing.

This is a multi-national study and will enrol ICU patients who are prescribed an antifungal agent (fluconazole, voriconazole, posaconazole, isavuconazole, caspofungin, anidulafungin, micafungin or amphotericin B). A minimum of 12 patients per drug will be enrolled across at least 15 countries and up to 80 ICUs.

Eligible patients are those admitted to the ICU, who are prescribed an antifungal agent (fluconazole, voriconazole, posaconazole, isavuconazole, caspofungin, anidulafungin, micafungin or amphotericin B). Blood samples will be taken to measure drug concentration. Sampling will occur on two occasions, first during study days 1-3 and then a second time between days 4-7, each over an 8-24 hour period. Blood samples will be taken from a vascular access device already inserted for ICU patient care. Abdominal samples from abdominal indwelling drains already inserted peri operatively will also be collected on these two occasions in the subgroup of patients with intra-abdominal infection. Data on infection, various blood tests and patient specific data will be collected using a structured case report form (CRF). Patients will also be followed up 30 days after enrolment into the study to evaluate 30-day mortality.

Collected samples will be frozen and stored locally and then shipped in large batches for processing at Burns Trauma and Critical Care Research Centre, The University of Queensland, Australia. Data analysis for development of antifungal dosing algorithms will also be undertaken at The University of Queensland, Australia.

status: Unknown status

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: The University of Queensland

location_country:
Italy
United States
Hong Kong
Netherlands
Spain
Finland
France
Malaysia
Greece
Belgium
Australia
Portugal
Canada

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Chu de BORDEAUX Hôpital Haut-Leveque - Réanimation

location_facility: APHP Hôpital Bichat - Réanimation médicale et Maladies infectieuses

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil

location_facility: International Islamic University Malaysia Medical Center

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: CHRU de Nîmes - Hôpital Universitaire Carémeau

location_facility: Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino

location_facility: Radboud University Nijmegen Medical Centre

location_facility: The Health Sciences Center University of Manitoba

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Centro Hospitalar Universitario de coimbra

lead_sponsor_type: academique

status_simplified: Unknown


title: An Open Label, Phase Ib, Dose-escalation Study Evaluating the Safety and Tolerability of Xentuzumab and Abemaciclib in Patients With Locally Advanced or Metastatic Solid Tumours and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-positive, HER2-, Breast Cancer, Followed by Expansion Cohorts.

summary:
This is a study in adult patients with different types of cancer. The purpose of this study is to find a safe dose of:

Xentuzumab in combination with abemaciclib
Xentuzumab in combination with abemaciclib and hormonal therapies The study also tests whether these medicines make tumours shrink in participants with lung and breast cancer.

Participants can stay in the study as long as they benefit from and can tolerate treatment. All participants get xentuzumab infusions and abemaciclib tablets. Participants who have breast cancer get different types of hormonal therapies in addition to xentuzumab and abemaciclib.

For all participants, the size of the tumour is measured regularly. Doctors also regularly check the general health of the participants."

status: Active, not recruiting

design_allocation: Non-Randomized

ipd_sharing: Yes

ipd_sharing_description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets

lead_sponsor: Boehringer Ingelheim

location_country:
Finland
France
Japan
Spain
Denmark
United States
Korea, Republic of

location_facility: University of Minnesota Masonic Cancer Center

location_facility: The University of North Carolina at Chapel Hill

location_facility: Copenhagen University Hospital, Rigshospitalet


title: Cardiac Implantable Electronic Device (CIED) Antibiotic Envelope Infection Prevention Trial

acronym: WRAP-IT

summary: Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded, post-market, interventional clinical study. This study will evaluate the ability of the TYRX™ envelope to reduce major Cardiac Implantable Electronic Device (CIED) infections through 12-months post-procedure following CIED generator replacement, upgrade, revision, or de novo cardiac resynchronization therapy defibrillator (CRT-D) implant. Additionally, this large device study provides the unique opportunity to prospectively characterize the performance of Medtronic's lead monitoring features in subjects whose CIED system includes a transvenous right ventricular (RV) defibrillation lead. Finally, the WRAP-IT study will serve as a post-approval study for those geographies requiring a post-approval study of the TYRX™ envelope.

primary_purpose: Prevention

ReferenceCitation: Poole JE, Swerdlow CD, Tarakji KG, Mittal S, Ellenbogen KA, Greenspon AJ, Kennergren C, Philbert BT, Moore J, Jones RC, Schaller RD, Hansalia R, Simmers T, Mihalcz A, DeBus B, Lexcen DR, Gunderson B, Wilkoff BL. Clinical performance of implantable cardioverter-defibrillator lead monitoring diagnostics. Heart Rhythm. 2021 Nov 9. pii: S1547-5271(21)02328-6. doi: 10.1016/j.hrthm.2021.10.032. [Epub ahead of print]

family: Poole

full_name: Jeanne E. Poole

given: Jeanne E.

family: Swerdlow

full_name: Charles D. Swerdlow

given: Charles D.

family: Tarakji

full_name: Khaldoun G. Tarakji

given: Khaldoun G.

family: Mittal

full_name: Suneet Mittal

given: Suneet

family: Ellenbogen

full_name: Kenneth A. Ellenbogen

given: Kenneth A.

family: Greenspon

full_name: Arnold J. Greenspon

given: Arnold J.

family: Kennergren

full_name: Charles Kennergren

given: Charles

family: Philbert

full_name: Berit T. Philbert

given: Berit T.

family: Moore

full_name: JoEllyn Moore

given: JoEllyn

family: Jones

full_name: R. Chris Jones

given: R. Chris

family: Schaller

full_name: Robert D. Schaller

given: Robert D.

family: Hansalia

full_name: Riple Hansalia

given: Riple

family: Simmers

full_name: Timothy Simmers

given: Timothy

family: Mihalcz

full_name: Attila Mihalcz

given: Attila

family: DeBus

full_name: Becky DeBus

given: Becky

family: Lexcen

full_name: Daniel R. Lexcen

given: Daniel R.

family: Gunderson

full_name: Bruce Gunderson

given: Bruce

family: Wilkoff

full_name: Bruce L. Wilkoff

given: Bruce L.

journal_name: Heart Rhythm

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Clinical Performance of Implantable Cardioverter Defibrillator Lead Monitoring Diagnostics

ReferenceCitation: Sohail MR, Corey GR, Wilkoff BL, Poole JE, Mittal S, Kennergren C, Greenspon AJ, Cheng A, Lande JD, Lexcen DR, Tarakji KG. Clinical Presentation, Timing, and Microbiology of CIED Infections: An Analysis of the WRAP-IT Trial. JACC Clin Electrophysiol. 2021 Jan;7(1):50-61. doi: 10.1016/j.jacep.2020.07.021. Epub 2020 Oct 28.

family: Sohail

full_name: M. Rizwan Sohail

given: M. Rizwan

ReferenceCitation: Wilkoff BL, Boriani G, Mittal S, Poole JE, Kennergren C, Corey GR, Krahn AD, Schloss EJ, Gallastegui JL, Pickett RA, Evonich RF, Roark SF, Sorrentino DM, Sholevar DP, Cronin EM, Berman BJ, Riggio DW, Khan HH, Silver MT, Collier J, Eldadah Z, Holbrook R, Lande JD, Lexcen DR, Seshadri S, Tarakji KG. Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial. Circ Arrhythm Electrophysiol. 2020 Oct;13(10):e008503. doi: 10.1161/CIRCEP.120.008503. Epub 2020 Sep 11.

name: Valley Health System, Ridgewood, NJ (S.M.).

name: Sahlgrenska University Hospital, Göteborg, Sweden (C.K.).

name: University of British Colombia, Canada (A.D.K.).

name: The Christ Hospital, Cincinnati, OH (E.J.S.).

name: Clearwater Cardiovascular and Interventional Consultants, Safety Harbor, FL (J.L.G.).

name: Saint Thomas Research Institute, LLC, Nashville, TN (R.A.P.).

name: Upper Michigan Cardiovascular Associates, Marquette (R.F.E.).

name: Cardiology Associates of Gainesville, FL (S.F.R.).

name: Virtua Health System, Camden, NJ (D.P.S.).

name: Temple University Hospital, Philadelphia, PA (E.M.C.).

name: Chula Vista Cardiac Center, CA (B.J.B.).

name: Arizona Arrhythmia Consultants, Scottsdale (D.W.R.).

name: Baylor Research Institute, Plano, TX (H.H.K.).

name: WakeMed Heart and Vascular, WakeMed Health and Hospitals, Raleigh, NC (M.T.S.).

name: MedStar Heart and Vascular Institute, Washington, DC (Z.E.).

name: Medtronic, Inc, Mounds View, MN (R.H., J.D.L., D.R.L., S.S.).

journal_name: Circulation: Arrhythmia and Electrophysiology

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Wilkoff BL, Boriani G, Mittal S, Poole JE, Kennergren C, Corey GR, Love JC, Augostini R, Faerestrand S, Wiggins SS, Healey JS, Holbrook R, Lande JD, Lexcen DR, Willey S, Tarakji KG; WRAP-IT Investigators. Impact of Cardiac Implantable Electronic Device Infection: A Clinical and Economic Analysis of the WRAP-IT Trial. Circ Arrhythm Electrophysiol. 2020 May;13(5):e008280. doi: 10.1161/CIRCEP.119.008280. Epub 2020 Apr 12.

name: Department of Cardiovascular Medicine and Heart and Vascular Institute, Cleveland Clinic, OH (B.L.W., K.G.T.).

name: Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Modena, Italy (G.B.).

name: Department of Cardiology, Section of Electrophysiology, Valley Health System, Ridgewood, NJ (S.M.).

name: Department of Medicine, University of Washington School of Medicine, Seattle (J.E.P.).

name: The Sahlgrenska Academy, University of Göteborg, Sweden (C.K.).

name: Department of Medicine, Duke Clinical Research Institute, Durham, NC (G.R.C.).

name: Maine Medical Partners, Maine Medical Center, Portland (J.C.L.).

name: Department of Internal Medicine, Ohio State University, Columbus (R.A.).

name: Department of Heart Disease, University of Bergen and Haukeland University Hospital, Norway (S.F.).

name: ARK-LA-TEX Cardiology, Christus Highland Hospital, Shreveport, LA (S.S.W.).

name: Population Health Research Institute, McMaster University, ON, Canada (J.S.H.).

name: Cardiac Rhythm & Heart Failure (CRHF) Therapy Development and Clinical Research, Medtronic, Mounds View, MN (R.H., J.D.L., D.R.L., S.W.).

ReferenceCitation: Mittal S, Wilkoff BL, Kennergren C, Poole JE, Corey R, Bracke FA, Curnis A, Addo K, Martinez-Arraras J, Issa ZF, Redpath C, Moubarak J, Khelae SK, Boersma LVA, Korantzopoulos P, Krueger J, Lande JD, Morss GM, Seshadri S, Tarakji KG. The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: Long-term follow-up. Heart Rhythm. 2020 Jul;17(7):1115-1122. doi: 10.1016/j.hrthm.2020.02.011. Epub 2020 Feb 19.

ReferenceCitation: Tarakji KG, Mittal S, Kennergren C, Corey R, Poole JE, Schloss E, Gallastegui J, Pickett RA, Evonich R, Philippon F, McComb JM, Roark SF, Sorrentino D, Sholevar D, Cronin E, Berman B, Riggio D, Biffi M, Khan H, Silver MT, Collier J, Eldadah Z, Wright DJ, Lande JD, Lexcen DR, Cheng A, Wilkoff BL; WRAP-IT Investigators. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. N Engl J Med. 2019 May 16;380(20):1895-1905. doi: 10.1056/NEJMoa1901111. Epub 2019 Mar 17.

name: From the Cleveland Clinic, Cleveland (K.G.T., B.L.W.), and the Lindner Research Center, Cincinnati (E.S.) — both in Ohio; Valley Health System, Ridgewood (S.M.), and Lourdes Cardiology Services, Cherry Hill (D. Sholevar) — both in New Jersey; Sahlgrenska University Hospital, Göteborg, Sweden (C.K.); Duke Clinical Research Institute, Durham (R.C.), and WakeMed Heart and Vascular, WakeMed Health and Hospitals, Raleigh (M.T.S.) — both in North Carolina; University of Washington School of Medicine, Seattle ...

repository_institution: University of Zurich - Zurich Open Repository and Archive

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country:
Finland
Malaysia
Greece
Belgium
Denmark
France
Poland
Slovakia
Norway
Canada
Chile
Sweden
Saudi Arabia
Switzerland
Netherlands
Singapore
China
Portugal
United States
Germany
United Kingdom
Italy
Austria
Israel
Spain

location_facility: University of Pittsburgh Medical Center UPMC Hamot

location_facility: North Memorial Heart and Vascular Institute

location_facility: University of Pittsburgh Medical Center UPMC Presbyterian

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Clearwater Cardiovascular & Interventional Consultants

location_facility: Szpital Kliniczny Przemienienia Panskiego

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Hamilton General Hospital / Hamilton Health Sciences

location_facility: Royal Brompton & Harefield NHS Foundation Trust - Harefield Hospital

location_facility: Saint Mary Medical Center (Langhorne PA)

location_facility: Universitäts-Herz-Zentrum Freiburg - Bad Krozingen

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

location_facility: The University Kansas Medical Center Research Institute Inc

location_facility: Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE

location_facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

location_facility: Oregon Health & Science University Hospital

location_facility: Great Lakes Heart and Vascular Institute PC

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Ziekenhuis Oost Limburg - Campus St.-Jan

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Virginia Commonwealth University Health System

location_facility: SCL Physicians Heart Institute of Colorado

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

location_facility: The University of Vermont Medical Center Inc

location_facility: Novant Health Heart and Vascular Institute

location_facility: Washington University School of Medicine

location_facility: Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)

location_facility: University Hospitals Case Medical Center

location_facility: Stredoslovensky ustav srdcovych a cievnych chorob a.s

location_facility: Prairie Education & Research Cooperative (Springfield IL)

location_facility: Helse Bergen HF - Haukeland Universitetssjukehus

location_facility: Northeast Ohio Cardiovascular Specialists

location_facility: CHU Hôpiteaux de Rouen - Hôpital Charles Nicolle

location_facility: Oklahoma Heart Hospital Research Foundation

location_facility: Hôpital de la Timone - Centre Hospitalier Universitaire de Marseille

location_facility: Centennial Heart Cardiovascular Consultants LLC

location_facility: Institut Jantung Negara - National Heart Institute

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Centre Hospitalier Universitaire Saint Étienne - Hôpital Nord

location_facility: Cardiovascular Research Foundation of Louisiana

location_facility: Wake Forest University Health Sciences / Baptist Medical Center / North Carolina Baptist Hospital

location_facility: University of California San Francisco UCSF Medical Center

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital

location_facility: Central Manchester University Hospitals NHS - Manchester Royal Infirmary

location_facility: University General Hospital of Heraklion

location_facility: University of Oklahoma Health Science Center (OUHSC)

location_facility: Upper Michigan Cardiovascular Associates PC

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: University of Florida Health Shands Hospital


type: Other Identifier

title: A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus

acronym: DEPICT 1

summary: The purpose of this study is to determine if adding dapagliflozin to insulin is a safe and effective therapy to improve glycemic control in patients with type 1 diabetes.

ReferenceCitation: Groop PH, Dandona P, Phillip M, Gillard P, Edelman S, Jendle J, Xu J, Scheerer MF, Thoren F, Iqbal N, Repetto E, Mathieu C. Effect of dapagliflozin as an adjunct to insulin over 52 weeks in individuals with type 1 diabetes: post-hoc renal analysis of the DEPICT randomised controlled trials. Lancet Diabetes Endocrinol. 2020 Oct;8(10):845-854. doi: 10.1016/S2213-8587(20)30280-1.

family: Groop

full_name: Per-Henrik Groop

given: Per-Henrik

family: Dandona

full_name: Paresh Dandona

given: Paresh

family: Phillip

full_name: Moshe Phillip

given: Moshe

family: Gillard

full_name: Pieter Gillard

given: Pieter

family: Edelman

full_name: Steven Edelman

given: Steven

family: Jendle

full_name: Johan Jendle

given: Johan

family: Xu

full_name: John Xu

given: John

family: Scheerer

full_name: Markus F Scheerer

given: Markus F

family: Thoren

full_name: Fredrik Thoren

given: Fredrik

family: Iqbal

full_name: Nayyar Iqbal

given: Nayyar

family: Repetto

full_name: Enrico Repetto

given: Enrico

family: Mathieu

full_name: Chantal Mathieu

given: Chantal

journal_name: The Lancet Diabetes & Endocrinology

ReferenceCitation: Mathieu C, Dandona P, Birkenfeld AL, Hansen TK, Iqbal N, Xu J, Repetto E, Scheerer MF, Thoren F, Phillip M. Benefit/risk profile of dapagliflozin 5 mg in the DEPICT-1 and -2 trials in individuals with type 1 diabetes and body mass index ≥27 kg/m(2). Diabetes Obes Metab. 2020 Nov;22(11):2151-2160. doi: 10.1111/dom.14144. Epub 2020 Aug 20.

name: Clinical and Experimental Endocrinology, UZ Gasthuisberg University of Leuven  Leuven Belgium

name: State University of New York at Buffalo  Williamsville New York USA

name: Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Centre Munich University of Tübingen  Tübingen Germany

name: German Center for Diabetes Research (DZD)  Tübingen Germany

name: Department of Internal Medicine, Division of Endocrinology, Diabetology and Nephrology Eberhard Karls University Tübingen  Tübingen Germany

family: Birkenfeld

full_name: Andreas L Birkenfeld

given: Andreas L

name: Steno Diabetes Center Aarhus Aarhus University Hospital  Aarhus Denmark

family: Hansen

full_name: Troels Krarup Hansen

given: Troels Krarup

name: Late‐stage Development Cardiovascular, Renal and Metabolism AstraZeneca  Gaithersburg Maryland USA

name: Global Medical Affairs AstraZeneca  Gaithersburg Maryland USA

name: Diabetes Medical Department AstraZeneca  Wedel Germany

full_name: Markus Florian Scheerer

given: Markus Florian

name: Late‐stage Development Cardiovascular, Renal and Metabolism AstraZeneca  Gothenburg Sweden

name: Schneider Children's Medical Center of Israel  Petah Tikva Israel

name: Sacller Faculty of Medicine Tel Aviv University  Tel Aviv Israel

title: Benefit/risk profile of dapagliflozin 5 mg in the DEPICT ‐1 and ‐2 trials in individuals with type 1 diabetes and body mass index ≥27 kg/m 2

ReferenceCitation: Parkinson J, Tang W, Åstrand M, Melin J, Ekholm E, Hamrén B, Boulton DW. Model-based characterization of the relationship between dapagliflozin systemic exposure and HbA1c response in patients with type 1 diabetes mellitus. Diabetes Obes Metab. 2019 Jun;21(6):1381-1387. doi: 10.1111/dom.13664. Epub 2019 Mar 14.

name: Quantitative Clinical Pharmacology, Early Clinical DevelopmentIMED Biotech Unit, AstraZeneca Gothenburg Sweden

name: Quantitative Clinical Pharmacology, Early Clinical DevelopmentIMED Biotech Unit, AstraZeneca Gaithersburg Maryland, USA

name: Global Medicines DevelopmentIMED Biotech Unit, AstraZeneca Gothenburg Sweden

title: Model‐based characterization of the relationship between dapagliflozin systemic exposure and HbA1c response in patients with type 1 diabetes mellitus

ReferenceCitation: Dandona P, Mathieu C, Phillip M, Hansen L, Tschöpe D, Thorén F, Xu J, Langkilde AM; DEPICT-1 Investigators. Efficacy and Safety of Dapagliflozin in Patients With Inadequately Controlled Type 1 Diabetes: The DEPICT-1 52-Week Study. Diabetes Care. 2018 Dec;41(12):2552-2559. doi: 10.2337/dc18-1087. Epub 2018 Oct 23.

ReferenceCitation: Dandona P, Mathieu C, Phillip M, Hansen L, Griffen SC, Tschöpe D, Thorén F, Xu J, Langkilde AM; DEPICT-1 Investigators. Efficacy and safety of dapagliflozin in patients with inadequately controlled type 1 diabetes (DEPICT-1): 24 week results from a multicentre, double-blind, phase 3, randomised controlled trial. Lancet Diabetes Endocrinol. 2017 Nov;5(11):864-876. doi: 10.1016/S2213-8587(17)30308-X. Epub 2017 Sep 14. Erratum in: Lancet Diabetes Endocrinol. 2017 Dec;5(12 ):e8.

location_country:
Italy
Austria
United States
Sweden
Mexico
Germany
Finland
France
Israel
Romania
Hungary
Australia
Belgium
Spain
Denmark
Canada
United Kingdom


title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus Erythematosus

summary: Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the initial 24 weeks of treatment and who are responding to therapy will have the option to continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythematosus studies and patient self reporting.

primary_purpose: Other

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

name: Dermatologist, Masters of Public Health Program; Harvard School of Public Health; Boston Massachusetts USA

family: Hannon

full_name: Cora W Hannon

given: Cora W

name: Department of Dermatology; Royal Victoria Hospital; Belfast UK

family: McCourt

full_name: Collette McCourt

given: Collette

name: Department of Dermatology, Clinical Unit for Research Trials and Outcomes in Skin (CURTIS); Massachusetts General Hospital; Boston Massachusetts USA

family: Lima

full_name: Hermenio C Lima

given: Hermenio C

name: Emory University Hospital; Emory Healthcare; Atlanta Georgia USA

family: Chen

full_name: Suephy Chen

given: Suephy

name: Office of Research and Innovation; Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn; Dublin Ireland

family: Bennett

full_name: Cathy Bennett

given: Cathy

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Bristol-Myers Squibb

location_country:
Peru
Romania
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Netherlands
Hungary
Puerto Rico
United States
Germany
Italy
Brazil
Lebanon
Mexico
Spain

location_facility: Centro de Radiodiagnostico Computarizado Medico de Tabasco S.A. de C.V.

location_facility: Rheumatology Associates Of North Alabama, P.C.

location_facility: Unidad Reumatologica Las Americas, S.C. P.

location_facility: Allegheny-Singer Research Institute (Asri)

location_facility: CPCLIN Centro de Pesquisas Clinicas LTDA

location_facility: Joint and Muscle Medical Care and Research Institute (JMMCRI)

location_facility: Consultorio Medico de Reumatologia Dr.Jesus Alberto Lopez Garcia

location_facility: Toronto Western Hospital, University Health Network

location_facility: Centro Integral En Reumatologia Sa De Cv

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C.

location_facility: The Feinstein Institute For Medical Research

location_facility: Beth Israel Deaconess Med. Center Div. Of Gastroenterology

location_facility: Centre De Recherche Musculo-Squelettique

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.

location_facility: Medyczne Centrum Hetmanska Indywidualna Spec. Praktyka Lekar

location_facility: Center For Rheumatology, Immunology And Arthritis

location_facility: Instituto de Asistencia Reumatologica Integral

location_facility: Instituto para el DeSarrollo Integral de la Salud S de RL de CV

location_facility: Instituto Nacional De Ciencias Medicas Y Nutricion S.Z.

location_facility: Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac

location_facility: Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.

location_facility: Servicos Especializados em Reumatologia SER

location_facility: The University of North Carolina at Chapel Hill

location_facility: Hospital General De Agudos J.M. Ramos Mejia

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

location_facility: Instituto De Investigaciones Clinicas De Mar Del Plata


location_country:
Italy
Austria
Hong Kong
Switzerland
Germany
France
Japan
Poland
Israel
Norway
Singapore
Belgium
Spain
United States
United Kingdom
Korea, Republic of
Taiwan

title: A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases

summary:
The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated with exemestane and everolimus

After implementation of CSP Amendment 10, only a limited number of subjects will remain in this study, in order to reduce the burden to study subjects, collection of data will be reduced and will focus mainly on acute safety, SSE, and OS. Once subjects are rolled over, the long-term safety will be collected and assessed entirely in the separate extended safety follow-up study.


intervention_type: Biological

lead_sponsor: Octapharma

location_country:
Netherlands
North Macedonia
Finland
Croatia
France
Japan
United States
Slovenia
Canada

location_facility: St. Marianna Univ School of Medicine Hospital

location_facility: Hôpital Purpan - Centre de Traitment Regional de l'Hemophilie Pole

location_facility: Centre Régional de Traitement de l'Hémophilie

location_facility: Hospital of the Univ of Occupational and Environmental Health

location_facility: PHI Institute of Transfusion Medicine of Republic of Macedonia

location_facility: Centre Régional de Traitement de l'hémophilie

location_facility: Centre Hospitalier Universitaire Félix Guyon

title: Prospective, Open-label, Multi-centre Phase 3b Study to Assess the Efficacy and Safety of Personalized Prophylaxis With Human-cl rhFVIII in Previously Treated Adult Patients With Severe Haemophilia A

summary: The rationale of this study is to further fine-tune and individualize prophylactic treatment of patients with severe Haemophilia A with the goal of keeping the trough FVIII level above 1% between doses. Because trough FVIII levels are likely to be important predictors of the efficacy of prophylaxis, the focus of this study is on pharmacokinetic (PK) data.


title: A Multi-centre, Double-blind, Parallel-group, Randomized Controlled Study to Investigate the Efficacy, Safety and Tolerability of Orally Administered BI 409306 During a 12-week Treatment Period Compared to Placebo in Patients With Alzheimer Disease

summary: The study is designed to compare the effects of 4 different doses of orally administered BI 409306 to placebo in patients with Alzheimers Disease

ReferenceCitation: Frölich L, Wunderlich G, Thamer C, Roehrle M, Garcia M Jr, Dubois B. Evaluation of the efficacy, safety and tolerability of orally administered BI 409306, a novel phosphodiesterase type 9 inhibitor, in two randomised controlled phase II studies in patients with prodromal and mild Alzheimer's disease. Alzheimers Res Ther. 2019 Feb 12;11(1):18. doi: 10.1186/s13195-019-0467-2.

family: Frölich

full_name: Lutz Frölich

given: Lutz

family: Wunderlich

full_name: Glen Wunderlich

given: Glen

family: Thamer

full_name: Claus Thamer

given: Claus

family: Roehrle

full_name: Michael Roehrle

given: Michael

family: Garcia

full_name: Miguel Garcia

given: Miguel

suffix: Jr

family: Dubois

full_name: Bruno Dubois

given: Bruno

currency_apc_doaj: GBP

journal_name: Alzheimer's Research & Therapy

oa_colors: green gold

evidence: oa journal (via doaj)

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

repository_institution: PubMed Central - Europe PMC

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

repository_normalized: HAL

repositories:
HAL
PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Evaluation of the efficacy, safety and tolerability of orally administered BI 409306, a novel phosphodiesterase type 9 inhibitor, in two randomised controlled phase II studies in patients with prodromal and mild Alzheimer’s disease

location_country:
Italy
Austria
United States
Netherlands
Spain
Germany
France
Poland
Belgium
Portugal
Canada
United Kingdom

location_facility: Non-Public Outpatient Clinic Neuro-Kard Ilkowski & Partners

location_facility: Orange County Neuropsychiatric Research Center LLC

location_facility: Hospital Universitari General de Catalunya

location_facility: Landeskrankenhaus Hall, Abt.f. Psychatrie & Psychotherapie A

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Private Practice for Psychiatry and Neurology

location_facility: ANI Neurology, PLLC, dba Alzheimer's Memory Center

location_facility: Memory Enhancement Center of America, Inc.

location_facility: True North Clinical Research Halifax, Inc.

location_facility: Institut universitaire de geriatrie Sherbrooke

location_facility: Neurologie und Psychiatrie / Psychotherapie

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Non-Public Outpat. Clinic "Dom Sue Ryder", PALLMED Sp. z o.o

location_facility: Reg. Specialist Hospital Wroclaw, Research & Develop. Center

location_facility: Zentralinstitut für seelische Gesundheit

location_facility: Non-Public Outpatient Clinic "Synapsa" Pawel Polrola, Kielce

location_facility: Podlassian Center of Psychogeriatry, Bialystok

location_facility: True North Clinical Research Kentville, Inc.


title: Study 200977: Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine in the Treatment of Subjects With Type 2 Diabetes Mellitus: The Switch Study

summary: This Phase IIIb, randomized, open-label, parallel group, active control, multicenter, treat to-target study of 26 weeks' treatment duration will evaluate the efficacy and safety of once-weekly albiglutide as replacement of prandial insulin in subjects with type 2 diabetes mellitus (T2DM) failing to achieve adequate glycemic control on their current basal bolus insulin regimen (with or without metformin). Approximately 794 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide + insulin glargine (with insulin lispro discontinuation at Week 4) (with or without metformin) or to intensification of insulin glargine + insulin lispro (with or without metformin). The study will comprise 4 study periods : Screening (2 weeks), Standardization (4 weeks), Treatment (26 weeks), and Post treatment Follow up (4 weeks). The total duration of a subject's participation will be approximately 36 weeks.

ReferenceCitation: Rosenstock J, Nino A, Soffer J, Erskine L, Acusta A, Dole J, Carr MC, Mallory J, Home P. Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial. Diabetes Care. 2020 Oct;43(10):2509-2518. doi: 10.2337/dc19-2316. Epub 2020 Jul 21.

ipd_sharing_description: IPD for this study is available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Brazil
South Africa
Mexico
Philippines
Germany
France
Korea, Republic of
Poland
Hungary
Spain
United States
United Kingdom
Canada


title: A Phase Ib Study of the Safety and Pharmacology of Atezolizumab Administered With Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma or Atezolizumab Administered With Obinutuzumab or Tazemetostat in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

summary: This open-label, multicenter, global study is designed to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of intravenous atezolizumab (MPDL3280A) and obinutuzumab in participants with refractory or relapsed follicular lymphoma (FL) or atezolizumab and obinutuzumab or tazemetostat administered in participants with refractory or relapsed diffuse large B-cell lymphoma (DLBCL). The anticipated duration of this study is approximately 4.5 years.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
France
Germany
United Kingdom

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

location_facility: University of North Carolina at Chapel Hill

location_facility: Hopital Claude Huriez - CHU Lille; Service des maladies du sang


ReferenceCitation: Wolf J, Kalocsai K, Fortuny C, Lazar S, Bosis S, Korczowski B, Petit A, Bradford D, Croos-Dabrera R, Incera E, Melis J, van Maanen R. Safety and Efficacy of Fidaxomicin and Vancomycin in Children and Adolescents with Clostridioides (Clostridium) difficile Infection: A Phase 3, Multicenter, Randomized, Single-blind Clinical Trial (SUNSHINE). Clin Infect Dis. 2020 Dec 17;71(10):2581-2588. doi: 10.1093/cid/ciz1149.

name: Department of Infectious Diseases, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA

family: Wolf

full_name: Joshua Wolf

given: Joshua

name: Gyermekinfektológia, Dél-pesti Centrumkórház Országos Haematológiai és Infektológiai Intézet, Budapest, Hungary

family: Kalocsai

full_name: Krisztina Kalocsai

given: Krisztina

name: Department of Paediatric Infectious Diseases, Hospital Sant Joan de Déu, Universitat de Barcelona, Barcelona, Spain

family: Fortuny

full_name: Claudia Fortuny

given: Claudia

name: Department of Pediatrics, Clinical Hospital for Infectious and Tropical Diseases “Dr. Victor Babeș,” Bucharest, Romania

family: Lazar

full_name: Stefan Lazar

given: Stefan

name: Pediatric Highly Intensive Care Unit, Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy

family: Bosis

full_name: Samantha Bosis

given: Samantha

name: Department of Pediatrics and Pediatric Gastroenterology, University of Rzeszów, Rzeszów, Poland

family: Korczowski

full_name: Bartosz Korczowski

given: Bartosz

name: Department of Pediatric Hematology and Oncology, Hôpital Trousseau, HUEP, APHP, Paris, France

name: Faculty of Medicine, Sorbonne Université, UMRS 938, GRC MyPAC, Paris, France

family: Petit

full_name: Arnaud Petit

given: Arnaud

name: Astellas Pharma B.V., Leiden, the Netherlands

family: Bradford

full_name: Daniel Bradford

given: Daniel

name: Astellas Pharma Development, Northbrook, Illinois, USA

family: Croos-Dabrera

full_name: Rodney Croos-Dabrera

given: Rodney

family: Incera

full_name: Elodie Incera

given: Elodie

family: Melis

full_name: Joost Melis

given: Joost

family: van Maanen

full_name: Rob van Maanen

given: Rob

journal_name: Clinical Infectious Diseases

repository_normalized: University of Melbourne - Minerva Access

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

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

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Borali E, De Giacomo C. Clostridium Difficile Infection in Children: A Review. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):e130-e140. Review.

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Italy
United States
Germany
France
Poland
Romania
Hungary
Belgium
Spain
Canada

location_facility:
Site FR33001
Site US10028
Site BE32001
Site CA15003
Site DE49010
Site US10037
Site FR33008
Site US10010
Site US10025
Site HU36004
Site FR33007
Site PL48004
Site US10008
Site US10034
Site DE49006
Site PL48007
Site BE32002
Site US10014
Site PL48012
Site US10030
Site IT39004
Site ES34003
Site US10032
Site DE49002
Site US10027
Site US10022
Site IT39001
Site FR33005
Site ES34007
Site DE49004
Site PL48002
Site DE49003
Site US10015
Site ES34002
Site US10038
Site DE49001
Site BE32003
Site ES34004
Site PL48006
Site RO40005
Site US10004
Site HU36006
Site PL48014
Site FR33002

title: A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects With Clostridium Difficile-associated Diarrhea

summary: The purpose of this study was to investigate the clinical response to fidaxomicin oral suspension or tablets and vancomycin oral liquid or capsules in pediatric participants with Clostridium difficile-associated diarrhea (CDAD). It also investigated the recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well as acceptance of the fidaxomicin oral suspension formulation.


title: A Randomized, Multicenter, Open Label Study of MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in Anthracycline Naive Patients With Locally Advanced/Metastatic HER2-Positive Breast Cancer

acronym: HERMIONE

summary: This study is an open label, randomized, multicenter trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting.

status: Terminated

ReferenceCitation: Miller K, Cortes J, Hurvitz SA, Krop IE, Tripathy D, Verma S, Riahi K, Reynolds JG, Wickham TJ, Molnar I, Yardley DA. HERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician's choice plus trastuzumab in patients with previously treated, anthracycline-naïve, HER2-positive, locally advanced/metastatic breast cancer. BMC Cancer. 2016 Jun 3;16:352. doi: 10.1186/s12885-016-2385-z.

family: Miller

full_name: Kathy Miller

given: Kathy

family: Cortes

full_name: Javier Cortes

given: Javier

family: Hurvitz

full_name: Sara A. Hurvitz

given: Sara A.

family: Krop

full_name: Ian E. Krop

given: Ian E.

family: Tripathy

full_name: Debu Tripathy

given: Debu

family: Verma

full_name: Sunil Verma

given: Sunil

family: Riahi

full_name: Kaveh Riahi

given: Kaveh

family: Reynolds

full_name: Joseph G. Reynolds

given: Joseph G.

family: Wickham

full_name: Thomas J. Wickham

given: Thomas J.

family: Molnar

full_name: Istvan Molnar

given: Istvan

family: Yardley

full_name: Denise A. Yardley

given: Denise A.

journal_name: BMC Cancer

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

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

title: HERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician’s choice plus trastuzumab in patients with previously treated, anthracycline-naïve, HER2-positive, locally advanced/metastatic breast cancer

lead_sponsor: Merrimack Pharmaceuticals

location_country:
Italy
Austria
United States
Germany
France
Belgium
Spain
Canada
Czech Republic

location_facility: Bon Secours Saint Francis Hospital Cancer Center

location_facility: Northwestern University- Robert H. Lurie Comprehensive Cancer Center

location_facility: Texas Oncology- Central Austin Cancer Center

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Johns Hopkins Medicine- The Sidney Kimmel Comprehensive Cancer Center

location_facility: AKh Allgemeines Krankenhaus der Stadt Linz

location_facility: University of Alberta- Cross Cancer Institute

location_facility: Smilow Cancer Hospital at Yale New Haven Hospital

location_facility: University of Miami Comprehensive Cancer Center

location_facility: Centro Riferimento Oncologico, IRCCS, Istituto Nazionale Tumori

location_facility: The University of Texas- MD Anderson Cancer Center

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Greenville Health System Cancer Institute

location_facility: University of Minnesota- Masonic Cancer Center

location_facility: Institut de Cancerologie de l'Ouest site Paul Papin

location_facility: Hospital Universitario Arnau de Vilanova

location_facility: North Shore Hematology Oncology Associates

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: The Center for Cancer and Blood Disorders

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Istituto Nazionale Tumori, IRCCS Fondazione G. Pascale

location_facility: Azienda Ospedaliero-Universitaria di Bologna

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Florida Cancer Specialists & Research Institute

location_facility: Azienda Socio Sanitaria Territoriale di Cremona


title: A Phase 2, Multicenter, Randomized, Open-label Trial Assessing the Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Resectable, Stage IIIB to IVM1a Melanoma

summary: This is a phase 2, multicenter, randomized, open-label study to estimate the efficacy of talimogene laherparepvec as a neoadjuvant treatment followed by surgery compared to surgery alone in subjects with completely resectable stage IIIB, IIIC, or IVM1a melanoma.

ReferenceCitation: Dummer R, Gyorki DE, Hyngstrom J, Berger AC, Conry R, Demidov L, Sharma A, Treichel SA, Radcliffe H, Gorski KS, Anderson A, Chan E, Faries M, Ross MI. Neoadjuvant talimogene laherparepvec plus surgery versus surgery alone for resectable stage IIIB-IVM1a melanoma: a randomized, open-label, phase 2 trial. Nat Med. 2021 Oct;27(10):1789-1796. doi: 10.1038/s41591-021-01510-7. Epub 2021 Oct 4.

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

lead_sponsor: Amgen

location_country:
Brazil
Switzerland
France
Poland
Greece
Australia
Russian Federation
Spain
United States

intervention_type: Procedure


title: Collaborative European NeuroTrauma Effectiveness Research in TBI (CENTER-TBI)

acronym: CENTER-TBI

summary:
The research aims of the CENTER-TBI study are to:

better characterize Traumatic Brain Injury (TBI) as a disease and describe it in a European context, and
identify the most effective clinical interventions for managing TBI.

Specific aims

To collect high quality clinical and epidemiological data with repositories for neuro-imaging, DNA, and serum from patients with TBI.
To refine and improve outcome assessment and develop health utility indices for TBI.
To develop multidimensional approaches to characterisation and prediction of TBI.
To define patient profiles which predict efficacy of specific interventions ("Precision Medicine").
To develop performance indicators for quality assurance and quality improvement in TBI care.
To validate the common data elements (CDEs) for broader use in international settings, and to develop a user-friendly web based data entry instrument and case report form builder.
To develop an open database compatible with Federal Interagency Traumatic Brain Injury Research (FITBIR).
To intensify networking activities and international collaborations in TBI.
To disseminate study results and management recommendations for TBI to health care professionals, policy makers and consumers, aiming to improve health care for TBI at individual and population levels.
To develop a "knowledge commons" for TBI, integrating CENTER-TBI outputs into systematic reviews.

ReferenceCitation: Citerio G, Robba C, Rebora P, Petrosino M, Rossi E, Malgeri L, Stocchetti N, Galimberti S, Menon DK; Center-TBI participants and investigators. Management of arterial partial pressure of carbon dioxide in the first week after traumatic brain injury: results from the CENTER-TBI study. Intensive Care Med. 2021 Sep;47(9):961-973. doi: 10.1007/s00134-021-06470-7. Epub 2021 Jul 24.

family: Citerio

full_name: Giuseppe Citerio

given: Giuseppe

family: Robba

full_name: Chiara Robba

given: Chiara

family: Rebora

full_name: Paola Rebora

given: Paola

family: Petrosino

full_name: Matteo Petrosino

given: Matteo

family: Rossi

full_name: Eleonora Rossi

given: Eleonora

family: Malgeri

full_name: Letterio Malgeri

given: Letterio

family: Stocchetti

full_name: Nino Stocchetti

given: Nino

family: Galimberti

full_name: Stefania Galimberti

given: Stefania

family: Menon

full_name: David K. Menon

given: David K.

family: Åkerlund

full_name: Cecilia Åkerlund

given: Cecilia

family: Amrein

full_name: Krisztina Amrein

given: Krisztina

family: Andelic

full_name: Nada Andelic

given: Nada

family: Andreassen

full_name: Lasse Andreassen

given: Lasse

family: Anke

full_name: Audny Anke

given: Audny

family: Antoni

full_name: Anna Antoni

given: Anna

family: Audibert

full_name: Gérard Audibert

given: Gérard

family: Azouvi

full_name: Philippe Azouvi

given: Philippe

family: Azzolini

full_name: Maria Luisa Azzolini

given: Maria Luisa

family: Bartels

full_name: Ronald Bartels

given: Ronald

family: Barzó

full_name: Pál Barzó

given: Pál

family: Beauvais

full_name: Romuald Beauvais

given: Romuald

family: Beer

full_name: Ronny Beer

given: Ronny

family: Bellander

full_name: Bo-Michael Bellander

given: Bo-Michael

name: on behalf of the Center-TBI participants and investigators

repository_institution: Università degli Studi di Milano - Institutional Research Information System

repositories_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

ReferenceCitation: Robba C, Rebora P, Meyfroidt G, Citerio G. The authors reply. Crit Care Med. 2021 May 1;49(5):e554-e555. doi: 10.1097/CCM.0000000000004961.

title: The authors reply

ReferenceCitation: Huijben JA, Dixit A, Stocchetti N, Maas AIR, Lingsma HF, van der Jagt M, Nelson D, Citerio G, Wilson L, Menon DK, Ercole A; CENTER-TBI investigators and participants. Use and impact of high intensity treatments in patients with traumatic brain injury across Europe: a CENTER-TBI analysis. Crit Care. 2021 Feb 23;25(1):78. doi: 10.1186/s13054-020-03370-y.

name: the CENTER-TBI investigators and participants

repository_institution: University of Stirling - Stirling Online Research Repository

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

ReferenceCitation: Borgen IMH, Røe C, Brunborg C, Tenovuo O, Azouvi P, Dawes H, Majdan M, Ranta J, Rusnak M, Wiegers EJA, Tverdal C, Jacob L, Cogné M, von Steinbuechel N, Andelic N; CENTER-TBI participants investigators. Care transitions in the first 6months following traumatic brain injury: Lessons from the CENTER-TBI study. Ann Phys Rehabil Med. 2021 Jul 22;64(6):101458. doi: 10.1016/j.rehab.2020.10.009. [Epub ahead of print]

journal_name: Annals of Physical and Rehabilitation Medicine

repository_institution: University of Oslo - Duo Research Archive

repositories_institution: University of Oslo - Duo Research Archive

title: Care transitions in the first 6 months following traumatic brain injury: Lessons from the CENTER-TBI study

ReferenceCitation: Robba C, Banzato E, Rebora P, Iaquaniello C, Huang CY, Wiegers EJA, Meyfroidt G, Citerio G; Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) ICU Participants and Investigators. Acute Kidney Injury in Traumatic Brain Injury Patients: Results From the Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury Study. Crit Care Med. 2021 Jan 1;49(1):112-126. doi: 10.1097/CCM.0000000000004673.

repository_institution: University of Liège - Open Repository and Bibliography

ReferenceCitation: Gravesteijn BY, Sewalt CA, Nieboer D, Menon DK, Maas A, Lecky F, Klimek M, Lingsma HF; CENTER-TBI collaborators. Tracheal intubation in traumatic brain injury: a multicentre prospective observational study. Br J Anaesth. 2020 Oct;125(4):505-517. doi: 10.1016/j.bja.2020.05.067. Epub 2020 Jul 31.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

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

repository_normalized: HELDA - Digital Repository of the University of Helsinki

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

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

repository_institution: Umeå University - DiVA at Umeå University

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repositories_institution: Umeå University - DiVA at Umeå University

repositories_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Gao G, Wu X, Feng J, Hui J, Mao Q, Lecky F, Lingsma H, Maas AIR, Jiang J; China CENTER-TBI Registry Participants. Clinical characteristics and outcomes in patients with traumatic brain injury in China: a prospective, multicentre, longitudinal, observational study. Lancet Neurol. 2020 Aug;19(8):670-677. doi: 10.1016/S1474-4422(20)30182-4.

ReferenceCitation: Robba C, Rebora P, Banzato E, Wiegers EJA, Stocchetti N, Menon DK, Citerio G; Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury Participants and Investigators. Incidence, Risk Factors, and Effects on Outcome of Ventilator-Associated Pneumonia in Patients With Traumatic Brain Injury: Analysis of a Large, Multicenter, Prospective, Observational Longitudinal Study. Chest. 2020 Dec;158(6):2292-2303. doi: 10.1016/j.chest.2020.06.064. Epub 2020 Jul 4.

ReferenceCitation: Riemann L, Beqiri E, Smielewski P, Czosnyka M, Stocchetti N, Sakowitz O, Zweckberger K, Unterberg A, Younsi A; CENTER-TBI High Resolution ICU (HR ICU) Sub-Study Participants and Investigators. Low-resolution pressure reactivity index and its derived optimal cerebral perfusion pressure in adult traumatic brain injury: a CENTER-TBI study. Crit Care. 2020 May 26;24(1):266. doi: 10.1186/s13054-020-02974-8.

name: the CENTER-TBI High Resolution ICU (HR ICU) Sub-Study Participants and Investigators

ReferenceCitation: Gravesteijn BY, Nieboer D, Ercole A, Lingsma HF, Nelson D, van Calster B, Steyerberg EW; CENTER-TBI collaborators. Machine learning algorithms performed no better than regression models for prognostication in traumatic brain injury. J Clin Epidemiol. 2020 Jun;122:95-107. doi: 10.1016/j.jclinepi.2020.03.005. Epub 2020 Mar 20.

ReferenceCitation: Huijben JA, Wiegers EJA, Ercole A, de Keizer NF, Maas AIR, Steyerberg EW, Citerio G, Wilson L, Polinder S, Nieboer D, Menon D, Lingsma HF, van der Jagt M; CENTER-TBI investigators and participants for the ICU stratum. Quality indicators for patients with traumatic brain injury in European intensive care units: a CENTER-TBI study. Crit Care. 2020 Mar 4;24(1):78. doi: 10.1186/s13054-020-2791-0.

name: the CENTER-TBI investigators and participants for the ICU stratum

ReferenceCitation: Van Essen TA, Volovici V, Cnossen MC, Kolias A, Ceyisakar I, Nieboer D, Peppel LD, Heijenbrok-Kal M, Ribbers G, Menon D, Hutchinson P, Depreitere B, de Ruiter GCW, Lingsma HF, Steyerberg EW, Maas AI, Peul WC. Comparative effectiveness of surgery in traumatic acute subdural and intracerebral haematoma: study protocol for a prospective observational study within CENTER-TBI and Net-QuRe. BMJ Open. 2019 Oct 16;9(10):e033513. doi: 10.1136/bmjopen-2019-033513.

ReferenceCitation: Steyerberg EW, Wiegers E, Sewalt C, Buki A, Citerio G, De Keyser V, Ercole A, Kunzmann K, Lanyon L, Lecky F, Lingsma H, Manley G, Nelson D, Peul W, Stocchetti N, von Steinbüchel N, Vande Vyvere T, Verheyden J, Wilson L, Maas AIR, Menon DK; CENTER-TBI Participants and Investigators. Case-mix, care pathways, and outcomes in patients with traumatic brain injury in CENTER-TBI: a European prospective, multicentre, longitudinal, cohort study. Lancet Neurol. 2019 Oct;18(10):923-934. doi: 10.1016/S1474-4422(19)30232-7.

repository_institution: Maastricht University - Research Publications

repositories_institution: Maastricht University - Research Publications

ReferenceCitation: Maas AI, Menon DK, Steyerberg EW, Citerio G, Lecky F, Manley GT, Hill S, Legrand V, Sorgner A; CENTER-TBI Participants and Investigators. Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI): a prospective longitudinal observational study. Neurosurgery. 2015 Jan;76(1):67-80. doi: 10.1227/NEU.0000000000000575.

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Ecole Polytechnique Fédérale de Lausanne - Infoscience

repository_institution: Auckland University of Technology - Tuwhera

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: Auckland University of Technology - Tuwhera

repositories_institution: The University of Glasgow - Enlighten: Publications

location_country:
Italy
Austria
Sweden
Serbia
Switzerland
Netherlands
United Kingdom
Finland
France
Lithuania
Israel
Norway
Hungary
Belgium
Romania
Spain
Denmark
Germany
Latvia

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Poloclinico

location_facility: Riga Eastern Clinical University Hospital

location_facility: University Hospitals Southampton NHS Trust

location_facility: Azienda Ospedaliera Università di Padova

location_facility: Center of neurovascular surgery, Clinic of neurology and neurosurgery, Vilnius University

location_facility: Hadassah-hebrew University Medical Center

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Kaunas University of technology and Vilnius University

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: St Olavs Hospital/Norwegian University of science and technology

location_facility: AOU Città della Salute e della Scienza di Torino


title: A Randomized, Blinded, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Umeclidinium (UMEC) 62.5 mcg Compared With Tiotropium 18 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

summary:
This is a multicentre, randomized, blinded, double dummy, parallel group study to evaluate the efficacy and safety of UMEC inhalation powder[ (62.5 microgram (mcg) once daily (QD)] when administered via a novel Dry Powder Inhaler compared with tiotropium (18 mcg QD) administered via a HANDIHALER® inhaler over a treatment period of 12 weeks (24 weeks in Germany) in subjects with chronic obstructive pulmonary disease (COPD). At the end of the run-in period, subjects who meet the randomization criteria will be randomized to receive UMEC 62.5 mcg administered via novel dry powder inhaler(nDPI) + Placebo administered via HANDIHALER inhaler OR Tiotropium 18 mcg administered via HANDIHALER inhaler + Placebo administered via nDPI in a 1:1 ratio. There will be up to 8 clinic visits conducted on an outpatient basis at Pre-Screening (Visit 0), Screening (Visit 1), a 7 to 14 day run-in period, randomization at Day 1 (Visit 2), and after randomization at Day 2 (Visit 3), Day 28 (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and Day 85 (Visit 7). For subjects enrolled in Germany, there will be an additional 3 visits at Day 112 (Visit 8), Day 140 (Visit 9) and Day 168 (Visit 10). The total duration of subject participation in the study will be approximately 15 weeks (27 weeks in Germany). The primary endpoint of the study is clinic visit trough forced expiratory volume in one second (FEV1) on treatment Day 85. All subjects will have spirometry performed at clinic Visits 1 though 7. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits 3 to 7.

HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG.

ReferenceCitation: Shah D, Driessen M, Risebrough N, Baker T, Naya I, Briggs A, Ismaila AS. Cost-effectiveness of umeclidinium compared with tiotropium and glycopyrronium as monotherapy for chronic obstructive pulmonary disease: a UK perspective. Cost Eff Resour Alloc. 2018 May 10;16:17. doi: 10.1186/s12962-018-0101-3. eCollection 2018.

family: Shah

full_name: Dhvani Shah

given: Dhvani

family: Driessen

full_name: Maurice Driessen

given: Maurice

family: Risebrough

full_name: Nancy Risebrough

given: Nancy

family: Baker

full_name: Timothy Baker

given: Timothy

family: Naya

full_name: Ian Naya

given: Ian

family: Briggs

full_name: Andrew Briggs

given: Andrew

family: Ismaila

full_name: Afisi S. Ismaila

given: Afisi S.

journal_name: Cost Effectiveness and Resource Allocation

repository_institution: PubMed Central - Europe PMC

version: acceptedVersion

ReferenceCitation: Feldman G, Maltais F, Khindri S, Vahdati-Bolouri M, Church A, Fahy WA, Trivedi R. A randomized, blinded study to evaluate the efficacy and safety of umeclidinium 62.5 μg compared with tiotropium 18 μg in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2016 Apr 7;11:719-30. doi: 10.2147/COPD.S102494. eCollection 2016.

family: Feldman

full_name: Gregory Feldman

given: Gregory

family: Maltais

full_name: François Maltais

given: François

family: Khindri

full_name: Sanjeev Khindri

given: Sanjeev

family: Vahdati-Bolouri

full_name: Mitra Vahdati-Bolouri

given: Mitra

family: Church

full_name: Alison Church

given: Alison

family: Fahy

full_name: William A Fahy

given: William A

family: Trivedi

full_name: Roopa Trivedi

journal_name: International Journal of Chronic Obstructive Pulmonary Disease

title: A randomized, blinded study to evaluate the efficacy and safety of umeclidinium 62.5 µg compared with tiotropium 18 µg in patients with COPD

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

location_country:
Italy
United States
Chile
South Africa
Germany
France
Romania
Argentina
Russian Federation
Denmark
Canada
Korea, Republic of
Ukraine


type: Other Grant/Funding Number

title: INtegratioN of Trastuzumab, With or Without Pertuzumab, Into periOperatiVe chemotherApy of HER-2 posiTIve stOmach caNcer: the INNOVATION-TRIAL

acronym: INNOVATION

summary: The purpose of this study is to find out whether either trastuzumab or the combination of trastuzumab and pertuzumab with standard chemotherapy shows more activity against gastro-oesophageal adenocarcinoma than standard chemotherapy given before and after surgery and it can be safely administered.

ReferenceCitation: Wagner AD, Grabsch HI, Mauer M, Marreaud S, Caballero C, Thuss-Patience P, Mueller L, Elme A, Moehler MH, Martens U, Kang YK, Rha SY, Cats A, Tokunaga M, Lordick F. EORTC-1203-GITCG - the "INNOVATION"-trial: Effect of chemotherapy alone versus chemotherapy plus trastuzumab, versus chemotherapy plus trastuzumab plus pertuzumab, in the perioperative treatment of HER2 positive, gastric and gastroesophageal junction adenocarcinoma on pathologic response rate: a randomized phase II-intergroup trial of the EORTC-Gastrointestinal Tract Cancer Group, Korean Cancer Study Group and Dutch Upper GI-Cancer group. BMC Cancer. 2019 May 24;19(1):494. doi: 10.1186/s12885-019-5675-4.

family: Wagner

full_name: Anna Dorothea Wagner

given: Anna Dorothea

family: Grabsch

full_name: Heike I. Grabsch

given: Heike I.

family: Mauer

full_name: Murielle Mauer

given: Murielle

family: Marreaud

full_name: Sandrine Marreaud

given: Sandrine

family: Caballero

full_name: Carmela Caballero

given: Carmela

family: Thuss-Patience

full_name: Peter Thuss-Patience

given: Peter

family: Mueller

full_name: Lothar Mueller

given: Lothar

family: Elme

full_name: Annelie Elme

given: Annelie

family: Moehler

full_name: Markus Hermann Moehler

given: Markus Hermann

family: Martens

full_name: Uwe Martens

given: Uwe

family: Kang

full_name: Yoon-Koo Kang

given: Yoon-Koo

family: Rha

full_name: Sun Young Rha

given: Sun Young

family: Cats

full_name: Annemieke Cats

given: Annemieke

family: Tokunaga

full_name: Masanori Tokunaga

given: Masanori

family: Lordick

full_name: Florian Lordick

given: Florian

repository_institution: Yonsei University Medical Library - YUHSpace

repository_institution: Université de Lausanne - SERVAL

title: EORTC-1203-GITCG - the “INNOVATION”-trial: Effect of chemotherapy alone versus chemotherapy plus trastuzumab, versus chemotherapy plus trastuzumab plus pertuzumab, in the perioperative treatment of HER2 positive, gastric and gastroesophageal junction adenocarcinoma on pathologic response rate: a randomized phase II-intergroup trial of the EORTC-Gastrointestinal Tract Cancer Group, Korean Cancer Study Group and Dutch Upper GI-Cancer group

ReferenceCitation: Integration of Trastuzumab, with or without Pertuzumab, into Perioperative Chemotherapy of HER2- Positive Stomach Cancer: The INNOVATION Trial (EORTC-1203-GITCG). Oncol Res Treat. 2016;39(3):153-4; discussion 155.

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

location_country:
Italy
Switzerland
Netherlands
Spain
France
Israel
Norway
Belgium
Portugal
Estonia
Germany
United Kingdom
Korea, Republic of

location_facility: Belfast Health and Social Care Trust - Belfast City Hospital

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: CHU de Bordeaux - Group Hospitalier Sud - Hopital Haut-Lévêque

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Technische Universitaet Muenchen - Klinikum Rechts Der Isar

location_facility: Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern

location_facility: Zuyderland - Orbis Medisch en Zorgconcern

location_facility: Universitaetsmedizin Goettingen - Georg-August Universitaet

location_facility: Institut Catala d'Oncologia - ICO L'Hospitalet

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Asklepios Kliniken GmbH - Asklepios Klinik Barmbek

location_facility: Hospital Clinico Universitario De Valencia

location_facility: The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

location_facility: Rabin Medical Center - Tel Avivi University

location_facility: Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum

location_facility: Academisch Medisch Centrum - Universiteit van Amsterdam

location_facility: Grand Hopital de Charleroi - Grand Hôpital de Charleroi - Site Notre Dame

location_facility: Instituto Portugues De Oncologia - Centro Do Porto

location_facility: Johannes Gutenberg Universitaetskliniken - Mainz University Medical Center

location_facility: Kliniken Essen-Mitte - Evang. Huyssens-Stiftung


title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Patients With Multiple Myeloma Following Autologous Stem Cell Transplant

summary: The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplant (ASCT).

ReferenceCitation: Kaiser M, Beksaç M, Gulbrandsen N, Schjesvold F, Hájek R, Moreau P, de Arriba de la Fuente F, Mateos MV, West S, Spencer A, Rajkumar SV, Suryanarayan K, Czorniak M, Li C, Teng Z, Labotka R, Dimopoulos MA. Adverse event management in the TOURMALINE-MM3 study of post-transplant ixazomib maintenance in multiple myeloma. Ann Hematol. 2020 Aug;99(8):1793-1804. doi: 10.1007/s00277-020-04149-5. Epub 2020 Jul 1. Erratum in: Ann Hematol. 2021 Jan;100(1):297-302.

family: Kaiser

full_name: Martin Kaiser

given: Martin

family: Beksaç

full_name: Meral Beksaç

given: Meral

family: Gulbrandsen

full_name: Nina Gulbrandsen

given: Nina

family: Schjesvold

full_name: Fredrik Schjesvold

given: Fredrik

family: Hájek

full_name: Roman Hájek

given: Roman

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: de Arriba de la Fuente

full_name: Felipe de Arriba de la Fuente

given: Felipe

family: Mateos

full_name: María-Victoria Mateos

given: María-Victoria

family: West

full_name: Sharon West

given: Sharon

family: Spencer

full_name: Andrew Spencer

given: Andrew

family: Rajkumar

full_name: S. Vincent Rajkumar

given: S. Vincent

family: Suryanarayan

full_name: Kaveri Suryanarayan

given: Kaveri

family: Czorniak

full_name: Michael Czorniak

given: Michael

family: Li

full_name: Cong Li

given: Cong

family: Teng

full_name: Zhaoyang Teng

given: Zhaoyang

family: Labotka

full_name: Richard Labotka

given: Richard

family: Dimopoulos

full_name: Meletios A. Dimopoulos

given: Meletios A.

journal_name: Annals of Hematology

repository_institution: University of Oslo - Duo Research Archive

ReferenceCitation: Schjesvold F, Goldschmidt H, Maisnar V, Spicka I, Abildgaard N, Rowlings P, Cain L, Romanus D, Suryanarayan K, Rajkumar V, Odom D, Gnanasakthy A, Dimopoulos M. Quality of life is maintained with ixazomib maintenance in post-transplant newly diagnosed multiple myeloma: The TOURMALINE-MM3 trial. Eur J Haematol. 2020 May;104(5):443-458. doi: 10.1111/ejh.13379. Epub 2020 Feb 22.

name: Oslo Myeloma Center Oslo University Hospital Oslo Norway

name: KG Jebsen Center for B cell malignancies University of Oslo Oslo Norway

name: Department of Internal Medicine V University Medical Hospital and National Center of Tumor Diseases University of Heidelberg Heidelberg Germany

name: Department of Medicine—Hematology Charles University Hospital Hradec Králové Czech Republic

name: Department of Hematology Charles University Prague Czech Republic

name: Department of Hematology Odense University Hospital University of Southern Denmark Odense Denmark

name: Department of Hematology School of Medicine & Public Health University of Newcastle Waratah New South Wales Australia

name: Statistical and Quantitative Sciences Takeda Pharmaceuticals Cambridge MA USA

name: Global Outcomes Research Takeda Pharmaceuticals Cambridge MA USA

name: Oncology Clinical Research Takeda Pharmaceuticals Cambridge MA USA

name: Division of Hematology Department of Internal Medicine Mayo Clinic Rochester MN USA

name: Biostatistics RTI Health Solutions Research Triangle Park NC USA

name: Patient‐Centered Outcomes Assessment RTI Health Solutions Research Triangle Park NC USA

name: Department of Clinical Therapeutics Hematology & Medical Oncology School of Medicine National and Kapodistrian University of Athens Athens Greece

title: Quality of life is maintained with ixazomib maintenance in post‐transplant newly diagnosed multiple myeloma: The TOURMALINE‐MM3 trial

ReferenceCitation: Dimopoulos MA, Gay F, Schjesvold F, Beksac M, Hajek R, Weisel KC, Goldschmidt H, Maisnar V, Moreau P, Min CK, Pluta A, Chng WJ, Kaiser M, Zweegman S, Mateos MV, Spencer A, Iida S, Morgan G, Suryanarayan K, Teng Z, Skacel T, Palumbo A, Dash AB, Gupta N, Labotka R, Rajkumar SV; TOURMALINE-MM3 study group. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2019 Jan 19;393(10168):253-264. doi: 10.1016/S0140-6736(18)33003-4. Epub 2018 Dec 10.

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

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

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

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

location_country:
Greece
Australia
Belgium
Denmark
Taiwan
Ukraine
France
Japan
Poland
Thailand
Norway
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Sweden
Switzerland
Netherlands
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey


ReferenceCitation: Stauffer VL, Turner I, Kemmer P, Kielbasa W, Day K, Port M, Quinlan T, Camporeale A. Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials. J Headache Pain. 2020 Jun 23;21(1):79. doi: 10.1186/s10194-020-01148-9.

family: Stauffer

full_name: Virginia L. Stauffer

given: Virginia L.

family: Turner

full_name: Ira Turner

given: Ira

family: Kemmer

full_name: Phebe Kemmer

given: Phebe

family: Kielbasa

full_name: William Kielbasa

given: William

family: Day

full_name: Kathleen Day

given: Kathleen

family: Port

full_name: Martha Port

given: Martha

family: Quinlan

full_name: Tonya Quinlan

given: Tonya

family: Camporeale

full_name: Angelo Camporeale

given: Angelo

journal_name: The Journal of Headache and Pain

ReferenceCitation: Bangs ME, Kudrow D, Wang S, Oakes TM, Terwindt GM, Magis D, Yunes-Medina L, Stauffer VL. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurol. 2020 Jan 17;20(1):25. doi: 10.1186/s12883-020-1609-7. Erratum in: BMC Neurol. 2020 Mar 13;20(1):90.

family: Bangs

full_name: Mark E. Bangs

given: Mark E.

family: Kudrow

full_name: David Kudrow

given: David

family: Wang

full_name: Shufang Wang

given: Shufang

family: Oakes

full_name: Tina M. Oakes

given: Tina M.

family: Terwindt

full_name: Gisela M. Terwindt

given: Gisela M.

family: Magis

full_name: Delphine Magis

given: Delphine

family: Yunes-Medina

full_name: Laura Yunes-Medina

given: Laura

ReferenceCitation: Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020 Feb;60(2):229-239. doi: 10.1002/jcph.1511. Epub 2019 Sep 4.

name: Eli Lilly and CompanyLilly Corporate Center Indianapolis Indiana

title: Population Pharmacokinetics of Galcanezumab, an Anti‐CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine

ReferenceCitation: Camporeale A, Kudrow D, Sides R, Wang S, Van Dycke A, Selzler KJ, Stauffer VL. A phase 3, long-term, open-label safety study of Galcanezumab in patients with migraine. BMC Neurol. 2018 Nov 9;18(1):188. doi: 10.1186/s12883-018-1193-2.

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:
United States
France
Hungary
Belgium
Puerto Rico
Canada

location_facility: New England Institute for Clinical Research

location_facility: Jacksonville Center for Clinical Research

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

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

title: A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 in Patients With Migraine

summary: The main purpose of this study is to evaluate the longer term safety of the study drug known as galcanezumab in participants with episodic or chronic migraine.


ReferenceCitation: Kim SB, Dent R, Im SA, Espié M, Blau S, Tan AR, Isakoff SJ, Oliveira M, Saura C, Wongchenko MJ, Kapp AV, Chan WY, Singel SM, Maslyar DJ, Baselga J; LOTUS investigators. Ipatasertib plus paclitaxel versus placebo plus paclitaxel as first-line therapy for metastatic triple-negative breast cancer (LOTUS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2017 Oct;18(10):1360-1372. doi: 10.1016/S1470-2045(17)30450-3. Epub 2017 Aug 8. Erratum in: Lancet Oncol. 2018 Dec;19(12):e667.

family: Kim

full_name: Sung-Bae Kim

given: Sung-Bae

family: Dent

full_name: Rebecca Dent

given: Rebecca

family: Im

full_name: Seock-Ah Im

given: Seock-Ah

family: Espié

full_name: Marc Espié

given: Marc

family: Blau

full_name: Sibel Blau

given: Sibel

family: Tan

full_name: Antoinette R Tan

given: Antoinette R

family: Isakoff

full_name: Steven J Isakoff

given: Steven J

family: Oliveira

full_name: Mafalda Oliveira

given: Mafalda

family: Saura

full_name: Cristina Saura

given: Cristina

family: Wongchenko

full_name: Matthew J Wongchenko

given: Matthew J

family: Kapp

full_name: Amy V Kapp

given: Amy V

family: Chan

full_name: Wai Y Chan

given: Wai Y

family: Singel

full_name: Stina M Singel

given: Stina M

family: Maslyar

full_name: Daniel J Maslyar

given: Daniel J

family: Baselga

full_name: José Baselga

given: José

family: Lee

full_name: Keun Seok Lee

given: Keun Seok

full_name: Hwei-Chung Wang

given: Hwei-Chung

full_name: Antoinette Tan

given: Antoinette

family: Sohn

full_name: Joo Hyuk Sohn

given: Joo Hyuk

family: De Laurentiis

full_name: Michelino De Laurentiis

given: Michelino

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

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:
Italy
France
Singapore
Belgium
Spain
United States
Korea, Republic of
Taiwan

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Chang Gung Medical Foundation - Linkou; Dept of Surgery

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

location_facility: Chi Mei Medical Center, Yong kang; Endocrinology

location_facility: Seoul National University Bundang Hospital

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: Istituto Oncologico Veneto IRCCS Farmacia Ospedaliera

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Farmacia

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

title: A Randomized, Phase II, Multi-Center, Placebo-Controlled Study of Ipatasertib (GDC-0068), an Inhibitor of Akt, in Combination With Paclitaxel as Front-Line Treatment for Patients With Metastatic Triple-Negative Breast Cancer

summary: This multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors.


title: A Phase 1/2 Study of CPI-0610, a Small Molecule Inhibitor of BET Proteins: Phase 1 (in Patients With Hematological Malignancies) and Phase 2 (Dose Expansion of CPI-0610 With and Without Ruxolitinib in Patients With Myelofibrosis)

summary:
Phase 1 Part (Complete): Open-label, sequential dose escalation study of CPI-0610 in patients with previously treated Acute Leukemia, Myelodysplastic Syndrome, Myelodysplastic/Myeloproliferative Neoplasms, and Myelofibrosis.

Phase 2 Part: Open-label study of CPI-0610 with and without Ruxolitinib in patients with Myelofibrosis.

CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.

lead_sponsor: Constellation Pharmaceuticals

location_country:
Italy
United States
Netherlands
Germany
France
Poland
Belgium
Canada
United Kingdom

location_facility: AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can

location_facility: Guys and St Thomas' Hospital - Haematology

location_facility: Northwestern University - Lurie Comprehensive Cancer Center

location_facility: Servizio Sanitario Regionale Emilia-Romagna - Azienda Unita Sanitaria Locale (AUSL) di Rimini - Ospedale Infermi di Rimini

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: Memorial Sloan Kettering Cancer Center Commack

location_facility: Washington University School of Medicne Neuromuscular Division Department of neurology

location_facility: Ospedale Maggiore Policlinico, Fondazione IRCCS Ca' Granda

location_facility: Instytut Hematologii i Transfuzjologii w Warszawie

location_facility: Universiteit Maastricht Academisch Ziekenhuis Maastricht

location_facility: Froedtert & Medical College of Wisconsin

location_facility: Institue of Hematology "L. and A. Seràgnoli"

location_facility: Mayo Clinic - Cancer Clinical Research Office

location_facility: Universitätsklinikum Jena, Innere Medizin II

location_facility: Ospedale di Circolo, PO Varese, AO Ospedale di Circolo e Fon

location_facility: CHU - Hopital Saint Louis - Centre D'Investigations Clinique

location_facility: CHRU de Lille - Hopital Claude Huriez - Maladies du Sang

location_facility: Erasmus Universitair Medisch Centrum Rotterdam

location_facility: University College London Hospital's NHS foundation Trust

location_facility: Academisch Ziekenhuis Vrije Universiteit

location_facility: Institut de cancérologie du Gard - Hematologie clinique

location_facility: IRCCS Policlinico San Matteo, Università degli studi di Pavi

location_facility: AZ Sint-Jan Burgge-Oostende - Campus Sint-Jan