Results 41 to 50 of about 41,480 (249)

A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials

Trials, 2019
Background Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known about current practice in terms of ...
Anna Rosala-Hallas, Carrol Gamble, Jane Blazeby, Paula R. Williamson   +3 more
doaj   +1 more source

Subacromial spacers for adults with symptomatic, irreparable rotator cuff tears: the START:REACTS novel group sequential adaptive RCT

Efficacy and Mechanism Evaluation, 2023
Background A balloon spacer is a relatively simple addition to an arthroscopic debridement procedure for irreparable rotator cuff tears. Objective To evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing ...
Metcalfe Andrew, Arnold Susanne, Parsons Helen, Parsons Nicholas, Bhabra Gev, Brown Jaclyn, Bush Howard, Diokno Michael, Elliott Mark, Fox Josephine, Gates Simon, Gemperlé Mannion Elke, Haque Aminul, Hutchinson Charles, Kearney Rebecca, Khan Iftekhar, Lawrence Tom, Mason James, Rahman Usama, Stallard Nigel, Ul-Rahman Sumayyah, Viswanath Aparna, Wayte Sarah, Drew Stephen, Underwood Martin   +24 more
doaj   +1 more source

Association Between Dinutuximab Beta Exposure and Post‐End‐of‐Treatment Survival in Neuroblastoma: A Weighted Patient‐Level Analysis of Three Clinical Studies

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Objectives The association between exposure to dinutuximab beta (DB) and event‐free survival (EFS) or overall survival (OS) of neuroblastoma patients was assessed using data collected during three clinical trials (five cohorts). Methods A systematic review (March 2026) was conducted to identify relevant studies (prospective; registered DB ...
Przemysław Holko, Holger N. Lode, Alberto Garaventa, Carla Manzitti, Roberto Luksch, Dominique Valteau‐Couanet, Marion Gambart, John Anderson, Juliet Gray, Adela Canete, Lucas Moreno, Aleksandra Wieczorek, Cormac Owens, Shifra Ash, Isaac Yaniv, Genevieve Laureys, Hans Loibner, Katarzyna Śladowska, Ruth Ladenstein, Paweł Kawalec   +19 more
wiley   +1 more source

Long‐Term Outcomes of Patients With Relapsed/Refractory Neuroblastoma Treated on ANBL1221: A Report From the Children's Oncology Group

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Results of COG ANBL1221 changed treatment paradigms for patients with relapsed/refractory neuroblastoma. Chemoimmunotherapy with irinotecan/temozolomide/dinutuximab is now used as both bridge therapy following suboptimal response to induction and as treatment in first relapse.
Elizabeth Sokol, Arlene Naranjo, Lulu Chen, Rajen Mody, Steven G. DuBois, Rochelle Bagatell, Navin Pinto   +6 more
wiley   +1 more source

Online remote behavioural intervention for tics in 9- to 17-year-olds: the ORBIT RCT with embedded process and economic evaluation

Health Technology Assessment, 2023
Background Behavioural therapy for tics is difficult to access, and little is known about its effectiveness when delivered online. Objective To investigate the clinical and cost-effectiveness of an online-delivered, therapist- and parent-supported ...
Chris Hollis, Charlotte L Hall, Kareem Khan, Marie Le Novere, Louise Marston, Rebecca Jones, Rachael Hunter, Beverley J Brown, Charlotte Sanderson, Per Andrén, Sophie D Bennett, Liam R Chamberlain, E Bethan Davies, Amber Evans, Natalia Kouzoupi, Caitlin McKenzie, Isobel Heyman, Joseph Kilgariff, Cristine Glazebrook, David Mataix-Cols, Eva Serlachius, Elizabeth Murray, Tara Murphy   +22 more
doaj   +1 more source

The role of the State Security Service (Stasi) in the context of international clinical trials conducted by western pharmaceutical companies in Eastern Germany (1961-1990).

PLoS ONE, 2018
BackgroundAfter the building of the Berlin Wall in the 1960s, a number of international pharmaceutical manufacturers from the West had their drugs tested in Eastern Germany (GDR). So far, the extensive collection of documents on the subject stored in the
Rainer Erices, Andreas Frewer, Antje Gumz   +2 more
doaj   +1 more source

Measurable Residual Disease Monitoring During Treatment for Pediatric Acute Myeloid Leukemia in First Relapse

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background Survival after relapse in pediatric acute myeloid leukemia (AML) remains poor, highlighting the critical importance of identifying prognostic factors to guide optimal relapse management. Methods We investigated the prognostic impact of multiparameter flow cytometry (MFC) measurable residual disease (MRD) in 188 patients with first ...
Camilla Poulsen, Kristian Juul Sandahl, Lene Karlsson, Jonas Abrahamsson, Nira Arad‐Cohen, Daniel Cheuk, Barbara De Moerloose, Linda Fogelstrand, Jose Maria Fernandez Navarro, Bianca F. Goemans, Kirsi Jahnukainen, Gertjan Kaspers, Zhanna Kovalova, Monica Cheng Munthe‐Kaas, Ulrika Norén‐Nyström, Josefine Palle, Ramune Pasauliene, Cornelis Jan Pronk, Kadri Saks, Anne Tierens, Henrik Hasle, Kristian Løvvik Juul‐Dam   +21 more
wiley   +1 more source

Survival by Race and Ethnicity in Children and Adolescents/Young Adults With Relapsed/Refractory Hodgkin Lymphoma: A Pooled Analysis of Children's Oncology Group Trials

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Purpose Despite 5‐year survival rates of over 90% among children and adolescents/young adults (CAYAs) with classic Hodgkin lymphoma (cHL), 15%–20% relapse after frontline therapy. Prior analysis of frontline Children's Oncology Group (COG) clinical trials demonstrated that, despite similar rates of relapse, non‐Hispanic Black (NHB) and ...
Mallorie B. Heneghan, Lindsay A. Renfro, Yue Wu, Katia M. Crisler, Erin Marcotte, Tanya Trippett, Terzah Horton, Bradford S. Hoppe, Frank G. Keller, Chris Forlenza, Cindy Schwartz, Kara M. Kelly, Peter D. Cole, Sharon M. Castellino, Justine M. Kahn   +14 more
wiley   +1 more source

The International Council for Harmonisation E6 (R3) revision and its impact on clinical research practice: A narrative review

Cancer Research, Statistics, and Treatment
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), established in April 1990, has released an updated version of its ICH E6 guidelines for Good Clinical Practice (GCP). This new version, ICH E6 (
Bhavesh A P Bandekar, Akriti Sood, Gargi Ganguly, Natasha Sisodia, Soumitra Saha, Akhil Kapoor, Satyajit Pradhan   +6 more
doaj   +1 more source

Selection bias in clinical stroke trials depending on ability to consent

BMC Neurology, 2017
Background Clinical trials are the hallmark of evidence-based medicine, but recruitment is often challenging, especially in stroke trials investigating patients not being able to give informed consent.
Benjamin Hotter, Lena Ulm, Sarah Hoffmann, Mira Katan, Joan Montaner, Alejandro Bustamante, Andreas Meisel   +6 more
doaj   +1 more source