Results 11 to 20 of about 9,396,775 (321)

Evaluation of the True Endpoint of Clinical Trials for Cancer Cachexia

Asia-Pacific Journal of Oncology Nursing, 2019
Cachexia is an old disease but a new research area that has recently been vigorously investigated. The diagnostic and staging criteria for cancer-associated cachexia have been established through an international consensus report (CR) published in 2011 ...
Tateaki Naito
doaj   +2 more sources

Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research.

European Heart Journal, 2021
AIMS The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials.
P. Généreux, N. Piazza, Maria C. Alu, T. Nazif, R. Hahn, P. Pibarot, J. Bax, J. Leipsic, P. Blanke, E. Blackstone, M. Finn, S. Kapadia, A. Linke, M. Mack, R. Makkar, R. Mehran, J. Popma, M. Reardon, J. Rodés‐Cabau, N. Van Mieghem, J. Webb, D. Cohen, M. Leon   +22 more
semanticscholar   +2 more sources

Validation of POD24 As a Robust Early Clinical Endpoint of Poor Survival in FL from 5,225 Patients on 13 Clinical Trials.

Blood, 2021
Observational studies and standalone trials indicate that patients with follicular lymphoma (FL) who experience disease progression within 24 months of front-line chemoimmunotherapy (POD24), have poor outcomes.
C. Casulo, J. G. Dixon, J. Le-Rademacher, E. Hoster, H. Hochster, W. Hiddemann, R. Marcus, E. Kimby, M. Herold, C. Sebban, E. Gyan, K. Foon, T. Nielsen, U. Vitolo, G. Salles, Q. Shi, C. Flowers   +16 more
semanticscholar   +1 more source

Recommendations for selection and adaptation of rating scales for clinical studies of rapid-acting antidepressants

Frontiers in Psychiatry, 2023
The novel mechanisms of action (MOA) derived from some recently introduced molecular targets have led to regulatory approvals for rapid acting antidepressants (RAADs) that can generate responses within hours or days, rather than weeks or months.
Christian Yavorsky, Elizabeth Ballard, Mark Opler, Jan Sedway, Steven D. Targum, William Lenderking   +5 more
doaj   +1 more source

Operationalizing selection criteria for clinical trials in Alzheimer's disease: Biomarker and clinical considerations

Alzheimer’s & Dementia: Translational Research & Clinical Interventions, 2023
Alzheimer's disease (AD) staging criteria lack standardized, empirical description. Well‐defined AD staging criteria are an important consideration in protocol design, influencing a more standardized inclusion/exclusion criteria and defining what ...
Ronald C. Petersen, Ana Graf, Chris Brady, Susan De Santi, Hana Florian, Jaren Landen, Mike Pontecorvo, Christopher Randolph, Kaycee M. Sink, Maria C. Carrillo, Christopher J. Weber   +10 more
doaj   +1 more source

Correlation of the combined symptom and medication score with quality of life, symptom severity and symptom control in allergic rhinoconjunctivitis

Clinical and Translational Allergy, 2022
Background The European Academy of Allergy and Clinical Immunology recommended the Combined Symptom and Medication Score (CSMS) as primary endpoint in clinical trials on allergen‐specific immunotherapy (AIT) in allergic rhinoconjunctivitis.
Binoy Palathumpattu, Ursula Pieper‐Fürst, Cengizhan Acikel, Hacer Sahin, Silke Allekotte, Jaswinder Singh, Mark Hess, Angelika Sager, Thomas Müller, Ralph Mösges   +9 more
doaj   +1 more source

Food and Drug Administration approvals in phase 3 Cancer clinical trials

BMC Cancer, 2021
Background Phase 3 oncologic randomized clinical trials (RCTs) can lead to Food and Drug Administration (FDA) approvals. In this study, we aim to identify trial-related factors associated with trials leading to subsequent FDA drug approvals.
Joseph Abi Jaoude, Ramez Kouzy, Marc Ghabach, Roshal Patel, Dario Pasalic, Elie Ghossain, Austin B. Miller, Timothy A. Lin, Vivek Verma, C. David Fuller, Vivek Subbiah, Bruce D. Minsky, Ethan B. Ludmir, Cullen M. Taniguchi   +13 more
doaj   +1 more source

Correlation between clinical trial endpoints of marketed cancer drugs and reimbursement decisions in China

Frontiers in Public Health, 2022
ObjectiveThis study aimed to assess whether different clinical trial endpoints in pivotal trials of cancer drugs were associated with reimbursement decisions in China.Materials and methodsCancer drugs marketed before June 30th, 2021 with publicly ...
Kexin Ling, Huli Qin, Yiman Feng, Hongxi Che, Jinxi Ding, Jinxi Ding, Wei Li, Wei Li   +7 more
doaj   +1 more source

Design and rationale of a multi-center, pragmatic, open-label randomized trial of antimicrobial therapy - the study of clinical efficacy of antimicrobial therapy strategy using pragmatic design in Idiopathic Pulmonary Fibrosis (CleanUP-IPF) clinical trial [PDF]

, 2020
Compelling data have linked disease progression in patients with idiopathic pulmonary fibrosis (IPF) with lung dysbiosis and the resulting dysregulated local and systemic immune response.
A Mishra, AW Brown, B Ley, BA Karimi-Shah, BT Baxter, CJ Ryerson, DG Pankratz, DJ Lederer, G Raghu, G Raghu, H Scheper, HR Collard, J Andrade, J Coast, J Coast, K Loudon, K Loudon, KA Getz, KD Brandt, KE Thorpe, KF Schulz, L Richeldi, L Shulgina, LB Krupp, M Fralick, M Hammond, MA Fischl, MA Perazella, MO Paterniti, MT Durheim, P Bhattacharyya, PL Molyneaux, PL Molyneaux, PL Molyneaux, R Dal-Ré, RM Califf, RM du Bois, SD Nathan, SS Birring, T Katsuyama, TE King Jr, VA Varney, WS Jones, Y Huang   +43 more
core   +1 more source

Value of Adaptive Trials and Surrogate Endpoints for Clinical Decision-Making in Rare Cancers

Frontiers in Oncology, 2021
Despite high-level endorsement, the number of adaptive Phase II/III trials in rare cancers needs to be improved, with better understanding of their value for clinical decisions in daily practice.
Andriy Krendyukov, Sanjay Singhvi, Markus Zabransky   +2 more
doaj   +1 more source