Results 21 to 30 of about 9,664,331 (394)

Qualifying a Novel Clinical Trial Endpoint (iBOX) Predictive of Long-Term Kidney Transplant Outcomes

Transplant International, 2023
New immunosuppressive therapies that improve long-term graft survival are needed in kidney transplant. Critical Path Institute’s Transplant Therapeutics Consortium received a qualification opinion for the iBOX Scoring System as a novel secondary efficacy
Amanda Klein, Alexandre Loupy, Mark Stegall, Ilkka Helanterä, Luke Kosinski, Eric Frey, Olivier Aubert, Gillian Divard, Kenneth Newell, Herwig-Ulf Meier-Kriesche, Roslyn Mannon, Thomas Dumortier, Varun Aggarwal, Jagdeep T. Podichetty, Inish O’Doherty, Ahmed Osama Gaber, William E. Fitzsimmons   +16 more
doaj   +1 more source

“Mobility as a Service” Platforms: A Critical Path towards Increasing the Sustainability of Transportation Systems

Sustainability, 2020
Urban mobility is experiencing a profound change. Mobility patterns are becoming more complex, and typical home–work–home travel is no longer the rule, as journeys tend to connect multiple points in a rather inconstant pattern.
C. Cruz, J. Sarmento
semanticscholar   +1 more source

Application of longitudinal item response theory models to modeling Parkinson’s disease progression

CPT: Pharmacometrics & Systems Pharmacology, 2022
The Movement Disorder Society revised version of the Unified Parkinson’s Disease Rating Scale (MDS‐UPDRS) parts 2 and 3 reflect patient‐reported functional impact and clinician‐reported severity of motor signs of Parkinson’s disease (PD), respectively ...
Haotian Zou, Varun Aggarwal, Glenn T. Stebbins, Martijn L. T. M. Müller, Jesse M. Cedarbaum, Anne Pedata, Diane Stephenson, Tanya Simuni, Sheng Luo   +8 more
doaj   +1 more source

Landscape analysis for a neonatal disease progression model of bronchopulmonary dysplasia: Leveraging clinical trial experience and real-world data

Frontiers in Pharmacology, 2022
The 21st Century Cures Act requires FDA to expand its use of real-world evidence (RWE) to support approval of previously approved drugs for new disease indications and post-marketing study requirements.
Jeffrey S. Barrett, Megan Cala Pane, Timothy Knab, William Roddy, Jack Beusmans, Eric Jordie, Kanwaljit Singh, Jonathan Michael Davis, Klaus Romero, Michael Padula, Bernard Thebaud, Mark Turner   +11 more
doaj   +1 more source

Disease progression joint model predicts time to type 1 diabetes onset: Optimizing future type 1 diabetes prevention studies

CPT: Pharmacometrics & Systems Pharmacology, 2023
Clinical trials seeking type 1 diabetes prevention are challenging in terms of identifying patient populations likely to progress to type 1 diabetes within limited (i.e., short‐term) trial durations. Hence, we sought to improve such efforts by developing
Juan Francisco Morales, Rhoda Muse, Jagdeep T. Podichetty, Jackson Burton, Sarah David, Patrick Lang, Stephan Schmidt, Klaus Romero, Inish O'Doherty, Frank Martin, Martha Campbell‐Thompson, Michael J. Haller, Mark A. Atkinson, Sarah Kim   +13 more
doaj   +1 more source

Development of a model‐based clinical trial simulation platform to optimize the design of clinical trials for Duchenne muscular dystrophy

CPT: Pharmacometrics & Systems Pharmacology, 2022
Early clinical trials of therapies to treat Duchenne muscular dystrophy (DMD), a fatal genetic X‐linked pediatric disease, have been designed based on the limited understanding of natural disease progression and variability in clinical measures over ...
Karthik Lingineni, Varun Aggarwal, Juan Francisco Morales, Daniela J. Conrado, Diane Corey, Camille Vong, Jackson Burton, Jane Larkindale, Klaus Romero, Stephan Schmidt, Sarah Kim, the Cooperative International Neuromuscular Research Group investigators and Duchenne Regulatory Science Consortium members   +11 more
doaj   +1 more source

Recommendations to Optimize the Use of Volumetric MRI in Huntington's Disease Clinical Trials

Frontiers in Neurology, 2021
Volumetric magnetic resonance imaging (vMRI) has been widely studied in Huntington's disease (HD) and is commonly used to assess treatment effects on brain atrophy in interventional trials.
Kirsi M. Kinnunen, Ariana P. Mullin, Ariana P. Mullin, Dorian Pustina, Emily C. Turner, Jackson Burton, Mark F. Gordon, Rachael I. Scahill, Emily C. Gantman, Simon Noble, Klaus Romero, Nellie Georgiou-Karistianis, Adam J. Schwarz   +12 more
doaj   +1 more source

The tensorflow partitioning and scheduling problem: it's the critical path! [PDF]

arXiv.org, 2017
State-of-the-art data flow systems such as TensorFlow impose iterative calculations on large graphs that need to be partitioned on heterogeneous devices such as CPUs, GPUs, and TPUs. However, partitioning can not be viewed in isolation.
R. Mayer, C. Mayer, Larissa Laich
semanticscholar   +1 more source

Reentrant topological phase transitions in a disordered spinless superconducting wire [PDF]

, 2013
In a one-dimensional spinless p-wave superconductor with coherence length \xi, disorder induces a phase transition between a topologically nontrivial phase and a trivial insulating phase at the critical mean free path l=\xi/2.
Adagideli, Inanc, Adagideli, İnanç, Brouwer, Piet W., Rieder, Maria Theresa   +3 more
core   +4 more sources

Empowering drug development: Leveraging insights from imaging technologies to enable the advancement of digital health technologies

Clinical and Translational Science, 2023
The US Food and Drug Administration (FDA) has publicly recognized the importance of improving drug development efficiency, deeming translational biomarkers a top priority.
Elena S. Izmailova, R. Paul Maguire, Timothy J. McCarthy, Martijn L. T. M. Müller, Philip Murphy, Diane Stephenson   +5 more
doaj   +1 more source