Results 61 to 70 of about 82,696 (289)

Evaluating Causal Effect Predictiveness of Candidate Surrogate Endpoints [PDF]

, 2006
Most methods for evaluating surrogate endpoints measure validity in terms of net effects (i.e., treatment effects adjusted for the biomarker measured after randomization).
Gilbert, Peter B., Hudgens, Michael
core   +1 more source

Effects of vildagliptin on ventricular function in patients with type 2 diabetes mellitus and heart failure: a randomized placebo-controlled trial [PDF]

, 2017
Objectives: This study sought to examine the safety of the dipeptidyl peptidase-4 inhibitor, vildagliptin, in patients with heart failure and reduced ejection fraction.
Bolli, Geremia B., Kothny, Wolfgang, Kozlovski, Plamen, Krum, Henry, Lewsey, James D., Lukashevich, Valentina, McMurray, John J.V., Ponikowski, Piotr   +7 more
core   +2 more sources

A Cre‐dependent lentiviral vector for neuron subtype‐specific expression of large proteins

FEBS Letters, EarlyView.
We designed a versatile and modular lentivector comprising a Cre‐dependent switch and self‐cleaving 2A peptide and tested it for co‐expression of GFP and a 2.8 kb gene of interest (GOI) in mouse cortical parvalbumin (PV+) interneurons and midbrain dopamine (TH+) neurons.
Weixuan Xue, Sandrine Picaud, Régine Hepp, Stéphanie Pons, Uwe Maskos, Bertrand Lambolez, Ludovic Tricoire   +6 more
wiley   +1 more source

Surrogate Endpoints in Pivotal Clinical Trials for Drug Approval in Japan Compared to the United States

Clinical and Translational Science
Regulatory guidance documents exist on surrogate endpoints in the United States. In Japan, there are no established rules or guidance regarding the use of surrogate endpoints, and various aspects remain unclear.
Yuko Yamamoto, Harumi Kosaka, Hanami Nojiri, Hideki Maeda   +3 more
doaj   +1 more source

Defining Surrogate Endpoints for Clinical Trials in Severe Falciparum Malaria. [PDF]

PLoS ONE, 2017
Clinical trials in severe falciparum malaria require a large sample size to detect clinically meaningful differences in mortality. This means few interventions can be evaluated at any time. Using a validated surrogate endpoint for mortality would provide
Atthanee Jeeyapant, Hugh W Kingston, Katherine Plewes, Richard J Maude, Josh Hanson, M Trent Herdman, Stije J Leopold, Thatsanun Ngernseng, Prakaykaew Charunwatthana, Nguyen Hoan Phu, Aniruddha Ghose, M Mahtab Uddin Hasan, Caterina I Fanello, Md Abul Faiz, Tran Tinh Hien, Nicholas P J Day, Nicholas J White, Arjen M Dondorp   +17 more
doaj   +1 more source

Structural insights into lacto‐N‐biose I recognition by a family 32 carbohydrate‐binding module from Bifidobacterium bifidum

FEBS Letters, EarlyView.
Bifidobacterium bifidum establishes symbiosis with infants by metabolizing lacto‐N‐biose I (LNB) from human milk oligosaccharides (HMOs). The extracellular multidomain enzyme LnbB drives this process, releasing LNB via its catalytic glycoside hydrolase family 20 (GH20) lacto‐N‐biosidase domain.
Xinzhe Zhang, Naoki Sunagawa, Toma Kashima, Kiyohiko Igarashi, Akimasa Miyanaga, Shinya Fushinobu   +5 more
wiley   +1 more source

Selection of Endpoints for Clinical Studies of Ophthalmic Drugs

Регуляторные исследования и экспертиза лекарственных средств, 2021
Until now, there have been no effective treatments for some ophthalmic diseases that have high social significance. Development of therapeutic approaches to such diseases may be complicated due to challenges in diagnosis and selection of clinical trial ...
M. O. Komarova
doaj   +1 more source

Peptide‐based ligand antagonists block a Vibrio cholerae adhesin

FEBS Letters, EarlyView.
The structure of a peptide‐binding domain of the Vibrio cholerae adhesin FrhA was solved by X‐ray crystallography, revealing how the inhibitory peptide AGYTD binds tightly at its Ca2+‐coordinated pocket. Structure‐guided design incorporating D‐amino acids enhanced binding affinity, providing a foundation for developing anti‐adhesion therapeutics ...
Mingyu Wang, Grace Du, Charity Yongo‐Luwawa, Angelina Lu, Brett Kinrade, Kim Munro, Karl E. Klose, William D. Lubell, Peter Davies, Shuaiqi Guo   +9 more
wiley   +1 more source

Real‐time assay of ribonucleotide reductase activity with a fluorescent RNA aptamer

FEBS Letters, EarlyView.
Ribonucleotide reductases (RNR) synthesize DNA building blocks de novo, making them crucial in DNA replication and drug targeting. FLARE introduces the first single‐tube real‐time coupled RNR assay, which enables isothermal tracking of RNR activity at nanomolar enzyme levels and allows the reconstruction of allosteric regulatory patterns and rapid ...
Jacopo De Capitani, Noemi E. Nwosu, Viktoria Gocke, Müge Kasanmascheff, Hannes Mutschler   +4 more
wiley   +1 more source

A multistate model for early decision making in oncology

, 2018
The development of oncology drugs progresses through multiple phases, where after each phase a decision is made about whether to move a molecule forward.
Beyer, Ulrich, Burger, Hans Ulrich, Dejardin, David, Meller, Matthias, Rufibach, Kaspar   +4 more
core   +1 more source