Results 91 to 100 of about 104,914 (293)

Nicotinamide riboside and pterostilbene reduces markers of hepatic inflammation in NAFLD: A double‐blind, placebo‐controlled clinical trial

Hepatology, EarlyView., 2022
NRPT 1X reduces ALT and ceramide 14:0 in 65% of subjects as compared to only 28% in the placebo group. Abstract Background and Aims The prevalence of NAFLD is increasing globally and on a path to becoming the most frequent cause of chronic liver disease. Strategies for the prevention and treatment of NAFLD are urgently needed.
Ryan W. Dellinger, Holly E. Holmes, Tina Hu‐Seliger, Rodney W. Butt, Stephen A. Harrison, Dariush Mozaffarian, Oliver Chen, Leonard Guarente   +7 more
wiley   +1 more source

Use of Most Bothersome Symptom as a Coprimary Endpoint in Migraine Clinical Trials: A Post-Hoc Analysis of the Pivotal ZOTRIP Randomized, Controlled Trial. [PDF]

, 2018
ObjectiveTo better understand the utility of using pain freedom and most bothersome headache-associated symptom (MBS) freedom as co-primary endpoints in clinical trials of acute migraine interventions.BackgroundAdhesive dermally applied microarray (ADAM)
Dodick, David W, Friedman, Deborah I, Gelfand, Amy A, Kellerman, Donald J, Schmidt, Peter C, Tepper, Stewart J   +5 more
core   +1 more source

Optimization of pharmaceutical research and development by early‐phase assessment of investigational medicinal products

British Journal of Clinical Pharmacology, EarlyView.
Small and mid‐sized pharmaceutical innovators often have limited in‐house health economics and market access expertise, and may struggle to align development strategies of investigational medicinal products with health system needs and payer expectations.
Zoltán Kaló, Attila Imre, Gábor Varga, Sándor Kovács, György Tímár, Balázs Nagy   +5 more
wiley   +1 more source

Alternative Administration of Antiretroviral Therapy in People with HIV Unable to Swallow: A Scoping Review

HIV/AIDS: Research and Palliative Care
Hilal Abdessamad,1 Christina Baroody,2,* Karolina Pogorzelski,3,* Wassim Jamaleddine,1,* Monicah Syomiti Kitonga,4 Habib Omar,5 Seth Adu Amankrah,5 Kristine Allen-Brown,5 Dima Dandachi1 1Division of Infectious Diseases, Department
Abdessamad H, Baroody C, Pogorzelski K, Jamaleddine W, Kitonga MS, Omar H, Amankrah SA, Allen-Brown K, Dandachi D   +8 more
doaj  

Setting up mother–infant pair lactation studies with biobanking for research according to regulatory requirements

British Journal of Clinical Pharmacology, EarlyView.
Within the ConcePTION project we set out to design two mother–infant pair studies collecting breast milk and plasma from the mother and plasma from the infant (for metformin and prednisolone) in order to demonstrate the premises and conditions for investigating potential drug transfer in association with breastfeeding.
Mats Hansson, Ida Björkgren, Jenny Svedenkrans, Helena Backman, Jarl Hellman, Linda Englund‐Ögge, Mikaela Magnusson, Inger Lindström, Andrea Wutte, Erica Sundell, Pawel Baranczewski, Laura Shaughnessy   +11 more
wiley   +1 more source

Navigating adverse immunostimulation: A practical guide for clinical researchers

British Journal of Clinical Pharmacology, EarlyView.
Problem Setting As drug development moves towards more complex products, early clinical development programmes are increasingly hampered by unwanted and/or unexpected activation of the immune system (adverse immune stimulation, AIS). Solution At the Centre for Human Drug Research, we have introduced standardized procedures to make AIS manageable, while
Juliette A. van den Noort, Anouk C. Meijs, Naomi B. Klarenbeek, Matthijs Moerland   +3 more
wiley   +1 more source

Retreatment with anti-EGFR based therapies in metastatic colorectal cancer: impact of intervening time interval and prior anti-EGFR response. [PDF]

, 2015
BackgroundThis retrospective study aims to investigate the activity of retreatment with anti-EGFR-based therapies in order to explore the concept of clonal evolution by evaluating the impact of prior activity and intervening time interval.MethodsEighty ...
Eng, C, Falchook, GS, Fu, S, Garrett, C, George, GC, Hess, K, Hong, DS, Janku, F, Karp, D, Kopetz, S, Kurzrock, R, Liu, X, Meric-Bernstam, F, Naing, A, Overman, MJ, Piha-Paul, SA, Raghav, K, Subbiah, V, Tsimberidou, AM, Wheler, JJ, Zinner, R   +20 more
core   +2 more sources

Adverse immunostimulation in early phase clinical trials: Key findings and recommendations based on the investigator's clinical experience

British Journal of Clinical Pharmacology, EarlyView.
Problem setting The emergence of therapeutic proteins has coincided with an increase of acute adverse immunostimulation (AIS). AIS has occured in clinical trials despite compliance with regulatory guidelines on preclinical evaluation and its incidence is anticipated to increase even further.
Juliette A. van den Noort, Marella C. E. van Ruissen, Lisanne C. A. Smidt, Naomi B. Klarenbeek, Philip H. K. Kremer, Manon A. A. Jansen, Jacobus Burggraaf, Joop M. A. van Gerven, Matthijs Moerland   +8 more
wiley   +1 more source

Efficacy and safety of empagliflozin for treating neutropenia and neutrophil dysfunction in paediatric patients with glycogen storage disease type Ib: A systematic review and meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Aims Glycogen storage disease type Ib (GSD‐Ib) is a rare genetic disorder causing neutropenia and neutrophil dysfunction in children. G‐CSF has been the primary treatment, but emerging data support the potential of empagliflozin, an SGLT2 inhibitor, as a promising investigational option.
Elizabeth Iwasyk, Ryan Jin, Fabio Tuzzolino, Giusy Ranucci, Donatella Madonia, Alessio Provenzani   +5 more
wiley   +1 more source

Mechanism‐informed machine learning for individualized tacrolimus dose adjustment in the early post‐kidney transplant period

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Tacrolimus dosing in the early post‐kidney transplant period is challenging due to a narrow therapeutic index and substantial interindividual pharmacokinetic (PK) variability. This study aimed to develop and validate mechanism‐informed machine learning (ML) models to support individualized tacrolimus dosing during this critical period ...
Hui Yu, Zihan Qin, Logan S. Smith, Jeong M. Park, Hao‐Jie Zhu   +4 more
wiley   +1 more source