A potential primary endpoint for clinical trials in glaucoma neuroprotection
Scientific Reports, 2023 The purpose of this retrospective, longitudinal study is to evaluate the relationship between MD slope from visual field tests collected over a short period of time (2 years) and the current United States’ Food and Drug Administration (FDA) recommended ...
Carlos Gustavo De Moraes +3 more
doaj +1 more source
Randomized trial comparing proactive, high-dose versus reactive, low-dose intravenous iron supplementation in hemodialysis (PIVOTAL) : Study design and baseline data [PDF]
, 2018 Background: Intravenous (IV) iron supplementation is a standard maintenance treatment for hemodialysis (HD) patients, but the optimum dosing regimen is unknown.
Anker, Stefan D. +12 more
core +4 more sources
IPF clinical trial design and endpoints [PDF]
Current Opinion in Pulmonary Medicine, 2014 There remains a dire need for therapies that impact the clinical course of patients with idiopathic pulmonary fibrosis (IPF). Indeed, there is a surge of interest in IPF therapeutics, with many candidate agents in various stages of development. Optimal design and implementation of the appropriate prospective clinical trials are essential to demonstrate
Nathan, Steven D., Meyer, Keith C.
openaire +2 more sources
Endpoints for clinical trials in ophthalmology
Progress in Retinal and Eye Research, 2023 With the identification of novel targets, the number of interventional clinical trials in ophthalmology has increased. Visual acuity has for a long time been considered the gold standard endpoint for clinical trials, but in the recent years it became evident that other endpoints are required for many indications including geographic atrophy and ...
Leopold, Schmetterer +6 more
openaire +2 more sources
Aprotinin may increase mortality in low and intermediate risk but not in high risk cardiac surgical patients compared to tranexamic acid and ε-aminocaproic acid - a meta-analysis of randomised and observational trials of over 30.000 patients [PDF]
, 2013 Background: To compare the effect of aprotinin with the effect of lysine analogues (tranexamic acid and ε-aminocaproic acid) on early mortality in three subgroups of patients: low, intermediate and high risk of cardiac surgery.
Herrmann, Eva +3 more
core +3 more sources
Individualized Angiotensin‐Converting Enzyme (ACE)‐Inhibitor Therapy in Stable Coronary Artery Disease Based on Clinical and Pharmacogenetic Determinants: The PERindopril GENEtic (PERGENE) Risk Model [PDF]
, 2016 Patients with stable coronary artery disease (CAD) constitute a heterogeneous group in which the treatment benefits by angiotensin-converting enzyme (ACE)-inhibitor therapy vary between individuals.
Akkerhuis, KM +14 more
core +1 more source
Clinical endpoints for efficacy studies
Vaccine, 2019 Well-established, validated and clinically meaningful primary and secondary endpoints are critical in advancing vaccines through proof of principal studies, licensure and pre-qualification. To that end, the field of vaccine development for Shigella, enterotoxigenic Escherichia coli (ETEC) as well as other enteric pathogens would benefit greatly from a ...
Chad K, Porter +2 more
openaire +2 more sources
Characteristics of ADHD symptom response/remission in a clinical trial of methylphenidate extended release [PDF]
, 2019 Clinical trials in attention-deficit/hyperactivity disorder (ADHD) have typically measured outcome using clinician ratings on the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) and the Clinical Global Impression ...
Adjei, Akwete L +5 more
core +2 more sources
Rifampicin and clarithromycin (extended release) versus rifampicin and streptomycin for limited Buruli ulcer lesions: a randomised, open-label, non-inferiority phase 3 trial. [PDF]
, 2020 BACKGROUND: Buruli ulcer is a neglected tropical disease caused by Mycobacterium ulcerans infection that damages the skin and subcutis. It is most prevalent in western and central Africa and Australia.
Abass, KM +31 more
core +3 more sources
Endpoints in cancer clinical trials
Journal of Visceral Surgery, 2014 Endpoints are measurable clinical and biological findings that are used for the development and assessment of treatment options. In the treatment of cancer, endpoints can be classified into two categories: "patient-centered clinical endpoints" including overall survival (OS) and health-related quality of life (QoL), and "tumor-centered clinical ...
F, Fiteni +5 more
openaire +2 more sources