We conducted a phase I bioequivalence trial in healthy Chinese subjects in the fasting and postprandial states. The goal of this trial was to compare the pharmacokinetics and safety of the test preparation Cefaclor granule (Disha Pharmaceutical Group Co.,
Xinyao Qu+15 more
doaj +1 more source
Importance The results of the American College of Surgeons Oncology Group Z0011 (ACOSOG Z0011) trial were first reported in 2005 with a median follow-up of 6.3 years.
A. Giuliano+13 more
semanticscholar +1 more source
The impact of clinical trial units on the value of clinical research in Switzerland
A prominent 2014 series by The Lancet on “Increasing value, reducing waste in biomedical research” provided recommendations on how to optimise precious resources, including in clinical research.
Belinda von Niederhäusern+2 more
doaj +1 more source
Impact of sitagliptin on endometrial mesenchymal stem-like progenitor cells : a randomised, double-blind placebo-controlled feasibility trial [PDF]
Background: Recurrent pregnancy loss (RPL) is associated with the loss of endometrial mesenchymal stem-like progenitor cells (eMSC). DPP4 inhibitors may increase homing and engraftment of bone marrow-derived cells to sites of tissue injury.
Brighton, Paul (Paul J.)+13 more
core +1 more source
Estimation of clinical trial success rates and related parameters
&NA; Previous estimates of drug development success rates rely on relatively small samples from databases curated by the pharmaceutical industry and are subject to potential selection biases.
Chi Heem Wong, K. W. Siah, A. Lo
semanticscholar +1 more source
A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19
Background No therapeutics have yet been proven effective for the treatment of severe illness caused by SARS-CoV-2. Methods We conducted a randomized, controlled, open-label trial involving hospitalized adult patients with confirmed SARS-CoV-2 infection,
B. Cao+64 more
semanticscholar +1 more source
Study protocol: a randomised controlled trial on the clinical effects of levothyroxine treatment for subclinical hypothyroidism in people aged 80 years and over [PDF]
Background: Subclinical hypothyroidism is common in older people and its contribution to health and disease needs to be elucidated further. Observational and clinical trial data on the clinical effects of subclinical hypothyroidism in persons aged 80 ...
Blum, M.R.+20 more
core +7 more sources
Estimating Design Operating Characteristics in Bayesian Adaptive Clinical Trials [PDF]
Bayesian adaptive designs have gained popularity in all phases of clinical trials with numerous new developments in the past few decades. During the COVID-19 pandemic, the need to establish evidence for the effectiveness of vaccines, therapeutic treatments and policies that could resolve or control the crisis emphasized the advantages offered by ...
arxiv
Potential implications of practice effects in Alzheimer's disease prevention trials. [PDF]
IntroductionPractice effects (PEs) present a potential confound in clinical trials with cognitive outcomes. A single-blind placebo run-in design, with repeated cognitive outcome assessments before randomization to treatment, can minimize effects of ...
Ard, M Colin+5 more
core +1 more source
Digitizing clinical trials [PDF]
AbstractClinical trials are a fundamental tool used to evaluate the efficacy and safety of new drugs and medical devices and other health system interventions. The traditional clinical trials system acts as a quality funnel for the development and implementation of new drugs, devices and health system interventions.
Omer T. Inan+21 more
openaire +4 more sources