Hypotheses Drugs Disorder of oxygen and piracetam, pyritinol, glucose utilisation nicergoline, EGb Reduced perfusion and dihydroergotoxine, microcirculation nicergoline, EGb Disorder of neuronal nimodipine calcium homeostasis Glutamate excess at memantine central synapses Acetylcholine deficiency tacrine, donezepil, at central synapses rivastigmine, galantamine Table 2 Efficacy and "unblinding
" in trials with EGb and ChE inhibitors (Dementia of Alzheimer's Type, in each case the most effective dose and statistical evaluation as "Intention-to-treat" (ITT) analysis).
"...a site-based image interpretation may be able in a randomized, double-blinded clinical trial of an investigational therapeutic drug where the imaging technology is widely available, the image is easily assessed by a clinical radiologist, and the investigational drug has shown little or no evidence of unblinding
effects.2 In this situation, the use of randomization and blinding controls bias in image interpretation." (3) This draft, which pre-dates the discussion that took place in July, indicates that local reads might be sufficient when certain conditions are met.
, the value of 1.07 mg/dL (94.7 [micro]mol/L) (Zscore = 2.93; 17% increase from baseline) measured at T1V1 appeared not to have been induced by the drug.
The company looks forward to evaluating and reporting interim data from an earlier completed randomised Phase II trial in front-line NSCLC and data from an HCV study later this year as Peregrine awaits unblinding
data from this second-line NSCLC trial in the first half of next year, added King.
occurred at 1 year or if the disease had progressed quickly and the researchers thought the patient's lifestyle was unsustainable.
, the colonoscopic results against which the virtual colonoscopies were measured showed that there were 70 true positive, 48 true negative, 12 false-positive, and 8 false-negative findings.
Of note: at the end of the study but prior to unblinding
, subjects were asked winch medication they preferred.
Thus the doubling of the statistically likely rate of unblinding
under sertraline fully explains the small difference in the reduction of the Hamilton scores which was seen between placebo and St.
Treating physicians and staff as well as patients were blinded to the treatment groups, but the electrophysiology staff was not, and there were some cases of unblinding
As a result of the recommendations made by the Supply Chain Manager, the sponsor was able to achieve a more efficient use of the available clinical trial materials which prevented potential stock outs and unblinding
scenarios and provided a more efficient drug shipment strategy.
GeoVax also reported the unblinding
of data for neutralising antibody (Ab) responses in part 1 of HVTN 205 - showing elicitation of unexpectedly high response rates of neutraliaing antibody for tier 2 isolates of HIV-1.
Vaccine-induced seropositivity can potentially lead to unblinding
of the study participants as well as researchers, with a risk of compromising the study data.