Patients in our experiment presented with cardinal symptoms
of CHD, such that the level of evidence provided by the symptoms led the vast majority of physicians to consider CHD as a diagnosis, and just over half of the physicians (51.
More controversy exists about whether or not patients who present with the cardinal symptoms
and rapid cycling should be categorized as bipolar not otherwise specified (NOS), but included in the spectrum, she said.
The cardinal symptoms
of PD are resting tremor, rigidity, bradykinesia, and postural instability.
Associations between symptomatic improvement and change in exercise tolerance were analysed in data from Tauchert (2002) by calculating Spearman's Correlation Coefficient of MWL and von Zerssen total score as well as by comparing rate of patients with improved cardinal symptoms
in the subgroups with or without improved MWL by [x.
Many of these children did not have the cardinal symptoms
of anorexia nervosa.
Based on an interim blinded intent-to-treat analysis of the primary endpoint of complete resolution of the cardinal symptoms
for the first approximately 147 patients to finish the trial, the Company believes that the trial at its conclusion will show a highly statistically significant outcome for SinuNase.
The endpoint of the study was an assessment of the 4 cardinal symptoms
of Psoriasis: erythema, scaling, skin plaques, and itching.
Accentia reports that the interim blinded Intent-To-Treat (ITT) results in the randomized clinical trial in which 50% of patients receive SinuNase and 50% receive a placebo-control shows that in the more than 250 patients who have finished the trial (approximately 84% of enrolled patients), there continues to be evidence of significant therapeutic effect with about 22% achieving the primary endpoint of complete resolution of both cardinal symptoms
of chronic sinusitis and another 23% achieving a complete resolution of at least one of the two cardinal symptoms
01% suspension) achieved, as anticipated, superior resolution of the cardinal symptoms
of chronic sinusitis (CS), as compared to placebo control arm, however, the analysis of the unblinded primary endpoint data did not show the required level of statistical significance when comparing the SinuNase arm to the control arm.
Over half of Europeans did not correctly identify Parkinson's as a neurological condition that affects movement and 77% did not recognise the inability to move - one of the cardinal symptoms
- as being a problem for people with of Parkinson's.
SinuNase lavage demonstrated superiority to placebo control lavage in resolving two cardinal symptoms
of CS (nasal congestion and sinus headache), and while the primary endpoint did not reach the 95% confidence level of statistical significance, the Company continues to believe that the additional data that is pending, including composite symptom scores, and objective measurements of fungal-induced inflammation such as CT scans, endoscopy, and biomarkers in nasal mucus will provide evidence of additional superior clinical benefit.
Furthermore, the analysis of the full data set has shown that the subjective primary endpoint of complete resolution of the cardinal symptoms
of sinus headache and nasal congestion as reported by study participants at the conclusion of the 16 week trial is not reliable.