Total clinical score

DBA/1 and C57BL/6 mice. Table 11.1 shows how clinical scores are assigned per mouse strain. The score is determined for all four paws. A maximal score of 4 can be reached per paw, resulting in a maximum total score of 16 per mouse (see Note 6). 

Alzheimer s Disease Assessment Scale (ADAS) Structured interview 21 items total 11 items in the cognitive (COG) subset. 10 items in the noncognitive behavioral subset. Each subset may be scored separately from the total ADAS score Takes 45 minutes to administer the ADAS and 35 minutes for the ADAS-COG. The ADAS-COG refers to the cognitive assessment subset commonly used to measure cognitive function in clinical drug trials. Requires training for administration and scoring... 

HA has been used as a hydrophihc carrier to deliver diclofenac topically for the treatment of premalignant skin lesions such as actinic keratoses (AK) (106-112) and for colon-26 adenocarcinoma (113-115). HA is the preferred carrier for transdermal delivery of diclofenac, as it has been shown to enhance the partitioning of the drug into the skin compared to other vehicles (116). Furthermore, in a clinical trial, the safety and efficacy of 3% diclofenac in 2.5% HA gel have been evaluated as a topical treatment for actinic keratosis (108). Patients treated with HA-diclofenac showed significantly lower target and cumulative lesion number scores and lesion total thickness scores compared to the placebo group. The treatment with 3.0% diclofenac in 2.5% HA gel was effective when used for 60 days and was well tolerated in patients with AK. 

A total of 1118 drugs with ADR information were included in the analysis. Incidence data ( common, frequent, infrequent, rare, not known ) associated with each COSTART term for each compound were transformed to binary data. Each ADR for a specific drug was scored as 1 if the COSTART term was listed in its label at any clinical frequency including not known, and as 0 if the term was not listed. Thus, each occurrence of the ADR in the label information is counted as a positive response. 

Other data arise as scores. These are frequently as a result of the need to provide a measure of some clinical condition such as depression or anxiety. The Hamilton Depression (HAM-D) scale and the Hamilton Anxiety (HAM-A) scale provide measures in these cases. These scales contain distinct items which are scored individually and then the total score is obtained as the sum of the individual scores. For the Hamilton Depression scale there are usually 17 items depressed mood, self-depreciation and guilt feelings, etc., each scored on a three-point scale or on a five-point scale. The five-point scales are typically scores 0 = absent, 1 = doubtful to mild, 2 = mild to moderate, 3 = moderate to severe and 4 = very severe while the three-point scales are typically 0 = absent, 1 = probable or mild and 3 = definite. 

TABLE 9-4. Mean item and total Manic Interpersonal Interaction Scale (MIIS) scores before and after clinical remission... 

Clozapine Acute Clinical Trials. Owen et al. conducted an open-label, compassionate use, clozapine treatment protocol in 37 chronically psychotic patients (25 schizophrenia 12 schizoaffective) (288). Clozapine produced a highly significant improvement in psychopathology as measured by the BPRS. Interestingly, schizoaffective patients had significantly lower total scores than their schizophrenic counterparts at the final rating. 

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