Exclusion criteria

The NINDS rt-PA smdy was divided into two parts. NINDS part I included 291 patients and NINDS part II included 333 patients. In both parts, acute ischemic stroke patients presenting within 3 hours of symptom onset were randomized to placebo versus treatment with the human rt-PA Alteplase (Activase). The dose was 0.9 mg/kg (maximum dose 90 mg), with 10% of the total dose given as a bolus and the remaining 90% infused over 60 minutes. Inclusion and exclusion criteria for both parts are listed in Table 3.2. These criteria are now the standard clinical criteria used to determine IV rt-PA eligibility in acute stroke patients. 

TABLE 3.2 Inclusion and Exclusion Criteria for Treatment with Intravenous Tissue Plasminogen Activator. ... 

A detailed clinical history, past medical and surgical history, medications, allergies, laboratory work-up, physical examination, and NIHSS should be obtained as quickly as possible for assessment of inclusion and exclusion criteria for lAT. Table 4.1 lists the criteria for catheter-based reperfusion therapy currently in place at the Massachusetts General Hospital (Table 4.1 see also www.acutestroke.com for updated criteria). 

The telemedicine-based evaluation of acute stroke is especially challenging. It requires a rapid neurological assessment, CT image acquisition and review, and a detailed history for rt-PA exclusion criteria. Low-cost teleradiology systems are now available for the transmission of compressed CT images viewable on a conventional personal computer (PC) monitor, in accordance with published standards. 

Inclusion and exclusion criteria are used to define eligibility parameters for study participation. These criteria are established to insure that the study... 

Examples of parameters used to define inclusion and exclusion criteria often include ... 

Obviously, the greater the number of subjects studied, the larger the cost. Nevertheless, having too few subjects may lead to inconclusive results, requiring that the study be repeated. Another important consideration is the availability of qualified participants. If the inclusion and exclusion criteria are very restrictive, the cost of recruiting subjects may exceed that of the actual testing. In pharmaceutical development trials, it is not unusual to see recruitment budgets of US 500- 1000 per randomized subject. Thus, for a Phase III development study with several hundred participants, often more than US 500 000 in cost is allotted to efforts to identify qualified subjects who are interested in participation. 

Site topography Exclusion Must have slope <1% Site must not be susceptible to flooding Shallow water table or tile drains must not interfere with sampling These are exclusion criteria that have to be carefully determined during on-site inspection Site must be level to prevent losses of agrochemical due to surface run-off and soil erosion Site must not be susceptible to runoff from other areas higher than test site... 

TABLE 8-6. Inclusion and Exclusion Criteria for Alteplase Use in Acute Ischemic Stroke... 

Evaluate the inclusion and exclusion criteria for thrombolytic therapy to determine if it is appropriate for the patient. 

Unfortunately, many clinical studies evaluating the efficacy of dietary supplements are flawed. Some of the flaws in the studies include non-randomization, being unblinded, lack of standardized products, small sample sizes, short treatment durations, and poorly defined inclusion and exclusion criteria. Many studies do not give detailed information about the dietary supplement used. When an herb is studied, the following information should be described plant species, part(s) used, product form (e.g., powdered crude herb, aqueous extract, ethanol extract, or aqueous alcohol extract) with stated proportions of water to alcohol, specifically extracted fractions, and quantities or concentrations used [48]. 

Most clinical trials, including the ones my colleagues and I analysed, are conducted on volunteers, many of whom are recruited for the trial by advertisements. Perhaps these depressed people are not as responsive to antidepressants as the patients seen in clinical practice. The STAR D trial that I described earlier was designed specifically to evaluate the effect of antidepressants on the kinds of patients who are typically seen in clinical practice. None of the patients in this trial were recruited by advertising. Instead, they were all patients who sought treatment for depression in family practice or psychiatric out-patient treatment facilities. Also, the usual exclusion criteria were relaxed, so that a broader range of patients was evaluated. The trial did exclude patients who had already tried antidepressants but had not responded to them, although this exclusion should result in better response rates, not worse ones. 

Posternak, Michael A., Mark Zimmerman, Gabor I. Keitner and Ivan W. Miller, A Reevaluation of the Exclusion Criteria Used in Antidepressant Efficacy Trials , American Journal of Psychiatry 159 (2002) 191-200... 

Delineation of case group Detailed description of in- and exclusion criteria... 

Pork is the product of a very complex process. All the various characteristics of pork quality cannot be assessed directly in each carcass because these measurements and assessments would be too expensive. Therefore, previous scientific quality assessment of meat is primarily an indirect approach based on a few easily detectable quantitative traits and on the prescription of minimal standards in relation to the product in terms of size or composition and in relation to the production process. The prescriptions and the exclusion criteria vary between countries or between labelling programmes. The most encompassing prescriptions are enshrined in the EC regulation on organic livestock production (EEC No. 2092/91). Owing to this approach, extreme deviations in quality traits and deleterious effects are prevented. However, there is still space left within these framework conditions for huge variability in pork quality. 

Time of symptom onset well established to be less than 180 minutes before treatment would begin Exclusion Criteria (all NO boxes must be checked before treatment)... 

In the case of panic disorder, the exclusion criteria specify that only certain types of panic attacks are relevant to this diagnosis (i.e., panic attacks resulting from drugs, other anxiety disorders do not count). One could sim-... 

---