Treatment groups

O Malley et al. (1992) conducted a double-blind study combining naltrexone and CBT for alcohohsm. Patients were randomly assigned to participate in cognitive-behavioral coping skills treatment or supportive therapy and to receive 50 mg/day of naltrexone or placebo. Naltrexone-treated patients who received supportive therapy had more continuous abstinence than the other treatment groups. However, naltrexone-treated patients who received CBT had a lower level of craving and lower risk of relapse than the other three groups. This interaction would not have been observed in a study that manipulated only psychosocial treatment or only medication. 

The postnatal effects of maternal treatment with 2,7-dichlorodibenzo-p-dioxin are summarized in Table VII. No significant changes were found. The progeny on becoming adult were mated within the treatment groups. No effects on male or female fertility, embryonic viability, and total implantation/corpora lutea ratio were observed. 

FIGURE 8 Antitumor activity of free DXR and DXR entrapped in different liposome types in solid IgM immunocytoraa-bearing Lou/M Wsl rats. 2 mg DXR/kg body weight was injected i.v. daily for 5 days (0-4) followed by one additional injection at day 11 after start of therapy. Results obtained during the first 21 days after start of treatment are shown. Treatment groups consisted of 10 animals. 

Each treatment group showed a dose-dependent decrease in core (Figure 6) and peripheral (not shown) body temperatures. The three highest dose groups... 

In Connecticut in the USA, Essock and co-workers randomized 227 patients to treatment with clozapine or to usual care and observed treatment outcome for 24 months (Essock et al, 1996). At the end of this period 88 (64%) of the original clozapine group ( = 138) were still taking clozapine. All randomized participants were in-patients who were resistant to or intolerant of conventional neuroleptics. The authors presented only brief results. Discharge rates for the two treatment groups were similar, but stark differences were observed in readmission rates 3% of patients taking clozapine were readmitted within 6 months of discharge, compared with 29% of... 

There have been three large randomized trials of streptokinase in acute ischemic stroke treatment, all of which were terminated early because of increased sICH and mortality in the treatment group (Table 3.1)." " " ... 

The PRO ACT-11 trial was designed to assess the clinical efficacy and safety of lA r-pro-UK. In this study, 180 patients were enrolled in a 2 1 randomization scheme to receive either 9 mg lA r-pro-UK plus 4 hours of low-dose IV heparin, or low-dose IV heparin alone. The primary clinical outcome, the proportion of patients with slight or no disability at 90 days (mRS of < 2), was achieved in 40% of the 121 patients in the r-pro-UK treatment group, compared to 25% of the 59 patients in the control group (absolute benefit 15%, relative benefit 58%, number need to treat = 7 p = 0.04). The recanalization rate (TlMl 2 and 3) was 66% for the r-pro-UK group and 18% for the control group (p < 0.001). Symptomatic ICH within 24 hours occurred in 10% of r-pro-UK patients and 2% of control patients (p = 0.06). All symptomatic ICHs occurred in patients with a baseline NIHSS... 

Small vessel/lacunar strokes have better short- and long-term (1-year) survival as compared to other stroke subtypes. In the NINDS trial of rt-PA within 3 hours of onset, patients classified as small vessel stroke on the basis of their clinical syndrome had a 50% chance of a normal NIHSS score at 3 months if they received placebo, increasing to 70% in the treatment group. In the Lausanne cohort, 95% were independent after their first event, as opposed to only 65% of the cardioembolic strokes and 49% with large vessel atherothrombotic infarctions. Eighty-two percent of patients with small vessel stroke were independent at 1 year. Even at the time of maximal deficit, between 38% and 64% of small vessel/lacunar patients were independent, with motor impairment and extent of white matter disease adversely affecting outcomes. " In TOAST, small vessel/lacunar stroke was the only subtype associated with a favorable outcome, independent of the NIHSS score. ... 

All clinical trials should have a pre-specified research question, which may be stated in the form of a primary hypothesis (or possibly a few primary hypotheses). An objective outcome measure or measures should also be clearly identified, such as the results of a biochemical test or the score on a validated scale. This allows statistical tests to be applied in order to assess the likelihood that any differences in response between treatment groups resulted from the active treatment and were not due to chance. 

Studies in patients with dementia sementics have revealed a higher rate of cerebrovascular adverse events, some resulting in fatalities in the active treatment group. 

The dry weights (104 C, 48 hr) of ten plants from each treatment group were taken at the termination of each experiment in order to compare growth effects with plant water status. Dry weight data were analyzed using analysis of variance (ANOVA) and Duncan s multiple-range test. Diffusive resistance and water potential were evaluated using the t-test. Each of these and subsequent experiments was replicated. 

Intent-to-treat All patients randomized to a study therapy. It is intended that they will be treated. Patients are analyzed according to randomized treatment group. 

Much like the previous demographics table example, the majority of the tables generated for clinical trial reporting compare a set of continuous and/or categorical variables across treatment groups. The purpose is to see whether therapy groups are comparable or whether they differ in some way. These kinds of tables include the following ... 

Comparison of Kaplan-Meier survival estimates is often called for in clinical trial analysis. With survival analysis, you are trying to determine which treatment group displays a better time-to-event distribution than another. Part of this analysis is the production of Kaplan-Meier estimates plots that show the probability of a given event over time for each treatment group. In the following example you see that New Drug displays better survival estimates over time than either Old Drug or Placebo. ... 

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