Clinical trials evaluation

Collaborative Working Group on Clinical Trial Evaluations (USA), J. Clin. Psyehiatry, 59 (Suppl 12), 3 (1998). 

Finally patients who fail standard treatment for metastatic colorectal cancer should be encouraged to participate in a clinical trial evaluating new treatment approaches for this incurable disease. Table 88-5 lists options for first- and second-line... 

Physical exercise as a treatment for clinical depression has not been studied as extensively as dmgs or psychotherapy, but there are a number of clinical trials evaluating its effectiveness.41 In some of these studies, exercise was compared to no treatment at all. In others, it was compared to psychotherapy, medication or attention-control procedures intended to control for the nonspecific placebo aspects of the exercise programme. Some of the trials also looked at the combination of physical exercise with... 

Fisher B, Costantino J, Redmond C, Poisson R, Bowman D, Couture J, et al. (1989) A randomized clinical trial evaluating tamoxifen in the treatment of patients with node-negative breast cancer who have estrogen-receptor-positive tumors. N Engl J Med 320(8) 479—484... 

In our review of the available data, concurrent gemcitabine and radiation possesses high activity in the treatment of advanced cancers of the head and neck. Unfortunately, the toxicity of this combination also appears to be significant. Strategies to reduce toxicity are needed in future clinical trials evaluating this combination. 

Li, Chines and Meredith (2004) quote three clinical trials evaluating the effectiveness of alendronate, risedronate and raloxifene in increasing BMD and reducing fracture risk in osteoporosis. These treatments are seen to reduce fracture risk by similar amounts 47 per cent, 49 per cent and 46 per cent respectively, yet their effects on increasing BMD are somewhat different 6.2 per cent, 5.8 per cent and 2.7 per cent respectively. Drawing conclusions on the relative effectiveness of these treatments based solely in terms of the surrogate BMD would clearly be misleading. 

Several clinical trails are reported with curcumin in cancer patients around the world. Some of our recent review [Anand et al., 2008 Goel et al., 2007 Kunnumakkara et al., 2008] gives a detailed description of the clinical trials with curcumin, which are summarized in Table 16.2. An early clinical trial evaluated the effectiveness of topical application of a curcumin ointment in patients with external cancerous lesions. Patients with cancers of oral cavity (37 patients), breast (7 patients), vulva (4 patients), skin (3 patients), and miscellaneous unspecified sites (11 patients) were enrolled in this study. Remarkable symptomatic relief was observed in this study with the reduction in smell in 90% of the cases, reduction in itching in almost all cases, and reduction in exudates in 70% of cases. Reduction in lesion size and pain was observed in about 10% of the cases and only one melanoma (scalp) patient showed an adverse effect of local itching, which may be due to the allergic reaction to curcumin. 

Randomized clinical trials evaluating glycoprotein Ilb/IIIa inhibitors in different clinical settings. 

The clinical utility of this approach will depend on the results of these initial clinical trials evaluating l7(3-estradiol and the outcomes of current DESs in higher-risk patients, Speculations about the clinical results are that an improved healing and re-endothelialization, although not completely abolishing neointima formation, will allow a controlled... 

Elliott, G.T., McLeod, R.A., Perez, J., von Eschen, K.B. Interim results of a phase II multicenter clinical trial evaluating the activity of a therapeutic allogeneic melanoma vaccine (theraccine) in the treatment of disseminated malignant melanoma. Semin Surg Oncol 9 (1993) 264-272. 

Many studies evaluated the use of topical NSAIDs in preventing CME after cataract extraction. Studies found consistent benefits in prevention of CME with administration of 0.5% ketorolac tromethamine, 0.03% flurbiprofen, and 0.1% diclofenac. A meta-analysis of 16 randomized clinical trials evaluating topical NSAIDs for prevention of CME found that NSAID use was beneficial in reducing the incidence of both angiographically evident and clinically relevant CME. 

Idraparinux is an analog of fondaparinux that has a very long duration of effect (see Table 19-6) and has been developed to be administered once weekly by subcutaneous injection." Idraparinux is currently undergoing phase III clinical trials evaluating its utility for both the acute and long-term management of VTE." ... 

I Adverse Effects. While all agents are effective in suppressing PTH levels, they differ in the degree to which they cause other metabolic abnormalities. Adverse effects of note with vitamin D therapy in patients treated for sHPT include hypercalcemia and hyperphosphatemia. Differences in calcitriol and vitamin D analogs have been demonstrated in animal studies and in clinical trials evaluating the effect on reduction of PTH while minimizing the risk of these adverse consequences. 

Approximately one-fifth of patients with SAD also suffer from an alcohol use disorder (AUD). Many people with SAD report that they use alcohol to cope with their anxiety. Most clinical trials evaluating... 

Each of the collagen-vascular diseases has its own recommended form of therapy. For most of these diseases, there are few well-controlled clinical trials evaluating pharmacotherapy. Treatment of most of these diseases requires anti-inflammatory or immunosuppressive drugs. Monitoring therapeutic outcomes is essential because drugs and drug doses may need to be modified frequently. 

Two concurrent clinical trials evaluated the use of SRL in kidney transplants. All patients in both studies received CSA and steroids and were randomly assigned to one of three groups. The U.S. trial compared patients randomly assigned to receive SRL in a fixed dose of a 6-mg loading dose followed by 2 mg daily (I), a fixed dose of a... 

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