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Over 3000 patients with high-risk breast cancer have now been treated in randomised studies and most of these studies show a modest benefit for the high-dose arm in preliminary analyses.
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Study design: 63 patients were treated in a randomised controlled trial of escalating interferon dose.
With a single dose of rizatriptan (10 mg), naratriptan (2.5 mg) and placebo, 522 migraine patients were treated in a randomised, double-blind parallel group study (double-dummy) [34].
Almost 700 migraine patients were treated in a randomised, double-blind four-period cross-over study with a single dose of 0.25, 1, and 2.5 mg naratriptan as well as placebo [55]; however, the study was evaluated regarding efficacy as a parallel group comparison (sample size estimation: 125 per group).
Six patients (three women and three men) with acquired GHD were treated in a randomised cross-over trial with GH (subcutaneous injections of GH 0.03 IU/kg/daily) or IGF-I (continuous subcutaneous infusion of 5 μg/kg/h recombinant IGF-I) for 5 days.
When using RPA analysis criteria, we found that the median survival times and 2-year survival rates of RPA III, IV and V classes in the current study compared favourably with patients in the RTOG databases who were treated in a randomised trial in the early 1990s (Table 4).
A total of 204 patients were treated in the randomised phase II trial (ClinicalTrials.gov Registration: NCT00410826) between December 2006 and October 2011, with 105 patients enrolled in the standard arm (cisplatin-radiation) and 99 patients enrolled in the experimental arm (cisplatin-radiation with erlotinib 150 mg daily; Martins et al, 2013a).
Patients with a histologically confirmed diagnosis of previously untreated, operable, and measurable primary breast cancer (tumour (T), nodes (N) and metastases (M) score: T2-3(≥ 3 cm) N0-2 M0) were treated in a prospectively randomised trial with four cycles of dose-dense (bi-weekly) doxorubicin and docetaxel (ddAT) chemotherapy, with or without tamoxifen, prior to surgery.
Those randomised to the manipulation package were further randomised to be treated in NHS or private premises, to allow the effect of treatment location on outcome to be measured.
The first group comprised people from Northeast Scotland that had been treated for melanoma and had participated in a randomised trial of GP-led follow-up for melanoma.
During the period when patients were treated, many patients were encouraged to participate in randomised trials, which also resulted in heterogeneous treatment strategies.
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