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Phase II CPT-11, LV and 5FU in Gastric Cancer
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A randomised phase III trial evaluating the efficacy of more intensive written information in patients having radical radiation therapy.
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Early PN trial
Expand descriptionWhen a critically ill patient cannot tolerate feeding delivered into the stomach, a special feeding solution (parenteral nutrition) is commonly given directly into the blood stream (intra-venous) to feed the patient. A recently published review of the literature suggested that lives could be saved if intra-venous feeding was provided earlier (within 24 hours of intensive care unit (ICU) admission) than it is currently provided. Because intra-venous feeding may be more expensive than standard care, we plan to conduct a multi-centre randomised controlled trial comparing the effects of early intra-venous feeding to standard care in patients who require at least two days of care in the intensive therapy unit. The trial will show whether earlier intra-venous feeding improves survival, reduces hospital length of stay and improves other measures of the patient's severity of illness.
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Understanding the role of self-management education in the rehabilitation of patients with chronic obstructive pulmonary disease.
Expand descriptionMethod: A randomised trial with allocation concealment, assessor blinded to group allocation and intention-to-treat analysis was conducted. Two hundred and sixty-seven people with COPD [mean age 72(9) years, FEV1 59(23)% predicted] were allocated to receive either eight weeks of twice-weekly group exercise training plus education or exercise training alone. Education was disease specific with a self-management focus. Primary outcome measures included six-minute walk distance and Chronic Respiratory Questionnaire. Secondary outcomes included dyspnoea, health behaviours, generic health related quality of life, self-efficacy, and healthcare usage with measurements taken immediately following completion and at six and 12 months. Results: There were no significant differences that indicated greater improvement in any health outcome with the addition of education. The two intervention groups had similar significant improvements immediately following intervention, and these were maintained comparably in the subsequent 12 months. Conclusions: The results of this investigation suggest that disease-specific group education is not an essential component of pulmonary rehabilitation. Pulmonary rehabilitation based on exercise training is an effective option in the management of patients with COPD if multidisciplinary education cannot be offered.
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VMCL
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ECF Gastric Study
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Oesophageal Trial
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Sandostatin LAR in HCC
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Mifepristone ovarian function study
Expand descriptionThe aim is to determine whether the administration of mifepristone alone or in combination with ethinyl oestradiol will effect the contraceptive efficacy of Implanon whose main mode of action is ovulation suppression and a secondary effect on cervical mucus making it impenatrable to sper. Both the treaments we will use have been shown to have a beneficial effect on bleeding patterns in women using progestogen-only contraceptive methods. Bleeding problems are the major reason for women discontinuing these highly effective contraceptives.Eligible women will be randomised to either mifepristone followed by 4 days of placebo or mifepristone followed by four days of ethinyl oestradiol. Women will undergo vaginal ultrasound to assess follicular size, assessment of cervical mucus quality and have blood taken for serum levels of oestradiol and progesterone 2 days before commencing treatment, on the third treatment day, 6 days after starting treament and then twice weekly for 3 weeks. Women will be required to use condoms for the duration of the study.
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Double-blind, Double-dummy, Randomised, Parallel-Arm Equivalence [Non-Inferiority] Study Comparing Hydromorphone Hydrochloride Extended-Release [HHER] Capsules to MS Contin Tablets, Dosed at a Ratio of 1:7.5 to relieve pain, in Cancer or Non-Cancer Patients with a History of Moderate to Severe Pain
Expand descriptionThis is a double-blind, double-dummy, randomised, parallel-arm controlle trial of HHER and MS Contin in patients with a history of chronic moderate to severe cancer or non-cancer pain.