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In vivo effects of a natural medicine formulation on human immune function
Expand descriptionTablets were self administered by the participants for 14 days. Blood samples were drawn for laboratory analysis and safety measures (full blood count, liver function tests and serum urea, electrolytes and creatinine). Baseline blood was drawn for laboratory measures of study parameters at day 1, day1+3hours, day 13 and day 14. Blodd measured for Ex vivo blood tests Ex vivo blood analysis includes the assessment of changes in the following lymphocyte subsets: ÿ¿ÿ· Mature T cells ÿ¿ÿ· B cells ÿ¿ÿ· Helper/Inducer T cells ÿ¿ÿ· Suppressor/Cytotoxic T cells ÿ¿ÿ· Natural killer cells Assessment of changes in non-specific immune response includes: ÿ¿ÿ· Phagocytosis of granulocytes ÿ¿ÿ· Respiratory burst of granulocytes Assessment of changes in specific immune response includes: ÿ¿ÿ· Lymphocyte activation ÿ¿ÿ· Production of the following 6 cytokines: o IL-2, INFa and INFg for type 1 immune response o IL-4, IL-5 and IL-10 for type 2 immune response
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Indicated Prevention of Psychotic Disorders with Low-dose Lithium
Expand descriptionTo investigate whether low-dose lithium is an effective agent in indicated prevention amongst subjects at ultra-high risk of developing a psychotic disorder. This aim will be achieved by treating a high-risk patient population with low-dose lithium (450mg/day) and investigating its effects using clinical, neuropsychological, neuroimaging and cell biological approaches. We will recruit 30 patients considered to be at ultra-high risk of developing a first psychotic episode, currently receiving treatment at the Personal Assessment and Crisis Evaluation (PACE) clinic in Melbourne, Australia. PACE criteria for identifying patients at high risk include subjects with a family history of psychosis and a decrease in functioning (30% GAF) AND/OR attenuated psychotic symptoms AND/OR brief psychotic symptoms (BLIPS) resolving without treatment. Patients who give informed consent will receive treatment with a slow release form of low dose lithium for a period of a year, plus supportive therapy. Patients who do not consent will receive supportive therapy only. Assessments will be conducted at baseline, twelve weeks and one year post-recruitment. Assessments will include cognitive functioning, structural MRI, 1H-MRS at 3Tesla and cell biological parameters (bcl-2, AP-1; NIMH, Washington DC). In addition, all patients will be seen on a monthly basis for a clinical interview, covering psychopathology, global functioning, and quality of life.
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The ENERGII Trial
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The acute effects of sandalwood oil and Massage on physiological and psychological parameters
Expand descriptionA randomised non-blinded study was conducted over 4 weeks using a two-step factorial design aimed at obtaining pilot data on the acute effect of essential oils alone and in combination with a back massage on a range of physiological and psychological parameters. The two factors were essential oil and massage. Four conditions were investigated in each participant: sandalwood oil applied with no massage, tea tree oil applied with no massage, sandalwood oil with massage, and tea tree oil with massage. In all cases 10mL of oil composed of 2.5mL active oil and 7.5mL almond oil were rubbed onto the participantÿ¢ÿ¿ÿ¿s back over a five-minute period. Participants then lay supine or were massaged for 30 minutes after the application of the oil. Waking state was maintained over the duration of the treatment. A convenience sample of 15 healthy subject volunteers between 18 and 65 years was recruited and each subject acted as their own control and was tested on all four conditions. Physiological and psychological outcome measurements were taken pre and post each treatment session. Physiological measurements included change in blood pressure, heart rate, skin temperature, oxygen saturation and galvanic skin response. Psychological outcome measurements comprised a self-assessment of well being using 11 parameters, 6 negative and 5 positive.
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A study to investigate the effect of taking CoenzymeQ10 supplements on abnormal artery blood vessel function in people with Type 2 diabetes who are on best-dose treatment with statin medication.
Expand descriptionNot applicable
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Effects of acute oxygen therapy on cognitive and driving performance in hypoxaemic COPD.
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Meal Replacement Study
Expand descriptionMean (± SEM) weight loss adjusted for baseline values was significantly greater in the meal replacement group (n=20) than the control group (n=21) at three months (4.7± 0.8 vs 1.3 ± 0.8 kg, P=0.007) and at six months (5.0± 5.2 vs 1.5± 5.2 kg, P=0.04) (Figure 1). The reduction in waist circumference was 1.4 cm greater in the meal replacement group than the control group at six months, but this difference was not significant. BMI reduced by 1.8kg/m2 in the meal replacement group and by 0.6kg/m2 in the control group (P=0.05).
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Second generation intervention research in the pre-psychotic phase of illness in schizophrenia and related psychoses
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Safety of Tramadol in Breastfeeding
Expand descriptionIn this study we wish to find out how much of the pain relieving drug tramadol, given to women after caesarean section, passes into breast milk. The information will be used to inform lactating women about the risk versus benefit of taking tramadol during early breast feeding. Tramadol has been used overseas for many years but only became available in Australia in 1998. It is now widely used in the treatment of many types of pain and is particularly useful after surgery. There is very little information about the transfer of tramadol and its break-down products into breast milk. One study looking at a single dose of tramadol suggests single doses are unlikely to be a problem, but there is not enough information to be certain about the safety of tramadol for new-born babies when mothers who are breast feeding are taking repeated doses. If the infant was affected in any way this would probabvly be seen as sleepiness, floppiness and poor feeding. We aim to obtain iformation about how much tramadol passes to the breast feeding infant and be able to advise about the likelihood of significant adverse effects. 75 women taking oral tramadol regularly (100 mg every 6 hours)for postoperative pain control will be recruited after removal of their patient controlled epidural analgesia device, usually on day 3 post caesarean section. Breast milk samples will be taken just before the fourth dose and in between the 4th and 5th doses along with a single blood sample. The milk and blood sample will be sent to the laboratory to measure the amount of tramadol and its break-down product. The baby will also be assessed afte the 4th dose for tone and alertness.
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A multicentre randomised clinical trial of laser treatment plus intravitreal triamcinolone for diabetic macular oedema (Thunderbird)
Expand descriptionEach study sites will apply for their own ethics approval from their local ethics committee. All study sites have been granted approval.