ANZCTR search results

Clinically significant levels of emotional distress and behavioural avoidance are quite frequent after a traumatic brain injury. Interventions with a traumatic brain injured (TBI) population have demonstrated general benefits of group programmes in addressing some of these issues but to date, programs have utilised cognitive behavioural therapy (CBT) as a treatment protocol. At this time, there appears to be no published studies using acceptance and commitment therapy (ACT) with a TBI population. Acceptance and Commitment Therapy (ACT) is one of the ‘third wave’ of behavioural therapies. It aims to change our relationship with internal experiences (thoughts, feelings, memories and physical sensations) so they no longer act as barriers to valued behaviour. The aim of the study is to implement a psychological treatment program to improve psychologically functioning following a traumatic brain injury utilising Acceptance and Commitment Therapy (ACT). With improved psychological functioning it is anticipated that participants will increase their participation in rehabilitation and movement towards a more valued life. The study will be a randomised controlled group treatment programme. Clients of the brain injury rehabilitation unit demonstrating clinically significantly levels of psychological distress will be randomly allocated to either the treatment group or the control group (consisting of an active control based on Befriending protocol). It is anticipated that the treatment will be offered over a two year period. The intervention will consist of six by two hour group treatment sessions offered weekly at the brain injury unit with a one month follow up session. Content of the sessions will be based on ACT theory including identification of values, defusing techniques, self as context and mindfulness. Testing will be undertaken prior to the commencement of treatment and after the one month follow up with brief measures being undertaken weekly at the beginning and conclusion of each treatment sessions relating to motivation and capacity to complete homework tasks. Demographic information will be collected and elicited from the existing brain injury unit database. Participants on the wait list control will be given the opportunity to participate in the intervention after the second outcome measures are undertaken. De-identified data form the outcome measures will be analysed statistically for changes pre and post intervention. De-identified demographic and medical information will provide descriptive data about the participants. Attendance at other therapy appointments in the brain injury unit will be reviewed to measure level of participation.

The objective of the study is to determine the acute neurocognitive effects of a dose of Panax quinquefolius in healthy middle aged volunteers. The Cognitive Drug Research (CDR) computerized assessment battery will be used to evaluate effects of Ginseng on attention, working memory and secondary memory. Mood will also be assessed. Several paper and pencil questionnaires will also be completed which are designed to evaluate state and trait feelings of anxiety and depression and also to asses any symptomatology associated with the extract. Furthermore the neurophysiological effects will be measured using high spatial resolution electrical brain recordings measured by the Steady State Probe Topography technique (SSPT)

Gabapentin is a drug that is officially used to treat chronic pain. This study looks at whether it can help with the more acute pain from having broken bones in the wrist or ankle repaired with screws and plates. This is very painful for a relatively short period and if we find that gabapentin can help with this pain then this could become part of normal treatment.

This study looks at the effectiveness of valproate in combination with interferon alpha in treating relapsed, recurrent or progressive neuroblastoma in children. Who is it for? You can join this study if you are 21 years or younger with relapsed or refractory (stubborn and resistant to treatment) neuroblastoma and you have no other effective treatment options available. Participants will receive treatment with a specific combination of valproic acid and interferon. Valproic acid is an anticonvulsant that has been shown to have an anti-cancer effect. New data has shown that the combination of valproic acid and interferon has an anit-neuroblastoma effect. The study aims to assess the effectiveness of this treatment, and monitor toxicity and side effects.

Background: AGRP is secreted from central part of the arcuate nucleus in the hypothalamus and candidate gene for human fatness, an appetite stimulator peptide and an acute motivator for appetite. It has an effective role on reception and selecting food, weight control and energy homeostasis. The aim of the present study was to investigate the impact of two weight loss protocol on the plasma AGRP in well trained wrestlers. Methods: Thirty trained wrestlers (The mean age of subjects: 24.33+/- 3.33, The mean Body mass index of subjects: 24.90+/-2.38, The mean body fat percentage of subjects:12.92+/-3.01) divided into the two experimental groups and one control group. Experimental group I: Used a 12-day weight loss program with three sessions per week practicing wrestling. Experimental groupII: Used the traditional two-day weight loss program and Sauna (DS) and Control group was without diet. Blood samples (10 cc from-brachial vein) were collected before and twelve hours after doing protocol. Furthermore, subject’s percent of body fat was measured with three point method. The levels of plasma AGRP was measured with special kit using Enzyme-Linked Immunosorbent Assay (ELISA) method. One way analysis of variance (ANOVA) was used for data processing and analysis by spss-16. Results: Both experimental groups have a significant reduction on body weight (p<0.001). D group has a significant reduction on percent of body fat (p<0.05). the plasma levels AGRP in the DS group has significantly increased (p<0.001). Conclusions: However, in aspect of descriptive consequence that traditional method (sauna, restriction food) couldn’t be a suitable method for weight loss. Furthermore, it may have harmful effects on wrestler’s performance, and also increasing of AGRP can be a sign of reduction of muscle glycogen stores. As well, the DS Group of wrestlers was a loss their weight in Non-academic method. This method has a negative effect on their performance. D Group showed a significant decrease in weight but there wasn’t significant increase in plasma AGRP levels. Furthermore, because of no significant change in percent of body fat, the weight loss in traditional method may be due to body dehydration and restriction food intake.

This will be the first time VRS-859 will be administered to humans. The principal aim of this study is to obtain safety and tolerability data from type 2 diabetic patients administered a subcutaneous dose of VRS-859. The study will also provide data on the single dose pharmacokinetics. Assessment of the activity of VRS-859 will be measured by testing fasting plasma glucose (FPG) and response to oral GTTs at selected times post-dose. This combined data will help establish the best dose and optimum dosage regimen for administration to patients. The study design provides an opportunity to evaluate the potential of VRS-859 to be administered monthly to patients that are already on a diet and exercise program with a well established standard of care, metformin. Interim safety assessments of each treatment group (cohort dose) will be made prior to escalating to the next higher dose thus providing additional opportunity to evaluate the overall safety of each dose and to define the safest monthly dose.

Falls are a common occurrence in older people and can have adverse affects on health and independence. It is unclear how best to provide interventions to prevent falls. The primary aim of this study is to evaluate the effectiveness of a hospital based specialist led falls and bone service at reducing the number of falls and number of fallers in a group of community living older people. Our hypothesis is that a hospital based specialist service is more effective at assessing fall and osteoporosis risk and coordinating interventions to prevent falls and treat osteoporosis than enhanced General Practice care.

Brief summary* Abdominal weight gain and insulin resistance (IR) significantly increase the risk of some age related conditions in midlife women, namely cardiovascular disease, dementia and breast cancer. The aim of early intervention in individuals with abdominal obesity and IR when they are still euglycaemic is to prevent progression to type 2 diabetes mellitus and the development of other co-morbidities. We hypothesise that treatment of obese midlife euglycemic women with metformin will result in improved insulin sensitivity (assessed by homeostasis model of assessment (HOMA-IR) and increase in sex hormone binding globulin (SHBG)), weight loss, improved lipid parameters and an increase in adiponectin levels.

The study will determine if AndroForte (R) 5 (testosterone cream) is bioequivalent to Testogel (R) 1% (testosterone gel) for the treatment of men with low testosterone levels. Participants will apply the cream or gel to their torso for 30 days during each treatment period and at the start and finish of each of the treatment periods, participants will provide blood samples at pre-determined time points for the measurement of blood testosterone levels. This study aims to establish that AndroForte (R) 5 is equally effective as Testogel (R) 1% (considered to be the standard comparator for transdermal testosterone worldwide), in increasing the testosterone levels in men with low testosterone to within the normal circulating range.