ANZCTR search results

The planned studies will evaluate the central-peripheral interactions in cardiac resynchronisation therapy to determine the changes induced by the process and their various roles in modulating overall clinical response in patients with heart failure

Oraxol is a combination of an oral tablet, HM30181 methanesulfonate, and capsules that contain paclitaxel. HM30181 is a drug that helps the body absorb paclitaxel, a drug used to treat cancer. The purpose of this study is to measure the levels of paclitaxel in your blood at different times when given by intravenous (IV) drip (through a vein in your arm) compared to the levels of paclitaxel at different times in your blood when given by mouth (as Oraxol).

This is a first in human trial testing the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of gerilimzumab. Four doses (1 mg, 5 mg, 15 mg, and 30 mg) will be tested in a sequential manner. After the completion of Day 7 at each dose level, a safety monitoring committee will meet and review blinded data to date. They will decide if the study should continue as planned. Only at that time will the next dose level be enrolled. This is a randomized, double-blind, placebo-controlled, single ascending dose study.

This study aims to investigate fat taste preference in a sweet vs. a savoury food and the differences between men and women. 30 males and 30 females (18-50 y, BMI: 18.5-25 kg/m2) will be included in the study. In addition, individual fat taste sensitivity will be measured by two different methods. The study will aid to the contributions of either salt, sugar, and fat on food pleasantness, and the minimum levels that are required for food pleasantness in order to prevent obesity.

This study will investigate whether, in patients receiving breast cancer surgery, pre-operative Propranolol compared with placebo, changes the cancer's gene expression. Who is it for? You may be eligible to join this study if you are a female aged 18-70 years old, have histologically-confirmed breast cancer and will undergo breast cancer surgery at Peter MacCallum Cancer Centre. Study details Participants will be randomly allocated (by chance) to one of two treatment groups. Patients in one group will receive Propranolol for 7 days prior to their scheduled breast cancer surgery while patients in the other group will receive a placebo tablet over the same period. Tablets will be taken two times a day. To determine the results of the study, the researchers will compare blood tests and tumour samples (biopsy and excision samples) obtained before and after administration of the study medication (at the time of surgery). In the samples, the investigators will be looking for the behaviour of specific ‘anti-cancer’ immune cells in the blood and in the tissue surrounding and controlling the tumour. The investigators will also be analysing the immune cells to understand the biological effects of the ‘stress’ that a patient may be experiencing. The information from this study will be presented to clinicians and researchers and will provide very useful information to guide a larger study examining the role of propranolol in all patients receiving breast surgery or in those patients where breast cancer has spread.

Medications recommended to reduce the risk of a subsequent stroke are prescribed after a stroke or Transient Ischemic event (TIA). To gain most benefit, patients need to be able to self-manage these medications. That is; to organize continued supply of these medications with their general practitioner and community pharmacy, to take them as agreed with the prescriber and to be able to communicate any unwanted effects they may experience. The primary aim of this study is to determine if a “patient centred educational exchange” added to usual care improves adherence to prescribed medications for secondary prevention for stroke patients compared with usual care. We have a number of secondary aims to investigate the further impact of this relationship based model of information exchange on sustaining adherence, self-reported medication taking behaviour, clinical outcomes, quality of life, changes in knowledge, beliefs towards medicines and illness and to determine the cost of the model. Patients who have been admitted to the Stroke Unit, Princess Alexandra Hospital, with a diagnosis of stroke or TIA and who are being discharged back to their own home will be approached to participate in this study. Participation in this project will involve completing a questionnaire on three or four occasions. The first will be before the participant is discharged from hospital, the second will take place over the telephone about 3 months after discharge and the third over telephone at 12 months after discharge. The questionnaire will take about fifteen minutes to complete. The questionnaire contains questions related to the participant’s quality of life, the participant’s views of stroke, the participant’s view and opinion of their medicines prescribed to reduce the risk of stroke and questions on the way the participant takes their stroke prevention medications. The telephone interviews will also ask questions about GP and Hospital visits, perceived medication related problems, Blood Pressure and Cholesterol results if known. About half of the participants in this study will be chosen (by randomisation) to have a longer interview with the researcher before discharge from hospital. This will be a conversation about the participants’ stroke medications. These participants will also be contacted by telephone approximately ten days after discharge from hospital. The telephone call will involve the same questionnaire, a conversation about their stroke medications and an opportunity to follow-up on any questions the participants’ may have about their medicines.

The project aims to evaluate the acceptability and clinical efficacy of the online Health Anxiety Program; and to examine the moderators and mediators of change during the Health Anxiety Program. Up to 60 people with Health Anxiety will be randomly assigned to either the active treatment group or a control group which receives psychoeducation about anxiety in the form of 6 brief fact sheets. The treatment group will commence the Health Anxiety program immediately, whereas the control group will commence once the treatment group has completed. The efficacy of the Health Anxiety program will be determined by comparing the health anxiety severity levels of the two groups at the time the treatment group completes treatment. Mediation analyses will be used to explore the role of variables that may influence positive change (such as changes in behaviours, catastrophic thinking, hypervigilance and intolerance of uncertainty)

Amnestic mild cognitive impairment (a-MCI) is believed to represent a transition period between normal aging and Alzheimer's disease. People with a-MCI experience problems with their memory without it impacting on their daily functioning. As a-MCI represents a stage prior to irreversible neurodegeneration, it is important from a therapeutic perspective that neural changes occurring in a-MCI are determined in order to see if there remains potential for response to treatment. Neuroplasticity refers to the brains ability to re-organize its function in response to the environment. One aspect of this is known as long-term potentiation (LTP), which is imperative in learning and memory. LTP-like plasticity can be induced through brain stimulation techniques including transcranial direct current stimulation (tDCS). Application of tDCS through a gentle electrical current can increase brain activity as measured through electroencephalography (EEG) and behavioural outcomes. When transcranial magnetic stimulation (TMS) is applied in combination with EEG, the cortical excitability of the stimulated and surrounding brain regions can be determined. This provides information about the LTP-like plasticity that is present. Recent evidence has shown that spaced application of tDCS may be more beneficial in enhancing cognitive performance and neural plasticity compared to only a single session. Therefore the aim of our study is to investigate whether LTP can be induced in a-MCI and if there are differences in LTP-like plasticity and cognitive performance with spaced application of tDCS compared to a single active tDCS condition.

This is a Phase IIa, randomized, double-blind, placebo-controlled crossover study to evaluate the efficacy and safety of oral CMX-020 in subjects with lumbosacral radiculopathy (sciatica).

Sacroiliac Joint Dysfunction (SIJD) and Pregnancy Related Pelvic Girdle Pain (PRPGP) can be grouped together under the heading of ‘Pelvic Girdle Pain’ (PGP) which makes up part of the generic ‘Low Back Pain’ (LBP) group. As a main pain source it is reported to account for between 10% and 30% of all nonspecific LBP. The cost to an industrialized country, from PGP, is significant (USA alone in the region of $10 to $60 billion a year). Treatment for SIJD and PRPGP tends to encompass either/and pain relieving modalities (acupuncture, pain medication, use of pillows and belts) and exercise. The overall evidence on the outcome of these modalities is poor. The use of pelvic belts has developed from biomechanical studies that have shown that the external forces from a belt can help increase the ‘force closure’ of the pelvis. Another important aspect is the position of the belt with greater stability being produced on the pelvis with the belts being positioned higher, just below the anterior superior iliac crests, as opposed to the symphysis pubis. The product being investigated is the SpineCor SI Brace (SSIB). The SSIB consists of a unique design of compressive shorts with an integrated belt that allows a variable amount and direction of compression to be applied to the pelvic girdle. It was felt that a more comfortable and biomechanically effective design could help this patient group. The hypothesis of this study is that the use of the SacroFix brace will result in a reduction in pain and disability and an improvement in the emotional state of patients suffering with pelvic girdle pain.