ANZCTR search results

Melanoma is the least common but the most life-threatening of all skin cancers, accounting for only about 4% of all cases but causing 79% of skin cancer deaths. Whilst early stage melanoma can be successfully treated by surgical removal, few effective treatments exist for melanoma which has progressed to a later stage. The purpose of this study is to investigate the effect of Coramsine® in patients with late stage melanoma as well as evaluate the safety and tolerability of the drug. Also, the effect of Coramsine on Progression Free Survival will be assessed (this is defined as the length of time during and after treatment that the cancer does not grow and includes the amount of time patients have experienced a complete response or a partial response, as well as the amount of time patients have experienced stable disease).

The low dose Sertraline Heart Study is a 3 month study evaluating improvements in energy, stress and well-being with very low dose Sertraline in patients with stable heart disease. Associated benefits may include improved sleep, weight and blood pressure. Being a serotonin reuptake inhibitor, we are also interested to monitor improvements in anxiety and mood, which have never been evaluated at this very low dose before. Half of the participants will receive 'blank' or placebo capsules. There are 4 visits to the study centre over the 3 months, at which symptoms will be monitored. Blood tests are undertaken initially and at 6 weeks. Subjects, Research Assistant and Medical Director are all blinded.

Patients undergoing cardiac surgery administered aprotinin will be enrolled. Patients will be randomised to receive a pre-operative heaprin infusion or placebo. A lung biopsy will be taken to determine if pre-operative heaprin prevents the development of microvascular thrombosis in the lungs. Hypothesis. Heparin prevents the formation of blood clots in the lungs following cardiac surgery. The patients enrolled, the therapists and the data collectors will all be blinded.

Docosahexaenoic Acid (DHA) is a long chain omega 3 polyunsaturated fatty acid which is important for growth and development. DHA also plays an essential role in the development of the central nervous system and retinal function in infants. Preterm infants are denied the large amount of DHA which is normally delivered via the placenta in the last trimester of pregnancy. The DINO trial is a multi-centre, randomized controlled trial to determine whether increasing the level of DHA in breast milk will improve the developmental outcome of preterm infants who are born less than 32 weeks gestation. Study participants, clinicians and trial personnel will be blinded to treatment allocation.

Chronic graft vs host disease (cGVHD) can affect a number of target organs following bone marrow transplantation. In such cases, numerous combinations of immunosuppressive drugs are used to try and control the cGVHD. Often these drugs are not particularly successful yet patients may need to remain on quite intensive immunosuppressant therapy in the long term. The aim of this study is to see whether the drug rituximab (also called mabthera) is effective in improving cGVHD in these patients so that the dose of immunosuppressant drugs can be reduced. Rituximab reduces the number of a type of white cell called B lymphocytes which may be over active in patients with cGVHD. Small studies overseas have shown that some patients with GVHD have responded very well to rituximab. This study is designed to treat a larger number of patients so we can more clearly define the value of this treatment.

Total knee arthroplasty (TKA) is a common, successful and safe operation for people who have end-stage knee arthritis. Pain-free knee flexion or bend of 135 degrees or more with stability is the goal of TKA. There are substantial improvements in pain and function. However, a major problem that persists is that patients do not consistently achieve knee flexion or bend greater than 110 degrees. The need to improve surgical technique and prosthetic designs to provide better flexibility and function is therefore essential. Many designs are available and currently in use. This study involves the use of one of these designs; the Profix Total Knee System (Smith & Nephew, Inc.). This system gives the surgeon the option to implant the prosthesis onto the leg using either increased flexion or standard instruments. The instruments are used by the surgeon to ensure accurate placement of the prosthesis. The objective of this study is to compare knee flexion range of motion (ROM), pain and functional outcomes of patients after primary TKA with the Profix Total Knee System. The primary hypothesis is that patients who have Profix TKA’s implanted by the surgeon with increased flexion instruments will achieve significantly greater knee flexion than those implanted with standard instruments. The secondary hypothesis is that this increased knee flexion will allow improved functional ability with less pain and as a result better quality of life. The trial is a double blind study with patients, assessors and data analysts blinded to group allocation

The aim of the study is to test two new drug treatments for mild to moderate Alzheimer's disease. Subjects and assessors are both blind to treatment allocation.

The aim of this research project is to examine the feasibility of implementing work-site based exercise training as a means of improving physical fitness and 'work-ability’ in older workers. This pilot project is a necessary first step to demonstrate ‘proof of concept’ in order for industry to commit funds for a larger trial. This project will test response to treatment and treatment effect size.

The purpose of this study is to determine the effectiveness of concentrated intranasal naloxone compared to intramuscular naloxone for treatment by paramedics of respiratory depression due to suspected opiate overdose in the pre-hospital setting. Subjects are unconscious prior to study enrolment, and consent from individuals for study participation is not required.

TENS is a therapeutic non-invasive modality mainly used for pain relief by electrically stimulating nerves via skin surface electrodes. TENS with electrodes over the lower back have also been used successfully to treat the overactive bladder to improve frequency and urgency of urination in patients. The association of treatment for faecal incontinence and urinary incontinence is evident in Sacral Nerve Stimulation (SNS). Based on clinical observation of effect of stimulation on the function of the anus and rectum in urology patients, SNS has been applied in patients with faecal incontinence. The concept is to enhance the activity of the anal muscles via the electrical stimulation of their nerve supply. The usefulness of SNS in faecal incontinence has been confirmed in a number of studies. However, SNS is an invasive procedure. It requires surgery under general anaesthesia to implant a permanent impulse generator under the skin. TENS with electrodes stimulating the same sacral nerves may result in similar benefits. Our hypothesis is that the use of TENS in patients with faecal incontinence may have a therapeutic effect. The advantage of this technique is that it is non-invasive, simple, and cost-effective and has minimal side effects.