ANZCTR search results

The study will investigate whether pretreatment with the drug Rosiglitazone attenuates the increase in activity of muscle 11betaHSD-1 following treatment with the potent steroid dexamethasone. Dexamethasone is well known to cause an increase in blood glucose levels in people with type 2 diabetes and we are investigating a possible mechanism for this.

For patients with malignant bowel obstruction that cannot be cured, palliative surgery is often required to relieve the obstruction. This usually requires the formation of a stoma or opening where the bowel is brought to the suface of the skin. An alternative to surgery is the placement of a metal tube or stent through the obstruction to allow the passage of stool. As these surgical interventions are palliative the most important outcomes are those relating to the patients quality of life. This study will determine whether patients' quality of life is greater following stent insertion than surgery to relieve bowel obstruction. It will also compare complication rates and resource utilisation for each intervention. An economic evaluation will determine the relative cost-effectiveness of the 2 procedures.

Australia and other Western communities face an “epidemic of obesity” among its people, particularly in the young. The health problems of obesity include diabetes mellitus, hyperlipidemia, micro- and macrovascular disease, disability and early death. Major public health interventions are required in Australia to reverse this serious and expensive trend. This is particularly true in young overweight women with polycystic ovary syndrome (PCOS) who have significant psychological, reproductive and metabolic consequences during the first five decades of life. Although research indicates that weight loss via dietary restriction can restore health and reverse the reproductive and metabolic consequences of PCOS, there is a lack of scientific understanding of the combined role of physical exercise in managing this condition. Furthermore, there remains no attempt to define the optimal mode of exercise to achieve long-term reproductive fitness and metabolic health and consequently a lack of exercise recommendations for this population exists. The overall significance of this research proposal is to provide scientific evidence for the effects of physical exercise combined with dietary weight loss to improve ovulatory rates and reproductive health in overweight women with PCOS. This study will also provide information on what, if any, is the most efficacious form of exercise for improving reproductive function in this patient group. This information will assist in the development and refinement of guidelines for managing PCOS through lifestyle behavioural change. Precise guidelines would be of great use for firstly improving conception rates through improvements in the metabolic state and secondly through minimising longer term diabetic and cardiovascular mortality and morbidity. Systematic study of the effects of exercise and variants of its modalities in combination with dietary change is imperative in order to make appropriate public health recommendation and to counsel individual patients.

During stabilisation of the shoulder which has been unstable (dislocated) the surgeon attaches back the damaged ligament to the bone with a 'Panalok" suture anchor. This is tied into place with a separate suture made of either panacryl which dissolves or ethibond which does not. The hypothesis is that there is no differenvce between the sutures but the bioabsorbable (dissolving) suture theoretically should be preferred because is disolves away completed and reduces the risk of foreign body reactions. The sutures are dyed the same colour so the surgeon, the patient , the ward staff and outcome assessors are blinded

The study was to assess the efficacy in reducing pain of the addition of a slow soaker infusion of Ropivacaine (a local anaesthetic) compared with a placebo of normal saline via fine catheter placed inside the sholder joint at the end of the operation. The amount of additional narcotic agents and oral analgesics required by the patients was measured between the active and placebo groups. The hypothesis was that the local analgesic did not give better pain relief or reduce the amount of extra analgesics required. In this randomised placebo controlled trial the surgeon, the patient, the ward nurses , physiotherapists and outcome assessor were all blinded to the treatment allocation.

The UCLA shoulder score is used to asess the outcome of rotator cuff surgery in the shoulder. Currently this score is assessed clinically- requiring patients to attend for a doctor's appointment. The hypothesis is that with adequate instruction the patient could complete this form at home and this would increase participation in studies which may follow up patients 10 years later. These patients would not have to travel long distances for a clinical assessment for research purposes only. Patients, assessors 1 & 2 are blinded.

Primary purpose of the trial is to assess the effect of spironolactone on improving heart function, and its ability to reduce the amount of fibrosis (scar tissue) in the transplant heart of patients who have evidence of stiff hearts and therefore likely have increased scar tissue in the hearts. The investigators including cardiologists seeing the participants in the outpatient clinic and performing the cardiac biopsies and coronary sinus blood sampling, nursing staff involved in the heart transplant outpatient clinic, the cardiologists reporting on the Echocardiograms and Cardiac MRI; and the pathologists reporting on the blood investigations will be blinded to the treatment arm that the patient has been randomized into. The research study pharmacist will be performing the randomization from the Pharmacy department at The Alfred Hospital, and records of patient randomization will be stored in a sealed envelope for the duration of the patient's involvement in the trial, but accessible in case it becomes medically necessary (eg for adverse effects) to withdraw the patient from the trial and unblind them.

This Phase IIa trial will assess the safety and tolerability of a topical gel containing 1% R-flurbiprofen, when applied to the skin of subjects with a history of non-melanoma skin cancer. This will be a double-blind, randomised, placebo-controlled trial. All subjects and study personnel will be blinded, except for the person allocating the active or placebo tubes to each subject, based on the randomisation schedule. Thirty subjects will receive the R-flurbiprofen gel, and 10 will receive a placebo gel. The gel will be applied topically once daily, for 28 consecutive days, to the face, ears, neck, forearms and hands. The primary outcome measure will be skin irritation at the site of gel application. Lay statement: This trial will test the safety of a gel when applied to the skin of people who have had at least one non-melanoma skin cancer. A future trial will test if this gel can prevent, or reduce the occurrence of, non-melanoma skin cancer.

The ANZ 0502 (Neo Gem) clinical trial is conducted by the Australian New Zealand Breast Cancer Trials Group (ANZ BCTG) in a number of hospitals in Australia and New Zealand. The trial is for women with newly diagnosed large operable breast cancer or locally advanced breast cancer - which often involves the lymph nodes under the armpit (axillary nodes). Larger operable and locally advanced breast cancers are associated with a poorer prognosis and higher risk of micometastatic disease. Standard treatment for this type of breast cancer usually includes chemotherapy to try to reduce the size of the cancer, followed by surgery and radiation therapy to treat any remaining cancer in the breast. Whilst this treatment is successful in removing the cancer from the breast in the majority of patients, there is a significant risk of the cancer recurring. The treatment in this trial will involve a course of standard chemotherapy (epirubicin and cyclophosphamide) followed by a course of two newer chemotherapy drugs for breast cancer (docetaxel and gemcitabine), followed by surgery. The delivery of chemotherapy prior to surgery offers the potential to substantially reduce the size of primary breast tumours and allow for breast-conserving surgery or surgical resection of previously inoperable tumours. It is hoped to also reduce the risk of recurrence of the breast cancer. The trial includes provision for patients with breast cancer tumours which overexpress HER2, by adding trastuzumab (Herceptin) to the docetaxel and gemcitabine (DGH) treatment cycles in order to maximise the efficacy of all three agents.