ANZCTR search results

Older people with depression have higher plasma concentration of a chemical called homocysteine than non-depressed older adults. The use of some vitamins of the B group are effective in reducing the plasma concentration of homocysteine. We designed this trial to determine if the use of adjunctive treatment with B-vitamins improves the efficacy of antidepressant treatment for people aged 60 years or over.

Investigating possible causes or predictors of adverse pregnacy outcomes.

to Assess the Safety and Clinical Activity of Intravenous Combretastatin A1 Diphosphate (OXi4503, CA1P)

This study looks at the feasibility and potential benefits of exercise for women undergoing primary treatment for ovarian cancer. Who is it for? You can join this study if you have ovarian cancer and you are about to start your first or second cycle of adjuvant or neoadjuvant chemotherapy (a treatment given in addition to surgery to try to prevent a cancer from coming back) and if you live within approximately 30kms of Brisbane CBD. Trial details Participants will take part in a specially-designed exercise program, which includes low to moderate intensity walking, for around 30 minutes daily, over 18 weeks of chemotherapy. It will measure chemotherapy completion rates, fatigue, physical function and distress. Participants will be required to complete two questionnaires to measure these. Approximately 36% of women do not complete adjuvant chemotherapy for ovarian cancer due to treatment side-effects, in particular fatigue. Incomplete chemotherapy may result in poorer survival. In other cancer groups, exercise programs are effective for increasing functional capacity, relieving fatigue, distress and extending survival.

Clinical trial objective is to show evidence that Information and Communication Technology (ICT) enabled home-based care process of cardiac rehabilitation patients provides equally good or better outcomes than traditional hospital based rehabilitation processes not using ICT tools. The trial will potentially provide evidence that the new process is equally or more cost effective than traditional rehabilitation process.

Today, there are approximately 800 patients with kidney transplants at the Royal Adelaide Hospital and The Queen Elizabeth Hospital combined. Bone density decreases both before and after transplantation. Fracture prevalence after kidney transplant is between 7 and 60%, with fracture risk up to four times higher in this group when compared with the normal population. Potential causes for low bone density and an increased rate of bone loss are: Hyperparathyroidism (overactive parathyroid glands). This can occur as a consequence of poor vitamin D levels. If this persists, the parathyroid glands may become permanently overactive leading to elevated parathyroid hormone (PTH) levels. Poor calcium absorption from the gut. Low Vitamin D levels. Drugs which prevent transplant rejection, particularly prednisolone. Hyperparathyroidism is of particular interest in this study, as it is a common finding in patients after kidney transplant. In these patients it has been associated with increased rates of bone loss as measured by markers of bone turnover and decreased bone mineral density. Moreover it is well established that in healthy elderly adults, increased markers of bone turnover is a risk factor for fractures. Postmenopausal women are known to have an increased rate of bone loss and have a mildly increased PTH level compared to premenopausal women. Previous studies showed that an oral calcium supplement reduced hyperparathyroidism and bone loss in this group. Based on these findings in postmenopausal women, and the need for better evidence based management of bone disease in kidney transplant patients, we will study the effect of an oral calcium supplement in patients with kidney transplants. We predict that supplemental calcium will be a simple, well-tolerated and safe treatment to help maintain bone health in these patients.

Most preterm babies have the umbilical cord clamped within 10 seconds of birth. Placental transfusion is a simple way of giving the baby extra blood at birth by (1) delaying the clamping of the umbilical cord by up to 60 seconds or (2) milking the contents of the umbilical cord into the baby after birth or (3) both methods combined. There is promising evidence from randomised trials that placental transfusion in babies less than 37 weeks of gestation may improve their blood pressure, reduce the number of blood transfusions needed and decrease bleeding into the brain, bowel disease and infection. However, we do not know if babies born before 30 weeks of pregnancy benefit or if placental transfusion increases or decreases death or childhood disability. Despite this uncertainty more doctors are recommending that all preterm babies are given a placental transfusion at birth. It is important to find out if placental transfusion does more good than harm. The Australian Placental Transfusion Pilot Study will enrol up to 100 women who will give birth to babies less than 32 weeks of pregnancy. These participants will be randomly assigned to 4 methods of cord clamping. The 3 mentioned above compared with standard treatment which is to clamp the cord within 10 seconds of birth. The main research question of the pilot study is whether haemoglobin concentration in the first few hours after birth is greatest in babies with which placental transfusion method.

This study looks at treatment with the drug Cediranib, in patients who have advanced or metastatic lung cancer. Who is it for? You can join this study if you have advanced or metastatic non-small cell lung cancer. Trial details: Participants will be randomly divided into two groups. Both groups will receive intraveneous chemotherapy treatment. The first group will also receive the new drug Cediranib. The second group will receive a dummy (placebo) treatment. Both groups will receive the chemotherapy drugs Paclitaxel and Carboplatin. This will be administered intraveneously once every 3weeks. The number of cycles will be determined by the physician. No more than 6 cycles will be administered. The group receiving the drug Cediranib will receive a daily dose of 20mg, administered orally, in addition to the chemotherapy treatment. The group receiving the dummy treatment will receive a daily dose, administered orally, in addition to the chemotherapy treatment. The study aims to see whether combining the drug Cediranib with chemotherapy treatment, compared with chemotherapy alone, improves overall survival rates. The study also looks at quality of life.

Chronic Kidney Disease (CKD) is associated with increased cardiovascular morbidity and mortality. Addressing traditional cardiac risk factors in this population does not ameliorate the disease burden to the same extent as the background population. As such, novel risks are being explored. Vitamin D is now recognised as having pleiotropic roles beyond bone and mineral homeostasis. The vitamin D receptor is found in almost all human tissues, and whilst it was once thought that only the kidneys metabolised vitamin D to its active form (calcitriol), other tissues (such as peripheral blood mononuclear cells, PBMCs) are recognised as possessing the metabolising enzyme, raising the question of whether vitamin D effects are in part an auto/paracrine response, highlighting the importance of precursor availability. Approximately 50% of patients with CKD stage 3 are vitamin D insufficient (measured as the serum precursor calcidiol). They have increased circulating inflammatory cytokines and are often sub-clinically insulin-resistant. These factors are known to be associated with cardiovascular risk, and are integrally linked. Indeed, Interleukin-1beta (IL-1b), Interleurkin-6 (IL-6)and Tumour Necrosis Factor alpha (TNFa)have been associated with pancreatic Beta-cell apoptosis, and diminished cellular insulin processing. In experimental models vitamin D can reduce the activation of the pro-inflammatory transcription factor Nuclear Factor-kappaB in various cell lines, and in isolated PBMCs vitamin D decreases production of IL-6 and TNFa. In vitro studies also suggest vitamin D may improve insulin receptor substrate phosphorylation and GLUT 4 translocation in skeletal muscle, together with direct effects on the pancreatic Beta-cells. Lastly, recent animal studies have implicated the vitamin D responsive bone protein osteocalcin in glucose metabolism, possibly through promotion of adiponectin production, an adipokine with known beneficial glycaemic properties. This double-blinded trial will assess the benefit of vitamin D supplementation in early CKD to raise circulating calcidiol and improve insulin resistance, possibly through reduced inflammatory burden. Patients will be randomised to either vitamin D3 2000IU/day or placebo for 6 months. At baseline and end-of-study a hyperinsulinaemic euglycaemic clamp study will be performed to assess peripheral insulin response and correlation with PBMC NF-kappaB activity and circulating inflammatory burden (as quantified by IL-1b, IL-6, TNFa, known gene products of NF-KappaB). Osteocalcin, adiponectin and markers of bone turnover will also be assessed.

Fluid resuscitation is widely used in the management of critically ill patients. There are a variety of different fluids available to doctors but there is little evidence regarding how effective they are which means that doctors often have little information on which to base their decisions regarding what fluid to choose. One of the most commonly used fluids in the world, a hydroxyethyl starch was recently approved by the Therapeutic Goods Administration for use in Australia. This project aims to compare how effective and safe this fluid is compared to another widely used fluid, saline, for resuscitation of critically ill patients admitted to intensive care units.