ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31383 results sorted by trial registration date.
  • HepaFatTM Scan for the non-invasive measurement of liver fat using magnetic resonance imaging

    This will be a retrospective study using existing demographic, clinical and MRI image data to develop HepaFatTM Scan, a non-invasive tool to quantify liver fat.

  • Study of the outcome of patients with myeloma nephropathy on treatment with High Cut Off Haemodialysis (HCO-HD) in addition to chemotherapy at the Launceston General Hospital

    Light chain myeloma commonly associated with renal failure. Therefore, it is important to preserve the renal function early by applying high cut off haemodialysis. It is worthwhile to asses the effectiveness of the combination of high cut off haemodialysis (HCO-HD) in addition of chemotherapy We are aiming to increase the awareness of this new treatment and also to document the results of the patients received this treatment in the last few years until end of next year.

  • Balanced fluid therapy and early kidney function in patients undergoing renal transplantation

    Background: Fifty people die every day in Australia with kidney related disease with recent data from December 2009 showing that 1,105 of the 10,341 people receiving dialysis (11%) were on the renal transplant waiting list. Only about 6% receive a transplant each year and when patients present for transplantation, intravenous fluid therapy is critical to ensure optimal graft perfusion and function. Fluid therapy is important to maintain intravascular volume during and after kidney transplantation whilst avoiding metabolic and electrolyte disturbances which may further compromise graft function. Traditionally normal saline (NS) or potassium-free fluids are the IV fluid therapy of choice in the perioperative period for patients undergoing kidney transplantation. The rationale for using NS is the avoidance of the administration of large volumes of potassium which is present in small concentrations in Plasmalyte solution (5mmol/L). The potassium contained in Plasmalyte solution may contribute to hyperkalemia although current evidence suggests that balanced fluid solutions may confer clinical benefits over NS as the administration of large volumes of NS has been strongly associated with the development of hyperchloremic metabolic acidosis which in turn may cause hyperkalemia through an extracellular shift of potassium. Study rationale: There are very few studies comparing the different types of crystalloid fluids that patients receive when undergoing renal transplantation. In order to prevent delayed graft function it is common for patients to receive 4 to 8 litres/day of crystalloid therapy per day to maintain sufficient intravascular volume. The commonest fluid used for patients undergoing renal transplantation at Austin Hospital is 0.9% Normal Saline, however its use is associated with severe metabolic disturbances. There is emerging evidence that for patients undergoing renal transplantation who receive a balanced crystalloid instead of Normal Saline, there may be beneficial effects on the incidence of early allograft dysfunction and electrolyte disturbances. Hypothesis: When used as crystalloid therapy for patients undergoing renal transplantation will the balanced crystalloid fluid Plasmalyte Solution, have more favourable effects on metabolic acidosis and early graft function compared to 0.9% Normal Saline. Study design: Single centre randomised controlled blinded study. Inclusion criteria: Adult patients (age > 18years) undergoing deceased donor renal transplantation (heart-beating or non heart-beating). Primary endpoint: 1. Standard base deficit immediately post surgery in the Post Anaesthesia Care Unit and at 24 hours & 48 hrs postoperatively 2. Serum potassium levels in the Post Anaesthesia Care Unit and at 24 hours & 48 hrs postoperatively 3. Serum Creatinine Secondary endpoints: 4. Strong-ion-difference 5. Serum Albumin 6. Serum Phosphate 7. Renal biomarkers including: serum and urine NGAL and Cystatin C 8. Requirement for Renal Replacement Therapy 9. Duration of Hospital Stay 10. Adverse events including myocardial infarction, pneumonia, cardiac arrythmias, pulmonary embolism, heart failure 11. Death within 30 postoperative days No of participants: 50 Recruiting Hospital: Austin Hospital Clinical significance: A finding that Plasmalyte solution has more favourable effects on renal transplant associated acidosis, strong-ion difference, hyperkaleamia and delayed graft function may influence the fluid chosen for patients undergoing renal transplantation.

  • Plasmalyte and Hartmann’s solution for cardiopulmonary pump prime during cardiopulmonary bypass

    Changes in acid-base balance, particularly metabolic acidosis are common in cardiac surgery with cardiopulmonary bypass. The mechanisms for such metabolic acidosis however, remain controversial, but previous research strongly suggests that the metabolic acidosis is iatrogenic in nature and that its extent and duration varies according to the priming solution of the cardiopulmonary bypass circuit. The priming solution has been implicated as one of the potential causes of the disturbances of pH associated with the development of metabolic acidosis on initiation of cardiac bypass. This acidosis is in part caused by hyperchloraemia and is more likely to occur with normal saline, which has a higher chloride load than the more balanced physiological solutions such as Plasmalyte or Hartmanns solutions. Attempts to prevent metabolic acidosis have entailed alterations to circuit prime fluids, including partial replacement of chloride by rapidly metabolised anions such as L-lactate, acetate and gluconate or else by bicarbonate. Study rationale: There are no published studies comparing Hartmann’s solution (contains anions lactate and chloride) and Plasmalyte (contains anions acetate, gluconate & chloride) as prime solutions for cardiopulmonary bypass. Both these crystalloid fluids are commonly used priming solutions for the cardiopulmonary bypass circuit. It is therefore not known if one solution has more beneficial effects on cardiopulmonary associated acidosis, strong-ion difference and unmeasured ions. Study design & hypothesis: We will conduct a single centre randomised controlled blinded study to test the hypothesis that when used as cardiopulmonary pump prime solution during cardiopulmonary bypass Plasmalyte solution will have a more favourable effect on metabolic acidosis than Hartmann’s solution. Primary endpoint: Standard base deficit on rewarming, just prior to separation from cardiopulmonary bypass Secondary endpoints: Strong-ion-difference; Total weak acids; Net-unmeasured-ions including lactate, acetate, gluconate; Serum creatinine; Renal biomarkers including: serum and urine NGAL, cystatin C; Pro-inflammatory effects using Interleukin-6; Cardiotoxic biomarkers using cardiac troponin. Inclusion criteria: Adult patients (age > 18years) undergoing elective Cardiac Artery Bypass Grafting (CABG) or valve surgery requiring cardiopulmonary bypass. No of participants: 50 Recruiting Hospital: Austin Hospital Clinical significance: A finding that Plasmalyte solution has more favourable effects than Hartmanns solution on cardiac bypass associated acidosis, strong-ion difference, and inflammation may influence the fluid chosen for prime solution in patients undergoing cardiopulmonary bypass.

  • Effect of dairy-based high-protein, variable-carbohydrate diets and exercise on muscle maintenance and movement

    The willingness of the majority of Australians to adopt a sedentary lifestyle accompanied by an excess energy intake underpins the current epidemic of lifestyle diseases. In an effort to prevent the rise of inactivity-related conditions, medical and health professionals prescribe energy-restricted weight-loss programmes combined with increased physical activity as a means to reduce body mass (weight) and improve health outcomes. However, typical diet-induced weight loss leads to an imbalance in body composition that reduces an individuals’ functional capacity (i.e., movement and activity patterns) and increases their susceptibility to metabolic disorders. Specifically, the complex interactions between elevated levels of body fat and a reduced muscle size result in a high fat: muscle ratio, leading to a cascade of events that accelerate pre-existing health conditions (i.e., sarcopenia) and simultaneously predispose an individual to further (new) health risks. At present, the optimal diet to achieve weight loss and promote favourable body composition changes in overweight adults remains highly controversial. More information is needed to determine the effects of different diets on energy metabolism, energy balance and body composition. Indeed, the biggest concern for the majority of Australian adults is how to lose fat mass while preserving muscle mass and the health benefits that accrue from a nutrient-rich high-quality protein diet and physical activity. Accordingly, the aim of this project is to discover and characterise the best composition of mildly energy restricted high-protein (dairy-based), variable-carbohydrate diets consumed in association with resistance training to improve health.

  • A trial of cediranib in the treatment of patients with alveolar soft part sarcoma

    This study is investigating whether the drug cediranib might be effective as a treatment for alveolar soft part sarcoma. It will test cediranib against placebo and measure the effects after 24 weeks. Who is it for? You may be eligible for this study if you are aged 16 years and over, have a histologically confirmed diagnosis of alveolar soft part sarcoma and give your consent to take part. The full inclusion criteria details can be found in the relevant section of this form. Trial details: In this study, you will receive either the drug cediranib or placebo in the form of one tablet once a day, taken orally over a total period of 24 weeks. If you are allocated to placebo, you will switch to cediranib after 24 weeks (or if your disease progresses before this time). If you are allocated to cediranib, you will continue on this treatment until such time as your disease progresses. You will be required to attend regular clinic visits for routine tests and assessments.

  • Evaluation of the efficacy of nilotinib in the treatment of patients with pigmented villo-nodular synovitis / tenosynovial giant cell tumour

    The purpose of this study is to explore the efficacy of nilotinib as a treatment of patients with progressive or relapsing pigmented villo-nodular synovitis / tenosynovial giant cell tumour (PVNS /TGCT) who cannot be treated by surgery. This study is an international, multicentre, non-randomised, open-label phase II clinical trial with a Bayesian design. Who is it for? You may be eligible for this study if you are aged 18 years and over, have a histologically confirmed diagnosis of inoperable progressive or relapsing PVNS/TGCT OR resectable tumour requesting mutilating surgery, and give your consent to take part. The full inclusion criteria details can be found in the relevant section of this form. Trial details: In this study, you will receive the drug nilotinib in the form of 2 x 200mg capsules twice daily, taken orally over a total period of 12 months. You will also be required to regularly attend clinic for routine tests and assessments.

  • New imaging technologies in the detection of colitis related colon cancer

  • A randomised, cross-over trial of upright sitting with or without positive expiratory pressure during nebulised delivery of medication to improve the pattern of aerosol deposition in participants with cystic fibrosis

    Research question: To determine whether the addition of positive expiratory pressure (PEP) improves uniformity of deposition of an inhaled aerosol in upright sitting in participants with cystic fibrosis. Methods: Inclusion criteria: greater than or equal to 18 years of age, confirmed cystic fibrosis, stable lung function. Participants will inhale a 4mL radioaerosol in two stategies in random order throughout the nebulisation period of 20 minutes: 1. Standard nebulisation period of 20 minutes, or 2. Nebulisation period of 20 minutes with the addition of a PEP device. After each nebulisation a gamma camera will perform a 20-minute deposition scan incorporating a transmission scan to outline the three-dimensional margin of the lung fields. This data will be reconstructed to determine the distribution of the deposited radioaerosol in the lungs. A 15% improvement in uniformity of deposition is the proposed minimum difference that would make further investigation of the PEP strategy worthwhile in patient populations. Significance of project: In many patient populations (eg, cystic fibrosis, HIV and bronchiectasis), the pattern of deposition of inhaled medication is poor and non-uniform. The ability to deliver a drug more uniformly to the lung using the addition of PEP may have a significant impact on treatment efficacy for people with lung disease. Data from healthy participants will aid interpretation of subsequent studies in patients.

  • A secondary prevention patient centred model for smoking cessation.

    The study focuses on patients admitted to hospital with cardiovascular diseases. The cardiovascular system includes the heart and blood vessels that carry blood around the body. Smoking is one of the major risk factors for cardiovascular disease and following diagnosis individuals continue to smoke. We aim to particularly focus on these individuals for intensive treatment via a smoking cessation program. A specially trained Registered Nurse will undertake motivational interviewing techniques that consider the person’s readiness to change smoking habits and promote lifestyle changes. For further support a cardiologist and psychologist will be available for consultation.

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