ANZCTR search results

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

You can narrow down the results using the filters

32893 results sorted by trial registration date.
  • Reduction of breast lymphoedema symptoms secondary to breast cancer: Phase I/II randomised controlled trial

    This study aims to investigate whether an exercise program reduces swelling in women with breast lymphoedema symptoms secondary to breast ca ncer. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above who has stage I-III breast cancer which has been surgically treated. You should have had stable breast lymphoedema for at least 3 months and be sedentary. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will participate in an exercise program that consists of 3 x 1 hour training sessions per week for 12 weeks. A trainer will meet women in this group at their local community gym 3 x per week for the first 2 weeks then reducing to once a week for the rest of the program. The program will consist of a 5 min warm-up, followed by 20 min of moderate to vigorous intensity aerobic exercise and 30 min resistance exercise in the limbs and trunk using free weights and resistance equipment, and finishing with a 5 min cool down. Participants in the second group will receive no exercise p rogram. Participants in both groups will be contacted by the study coordinator on a weekly basis to monitor their progress. Participants will also undergo clinical assessment at baseline and 3 months, and be asked to complete questionnaires about their symptoms, quality of life and dietary intake.

  • The National Suicide Call Back Service Carers and Bereaved Online Counselling Pilot: A Clinical Controlled Trial.

    Over 2000 Australians die by suicide each year, and many more are at ongoing risk of suicide. The consequences are profound for those who are caring for someone who is at risk of suicide, and for those who are bereaved by suicide. The National Suicide Call Back Service (SCBS) is a professional mental health service that provides counselling by telephone to those at risk of suicide, those bereaved by suicide, and those who are caring for someone at risk of suicide. The SCBS has been funded to trial the delivery of its counselling service through online chat for carers and bereaved clients. Given the rapidly burgeoning nature of the internet, an increasingly broad section of the general population can access mental health services online with ease. Literature suggests that online counselling is effective in treating a range of mental health issues. However, to date, no study has evaluated the efficacy of online counselling for carers and those bereaved by suicide. The current study encapsulates two broad aims: 1) to examine the efficacy of counselling delivered through online, synchronous, text-based chat for carers and bereaved persons; 2) to examine the comparative efficacy of counselling delivered through telephone and online chat. Two groups of participants, carers and those bereaved by suicide, will choose to receive a program of weekly counselling from the SCBS by telephone or through online chat. Participants will be asked to complete a number of psychological questionnaires prior to commencing therapy and following its completion. Results will be analyzed to assess if any improvements in assessed psychological domains have occurred in conjunction with the delivery of therapy. Based on the relevant literature, it is hypothesised that both the telephone and video-conferencing counselling conditions will display simply benefits for carers and bereaved participants. It is hoped that findings from this project will contribute to our understanding of online therapies and provide a valuable evidence base upon which to build an ongoing SCBS online counselling service.

  • Filter Life In Renal Replacement Therapy

    Dialysis is the process of removing fluid and waste products from the blood of patients who have kidney failure. Most people may be familiar with conventional hemodialysis in specialized kidney wards, for patients who have kidney disease and are otherwise well. It is usually performed for around 4 hours, 3 days per week, however these short periods of high intensity dialysis are often not tolerated by the very sick who are better managed with less intense but continuous dialysis. This continuous type of dialysis is called Continuous Renal Replacement Therapy (CRRT) and it is continued in patients in ICU who have kidney failure, until the patient’s kidneys start to work again or they are well enough to move to intermittent dialysis in a kidney ward. During dialysis, blood from the patient is continuously circulated through a filter in the kidney machine, and waste products are removed. There is always the possibility that the blood may clot as it passes through the filter. Patient stability and carefully controlled fluid removal can be compromised if the kidney machine fails too frequently. The most common reason for failure is blood clotting inside the filter – the more this occurs, the less the patient actually receives treatment, and as each filter costs roughly $400 the treatment becomes increasingly expensive. If blood clotting is prevented inside the filter it can last longer - between 24 and 72 hours. Common methods to stop blood clotting (known as anti-coagulation) include adding heparin or citrate to the circuit in the dialysis machine. The primary aim of this study is to compare the filter life using two methods of anticoagulation in CRRT in the Alfred Intensive Care Unit. The first method involves the use of a blood thinner called heparin. Sometimes when higher doses of heparin are required, another drug called protamine that reverses the blood thinning effect is added to the blood in kidney machine circuit. Adding heparin with or without protamine is the method that is currently most used at the Alfred for CRRT. The second method involves the use of citrate fluid in the kidney machine. The citrate binds with calcium and has an anticoagulant effect. Previously, this method proved more labor intensive for the nurses as additional pumps were needed. It tended to be used in special situations e.g. in patients who were allergic to heparin and/or could not receive blood thinners due to a high risk of bleeding. However, recent improvements in the technology of kidney machines have allowed this method to be used much more simply and efficiently. This study has been designed by our doctors at the Alfred Intensive Care Unit to find out if using citrate in the kidney machine is a better and safer way of using CRRT than using heparin in the kidney machine.

  • Meeting Heart Failure Patients needs for self-care education with a multi-media educational intervention: The Self-Care Educational Intervention study

    The aim of this study is to determine the effectiveness of a multi-media educational intervention for heart failure patients in reducing unplanned hospital admissions. Associated with this outcome, the study also aims to investigate whether patients who participate in this educational intervention demonstrate improvement in their knowledge and self-care abilities.

  • A study to investigate whether a biomarker in the blood can predict cancer recurrence in patients with pancreatic cancer

    The aim of this study is to work towards developing a diagnostic technique to determine patients response to chemotherapy and surgery using circulating tumour (ct) DNA biomarkers. This will reduce the need for excessive chemotherapy treatment therefore reducing the unwanted adverse effects of treatments. Genes are substances in the body which contain information about characteristics about us as indivuals. Previous studies have found that the majority (more than 9 out of 10) of pancreataic cancers contain a mutation in KRAS gene which can be detected in the blood. Identifying biomarkers are important because: they may be linked with disease progression; they may help to identify people who are most likely to benefit from a certain treatment such as chemotherapy and how much treatment they need; and they help to identify people who have partial or complete response to treatment without the need for chemotherapy after surgery

  • Impact of Probiotics on Gut Microflora and the Metabolism of Orange Juice Flavonoids

    This study will be conducted in healthy individuals to investigate the impact of a co-delivery versus a 3 week course of microencapsulated probiotic (Bifidobacteria) on the degradation and absorption of orange juice flavanones. This will be assessed by: a) Quantitative evaluation of the effective delivery of microencapsulated (MicroMAX Pro (Registered Trademark) – milk protein-sugar-carbohydrate powder) probiotic (Bifido bacteria) by faecal sample examination. b) Analysis of the phenolic acids and flavanone glucuronide and sulphate metabolites in urine and faecal water using high-level analytical techniques (GC-MS and HPLC-MS-MS). This information will provide insights into the impact of a microencapsulated probiotic on the gut microflora, and on the absorption and metabolism of ingested orange juice flavanones. The specific aims of this investigation are: 1. To investigate co-delivery of probiotic with orange juice on the metabolism amnd absorption of flavanones in the large intestine 2. To investigate the impact of a 3 week course of probiotic on the metabolism and absorption of flavanones in the large intestine.

  • UREMIC TOXIN: Utility in REnal disease of Measuring Indoxyl sulphate and p-Cresyl sulphate To predict OXidative stress, Inflammation and cliNical outcomes

    The roles of indoxyl sulphate and p-cresyl sulphate as nephro- and cardiovascular toxins has recently gained recognition, although their true association and mechanisms behind their putative deleterious actions are yet to be investigated in human studies. The aim of this observational study is to gain a better understanding of the associations between these two protein-bound uremic toxins, IS and PCS, and Cardio Vascular Disease (CVD) and CKD progression, along with other poor outcomes seen in CKD. A secondary aim is to determine whether live kidney donors post nephrectomy have an increase concentration of these toxins and any association with morbidity in this population.

  • A pilot study of Focal Ablative Stereotactic Radiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases.

    Stereotactic body radiotherapy (SBRT) is an new form of cancer treatment involving highly precise radiotherapy. SBRT appears to be effective in controlling cancer in other sites in the body, including the lung and the liver. We aim to test the ability of this new technique to control cancers in the kidney. This is the first step of the research, and is a ‘pilot’ study. Who is it for? You may be eligible to join this study if you are aged greater than 18 years and have a radiological diagnosis or biopsy confirmed diagnosis of either renal cell carcinoma or solitary adrenal metastases. Trial Details If you participate in this study, you will have either a single session of stereotactic body radiotherapy (SBRT) or three sessions of SBRT, depending on how big your cancer is. In order to deliver this treatment, you will need to attend a ‘planning’ session where your body measurements are taken in the position that you will be lying in for your radiotherapy. This visit takes approximately one hour. Once the radiotherapy treatment has been planned, a further ‘mock-up’ visit is required to ensure that the radiotherapy plan can be physically delivered when it comes to the time of treatment. This session will take approximately 45 minutes. When the treatment starts, the total time required to deliver the treatment will be one hour. In addition to the visits required to plan and deliver the radiotherapy, blood samples will be taken as part of this research. These will be taken at the same time as blood is collected to assess your kidney function (which would be standard care). Therefore will not require any additional blood collection visits than would be routinely performed to treat your cancer. Both the kidney function blood sample (standard of care) and the research related blood sample will be taken a total of 3 times; once before treatment, two weeks after treatment, and approximately 70 days to 3 months after treatment. Follow-up will involve a visit at approximately 2.5 to 3 months, and then at 6 months, 9 months, and 12 months from treatment. If you have a primary kidney cancer (renal cell carcinoma), then in addition to the steps outlined above you will have a research related ‘Diffusion weighted-MRI’ scan performed a total of three times; once before treatment, two weeks after treatment, and approximately 70 days to 3 months after treatment. The Diffusion weighted-MRI scan is similar to a standard MRI scan, but is taken over a longer period of time. Each Diffusion weighted-MRI scan takes approximately 30 minutes. For those patients with adequate kidney function, you will also have a contrast injection at the time of the MRI, which will add an additional 10 minutes to the scan time. The MRI allows us to examine the blood flow into kidneys and the cancer. To assess the function of the kidney after the SBRT treatment, a ‘positron emission tomography’ (PET) scan will be taken at approximately the same timepoints as the perfusion scans; once before treatment, two weeks after treatment, and approximately 70 days to 3 months after treatment. This will involve injection of a radioactive tracer and a subsequent scan which will take approximately 30 minutes to capture. This will require you attending the PET Centre for a period of 2 or 3 hours. Participation in this study will involve no extra cost due to either having these scans or the treatment.

  • Study of the control of oxygen levels during cardiopulmonary bypass - the SO-COOl study

    Heart surgery is a common procedure, with more than 2500 operations each year in New Zealand. Damage to organs, including kidneys, liver and heart is common after heart surgery and some of the damage may be caused by extra oxygen given on cardiopulmonary bypass. This study will randomise patients to receive normal levels of oxygen or the traditional high levels during heart surgery. Endpoints include a number of blood tests that are very sensitive for detecting damage to the kidney, liver, heart and other organs. In total 286 patients having heart surgery at Auckland City Hospital will be included in this study over a two year period.

  • Feed and Stop after Twenty hours for Four hours – Pilot trial of a revised enteral nutrition protocol

    The purpose of this pilot study is to is to evaluate and assess a revised enteral nutrition protocol to deliver prescribed volumes of nutritional formula through a cyclic (also known as intermittent) 20-hour continuous method .The current enteral nutrition protocol is based on a 24- hour continuous cycle to deliver prescribed volumes of formula. However, various planned processes and events (such as fasting for endotracheal extubation) often interrupt a 24 hour continuous cycle of feeding potentially resulting in sub-optimal levels of nutrition delivery. Hence, the 20 hour continuous method (with a higher rate of feeding per hour) has been developed so that adequate nutrition can be delivered and planned interruptions can take place within the 4 hour non-feeding “gap” period. a minimum of forty patients will be enrolled from the Monash Medical Centre Intensive Care Unit and will be randomly allocated to a control group ( current 24 hour enteral feeding protocol) or an intervention group (revised 20 hour enteral feeding protocol). Data relating to nutritional and clinical outcomes will be collected for up to 12 days for each participant. The hypotheses is that the new protocol will safely and effectively improve current levels of nutritional adequacy from 48 % (based on local audit) closer to the optimal levels recommended in the literature ( > 80 %) We postulate that this increased provision of calories and protein may translate into improved nutritional and clinical outcomes, but the current study is not powered to demonstrate such a difference.

Tags:
  • Finding clinical trials