ANZCTR search results

In subjects with active Rheumatoid Arthritis (RA), MK-8457 100 mg twice a day will be superior to placebo as measured by the proportion of subjects who achieve ACR20 (American College of Rheumatology Rheumatoid Arthritis Clinical Response Criteria) response after 12 weeks of treatment.

The study aims to investigate the association between maternal diet and colic, irritability, reflux, atopy and gastrointestinal dysfunction in exclusively breast-fed infants aged zero to four months; and to develop an evidenced based treatment algorithm for the non-invasive treatment of colic and associated symptoms in infants. A series of hypotheses have been developed for this study, these include. H1: Food allergy contributes significantly to persistent infant colic and other symptoms of allergic disease in exclusively breast fed infants. Thereby, eliminating major contributors to food allergy, specifically CMP and hen’s egg from the maternal diet significantly reduces persistent infant colic and other symptoms suggestive of protein specific food allergies in exclusively breast fed infants aged birth to four months. H2: Food intolerance contributes significantly to persistent infant colic in infants aged birth to four months. Eliminating major contributors to food intolerance, specifically, high FODMAP foods from the maternal diet significantly reduces persistent infant colic and other symptoms suggestive of food intolerance in exclusively breast fed babies. H3: The Vitamin D status of the mother and infant affects the predisposition to food allergy/intolerance in exclusively breast-fed infants aged birth to four months. H4: Breast milk composition with regard to microbiota profile is associated with allergy in infants aged birth to four months. H5: Sensory processing disorders (sensory hypersensitivity) contributes to infant colic.

This study aims to evaluate the safety and efficacy of combination Degarelix, Abiraterone, Bicalutamide and Prednisolone in high-risk localised prostate cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have confirmed prostate cancer which is suitable for radical prostatectomy with curative intent. Trial details All participants in this trial will be treated with 'super castration' triple therapy. This involves taking the medications Degarelix, Bicalutamide, Abiraterone and Prednisone for a period of 6 months prior to radical prostatectomy. Participants will be assessed at regular intervals in order to determine the safety, tolerability and response rate to treatment when compared with historically treated patients.

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.

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.

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.

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.

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

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.

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.