ANZCTR search results

The purpose is to investigate whether treatment with the medication, fampridine, can help improve the ability to function in patients who have chronic inflammatory demyelinating polyneuropathy (CIDP). Who is this for? You are eligible to participate in this study if you are ages between 18-80, have CIDP and currently suffer from fatigue and a decreased functional ability. Trial detials In this studywith patients will receiving 12 weeks of Fampridine (active drug) at a dose of 10mg oral tablet twice daily, and 12 weeks of placebo (sham) treatment consisting of lacotse tablets, separated by a 4-week washout period. During the trial, participants will not know if they are receiving active drug or the placebo. Participants will be assessed at basline foloowed by 4 weekly intervals to measure fatigue, functional ability and nerve function.

The purpose is to investigate whether treatment with the medication, fampridine, can help improve the ability to function in patients who have Multiple Sclerosis. Who is this for? You are eligible to participate in this study if you are ages between 18-80, have Multiple Sclerosis and currently suffer from fatigue and a decreased functional ability. Trial detials In this studywith patients will receiving 12 weeks of Fampridine (active drug) at a dose of 10mg oral tablet twice daily, and 12 weeks of placebo (sham) treatment consisting of lacotse tablets, separated by a 4-week washout period. During the trial, participants will not know if they are receiving active drug or the placebo. Participants will be assessed at basline foloowed by 4 weekly intervals to measure fatigue, functional ability and nerve function.

The drug Mycophenolate mofetil (MMF) was introduced into routine clinical practice in 1995 to prevent the rejection of kidney transplants in the USA and in Europe in 1996. A second formulation of its active metabolite, mycophenolic acid (MPA), became available as an enteric-coated tablet called mycophenolate sodium (EC-MPS). and clinical trials showed that EC-MPS was as effective and safe as MMF. Equipotent doses of EC-MPS and MMF result in equivalent amounts of active metabolite ie MPA in the blood. On this basis MMF was trialled in patients with autoimmune and several immunologically mediated renal diseases. A recent meta-analysis of randomized controlled trials showed that MMF was not only better at gaining control of severe lupus nephritis (LN), an immunologically mediated kidney disease,, but also caused fewer side effects than the historically best treatment of pulsed cyclophosphamide. Up to 2 g of MMF each day were initially used to treat LN. Subsequent dosing regimens started with 2g MMF/day but subsequently titrated up to a maximum of 3 g/day . In one study a median dosage of 42mg/kg body weight MMF was used for 20-24 weeks and most patients (91.3%) tolerated MMF doses of up to 2.5-3.0 g/day. MMF 1000mg equates to about 720mg of MPS . However the amount of MPA in the blood varies from patient to patient. The factors causing these differences have been studied in transplant patients but not in LN patients. Nor has the relationship between MPA concentration and its effect on the kidney disease been described in LN patients. We propose using therpeutic drug monitoring of MPS to 1) describe any inter–patient variability in MPA blood concentrations among LN patients treated with MPS 2) correlate dose used with its efficacy and safety and 3) explore the relationship between treatment failures and underdosing of MPS in patients with LN. The results of these studies will tell us whether we ought to change our clinical practice, specifically whether therapeutic drug monitoring, not currently done, and consequent personalisation of MPS doses ought to become part of how we manage LN.

The main purpose of this study is to determine objectively whether orthopaedic in-patients are able to reproduce partial weight bearing orders by assessing dynamic weight bearing using a highly accurate insole monitor. The study also seeks to investigate factors that influence patients’ ability to accurately reproduce partial weight bearing orders. Finally, the study will investigate, in a preliminary manner, whether the ability to accurately reproduce partial weight bearing orders affects clinical outcomes.

Overactive bladder (OAB) is a common problem in the elderly and undertreatment is a concern due to the perception by clinicians with regard to side-effects. Amongst Geriatricians the cognitive side-effects are of particular concern and these drugs are relatively contraindicated in cognitive impairment. Treatment is often tailored to individual needs and comorbidities and there is no standard treatment for overactive bladder for this cohort. Where the drug is clinically indicated, there is anecdotal evidence that Geriatricians will prescribe solifenacin rather than oxybutynin due to theoretically less impact on cognitive function. Unfortunately trial evidence examining the cognitive impact of these drugs is lacking. This investigator initiated pilot study is designed to explore the cognitive effects of two different treatment licensed treatments for OAB, namely solifenacin and oxybutynin patch. Efficacy and tolerability will be assessed as secondary outcomes. The oxybutynin patch has been chosen over oral oxybutynin as the frequency of side-effects is recognised to be lower. There is no placebo as such, but cognition and bladder function will be assessed following significant washout periods during the study. A cross-over design has been chosen over a parallel group study for this pilot study as the numbers for a parallel group study would be prohibitively large and our design allows good within subject comparisons of cognition. It is reasonable to conduct this pilot as currently there is only one cognitive study looking at single doses of solifenacin in healthy elderly people, which showed solifenacin was not associated with cognitive impairment. We speculate that solifenacin will have less effect on cognition than oxybutynin patch with repeat dosing in healthy elderly female volunteers. The proposed dose of solifenacin used is based on available clinical data that shows most of the dose-response is achieved at 5mg while the use of 10mg dose is more likely associated with adverse effect . There is minimal additional clinical benefit from 10mg compared to 5mg. The use of 3.9mg transdermal patch is supported by a placebo, controlled dose escalation trial. Subjects will be recruited from the Women’s Health Centre outpatient clinic at the RAH or through advertisement. To participate in this trial, all subjects will meet criteria for treatment with these agents. They will be female, age 60 or above with overactive bladder syndrome who have not been on treatment or been off treatment for one month. There will be periods with no treatment during the initial run-in and between treatments in order to establish baseline bladder and cognitive function - this will be discussed with patients prior to commencing the clinical trial. The subjects will have the opportunity to try two different treatment for OAB. Possible risks that can occur in subjects include the following: Study drugs: Adverse effects listed in product information for solifenacin and oxybutynin Blood sampling: Discomfort, bruising or infection on the venipuncture site Cognitive testing: Mental fatigue and potential distress

Does consumption of low doses of fat prevent subsequent rises in circulating lipid levels?

The primary aim of this study is to assess the effect of sedation on lower oesophageal sphincter (LOS) function and to compare the effects of two types of sedating drugs, Remifentanil and Dexmedetomidine, on LOS function. This is performed to assess the risk of aspiration during sedation both in theatres as well as the intensive care unit.

This trial is a feasibility/ pilot study to establish if the administration of the treatment enteral feed (1.5 kcal/ml) increases mean daily energy delivery (kilocalorie per day) by > or equal to 20% compared to the control (1.0 kcal/ml). The study will provide baseline data to allow for the planning and funding of a larger multi centre trial to determine if delivery of additional energy to critically ill adults over the first 10 days of their ICU stay affects clinically important outcomes. Following the 10 day study treatment period, if required, patients in both groups will receive additional nutrition according to the centres standard care. The pilot study will be conducted in 6 centres in Australia with 100 patients enrolled over a six month period.

Chronic kidney disease (CKD), defined as an eGFR <60 ml/min/1.73 m2 and/or the presence of kidney damage (albuminuria or proteinuria) for at least 3 months, is a major public health problem affecting approximately 1.6 million Australian adults. Of these affected individuals, approximately 930,000 have stages 3-4 CKD (eGFR 15-60 mL/min/1.73 m2). CKD patients have a greatly increased risk of adverse renal and cardiovascular (CV) outcomes, even in its early stages. CKD patients are at increased risk of progression to end-stage kidney disease (ESKD). The incidence of ESKD is increasing in Australia by 6% per annum. Apart from an increased risk of ESKD, the presence of CKD is one of the most potent known risk factors for cardiovascular disease (CVD), such that individuals with CKD are more likely to die, mostly from CVD, than survive to the point of needing dialysis or kidney transplantation. A reduction in eGFR <60 ml/min/1.73 m2 is associated with increased risks of all-cause and CV mortality. The CKD-FIX trial aims to critically examine the efficacy and safety of allopurinol as an agent to slow the progression of chronic kidney disease (CKD).

To compare patient outcome, the primary endpoint being the incidence of post-operative nausea and vomiting (PONV), associated with the use of either neostigmine and glycopyrrolate or sugammadex for the routine reversal of neuromuscular block following laparoscopic gynaecological surgery. Secondary outcomes to be assessed include readiness to discharge, return of normal bowel function, patient recovery and well-being.