ANZCTR search results

National Heart Foundation guidelines recommend long-term statin therapy in several major patient groups, but adherence rates are low, even following life-threatening events such as acute coronary syndrome. Muscle-related symptoms are the most commonly reported reason for statin discontinuation and about 1 in 5 patients taking statins report some degree of muscular pain. Placebo-controlled trials indicate overall in a treated population most symptoms are not due to the statin, but for an individual patient it is typically impossible to be certain. N-of-1 (single-patient multiple crossover) trials offer a simple, intuitive way to resolve this uncertainty. While N-of-1 trials have been used for more than 20 years, to date, few clinical services in Australia are conducting N-of-1 trials on a regular basis to improve the management of individual patient. Fewer studies have looked at the potential of using N-of-1 trials to determine statin tolerability. A recently published study suggested that N-of-1 trials can improve the assessment of statin-related myalgia in selected patients from endocrinology clinics in Canada. However, the results were limited by its small sample size and the potential for expanded use of N-of-1 trials to improve the compliance of statin therapy among statin intolerant patients remains unclear. The study will include up to 15 N-of-1 trial participants. Patients with prior history of intolerance of both atorvastatin 10 mg AND rosuvastatin 5 mg monotherapy, had statin-related myalgia occurring within three weeks of starting statin therapy and consequently discontinued statin use will be invited to participate. Each person will go through 3 double-blind, crossover comparisons of statin versus matching placebo. Each treatment and control period will last for 3-weeks and there will be a 3-week placebo wash out period after each of the active statin treatment. The total trial period for each participant will be 27 weeks. Myalgia scores will be recorded on a weekly basis during the study period. Brief Pain Inventory Questionnaire will be completed and blood sample collection will be done at baseline and at the end of each active treatment and control period to measure serum CK, ALT, AST, FGF21 and creatinine levels. To avoid unblinding of treatment allocation during the trial period, additional blood samples will be stored to measure lipids’ levels upon study completion. Genotype analysis will also be done at the end of the study to determine if genotype is associated with statin-induced myalgia.

Over 7 million Australians are living with a chronic conditions that cause more than half of all preventable hospital admissions. Once people leave hospital only about 50% adhere to prescribed medicines and at best 30% achieve lifestyle change. Simple strategies to improve ‘out-of-hospital’ management and support are needed. Text messaging has been shown to be effective and simple and is supported by quantitative and qualitative evidence led by CIs who have developed text message programs that promote lifestyle change. At the same time, Sydney Local Health District (LHD) has a text message system for contacting and following-up patients with chronic disease. However, these programs are not linked and in this research we will expand, refine and integrate our existing message programs then test and examine implementation. We propose a 3 phase project combining implementation science, a pragmatic trial, qualitative research and stakeholder engagement with appropriate ethical approval and following CONSORT guidelines. Phase 1 will see expansion of existing software and message content. Phase 2 is a pragmatic randomised implementation trial (n=310) with clinical and cost-effectiveness outcomes coupled with a process evaluation to inform scalability and implementation across settings. Phase 3 is a post-implementation assessment of success and challenges: to enable refinement of program content and features so as to maximise future success and ensure scalability.

The primary purpose of this trial is to evaluate the efficacy of oral testosterone for the prevention and treatment of sarcopenia in men with prostate cancer on Androgen Deprivation Therapy (ADT). Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with prostate cancer, for which you are undergoing ADT. Study details All participants enrolled in this study will be randomly allocated (by chance) to receive either oral testosterone once per day for six months, or to receive an inactive sham tablet once per day for six months. All participants will be reviewed for sarcopenia by assessment of muscle mass with DEXA at six months, and for prostate cancer progression by PSA. It is hoped that the findings from this trial will provide information on the efficacy of oral testosterone for the prevention of sarcopenia in patients commencing ADT and the reversal of sarcopenia in patients on long term ADT, whilst evaluating whether this treatment has any impact on prostate cancer progression.

This is a first in human phase 1, randomized, blinded, placebo-controlled single-centre, dose escalation safety and tolerability study that will evaluate 5 doses of FDY-5301 by sequentially increasing the dose of intravenous FDY-5301

The primary purpose of this trial is to evaluate the safety and efficacy of KappaMab in combination with Lenalidomide and Dexamethasone for the treatment of relapsed/refractory multiple myeloma. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over with relapsed/refractory kappa restricted multiple myeloma for which you have received Received 1-3 prior lines of therapy. Study details Half of the participants in the study will be administered KappaMab only and half will be administered with KappaMab in combination with Lenalidomide and Dexamethasone. KappaMab will be administered weekly for the first eight weeks of study and every 28 days therafter. Lenalidomide will be taken for the first 28 days of study and the first 21 days of cycle 2. Dexamethasone will be taken weekly for the duration of the study. Participants will have blood samples taken once per month along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma. It is hoped that the findings of this trial will establish the benefits of a KappaMab and Lenalidomide based immune-oncology approach for the treatment of multiple myeloma patients relatively early in their disease course.

HYPOTHESIS – That a psychology based obesity intervention in a GP setting will result in sustainable improvements in both QOL (quality of life) of overweight, obese & morbidly obese patients and result in improvements in measurable outcome parameters such as reduced visceral fat, improved blood sugar, lipids and fatty liver.

The proposed project will evaluate the feasibility of using pedometers as a motivational tool to improve mobility outcomes in inpatient rehabilitation. All eligible patients on the rehabilitation ward will be invited once they are able to walk with or without the assistance of one person, with our without a gait aid for a minimum of 3 metres. All participants will be provided with a pedometer for the duration of their stay. Those in the pedometer intervention arm will record daily step counts and be encouraged by staff, family and friends to take more steps each day. Those in the control arm will wear pedometers fixed shut and will be encouraged to walk further each day. Mobility outcomes will be measured at two points, before allocation and discharge from the ward. Pedometer usability by participants will also be evaluated.

Concentrated carbohydrate loads are often used in CF to help meet increased energy requirements and could have a role in the poor glycaemic control observed in CF. The aim of this project is therefore to establish the feasibility of implementing a low glycaemic load, high calorie dietary management plan for patients with CF and impaired glycaemic status (IGT). A secondary aim is to assess the effect of a low GL diet on clinical outcomes of glycaemic control, lung function and weight. Patients with IGT at the RPA CF clinic will be eligible to participate in this study. Weight, glycaemic control, lung function, diet history and quality of life will be measured at baseline and also at 3 months, following dietary intervention of a low GL diet.

Aims of the study: 1-To compare the number of episodes of hypoglycaemia, and time spent in hypoglycaemia between a pre-mixed insulin regimen and a basal-plus 2, Toujeo-based regimen in an elderly population with T2DM using CGM. 2-To compare total insulin requirements, measures of glucose variability and glycaemic control, weight gain and other health-related outcomes between the two insulin regimens. 3-Assess the impact on quality of life in elderly T2DM patients switching from pre mixed insulin to a basal-plus 2 regimen. 4-Assess the incidence and rate of hypoglycemia reported by Self Monitored Blood Glucose (SMBG) during the treatment periods of non CGM recording -Hypothesis: We postulate that hypoglycaemia (interstitial glucose <3.9, or critically <2.5 mmol/l) assessed by (CGM) will remain more prevalent in patients continuing biphasic insulin, compared with those switching to a basal-plus 2 insulin regimen. We hypothesise that subjects switched to a basal-plus 2 regimen will have reduced glycaemic variability and lower insulin requirements. We further postulate that switching to a basal-plus 2 insulin regimen will be not inferior to premixed insulin in term of quality of life (QOL).

CelGro "Registered Trademark is an acellular type I/III collagen matrix of porcine origin. The product consists of natural collagen bundles without cross-linking or chemical additives. It is free from animal-derived DNA and pathogens. Treatment of injuries to peripheral nerves is a challenging surgical issue. The primary aim of surgical repair is to guide regenerating axons correctly into place in the distal nerve, with minimal loss of nerve fibres at the site of repair. This results in reinnervation of distal tissues, and restores autonomic, sensory and motor function. Direct, tensionless, end-to-end repair using epineural microsutures (neurorhaphy) provides the most favourable outcomes. Tensionless repair is acknowledged as a major factor in successful recovery of sensorimotor function. However, if a tensionless repair cannot be achieved, autologous nerve grafting is the gold standard treatment for surgical treatment of nerve gaps. However, autologous nerve grafting results in significant donor-site morbidity; is more technically difficult to perform; requires more operative time; and elevates treatment costs. The search for alternatives to nerve grafting has resulted in the development of nerve conduits, which are tubes fashioned of biocompatible materials. The proximal and distal ends of the severed nerve are inserted into the tube and sutured in place. The conduit provides gross alignment for the regenerating nerve, and retains fluids leaking from the nerve ends, enriching the microenvironment with neurotrophic growth factors. Conduits manufactured from bioabsorbable materials are preferred as non-degradable materials such as silicone require additional surgery for removal, and may have detrimental effects on nerve regeneration. Collagen is one of the most commonly used biomaterials for construction of nerve conduits. Key advantages of collagen are that it is biocompatible and has a natural structure that has been shown to support and guide tissue regeneration in vivo. Clinical studies have shown that digital nerve gaps of up to 40mm can be bridged with collagen conduits, resulting in good to excellent sensory outcomes in up to 75% of patients. CelGro"registered trademark" is a next-generation membrane that is manufactured using collagen originating from animals bred and exclusively raised in Australia, eliminating disease transmission concerns associated with foreign products. Additionally, the collagen bundle structure of CelGro"registeris mechanically stronger and more elastic than other collagen membrane products of this type. The main complication related to conduit implantation is protrusion or extrusion of the conduit. This is most common when the repair occurs across a joint or where the quality of covering soft tissue is reduced. However, in a systematic review of digital nerve repair using resorbable FDA- and CE-approved nerve conduits, protrusion or extrusion of collagen conduits was not observed