ANZCTR search results

The purpose of this study is to evaluate hunger, energy intake, antropyloroduodenal motility, and plasma concentrations of the gut hormones, ghrelin, cholecystokinin (CCK), peptide YY3-36 (PYY3-36), and glucagon-like peptide-1 (GLP-1), in response to exercise of two intensities, 35% and 70% of peak oxygen consumption (VO2), and a no-exercise control condition, in healthy, lean young men. Each subject will be studied on three occasions. Each visit will be either sedentary or involve exercise at one of two intensities (35 and 70% VO2max) for 60 minutes, with the three interventions administered in a counter-balanced order. On each occasion antropyloroduodenal motility, plasma CCK, ghrelin, GLP-1, and PYY3-36 concentrations, appetite perceptions, energy intake and energy expenditure will be measured. Peak aerobic capacity of each subject will be determined within a week before the start of the study using a screening treadmill test. During this screening test, as well as at intervals during the study, subjects will breathe through a mouthpiece equipped with a two-way valve. VO2max will be measured from expired gases that are continuously sampled by a metabolic cart.

Vitamin D deficiency is common in Australia. But Australia has high skin cancer incidence. While advice is given on safe sun exposure to avoid the risks of skin cancer, it is not clear how much sun exposure is required, at different locations in Australia, to maintain sufficient vitamin D levels throughout the year. This study thus addresses the following public health questions: 1). Can safe patterns and doses of sunlight exposure achieve and maintain vitamin D adequacy with no vitamin D supplementation? and 2). How does sun exposure advice calibrate against 2 different doses of vitamin D3 supplementation to manage mild vitamin D deficiency? We will recruit 228 Australian adults aged 18-64 years who have been diagnosed with mild vitamin D deficiency on routine testing (25(OH)D of 40-60nmol/L) in each of four regions in Australia - Canberra, Melbourne, Brisbane, Perth. Participants will be randomly allocated to one of four groups receiving different types of sun exposure advice and supplementation. Outcomes will be the proportion of participants who are vitamin D sufficient at 12 months, and at the end of winter, the time when vitamin D levels are usually lowest.

The study is evaluating the efficacy of substituting the drug, alemtuzumab, for another drug known as ATGAM, as part of combination therapy for steroid-refractory acute graft versus host disease in post haematopoietic progenitor cell transplantation patients. Who is it for? You may be eligible to join this study if you are a male or female aged between 18-69 years who has been diagnosed with grade II or higher steroid-refractory acute graft versus host disease (SR-GVHD) following haematopoietic progenitor cell transplantation (HPCT). Trial details All participants in this trial will be given the drug alemtuzumab for 5 consecutive days. Alemtuzumab will be administered intravenously (into the vein) over a period of 2 hours each day. All patients will also receive standard premedication (including paracetamol, phenergan and hydrocortisone) 30 minutes prior to alemtuzumab. Participants will be assessed at 6 months in order to evaluate response to treatment and survival.

The aim of this project is to demonstrate the feasibility of using visual feedback to increase minimum toe clearance during walking in people with stroke. This intervention has the potential to improve walking safety and reduce falls. Ten participants will be required to attend 10 sessions. The training sessions will occur over a 3-4 week period, with at least one rest day between sessions. At all sessions, participants will be required to walk on a treadmill for 5-10 minutes. They will wear exercise shorts and also a safety harness which will prevent them from falling. Participants will also have markers placed on their lower limbs, and a special camera (Optotrak) will record the movement of these markers while participants walk. They will also wear insoles in their shoes (FScan), which will record pressure under their feet. Data will be recorded during assessment sessions, and additional clinical data will also be obtained. Participants will be asked some questions about their risk of falls. During the training sessions, participants will be asked to modify their walking pattern to match a “target” minimum toe clearance.

Women with severe urgency of micturition and urge incontinence, who have not responded to treatment with bladder training and appropriate tablets for two years, will be invited to join a study whereby they will receive a highly effective tablet (darifenicin) as well as either 6 weeks of antibiotics, or 6 weeks of placebo. Followup of clinical outcome will occur over 6 months.

This study will investigate the safety and tolerabilty of escalating doses of oral azacitadine in combination with a fixed dose of lenalidominde and dexamethasone in patients with relapased/refractory multiple myeloma. This study is for patients who have previously been diagnosed with multiple myeloma and who have previously been treated unsuccessfully with lenalidomide. The dose levels of oral azacitadine are: 1 (A) 100mg for days 1-14 of 28 day cycle 2 (B) 100mg for days 1-21 of 28 day cycle 3 (C) 150mg for days 1-14 of 28 day cycle 4 (D) 150mg for days 1-21 of 28 day cycle 5 (E) 200mg for days 1-14 of 28 day cycle 6 (F) 200mg for days 1-21 of 28 day cycle The fixed dose of lenalidomide is 25mg on Day 1 to 21 of each 28-day cycle. The fixed dose of dexamethasone is 40mg on Day 1, 8, 15 and 22 or each 28-day cycle. A total of up to 30 patients may take part in this trial. The first 3 patients will be enrolled in the lowest dose level 1(A). If this dose level is tolerated well by these patients, the next 3 patients will be enrolled in the next dose level 2(B), and so on until a dose level is reached where too many side effects are experienced. The dose level below the one with too many side effects will be declared the Maximum Tolerated Dose (MTD) and patients will drop back to this dose level and continue at this dose. This MTD dose level will be expanded to allow up to 22 patients to receive this dose. You may be eligible to join this study is you are above 18 years of age and have adequate liver, kidney and bone marrow function; have no contrainidications to the use of azacitidine, lenalidomide or dexamethasone; you provide consent; you have not had therapy for your multiple myeloma in the last 4 weeks and agree to practise abstinence or use contraception for the specified time period.

Femoroacetabular impingement (FAI) is a common condition that can cause hip and/or groin pain in young active adults, as well as give rise to stiffness, muscle weakness, reduced physical function and lower quality of life. It has also been proposed as a possible risk factor for early onset of hip osteoarthritis. In symptomatic FAI, treatment often involves arthroscopic surgery. Currently, post-operative management is quite variable and dependent on surgeon preferences. Post-operative physiotherapy is not routine practice, largely because it has not been established if rehabilitation following surgery is needed to improve patient outcomes. Thus, this project primarily aims to investigate the effectiveness of physiotherapist-supervised rehabilitation following hip arthroscopy surgery for FAI in young adults.

Infants born prematurely (< 30 weeks gestational age) have a higher risk of developing cerebral palsy than infants born at term, due to immaturity of the developing brain at birth, and potential brain injuries that can occur in the neonatal period. Cerebral palsy is frequently not diagnosed till the second year of life, delaying the start of early intervention treatments which may be of benefit in minimising functional limitations and providing key family supports. To date magnetic resonance imaging (MRI) at term equivalent age and general movement assessment provide the most accurate prediction of neurodevelopmental outcome at 12 months corrected age. This project aims to investigate the relationship between earlier brain MRI and neuromotor/neurobehavioural assessments at 30 weeks gestational age, and their ability to predict outcomes of cerebral palsy and motor difficulties at 3 and 12 months corrected age. We aim to achieve this in a longitudinal prospective cohort study of 80 infants born at less than 30 weeks gestational age, at the Royal Brisbane and Women’s Hospital. Infants will undergo a brain MRI scan at 30 and 40 weeks gestational age to develop our understanding of very early brain structure at 30 weeks; and maturation that occurs between 30 and 40 weeks gestational age. A combination of neurological (Dubowitz neurological assessment), neuromotor (General Movements, Test of Infant Motor Performance, visual functions) and neurobehavioural assessments (the NICU Network Neurobehavioural Scale) will be performed at 30 and 40 weeks GA to understand the relationship between brain structure and function. These data will be compared to motor assessments at 12 weeks post term and 12 months corrected age. These data will be compared to outcomes at 12 months CA including a developmental assessment by a paediatrician (Bayley scales of Infant and Toddler Development), motor assessments (Alberta Infant Motor Scale, Neurosensory Motor Developmental Assessment) to differentiate atypical development (including cerebral palsy and/or motor delay). At a time of increasing demand on health care resources, reliable ways of predicting neurodevelopmental outcome in premature infants is desirable to determine those that may benefit most from early intervention.

This study aims to compare radiation treatment combined with either cetuximab or cisplatin in patients with locoregionally advanced HPV positive oropharyngeal squamous cell carcinoma (OPSCC) (located at the base of tongue or tonsil) Who is it for? You may be eligible to join this study if you are aged 18 years or more, and have been diagnosed with locoregionally advanced HPV positive oropharyngeal squamous cell carcinoma (OPSCC). You should not have received any prior treatment for this cancer. Trial details; Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will receive radiation treatment 5 days a week over 7 weeks, in conjunction with weekly doses of a drug called cetuximab. This drug is administered intravenously, i.e. directly into the vein. Participants in the other group will receive radiation treatment 5 days a week over 7 weeks in combination with the chemotherapy drug cisplatin, which is also administered intravenously. Participants will be assessed weekly during treatment, then at 1, 3, 5, 9, 13 weeks post-treatment and at months 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 42, 48, 54, and 60 post-completion of treatment. Assessments will involve blood tests, questionnaires, clinical examination, hearing tests, swallowing tests, and radiological examination. The main research question being answered is whether those treated with weekly cetuximab and conventionally fractionated radiotherapy will experience less acute symptom severity than patients receiving weekly cisplatin and conventionally fractionated radiotherapy.

The aim of this study was to conduct a pilot randomised study into the efficacy of omalizumab in allergic bronchopulmonary aspergillosis.