ANZCTR search results

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.

Survival from breast cancer has improved significantly over the past 30 years. This has been due to the coordinated approach of surgery, chemotherapy and/or radiation therapy with each member of your treating specialist team contributing to your treatment recommendation. For each of these three disciplines of treatment, the conduct of clinical research has led to more effective ways of performing surgery and delivery of the best drug combinations and radiation therapy. In addition, research has also aimed to reduce side effects and therefore make each of these treatment approaches, safer and less intrusive to the quality of your life. However, it is still likely that patients will experience side effects of some kind as a result of their surgery, chemotherapy and/or radiation therapy. Currently, it is not known how often the specialist treating team or the patient’s general practitioner is managing these side effects; and how successful the treatment recommended is. Understanding the frequency of side effects that lead to an unplanned visit with a member of your specialist treating team or GP and how these side effects are managed, will allow us to plan more effective ways of coordinating the care, to ultimately improve the well-being of breast cancer patients as they undergo the various stages of their breast cancer treatment.

Submitted on 29 Jan, 2013, [Dr. Deborah Zion, the Chair of the Victoria University Human Research Ethics Committee informed this ANZCTR is required before final approval is given.] (Office for Research, Victoria University, PO Box 14428, Melbourne, VIC, 8001 or phone (03) 9919 4781.)

The purpose of this study is to find a new way of treating central sleep apnoea and drug tolerance caused by opioid medication prescribed for chronic pain. The medication tested in this study is Minocycline, a commonly used antibiotic with effects on the central nervous system's immune system. Hypothesis Minocycline will reduce the severity of central sleep apnoea in patients prescribed opioids for chronic pain. Minocycline will increase the analgesic efficacy of opioids prescribed to chronic pain patients.

There is evidence that exercise capacity is reduced in patients with type 2 diabetes. Beta-alanine has been shown to increase exercise capacity in younger, apparently healthy individuals and in elderly subjects. To date, no previous exercise trials have evaluated the effects of B-alanine supplementation on exercise capacity in a cohort of patients with T2DM. An improvement in exercise capacity in this population is valuable in that it may translate to an improvement in GLUT4 translocation and, consequently, an increase in glucose uptake. Further increases in exercise capacity secondary to B-alanine supplementation may yield significant improvements in insulin sensitivity, resulting in an overall improvement blood glucose management (HbA1c) and possibly a reduction in diabetes medications or dosages.