ANZCTR search results

The primary purpose of this study is to determine if panobinostat maintenance in patients with multiple myeloma (MM) who have failed to achieve complete remission (CR) following high-dose chemotherapy conditioned autologous stem cell transplantation (ASCT) will lead to an increased/improved rate of conversion to CR or very good partial response (VGPR). You may be eligible to join this study if you have previously been treated with a thalidomide, and/or lenalidomide and/or bortezomib containing induction regimen pre-ASCT. Participants in this trial will receive the oral drug panobinostat at a dose of 45mg three times per week every other week as part of a 4-week (28 day) treatment cycle. You will be treated for 6 cycles and then assessed for response. If after 6 cycles you have not achieved a very good partial response (VGPR) or CR, your panobinostat treatment will cease. If, however, you have achieved the required response, you will continue on panobinostat until disease progression or unacceptable toxicity.

This study aims to evaluate the effect of changing the current model of care in 15 BUPA nursing homes, to a model that employs GPs directly within the homes, in terms of resident health and healthcare resource use outcomes (primary outcomes: polypharmacy, unplanned hospital transfers, general practitioners’ out of hours calls). Nursing homes in four states and in metropolitan and regional locations will be inducted into the program in a randomised and step-wise order, with seven weeks of preparation in the facility before the GP is employed. It is envisaged that employment of GPs will improve several important factors, including medical access and care for residents; increased satisfaction to residents and relatives of residents; reductions in medical costs associated with aged care; improved job satisfaction for employees with subsequent decreased turn-over rates and absenteeism.

We know that after an acquired brain injury (ABI), a number of adolescents experience increased levels of anxiety. So far, very little research has looked at the ways we can help young people with ABI overcome these difficulties and improve the way they are able to get along with others at school, home and in the community. Our aim is to trial a program for managing anxiety for adolescents with ABI. The program incorporates cognitive behaviour therapy which previous research has shown to be helpful for adolescents who do not have brain injury. Components of the program have been especially adapted for young people who may have cognitive difficulties associated with TBI (e.g., memory impairments). This study aims to evaluate this adapted program for managing anxiety in a sample of young people who have had an ABI. The program aims to reduce anxiety and increase levels of participation in everyday activities of young people following ABI. If effective, the program used in this trial will be developed into a manual thereby allowing for applicability of the program in a range of therapeutic settings.

To properly manage type 1 diabetes, individuals are required to measure blood glucose levels (BGL's)regularly and adjust the amount of insulin to be given accordingly. This has been done by matching the amount of insulin with the amount of carbohydrate in a meal. Recent studies have shown that meals high in protein can also significantly increase the BGL. There are recommendations that additional insulin be given with meals containing high levels of protein to prevent post prandial hypergycaemia (elevated BGL's after a meal). However, at this time there is insufficient data to determine how these additional insulin doses should be calculated. A current algorithm used to calculate additional insulin based on protein content in a meal has been shown to cause unacceptable levels of hypoglycaemia. We will recruit 31 people with type 1 diabetes between the ages of 7 and 40 years diagnosed for more than 1 year, using either insulin pump therapy or multiple daily injection therapy. Participants will have a glycated haemaglobin of <8.5% and body mass index <91st centile. Exclusion criteria will be those with co-existing medical conditions. The aim of this study will be to: Define the impact of variable protein loads on post prandial BGL's up to 8 hours. The participants will be contacted daily for the first week to monitor BGL's and adjust insulin doses. A continuous glucose monitoring system (CGMS) which provides continuous measurement of BGL's will be inserted on the first day. For 5 consecutive days participants will be instructed to eat a standardised evening meal containing consistent quantities and type of carbohydrate. The participant will give a standard insulin bolus for the carbohydrate in the meal. They will then be instructed to eat a test meal (protein shake) 4 hours after the evening meal. The participant will fast over night and check the BGL in the morning prior to eating breakfast. If the participant has has a BGL <3.5 mmols/L or has symptoms of hypoglycaemia at any time they will eat 15 grams of carbohydrate as per their usual management. During the test meal study days exercise and evening food will be standardised.

Research question: Does therapeutic ultrasound reduce the severity of rhinosinusitis in adults with cystic fibrosis (CF)? Methods: Adults with CF and chronic rhinosinusitis will be randomly allocated to receive ultrasound or sham ultrasound in a hospital outpatient clinic, 6 times in 2 weeks. The primary outcome will be the severity of rhinosinusitis symptoms, measured using the 22-item Sino-Nasal Outcome Test after the treatment period. Secondary outcome measures will be peak nasal inspiratory flow, lung function, global rating of change, a generic health-related quality of life questionnaire, medication use, and adverse events. Measurements will occur during and 6 weeks beyond treatment. Significance: This study will determine whether therapeutic ultrasound reduces rhinosinusitis symptoms in adults with CF to a clinically worthwhile extent and whether any effect extends beyond the treatment period. Growing evidence indicates that sinusitis seeds the lower respiratory tract with infection, so an effective rhinosinusitis treatment may also have respiratory benefits, which are crucial for people with CF. Ultrasound use has decreased since it was shown to be ineffective for many conditions. If the study shows ultrasound is effective for CF rhinosinusitis, physiotherapists’ apply their skills and this equipment to treat CF rhinosinusitis.

The Analgesia nociception index (ANI) is a novel score aiming to enable anaesthetists to estimate pain perception in anaesthetized patients. It work via 2 sticky (single use) electrodes applied to the chest (like ECG electrodes) from which it derives ECG data. This is then transformed into an index from 0-100, the ANI which will be larger in states of comfort and smaller in states of more pain. Although non-invasive and risk free, very few data exist to show the association of ANI with standard measures of nociception/pain in unconscious subjects: changes in blood pressure, heart rate or patient movement. We aim to do an observational trial on 30 patients in which we attach ANI monitoring to anaesthetized patients, record the ANI score continuously and match these records with other patient data obtained at the same time (blood pressure, heart rate, patient movement). This should enable us to get a better idea about the predictive value of ANI changes to preempt changes in above mentioned standart observations.

The primary aim of the study to evaluate the effectiveness of MPD as a monotherapy and adjunctive antidepressant treatment in patients with melancholic depression who have failed orthodox antidepressant options. Key Hypotheses: 1. Those receiving MPD and an antidepressant will show superior responder and remission rates compared to those receiving an antidepressant only 2. Those receiving MPD monotherapy will show comparable remission and responder rates to those in Group 2 (a non-inferiority hypothesis). 3. Those receiving MPD will improve more rapidly than those on antidepressants only 4. Substantive side-effects and drop-out rates will be lowest for patients on MPD only.

This study is an observational study investigating the use of new tracer for Positron Emission Tomography (PET). This tracer is preferentially taken up by cells that undergo rapid proliferation. The study has two aims: to assess the feasibility of conducting a larger trial, and to assess the sensitivity and specificity of FLT PET. The target patient population is those with locoregionally advanced mucosal head and neck squamous cell carcinoma undergoing definitive chemoradiation. You may be eligible to join this study if you are aged 18 and over, and have a previously untreated biopsy proven mucosal head and neck Squamous Cell Carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx - Stage III or IV (TNM staging). You must be suitable for definitive radiotherapy + concurrent systemic treatment. Further details on the inclusion criteria for this study can be found in the relevant section on this form. Trial details All participants in this trial will undergo their standard cancer treatment, but with the addition of 2 18Fluoro-L-Thymidine and Positron Emission Tomography (FLT-PET) scans at baseline and at week 3 of radiotherapy. This will involve injection of FLT (study tracer) with scan commencing 60 minutes later.

The broad aim of the project is to test the effectiveness of a new service program to be made available to mothers of young children. The unique feature of the program is that it will combine the skills of community nurses and web-based technology to enhance support for mothers of infants. Following the development of the new program, it's effectiveness will be tested in trial involving approximately 800 mothers and infants. Half of the mothers and infants will receive the combined program while the other half will receive routine care provided for by CaFHS. We will test whether the combined program achieves equivalent outcomes to that achieved by routine care. The outcomes this project will assess include levels of parenting self-efficacy, perceived support, maternal mental health, infant development and the quality of mother-infant attachment.

Those randomised to the intervention group will receive the services of a Mobile Rehabilitation team who will deliver rehabilitation services while the participant is admitted to the acute wards. Those randomised to the control group will have usual care. Both groups will be followed up by phone interview at 3 months for those with moderate injury and 6 months for those with severe injury to determine health outcomes.