ANZCTR search results

This study compares the complementary therapy of Healing Touch to a mimic healing touch treatment (a placebo) to determine if Healing Touch can assist older women who are living on their own in the community to remain functionally independent.

Allergies have been on the rise in Australia, and evidence suggests vitamin D may play a role. Vitamin D has been shown to influence the immune system and has been linked to asthma, eczema and food allergies. This study will help determine whether vitamin D supplements given to infants will alter the risk of development of allergic disease.

The primary purpose of the study is to compare the effects of brief vesus extended feedback and advice in promoting cannabis help/information seeking and assisting individiuals to reduce their cannabis use. Hypotheses: Relative to individuals who receive brief feedback, individuals who receive extended feedback will report (a) more information-seeking and help-seeking, (b) greater reductions in past-month cannabis use, (c) greater reductions in past-month cannabis dependence symptoms, (d) greater reductions in past-month cannabis abuse symptoms, and (e) greater satisfaction with the screening/feedback program.

The goal of this study is to investigate the efficacy of Bacopa as an adjunctive therapy to existing pharmaceutical treatments for Alzheimers patients. The study will test individuals diagnosed with mild to moderate Alzheimer's Disease, in a double blind, placebo controlled, parallel groups design. Particpants will either take Bacopa monniera for 90 days or a placebo for 90 days. Participants will attend an initial pre-screening and pratice session, baseline session and one follow-up testing session following 90 days of supplementation. During these session, participants will be required to complete several cognitive tests, which have been widely used to assess both enhancement and impairment of human cognitive performance. Mood and quality of life will also be assessed. It is hypothesised that measures of attention, processing speed and memory will improve in the Bacopa group relative to the placebo group. A further aim of the study is to investigate differences in mood and quality of life in the Bacopa treatment group relative to placebo.

The purpose of this study is to compare two proven skin care products (creams) in the context of patients undergoing radiation therapy for breast cancer in the tropics. Who is it for? you may be eligible to join this study if you are aged 18 years or older and are undergoing radiation treatment at the Radiation Oncology Unit, The Townsville Hospital, for cancer of the breast. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will apply CavilonTM Durable Barrier Cream twice per day to the radiation therapy treatment area from the first day of treatment up until 4 weeks following the end of the radiation therapy. Participants in the other group will use 100% Pure Sorbolene cream instead. Participants will be assessed weekly during treatment and at one month post treatment in order to identify if one cream is more effective than the other at preventing skin reactions associated with radiation therapy for breast cancer.

Surgical decompression of the lumbar canal in patients with significant symptoms of claudication or radicular pain and a radiological diagnosis of canal stenosis is both efficacious and well tolerated, with sustained long term benefits. Historically, lumbar canal stenosis was treated with complete laminectomy but recognition that the pathology is largely at the level of the disc and interlaminar space has led to less destructive approaches such as interlaminar decompression or laminotomy. Despite this, all published series report some morbidity and complications from surgery in what is typically an elderly population, such as dural tear, infection, persistent back pain and the need for blood transfusion or further surgical intervention. One concern is that of post-operative spondylolisthesis, which is thought to occur from disruption of the spinous processes and interspinous ligament, observed in up to 30% in some series. Minimally invasive techniques for decompression of the lumbar canal using a micro-endoscopic approach have been described and are growing in popularity. Instead of a midline posterior approach to the spinal canal, where the muscles are dissected bilaterally and the posterior spinal structures removed, a minimally invasive technique uses a unilateral, paramedian approach where the muscles are preserved and surgery is carried out through an 18mm diameter working tube. The surgical field is illuminated and magnified under the operating microscope and custom designed bayoneted instruments are employed to avoid obscuring vision. The spinal canal is decompressed in the same way as one would using an open approach but the posterior spinal structures are largely preserved, which offers a biomechanical advantage with the potential to reduce late spondylolisthesis. The less destructive approach should also reduce early post-operative back pain, promote more rapid mobilisation, and consequently reduce the number of inpatient hospital days. There is a growing body of evidence supporting the efficacy of this technique for treating patients with lumbar canal stenosis though there are concerns over the adequacy of decompression through a small operating tube and the learning curve associated with the adoption of this less invasive but potentially more restricted technique. Thus far, a number of observational studies have implied early advantages to patients offered minimally invasive over open lumbar canal decompression, there has yet to be a properly conducted and appropriately powered randomised controlled trial to confirm that the techniques are similarly effective in terms of medium to long-term functional outcome. A phase III non-inferiority trial design, i.e., to show that minimally invasive lumbar canal decompression is not inferior to standard open lumbar decompression, is considered to be the most stringent and statistically appropriate trial design to answer this important question. Trial participants will be recruited from patients undergoing elective open or minimally invasive decompressive lumbar laminectomy for degenerative lumbar canal stenosis at the Mater Misericordiae Private Hospital. After obtaining consent for the patients’ participation in the trial, they will undergo pre-operative clinical and radiological assessment by their consultant surgeon, including MRI and X-ray lumbar spine, in the usual way. Baseline questionnaires will be obtained pre-operatively. After randomisation to either surgical arm, open or minimally invasive lumbar decompression surgery will proceed in the usual way. There will be no changes to the usual surgical management of the patient resulting from the trial. Post operative management will proceed in the usual way, with no changes to normal post operative surgical management. Patients will complete outcome questionnaires prior to discharge. Patients will be assessed for discharge by a physiotherapist and their surgeon, and discharged at a clinically appropriate time in the usual way. Patients will be followed up at their routine appointment with the consultant surgeon. Outcome questionnaires will be completed at periods up to 24 months post operatively, and a follow up X-ray and MRI lumbar spine will be obtained. Data obtained will allow comparison of the outcomes of the two surgical procedures, including patient outcome measures, morbidity and adverse events, and radiological outcomes including extent of decompression and development of late spondylolisthesis.

The trials is a open label case series study in which we will investigate the effect of nebulised frusemide on patients with advanced diseases and dyspnoea, refractory to current therapeutic modalities. We will administer 20-40mg of frusemide via a jet nebuliser twice daily over a 2 day period. Patients' levels of the sensation of breathlessness and the unpleasant feeling elicited will be measured by a modified BORG scale and HADS-A subscale.

This study aims to determine the feasibility of a personalised treatment strategy, on the basis of a tumour molecular signature via genomic sequencing and protein expression, in patients with advanced recurrent or metastatic pancreatic adenocarcinoma. Who is it for? You may be eligible to join this study if you are aged 18 years or above, with histologically confirmed primary adenocarcinoma of the pancreas, and have one of the following three molecular signatures: 1. HER2 positive (HER2/neu amplification) subgroup 2. Homologous recombinant defects (BRCA1/BRCA2 or PALB2 mutation) subgroup 3. antiEGFR responsive sub-group (KRAS wildtype or KRAS codon13 mutation) Study details Ten patients will be enrolled in a feasibility stage to determine the technical feasibility of enrolling patients to a personalised treatment approach (including the logistics of recruitment, delivery of personalised treatment and general trial conduct). Recruitment to the HER2 positive subgroup will be reviewed after 1 patient has received personalised treatment. Personalised treatment based on genetic signature will comprise of the following: 1. HER2 positive sub-group - gemcitabine 1000mg/m2 over 30 minutes, given intravenously on days 1, 8 & 15 every 28 days until progression or unacceptable toxicity plus trastuzumab 4mg/kg intravenously day 1 only, followed by trastuzumab 2mg/kg given intravenously day 8, then weekly every subsequent week until progression or unacceptable toxicity or a total of 6 months treatment is completed. 2. Homologous recombinant defects subgroup - gemcitabine 1000mg/m2 over 30 minutes, given intravenously on days 1, 8 & 15 every 28 days until progression or unacceptable toxicity plus cisplatin 50 mg/m2 given intravenously over 60 minutes on days 1& 15 every 28 days until progression or unacceptable toxicity 3. antiEGFR responsive sub-group - gemcitabine 1000mg/m2 given intravenously days 1,8 & 15 each 28 day cycle until progression or unacceptable toxicity plus erlotinib 100mg orally daily continuously until progression or unacceptable toxicity Note: Patients may have received up to one cycle of standard gemcitabine treatment or gemcitabine in combination with abraxane prior to personalised treatment Patients will be evaluated at least 4 weekly to see how they are responding to treatment until progression, unacceptable toxicity or a total of 6 months treatment is completed.

The purpose of this study is to find out whether treatment with zoledronic acid or switching from tenofovir to another anti-HIV drug is more effective for improving low bone density over 24 months. These two options can improve low BMD in patients receiving tenofovir, but it is not yet known which one is the best as both strategies have their own advantages and disadvantages. Current evidence suggests that zoledronic acid may be better in terms of increasing bone density but it is not known for sure, hence the purpose of this study.

This study looks at whether we can obtain information about lung function (showing us areas of lung that work well and areas that do not) from a type of computed tomography scan (CT scan) known as four dimension computed tomography scan (4D-CT scan). Unlike other types of CT scans, 4D-CT scans have the potential to provide lung function information as well as the usual anatomical information. It is hoped that we can then include this lung function information in the planning of radiotherapy treatment to reduce the chances of irradiating the functioning lung areas. This has the potential to minimise side-effects. 4D-CT scans are mainly used for early stage lung cancer patients where it provides highly accurate anatomical information, however, we are testing its use in providing additional information, lung function information, for all stages of lung cancer. If this study shows that 4D-CT scans can provide accurate lung function information, it will be used for the treatment planning of all stages of lung cancer which will allow better treatment delivery and hopefully better treatment outcomes. Who is it for? You may be eligible for this study if you are 18 and over and have been diagnosed with lung cancer and scheduled or not scheduled for treatment with radiotherapy. Further inclusion details for this trial can be found in the Inclusion Criteria section of this form. Trial details This is a 30 lung cancer patient clinical imaging study in assessing the accuracy of a new type of imaging data from computed tomography (CT) known as CT ventilation imaging. Patients will undergo CT scans, data from which will be used to create a ventilation image which will be compared to their ventilation image acquired from a nuclear medicine scan, considered to be the 'gold standard'. If CT ventilation imaging is found to be physiologically accurate, its great advantage lies in its easy implementation in radiotherapy planning to minimise radiation induced lung toxicity.