ANZCTR search results

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.

In subjects with active Rheumatoid Arthritis (RA), MK-8457 100 mg twice a day will be superior to placebo as measured by the proportion of subjects who achieve ACR20 (American College of Rheumatology Rheumatoid Arthritis Clinical Response Criteria) response after 12 weeks of treatment.

The study aims to investigate the association between maternal diet and colic, irritability, reflux, atopy and gastrointestinal dysfunction in exclusively breast-fed infants aged zero to four months; and to develop an evidenced based treatment algorithm for the non-invasive treatment of colic and associated symptoms in infants. A series of hypotheses have been developed for this study, these include. H1: Food allergy contributes significantly to persistent infant colic and other symptoms of allergic disease in exclusively breast fed infants. Thereby, eliminating major contributors to food allergy, specifically CMP and hen’s egg from the maternal diet significantly reduces persistent infant colic and other symptoms suggestive of protein specific food allergies in exclusively breast fed infants aged birth to four months. H2: Food intolerance contributes significantly to persistent infant colic in infants aged birth to four months. Eliminating major contributors to food intolerance, specifically, high FODMAP foods from the maternal diet significantly reduces persistent infant colic and other symptoms suggestive of food intolerance in exclusively breast fed babies. H3: The Vitamin D status of the mother and infant affects the predisposition to food allergy/intolerance in exclusively breast-fed infants aged birth to four months. H4: Breast milk composition with regard to microbiota profile is associated with allergy in infants aged birth to four months. H5: Sensory processing disorders (sensory hypersensitivity) contributes to infant colic.

This study aims to evaluate the safety and efficacy of combination Degarelix, Abiraterone, Bicalutamide and Prednisolone in high-risk localised prostate cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have confirmed prostate cancer which is suitable for radical prostatectomy with curative intent. Trial details All participants in this trial will be treated with 'super castration' triple therapy. This involves taking the medications Degarelix, Bicalutamide, Abiraterone and Prednisone for a period of 6 months prior to radical prostatectomy. Participants will be assessed at regular intervals in order to determine the safety, tolerability and response rate to treatment when compared with historically treated patients.

This study aims to investigate whether an exercise program reduces swelling in women with breast lymphoedema symptoms secondary to breast ca ncer. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above who has stage I-III breast cancer which has been surgically treated. You should have had stable breast lymphoedema for at least 3 months and be sedentary. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will participate in an exercise program that consists of 3 x 1 hour training sessions per week for 12 weeks. A trainer will meet women in this group at their local community gym 3 x per week for the first 2 weeks then reducing to once a week for the rest of the program. The program will consist of a 5 min warm-up, followed by 20 min of moderate to vigorous intensity aerobic exercise and 30 min resistance exercise in the limbs and trunk using free weights and resistance equipment, and finishing with a 5 min cool down. Participants in the second group will receive no exercise p rogram. Participants in both groups will be contacted by the study coordinator on a weekly basis to monitor their progress. Participants will also undergo clinical assessment at baseline and 3 months, and be asked to complete questionnaires about their symptoms, quality of life and dietary intake.

Over 2000 Australians die by suicide each year, and many more are at ongoing risk of suicide. The consequences are profound for those who are caring for someone who is at risk of suicide, and for those who are bereaved by suicide. The National Suicide Call Back Service (SCBS) is a professional mental health service that provides counselling by telephone to those at risk of suicide, those bereaved by suicide, and those who are caring for someone at risk of suicide. The SCBS has been funded to trial the delivery of its counselling service through online chat for carers and bereaved clients. Given the rapidly burgeoning nature of the internet, an increasingly broad section of the general population can access mental health services online with ease. Literature suggests that online counselling is effective in treating a range of mental health issues. However, to date, no study has evaluated the efficacy of online counselling for carers and those bereaved by suicide. The current study encapsulates two broad aims: 1) to examine the efficacy of counselling delivered through online, synchronous, text-based chat for carers and bereaved persons; 2) to examine the comparative efficacy of counselling delivered through telephone and online chat. Two groups of participants, carers and those bereaved by suicide, will choose to receive a program of weekly counselling from the SCBS by telephone or through online chat. Participants will be asked to complete a number of psychological questionnaires prior to commencing therapy and following its completion. Results will be analyzed to assess if any improvements in assessed psychological domains have occurred in conjunction with the delivery of therapy. Based on the relevant literature, it is hypothesised that both the telephone and video-conferencing counselling conditions will display simply benefits for carers and bereaved participants. It is hoped that findings from this project will contribute to our understanding of online therapies and provide a valuable evidence base upon which to build an ongoing SCBS online counselling service.