ANZCTR search results

Overview: Raynaud's Phenomenon is characterised by spasms of blood vessels in the peripheries and in both hands and feet it can lead to pain, ulceration, and amputation of fingers and toes. It is a common feature of the autoimmune disease, Systemic Sclerosis. The pain and difficulty in using the fingers creates substantial limitations on everyday activities with subsequent decrease in the quality of daily living. A patient of one of the investigators had the initiative to try electrically heated gloves and found them "life changing". This project is a pragmatic clinical trial to examine the usefulness of heated gloves for these patients. Participants will have Raynaud's Phenomenon secondary to Systemic Sclerosis. A cross-over randomised controlled trial design will be used with the interventions being: (a) use of electrically heated gloves, or (b) routine practice. The trial will take place during the Adelaide winter months of July to Sept. The objective of the trial is to determine whether use of electrically heated gloves improves quality of life for patients with Raynaud's Phenomenon compared to their usual practice.

The primary aim of this study is to examine to acceptability and efficacy of an internet delivered VCBT for GAD. A secondary aim is to examine the acceptability and efficacy of a brief VCBT treatment for GAD. The aim of this study is to recruit and treat participants with generalized anxiety disorder using a cognitive behavioural treatment program administered remotely via internet videoconferencing. Participants in the treatment group will begin the program immediately, and their results will be compared with a waitlist control condition. Participants in Group 2 will receive access to a brief version of the program when Group 1 completes treatment (Week 10). Outcome measures will be administered at baseline, mid treatment, post treatment and 3 month follow-up. Based on the limited existing literature it is hypothesized that high intensity VCBT will 1) be acceptable to individuals with GAD; 2) result in significant reductions in symptoms, resulting in large within-group and between-group effect sizes at post-treatment and three-month follow up; and 3) brief VCBT will result in outcomes similar to those seen in standard face-to-face treatment.

The primary objective of this study is to evaluate the effect of CYP3A/P-gp inhibition on the pharmacokinetics of GS-5718 and the effect of GS-5718 on the pharmacokinetics of OATP/BCRP substrates.

The purpose of this study is determine whether it is possible to use a drug called prazosin when men are undergoing radiotherapy for the treatment of prostate cancer. Who is it for? You may be eligible for this study if you are an adult man who has been diagnosed with non-metastatic prostate cancer. Study details All participants in this study will be asked to take prazosin two times day starting the week before and until the completion of their radiotherapy treatment for prostate cancer. There will be 6 dose levels that participants could be assigned to depending at what stage they enroll; the doses range between 0.5mg twice daily and 5mg twice daily. The dose will start at 0.5mg twice daily one week before radiotherapy starts and, if necessary, increase each week until the target dose is reached. Participants will be monitored throughout the treatment period to determine if they are willing to take the medication alongside their radiation, and followed for 9 months for any side effects. Participants will also be asked to provide blood samples at 3, 6 and 9 months after commencing the study, however these are part of standard follow-up tests after radiotherapy for prostate cancer. It is hoped that this study will help determine if it is possible to use prazosin while participants are completing radiotherapy, and help guide the development of a large scale clinical trial which will be used to investigate the efficacy of prazosin combined with radiotherapy

Augmentation of anterior cruciate ligament reconstruction using autologous hamstring graft, with a modified iliotibial band tenodesis or lateral extracapsular tenodesis, for patients with a residual pivot shift: A 2 year prospective randomised controlled trial comparing recurrence rate and clinical outcome. Background: Approximately 10% of ACLs injuries are associated with damage to the anterolateral complex (ALC) of the knee, manifest as greater anterolateral rotatory instability (ALRI). The pivot shift test is the best available clinical test for ALRI. Addition of an ALC reconstructive procedure can improve stability of the knee and clinical outcome in these patients following ACL reconstruction. There is little data comparing the efficacy of the various ALC procedures. Hypothesis: We hypothesized that the clinical outcome would be similar when either a modified ilio-tibial band tenodesis (MITBT) or lateral extracapsular tenodesis (LET) was added to ACL reconstruction. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: The inclusion criteria were a residual pivot shift following ACL reconstruction, in a skeletally mature patient, pre-injury Tegner Activity Score of at least 7, desirous to return to a similar level of activity, an intact contra-lateral ACL ligament and consenting to be randomly allocated to either treatment group. Patients in group A underwent MITBT, those in group B, LET, in addition to their ACL reconstruction. The primary outcome was recurrent ACL rupture and / or meniscal tears. Secondary outcomes were the Knee injury Osteoarthritis and Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score, ACL Quality of Life Questionnaire (QOL) and Tegner activity scores (TAS). Patients were reviewed at 12, and 24 months postoperatively. Statistical comparison of the groups was performed, P<0.05 denoting significance. A power analysis determined that 140 patients were required to achieve a power of 80% and 5% risk of a type 1 error.

People with coeliac disease have an acquired immune reaction that can cause acute symptoms similar to food poisoning within two hours of eating gluten. This study aims to define the minimum amount of gluten that activates the immune response to gluten, injures the gut and causes symptoms in patients with coeliac disease. This will be achieved by assessing symptoms and measuring a specific type of molecule (biomarker) in the blood and tissue called interleukin 2 (IL-2) after participants consume a defined dose of gluten. Study findings may be used to inform food safety standards for people with coeliac disease and will advance knowledge and understanding of the clinical effects of gluten in people with coeliac disease.

Stroke survivors suffer from impaired movements that affect their activities of daily living. Conventional physio and occupational therapies are provided to regain some of these lost motor abilities. However, even with intensive conventional therapy, a large portion of patients do not receive sufficient recovery to function independently. This deficit leads to significant social and economic burdens. Therefore, there is a clear need for the development of novel and effective intervention strategies. To address the gap, alternative therapies, including brain-computer interfaces, have been proposed to recover impaired hand functions following stroke. A brain-computer interface (BCI) can translate the imagination of hand movement to the movement of an object on a screen or even the actual hand movement provided by a robotic hand. In a BCI system, a specific cap records the electrical activity of the brain on the surface of the scalp during the imagination of the hand movement. A machine learning algorithm processes the recorded brain signals and determines if the imagination of movement has been performed. When the algorithm detects the movement imagination, it sends commands to the outside world and provides feedback to the user. A specific type of feedback may be supplied via a robotic hand to move a paralysed hand passively, during the imagination of the hand movement. There is a growing body of research, demonstrating the promising primary results of the application of BCIs for movement recovery after stroke. However, to supply BCI as standard therapy in clinics, its consistency and efficacy need to be improved. One of our prior studies suggests the outperformance of proprioceptive feedback over traditional visual feedback in the provision of a better substrate for the occurrence of operant learning. Further, we have demonstrated that provision of the correct delay between the brain activation and the passive hand movement is critical and must be customised according to individual’s attributes. Putting together the findings of the two prior studies, we improved the hand movement of a stroke patient, who had had a stroke 3.5 years before the study, by 36% after ten sessions of therapy. Observing the promising results of the aforementioned studies, we are investigating how our novel BCI therapy recovers the hand movement for a group of stroke survivors.

Preterm babies can develop brain injury which leads to long-term developmental problems. Most brain injuries occur within the first 5 days of life and protection of the brain during this critical period is essential. Fluctuating brain oxygen levels is one reason for brain injury to develop, which can also cause bleeding in the brain. Keeping brain oxygen levels in a specific range may be protective. The purpose of the study is to investigate in preterm babies, whether it is possible to keep brain oxygen levels in a specific range for the first 5 days by NIRS monitoring and following a dedicated clinical treatment guideline. We hypothesise that a combination of brain oxygen monitoring and offering treatment when brain oxygen levels are outside the range may reduce fluctuations in brain oxygen levels and reduce brain injury. Babies in this study will have either (a) the usual treatment (given to all babies), or (b) they will be in the group where the focus is on keeping brain oxygen levels in a specific range for the first 5 days of life using NIRS monitoring.

This study is investigating whether it is feasible to administer an exercise program prior to radical surgery for patients with bladder cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with bladder cancer, you will be undergoing radical open cystectomy and you have been invited to participate in the program by one of the investigating urologists who are based in Western Australia (Professor Hayne and Dr La Bianca). Participants who are not being treated in Western Australia will not be eligible for this study. Study details Participants who are invited to participate in this study will be prescribed an exercise program to be completed 2-3 times each week for a maximum of 4 weeks, dependent upon when their surgery has been scheduled, for cystectomy only and for those undergoing neo-adjuvant chemotherapy for approximately 12 weeks. Participants will undergo one-on-one training with an exercise physiologist for 2-3 one hour sessions each week, and will also be asked to complete another 20-30 minute exercise sessions (e.g. walking) on the other 2 days at home. The supervised sessions will involve two types of exercise, resistance training that may involve lifting weights or performing strength exercises, and aerobic training that may involve walking or jogging on a treadmill, cycling or rowing on a stationary machine. The exercise regime will finish prior to your scheduled surgery. You will be asked to complete a series of questionnaires before starting the exercise program, after completing the program, and 3 months after your surgery. It is hoped this research will demonstrate that a pre-surgical exercise program is safe and feasible to deliver to patients with bladder cancer, and that the exercise program may improve post-operative outcomes in these patients.

We will assess the effect of Photobiomodulation therapy (PBMt; ‘light therapy’) on nipple pain in breastfeeding women to contribute information for establishing optimal treatment settings. The study will be conducted at The Possums Clinic, Brisbane. Forty-six eligible participants with nipple pain will be recruited for this study and randomised into either intervention Group A (standard gestalt intervention plus light therapy) or Group B (standard gestalt intervention plus sham light therapy). In addition to the review of the gestalt therapy techniques at every appointment (thrice weekly for the duration of the study), light therapy will be administered three times per week and thrice weekly treatment will continue until the participant reports zero pain, or for 4 weeks, whichever occurs sooner. We expect that the use of light therapy will reduce nipple pain earlier than would be expected with standard gestalt therapy alone.