ANZCTR search results

It is known that some patients can develop significant reflux following sleeve gastrectomy for morbid obesity, but due to a lack of prospective evaluation the factors underlying the risk for reflux are unknown. In this study, patients before undergoing sleeve gastrectomy will undertake a validated reflux score, have and endoscopy and High Resolution Impedance Manometry and 24 hour Impedance pH testing. 6 months post operatively they will repeat the reflux questionnaire, the manometry and pH testing.

This study will collect data related to the management of women and men with HER2 positive metastatic breast cancer who are treated in routine clinical practice. Who is it for? You may be eligible to join this study if you are a patient of any age and any level of fitness with HER2+ metastatic breast cancer, of any hormone receptor status, either recurrent or de novo metastatic disease, who has either been diagnosed with metastatic disease within the last 3-6 months or who has progressed on 1st line therapy in the last 3-6 months. Study details For all patients enrolled in this study, data will be collected on the types of anti-HER2 therapies and chemotherapies used, how long treatment is given for, reasons for any changes in treatment, the impact of anti-HER2 therapies on heart function, and how often certain parts of the body, including the brain, are affected by HER2+ metastatic breast cancer. No personal/identifying data will be collected. This study will help to improve our knowledge of the way that HER2+ metastatic breast cancer behaves, what types of treatment are effective, and the risks and benefits of these treatments within usual clinical practice conditions, with the aim of guiding future research of this disease and improving the outcomes for anyone affected by HER2+ metastatic breast cancer. All collected data will be compiled in a registry, which will be managed by BioGrid Australia. BioGrid Australia is a non-profit company that was set up to help with data collection and analyses for medical research.

Neck pain is a common health disorder in adults. This research aims to evaluate the efficacy of home based training in patients with chronic neck pain. Home training will include exercises designed to advance coordination and control of the neck. A secondary aim will be to evaluate the differences between training with a laser beam feedback, to a virtual reality gaming scenario. It is hypothesised that both types of training will advance patients’ performance, and possibly the VR may have some advantages. Ultimately this methodology could have important implications for future use in remote e-health.

The study will trial a common nasal decongestant to determine its effect on OSA severity in people with tetraplegia.

The purpose of this study was to investigate an internet based treatment for pathological gambling. Participants were randomly allocated to three groups; an internet based treatment based on cognitive behavioural strategies, an internet based treatment based on motivational and supportive techniques, and a waitlist control. The two treatment groups consists of one weekly session, for six weeks duration. Participants in the waitlist control group were offered treatment on completion of the six week wait period. Measures were taken pre treatment, mid treatment/ wait, and post treatment/ wait, as well as some weekly measures throughout treatment.

The current approach in the management of osteoarthritis is primarily palliative and is aimed at alleviating symptoms. By contrast, current literature is increasingly advocating the identification of prognostic indicators, such as muscle weakness, mal­alignment and depression that may be amenable to treatment. That is, to provide a more holistic approach to the management of osteoarthritis as well as to facilitate an improvement in an individual’s joint pain and function rather than treating every patient with a “one size fits all” approach. With this is mind, the primary aim of this pilot study is to establish whether a “stepped up”, adaptive treatment protocol can increase frequency of disease remission and improve long­term functional outcomes such as pain and stiffness among persons with medial tibiofemoral knee osteoarthritis. Participants in this pilot study will be randomized into either a control or treatment group. The treatment group will follow a diet and exercise program for 18 weeks. Reassessment of their Patient Acceptable Symptom Score (PASS) occurs at 20­week and participants who fail to reach the threshold level for disease remission based on disease symptoms and an individual’s perceived functionality will then enter into the Adaptive Treatment Protocol phase. Participants will receive additional treatment for muscle weakness, mal­alignment or depression. The control group will be provided with educational pamphlets about knee OA, largely focused on diet, exercise and weight loss. Final follow-up and assessment of disease remission will take place at 32­week. The purpose of this protocol is to develop a clinical algorithm for individualised patient treatment.

This study aims to determine whether 3 months of treatment with oral dichloroacetate can supress multiple myeloma. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a diagnosis of Plasma Cell Myeloma which is in a 'Plateau-Phase', i.e. a period of neither progression nor response at least 28 days following the last change in myeloma treatment. Study details: All participants in this study will be treated with a drug called dichloroacetate. This will be taken orally (by mouth) daily for 3 months A number of blood samples will be taken throughout treatment in order to determine how the body responds to treatment. This information will help us determine how well dichloroacetate is tolerated, and whether it has the ability to suppress multiple myeloma.

To achieve the benefits of a medicine, the patient must be willing to take it in the correct amount at the appropriate time. Most medicines are not formulated for use in children. For those that are, few are considered sufficiently palatable. Lack of palatability can be attributed to poor taste and, for children below 6 years, the inability to swallow solid medicines, such as tablets. Midazolam is a highly effective oral sedative and pre-procedural medicine for children and adolescents. The lack of an oral commercial product in Australia has led the local hospitals to administer midazolam injection solution which has a foul taste and is often rejected by the children. Inadequate sedation presents difficulties in children who are very anxious or uncooperative in the preoperative setting (e.g. children with autism). Uncooperative children have then to be held down and restrained for the induction of anaesthesia, which is traumatizing for the child and the family. In adolescents, this can also pose significant safety risks for the attending staff. We believe that chocolate-based mini tablets can effectively provide palatable formulations for bitter drugs such as midazolam to assist clinicians achieve the desired therapeutic outcomes in paediatric patients. The aims of this project are: 1. To evaluate the rate of acceptance of the chocolate-based midazolam tablets in children (age 3-16) required pre-procedural midazolam 2. To evaluate the pharmacokinetic prarameters of the chocolate-based midazolam tablets in children We have developed prototype chocolate tablets measuring 0.5 x 1 x 0.5 cm that can mask the taste of the highly bitter drug. The aims of this project are to perform further clinical evaluations on these formulations to fully realise the potential of midazolam for preprocedural sedation and anxiolysis of sick children in WA. This study will pave the way for the scaled up manufacture of chocolate-based midazolam tablets for use in WA paediatric hospital wards, and the adaptation of the chocolate base for the formulation of other bitter drugs (e.g. antibiotics). Pharmaceutically, the chocolate tablets, which are prepared without water, will provide more stable products for labile drugs than liquid mixtures. They are also more convenient and cheaper to store and transport than bulky liquid formulations.

A preliminary trial to assess the effectiveness of lifestyle and dietary intervention for the management of T2DM using electronic reminders, a fitness tracker wristband collecting exercise data and a web-based questionnaire to encourage participation. The question to be answered is whether the provision of quality dietary and exercise information known to be of benefit in T2DM control is better adopted by diabetics using simple electronic reminders and easy access to that information. There will be no control group, and this is an "n-of-one" trial in which each participant acts as their own control the beginning of the study. The degree of the participation will be matched to the outcome measures (HbA1c) to determine effectiveness of the entire approach. There is potential for follow-up of willing participants at 12 months. The hypothesis investigated for this clinical trial proposes to demonstrate that blood HbA1c levels can be successfully and significantly reduced through a healthy eating / exercise programme that is implemented at baseline to 25 weeks participation. Blood levels of HbA1c is an objective and accurate marker of metabolic syndrome status and T2DM progression. A 13.5 % (from at least e.g., 55.5 mmol/mol to 48 mmol/mol) reduction in blood HbA1C level will be associated with significant improved health outcomes from baseline. This benefit may translate into a significant reduction in health care costs associated with T2DM. The electronic intervention serves as a motivating tool and guide that supports patient programme compliance, resulting in fewer doctor and other allied health affiliated practitioner visits and most importantly decreased T2DM disease progression.

The aim of this study is to investigate the safety and feasibility of an advanced technique of external beam radiotherapy, termed stereotactic body radiotherapy (SBRT), in men with prostate cancer. Who is it for? You may be eligible to join this study if you are a male aged 18 years or above who has a confirmed diagnosis of intermediate or high risk prostate cancer. Study details Studies have shown that escalated doses of radiotherapy increase cure rates for prostate cancer. Higher doses are achievable with high dose rate (HDR) brachytherapy, and data suggests outcomes are superior. However, HDR brachytherapy is invasive, expensive and requires access to operating theatres and specialised equipment. In this study we aim to investigate whether an advanced technique of external beam radiotherapy, termed stereotactic body radiotherapy (SBRT), is able to emulate the doses and outcomes of HDR brachytherapy while being a noninvasive technique that employs commonly available radiotherapy equipment. All participants in this study will receive SBRT and be monitored for up to five years. in order to evaluate treatment toxicity, feasibility and efficacy.