ANZCTR search results

Computer assisted surgery has been developed to assist in obtaining ideal alignment of knee replacement prosthesis in patients with advanced knee osteoarthritis. Obtaining the precise positioning during sugery can be difficult. Using intraoperative dynamic movement of the knee a computer can take into account three dimensions and obtain a true "functional flexion axis" (FFA) of the knee which may more closely represent the true anatomical axis of the knee. This study will assess whether measurement of the "functional flexion axis" of the knee during surgery using specialised computer software is closely related to the Trans-Epicondylar Axis (TEA) obtained from an Computed tomography (CT) scan.

Study 105 (VX08-770-105) is an open-label, VX-770 treatment extension of Study VX08-770-102 (Study 102) and Study VX08-770-103 (Study 103). This rollover study evaluates the long-term safety and efficacy of treatment with the experimental drug, VX-770, for a duration of up to 96 weeks. Male and female subjects 6 years and older with cystic fibrosis who have completed Study 102 or 103 without major protocol violations are eligible to enrol. This project is an international, multi-centre trial, with subjects from 70 sites worldwide including Australia, Europe and North America. [Study 102: NCT00909532] [Study 103: NCT00909727]

The aim of this trial is to examine whether 50mg of DCS can augment a single session of graded exposure therapy in children suffering from spider or dog phobia. The researchers are particularly interested in whether treatment gains can be maintained one week later both within and outside of the treatment context, as measured by Behavioral Approach Tests. The researchers hypothesize that children who receive the DCS in addition to exposure therapy will be less fearful of spiders or dogs one week later both within and outside of the treatment context.

Intense exercise can lead to muscle damage, pain, swelling and loss of strength, which can take up to 7 days to recover. This recovery can impact negatively on athletic training and competition and predispose to injury. Cycloidal vibration therapy has been shown in recent studies to reduce limb swelling in patients who have undergone surgery and may be an effective treatment for reducing muscle swelling after exercise and promote recovery from intense exercise. The aim of the project is to evaluate the potential for the use of cycloidal vibration therapy to promote muscle recovery following exercise by examining effects on the return of muscle strength and the reduction in swelling, muscle damage and inflammation following intense exercise. This will provide evidence to support the use of cycloidal vibration therapy by athletes to promote recovery after exercise.

Continous postitive airway pressure (CPAP) is a proven therapy when administered in the emergency department. The evidence supporting it's use in the preshospital setting is not definitive and consisits of surrogate outcome measures hence this trial, powered to detect a difference in the true outcome of mortality, should provide important evidence. Our hypothesis is that adding continous positive airway pressure to standard care in the prehospial setting will decrease hospital mortality comparted to standard care alone.

Learning difficulties are common and can cause school failure and poor self-esteem. They are associated with specific problems with temporarily remembering and using information (‘working memory’). Research suggests that improving working memory might improve academic achievement. We will study this intervention in a large group of primary school children who have poor working memory. If successful, the intervention will provide a way to improve the learning skills of these high-risk children.

The study aimed to determine the degree of association between calculated glycemic load (GL) and glucose and insulin responses in healthy subjects consuming iso-energetic portions of single foods and mixed meals. 10 groups of healthy subjects consumed 1000 kJ portions of 121 single foods in 10 food categories and other 2 group of subjects consumed 2000 kJ of 13 mixed meals. Foods and meals varied widely in macronutrient content, fibre and GL. Glycaemia and insulinemia were quantified as incremental area under the curve relative to a reference food (=100). Then the results were correlated with GL to determine the extent that GL can explain the variability of glucose and insulin responses in healthy subjects.

In some cases, nausea remains refractory to treatment despite multiple lines of treatment, often in combination. This is a randomised controlled double-blind trial evaluating the effectiveness of one drug (levomepromazine) against placebo with rescue antiemetics (BSC) in both arms in patients with nausea that has been demonstrated to be refractory to standard guideline driven targeted antiemetic therapy or single agent therapy with haloperidol. This test drug has not yet been rigorously evaluated in this setting and does not yet have a registered indication for use in palliative care. The hypothesis to be tested is that for cancer patients with nausea not related to anticancer treatment, there is no difference in response at 72 hours to levomepromazine versus a placebo with rescue antiemetics. Response to treatment is defined as a minimum two point improvement from baseline and end score <3 on an 11 point (0-10) numeric rating scale for average nausea in the previous 24 hours, measured 72 hours after treatment.

Nausea in advanced cancer is a multifaceted problem. Recent systematic reviews have concluded that aetiology based guidelines may be effective in reducing nausea, but no rigorously controlled studies have been undertaken to trial this approach. Moreover, evidence to support the implementation of guidelines in practice is limited and contradictory, and a number of barriers to the implementation of the guidelines have been identified. This is a randomised open label study to compare the effectiveness of aetiology based antiemetic guideline therapy (targeted) versus haloperidol (single agent therapy) in improving the management of nausea not related to anticancer therapy in patients with advanced cancer. The hypothesis is that for advanced cancer patients with nausea not related to treatment, there is no difference in response to targeted aetiology-based antiemetic guideline treatment compared to using haloperidol alone, after 72 hours of treatment. Response to treatment is defined as a minimum two point improvement from baseline and end score <3 on an 11 point (0-10) numeric rating scale for average nausea for the previous 24 hours, measured 72 hours after the first study antiemetic administered Participants will be randomised into one of two study arms. In Arm 1, guideline driven antiemetic therapy is given orally or parenterally (subcutaneous or intravenous) according to the presumed cause of nausea using freely available PBS listed antiemetics in a 3 step dose escalation schedule. In Arm 2, Haloperidol is administered in a 3 step dose escalation schedule from 1mg/24 hours to 3mg/24hours orally or parenterally (subcutaneously). The active comparator is standard guideline treatment.

The overall objective of this study is to develop a well tolerated chemo-radiotherapy regimen for patients with Merkel Cell Carcinoma (MCC) of the skin that achieves high rates of control. You may be eligible to join this study if you are aged 18 or over and have been diagnosed with stage II or stage III Merkel Cell Carcinoma of the skin with no evidence of distant spread. All participants in this study will undergo radiation therapy for 5 days per week for 5 weeks whilst being administered Carboplatin intravenously (i.e. directly into the vein) once per week. Three weeks after the end of radiation therapy, patients will commence 3 x 3-week cycles of intravenous Carboplatin, administered on day 1 of each cycle, and intravenous Etoposide, administered on days 1-3 of each cycle. Patients will be assessed by PET scan, CT and/or bone scan, and monitored for therapy side effects and survival every 3-6 months for 5 years. The PET scans will be used to assist in staging and planning the patient's treatment as well as assessing response at the conclusion of treatment. It is hoped that the findings of this trial will lead to a greater understanding of the effect and toxicity of Carboplatin-Etoposide chemotherapy in combination with radiation therapy for stage II and III Merkel Cell Carcinoma.