ANZCTR search results

The primary purpose of this pilot study is to assess the clinical tolerability and safety of a new synthetic soft tissue implant material in the skin of healthy volunteers.

This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic PE with or without symptomatic DVT (Einstein-PE). (11702b) This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT or PE who completed 6 or 12 months of treatment with rivaroxaban or VKA are eligible for this trial (Einstein-Extension study). (11899)

Use of chemotherapy and growth factors can affect the number of stem cells and cancer cells in blood circulation. Few studies have also shown that number of cancer cells can be of prognostic significance. There are no studies till date which have looked systematically at the influence of chemotherapy and growth factors on these cells. Hence present study was designed to answer these questions. The results of the study may not directly influence the way we treat the patients today but will definitely help us to understand the complex nature of breast cancer.

A randomised within-subjects design will be used to determine the effect of regular passive movements on the ankle. One ankle of each subject will receive 20 minutes of passive movements, five days a week for 6 months. The other ankle will not receive passive movements. The primary outcome measure is passive ankle dorsiflexion with the application of 17Nm torque. All measurements will be taken by blinded assessors.

The overall aim of this research is to test the efficacy of a brief, early cognitive-behavioural therapy (CBT) intervention in reducing anxiety [including cancer-related Posttraumatic Stress Disorder (PTSD)], and/or depression and improving the psychological well-being and quality of life for adult individuals newly diagnosed with head and neck cancer (HNC) who have been scheduled to receive radiation treatment. It is hypothesized that the CBT program (experimental condition) will help reduce anxiety and depressive symptoms both in the short- and longer-term (up to 12-months) following the completion of patients’ radiotherapy regimens, compared with a non-directive Supportive Counselling (SC) program (active control condition).

Recent work has reflected importance of estrogen in causation of lung cancer. This is especially true for female population and non smokers. Present trial is designed to test the hypothesis that decreasing estrogen along with inhibiting nutrient pathway in cancer cells could lead to disease control. There is preliminary data to suggest that the combination might be useful for other patients as well. The other highlight of the study is the oral treatment in contrast to other treatments which are injectable chemotherapy.

The purpose of this study is to demonstrate that the efficacy and safety of 20 mg once daily rivaroxaban in preventing thromboembolic events in subjects with atrial fibrillation not related to mitral valve stenosis. Subjects with moderate renal impairment at screening (defined as calculated creatinine clearance between 30 and 49 ml/min inclusive) will receive a dose adaptation to rivaroxaban 15 mg once daily.

The aim of this study is to compare the effectiveness of an internet-based lifestyle modification (high protein diet) program, tailored for overweight/obese young women (age 18 to 35 years), against metformin or placebo treatments in achieving and maintaining weight loss. We also want to assess the effects of different methods of weight loss on reproductive function, metabolic health, and nutritional status. Information on psychological well-being and general health will also be collected.

We have developed a unique transfer technique which utilizes cells cultured on a therapeutic contact lens and propose that this may be a potentially novel treatment strategy for patients suffering severe corneal disease where corneal epithelial wound healing is not properly regulated, possibly as a consequence of stem cell damage, stem cell failure or stem cell depletion. Currently, patients are treated by grafting foreign or autologous stem cells that are cultured in the presence of animal products or by using techniques which involve growing ocular stem cells on amniotic membrane (foreign biological material) then transferring these cells along with the amniotic membrane to the damaged cornea. Our proposed system would be entirely autologous.

Many patients experience some degree of breathing difficulty after major surgery and breathing difficulties may be the basis for serious, but uncommon complications of anaesthesia and surgery. The use of sedatives and morphine-like drugs for the relief of pain, although very necessary, contributes to decreased breathing effort, pauses and obstruction. Patients with obstructive sleep apnoea (OSA) syndrome, associated with a history of snoring, observed pauses in breathing during sleep and daytime sleepiness, may be at especially high risk with anaesthesia. This syndrome is associated with obesity, and may be a partial cause for, many types of heart and lung disease. Specialized high-dependency postoperative care is advocated for these patients. We are interested in patients who do not have a definite diagnosis of OSA or severe symptoms, but who do have a high body mass index (BMI) and some abnormal airway features that imply increased risk of obstruction. Such patients may make up to 20% of patients presenting for elective surgery at the RMH. An initial respiratory monitoring study in progress, suggests that patients with these risk factors have increased breathing difficulties and reduced blood oxygen in the period after surgery. In the proposed study, patients who are considered to be at risk of breathing problems on the basis of questionnaires and examination prior to surgery, will be randomized to either standard opioid (morphine) pain relief for the first day after surgery or to a group where other pain relieving dugs (ketamine, parecoxib and tramadol) are used in an attempt to reduce opioid use while maintaining adequate pain relief. In both groups dugs will be used according to protocols approved by the Acute Pain Service at the Royal Melbourne Hospital.