ANZCTR search results

Delayed Onset Muscle Soreness (DOMS) and muscle damage are common and expected self-limiting sports training related conditions that can result in a loss of muscle force and significant pain. For athletes required to train and compete in close succession, DOMS can pose an obstacle to optimal performance. At present there are multiple methods for treating DOMS. Methods include; cryotherapy, anti-inflammatory medications, stretching, hypo-baric oxygen therapy, homeopathy, ultrasound, E-stimulation, L-carnitine, rest and light exercise. To date, a sound and consistent treatment for DOMS has not been established. High-quality scientific research into Complementary and Alternative Medicines (CAM) and DOMS is limited despite the increase usage of such products by athletes. This is a randomised, double blind, placebo controlled trial that looks at four selected CAM’s in four sub-studies and their effect on DOMS and muscle damage in sub-elite athletes.

Sleep disorders are a significant public health issue in Australia. The direct ‘health care’ costs of sleep disorders account for only 2% of their estimated economic impact ($10.3 billion) which suggests that there may be too little investment in the prevention and treatment of sleep disorders. In a first of its kind, this project proposes to conduct a screening and awareness program to be run through community pharmacies by specially trained pharmacists. Further, the project aims to conduct a randomised controlled trial to evaluate the effectiveness of two sleep health models in the community pharmacy setting; a basic online screening tool for identification of sleep disorders versus a more comprehensive sleep screening and sleep health program for the diagnosis and reduction of patient risk factor profile for developing sleep disorders. Through the participation of pharmacists, patients with sleep disorders will have improved access to information about the diagnosis, treatment and management of their conditions, especially in rural settings. The increased awareness and education about sleep health amongst pharmacists and the general public will allow for improved identification of sleep disorders and disease management, and lead to cost savings for patients, providers and the health care system. Given previous success of pharmacy based screening and intervention programs by the research team, the project has a high likelihood of success, and will deliver very valuable outcomes. This will be the first project to test the effectiveness of community pharmacies as an alternative health care site for the improvement of sleep health outcomes in Australia, and one of the first globally.

This Phase Ib/II, open-label, multicenter trial is designed to evaluate the safety, pharmacokinetics, and efficacy of Apo2L/TRAIL when combined with rituximab in subjects with follicular, CD20+, B-cell NHL that has progressed following a response of = 6 months duration to a prior rituximab-containing therapy. The multicenter, international, randomized Phase II part of this study will commence only after the safety and available pharmacokinetic data from the Phase Ib part of the study have been evaluated by the Sponsor and have been provided to participating investigators and the FDA.

The objective of this pilot trial is to assess the safety of antibiotic drop instillation compared to a control group using saline drops instead of antibiotic during continuous lens wear.

The purpose of this project is to evaluate the success of two types of surgical procedures in the treatment of women with exertional or activity related urinary incontinence, commonly brought on by coughing and sneezing. Modern advances involve development of minimally invasive procedures which saw the introduction of tension free vaginal tapes (TVT) and transobturator tape (e.g. Monarc) which provides good success rates when compared to the traditional operation, although with the advantage of a quicker recovery. Both the TVT and Monarc tape have a success rates in the order of 85-90% but do attract complications such as bleeding and bladder injury (4-9%) at the time of needle passage, difficulty in passing urine, urinary urgency (2.9%), mesh material making its way through to the vagina (1%) or thigh pain. The MiniArc sling is a procedure that places the tape in a different way. It is inserted through a small vaginal incision with no exit site and acts more as a “hammock”. It may have less complication than the Monarc slings because of its exitless design. We aim to compare the success rate of MiniArc versus Monarc slings in treatment of female stress urinary incontinence with the hypothesis that MiniArc has at least the equivalent success rate

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This study will examine the effectiveness of a psycho-educational intervention aimed at promoting coping and psychological wellbeing in family caregivers caring for a relative receiving home based palliative care. The intervention will be offered in a full version (two home visits and one phone call) and the 'rural' format (one home visit and two phone calls). The main hypotheses are: 1. Primary family caregivers who receive the intervention will report: increased perceived competence for their caregiving role; increased perceived preparedness for their caregiving role; increased positive emotions associated with their role; decreased unmet informational needs; decreased levels of psychological distress, when compared with caregivers in the control group one week after the intervention. 2. Family caregivers receiving the intervention will report decreased levels of psychological distress when compared to controls 3 months following bereavement.

The study is a randomised, double-blind, multi-centre clinical trial to evaluate the use of Chinese herbal medicine in the management of endometriosis. Formulated Chinese herbs will be assessed against an inert placebo. Trial participants will be randomly allocated to either Chinese herbal medicine or placebo. Neither participants nor researchers/assessors will have knowledge of the allocation. It is a prospective clinical study in which participants are reviewed monthly for six months, and three month follow up. Stringent methodology includes an objective laparoscopy diagnosis of endometriosis and suitable outcome measures. The study also includes ensuring participants completing the trial and, facilitating consistent data collection and validity. The trial will be a multi-centre clinical trial with participants recruited and reviewed at several health centres. This will be the first clinical trial in Australia combining Chinese herbal medicine, an objective diagnosis (laparoscopy) and a strict methodological protocol.

Vascular dementia (VaD) is the second most common form of dementia and is a major cause of mental and physical disability in the elderly. There are currently no satisfactory or widely accepted medical options to help alleviate the symptoms associated with this disorder. Traditional Chinese medicine has a well-documented history of using herbal formulations for treatment of dementia-like disorders, but its therapeutic effectiveness has very little or no scientific validation. This controlled clinical trial will investigate the therapeutic effectiveness of a Chinese herbal medicine formula used in the treatment of VaD. 120 patients will be recruited to trial this formula over a four-month period.

Some evidence suggests that Chinese & western herbs may help reduce menopausal symptoms. Therefore, this study will investigate the effectiveness of a herbal formula to alleviate menopausal vasomotor symptoms and improve quality of life. The trial will consist of two arms, an intervention and a placebo group, with random assignment of participants. All participants and trial researchers will be blinded to treatment allocation. Preliminary data will also be gathered on the effect of herbal therapy on bone metabolic markers.