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Recurrent headache is a common, disabling condition affecting millions of Australians. Migraine is a major cause of burden of disease ranking up to 6th highest cause of major disability worldwide. Globally, an estimated 0.8 billion people suffer from migraine. Headaches are a leading cause of lost work productivity, with reduced performance rather than absence from work being the main cause of lost productive time. There would therefore be considerable value in a simple, highly tolerable preventive therapy for the large number of people suffering from frequent migraine. In the pilot phase of this trial, the key objectives are to determine the recruitment, adherence, BP and LDL differences and assess the safety of the inventions consisting of a low-dose BP lowering combination and/or a low-dose statin in participants who experience frequent migraine.

There’s still so much we don’t know about how diet might affect the health of pregnant women and their babies. A healthy diet during pregnancy is recommended for good health, but many women find it difficult to eat healthily during pregnancy. We’ve developed an educational dietary program and would like to see how it compares to the support and dietary advice that women receive from their healthcare providers during pregnancy in influencing various health endpoints. This study is recruiting women in their second trimester (14 - 25 weeks) of pregnancy, so that they can participate in the study from the beginning of their third trimester (week 26), through to 4 weeks after their babies are born. What will the research achieve? The study will evaluate whether the program is helpful in supporting pregnant women to eat healthily during their pregnancy, and whether the procedures are practical and feasible. It also assesses the possible effect of the dietary program on certain biological aspects of health in pregnant women and their babies.

The main aim of this study is to trial the use of ultrasonic shear wave elastography to test the strength of the maternal cervix during pregnancy. The primary objective of this research is to establish the correlation between cervical stiffness and risk of preterm birth due to reduced cervical strength. This research will have multiple hypotheses. The first being that the cervical stiffness registered in non-gravid participants will be greater than in gravid participants. Secondly participants who deliver at preterm will have a reduced cervical strength compared to women who deliver at term. A further hypothesis is that cervical length will be related to cervical strength, the longer the registered cervical length, the greater the strength of the cervix, and also the cervical strength will be greater than the strength of the myometrium (muscle of the uterus).

The glycocalyx is a particle that is important in maintaining blood vessel health. High blood pressure is common, closely related to salt regulation, and affects the health of blood vessels. Animal studies have shown that the glycocalyx is affected in high blood pressure. Laboratory studies indicate that the use of spironolactone, a common blood pressure medication, can offset the effects of a high-salt environment on the glycocalyx. The purpose of this study is to assess if the glycocalyx is affected in people who have high blood pressure, whether the glycocalyx can be improved with good blood pressure control, and whether spironolactone has any additional protective benefits on the glycocalyx.

Premenstrual symptomatology is now widely recognised to be a major social and health problem, with epidemiological surveys estimating that up to 95% of women experience physical and psychological changes premenstrually (Mortola 1992). Up to 40% experience moderate distress, categorised by clinicians and researchers as Premenstrual Syndrome (PMS), and 13-19% experience severe distress and disruption to their lives, categorised as Premenstrual Dysphoric Disorder (PMDD) (Halbreich, Borenstein et al. 2003). The costs of premenstrual distress, in terms of impact upon women’s quality of life and economic functioning, are estimated to be considerable (Robinson and Swindle 2000). A range of PMS treatments have been developed, however, these have been directed solely at women with PMS, consisting of individual psychological therapy or medical intervention, and there have been no systematic evaluations of couple-based interventions for PMS. This negates research evidence that PMS is a relational issue, with premenstrual distress developing, and being positioned as ‘PMS’, within family relationships (Perz and Ussher 2006; Ussher 2006). Based within the University of Western Sydney, in partnership with FPA Health (Family Planning Association, NSW), the aims of this project were to draw on and augment an ongoing program of PMS research through: 1. Evaluating the relative efficacy of a brief couple-based PMS intervention, in comparison to an empirically supported one-to-one PMS intervention, and a wait-list control, within a randomised controlled trial, using the triangulation of qualitative and quantitative methods.

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of palbociclib in patients with advanced cancers and tumours with mutations in components of the Rb-pathway. Who is it for? All participants in this study must have completed screening as part of the Cancer Molecular Screening and Therapeutics (MoST) Program (ACTRN12616000908437), and been identified as having tumours carrying somatic mutations in the Rb-pathway including amplification or activating mutations in CCND1, CCND2, CCND3 or CDK4, or loss of function mutations in CDKN2A. They must also be able to swallow capsules. Study details All participants in this study will take the drug, palbociclib, orally once daily at a dose of 125mg/day for days 1-21, every 28 day cycle (3 weeks on, 1 week off). Treatment will continue until progression, unacceptable toxicity or withdrawal. All participants will undergo assessments at 8 weekly intervals or as clinically indicated in order to evaluate tumour response, safety and tolerability of treatment, health related quality of life during treatment, and overall survival. We cannot guarantee that patients will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that palbociclib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

There is an ongoing need for clinician participation and collaboration in biomedical and health research worldwide. In Australia, clinical research activities have traditionally been based in major tertiary public hospitals with affiliated academic departments and research institutes. Australia’s growing private healthcare sector accounts for a third of hospital beds and two-thirds of elective surgical admissions. Despite potential research opportunities, there is anecdotal evidence that many medical specialists are reluctant to participate in research in private hospitals. The majority of published studies regarding incentives and barriers to Australian clinicians’ research participation focus on trainees, general practice, allied health practitioners and public hospitals. Other countries with substantial private healthcare systems such as the United States have significantly different funding and organisational models. The aim of this study is to determine factors that may encourage clinicians’ participation in research in Australian private practice, by surveying medical specialists who are frequent attenders at Epworth HealthCare. The results of the study will provide information on doctors’ current and intended levels of, and perceived barriers and incentives to, participation in research activities, and whether these differ between private and public settings.

The FOCUS IN study is a clinical trial evaluating the impact of omega-3 fatty acids, found in fish oil, on inflammatory factors that contribute to heart disease. Coronary heart disease is due to a process called atherosclerosis, which the build-up of fatty tissue and plaque in arteries. Inflammation has been shown to be an important causal factor in atherosclerosis, and omega-3 fatty acids have been shown to have anti-inflammatory properties in previous studies. Study participants will be randomised to supplementation with various types of fish oil or a placebo for 30 days, and serum will be taken before and after supplementation. Serum will be added to cells in culture, derived from blood vessels and fat cells, and the impact of the serum on inflammatory factors that contribute to heart disease will be measured. This method of adding omega-3s to cells is a more biologically plausible method of studying the impact of omega-3 consumption on cellular function than adding pure omega-3s directly. The results of this study will guide further human studies of omega-3 supplementation on the development of heart disease.

People with dementia, their carers and families will be supported to identify services that meet their individual need and provide them greater control and choice. This will help ensure that these services/supports include opportunities for people with dementia full access to ‘life activities’ such as employment and recreation. Support will also focus on providing family members and/or carers the ability to actively participate in society and not be disadvantaged by their caring role. Active participation may mean continuing to work, attend school, university and receiving appropriate support in these environments. Staff providing support to people with dementia and their carers/families will be provided with: adequate resources and autonomy, capped case loads, access to appropriate emotional support, and an assistant and volunteer staff to assist with the identification/creation of services/activities and where appropriate the provision of support.

SAFE will be a pragmatic randomised controlled trial comparing, a McKenzie based self-management method where participants in the intervention group will attend 2 x 30 minute individual sessions with a trained physiotherapist and the control group will receive advice delivered over the phone and an educational booklet on how to manage back pain. 396 participants, who have recently recovered from an episode of non-specific low back pain, will be recruited through community and website advertisement and primary care clinicians (GPs, physiotherapists and chiropractors). Participants will be followed up for a minimum of 12 months. The primary outcome will be days from randomisation to first self-reported recurrence of an episode of activity limiting LBP (somewhat or greater activity limitation measured using an adaptation of item PI9 of the PROMIS item bank to measure pain interference). The secondary outcomes will be days from randomisation to first self-reported recurrence of (i) an episode of non-specific LBP (intensity equal or greater than 3/10 on the numeric pain rating scale, lasting at least 24 hours), (ii) an episode of care seeking (with consultation to a health care provider) LBP and impact of back pain measured by the Impact of Back Pain Questionnaire using 9 items of the 29-item PROMIS form.