ANZCTR search results

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.

Many babies are born early for a variety of reasons. These premature babies have more problems with growth and later development than other babies born at term. Babies born between 6 and 10 weeks early miss out on the important nutrition from the placenta. In addition, these newborn babies often lose further weight in the first week of life. Despite these recognised problems there is very little research about how best to address these issues. At present, these babies receive a simple sugar and water solution through an IV line whilst building up oral feeds with either breast milk or artificial formula. As a result many babies lose weight but also protein and fat as the simple sugar and water solution is unable to provide these babies with the more complex mixture of dietary supplementation they require. It is the purpose of this study to provide premature babies born between 6 and 10 weeks early with a more complex dietary infusion delivered through an IV line to improve their nutrition and reduce weight loss after premature birth. Ninety babies will be enrolled in the study with each having an equal chance of receiving either the routine sugar and water IV solution or a combined solution of sugar, protein, fat and water also through an IV line. The baby’s growth will be monitored up to three weeks of age. This study will provide important information about how best to improve the nutrition in premature babies, which we hope will also improve their longer term outcomes.

Identifying and treating women early in pregnancy with significant hyperglycaemia at glucose values on oral glucose tolerance testing (OGTT), characterised as Diabetes in Pregnancy (DIP), is important as it improves maternal and fetal outcomes. Similarly, there is good evidence from randomised controlled trials (RCTs) that identifying women with lesser degrees of hyperglycaemia on OGTT and characterised as Gestational Diabetes (GDM) at the end of the second trimester of pregnancy, also improves such outcomes. There is, however, currently no randomised controlled trial (RCT) evidence that using the same criteria to diagnose and treat women for GDM prior to 24-28 weeks gestation, benefits either babies or their mothers, while there is potential for harm through fetal undernutrition, inappropriately medicalising some pregnancies, and increasing overall clinical workload. ToBOGM is a multicentre RCT comparing immediate referral for treatment for those women with ‘booking GDM’ on OGTT vs treating such women as normal and awaiting the results of a repeat OGTT at 24-28 weeks, proceeding to treatment only if GDM is diagnosed at that stage. TOBOGM has been through peer review and is to be funded by the National Health and Medical Research Council (NHMRC).

Summary People diagnosed with ovarian cancer will receive chemotherapy either prior to (neoadjuvant chemotherapy) or following surgery (adjuvant chemotherapy). Previous research has confirmed the importance of treating people with ovarian cancer with regimes that contain carboplatin. As with all chemotherapies there are side effects associated with carboplatin treatment which include fatigue, nausea, vomiting and altered kidney function. More importantly, carboplatin treatment can have a significant effect on the bone marrow of people being treated, leading to anaemia and immunosuppression. In particular, carboplatin can decrease the number of cells known as platelets which are responsible for blood clotting. Therefore people whose platelet cell count is low as a result of carboplatin treatment are at risk of bleeding and the treatment doses and timing are affected. Currently, there is no adequate explanation for this observation. There have been reports confirming that paclitaxel can increase the blood concentrations of particular proteins associated with inflammation (cytokines) that are also responsible for stimulating platelet production. One such cytokine is called interleukin-6 (IL-6). This study aims to investigate whether the IL-6 protein is responsible for protecting platelets in people receiving paclitaxel. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above, with histologically confirmed epithelial ovarian cancer considered for neoadjuvant chemotherapy. Study details Participants in this study will receive the standard doses of carboplatin and paclitaxel used for first-line chemotherapy in the ICON Cancer Care, Johns Hopkins and MD Anderson and Gustave Roussy Gynaecological Oncology units. Chemotherapy regimens will be given as per local unit guidelines until the point of completing at least 3-4 cycles of treatment or prior study withdrawal. The primary difference between standard of care and this research is the collection of 10 ml blood for plasma samples for pharmacodynamic assessments at pre-treatment with each cycle of chemotherapy.

Arthritis is a disease that affects mainly the joints. Arthritis is a chronic, inflammatory disease characterized by swelling, tenderness and pain. AKP-11, is an experimental topical (applied to the skin) formulation being investigated for its potential as a treatment for arthritis. AKP-11 is anti-inflammatory drug candidate being developed for the treatment of arthritis, including gout, with mode of action targeting many pathological events at the same time.