ANZCTR search results

This randomised pilot study measured the effects of a group Mindfulness in Pregnancy Program (MiPP) on stress, depressive symptoms, and awareness of present moment experience, compared to an active control Pregnancy Support Group.

This trial will compare the clinical performance of formofilcon B silicone hydrogel and etafilcon A hydrogel contact lenses against commercial silicone hydrogel and hydrogel contact lenses when worn for 30 days. The hypothesis is the subjective responses with test lenses are not different to the control contact lenses.

1. Hypothesis We hypothesise that red and processed meat and refined grains negatively affect insulin sensitivity or insulin secretion, compared with dairy products, legumes, nuts and whole grains. 2.Aims If a dietary pattern rich in nuts, legumes, whole grains and dairy products improves insulin sensitivity, this study will strongly support the recommendation of this diet for people with no diabetes. If a dietary pattern high in red, processed meat and refined grains affects negatively insulin sensitivity, this outcome will provide a convincing rationale in reducing the amount of intake of red, processed meat and refined grains for those with insulin resistance. This study will provide clarification on dietary influences on insulin sensitivity and contribute to lowering risks of developing type 2 diabetes by changing the dietary patterns. 3. Primary and secondary endpoints The primary endpoint of this study is to assess insulin sensitivity and the secondary endpoint is to analyse the biomarkers of insulin resistance.

Study IPX233-B14-02 will evaluate the placebo-controlled safety and the PK of repeated once-daily doses of a 4 mg dose of an ER formulation of IPX233 in healthy adults.

The purpose of this study is to investigate the feasibility of a 12 week progressive resistance training program versus usual care in overweight women with polycystic ovary syndrome. Participants will be required to attend two baseline and two follow up session for 1-2 hours at the University of Western Sydney Campbelltown for the assessment of body composition, isometric strength, menstrual cycle and psychological status. On separate days participants will also be asked to undertake fasting blood samples first thing in the morning at Douglas Hanly Moir pathology. Upon completion of baseline testing participants will be randomised to either the PRT or usual care group and will be given to participants in a sealed envelope. Participants randomised to the PRT group will be required to exercise four sessions per week, where two sessions will be supervised at the University Western Sydney Campbelltown campus while the other two sessions will be unsupervised (i.e. home based). . If you are allocated to the usual care group, you will be required to continue with your usual care management for the duration of the trial. The researcher will contact you weekly to document for any adverse events or reactions. Participants will also be required to maintain a diary to record their menstrual cycle details such as cycle length (i.e. day one of period and day one of next period), signs and symptoms etc.

The study is evaluating if a mobile phone based system can support patients to monitor their side effects, promote the delivery of evidence based self-care advice in a timely manner, and mediate the role of nurses to effectively provide real-time patient support. Who is it for? You may be eligible to join this study if you are aged over 18 years and have a diagnosis of one of three haematological cancers (Hodgkin's Lymphoma, Non-Hodgkin’s Lymphoma or Chronic Lymphocytic Leukaemia), and are receiving four or more cycles of chemotherapy treatment. Trial details Participants in this study will be randomly (by chance) divided into one of two groups. Participants in one group will be required to complete a symptoms questionnaire twice daily on a device (morning and afternoon) from Cycle 1 - Cycle 4 of their chemotherapy treatment. The intervention nurse monitors symptoms and responds if any alerts are triggered. A red alert occurs if a patient reports a symptom requiring urgent attention, and an amber alert occurs if a patient reports a symptom requiring non-urgent attention. In the case of an alert, the nurse will contact the patient by phone and query the symptom, provide self-care advice and support. The device is a mobile phone enabled Android tablet. The handset contains an application that prompts patients to complete a side-effect assessment questionnaire by following instructions on the touch screen tablet. Normal phone functions are disabled. All patients will be provided with the android tablet device and SIM card for the trial. Participants in the second study group will continue to receive usual care, which involves the regular appointments with their medical treatment team, provision of hospital contact details and education about chemotherapy prior to first cycle.

This study aims to add hormone treatment (aromatase inhibitor (letrozole)) to standard neoadjuvant chemotherapy and find out if this treatment is more effective in reducing the size of large breast cancers before surgery. More effective down-staging of large breast cancers before surgery increases the likelihood of achieving a complete surgical resection and can increase the rate of breast conserving surgery. Who is it for? You may be eligible for this study if you have ER-positive, HER2-negative invasive breast cancer that is > 20 mm in size, and is suitable for neoadjuvant chemotherapy with the aim to have surgery - either breast conservation surgery or mastectomy. Trial Details Participants will be planned for 18-24 weeks (or 6 to 8 three-weekly cycles) of chemotherapy before surgery (mastectomy or breast conserving surgery). Participants will be randomised at a ratio of 2:1 to either standard chemotherapy plus letrozole (before surgery) or to standard chemotherapy alone (before surgery). The participants randomised to standard chemotherapy plus letrozole treatment will take a letrozole tablet once per day at the same time they are having their chemotherapy treatment. Participants who are pre- or perimenopausal will also have a goserelin implant inserted under their skin to stop their ovaries producing oestrogen. All participants will have pre-treatment bilateral mammogram, ipsilateral breast and axillary ultrasound, research core biopsies and marking of the tumour, MRI of the breast and serial research blood tests. Additional research core biopsies will be taken prior to the 3rd chemotherapy cycle (between week 6 and week 7 if receiving weekly chemotherapy). Participants will be clinically assessed prior to each chemotherapy cycle or once every 3 weeks if receiving weekly chemotherapy. A post-treatment breast MRI will be done prior to surgery. Research biopsies of the breast tumour are required from the tumour at surgery. The effectiveness of adding the hormone treatment (letrozole) will be assessed by the size of the tumour at surgery. There will be one post-surgery follow-up visit.

The intranasal (IN) route of drug administration has many advantages. It has the potential to eliminate the pain, anxiety, and distress that can be associated with the use of needles for IV or IMI drug delivery. The risk of needle-stick injury and blood-borne infection is also minimized by the use of needleless systems. In addition, drug administration can occur more quickly than intravenous administration as there is no need to spend time siting a cannula and there is reduced resource utilisation. Recent observational research in the ED setting has revealed that more than 50% of inserted intravenous cannulae are never used for therapeutic purposes and pose a significant risk for skin infection and septicaemia if left in-situ. There is currently no data examining the pharmacokinetic profile of intranasal droperidol. However, based upon results with intranasal haloperidol, it is likely that droperidol, having similar pharmacokinetic properties, may display a comparable intranasal absorption profile. Currently, there are no anti-emetics or antipsychotic medications being administered intranasally in the clinical setting. As a result, if the pharmacokinetic profile is favourable, droperidol may be a useful drug to consider for clinical trials of intranasal treatment of acute behavioural disturbance and anti-emesis.

This study will evaluate the safety and efficacy of adjuvant Aspirin 200mg versus Placebo 200mg for patients with Dukes C colon cancer, high risk Dukes B colon cancer, Dukes B rectal cancer or Dukes C rectal cancer patients. Who is it for? You may be eligible for this study if you are aged 18 years or above, and have confirmed Dukes C colon cancer, high risk Dukes B rectal cancer or Dukes C rectal cancer for which you have had surgery to remove the primary tumour and completed at least 3 months of chemotherapy. Study details Participants in this trial will be randomly (by chance) allocated to one of two groups. One group will be provided with Aspirin 200mg daily for 3 years and the other group will be provided with a matching Placebo 200mg daily for 3 years. Participants will be asked to attend clinic visits every 3 months for a period of 3 years and thereafter every 6 months for 2 years to determine disease free survival, overall survival and quality of life.

Older Australians are now heavier than they were a generation ago, with 75% of this age group classified as either overweight or obese. Much of this overweight/obesity is likely to have resulted from poor diet and/or low levels of physical activity, which in the long-term contributes to chronic disease and related conditions. This intervention research will actively promote improvements in levels of physical activity, strength exercises and healthy diet via a home-based intervention that will educate, support and motivate participants through a range of strategies. Specifically, this intervention will target adults aged 50 to 69 years at risk of metabolic syndrome, residing in regional Australia (Albany). Participants will be required to be insufficiently active (< 150 minutes of moderate physical activity per week), and satisfy the diagnostic criteria for the metabolic syndrome (a predictor of type 2 diabetes mellitus and cardiovascular disease). It is hypothesised that by the end of the intervention, the intervention group participants compared to the control group will show significant improvements in: metabolic syndrome parameters; blood pressure; body weight; physical activity level; fat intake; fruit and vegetable consumption; sugar and fibre intake. The study will provide information on the impact of the physical activity and nutrition intervention on a range of physical and clinical variables in the older population in a regional setting.