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Phase 1 PK study with Descriptive statistics for Chrono Nicotine Replacement Therapy System (IDC-5) Including assessment of general safety

This study will investigate the effects of a workplace exercise intervention on cardiovascular disease risk, physical fitness and psychological health in adults aged 18-65 years working within an academic institution. It is hypothesised that adherence to a regular exercise program will result in decreased cardiovascular disease risk and increased physical fitness and psychological health.

This project aims to investigate whether the use of an individually tailored intervention (adapted from the Parenting Strategies Program, www.parentingstrategies.net/alcohol) is more effective at: a) reducing parental alcohol consumption, b) modifying parental attitudes and behaviours toward alcohol use (so as to be more in concordance with the Parenting Guidelines for Adolescent Alcohol Use), and c) reducing intention to drink in adolescents of parents within the intervention group, as compared to a control group whereby the parent participants receive a non-tailored summary of the Australian Guidelines for Reducing Health Risks from Drinking Alcohol (National Health and Medical Research Council, 2009).

Knee osteoarthritis is one of the most common forms of arthritis. Pain, the main symptom, is poorly controlled by current treatment strategies. Pain is thought initially to originate from structural changes in an affected joint. However, after a while, in some people, changes occur in the nervous system that perpetuate the pain. These changes are referred to as pain sensitisation. They are not addressed by current treatments. Amitriptyline is commonly used to treat pain related to pain sensitisation, such as in shingles or diabetic neuropathy. This study is a randomised controlled trial of the use of amitriptyline, in addition to usual care, to manage pain in people with painful knee osteoarthritis. People with knee osteoarthritis will be randomised to receiving low dose amitriptyline or a placebo with many of the same side effects of the active drug, benztropine. They will be followed for 12 weeks to determine the effect of amitriptyline on pain, function and other symptoms of knee osteoarthritis.

To compare fibroptic guided intubation through two supraglottic devices. This is helpful in the management of patients with difficult airways where conventional intubation is unable to be achieved

This study aims to determine how many people who are unsuitable for screening with the faecal occult blood test (FOBT) will take up bowel cancer screening with the new blood test instead. Who is it for? You may be eligible to join this study if you are aged between 50 and 74 years (inclusive), are at higher risk of developing bowel cancer and are unwilling or unable to participate in faecal screening tests for bowel cancer due to either personal or medical reasons. Study details: Bowel cancer screening is typically achieved with a FOBT which detects small amounts of blood in faeces. While this form of screening has been shown to be effective at detecting cancer at an early and more treatable stage, there are many people in the community who are unable to complete the screening test. This can be due to a dislike of sampling from faeces, or due to a condition that causes bleeding from the bowel (such as haemorrhoids) which would interfere with the results of the FOBT. We have recently developed a new form of screening for bowel cancer with a blood test which could provide an appropriate means of testing for these individuals. In our study we will determine how many people who are unsuitable for FOBT testing will take up bowel cancer screening with the new blood test instead. We will also determine what factors may influence their decision on whether to complete a screening test. As part of the study we will provide the participants (and their GPs) with their test result, and advice on further medical investigations should they test positive. A better understanding of how to provide better screening options for people at higher risk for bowel cancer is important and could have significant implications for public health practice.

Residents in aged care facilities are often the frailest in our society. They regularly have issues with cognition which can hinder their decision making capacity and which deteriorates over time. Residents or substitute medical decision-makers (Persons Responsible) often complete advance care plans to help inform future medical decisions in case of clinical deterioration. The residential aged care facility “Goals of Patient Care” form is a medical treatment order based on the patients advance care plan or wishes. This serves as a communication tool for staff in the aged care facility, visiting doctors (regular or locum GPs), ambulance staff and emergency department staff. The form helps guide healthcare decisions made on behalf of the resident in both planned and emergency situations. The form is filled in with the resident, or substitute medical decision maker, if the patient is unable due to presence of dementia. Residents’ GPs will be invited to be involved in the process also. We intend to implement the form in 3-4 pairs of residential aged care facilities. In each pair will be one facility using the intervention and one not using it. We will compare outcomes in both the intervention facilities (using the medical treatment order) and the control facilities (not using the medical treatment order). This comparison will look at residents’ usage of hospital services, including emergency reviews, emergency admissions, length of stay and outpatient reviews, to see the effect “Goals of Patient Care” has on these. We will also gather baseline characteristics on all residents involved including their previous 12 month hospital usage. We will investigate the uptake of the “Goals of Patient Care” form, ability of the residents to make healthcare decisions, presence of dementia without diagnosis in the residents, and death and place of death of residents. Our qualitative outcomes will include improvements in communication, ease of medical decision making and effect on conflict. We will gather data up to 12 months after the implementation of the form. We will survey the healthcare workers prior to implementation, and organise focus groups and brief interviews to investigate our qualitative outcomes with the healthcare providers involved at 6 and 12 months.

Diet and lifestyle change are key elements of the management of blood sugar levels and blood pressure in those with type 2 diabetes. There is growing evidence that foods containing lupin could make a positive contribution to management of diabetes. Lupin can be used as a novel food ingredient. It is rich in protein and fibre and contains negligible sugar and starch (glycaemic carbohydrate). It can be incorporated into foods such as bread to reduce the glycaemic (blood sugar raising) carbohydrate. We will conduct an intervention study in type 2 diabetic subjects to investigate the effects of regular consumption of lupin-containing foods on short-term control of blood sugar levels, blood pressure and attention and memory.

This study will examine the role of exercise in optimising asthma management. We will compare and contrast the effects of two exercise intensities: a single exercise session at a moderate-intensity (i.e. exercising at the level of a brisk walk or dancing) versus a single exercise session at a vigorous-intensity (more exhaustive, i.e. at the level of running or playing soccer). We will also compare these two exercise types with no exercise (control condition). We anticipate that while moderate-intensity exercise will be beneficial to asthma, the effects of vigorous-intensity exercise are unknown. We will collect sputum samples from 60 adults with asthma, both before and 4 hours following their exercise or rest session, and blood samples before, and 2 and 4 hours following the exercise or rest session. These samples will provide a direct measure of inflammation and antioxidants, both in the airways and bloodstream, thus enabling us to quantify the benefit or consequence of each type of exercise on inflammation in adults with asthma.

Diabetes results in an increase in the stickiness of platelets, which may result in blockage of arteries and other cardiovascular diseases. This is usually prevented with conventional cardiovascular medication (most commonly used Aspirin). Aspirin is a commonly used antiplatelet therapy (blood thinner) for patients with cardiovascular disease. However, it has greatly reduced efficacy in diabetes. This project is being conducted to evaluate an alternative to aspirin such as anthocyanin which is an antioxidant that has been shown to reduce narrowing of arteries. This study will compare the protective effects of aspirin with anthocyanin supplement, which is a rich natural antioxidant, on platelet (blood cells involved in clotting of blood and when not functioning normally can lead to risk of cardiovascular diseases such as stroke, heart attack or other heart diseases) function and activity as well as lipid (cholesterol and other fats) profile and inflammation. Any decrease in platelet activity and improvement in lipid profile and inflammation following the treatment will be suggestive of decreased thrombotic (narrowing and blocking of arteries responsible for heart attack and strokes) tendency and risk of heart disease in patients with diabetes. One hundred participants from 4 groups (normal healthy, diabetes with history of cardiovascular diasese, diabetes without cardiovascular disease and pre-diabetes populations) will consume either aspirin tablets 81 mg/day (1 tablet daily) or 320mg (4 tablets daily) anthocyanins (antioxidants from billberries and blackcurrant) for four weeks each as first treatment. they will then take second treatment after 4 weeks washout period. The fasting blood and urine sample will be collected at the baseline and post first treatment and again pre and post second treatment. Each blood sample will be tested for full blood examination, 3 different types of platelet function tests, coagulation profile, inflammation marker, HbA1c, lipid profile, uric acid and full blood + urine antioxidant levels and microalbumin. The data from this study will be used to guide management of antiplatelet and anticoagulant therapy more effectively in this population.