ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31611 results sorted by trial registration date.
  • International Study to Predict Optimised Treatment in Children and Adolescents with Attention Deficit/Hyperactivity Disorder

    The primary purposes of the iSPOT-A study are 1) to identify objective markers of ADHD, using cognitive, brain and genetic markers, and 2) to identify objective markers that predict treatment response to short-acting methylphenidate using cognitive, brain and genetic markers.

  • An open trial of a Cognitive Behavioural Therapy (CBT)-based smoking cessation plus Varenicline intervention in people with a psychotic disorder

    Rates of smoking are very high (>70%) amongst people with psychotic disorders such as schizophrenia, and this contributes to overall cardiovascular disease and other health risk, and contributes to premature morbidity. Current treatments targeting smoking in this group have had unsatisfactory outcomes, leaving a major gap in service provision. This study aims to evaluate a validated cognitive-behavioural smoking cessation intervention together with Varenicline, a novel smoking cessation medication. Given that this agent has the potential to have psychiatric side effects in people with a predisposition to mental illness, comprehensive safety checks will be put in place to ensure safety of participants.

  • The effect of daily versus depot vitamin D3 supplementation on vitamin D deficiency in Aboriginal children and adolescents in metropolitan and rural Western Australia

    The aims of the study are: 1. To examine if vitamin D deficiency is common problem in Aboriginal children in Western Australia (WA) 2. To determine if depot and daily vitamin D therapy have the same therapeutic outcomes. 3. To examine the relationship between vitamin D levels and childhood infections. 4. To determine the predictors of vitamin D deficiency in Aboriginal children We hyypothesize that: 1. Vitamin D deficiency is a common problem in Aboriginal children in WA 2. Depot vitamin D therapy results in better therapeutic outcomes than traditional daily vitamin D therapy. 2. Children with lower vitamin D levels have a higher burden of childhood infections. 3. Age, sun exposure, skin pigmentation and nutrition will influence vitamin D levels in children

  • The IDEAL Study: a clinical trial of the timing of kidney dialysis initiation on survival in subjects with chronic kidney disease.

    It has been suggested that dialysis should be commenced early, in subjects with progressive chronic kidney disease, in order to prevent illness and complications however this had never been proven. The IDEAL study was designed to determine when is the best time to commence kidney dialysis for the very first time. 8 Centers are participating in New Zealand. 24 Centers are participating in Australia.

  • The effect of a combined aerobic and resistance exercise program on people with Type 2 diabetes and peripheral neuropathy

    This research aims to investigate the effects of a combined aerobic and resistance exercise program on measures of strength, function and sensation in those with Type 2 diabetes and peripheral neuropathy. It will also aim to explore the safe prescription of exercise for these individuals, its effects on levels of quality of life, and to identify the potential barriers and enablers to a sustained exercise program.

  • A double-blind, randomised, multiple dose, phase III, multicentre study of Alpharadin in the treatment of patients with symptomatic hormone refractory prostate cancer with skeletal metastases

    Alsympca is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases. The aim of the study is to compare, in patients with symptomatic HRPC and skeletal metastases, the efficacy of best standard of care plus Radium-223 dichloride versus best standard of care plus placebo, with the primary efficacy endpoint being overall survival (OS). Patients will be randomised in a 2:1 allocation ratio (Radium-223 dichloride:Placebo). The study treatment consists of 6 intravenous administrations of Radium-223 dichloride or placebo (saline) each separated by an interval of 4 weeks. The patient will be followed until 3 years after first study drug administration. Within the U.S., the trial is conducted under an IND sponsored by Bayer HealthCare Pharmaceuticals. All patients received BSoC (Best Standard of Care)

  • Effect of three different breakfast meals with varying glycaemic load and dairy composition on cognition and satiety in healthy children

    The aim of the study is to examine the effect of dairy consumption on satiety and certain aspects of cognition (speed of processing, short term memory, working memory, attention and speed of reasoning) in a sample of primary school children aged 10-12 years. Primary outcome measures are post prandial glucose levels, satiety and cognitive functioning. It is hypothesized that meals with a lower glycaemic load and higher dairy composition will be associated with improvements in measures of cognitive function and satiety compared to a meal high in glycaemic load and containing no dairy food.

  • Optimising regulatory T cell depletion with cyclophosphamide in combination with chemotherapy for enhanced anti-tumour immunity in patients with non-small cell lung cancer (NSCLC) and malignant mesothelioma (MM).

    This study looks at the effectiveness of the chemotherapy drug cyclophosphamide in combination with pemetrexed-based chemotherapy in people with advanced malignant mesothelioma or advanced non-small cell lung cancer receiving first or second line palliative treatment. Participants will all receive low-dose repeat treatment with cyclophosphamide in combination with the conventional dose of pemetrexed-based chemotherapy commencing from the second cycle of chemotherapy, up to a maximum of 6 cycles. Patients will be monitored for safety at the beginning of treatment, weekly whilst on treatment, and at 90-days follow-up. The tumour will be assessed on CT scan at baseline, after every 2 cycles of treatment, and at least 3 monthly after the completion of treatment, until any progression of the disease. The study aims to see whether this treatment is effective by improving the way the immune system reacts against the cancer by assessing the number/activation/proliferation of various immune cells from weekly blood tests taken at baseline, weekly whilst on chemotherapy, and at 90-day follow-up visit.

  • Azithromycin in older people with airway disease

    The primary purpose of the study is to further the identification of effective treatment options for people with obstructive airway diseases, such as asthma and chronic obstructive pulmonary disease, and neutrophilic inflammation. The study will investigate the anti-inflammatory effect of a macrolide antibiotic, azithromycin, on airway inflammation, symptoms, quality of life and lung function. It is hypothesised that azithromycin therapy will reduce bacteria in the sputum and inflammatory cells of participants with neutrophilic airway disease.

  • A pseudo-randomised dietary intervention to evaluate the effects of a high protein diet on weight loss, body composition and other health outcomes in obese individuals who have gastric banding surgery.

    This study aims to investigate the usefulness of a high protein diet for obese individuals who have undergone gastric banding. It is a pseudo-randomised control trial comparing a high protein diet with usual dietetic care after surgery. The intervention period will be of six months duration with a further six months of follow-up. This study will help to inform best practice nutritional management for individuals who have had gastric banding.

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