ANZCTR search results

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

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31352 results sorted by trial registration date.
  • A Single-Center, Randomized, Double-Blind, Placebo Controlled Study of the Safety, Tolerability and Pharmacokinetics of Various Concentrations of Topical SM04554 Solution in Male Subjects with Androgenetic Alopecia.

    The main purpose of this study is to assess how safe and how well a topical solution, which is applied to the scalp of male participants who have a condition called male pattern baldness is tolerated. The secondary purpose is to assess how effective the topical solution is and also to assess the way the body absorbs, distributes and gets rid of the drug SM04554. .

  • Evaluation of the Pharmacokinetics of IPX231 (L0007, C0001) in Healthy Subjects

    To compare the pharmacokinetics of three IPX231 formulations administered subcutaneously as well as a single IPX231 formulation (IPX231-L0007) administered sublingually by two different methods: instillation via syringe versus spray in healthy adults.

  • Improving Vitamin D status and related health in young women: The Safe-D study – Part B

  • A study in healthy males to assess the safety and tolerability of two different formulations of the study drug, (MSP-2017), administered intranasally.

    The primary purpose of this study on healthy volunteers is to determine the safety and tolerability of two different formulations of study drug when administered via the intranasal route. There will be four study treatments: two active formulations and two placebos, or dummy treatments. Neither the study staff or the participants will know which treatment they are on. All formulations will be administered by the intranasal route using a single use nasal spray syringe. Each participant in each dose level group will receive two single doses of either both active drugs or both placebos, with the doses administered 48 hours apart via the nasal spray, in alternating nostrils.

  • Melatonin and Cognitive-Behaviour Therapy for the treatment of insomnia in individuals with schizophrenia

    The study is to evaluate the effectiveness of (i) Cognitive-behavioural therapy for insomnia in schizophrenia [CBT-I(S)] (ii) melatonin, (iii) a combination of CBT-I(S) and melatonin, and (iv) placebo, on insomnia symptoms, clinical symptoms, cognition, and functional health, in individuals with schizophrenia.

  • Study of F03 in Patients with Mild Cognitive Impairment due to Alzheimer's Disease

    The purpose of this study is to assess safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of F03 in subjects with mild cognitive impairment.

  • Dietary Fats and Biomarkers of Human Health: Excess Saturated Fat or Lack of Omega 3 Fatty Acids (Chronic Study)

    Consumption of foods rich in saturated fats have been associated with elevated blood lipid levels and adverse health effects. However studies using animal models have demonstrated that dietary saturated fats raise blood lipid (cholesterol and triglyceride) levels only when the diet is deficient in n-3 PUFA. If the same is true for humans, this research will have important implications for the prevention of cardiovascular and other chronic diseases. Therefore we hypothesise that saturated fat consumption does not raise blood lipid levels if the diet is sufficient in omega-3 polyunsaturated fatty acids. We also hypothesise that the benefits of n-3 PUFA can be optimised when consumed in combination with saturated fats. This is a randomised controlled, dietary intervention trial, in parallel design with healthy adults. Blood samples will be collected at baseline and after 6 weeks of dietary intervention with omega-3 polyunsaturated fatty acids (n-3 PUFA) supplementation either in combination with saturated fat or omega-6 Polyunsaturated fatty acids (n-6 PUFA). The saturated fat group will consume butter (24g, which can be spread on bread, muffins or crackers), white chocolate (40g) and 4 capsules of fish oil (4 x 0.5g), participants will also be advised on how to use more foods containing saturated fat for cooking. The n-6 PUFA group will consume margarine (20g, which can be spread on bread, muffins or crackers), sunflower seeds (42g) and 4 capsules of fish oil (4 x 0.5g), participants will also be advised on how to use more foods and oils containing n-6PUFA for cooking. Participants will be asked to fill a medical and a physical activity questionnaire and will have their anthropometric measurements taken in each of their visits. Subjects will also complete a 3 day food record.

  • In-hospital mortality rates after a cemented femoral component for displaced neck of femur fractures.

    This cohort study aims to investigate the in-hospital mortality of patients with a displaced femoral neck fracture when treated with a cemented femoral component. This un-selected series will be the largest in the current literature. There is some discussion in the orthopaedic community about the role of cement in post-operative mortality. The aim of this study is to examine this more closely in a controlled setting where every patient requiring arthroplasty receives the same cemented prosthesis as standard care.

  • What is the efficacy of therapist-guided internet-treatment, self-guided internet-treatment with pre-treatment contact, and purely self-guided internet-delivered for older adults (60+) with symptoms of anxiety and depression?

    This project is part of a research program funded by beyondblue to develop and evaluate Internet based treatment programs for older adults (60+) with anxiety and depression. This project examines the relative efficacy of guided and self-guided internet delivered treatment. Additionally, the study aims to examine the effect of a pre-treatment interview upon treatment outcomes for self-guided interventions. We expect that the guided intervention will result in superior outcomes to the self-guided interventions. Additionally, we expect that the self-guided intervention which includes a pre-treatment interview will result in superior outcomes when compared to the self-guided intervention without the interview.

  • The effect of different media for sperm handling and injection at intracytoplasmic sperm injection (ICSI) on subsequent embryo cleavage: a comparison of the use of polyvinylpyrrolidone (PVP) and hyaluronan.

    Polyvinylpyrrolidone (PVP) has been routinely used in the intracytoplasmic sperm injection procedures to facilitate sperm handling for years although it's not degradable by the egg. Hyaluronan is a new alternative to PVP with all the features that PVP has and it's degradable by the egg. The proposed study aims at comparing the embryonic effect between these 2 reagents by using time-lapse analysis.

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