ANZCTR search results

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

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32707 results sorted by trial registration date.
  • Droperidol, Ondansetron, Placebo Antiemetic Trial for adult Emergency Department patients with nausea. (DOPAT)

    Study Purpose: Previous ED-based antiemetic research has failed to show a benefit of antiemetic drugs over placebo, with the possible exception of droperidol 1.25 mg IV. This has led to doubts about the value of ED antiemetic drug use, or further ED-based antiemetic research. Recent literature has suggested that the primary outcome measure in the ED-based placebo controlled RCTs to date (comparison of mean VAS change between groups) may not have been sensitive enough to detect true differences. Hence, for this study, an alternate primary outcome measure of VAS reduction in excess of 5 mm is being used, as this cut-off level has been shown to equate with symptom improvement. Study findings should then clarify whether or not antiemetic drugs do have value for ED patients, and may guide future research directions regarding antiemetic drug use in the ED.

  • A community based cross-sectional study on the association between Vitamin B12 status and sleep quality

    We aimed at examining the association between vitamin B12 status and sleep quality of healthy people in Melbourne between age of 18-65 years with diverse dietary plans and life style at a community-based setting. Based on the known roles of B12 on proper neuronal functions and the fact that one of the symptoms of its deficiency is tiredness, we hypothesis that B12 plays crucial role in maintaining good sleep quality in humans.

  • Effect of consumption of fruit juice on blood pressure and cognition in older adults over 8 weeks

    Anthocyanins are compounds found naturally in fruits and vegetables that provide the rich colour such as blue and deep red. These compounds possess strong antioxidant abilities which may protect the cells of the body from damage. Over recent years, there has been considerable interest in the health effects of diets that are high in plant foods, and particularly the role of anthocyanin content of foods. There is some research that has shown that intake of foods and beverages that are rich in anthocyanins may protect against age-related diseases, such as cancer, cardiovascular disease and neurodegeneration. The purpose of this study is to determine the effect of consumption of fruit juice for 8 weeks on blood pressure and memory and cognition in generally healthy older adults. The study will also determine if the fruit juice affects inflammatory markers in the blood (these are produced as the body's response to injury or infection) and change in gut microbiota population.

  • The influence of aerobic exercise on Conditioned Pain Modulation (CPM) and Manipulation Induced Pain Modulation (MIPM) effects in participants with tennis elbow.

    This study will investigate 2 natural responses that our nervous system uses to relieve pain called conditioned pain modulation (CPM) and manual therapy-induced pain modulation (MIPM). CPM refers to the capability of our body to inhibit the painfulness of one stimulus when another stimulus is also felt. For example, if you have a headache but then you stub your toe, the headache is forgotten. MIPM is the pain relieving effect you get following a manual therapy treatment. In this study, we are comparing CPM and MIPM responses in people with tennis elbow. If we find that both CPM and MIPM responses behave in the same way, then this may potentially indicate that they share similar pain processes in the nervous system. This will broaden our knowledge about the way in which physiotherapy influences natural pain relieving effects in the body, which will allow us to enhance the effect of manual therapy in clinical practice, Eligible participants attend the Physiotherapy Clinic at the School of Physiotherapy and Exercise Science at the Bentley campus of Curtin University for 2 test sessions, with a rest period of 3 days in between. Each test session will each take approximately one and half hours. They will be required to avoid taking pain medications 24 hours before each test occasion although they can continue to take them during the course of the experiment. We will also ask them to avoid any additional physiotherapy treatment and other physical treatments. Eligible participants will be randomly allocated to 15mins session of low intensity or moderate intensity aerobic cycling group by the Physiotherapy Clinic supervisor. Participants in each group will be initially tested for PPT at both elbow and wrist measurement sites. They will then be randomized to undergo a precondition CPM assessment protocol and an MIPM assessment protocol, in two separate test sessions (i.e. two study days) separated by three days. All CPM and MIPM protocols will be performed by the same assessor who will remain blinded to the level of aerobic exercise subjects are completing. Following completion of the aerobic exercise, all subjects will be reassessed for CPM and MIPM by the blinded assessor. The PPT value will then be analysed to determine if there is an association and/or a difference in the CPM and MIPM following the physiotherapy intervention. If both forms of pain modulation demonstrate a similar pattern of response, this would suggest a common underlying mechanism of action. This may provide a base from which to investigate the possibility of enhancing manipulation-induced pain modulation effects . It will therefore extend our knowledge of manipulation-induced analgesia (MIA).

  • Association between the analgesic effects of Conditioned Pain Modulation (CPM) and Manipulation induced Pain Modulation (MIPM)

    The proposed research is part of a PhD project in which we are investigating 2 natural responses that our nervous system uses to relieve pain called conditioned pain modulation (CPM) and manual therapy-induced pain modulation (MIPM). CPM refers to the capability of our body to inhibit the painfulness of one stimulus when another painful stimulus is also felt. For example, if you have a headache but then you stub your toe, the headache is forgotten. MIPM is the pain relieving effect you get following a manual therapy treatment. In this proposed experimental study, CPM and manual therapy analgesic responses will be assessed using CPM and MIPM assessment protocols, respectively, in patients with Lateral Epicondylalgia (LE; Tennis Elbow). Participants will initially undergo a through clinical screening to confirm that eligibility criteria are met. Eligible participants will then undergo CPM assessment followed by MIPM assessment, with a 15mins rest in between. Both protocols will use pressure pain threshold (PPT) as the main outcome measure to quantify the analgesic changes in response CPM and MIPM stimuli. The PPT values will then be analysed to determine if there is an association between the CPM and MIPM responses in this patient population. If both forms of pain modulation demonstrate a similar pattern of response, this would suggest a common underlying mechanism of action. This research may provide a base from which to investigate the possibility of enhancing MIPM effects by combining manual therapy with other treatment modalities. It will therefore extend our knowledge of manual therapy induced analgesia.

  • A randomised controlled study of the Health Intervention “SNAP” in Northern Territory prisons- where smoking is banned- to prevent relapse to smoking

    The Northern Territory (NT) prison population comprises 92% Indigenous Australians and 88% smokers. The NT prison smoking ban creates a population-wide abstinence. 864 men will be randomised to receive the Health Intervention SNAP (Smoking, Nutrition, Alcohol and Physical activity), or usual care (control group). Released participants will be followed up to examine relapse to smoking at Day 30 and 90 post-release. An additional outcome will be the comparison of the two groups on Nutrition, Alcohol and Physical activity risk factors post-release. Participant records will also be prospectively linked with PBS, Medicare, AIHW, and PHRN records.

  • A Phase II dose escalation study of cyclophosphamide in haematopoietic stem cell transplantation in severe systemic sclerosis patients unfit for standard dose cyclophosphamide.

    Patients with severe systemic sclerosis with cardiac complications requiring a stem cell transplant after their disorder progressing after standard treatment not deemed suitable for standard dose cyclophosphamide can be enrolled into an available cohort group to receive one of 3 different LOW doses of cyclophosphamide This study aims to reduce Treatment related side effects by reducing the intensity of conditioning, in particular cyclophosphamide dosage, in order to offer the potential benefits of stem cell transplant to patients normally excluded from HSCT whilst potentially maintaining efficacy. It is hypothesised that a lower dose cyclophosphamide stem cell transplant regimen of 12.5-35mg/kg/day in 3 cohorts will be tolerated with less toxicity than an historical cohort of 50mg/kg/day in patients with severe systemic sclerosis

  • Orthotopic heart transplantation followed by autologous stem cell transplantation in patients with cardiac AL amyloidosis - a Phase II study

    This study aims to investigate the safety and efficacy of autologous stem cell transplantation in AL amyloid patients with advanced cardiac disease. after a orthotopic heart transplantation. Who is it for? You may be eligible to join this study if you are aged between 18-65 years and have been diagnosed with cardiac AL amyloidosis. Study details All participants in this study are required to have previously received chemotherapy and a orthotopic heart transplantation before being enrolled in the study to received an autologous stem cell transplantation. Patients will undergo autologous stem cell transplantation (ASCT) within 3-6 months after OHT. patient will have an Autologous stem cell transplant using Melphalan 200mg/m2 on day -1 with stem cell collected given on day 0 previously from the patient before the study. All participants will be followed up every 3 to 6 months for a period of 5 years, in order to assess survival, and safety and efficacy of treatment. This pilot study will determine if treating patient with a stem cell transplant with cardiac amyloid after receiving a heart transplant will increase disease free survival

  • Effects of statins on cognition in older adults with dementia

    Background: Statins are effective in treating dyslipidaemia in older adults, reducing the cardiovascular related morbidity – however their adverse effects are more common and harmful amongst older adults. Additionally, the impact on cognition is unclear, with previous studies producing mixed results. The N-of-1 method has been demonstrated to be a feasible method of conducting deprescribing trials, generating strong-patient specific evidence as to the effects of discontinuing statin use on cognition. Aims: 1. To determine the effect on cognition of discontinuation and rechallenge with statins. 2. To determine the effects on quality of life and functional status of discontinuation and rechallenge with statins. Methods: A pilot interventional study of 30 older adults 80 years of age or older admitted to Royal North Shore Hospital, Sydney with current dementia diagnosis, and taking statins for at least 6 months will be conducted. Participants will be randomly assigned to statin and placebo treatment pairs with discontinuation and rechallenge of statins over the course of 4-months. At baseline (0-weeks), recruited patients will be subsequently randomised into either continuation of active statin treatment or placebo replacement for a period of 5-weeks. Participants will be followed at 5-weeks (Visit 2), 10-weeks (Visit 3) and 15-weeks (Visit 4). At each visit, patients will be crossed over into opposing intervention, either continuation of active statin or placebo. The primary outcome will be measured using the cognitive portion of the Alzheimer’s Disease Assessment Score (ADAS-CoG), which assesses the level of cognitive impairment on a 30-point scale with a psychometric test. The patients’ general practitioners will be contacted two months after trial completion to ascertain whether patients had discontinued, lowered dose, or continued their statin medication. Hypothesis: We hypothesise that patients will have improved cognition and quality of life when on placebo compared to when on statins.

  • Does nifedipine improve implantation and pregnancy rates in women undergoing in-vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) cycles?

    Implantation failure is the main factor affecting the success rate of IVF procedures. Excessive uterine contractions have been described as a potential reason for reduced implantation rates in IVF cycles. Contractile activity of the uterus could move the implanted embryo towards the Fallopian tubes or cervix/vagina or the embryo might even be expelled out of the uterus. Mechanical measures to reduce the uterine contractions at the time of embryo transfer include using a soft catheter without touching the fundus (the top of the uterus) and the use of ultrasound to guide embryo transfer. Various medications have been investigated to reduce uterine contractions, including cyclo-oxygenase inhibitors, B2-adrenoreceptor agonists, phosphodiesterase inhibitors. These have yielded variable results with atosiban, an oxytocin/vasopressin receptor antagonist, looking most promising for improving implantation and pregnancy rates. Calcium channel blockers are non-specific smooth muscle relaxants, used for the treatment of high blood pressure in adults and have an established role in preterm labour due to its uterine relaxing properties. In the uterus, the calcium channel blockers exert their “anti-contraction” effect by preventing the influx of extracellular calcium ions into the myometrial cell (the middle wall of the uterus) and have been demonstrated in laboratory experiments to have potent relaxant effect on human myometrium (the middle wall of the uterus). The most widely used and studied calcium channel blocker is nifedipine and there is evidence that this can be safely used in pregnancy. The objective of this study is to evaluate the effectiveness of nifedipine administration in improving implantation and pregnancy rates in IVF/ICSI fresh or frozen embryo transfers.

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