ANZCTR search results

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

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31349 results sorted by trial registration date.
  • An investigation of sleep monitoring techniques and the impact of the clinical environment on Intensive Care patients sleep.

    Sleep is an essential biological function which is required by all animal. The Intensive Care Unit (ICU) environment fails to be propitious for sleep, which has been attributed to immediate and long term physiological and psychological morbidities. It is widely acknowledge that sleep is critical for ICU patients’ recovery, however the ability to monitor and evaluate sleep amongst this patient cohort has eluded clinicians. Bio-physiological monitoring of sleep undertaken via polysomnography is not viable for widespread implementation into intensive care as it is cumbersome, expensive, technically difficult, and requires expertise in data analysis. However, identifying alternative sleep monitoring methods that are both accurate and feasible have eluded clinicians. The role of sleep is an aspect of clinical care that is imperative to address in order to improve patient health, support physiological homeostasis, and to implement strategies that mitigate the short and long term adverse effects associated with sleep disturbance that complicates patient’s recovery. This study is investigating whether sleep monitoring conducted by actigraphy will provide an accurate objective assessment of total sleep time and sleep fragmentation compared to polysomnography. Objectives: 1.To determine the total sleep time of patients admitted to ICU. 2.Evaluate the sleep architecture of patients admitted to an Australian Intensive Care Unit

  • Acupuncture for knee osteoarthritis and chronic low back pain

    Chronic non-specific low back pain and knee osteoarthritis are among the most prevailing chronic pain conditions. Despite the a wide array of treatment options available, not everyone receives satisfactory pain relief. This may be because people respond differently to pain treatments. An optimal and safe treatment is necessary. This project aims to determine whether people with two forms of pain adaptability respond differently to local acupuncture needling. We test this aim in people with knee osteoarthritis or low back pain. The pain adaptability of the participants has previously been determined using a cold pressor test. The acupuncturist is blinded from participants’ pain adaptability and delivers an acupuncture treatment of 8 sessions. The response to acupuncture is measured by assessing the change in pain at the knee or lower back through a pain diary before and after the acupuncture treatment. This project will contribute to the development of individualised medicine by targeting those who respond better to acupuncture.

  • The ‘Link onto Life’ Program: A Pilot Intervention using Dialectical Behaviour Therapy (DBT) to Enhance Coping and Wellbeing in Young People (18-24 years).

  • Rapid and accurate categorization of critically ill patients to measure recovery after hospital admission.

    The purpose of this feasibility study is to evaluate whether it is possible to accurately, rapidly, completely and confidently, categorized critically ill patients early in their ICU admission into eight unique and predefined categories for the purpose of follow up.

  • Australasian Decrease in IntraPelvic Obesity for Surgery trial: Efficacy of a very low energy diet (VLED) to reduce weight and improve outcomes in obese patients undertaking laparoscopic rectal cancer surgery

    The primary purpose of this study is to determine whether a very low energy diet (VLED) can reduce weight and improve outcomes in obese patients undergoing surgery for rectal cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or over with a BMI greater than or equal to 30 and have been diagnosed with adenocarcinoma of the rectum for which surgery has been prescribed. Study details Participants will be randomly allocated (by chance) to either the Optifast diet treatment, or the usual care treatment. Participants on the Optifast diet treatment will be restricted to 800 calories or less per day for 4 - 6 weeks before the surgery, using the Optifast diet products including nutritionally complete soup sand shakes. Participants in the usual care treatment group will receive care and advice prior to their surgery as normal. Patient outcomes will then be assessed at visits in the hospital stay at day three, then at day 14, four to six weeks, 3 months, 6 months, 9 months, 12 months, 18 months and 24 months after discharge. Further long-term follow-up will be conducted annually for an additional three (3) years after the 24 months follow up visit at which participants will undergo a blood sample and physical examination. It is hoped that the findings of this trial will increase understanding of the potential benefits of a VLED prior to surgery in obese patients with rectal cancers.

  • Effect of single versus multi-strain probiotic supplementation on the time to full enteral feeds in preterm neonates – a double blind randomised controlled trial

    Probiotics are live micro-organisms which, when administered in adequate amounts, confer a health benefit on the host. Probiotics have been proven to reduce necrotizing enterocolitis, a devastating and life threatening emergency in neonates. Over recent years, the role of probiotics in improving gut motility and function has emerged. Probiotics, especially specific strains could improve nutrition in neonates by improving tolerance of oral feeds. Intolerance or poor tolerance of feeds along with repeated infections are some of the factors contributing to malnutrition in these high risk infants. Prevention of nutrition related issues in newborns will improve their long term development as well as their growth. We propose to compare single strain probiotic as compared to multiple strain probiotic for their ability to improve oral feed tolerance in neonates. We will be administering either the single strain or multi strain probiotic after allotting the infant into either one or the other group and then examine the baby’s stool for presence of these good bacteria (contained in the probiotic). We will also be looking at the complex genetic structure of the bacteria in stool and study if probiotics could change the bad bacteria to good beneficial ones. We will enrol all newborns less than 28 weeks of gestation, after parental consent. The probiotic supplements will be administered to the baby after starting oral feeds and continued till the baby is near term (37 weeks of gestation). Since probiotics improve intestinal motility, we will be investigating whether multiple strain probiotic will improve it to a better extent as compared to single strain probiotic. We will administer a small amount of dye orally to the infant and observe its excretion into stools. The better the effect on gut motility, the faster will be the excretion and shorter will be the time to excrete the dye as well. In summary, this project will help us to conclude whether multiple strain probiotic will be more beneficial as compared to single strain for routine use in this high risk population.

  • TOPS: Trial Of Prevention Strategies for low back pain in patients recently recovered from low back pain

    TOPS will be a pragmatic comparative effectiveness randomised controlled trial with a parallel economic evaluation. It will combine three separate cohorts (TOPS Workers, TOPS Primary Care, TOPS Defence), pending funding approval, using an identical methodology. 1482 participants who have recently recovered from low back pain will be randomised to either a comprehensive exercise and education program conducted over 12 weeks, consisting of a single one-hour assessment session, 3 individual half-hour education sessions and 8 one-hour supervised group exercise sessions; or a minimal intervention consisting of the ‘Guide to Positively Managing Back Pain’ booklet and one 30 minute education and advice session. Participants will be followed up for a minimum of 1 year. The primary outcome will be days till recurrence of low back pain.

  • The NACSTOP trial: Investigation of the early cessation of N-acetylcysteine after paracetamol overdose.

    The primary purpose of the study is to investigate whether ceasing the use of antidote (NAC) in patients presenting early with paracetamol overdose in a low risk population is feasible and safe.

  • Does fortnightly telephone based support improve adherence to home exercise programs in obese clients awaiting bariatric surgery? A randomised controlled trial.

    The study aims to determine the benefit of phone coaching by an exercise physiologist to improve adherence to a prescribed home exercise program in the bariatric population. Improved adherence should increase physical function and quality of life and provide evidence for the development of a standardized approach for weight management.

  • Relative Bioavailability and Effect of Food and Esomeprazole on the Pharmacokinetics of PRN1008 in Healthy Volunteers.

    This will be a single center, four-period, open-label, complete crossover study to investigating the single dose pharmacokinetics of PRN1008 when administered as a liquid formulation compared to a tablet formulation under fasted conditions, the effect of a meal on the single dose pharmacokinetics of PRN1008 when administered as a tablet formulation and also, the effect of prior administration of a Proton Pump Inhibitor on the single dose pharmacokinetics of PRN1008 when administered as a tablet formulation. Participants will be screened for participation within 28 days before dosing. Participants will be admitted to the study unit the day before dosing (Day -1), then dosed in the mornings of Days 1, 3, 5 and 10, and will remain in the clinic up to Day 11, after collection of the final PK sample. Total participation will be approximately 47 days.

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