ANZCTR search results

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

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32101 results sorted by trial registration date.
  • The effects of the herbal preparation, STW5-II, on gastrointestinal motility in healthy volunteers

    This trial will observe the physiological gastrointestinal responses to a single dose (20 drops, 1.1 ml) of STW5-II, vs placebo, to investigate the mechanisms by which this herbal preparation may exert its gastrointestinal symptom relieving effects. Participants will attend two visits at which they will receive either STW5-II or placebo, and gastrointestinal motility will be measured for the following three hours. The hypothesis is that STW5-II will increase antral contractility compared with placebo.

  • Effect of mepolizumab on alternative functions of eosinophils in severe eosinophilic asthma

    Inflammation in the lungs and circulation can cause asthma symptoms and can be treated with anti-inflammatory medications. For people with severe asthma, the inflammation and associated asthma symptoms are still problematic despite treatment with high dose puffer medications. Eosinophils are a type of cell in the blood and airways that promote inflammation. Mepolizumab (Nucala) and benralizumab (Fasenra) are treatments that can be prescribed for people with a type of severe asthma who have high eosinophil counts in their blood. Mepolizumab and benralizumab lower the number of blood and airway eosinophils and have been shown to reduce asthma flare-ups by about half. Recent research has described some new biological functions of eosinophils in inflammation. This study will aim to determine if these eosinophil functions and other important inflammation processes are a) changed in severe asthma in people with or without high blood eosinophil counts and b) whether any inflammation remains in people treated with mepolizumab or benralizumab. This new knowledge could help researchers to develop new asthma medications and better use existing medications in the future.

  • The effect of an online diabetes risk communication intervention for people impacted by alcohol and other drugs: A randomized controlled trial

    Diabetes has been understudied in the substance use population and there have been strong calls to address this paucity. People with substance use problems are at high risk of developing T2D yet screening and education is not integrated into routine care. The aim of the proposed study is to assess the effectiveness of the T2D risk communication tool on T2D risk perceptions and behavioural intentions among people with alcohol or other drug problems (i.e. participants who are receiving treatment/support for substance use problems). Specifically, the study will examine whether personalised T2D risk feedback is more effective in improving risk perceptions and increasing health behavioural intentions to reduce T2D risk compared to an active control group. We hypothesise that participants receiving the personalised T2D risk feedback will report significantly more accurate T2D risk perceptions and greater behavioural intentions compared to participants in the active control group.

  • STED: Shorter therapies for non-underweight Eating Disorders

    Cognitive-behavioural therapy approaches for eating disorders (CBT-ED) are typically 20 sessions duration and can be challenging to access for consumers due to the time, cost and difficulty finding therapists who have the required expertise. While shorter guided-self interventions (GSH-CBT) designed to be used by non-experts have existed for a while as a first option in a stepped care approach, it has only been recently that a 10-session version of CBT-ED (CBT-T) has been available. This study compares these two brief CBT interventions to determine if either one is superior in treating non-underweight individuals with eating disorders.

  • STOP : Study of Tranexamic acid On Post Tonsillectomy haemorrhage

    STOP is intended to be a small pilot study conducted in a specialised paediatric emergency department (ED) examining the effect of giving the medication tranexamic acid or 'TXA' via a nebuliser on children aged 3-16y ears who come to the ED with throat bleeding after tonsillectomy surgery. We intend to study whether nebulised TXA is a safe and effective alternative to intravenous TXA, which is currently part of the standard treatment for this condition in the institution involved. Each child presenting to our ED with bleeding following tonsillectomy surgery will be screened for suitability, considered for enrolment and approached for consent to participate. Half of the patients will be allocated to a single initial dose of nebulised TXA and half will be allocated the standard single dose intravenous TXA treatment. We will grade the severity of bleeding from the throat on each patient firstly on their arrival to the ED and again 15 minutes after the TXA has been administered. We will also capture data concerning the timing of treatment, the acceptability and tolerance to nebulised TXA for this condition and information regarding the patient's episode of hospital care. The results will help us understand whether nebulised TXA is tolerated, easy to administer, its safety profile and its impact on post tonsillectomy bleeding in comparison to IV TXA treatment. We will also seek to establish if there is any evident differences in subsequent hospital stay and medium term adverse effects.

  • AVAL: Australian Vinorelbine use in Advanced Lung cancer

    The purpose of this study is to review the use of Vinorelbine as a chemotherapy treatment option in patients post immunotherapy for metastatic non-small cell lung cancer (NSCLC). Who is it for? You may be eligible for this study if you, have received immunotherapy for metastatic NSCLC and are a patient at one of the participating sites. Study details Participants in this study will continue to receive routine clinical care, which will not be impacted by involvement in this study. Enrolled participants will have clinical data collected at one time point from their medical record. Data will be collected on the tolerability and duration of Vinorelbine chemotherapy when used following immunotherapy treatment in patients with metastatic NSCLC. It is hoped this research will offer insight into the use of Vinorelbine as a potentially beneficial treatment option for patients with metastatic NSCLC in the post immunotherapy setting.

  • A randomised double-blind placebo-controlled study to evaluate the effect of curcumin on BDNF levels in otherwise healthy adults.

    A randomised double-blind placebo-controlled study to evaluate the effect of curcumin on BDNF levels in otherwise healthy adults. The aim of this study is to assess the effectiveness of a bioavailable form of curcumin on BDNF levels compared to a placebo in otherwise healthy adults aged between 18 and 40 years old.

  • To assess the safety, tolerability and pharmacokinetics of INCB86550 in healthy adult population.

    The purpose of this study is to assess the safety, tolerability of the drug INCB086550 and assess how this drug acts in the body with and without food and in combination with other drugs. who is it for? You may be eligible for this study if you are a male or female, aged 18 to 55, and you are in good health with no existing conditions. Study Details In Cohort 1 all participants will receive a single dose of the drug (orally in a fasted (no food) or fed (med calorie food) condition in Periods 1 and 2 by random assignment. In Cohort 2 through 5 subjects will be dosed with INCB086550 in combination with other drugs specified earlier. It is hoped this research will provide information as to how this drug acts in the body in fed and fasted conditions and in combination with other drugs, results from the study will affect how patients with cancer use this medication

  • A non-interventional study looking at safety and efficacy of medicinal cannabis prescribed to patients with symptoms of Irritable Bowel Syndrome (IBS).

    CALM-GUT study is an observational study that aims to evaluate cannabinoid based medicines as a potential therapy for reducing symptoms of irritable bowel syndrome (IBS). Patients over 18 years of age who attend Emerald Clinics for treatment of IBS symptoms with cannabinoid based medicines will be offered participation in the study. Patients are observed for 12 weeks, using a combination of validated questionnaires, self-reported symptoms, and regular follow up with a specialist GP or gastroenterologist. Baseline symptoms and responses to questionnaires will be compared to results after 12 weeks to determine if the treatment is safe and effective in this patient cohort.

  • Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Rosuvastatin Extended Release Capsules

    This is a single center, open-label, study of rosuvastatin 140 mg ER capsules (LYN-047) to evaluate its safety, tolerability, and PK when administered as 2 weekly doses in healthy male and female volunteers.

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