ANZCTR search results

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

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32712 results sorted by trial registration date.
  • A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FlecIH-104 in Healthy Volunteers

    This research project is being conducted to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single 35, 70, and 90 mg doses of FlecIH-104 when administered in healthy adult subjects via oral inhalation.

  • Assessing the glycemic lowering potential of kombucha when consumed with a high glycemic index meal by healthy volunteers with normoglycemia.

    The primary goal of this study is to assess if a 330ml kombucha drink will reduce the glycemic response to a meal.

  • Australian MRI-Linac Patient Imaging Trial

    The purpose of this study is to try out a new imaging machine, called Integrated Magnetic Resonance Imaging Linear Accelerators (MRI-Linacs) Who is it for? You may be eligible for this study if you are aged 18 years or older and are undergoing radiation therapy for cancer at Liverpool or Macarthur Cancer Therapy Centres in Sydney. Study details All participants in this study will have two MRI-Linacs scans. The scans will be about a week apart, and involve lying still on on different positions depending on site of treatment within a confined doughnut like machine. In addition to the scans, participants will also answer questionnaires, consent to access medical records, You may require a dye injected through your viens to enhance image quality depending on the area you are having treatment to. It is hoped this research will provide information to develop new imaging procedures on the Australian MRI-Linac. The data collected will be critical in developing future MRI Linac treatments on this device.

  • A Randomised, Double-Blind, Vehicle-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Two Dosage Forms of BTX 1801 Applied Twice Daily for Five Days to the Anterior Nares of Healthy Adults Nasally Colonised with Staphylococcus aureus

    The purpose of this study is to demonstrate the effectiveness of BTX 1801 presented as two different dosage forms to eradicate carriage of Staph. aureus on Day 12 in the anterior nares of individuals who are persistent carriers of Staph. aureus. The study will look to see whether there is a difference in the percent of anterior nares culture that are negative for Staph. aureus at Day 12 between active BTX 1801 formulations and the combined Vehicle formulations applied twice daily for 5 days.

  • Akynzeo for post-operative nausea and vomiting after bariatric surgery.

    Postoperative nausea and vomiting (PONV) is common in the setting of bariatric surgery and can be detrimental to patient recovery. Multimodal antiemetic strategies have been shown to be more effective than monotherapy to target the high incidence of PONV after laparoscopic surgery. The proposed randomised controlled trial will evaluate the efficacy of Akynzeo® (netupitant/palonosetron) to prevent PONV in patients with morbid obesity following bariatric surgery.

  • Can intravenous high dose zinc improve clinical outcomes in patients with COVID-19 infection?

    An outbreak of a new virus called novel coronavirus (COVID-19 or 2019-CoV) infection has posed significant threats to the health of people worldwide and the global economy. There are no vaccines for this virus, and there is no specific treatment for people infected with the virus. In severe cases, COVID-19 virus can spread to the lungs and cause extreme difficulty with their breathing. We call this acute respiratory distress syndrome (ARDS). Zinc is a naturally occurring essential metal required for the normal function of the body. Numerous studies have been done showing the potential of zinc to inhibit viral infections (including the common cold) in clinical trials and experiments. It is our study hypothesis that zinc will reduce the severity of COVID-19 infection and improve the clinical outcomes of patients with COVID-19 infection. Therefore, we plan to perform a study to test whether zinc (given as Zn chloride) is effective and safe in subjects with COVID-19 infection and to work out whether giving zinc to patients can make them get better quicker.

  • Effects of time restricted eating compared to diet modification in people with type 2 diabetes

    The proposed study will be the first to compare the benefits of TRE for improving glycaemic control compared with standard dietetic advice, in individuals with T2D in a chronic (6 months) randomised controlled trial. Evidence-based findings for the improvement of blood glucose control and longer term outcomes need to be developed in order for this information to be available for the design of larger studies, prior to being incorporated into current dietary guidelines and inform best practice. The combination of physiological and psychosocial measures will allow us to demonstrate the efficacy and safety of using TRE in a real-world setting to reduce the psychological burden of dietary modifications, whilst improving glycaemic control, for individuals with type 2 diabetes.

  • Nanofat: a novel therapeutic approach for vocal cord paralysis

    Glottic insufficiency can have negative effects on patient quality of life. This condition mainly affects the quality and strength of voice. Glottic insufficiency can be due to vocal cord paralysis. Autologous fat injection is a well-known technique used to manage paralysis, and has been utilised for many years as a valid technique. A new method of processing fat has been described whereby harvested fat can be processed and filtered quickly and efficiently, leaving behind an easily injectable liquid with a high number of stem cells, without requiring long processing times and highly specialised equipment. It is potentially a modern refinement and improvement of a long-standing technique. The proposed benefit of nanofat supplementation is that the volume of the injected cord is maintained for longer compared to fat grafting alone. due to increased adipocyte survival. Patients will be recruited to undergo nanofat injection for vocal fold paralysis. Prior to the surgery, patients will fill out questionnaires and have their vocal cords examined via stroboscopy and undergo objective acoustic and aerodynamic assessment. They will then undergo treatment with follow up assessments occurring at multiple timepoints thereafter, as described in our protocol. The effect of nanofat treatment will be compared with standard of care treatment.

  • Nanofat: a novel therapeutic approach for vocal cord scar

    Glottic insufficiency can have negative effects on patient quality of life. This condition mainly affects the quality and strength of voice. Glottic insufficiency can be due to vocal fold scar. Autologous fat and steroid injections have been described to manage vocal fold scar, and have been utilised for many years as a valid technique. A new method of processing fat has been described whereby harvested fat can be processed and filtered quickly and efficiently, leaving behind an easily injectable liquid with a high number of stem cells, without requiring long processing times and highly specialised equipment. It is potentially a modern refinement and improvement of a long-standing technique. The proposed benefit of nanofat supplementation is that the volume of the injected cord is maintained for longer compared to fat grafting alone. due to increased adipocyte survival. It also has anti-fibrotic effects that are favourable in the treatment of vocal fold scar. Patients will be recruited to undergo nanofat injection for both vocal fold scar. Prior to the surgery, patients will fill out questionnaires and have their vocal cords examined via stroboscopy and undergo objective acoustic and aerodynamic assessment. They will then undergo treatment with follow up assessments occurring at multiple timepoints thereafter, as described in our protocol. The effect of nanofat injection will be compared with steroid injections.

  • Maternal and neonatal outcomes from women infected with SARS-COV2 (COVID-19) during pregnancy

    This is a national study of women with confirmed COVID-19 in pregnancy in Australia. The study will collect information about all pregnant women who are confirmed to have SARS- CoV2 infection. The information will be analysed on a continuous basis to inform ongoing guidance for women and maternity staff as we respond to the pandemic. Specifically, the study will describe incidence, management and outcomes of COVID-19 in pregnancy and identify factors associated with better outcomes for women and their babies. Anonymous information will be collected by clinicians or clinical researchers who are based in maternity units in the Australia. Data collectors will have been sent a live link to a RedCap database to allow them to notify cases and complete an anonymous data collection form. SARs-COV-2 is a new strain of coronavirus that has not previously been identified in humans. which causes a respiratory illness, but it is not known what impact it will have on pregnant women and their babies. In order to investigate risk factors, management and outcomes, the researchers plan to extend data collection to include data on all pregnant women with SARS-CoV-2. The aim of this study is to learn more about the effects of SARS-COV-2 and its treatment on pregnant women and their babies. Pregnant women, are known to be at increased risk of developing more serious problems from respiratory viral infections, as was shown in the MERs, SARS and H1N1 'swine flu' epidemics. But little is currently known about this virus. This study will collect and report contemporary data to inform ongoing pregnancy and neonatal management in order to optimise modifiable outcomes.

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