ANZCTR search results

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

You can narrow down the results using the filters

31251 results sorted by trial registration date.
  • Effect of a chewing gum on growth of dental plaque and gum inflammation in the presence of oral hygiene: A Pilot Study.

    There is evidence that casein, a major protein in milk, combined with calcium and phosphate, called CPP-ACP may inhibit growth of dental plaque, alter the bacterial composition of plaque and inhibit development of gum inflammation. A large clinical study has been proposed, which will measure the effects of chewing gum containing CPP-ACP on dental plaque growth, plaque bacterial composition and gum inflammation. A previous pilot study compared the effect of chewing gum containing and not containing CPP-ACP in the absence of all oral hygiene. In order to further determine whether this study is feasible, a smaller scale study (pilot study) is required to be conducted that will compare the effects of gum containing two different amounts of CPP-ACP on these parameters in the presence of oral hygiene. The aims of this pilot study are to compare re-growth of dental plaque, changes in bacterial composition of plaque, and development of gum inflammation after chewing with two sugar-free gums containing two different amounts of CPP-ACP and no gum chewing at all, each for 14 days each, with concomitant twice daily toothbrushing with fluoride toothpaste. Eighteen adult participants will be recruited from staff and students of the Melbourne Dental Schools and their friends and family. Potential participants will first be screened by filling out a health questionnaire, having a dental examination by a qualified dentist on the research team, and providing two saliva samples; one at rest and one while chewing sugar-free gum, for two minutes each to ensure they produce normal amounts of saliva. These procedures will ensure participants will have no medical or dental conditions that might put them at risk by participating in this study. There will be three 14-day treatment periods, during which participants will complete a different treatment. The treatment periods will be separated by two 14-day rest periods. For one week prior to the first treatment period and for each treatment and rest period, participants will brush their teeth twice daily with fluoride toothpaste and abstain from using any other oral hygiene aids; e.g. toothpicks, floss, mouthrinses and will not chew with any gums other than their allocated gums during the treatment periods. The order of the three treatments will be random for each participant and unknown to researchers analysing the results. If they are chewing gum, they will chew one slab or two pellets of their allocated gum six times a day for 20 minutes each time. If they are not chewing gum they will just brush their teeth twice daily and abstain from all oral hygiene practices and not chew any other gum. The identity of the gums will be unknown to the participants At the start and end of each treatment period, participants will have a dental examination by the dentist on the research team to measure plaque (by staining their teeth with a plaque disclosing dye) and measure the amount of gum inflammation by visual inspection. They will also have plaque above the gums collected from all four upper molar teeth, which will be analysed for bacterial composition. They will then have all their teeth cleaned by the dentist, At the end of the study they will also have a professional fluoride treatment. Participants will be instructed to contact the research team if they experience any problems during the study so that a qualified dentist on the team can assess and deal with the problem accordingly. Participants will be paid for their time and commitment to the study and will be free to exit the study at any time.

  • Effect of a chewing gum on growth of dental plaque and gum inflammation in the absence of oral hygiene: A Pilot Study..

    There is evidence that casein, a major protein in milk, combined with calcium and phosphate, called CPP-ACP may inhibit growth of dental plaque, alter the bacterial composition of plaque and inhibit development of gum inflammation. A large clinical study has been proposed, which will measure the effects of chewing gum containing CPP-ACP on dental plaque growth, plaque bacterial composition and gum inflammation. In order to determine whether this study is feasible, a smaller scale study (pilot study) is required to be conducted. The aims of this pilot study are to compare re-growth of dental plaque, changes in bacterial composition of plaque, and development of gum inflammation after: 1) chewing with sugar-free gum containing added CPP-ACP; 2) chewing with sugar-free gum without added CPP-ACP; 3) no gum chewing at all, each for 14 days each in the absence of all oral hygiene practices. Eighteen adult participants will be recruited from staff and students of the Melbourne Dental Schools and their friends and family. Potential participants will first be screened by filling out a health questionnaire, having a dental examination by a qualified dentist on the research team, and providing two saliva samples; one at rest and one while chewing sugar-free gum, for two minutes each to ensure they produce normal amounts of saliva. These procedures will ensure participants will have no medical or dental conditions that might put them at risk by participating in this study. The order of the three treatments will be random for each participant and unknown to researchers analysing the results. If they are chewing one of the gums, they will chew two pellets of their allocated six times a day for 20 minutes each time and abstain from all oral hygiene practices and not chew any other gum for the 14 days. If they are not chewing gum they will just abstain from all oral hygiene practices and not chew any other gum for the 14 days. The identity of the gums will be unknown to the participants. At the start and end of each treatment period, participants will have a dental examination by the dentist on the research team to measure plaque (by staining their teeth with a plaque disclosing dye) and measure the amount of gum inflammation by visual inspection. They will also have plaque above the gums collected from all their posterior teeth, which will be pooled together and analysed later for bacterial composition. They will then have all their teeth cleaned by the dentist, At the end of the study they will also have a professional fluoride treatment. Participants will be instructed to contact the research team if they experience any problems during the study so that a qualified dentist on the team can assess and deal with the problem accordingly. Participants will be paid for their time and commitment to the study and will be free to exit the study at any time.

  • Trans-nasal Humidified Rapid- Insufflation Ventilatory Exchange in Children Requiring Emergent Intubation (Kids THRIVE): A Randomised Controlled Trial.

    Children may present to an emergency department with life threatening conditions that require immediate treatment to support their breathing to allow enough oxygen to be supplied to the body. In these circumstances a child is anesthetized and intubated, this process is associated with a high risk for low oxygen levels (14%) in the body or low blood pressure or heart rate. Newer methods to avoid these risks and improve patient safety are important to investigate. In this study we investigate a new approach called Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE); to prevent a drop in oxygen levels during intubation using nasal high flow oxygen delivery. This method allows continued post induction oxygen delivery during attempted intubation, whereas once the face mask is removed during traditional intubation the oxygen reservoir is no longer renewed and lower O2 levels can occur. We have tested this method in children with healthy lungs undergoing anaesthesia for elective surgery, and we found that we can maintain oxygen levels more than twice as long as using standard intubation methods. These findings would allow the operator in emergency settings more time and a safer condition to secure the airway in a sick child. It is though that by providing oxygen throughout the intubation adverse events such as oxygen desaturation are reduced and he number of successful first intubation attempts increases. The high flow system used for the THRIVE method is not new and is often used in hospitals to treat children with respiratory illness such as bronchiolitis. Therefore we aim to compare the addition of the THRIVE method to standard intubation practice with the current standard practice to intubate a child in an emergency situation. We aim to demonstrate that the new THRIVE method will reduce the risk for low oxygen levels in the blood and prevents low blood pressure associated with intubation.

  • Comparing the outcomes of two physiotherapy treatment approaches for persistent low back pain.

    Low back pain that persists for longer than 6 months is an expensive and troublesome problem for individuals and society. In this randomised controlled trial, volunteers with persistent low back or leg pain (> 6 months duration) will all receive 1 x 45-minute physiotherapy assessment plus 12 x 30-minute physiotherapy treatment sessions (over a 6-month period) and complete outcome questionnaires over a 12-month period. The trial compares two different physiotherapy treatment approaches. Participants will not know what the two treatment approaches are, and they will not know the study hypothesis. Treating physiotherapists will not know what treatment participants in the other group are receiving, Information about the two treatment approaches has therefore been withheld from the registry to maintain blinding, but full details have been uploaded to the registry and will be released at the conclusion of the trial.

  • Project Z: A pilot trial of a mobile-phone application to improve sleep in adolescents

    The aim of this project is to evaluate a recently developed mobile phone application (app) designed to reduce adolescent sleep problems, which are a common precursor to the onset of mental health problems. This project will investigate whether the sleep app is a feasible and acceptable tool to improve adolescent sleep, and whether there are any secondary effects on depression and anxiety. The app was developed by the research team, in collaboration with young people, who were consulted in a series of focus groups. We have used the information provided by adolescents to inform the concept and features of the app, which delivers evidence-based psychological strategies to address sleep problems, based on Cognitive Behavioural Therapy for Insomnia. The purpose of this project is to evaluate whether the app, Sleep Ninja, effectively reduces sleep problems experienced by young people with possible capacity to prevent common mental health problems such as depression and anxiety.

  • A study to compare a two novel ketamine wafer formulations to intravenous ketamine in healthy adult volunteers.

    Participants will be admitted to the research clinical for three separate inpatient periods, each period separated by a minimum of 3 days. Participants will check in the afternoon before planned dosing and will stay inpatient for 24 hours after study medication for each inpatient period. In one period, a single dose of intravenous ketamine 10 mg will be administered and in the two other periods a single 25 mg ketamine wafer (two different formulations) will be administered under the tongue. No food or drink except water is allowed starting 10 hours before each study medication dose and for 4 hours after dosing. Water is restricted 1 hour before and after dosing.

  • The use of duloxetine for the treatment of chemotherapy-induced peripheral neuropathy

    This trial aims to assess whether treatment with duloxetine results in a reduction in chronic neuropathic symptoms experienced as a result of neurotoxic chemotherapy treatment. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have had daily symptoms of peripheral neuropathy for at least 3 months after completing chemotherapy. Study details Participants in this study will be randomly allocated (by chance) to receive the drug duloxetine or placebo (inactive treatment) for 8 weeks. After a two week washout period, participants will switch conditions and receive placebo or study drug for another eight weeks. Those allocated to the study drug arm will be started on duloxetine 30 mg once daily, increasing to 60mg daily for weeks 2-7, and back to 30mg daily for week 8. Participants randomised to the control group will receive a daily placebo capsule to the dosage matching the treatment arm. Placebo tablets will look identical to duloxetine, and participants will not know which treatment they are receiving. All participants in the trial will receive duloxetine for 8 weeks. All participants will have liver and kidney function tests performed at baseline and at monthly intervals. Clinical examination, nerve conduction and excitability studies, functional assessment (nine-hole peg test) and self-report measures will be undertaken at baseline and after each 8 week treatment period. Patients will be asked to keep a symptom diary, which will be checked at each study visit.

  • Pilot study of Hippocampal Avoidance Technique for Whole Brain Radiotherapy in stage IV breast cancer with brain metastases

    This pilot study will gather preliminary data on the impact of Hippocampal Avoidance Technique for Whole Brain Radiotherapy on cognition and clinical feasibility for the treatment of brain metastases in patients with breast cancer Who is it for? You may be eligible to join this study if you are aged 18 years or above, have pathologically proven diagnosis of breast cancer stage IV disease with brain metastases which are outside of a 5 mm margin around either hippocampus Study details Whole brain radiotherapy (WBRT) is effective in providing local control of brain metastases and thereby preserving overall neurocognitive function as well as quality of life. Unfortunately, an adverse effect of WBRT is an often rapid decline in certain neurocognitive functions, particularly memory. This has been correlated with radiation induced injury thought to be crucial to memory formation. The planning of the treatment encompass the whole brain excluding the hippocampal avoidance regions, defined as the hippocampus with a 5 mm expansion. All participants will receive Whole Brain Radiotherapy using the Hippocampal Avoidance Technique of 10 radiotherapy sessions over a two-week period. The radiotherapy treatment will take approximately 5-10 minutes daily, however the total time in the department will be approximately an hour. Participants will be followed-up for up to 12 months after the completion of radiotherapy treatment in order to determine feasibility, safety, clinical benefit, survival rates and quality of life. Participants will also be asked to complete short verbal and written questionnaires to assess memory function and quality of life. These will be done before radiotherapy, on completion of radiotherapy and at follow-up appointments at 3, 6, 9 and 12 months. A CT scan and MRI scan of the head will be arranged prior to treatment, for the purpose of planning the radiotherapy. A follow-up brain MRI scan will be arranged at 3 months and 9 months after radiotherapy or when clinically indicated. This is consistent with current standard practice.

  • Does social media literacy mitigate impacts of social media in adolescents?

    The aim of this project is to examine whether social media literacy mitigates the negative impact of social media engagement on body dissatisfaction, disordered eating and well-being. As a means to address this question, the impact of a brief, universal, class-room based social media literacy intervention for grade 7 and 8 girls and boys on these outcomes will be evaluated and the moderating effect of social media literacy examined.

  • The effect of alcohol consumption on adult social drinkers' liking of snack foods

    This study will investigate the impact of consuming alcohol on the liking and characteristics of two different sets of savoury food snacks (newly developed food snacks, uncommon food snacks and common food snacks). Participants in this study will attend the study on two testing evenings and will be randomly allocated to a different set of snacks on each evening. Participants will drink a moderate dose of alcohol and then consume the provided snacks until they are comfortably full. They will be asked to complete questionnaires on their liking of the different snack foods including the flavour, appearance, mouth-feel and texture. Other data that will be collected from participants on each testing evening include multiple appetite and hunger ratings, blood samples collected to observe changes in biomarkers and breath alcohol concentration measurements. The results from this study will assist with the potential development of new food snacks to have when consuming alcohol for social drinkers.

Tags:
  • Finding clinical trials