ANZCTR search results

It is well recognised that wellbeing has close links with learning (NSW Department of Education and Communities, 2015b); where improvements in wellbeing have the potential to bring about positive change in self -concept and a lack thereof, can negatively affect a student’s engagement and success in learning (NSW Department of Education and Communities, 2015b). Consequently, there has been increased attention given to the study of wellbeing over the past decade, particularly in educational or school settings. The wellbeing of adolescents has become a recent focus in public health due to the prevalence and rise in mental health disorders in this age group in recent times (with approximately 20% of adolescents worldwide having a diagnosed mental health illness) (Patton et al., 2012); and with the negative health consequences associated with physical inactivity trends in this age group (World Health Organisation, 2014). In Australia, the proportion of young people aged 16–24 years having high or very high levels of psychological distress is approximately 9%, the prevalence of mental disorders is approximately 26% (Australian Institute of Health and Welfare, 2011), and almost 80% of adolescents are not meeting physical activity guidelines (Hallal et al., 2012). Mental disorders and physical inactivity are now considered leading causes of ill-health in this age group, often with lasting effects throughout adulthood (Kieling et al., 2011; Kohl III et al., 2012; World Health Organisation, 2014). Of note, there is a distinct gender pattern in physical and mental health after the age of 13 years, with adolescent girls generally reporting more mental health problems than boys and exhibit lower levels of physical activity (Beets, Bornstein, Beighle, B.J., & Morgan, 2010; Myrin & Lagerstrom, 2008; Nitzko & Seiffge-Krenke, 2009) When combined with inadequate coping strategies, increased stress levels in the adolescent years can have profound and negative health consequences (including anxiety and depression) (Chrousos, 2009; Dougall, Hyman, Hayward, McFeeley, & Baum, 2001; K. A. McLaughlin & Hatzenbuehler, 2009a, 2009b; K. J. McLaughlin, Baran, & Conrad, 2009; Seiffge-Krenke, Aunola, & Nurmi, 2009)

This is a double-blind, placebo-controlled, crossover study assessing the therapeutic effects of curcumin in 60 youth suffering from attentional problems. Each participant receives both treatments (8 weeks of curcumin and placebo) and randomisation is used to determine the order in which the participant receives each treatment,( i.e. curcumin followed by placebo, or placebo followed by curcumin). The curcumin dosage is 500mg of BCM-95 'Registered Trademark' twice daily. Changes in attentional symptoms will be assessed via a computerised test for attention and the completion of several questionnaires.

This is a double-blind, placebo-controlled study assessing the therapeutic effects of saffron in 80 youth suffering from depressive and/ anxiety symptoms. Participants will be randomly allocated into either a saffron (affron 'Registered Trademark' - 14mg twice daily) or placebo group and changes in symptoms will be measured over an 8-week period.

The aim of this study is to examine whether very early dietetic intervention for people with newly diagnosed upper gastrointestinal cancer will enhance quality adjusted life years lived compared with usual dietetic care. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have primary new diagnosis of oesophageal or stomach or pancreatic cancer. Study details Participants will be randomised (allocated by chance) to one of three treatment groups (usual care, early intervention telephone or early intervention electronic messages via mobile application). For those randomised to intervention groups, participants will receive the active intervention for 18 weeks, commencing as soon as possible after diagnosis. Personalised nutrition support/ advice will be provided. Outcomes will be measured at baseline and at follow up at 3, 6 and 12 months. It is hoped that this study will demonstrate effectiveness of early and frequent dietetic intervention in enhancing quality of life and that intervention will be cost-effective while also minimising nutritional decline (weight loss).

This study will assess the use of cyclophosphamide post stem cell infusion as preventative treatment for Graft versus Host disease in patients requiring a haplo-identical stem cell transplant. Who is it for? You may be eligible to join this study if you are 16 – 70 years of age and have haematological malignancies requiring allogeneic transplantation, but have no readily available fully HLA-matched related or unrelated donors. Study details All patients will receive peripheral blood stem cell transplant from haploidentical relatives. Patients will either undergo myeloablative or non- myeloablative conditioning treatments prior to receiving stem cell transplants. The conditioning treatment selected is determined by the transplant specialist. Two groups will then receive a treatment aimed at prevention of Graft versus Host disease after stem cell transplant. If you receive myeloablative conditioning treatment, your post-transplant treatment will include cyclophosphamide 50mg/kg administered on day 3 and day 4 after transplant with cyclosporine [dose calculated on body weight] and mycophenolate [dose calculated on body weight ] commencing on day 5 after transplant. If you receive non- myeloablative conditioning treatment, your post-transplant treatment will include cyclophosphamide 50mg/kg administered on day 3 and day 4 after transplant with tacrolimus [dose calculated on body weight] and mycophenolate [dose calculated on body weight] commencing on day 5 after transplant. Total duration of treatment will depend if graft versus host diseas develops and how severe. It is anticiapted adding cyclophosphamide post stem cell infusion will prevent Graft versus Host disease or affect the rate of acute and chronic Graft versus Host disease

This is a phase 1/2, open label, multiple center, multiple dose study to assess the safety, and efficacy of ZYN002 administered as a transdermal gel for the treatment of children and adolescent patients ages 6 to 17 years with Fragile X Syndrome (FXS). Approximately 20 participants will be enrolled in this trial to assess the safety and efficacy of ZYN002 administered as a transdermal gel. The initial dose is 50 mg daily (QD) (Treatment A). Patients can have their dose adjusted up to 50 mg every 12 hours (Q12 H) after 2 weeks (Treatment B), and further up to 125 mg Q12 H (Treatment C) at Week 4. Through Week 6, dosing will be flexible (Treatment A, B or C) and, based on the Investigator judgement and the relevant assessments; the dose can be adjusted upward or downward as deemed appropriate. Patient safety will be monitored during study visits using standard measures, including physical exams, examination of skin at application site, vital signs (including oral or tympanic temperature), 12lead electrocardiograms (ECGs), a Modified Suicidality Checklist for FXS patient population, safety laboratory tests, urinalysis and Adverse Event (AE) monitoring. Each participants will be followed up 4 weeks post patient's last dose of study drug. If the participant has completed the Part 1 of this study (12 weeks of treatment) successfully and has shown a demonstrable response to ZYN-002, he/ she will have an opportunity to continue on to the Part 2 of the study which extends up to Week 64.

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.

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.

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.

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.