ANZCTR search results

The purpose of the present study is to quantify, measure and investigate the effects of time-restricted feeding of a high-fat diet on circadian metabolomics, blood glucose, insulin, lipids and hormones with regulatory roles in satiety/appetite compared to unrestricted feeding of the same high-fat diet. We hypothesize that in the face of a high-fat diet (HFD), time-restricted feeding will ‘rescue’ the disruptions to circadian metabolomics observed with unrestricted intake of a HFD (previously demonstrated in animal models).

The primary purpose of this trial is to evaluate the effectiveness of Ex-Med Cancer, a community-based exercise medicine program designed to improve physical and psychosocial wellbeing in cancer survivors. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and have completed cancer treatment (surgery, chemotherapy and/or radiotherapy) within the previous one year (Note: participants are eligible if they are currently receiving/scheduled to receive hormone therapy). Study details All participants enrolled in this trial will complete a 12 week group-based, supervised exercise program delivered 3 times per week in community fitness centres/gyms in Victoria. Participants will receive an individualised exercise plan developed by an up-skilled exercise physiologist. Exercise sessions will last approximately one hour and comprise of a combination of aerobic, strength and flexibility training. This trial will provide information on whether Ex-Med Cancer is an acceptable, efficacious and sustainable model of care that has the potential to be translated into cancer care.

Heart disease is a major cause of death and disability in Australia. We have already shown that diet has a key role to play in maintaining blood vessel health. A low magnesium diet is emerging as a risk factor for heart disease and is associated with an increased risk of fatal and nonfatal ischaemic heart disease. Few studies have examined the effect of Mg on endothelial function in healthy adults. The hypothesis is that an improvement blood vessel function measured by flow mediated dilatation after a high magnesium diet achieved using dietary supplements.

A prospective randomised controlled trial comparing skin closure of surgical incisions in children using either a wound dressing only, adhesive tape (SteriStrips) or adhesive glue (Dermabond). The choice of which of these techniques is used is usually dependent upon the surgeon’s preference and there is little evidence to show which of the three is better. This study will help to determine which of these three techniques, if any, is better and will help paediatric surgeons choose the best skin closure technique for their patients. Parents of children presenting for elective surgical procedures will be approached for enrolment. Participating children will then be randomised to have surgical incision skin closure with sutures and then either adhesive tape, adhesive glue or a simple wound dressing. Postoperatively, children will be followed up at 2 weeks via telephone survey where a parental satisfaction survey in terms of the wounds will be performed. Parents will also be asked questions related to: 1. Wound healing 2. The presence of any complications such as wound infection 3. Requirement to see a doctor regarding the wound postoperatively, 4. Time taken for each skin closure type to come off 5. Any parental concerns regarding the type of skin closure used. Parents will also be asked to fill out an online survey in which they will rate the cosmetic outcome of the wound. Parents unable to be reached via telephone will have a link emailed to their email address to complete the entire survey online. There will be a second followup at 6 weeks postoperatively where children will be reviewed by a paediatric surgeon in the Outpatients Clinic to assess the cosmetic outcome of the surgical wound and parents will be asked to complete a survey in hard-copy or on an iPad about the cosmetic outcome of the wound and overall parental satisfaction with the skin closure technique. Data collected will then be used to assess for differences between the three patient groups including blinded photographic assessment of the surgical wounds. This project will aim to look for differences between the three groups in terms of cosmetic outcome (as rated by the parents and a blinded paediatric surgeon assessor), differences in wound infection and wound breakdown rates and a comparison of parental satisfaction with the skin closure technique. It is hypothesised that, as all three wound closure techniques are used in clinical practice, it is likely that there will be minimal difference between the three groups. However these techniques have not been compared in a controlled trial.

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.