ANZCTR search results

The aim of this study is to investigate the effects of daily consumption of gold kiwifruit on psychological health and wellbeing and other health related outcomes including biochemical parameters, and gut symptoms in adults aged 35-60 years with elevated (mild to moderate) stress, anxiety and depression. Gold kiwifruit contain exceptionally high levels of vitamin C. Vitamin C is recognised for its important role in mood, cognition and physical health and wellbeing. Gold kiwifruit has the potential to infer beneficial effects on the constructs of psychological wellbeing and gut health and functioning. The CSIRO will lead a 10-week trial involving daily delivery of gold kiwifruit in adults experiencing current mild to moderate levels of psychological distress and who present with sub-optimal vitamin C concentrations.

The use of cognitive training to target neuropsychological dysfunction in ‘at-risk’ patients including individuals with depression, and/or with subjective or objective cognitive impairment (including those with diagnosed mild cognitive impairment) represents a promising therapeutic option in the absence of any existing treatment. However, there remains a paucity of cognitive training programs being offered in public mental health settings, and in the context of a global pandemic, face-to-face interventions remain suspended. While our group has recently demonstrated feasibility, tolerability and acceptability for our group-based, face-to-face cognitive training program, due to the restrictions resulting from the current pandemic, we have been unable to continue to offer this valuable intervention to vulnerable older people. There is now an urgent need to evaluate whether we can deliver this intervention in a virtual mode for 'at-risk' older adults, who are now presenting in increased numbers due to the pandemic.

The aim of this study (registry) is to document diagnosis, treatment and outcomes for patients with advanced melanoma over time, in order to better understand survival and treatment efficacy in these patients. Who is it for? You may be eligible for this study if you are aged 18 years or older, and have been diagnosed with stage III or IV cutaneous or unknown primary melanoma. Study details Information regarding the multi-disciplinary management of melanoma, including surgery, radiotherapy, systemic therapy, and palliative care in the routine clinical practice setting is obtained via medical records. Information regarding the clinical outcomes of treatment, including time to disease progression and overall survival, will also be collected. Participants will be followed up for a minimum of 12 months and a maximum of 5 years, if funding for this extension can be secured. No additional tests or time commitment by participants is required. It is hoped that this study will allow a comprehensive analysis of melanoma diagnosis, treatment and outcomes, supporting much needed basic, translational and clinical research of this disease. This may help to provide insight into optimal management of advanced melanoma in light of new and emerging treatments.

Penicillin allergy labels are common and are associated with adverse outcomes. It is widely recommended that people with a penicillin allergy label have an assessment to check if they are truly allergic. However, access to penicillin allergy assessment services is currently very limited. This study will assesses the implementation of the ASCIA (Australian Society for Clinical Immunology and Allergy) 'Consensus statement for the assessment of patients with suspected penicillin allergies' in a real-world health care system. The study aims to identify children with a penicillin allergy label who are at no or low risk of a true penicillin allergy, arrange for them to undertake an assessment and de-label those with inappropriate penicillin allergies. The study aims to demonstrate that this model of care is safe, effective and is associated with health-economic benefits. It is hypothesised that children who are eligible for the study can be can be safely assessed and have have their allergy status verified in a community based private health service with no costs to the patient. It is hypothesised that the majority of patients will have their penicillin allergy label removed. Patients are assessed via the administration of a questionnaire and oral provocation challenge, if indicated. During an oral provocation challenge the patient takes a small and then larger amount of the antibiotic and observed to see if they react. If the patient does not have an immediate reaction they will complete a 5 days course of the antibiotic at home to assess for a delayed reactions. Patients are provided with documentation clearly stating their allergy status and which antibiotics can be safely taken. Parents and GPs are asked to update the My Health Record with their confirmed allergy status. Patients are followed-up for 12 months post intervention with a phone call at 4, 8 and 12 months.

Recently in countries that have vaccinated large volumes of their population, there have been many reports of women on social media and in other media describing changes in the menstrual cycle after receiving the Pfizer-BioNTech and Astra_Zeneca vaccines for COVID-19. The changes reported include alterations in the pattern of bleeding, postponement or advancement of the menstrual period, intermenstrual spotting, prolongation of bleeding and increased menstrual bleeding. Certain vaccines can cause a physiological trigger and increase cortisol levels in the body and thus can cause a temporary change in the menstrual cycle. A state of stress (conscription, war, significant life event) may directly impact on the menstrual cycle. Furthermore, the inflammatory response induced by a vaccine results in immune system products including cytokines and interleukins which also can have transient actions on the endometrium. In addition, the vaccine may affect menstrual symptoms such as dysmenorrhea, in other ways, via cytokines and other immune-mediated messengers. The study hypothesis is that the COVID 19 vaccine will cause no change to the pattern of bleeding (duration, volume, intensity, timing) and period related pain in reproductive age women both after a first dose and after two doses.

People living with inflammatory bowel disease (IBD) are susceptible to anxiety and depression, with up to 66% reporting symptoms of these disorders. Those with IBD who have anxiety and/or depression experience more frequent flare-ups, a more aggressive disease, and increased rates of hospital admissions and surgery. The present trial aims to establish whether including a psychotherapy program, ACTforIBD, into usual care for IBD is practical and whether it has a potential to improve wellbeing in IBD. ACTforIBD is an 8-week telehealth intervention that draws on Acceptance Commitment Therapy (ACT). ACT encourages acceptance of the incurable disease and improves people’s ability to work with problems that cannot be easily solved. To date, only one study examined ACT in IBD demonstrating its preliminary efficacy, but no studies targeting people with IBD and anxiety/depression are available. The program has been evaluated with good results by a consumer group.

This study will test the feasibility and acceptability of an information and Acceptance and Commitment Therapy based (ACT) self-help intervention for people who self-identify as carers of a person diagnosed with advanced cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, you self-identify as a carer of a person diagnosed with advanced cancer (defined as a diagnosis that has been described to the person as stage 4/advanced/metastatic, and is incurable or terminal) and you are living in New South Wales, Australia. People who have been diagnosed with cancer will not be eligible for this study. Study details All participants who choose to enrol in this study will be provided access to an online information hub, an an acceptance and commitment therapy (ACT) manual and an online support group for participants facilitated by the study psychologist. The information hub will be embedded within the study web page and will contain links to legitimate sources of written and video information that includes topics such as physical, psychological, spiritual and cultural, caring tips and information, patient and carer perspectives. The ACT self-help manual is designed to help carers cope better with their situation through psychoeducation and experiential exercises, including 4 accompanying audio recordings. It will be available to participants in hard copy and as an electronic version on the study website. A study psychologist will contact participants within one week of recruitment/baseline assessment and offer up to four support check-ins. Participants will be offered the opportunity to join the study’s Facebook support group page. At the conclusion of the study, participants will be asked to attend a one-on-on interview with a member of the research team to discuss their experiences during their participation in the study. It is hoped this research will demonstrate that self-help therapeutic practices for carers of people with advanced cancer are feasible to deliver remotely, and that these practices may reduce stress and improve the quality of life for these carers.

The primary purpose of this study was to examine if participants in the Collaborative and Proactive Solutions and Parent Management Training groups, treated in a community setting, would exhibit significant improvement in ODD symptoms at post-treatment and 6-month follow-up. We were also investigating if improvement in the CPS group would be similar to outcomes in the PMT condition. This study featured components of efficacy studies (studies set in universities with stringent criteria) and effectiveness studies (studies set in community settings with experienced settings). We further expected that there would be no differences in treatment outcomes related to elements of efficacy and effectiveness design (Michelson et al., 2013). In all, it was intended that this study would strengthen conclusions reached about the effectiveness of CPS by reproducing earlier RCT's in a community setting in Sydney, Australia.

This is a Phase 1, single-center, randomized, placebo controlled, single dose, double blind, parallel, pioneer-group, first-in-human (FIH) study to assess the safety, tolerability, and pharmacokinetics of RECCE®327 when administered as a single dose via a 1-hour IV infusion. All subjects will receive pretreatment with the antihistamine compound, cetirizine (Zyrtec®). Eight dose cohorts will be studied . An initial dose of 50 mg or placebo will comprise the 1st cohort of 10 subjects. The study will consist of a Screening period (up to 28 days), followed by Baseline assessments (Day -1), an in-patient Study Treatment Period (Day 1 and Day 2), and follow-up visit to the clinic at Day 7 (End of Study [EOS]). After fulfilling Screening requirements, all subjects will check into the clinic in the afternoon of Day –1 for Baseline assessments. Subjects will be randomized on Day -1 to the sequence of RECCE®327 or placebo. Subjects will remain under observation at the investigational site for the duration of the study, from admission on Day –1 until discharge from clinic on Day 2. All subjects will return on Day 7 for a follow-up visit, or sooner as the Investigator deems necessary.

This study aims to compare the effectiveness of a telehealth-delivered exercise program against a supervised clinic-based program at improving physical and mental health outcomes for prostate cancer patients. Who is it for? You may be eligible for this trial if you are an overweight/obese male aged 18 years or over, undergoing treatment or previously treated for prostate cancer involving androgen deprivation therapy. Study details Participants will be randomly assigned to a telehealth-delivered program or the supervised clinic-based program involving resistance and aerobic exercise for 6 months and then will be followed up for an additional 6 months. Additional consultations with a dietitian to address nutritional and dietary changes will also be involved. Information from this study will help develop a low cost and feasible program to improve the health outcomes of prostate cancer patients.