ANZCTR search results

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

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31593 results sorted by trial registration date.
  • Uterosacral ligament thickness: a novel ultrasound measurement for diagnosing endometriosis

    Endometriosis is a common and chronic condition. Whilst deep forms of the disease (ovarian endometriomas and deep-infiltrating endometriosis) are reliably diagnosed on ultrasound prior to surgery, superficial pelvic disease is not. This pilot study aims to assess a new ultrasound measurement to determine its accuracy in diagnosing superficial endometriosis. Patients scheduled for key-hole surgery will undergo pelvic ultrasound 1-2 months before surgery, then standardised surgical samples of the uterosacral ligaments (fibrous bands originating at the lower uterus) will be analysed. Should this ultrasound measurement be successful, it will improve diagnostics for endometriosis, and guide which patients may benefit most from surgery.

  • Identifying the ideal location for Deep Brain Stimulation (DBS) in the Treatment of Parkinson's Disease.

    Deep brain stimulation (DBS) is an established treatment for Parkinson’s disease (PD) and has been shown to improve the symptoms and quality of life of patients with this condition. The effectiveness of DBS relies on applying DBS therapy to an ‘ideal’ location to achieve maximal symptom improvement. This ‘ideal’ location is dependent on where the DBS lead is implanted during surgery and where the doctor choses to apply DBS therapy along the lead after surgery. Electrical signals recorded in the brain during DBS surgery may help doctors in identifying: 1) the ‘ideal’ location to implant DBS leads during surgery and 2) the ‘ideal’ location to apply DBS therapy after surgery. Evoked resonant neural activity (ERNA) is a new electrical brain signal that has been recorded from DBS leads during surgery in patients with PD. ERNA holds significant promise as an electrical brain signal that could guide DBS lead implantation during surgery and assist doctors in selecting the ‘ideal’ location to apply DBS. However, the reliability of recording ERNA signals in the brains of patients with PD is unknown. Therefore, the primary purpose of this study is the establish whether the ERNA signal can be reliably and safely recorded in the brains of patients with PD during DBS surgery. The secondary purpose of this study is to determine how the ERNA signal relates to the location of the DBS leads in the brain and the response of the patient to DBS therapy.

  • A mental health-informed, online health promotion and balance exercise program for adults aged 60+ years: the MovingTogether trial

    MovingTogether is a health promotion program for socially isolated, older adults that targets modifiable risk factors including physical inactivity and balance to improve mental and physical health outcomes. The program is delivered online, through a private Facebook group. Allied health professionals e.g. exercise physiologists and a dietician provide education, individual guidance and promote social connection within the group. Topics covered include increasing physical activity, decreasing sedentary behaviour, healthy eating, goal setting and balance training. The balance training portion of the program is covered by the inclusion of NeuRA’s StandingTall app. Our previous pilot study demonstrated feasibility, acceptability and preliminary effectiveness. With the general protocol maintained and improvements made to program design since, we hypothesise that the program will be effective in comparison to a control group.

  • The effectiveness of SunGold (trademark) Kiwifruit consumption in supporting psychological wellbeing in an adult population.

    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.

  • A feasibility RCT of a virtual version of Club Connect: a healthy brain ageing cognitive training program for 'at-risk' older adults

    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.

  • Real world management and outcome of melanoma patients in Australasia using the MASTER registry.

    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 De-Labelling in Paediatric OutPatients (PADLPOP) study

    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.

  • The effect of the vaccine for COVID-19 on menstrual cycle symptoms in healthy women

    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.

  • Acceptance Commitment Therapy (ACT) for distress associated with inflammatory bowel disease

    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.

  • iACT: Information and acceptance and commitment therapy (ACT) based self-help intervention for carers of people with advanced cancer.

    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.

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