ANZCTR search results

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

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33057 results sorted by trial registration date.
  • An evaluation of the Mentalization- Based Treatment Families and Carers Training and Support Programme (MBT-FACTS) in a Child and Youth Mental Health Service

    The Mentalization-Based Treatment Families and Carers Training and Support Programme (MBT-FACTS) is a five session Mentalization Based Treatment (MBT) informed skills and education program for family members and carers of someone with Borderline Personality Disorder (BPD) (Bateman & Fonagy, 2019). MBT-FACTS focuses on providing family members and carers the knowledge and skills to interact more effectively with their family member with BPD. The sessions are structured and semi-manualised and include didactic psychoeducation, group discussions, in-session practice of skills and homework tasks to practice between sessions. The program was designed to be delivered by family members or carers with lived experience of caring for a person with a diagnosis of BPD. At Alfred CYMHS the program will be facilitated by both a carer support consultant with lived experience of caring for a family member with BPD, and a trained mental health clinician. The program is designed to provide families and carers the skills to understand and interact with their person with BPD differently. The project will evaluate the impact of the program on the experience of adverse events by family members and carers in relation to the person with BPD, and the wellbeing, depression, anxiety, stress, family functioning, and experience of burden outcomes for the family members and carers participating. The project will also evaluate the impact of the program on the experience of family functioning as reported by the person with Borderline Personality Disorder via survey, and also their broader experience and perception of having their person complete the MBT-FACTS program which will be gathered via focus group. The project will utilise a delayed-treatment Randomised Control Trial (RCT) design, with half of the referred families and carers allocated randomly to commence in the first treatment group, and the other half allocated to commence the program approximately 3months after the commencement of the first group. The young person with Borderline Personality Disorder will continue to receive treatment as usual regardless of the randomisation group of their family member or carer. Any usual supports available to the carer of family member will also remain available.

  • A study that examines the feasibility of establishing a database that examines how genes affect opioid drug response in palliative care patients

    Pain occurs in about 60% of people with advanced cancer. Currently, there is no method of predicting which opioid pain medication works best for each person, nor predicting who will develop side effects from which medication. This project will determine if it is feasible to collect clinical, biological and genetic data, in order to provide a personalised method of achieving optimal pain control. Who is it for? You may be eligible for this study if you are an adult with pain related to cancer. Study details All participants in this study will be seen twice in addition to their usual care – once at the enrolment into the study and once 7 days later. On these days participants will be asked for clinical information and to complete some questionnaires about their symptoms (questions about pain relief, side effects and levels of function) and given questionnaires to complete regarding their. A blood test will also be taken during this time, which includes samples for opioid levels in the blood, markers of inflammation and genetic markers. It is hoped that this research will determine whether it is possible to provide more personalised pain relief based on a patient’s clinical, biological and genetic information.

  • A prospective study conducted in an adult intensive care unit to measure the breakdown products of citrate during kidney dialysis

    The primary aim of the study is to quantify to plasma concentration of citrate metabolites (eg: triglycerides) when using RCA with CRRT. We expect to establish a means and standard deviations for these plasma concentrations. Our secondary aim is to track the concentration of citrate over time.

  • Does the use of oxytocin in a pulsatile fashion (intermittent boluses), when compared to the use of continuous oxytocin, for the commencement and/or assistance of labour, result in a reduction in the number of caesarean sections that are required?

    In 2017, at The Northern Hospital, one in three women required an induction (commencement) and/or augmentation (assistance) of their labour. Induction and/or augmentation is initiated with a medication called oxytocin that is given to you intravenously via a cannula (drip) that is placed on one of the veins on the back of your hand. Oxytocin may be given continuously, or it may be given in a pulsatile fashion (small amounts of the same medicine every 15 minutes). We believe that oxytocin given in a pulsatile fashion is more physiologically normal, which might reduce the incidence of emergency (unplanned caesarean sections) as well as reduce the frequency and severity of post partum haemorrhage (bleeding post the delivery of your baby).

  • The ICU Feedback Study: comparing response rate of paper based questionnaires versus electronic questionnaires in patients with a recent intensive care stay.

    Our study will mainly look at the response rate to follow up questionnaires in patients 3, 6 or 12 months after an intensive care stay of 48 hours or more. We want to asses whether a paper based follow up has a lower response rate compared to an e-mail or website based follow up. Secondary we want to asses the cost effectiveness of both methods. We hypothesize that the response rate will be higher when e-mail/website based follow up is used and that this method will also be more cost effective than paper bases follow up questionnaires.

  • Lifting light weights with blood flow restriction to improve muscular fitness and functional abilities in older people

    The application of blood flow restriction (BFR) via inflatable cuffs during low-intensity resistance exercise has been consistently demonstrated to enhance muscular development to training (i.e. large increases in muscle size and strength). This type of exercise could benefit older adults who cannot tolerate the mechanical stress associated with higher-intensity exercise. As such, research is needed to explore the muscular fitness adaptations (i.e. increased muscle size and strength) and functional outcomes (i.e. performance in tasks that relate to daily activities for older people) that can be achieved by performing low-intensity exercise with the addition of BFR. Importantly, this strategy could be beneficial for the initial phases of training, when older people are becoming accustomed to lifting weights and cannot lift heavy loads while they learn exercise techniques. The aims of this project are: 1) To investigate whether the application of BFR during 4-weeks of low-intensity resistance exercise prior to an 8-week heavier training program will enhance muscular size/strength and functional performance in older adults. 2) To determine whether the application of BFR during 4-weeks of low-intensity resistance exercise prior to an 8-week heavier training program will confer lasting benefits (increased muscle size/strength, and functional performance) for 4-weeks after the training program concludes.

  • Use and Effectiveness of the Smiling Mind Smartphone Application on Wellbeing of Children and Adults with Autism Spectrum Disorder and Their Caregivers

    We are testing the effectiveness of the Smiling Mind meditation app on wellbeing for individuals with Autism Spectrum Disorder (ASD) and their parents/caregivers. We want to know if regular use of this app can help individuals with ASD and their families manage feelings of stress, anxiety and depression.

  • A Phase II, Signal-Seeking Trial of the Clinical Benefit Rate Associated with Pamiparib in Subjects with Germline or Somatic BRCA1/2 High Grade Serous Ovarian Cancer or carcinosarcoma who have progressed on P-gp substrate chemotherapy or PARP inhibitors with the Presence of an ABCB1 Fusion and the Absence of a BRCA1/2 Reversion

    Ovarian cancer is the deadliest gynaecologic cancer in Western women. The purpose of this study is to test the effect of a new drug called Pamiparib in patients with high grade serous ovarian cancer with BRCA1/2 mutations who have progressed on PARPi or chemotherapy. Who is it for? You may be eligible for this study if you are aged 18 or over and have a diagnosis of high grade serous ovarian cancer or carcinosarcoma of the ovary (including primary peritoneal cancers and Fallopian tube cancers). Study details All participants in this study will take three capsules (60mg) of the medication Pamiparib every morning and evening continuously and will have hospital visits for assessments every 28 days for the first 8 months, then every 3 months thereafter, 28 days is defined as 1 treatment cycle. Participants will be asked to provide blood samples, biopsy tissue for analysis and allow access to medical records. Treatment with pamiparib will continue until disease progression, unacceptable toxicity for the participant, or participant discontinuation/withdrawal from the study. It is hoped this research will demonstrate the sensitivity of high-grade serous ovarian cancer and carcinosarcoma of the ovary to this new medication, expanding treatment options for patients with these cancer types.

  • Outcomes of surgery after removal of transvaginal mesh

    Transvaginal mesh for pelvic organ prolapse was approved for use in Australia in 2005. Since then, there have been complications and complaints which culminated in a Senate Inquiry. The Senate Inquiry reported back in March 2018. From January 2018, transvaginal prolapse mesh was withdrawan from use by the TGA in Australia. Mesh slings for urinary stress incontinence are still available in Australia. Following the Senate Inquiry, the Australian Commission on Safety and Quality in Health Care (ACSQHC) provided information for consumers on treatment options for pelvic organ prolapse and urinary stress incontinence, guidance documents for care pathways and guidance documents for credentialing of specialists for mesh implant and removal. The ACSQHC guidance document on mesh implant removal (attached) also recommended monitoring patient outcomes following surgical removal of mesh. Women with mesh complications, who elect and are suitable for mesh removal, will have a questionnaires (see attached) completed pre-operatively and at follow up visits. The questionnaires include symptomatology and visual analogue scores for pain. The aims of this study are to review our surgical transvaginal mesh removal outcomes in women who have had substantial mesh removed (retrospectively and prospectively) and review our surgical techniques.

  • Brentuximab Vedotin in combination with donor lymphocyte infusions for Hodgkin lymphoma relapsing or persisting after allogeneic stem cell transplantation

    This study investigates the effectiveness and safety of the combination of Brentuximab vedotin and donor lymphocyte infusions for Hodgkin lymphoma that has relapsed or persists after an allogeneic stem cell transplant. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with CD30+ Hodgkin lymphoma in any remission status, for which you are undergoing allogeneic hematopoietic cell transplantation (alloHCT) OR are less than or equal to 60 days post-alloHCT from a matched related or unrelated adult donor. Study details All participants in this study will be monitored for relapse of Hodgkin lymphoma by positron emission tomography (PET) scans commencing 60 days after allogeneic transplant, and then 3 monthly thereafter. Upon identification of relapse of Hodgkin lymphoma, patients will receive treatment with brentuximab 1.8mg/kg every 3 weeks intravenously. After 3 doses of brentuximab, patients will also commence donor lymphocyte infusions at an initial dose of 1x10^6 T cells/kg intravenously, escalating to a maximum of 1x10^8 T cells/kg in a graded fashion. Donor lymphocyte infusions will be administered once every 3 weeks for a total of up to 5 infusions. Participants will undergo PET scans to assess response every 3 months for 24 months. This research will examine the effectiveness of treatment with the combination of brentuximab vedotin and donor lymphocyte infusions, which may be an important strategy for patients with Hodgkin lymphoma that relapses after allogeneic transplant.

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