ANZCTR search results

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

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33678 results sorted by trial registration date.
  • Phase I clinical trial of autologous Epstein–Barr virus-specific T cell therapy as treatment of progressive multiple sclerosis

    In this research project, we are trying to boost immune response against Epstein-Barr virus, with the aim of delaying the progression of multiple sclerosis (MS) and decreasing symptoms. Specifically, this trial aims to improve the killer T cell response against EBV, to enable the effective killing of virus-infected B cells. To do this, we are testing an experimental treatment for MS called adoptive immunotherapy. Adoptive immunotherapy involves collecting a patient's own blood, and then stimulating their T cells in the laboratory. This stimulation causes the EBV-specific T cells to multiply. Once the patient's EBV-specific T cells have been grown in the laboratory, they will be transferred back into the patient's blood, with the aim that they will recognise EBV-infected B cells in the brain and kill them. However, because some laboratory studies have suggested that EBV-specific T cells might aggravate inflammation in the brain and actually worsen MS, this treatment needs to be used cautiously.

  • The effects of prolonged wear of textured shoe insoles on walking in people with Multiple Sclerosis

    Many people with Multiple Sclerosis (MS) experience problems with walking, which can make day to day activities difficult and often leads to falls. Improving walking ability is, therefore, of primary importance in maintaining health, independence, and quality of life in people living with MS. Walking problems in MS are often caused by a combination of typical symptoms, such as altered function of muscles, nerves, and senses. The key to improving mobility is, therefore, to use a range of different treatment techniques which address each of these symptoms. Foot sensation plays an important role in keeping the body upright and balanced whilst walking, yet, we know from previous studies that people with MS often have poor sensation on the soles of their feet. It is, therefore, possible that wearing a specially designed shoe insole, which enhances sensory information at the feet, could help people affected by MS to walk better. This would offer health care professionals a new, additional treatment technique to help manage walking problems in MS. This study will explore whether long-term wear of a textured shoe insole can improve walking in people with MS. We will analyse how people with MS walk over an even and uneven surface, when they are wearing the insoles for the first time, and after wearing the insoles for three months. We will explore whether wearing the insoles changes the way the body moves, or the leg and trunk muscles work during walking. We will also monitor any changes in the perception of foot sensation and the awareness of foot position, to help us better understand how our insoles may bring about their effects on walking. The benefit for people affected by MS is that this study could lead to the development of a new treatment technique, specifically an inexpensive, easy-to-administer shoe insole, which could help towards improving mobility and independent living.

  • Does masters sport participation increase physical, psychological, cognitive and social functioning in recreational cyclists aged over 40 years old?

    To determine of masters sport participation increases physical, psychological, cognitive and social functioning Hypothesis - masters sport participation will increase physical, psychological, cognitive and social functioning functioning

  • A Randomised Controlled Trial Investigating Medical Hypnosis for Faster Healing & Pain Reduction in Children Following Burn Injury

    It is well­-documented that burns and the associated wound care procedures are painful and distressing for children. Non-­pharmacological techniques are used in addition to pharmacological methods for control of pain and anxiety. Medical hypnosis in adults undergoing burn wound debridement (wound-cleaning and removal of dead tissue) has resulted in reductions in pain and anxiety. To our knowledge, there have not been any randomised controlled trials that have examined the efficacy of medical hypnosis to decrease healing times and pain/anxiety scores in paediatric burn patients. The aim of this study is to investigate whether medical hypnosis reduces pain and anxiety and enhances re­-epithelialisation (i.e. wound-healing) in children with acute burn injury. We hypothesise that there will be significantly lower pain and anxiety scores, lower levels of biological stress markers (cortisol and alpha-­amylase) and faster wound re-epithelialisation in the intervention group compared with the control group.

  • Assessment of Cerebrovascular Function in Patients with previous Aortic Coarctation Repair

  • The efficacy of intravitreal aflibercept given in a ‘treat and extend’ regime in the treatment of cystoid macular oedema secondary to central retinal vein occlusion.

    In this prospective case series participants with cystoid macula oedema secondary to Central Retinal Vein Occlusion (CRVO) who are treatment naive will receive treatment with Eylea using an ‘inject and extend’ treatment protocol. In this study we aim to assess whether a ‘treat and extend’ regimen is a useful option in the treatment of CME associated with CRVO. We hypothesise that visual acuity outcomes will be non-inferior to that achieved in the pivotal trials and that this will be achieved with fewer visits to the clinic. The study will run for approximately 36 months. The recruitment period will last approximately 12 months. Participant involvement will last approximately 24 months.

  • Neurobiological correlates of improvements in depression with repetitive transcranial magnetic stimulation

    Repetitive transcranial magnetic stimulation has been shown to be efficacious for treating depression and has been approved by the TGA for the treatment of depression in adults who have not responded to at least 2 trials of antidepressant medications. However, some people do not respond to the treatment. Sleep-wake cycle disruption, reduced cognitive functioning and changes in brain chemistry are prominent features of depression. It is unclear how rTMS affects these features and whether they are associated with response to rTMS treatment. We seek to investigate whether these features of patients are associated with rTMS treatment response.

  • A pilot study of inferential comprehension intervention for children with specific language impairment.

    There is currently a lack of research investigating interventions which target oral inferential comprehension in children with specific language impairment (SLI). This is despite the knowledge that children with SLI demonstrate poor oral inferential comprehension, and the evidence showing the importance of this skill for later reading comprehension and learning. Therefore, this study will involve developing and piloting an intervention targeted at improving oral inferential comprehension in a small randomised controlled trial of children with specific language impairment. The intervention is evidence-based, designed based on the intervention principles pertaining to the large body of research in speech pathology journals regarding interventions for children with specific language impairment . The findings will therefore add to the evidence-base of interventions and effective practice in the area of language comprehension, leading to improved long-term language and literacy outcomes for children with specific language impairment. The participants will be randomly allocated to one of two intervention groups (the inferential comprehension intervention or the comparison intervention targeting phonological awareness). The participants will then take part in the intervention, implemented by the researcher. The intervention will involve small group (4 children) activities, for approximately 30 minutes, twice per week for 8 weeks over the course of one Term. It is anticipated that the participants receiving the inferential comprehension intervention will demonstrate a significant improvement in their oral inferential comprehension compared to the participants receiving the phonological awareness intervention. It is also anticipated that the participants receiving the phonological awareness intervention will demonstrate a significant increase in their phonological awareness skills compared to the participants receiving the inferential comprehension intervention. This finding will provide preliminary support for the effectiveness of oral inferential comprehension intervention with this age group and population, and inform the practice of speech pathologists and educators working with children with SLI.

  • An evaluative study on the safety and efficacy of standard anti-emetics compared to standard anti-emetics plus natural cannabinoids extract for the treatment of chemotherapy induced nausea and vomiting

    This clinical trial aims to compare the safety and efficacy of Cannabinoid Nasal Spray Micelle as an adjunct therapy for the treatment of chemotherapy induced nausea and vomiting in chemotherapy-naive oncology patients. Who is it for? All chemotherapy-naive patients receiving moderate-high emetogenicity chemotherapy aged 18 years or over. Study details: All participants in this study are randomly allocated to one of the two groups. Participants in one group will use a cannabinoid derived nasal spray in addition to standard nausea and vomiting treatment for five chemotherapy days. Participants in the second group will use a nasal placebo spray in addition to standard nausea and vomiting treatment for five chemotherapy days. There is a 50% chance of being assigned to one of the two groups. Participants are expected to have routine blood tests as standard of care provided by the medical oncologists. In addition, participants are expected to complete multiple questionnaires provided by the study investigators. The questionnaires will include 1) One RINV questionnaire per day (one on the day of chemotherapy, and one each of the 4 days post chemotherapy. 2) Two FACT-G/FACIT-F questionnaires per cycle. 3) One FLIE-5DR questionnaire per cycle. 4) Two ESAS questionnaires per cycle. 5) One Adherence Questionnaire for each day the participant receives the study medication. This study aims to see a 'complete response', where 'complete response' is defined as no vomiting and no use of rescue medication.

  • Optimizing post operative outcomes in Total Knee Arthroplasty (TKR) through improved pain and fatigue management: a randomized placebo controlled trial.

    This study aims to improve sleep and pain post operatively after total knee replacement. It will compare 3 well known medications used for pain and sleep management post operatively.

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