ANZCTR search results

The benefits of interdisciplinary programs have been widely acclaimed, however there is little evidence regarding their effectiveness in chronic disease management programs, particularly for people with one or more different chronic diseases (i.e., cardiovascular disease, diabetes, renal disease). This study aims to investigate the effectiveness over time of a unique interdisciplinary student clinic (CAHP) in Central Queensland that provides prevention and intervention programs to people with one or more chronic diseases. It is expected that information will be gained regarding the health outcomes and cost effectiveness of such a program. This information will assist in developing an ongoing evaluation framework for the CAHP clinic and for similar programs that may be set-up by Queensland Health, and will provide information to design a controlled clinical trial.

This study is a randomised controlled trial to evaluate the clinical benefits, and cost-effectiveness of two feeding treatment programs for children with ASD and feeding difficulties, including a restricted range of dietary intake (<30 foods across the food groups). Baseline assessment will include parent-completed questionnaires and on-site (Herston) feeding and growth assessments. There are two arms of intervention. Arm One is an individual behaviour modification program. Arm Two involves individual systematic desensitisation therapy. Both arms will involve parent education regarding nutrition and behaviour management for children with feeding difficulties. Intervention will be provided over two phases. Parents will elect to participate in weekly intervention (10 sessions over 10 weeks) or intensive intervention (10 sessions over one week).

The primary aims of this study are to determine the effectiveness of selective laser trabeculoplasty (SLT) with topical medication therapy in the treatment of early Glaucoma with regards to Quality of Life and Cost-effectiveness. The study also aims to determine factors associated with the outcomes of these two therapies, such as pre-treatment IOP and compare the safety and efficacy of the two therapies. Two groups of patients will be recruited for the study: 1) patients with a diagnosis of Primary Open Angle Glaucoma who have not previously received treatment for this and; 2) patients with a diagnosis of Pseudo-exfoliative Glaucoma who have not previously received treatment. Patients will be asked to undergo a Quality of Life Questionnaire Interview over the telephone and will be asked to provide information on the costs related to their health care, treatment of their glaucoma and attendance at appointments. They will also be clinically examined where information including their intraocular pressures, visual fields, optic discs and visual acuity will be recorded. They will also be asked to provide information relating to their ethnicity, level of education, date of birth, employment status and medical history. Participants will be randomized to either receive Selective laser Trabeculoplasty or Topical eye drops at the Baseline visit. They will then be seen every 6 months for 2 years. If in the first 6 months, however, they do not achieve a 25% reduction in Intraocular Pressure from baseline levels, they will be seen 6 weekly until this is achieved. Analysis of the data will be on an intention to treat basis where participant outcomes will be analysed according to the group they were randomised rather than the actual treatment they received. The types of analysis to be performed includes Rasch analysis of the Quality of Life questionnaire responses, Cost Effectiveness analysis, multivariable regression models and generalised estimating equations. This study addresses novel outcomes that have previously not been addressed before, including taking into account the patients perspective by examining the impact of the two types of treatment on patients quality of life and also the cost of the two treatments, both to the patient and to society.

Selective serotonin reuptake inhibitors (SSRIs) are a type of medication and are a first line treatment for major depression and anxiety. While recent studies have shown that neuroimaging and genetics may be used to predict response to SSRI treatment, (see Kemp, Gordon, Rush, & Willams, 2008 for review) basic experimental research is needed to determine exactly how the effects of SSRIs improve symptoms of depression and anxiety. Acute administration of SSRIs may increase processing of positive emotional information, providing a foundation for subsequent changes in thoughts and behaviour (see Harmer, 2008). In order to examine this further, a number of critical issues remain to be addressed. One such issue is the serotonin transporter (5­HTT) gene. The different forms of this gene (5­HTT polymorphisms; l/l, l/s, or s/s alleles) have been reported to moderate the impact of SSRIs on emotion perception (Hinkelmann et al., 2010). However, researchers are yet to examine the interacting roles of SSRIs and the 5­HTT polymorphisms on emotional processing in real­time. A second issue is that researchers are yet to account for the different types of emotional processing and emotion regulation strategies under different conditions. Aims: The aims of this study are to examine the impact of acute administration of an SSRI (escitalopram oxalate) and 5­HTT polymorphisms on covert and overt emotion processing and strategies to regulate this processing. Participants: 50 students will be recruited from first year Psychology students, genotyped and scanned under placebo and escitalopram conditions using a randomised controlled design. Given 5­HTT polymorphisms frequencies of 30% (l/l), 50% (l/s), and 20% (s/s) it is expected that a minimum of 15 participants homozygous for the L ­allele and 35 participants with at least one copy of the S ­allele will be recruited. Treatment: Administration of escitalopram oxalate (20mg) or placebo (saccharin, an artificial sweetener). Participants will complete experimental tasks once peak absorption has been reached. One week later (for compete elimination of drug), participants will be administered the alternate treatment and complete the experimental tasks once again. Tasks: Data will be collected using functional magnetic resonance imaging (fMRI) during rest, covert and overt emotion processing of different images from the International Affective Picture System. Participants will be asked to either passively view or reappraise emotions evoked by the presented stimuli. Questionnaires: Depression, Anxiety and Stress Scales; Patient Health Questionnaire; GAD­7 anxiety questionnaire; Early life stress; Ratings of emotional images Experimental Design: 2 Group (5­HTT s­allele, l­allele) X 2 (escitalopram oxalate, placebo) within­-subject design.

A randomised trial assessing the efficacy of Clorpactin instillation in women with Bladder pain syndrome/Interstitial cystitis

Weight loss can be difficult to achieve and maintain and long term dietary adherence rates are low. A major challenge for successful weight management is tailoring programs to meet individual needs, that is matching personal attributes and behaviours to a particular dietary weight loss strategy. This study investigates the matching of personality traits to compatible dietary weight loss programs for optimal weight loss

This study aims to determine the effect of sentinel lymph node biopsy on survival in people with high risk non melanoma skin cancer. Who is it for? You can join this study if you are aged 18 years or more, have high risk non melanoma skin cancer, and will be available for a 5 year follow-up assessment. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Both groups will undergo removal of their skin cancer. In addition, participants in one group will receive sentinel lymph node biopsy. This is a procedure in which the local lymph node ("gland") that drain the patch of skin containing the tumour are excised. These lymph node(s) are examined under a microscope to determine whether cancer cells are present. If cancer cells are found, patients will undergo completion lymphadenectomy (i.e. surgical removal of the rest of the regional lymph nodes). Participants in the second group will undergo observation of regional lymph nodes, and those that develop cancer cells will undergo completion lymphadenectomy. All patients will undergo continued observation for a period of 5 years to determine survival and quality of life.

This study aims to determine the safety, efficacy, and feasibility of sentinel lymph node biopsy for people with high risk non melanoma skin cancer. Who is it for? You can join this study if you are aged 18 years or more, have high risk non melanoma skin cancer, and will be available for a 5 year follow-up assessment. Trial details Participants in this trial will receive wide local excision of their skin cancer and sentinel lymph node biopsy (SLNB). SLNB is a procedure in which the local lymph node ("gland") that drain the patch of skin containing the tumour are excised. These lymph node(s) are examined under a microscope to determine whether cancer cells are present. If cancer cells are found, patients will undergo completion lymphadenectomy (i.e. surgical removal of the rest of the regional lymph nodes). This trial will evaluate the rates of positive sentinel lymph nodes in patients with high risk non melanoma skin cancer and assess morbidity or injury associated with the sentinel lymph node biopsy procedure.

This study aims to determine whether morphine reduces the feeling of breathlessness in patients with mesothelioma, asbestosis or interstitial lung disease. Who is it for? you can join this study if you are 18 years or more, and suffer from a feeling of breathlessness (dyspnoea) as a result of maximally treated mesothelioma, asbestosis, or interstitial lung disease. You must be able to speak English and should not be taking regular opioid medication (painkillers). Trial details Participants in this trial will be randomly (by chance) assigned to receive either 20mg sustained-release morphine (by oral capsule) together with a laxitive Coloxyl and Senna, or placebo (sham) tablets for one week. They will receive no medication for the second week and will then receive the alternate treatment ( morphine or placebo) for the third week. Participants will not know when they are taking the active drug or placebo. Participants will be asked to complete questionnaires and keep a diary over the 3 weeks of the trial to determine their response to treatment. They will also be phoned and visited at home by a nurse to monitor any side effects of treatment.

We hypothesise that multi-media patient education technology is superior to pamphlet delivery of this information. A secondary hypothesis is that increased understanding of epidural anaesthetic in labour will increase patient anxiety levels.