ANZCTR search results

A randomised controlled trial of instructions for taking Polyethylene glycol + electrolytes (PEG+E) in the treatment of faecal impaction in children aged 4 to 18 years presenting to an emergency department (ED). This study aims to compare effectiveness of two different sets of instructions provided with PEG+E for paediatric faecal impaction treatment in an ED. This is a single-centre, prospective, randomised controlled trial of two instructions (standard instructions vs. extended instructions) provided in both written and video for the intake of PEG+E treatment. Primary: Main symptom improvement, remission from the inclusion criteria at day 6 post study treatment initialization as rated by the participant or his/her guardian. Secondary: stool frequency/consistency/ease of stool passage and stool volume (questionnaires)

Anxiety and depression are common in the perinatal period (i.e. during pregnancy and the first year after childbirth). Postnatal depression and anxiety disorders affect around 15% of women, with up to 45% of cases beginning in pregnancy (e.g., Austin et al., 2010). Early evidence shows that iCBT is effective for reducing postnatal depression, anxiety, general distress and parental distress (Danaher et al., 2013; Pugh, Hadjistavropoulos, & Dirkse, in press). Tailored iCBT programs are needed to provide women in the perinatal period with practical coping skills to manage depression and anxiety symptoms, as well as deal with the unique difficulties they may face which can impact on depression and anxiety (e.g. complications during pregnancy and/or delivery, body image, difficulty breastfeeding, an unsettled baby, and unrealistic expectations about motherhood). The primary purpose of this trial is to evaluate the clinical efficacy of a newly developed internet-delivered cognitive behaviour therapy (iCBT) program, the Perinatal MUMentum Program. This iCBT program has been tailored to maternal anxiety and depression experienced during the perinatal period. The MUMentum Program consists of two 3-lesson courses: Pregnancy and Postpartum. The courses can be completed separately or in conjunction with each other and have been designed in consideration of several key issues experienced during the perinatal period when seeking and completing treatment, including a lack of time, fatigue, and stigma. The main hypotheses to be tested for Study 1 (Pregnancy Course) are as follows: 1. Internet cognitive behavioural therapy delivered during pregnancy will significantly reduce symptoms of anxiety, depression, distress and disability. 2. Internet cognitive behavioural therapy delivered during pregnancy will be significantly more effective than the control group at reducing symptoms of anxiety, depression, distress and disability. It is hoped that the findings of this trial will provide further information regarding the efficacy and acceptability of the Perinatal MUMentum Program in reducing maternal anxiety and depression experienced during the perinatal period.

Anxiety and depression are common in the perinatal period (i.e. during pregnancy and the first year after childbirth). Postnatal depression and anxiety disorders affect around 15% of women, with up to 45% of cases beginning in pregnancy (e.g., Austin et al., 2010). Early evidence shows that iCBT is effective for reducing postnatal depression, anxiety, general distress and parental distress (Danaher et al., 2013; Pugh, Hadjistavropoulos, & Dirkse, in press). Tailored iCBT programs are needed to provide women in the perinatal period with practical coping skills to manage depression and anxiety symptoms, as well as deal with the unique difficulties they may face which can impact on depression and anxiety (e.g. complications during pregnancy and/or delivery, body image, difficulty breastfeeding, an unsettled baby, and unrealistic expectations about motherhood). The primary purpose of this trial is to evaluate the clinical efficacy of a newly developed internet-delivered cognitive behaviour therapy (iCBT) program, the Perinatal MUMentum Program. This iCBT program has been tailored to maternal anxiety and depression experienced during the perinatal period. The MUMentum Program consists of two 3-lesson courses: Pregnancy and Postpartum. The courses can be completed separately or in conjunction with each other and have been designed in consideration of several key issues experienced during the perinatal period when seeking and completing treatment, including a lack of time, fatigue, and stigma. The main hypotheses to be tested for Study 2 (Postpartum Course) are as follows: 1. Internet cognitive behavioural therapy delivered during the postpartum period will significantly reduce symptoms of anxiety, depression, distress and disability. 2. Internet cognitive behavioural therapy delivered during the postpartum period will be significantly more effective than the control group at reducing symptoms of anxiety, depression, distress and disability. It is hoped that the findings of this trial will provide further information regarding the efficacy and acceptability of the Perinatal MUMentum Program in reducing maternal anxiety and depression experienced during the perinatal period.

Of interest to this study is the role specific species and strains of probiotics could play in reducing the incidence and/or severity of respiratory and gastrointestinal symptoms infections in elite team sport athletes who travel frequently. The impact of endurance exercise on immune function is well established with a body of research to support that in a significant number of athletes, the physical and mental stress endured by elite athletes can result in an increased susceptibility to gastrointestinal and respiratory infections. Furthermore, a number of trials have investigated the efficacy of supplementing with specific Lactobacilli and Bifidobacteria in reducing respiratory infections.

This study will evaluate the feasibility and safety of adjuvant chemotherapy in patients with oesophageal cancer who received neoadjuvant chemotherapy and undergone curative surgery. You may be eligible to join this study if you are aged 18 years or above and have histologically or cytologically proven adenocarcinoma of the oesophagus or oesophagastric junction. All participants will receive adjuvant cisplatin and 5-fluorouracil (CF) chemotherapy intravenously every 3 weeks for 12 weeks (4cycles). The intervention will start within 8-10weeks after the neoadjuvant CRT and surgery. Participants will be followed every 3weeks before each chemotherapy treatment for 12 weeks to determine the feasibility and safety of adjuvant CF chemotherapy . After completion of treatment, follow up would be every 3months for 3 years to the 1 year and 3 years disease free survival.

The primary aim of this project is to evaluate the effectiveness of shoe stiffening inserts in the treatment of pain associated with osteoarthritis of the first metatarsophalangeal joint (MTPJ) of the foot. This study is a parallel group, participant- and assessor- blinded, randomised controlled trial with a 52 week follow-up. Ninety participants will be randomised to a control group (‘sham’ shoe inserts) or an experimental group (shoe stiffening insert(s). Both groups will be prescribed the same ‘rehabilitation therapy’ program. Primary and secondary outcome measures will be collected at baseline and at 4, 12, 26 and 52 weeks. The primary outcome measure will be the foot pain domain of the Foot Health Status Questionnaire (FHSQ). Secondary outcome measures will include foot-related disability, severity of foot pain when walking, self-reported magnitude of symptom change, level of physical activity, health-related quality of life, and use of paracetamol rescue medication and co-interventions.

The aim is to determine if professional advice for perceived insufficient milk supply results in a change in perception of milk supply, and whether objective measurement of milk supply before and after receiving professional advice shows a measurable difference in breastmilk production and affects the change in perception. When participants have a perception of insufficient breastmilk supply, we predict that there will be a significant change in the participants’ perceptions from before to after receiving advice from a lactation consultant, and there will be a measurable difference in milk production. We would like to know if objective measurement of milk production before and after following advice affects the change in perception.

Advances continue to be made in the diagnosis and treatment of coronary heart disease. As well as innovations in opening up blocked arteries, ways of accessing the heart arteries have improved leading to reduced complications following a procedure. One such approach uses the radial artery, an artery in the wrist. Various methods exist to stop the bleeding following a procedure with the most common device being a TR BandTM (Terumo) which is applied to the wrist. A balloon in the device, when inflated with air, applies pressure to the puncture causing it to close. The manufacturers of the device recommended an inflation time of 120 minutes. Yet, no research was conducted to determine if that time was effective. Anecdotally, there are variations on the inflation time with little evidence to support those choices. The ORBIT trial will compare the manufacturer's inflation time (120 mins) [Control} with a 60 minute inflation time.[Experiment]. Two cohorts of patients will be recruited: people only having a diagnostic procedure, and people who are having a procedure to open up a blocked heart artery. IT is hypothesized that there will be no difference in bleeding [Primary Endpoint} between the control (120 mins) and experimental (60 min) groups.

Melasma is a common disorder of hyperpigmentation, primarily affecting the face. It can affect all racial types but predominately affects women with darker skin types. The exact cause of melasma is unknown, but it is thought to be due to many things including pregnancy, hormonal contraception, and sunlight. Melasma can be very difficult to treat and often frustrating for the participant and doctor with evidence showing that it may adversely affect quality of life. Over the past decade, there has been growing use of topical, oral and injectable TXA in Asia. More recently, clinical research in Asia has shown promising results with oral tranexamic acid for the treatment of melasma. The dose used in melasma is less than that for menorrhagia. Typically 500-750mg daily is used for melasma. Despite promising results with oral TXA for the treatment of melasma in Asian studies, none have been conducted in the western world to date. You will be asked to come for 6 study visits. An initial screening visit will be followed (if you qualify for the study) by a review at weeks 0, 4, 8, 12 and 24. You will be randomly allocated into one of 2 arms. In the TXA group, participants will take two 250 mg tablet (this will be a 500mg tablet that will be broken into a half). This will be taken daily for 12 weeks from the baseline visit. Participants in the placebo arm will follow an identical protocol with placebo capsule, which does not contain the active medication. All participants will use sunscreen to the entire face during the day. After week 12 participants will stop taking the medication and continue sunscreen for an additional 12 weeks. The researchers will be providing all participants with a standard sunscreen of at least SPF 30. Participants will be instructed not to use any other medications for melasma during the study period. Although no adverse effects have been reported with TXA in pregnancy and no theoretical basis of risk exists, it has not been formally studied in pregnant women. Therefore, we requested to avoid becoming pregnant and use non-hormonal contraceptive methods during the study if you are sexually active. If pregnancy occurs please discontinue the study medication and inform the study investigators if pregnancy occurs. This study aims to determine how effective oral tranexamic is for melasma and also assess its safety.

The primary purpose of this trial is to evaluate the safety and feasibility of exercise in women who are either undergoing treatment or have recently completed treatment for Stage II+ breast cancer. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over, reside or work in greater Brisbane, and have been diagnosed with stage II+ breast cancer for which you are either still undergoing treatment, or completed treatment within the last 24 months. All participants must also report at least one cancer-related or treatment-related health condition, e.g. fatigue, obesity, high blood pressure etc. Study details All participants in this trial will be randomly allocated (by chance) to receive the exercise program at enrolment, or 12 weeks following enrolment. The exercise program lasts for 12 weeks and involves completing 150 minutes of moderate intensity aerobic and resistance exercise under the guidance of an accredited exercise physiologist (an allied health professional with expertise in prescribing exercise to people with chronic diseases). Supervised session (between 5 and 20 sessions) will be scheduled for a time and location that is convenient to each participant. Participants will be asked to report any side effects of the treatment and complete questionnaires and function/fitness testing to evaluate the exercise program. It is hoped that the findings from this study will inform physicians and patients on the safety and feasibility of exercise in breast cancer patients with a high disease burden, in the hopes that it may be prescribed as a safe and effective adjuvant therapy for these patients to improve function, quality of life and survival.