ANZCTR search results

The recommended dosage for some drugs currently used to treat HIV infection is highly effective but clinical data suggests that the doses could be reduced without compromising their effectiveness. Lower drug doses could have fewer side effects and could be tolerated better, making it easier for people to take and stay on their anti-HIV medication. Dose reduction would also make the drugs cheaper; this would allow more people to be treated and free up money for other important work in the fight against HIV such as education and prevention programs. Two different regimens containing either the standard dose or a reduced dose of efavirenz will be compared: I. efavirenz 600mg + truvada (tenofovir and emtricitabine) II. efavirenz 400mg + truvada (tenofovir and emtricitabine) Tenofovir, emtricitabine and efavirenz are all licensed as individual drugs for the treatment of HIV disease in many countries around the world. Efavirenz is only licensed at the standard dose of 600mg. Emtricitabine and tenofovir are provided as a fixed dose combination that is not currently licensed in every country involved in this study. A fixed dose combination means that the two drugs are incorporated into one pill.

This study will assess the safety of THVD-201 and how well it is tolerated. It will investigate the effects on your bladder symptoms of THVD-201 compared to tolterodine alone, and placebo. The study will also investigate whether the combination treatment reduces the unwanted side effects associated with taking tolterodine alone.

This study formally investigates specific breathing exercises, using a threshold device, for patients who require a breathing machine. It is hoped that the study will demonstrate that this training reduces breathing muscle weakness and also enhances quality of life, with significant improvements even 2 weeks following weaning from the breathing machine. The results of this study will guide physiotherapists in the optimal treatment of breathing muscle weakness for patients who have needed a breathing machine.

Previous studies of “diastolic heart failure” have been limited by confusion about the definition of this entity, and evidence for specific treatments are undefined. The characterization of IFPE will permit us to identify a homogeneous group. However, the most appropriate therapeutic response to increased filling pressure causing exertional dyspnea is undefined.

This study will examine whether a correlation exists between contamination of contact lens cases with Stenotrophomonas maltophilia and CIEs, when contact lenses and worn on a daily wear basis. The hypothesis is case contamination with Stenotrophomonas maltophilia does not correlate with CIEs.

It has been established that regular aerobic activity enhances synaptic plasticity, but it is not known whether a single session of exercise promotes neuroplasticity within the motor cortex of the brain. The mechanisms which might mediate this effect are likely to involve changes in expression or concentrations of key neurotrophins such as brain-derived neurotrophic factor. Our specific hypothesis is that a single session of aerobic exercise will enhance neuroplasticity in the brain.

Based on previous studies reported in the literature (Riley et al., 2007; Steele & Wade, 2008) we propose that a treatment that targets clinical perfectionism will be as effective as a treatment that targets anxiety and depression. Due to only a small number of trials to date, with relatively small sample sizes, our study is required to effectively test this hypothesis in a Randomised Control Trial with an adequate sample size.

In this 2-part study, a total of 48 healthy male subjects will be enrolled and will be randomized to 1 of 8 sequences (4 in each study part), in groups of 4 subjects each. Part A of the study will be a 3-way crossover design. Part A1 will evaluate two single ascending doses of the single agent C-10276 (an ATV isotopolog), and a dose of Reyataz. Part A2 will evaluate the single agent C-10276 at two dose levels and co-administration of CTP-518 and C-10276. Part B will consist of two subparts. In the first subpart, C-10297 and C-10299 will be administered in 200 mg doses, in two groups of 4 subjects each. The second subpart consists of three groups of 8 subjects that will participate in a 3-way partial crossover study design. C-10297 and C-10299 will be administered in 400 and 600 mg doses, C-10276 will be administered in 600 mg and Reyataz will be dosed in 400 and 600 mg doses. All study drug doses, including the comparator, Reyataz, will be administered as single, open-labeled doses to subjects after a light meal. There will be a 7-day washout between individual subjects’ doses.

The Primary Aim of this study is to assess the efficacy of transdermal testosterone therapy on sexual function over 3 months in women at midlife being treated for depression with a selective serotonin re-uptake inhibitor (SSRI) who are experiencing at least one of: loss of sexual desire, sexual arousal disorder or delayed orgasm/anorgasmia for which they desire treatment Study hypothesis Transdermal testosterone, compared with placebo, will result in a clinically meaningful improvement in the total score of the Sabbatsberg Sexual Self Rating Scale indicating improvement in sexual dysfunction secondary to the use of SSRI/SNRI medication .

Obesity in pregnancy has increased to epidemic proportions in developed countries. It is associated with adverse outcomes for both mother and child. Maternal risks for hypertensive disorders, gestational diabetes, thrombo-embolism, haemorrhage, infections and death are increased in obese women and there are attendant risks and resourcing issues associated with obesity and childbirth. Compared to women who have a BMI between 20.1- 25, obese women are more likely to experience: increased rates of induction of labour and failed induction; anaesthetic difficulties; caesarean section; a stay in hospital of more than five days and obese women require specific equipment for accurate monitoring and safe maternity care. The risks of adverse outcomes for fetuses and neonates are also increased While there is limited evidence to support the effectiveness of dietary and physical activity lifestyle interventions in preventing excessive gestational weight gain, the American Institute of Medicine (IOM) published revised guidelines (2009) on how much weight a woman should gain during pregnancy and highlighted the importance of intervention in pregnancy to prevent both postpartum weight retention and childhood obesity. The American IOM recommends that pregnant women who are obese (BMI >/= 30 ) should gain 5 to 9 kg. Excessive gestational weight gain is defined as weight gain above this recommended guideline. Maternity reform at both Australian federal and state levels of government promote the benefits of continuity of care to women at low risk of complications and the expanded role of midwives working collaboratively in multidisciplinary teams. Continuity of care can be defined as care that is provided by the same clinician or small group of clinicians throughout pregnancy, birth and the postnatal period. Continuity of care can empower women and promotes participation in their care improve the sense of control women perceive, and improve satisfaction with care. However the impact of continuity of care as an intervention to improve outcomes for women who are obese has not been explored. The primary aim of this trial is to measure the impact of continuity of care in preventing excessive gestational weight gain in obese women. Following the calculation of their BMI at the booking in visit, women with a BMI>/=30 and meeting the additional selection criteria will be provided with written information about this project by the attending midwife or doctor (not members of the study group) and invited to participate. Women will be given time to answer questions and to provide written informed consent. Women agreeing to participate will be randomised to receive continuity of care (intervention) or routine care (control group). Women in both group will receive an information booklet on restricting gestation weight gain for women with a BMI>/= 30. A secondary aim of the study is to measure the impact of continuity of care on obese women receiving evidenced based care as defined by the 2010 guidelines for management of women with obesity in pregnancy developed by the Centre for Maternal and Child Enquires and the Royal College of Obstetricians and Gynaecologists. An audit of participants’ pregnancy records after birth will assess whether or not standards of care have been achieved. Information will also be obtained on participants’ demographics, previous pregnancies, medical problems, interventions for labour and birth, mode of birth and baby’s weight at birth. Another secondary aim is women’s satisfaction with care. Participants will complete two surveys, one at recruitment and another at 36 weeks gestation.