ANZCTR search results

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

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31330 results sorted by trial registration date.
  • Are endometrial nerve fibres unique to endometriosis? A prospective case control study of endometrial biopsy as a diagnostic test for endometriosis in women with pelvic pain.

    There is currently no non invasive way to diagnose endometriosis. The gold standard is laparoscopy plus directed biopsy. Previous studies have suggested that endometrial nerve fibre detection may function as a less invasive outpatient test of endometriosis. This work suggested that if fine nerve fibres (C type unmyelinated) are present in the functional layer of the endometrium then the patient has endometriosis and if the fibres are not present the patient does not have endometriosis. We wish to recruit women with pelvic pain as we wonder if the nerve fibres relate to the painful condition rather than to endometriosis. We will perform endometrial nerve fibre detection in 20 women with pain and no endometriosis and 20 women with pain who have endometriosis. Our hypothesis is that fine nerve fibres will be found in the functional layer of the endometrium in women both with and without endometriosis who also have pelvic pain. Thus endometrial nerve fibre detection is not a useful way to diagnose endometriosis.

  • Effects of low salt weight loss diets on the way blood vessels work

    The purpose of this study is to see if a combination of weight loss and low salt diets have a beneficial effect on how blood vessels work. We hypothesise that decreasing salt in the diet and losing weight will improve blood vessel function.

  • A Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of AD-6626 in Normal, Healthy Volunteers and Subjects Heterozygous for the Aldehyde Dehydrogenase 2*1/*2 Genetic Variant With and Without Alcohol Administration

    The primary purpose of this study on healthy volunteers is to determine the safety and tolerability of AD-6626 without and without alcohol administration in normal healthy volunteers and subjects heterozygous (HeZ) for the aldehyde dehydrogenase 2 (ALDH2)*1/*2 genetic variant

  • Does the P.A.R.T.Y. program (Prevent Alcohol and Risk-related Trauma in Youth) reduce alcohol-related harms in naval trainees?

  • Effects of mild brain stimulation in children with attention deficit hyperactivity disorder (ADHD)

    Applying a mild electrical current to the head is known to improve brain functions related to attention and learning without causing significant adverse side effects other than a mild local skin irritation at the stimulation site. The current study investigates stimulation effects whilst children - diagnosed with mild to moderate attention deficit hyperactivity disorder - undergo their regular occupational therapy.

  • PumpTune computer recommended insulin pump settings compared to Doctor advised settings in children with Type 1 Diabetes: A randomised controlled trial

  • The securement and dressing of percutaneous central venous access devices (CVADs) in the paediatric intensive care: a pilot randomised controlled trial

    Children admitted to a paediatric intensive care unit (PICU) frequently require the insertion of a CVAD for the administration of medication and fluids. These CVADs are associated with a high rate of failure, including CVAD-related bloodstream infection (BSI). In order to prevent failure, dressings, such as bordered polyurethane (BPU), are used to protect the CVAD insertion site from contamination. Additional securement devices, such as sutures, are used to reduce movement of the catheter. New products, including tissue adhesive (TA), sutureless securement devices (SSD), and combined securement and dressing products (CSD), are available to clinicians to provide securement and dressings for CVAD. It is not known whether these new products are effective at reducing CVAD failure, in comparison to standard care (BPU and suture). The primary aim of this research is to evaluate the feasibility of launching a full-scale efficacy trial, using pre-defined feasibility criteria for recruitment, retention and protocol fidelity. The secondary aim is to compare the effectiveness of dressings and securement products on CVAD failure due to infection, occlusion, dislodgement, thrombosis, or breakage, for children with percuteanous CVAD in the PICU.

  • Trial of KPT-330 in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) and Cutaneous T cell Lymphoma (CTCL)

    This study will determine whether selinexor has any effects against Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL) and Cutaneous T cell Lymphoma (CTCL). Who is it for? You may be eligible to join this study if you are aged 18 years or above and Relapsed or Refractory PTCL or CTCL Study details This study drug, selinexor, works by trapping “tumour suppressing proteins” within the cell and thus causing the cancer cells to die or stop growing. Selinexor has previously been tested in humans to define a safe dose to be administered. It is not known at this time if selinexor will treat PTCL/CTCL. This study will examine the effects of selinexor on PTCL/CTCL and look at the side-effects. After signing the consent, participants will undergo screening assessments up to 30 days before the first dosing. These include: medical and medication history taking, eye examination, ECG, Echocardiogram or MUGA scan, chest X-ray, CT/MRI scans, tumour or skin biopsy, bone marrow aspirate or biopsy, height, weight, vital signs measurement, physical exam, and urine and safety blood tests. Eligible participants will receive oral selinexor tablets on Days 1 and 3 of Weeks 1-3 of each 4-week (28 day) cycle (6 doses/cycle) until disease progression or intolerability. The dose of selinexor will be either 100mg or 80 mg depending on the participants’ body surface area (calculated from their height and weight). Participants will also take dexamethasone to improve selinexor tolerability and antinausea drugs (e.g. ondansetron) to minimise nausea. Additional anti-nausea and anti-anorexia agents may be given as needed. The assessments done at screening will be repeated at various intervals to monitor safety and assess efficacy of the selinexor. In addition, photographs of skin lesions (CTCL patients only) will be taken and blood samples will be taken to check the level of selinexor in the blood at certain timepoints, and to test the binding of selinexor in the blood. Follow-up visits will occur 30 and 60 days after the last dose of selinexor, then participants will be contacted every 3 months to check on their disease status and other treatments.

  • Dressing and securement of peripherally inserted central catheters (PICCs) in paediatrics; a pilot, randomised controlled trial

    Children admitted to an acute care facility frequently require the insertion of a peripherally inserted central catheter (PICC) for the administration of medication and fluids. These PICCs are associated with a high rate of failure, including PICC-related bloodstream infection (BSI). In order to prevent failure, dressings, such as bordered polyurethane (BPU) and sutureless securement devices (SSD), are used to protect the PICC insertion site from contamination. Additional securement devices, such as sutures, are used to reduce movement of the catheter. New products, including tissue adhesive (TA), and combined securement and dressing products (CSD), are available to clinicians to provide securement and dressings for PICC. It is not known whether these new products are effective at reducing PICC failure and complication, in comparison to standard care (BPU and SSD). The primary aim of this research is to evaluate the feasibility of launching a full-scale efficacy trial, using pre-defined feasibility criteria for recruitment, retention and protocol fidelity. The secondary aim is to compare the effectiveness of dressings and securement products on PICC failure and complication due to infection, occlusion, dislodgement, thrombosis, or breakage, for children with PICC in acute care.

  • Single Ascending Dose and Multiple Ascending Dose Phase I study of PXS-4728A Administered Orally in Healthy Adult Males.

    This is the first in human study with PXS-4728A. The primary aim of the study is to establish the safety and tolerability while the secondary aim is to understand the pharmacokinetics and pharmacodynamics of PXS-4728A in healthy males.

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