ANZCTR search results

This study is an interventional study. One arm is assigned to an intervention group, which entails health and lifestyle adjustments to see the effect on GBS colonisation in pregnancy. Both arms of the study will involve observation throughout pregnancy. The intervention study arm will be asked to undertake a 'bundle' of interventions-: • take vitamin D supplements if their levels are low (<50mmol) • take an oral probiotic daily • limit sugar intake (<30gms/day) • increasing pre/probiotic food intake (5 x week) • increase exercise to 3 hours per week • Complete a weekly survey to ascertain compliance • Participate in GBS Screening at 35-37 weeks as part of antenatal care Our hypothesis is that women in the intervention group will have lower rates of GBS at the 35-37 week screening.

Preterm infants, especially those born before 28 weeks of gestation, are at high risk of complications related to their brain and development. In this international research study conducted at multiple sites, cells (including stem cells) extracted from the baby’s own cord blood will be infused back to them. Babies will be randomised to treatment. It means half of the babies in the trial will receive their cord blood derived cells in the first two weeks of life (in some cases two infusions) in addition to routine neonatal intensive care, while the other half will only receive placebo treatment in the newborn intensive care unit. A randomised study is the most scientific way of assessing whether a treatment is beneficial. Further whether the baby receives the intervention will not be known to the parents, or the treating team. The main outcome studied in this trial will be baby’s survival at two years without major disability related to the brain. We expect that cord blood cell therapy may increase the baby’s chances of survival without any major disability, and if proven to be true at the end of this study, it may offer a new therapy for these vulnerable infants.

The study Sponsor (Parvus Therapeutics) is developing a new drug called PVT201 for the treatment of Primary Biliary Cholangitis (PBC). This research study will examine the safety and tolerability of PVT201 for humans. This is a double-blind, randomized, placebo-controlled study where 4 dose levels of PVT201 will be evaluated in healthy volunteers. All participants will receive a single dose of PVT201 or Placebo on Day 1 of the study and participants will be followed up on Day 2 & Day 7 of the study.

This study will investigate the effect of post-exercise serum biomarkers in healthy volunteers on keratinocyte cancer cell lines Who is it for? This is a study in healthy volunteers. You may be eligible to join this study if you are aged between 25 and 40 years old and recreationally active and do not have any chronic illnesses or previous history of any type of skin cancer. Study details Participants in this study will be randomly allocated (by chance) to one of two groups: an exercise group, where the exercise will be a short bout of moderate intensity aerobic exercise (cycle ergometry) or a second group where participants will go about their daily activities (no cycle ergometry). All participants will provide blood prior to their activity, immediately after their activity and 24 hours after the activity. Participants in each group will do this three times every 4 weeks over a 12 -week period. Participants’ blood samples at each visit will be analysed for cell viability and immune biomarker levels. This project will provide clarity, through the investigation of underlying mechanistic factors, to a field that currently has conflicting and limiting evidence. This may ultimately benefit individuals with keratinocyte cancer, in a downstream fashion, by potentially identifying a novel effective adjuvant therapy.

The purpose of this study is to evaluate the extent of scar formation and to provide safety information for a new approach to scar formation after a surgical procedure. TetraDERM device uses the natural heat from the body to form an elastic hydrogel scaffold, the controls moisture within the wound bed whilst providing a cushioning effect physically to reduce the tension of the wound. TetraDERM creates an environment for new skin tissue to form that is similar to our bodies natural healing response. TetraDERM’s capability to control the hydration within the wound bed, to reduce wound tension and support healing work to reduce scar formation. There is a seperate ANZCTR application for cohort 1, this is the application for cohort 2 and 3. Up to 45 participants will be enrolled in cohorts 2 and 3 in Australia. There will be a total of 11 subject visits occurring over 12 months.

This research project forms part of the RATIONAL Platform Trial. This study is being conducted to find out how safe and effective different strategies of infection prevention are in comparison to each other, for preventing infection in patients with blood cancers. While immunoglobulin is commonly used long term in patients with blood cancer, we don’t know whether oral antibiotics are just as good at preventing serious infections. The research project is investigating using oral antibiotics (in tablet form) to determine if they are as effective as IVIg or SCIg in reducing the risk of infections in people with blood cancers. Who’s it for? Patients with a blood cancer and low levels of certain antibodies (immunoglobulins) in the blood. Your treating doctor will check your eligibility to participate in this study. You will need to undergo screening assessments to find out if it is safe for you to be involved in the study. Study details: In this clinical trial domain, participants will be divided into two groups (arms) to compare the different treatments. There is one usual care group and one investigational group. The two groups are: 1. Start immunoglobulin (IVIg or SCIg) replacement therapy. 2. Start oral antibiotics to take every day. Each participant is put into a group by chance (randomly). If eligible to participate in a domain of the RATIONAL-PT, your active study participation in that domain will last for 13 months and all participants will return to the hospital for a study visit every 3 months (4 more in-person visits after Day 1). During each month of the 12-month treatment period except the months in which you are attending in-person study visits, you will receive a phone call from your treating clinical team to check your progress (8 calls in total). Even if you are recommended to, or choose to, stop your domain treatment during the 12-month treatment period, you will be asked to continue attending study visits and having phone calls until the end of the trial period (13 months in total) because we are still interested in your outcomes. At the end of your participation on the study, your doctor will decide if you still require treatment to prevent infection, and if you do, whether to continue on the treatment you received during the study (immunoglobulins, antibiotics or none). The results of this trial will inform clinical decision making about the use of immunoglobulin and oral antibiotics for patients with blood cancers. Your participation may help doctors who treat patients with blood diseases in the future to know whether to prescribe oral antibiotics or immunoglobulins to try to prevent the onset of serious infections.

This research project forms part of the RATIONAL Platform Trial. This study is being conducted to find out if patients with blood cancers receiving immunoglobulin for the purpose of preventing infections can safely stop after six months of therapy, and take oral antibiotics instead to prevent serious infections. The study will also test if the oral antibiotics should be taken every day or only as soon as an infection starts. Who’s it for? Patients with a blood cancer and low levels of certain antibodies (immunoglobulins) in the blood. Your treating doctor will check your eligibility to participate in this study. You will need to undergo screening assessments to find out if it is safe for you to be involved in the study. Study details: In this clinical trial domain, participants will be divided into three groups (arms) to compare the different treatments. There is one usual care group and two investigational groups. The three groups are: 1. Continue receiving immunoglobulin (IVIg or SCIg) – this is the usual care group. 2. Stop immunoglobulin (IVIg or SCIg) and be given oral antibiotics to take every day. 3. Stop immunoglobulin (IVIg or SCIg) and be given oral antibiotics to keep at home to use as soon as symptoms of an infection develop. Each participant has a one in three chance of being in each group. Each participant has a two in three chance of receiving oral antibiotics. Half of the participants receiving oral antibiotics will be asked to taken them every day, the other half will be asked to take them only if symptoms of infection develop. If eligible to participate in a domain of the RATIONAL-PT, your active study participation in that domain will last for 13 months and all participants will return to the hospital for a study visit every 3 months (4 more in-person visits after Day 1). During each month of the 12-month treatment period except the months in which you are attending in-person study visits, you will receive a phone call from your treating clinical team to check your progress (8 calls in total). Even if you are recommended to, or choose to, stop your domain treatment during the 12-month treatment period, you will be asked to continue attending study visits and having phone calls until the end of the trial period (13 months in total) because we are still interested in your outcomes. At the end of your participation on the study, your doctor will decide if you still require treatment to prevent infection, and if you do, whether to continue on the treatment you received during the study (immunoglobulins, antibiotics or none). The results of this trial will inform clinical decision making about the use of immunoglobulin and oral antibiotics for patients with blood cancers. Your participation may help doctors who treat patients with blood diseases in the future to know whether to prescribe oral antibiotics or immunoglobulins to try to prevent the onset of serious infections.

This research project forms part of the RATIONAL Platform Trial. This study is being conducted to find out if a lower dose of immunoglobin is as effective in preventing infections in patients with blood cancers receiving immunoglobulin who have trialled stopping in the past without success or are not suitable to trial stopping immunoglobulin. This research will investigate if patients can safely reduce their immunoglobulin dose after six months of therapy. Who’s it for? Patients with a blood cancer and low levels of certain antibodies (immunoglobulins) in the blood. Your treating doctor will check your eligibility to participate in this study. You will need to undergo screening assessments to find out if it is safe for you to be involved in the study. Study details: In this clinical trial, participants will be divided into two groups (arms) to compare the different treatments. There is one usual care group and one investigational group. The two groups are: 1. Continue standard-dose immunoglobulin (IVIg) replacement therapy 2. Commence low-dose immunoglobulin (IVIg) replacement therapy Each participant is put into a group by chance (randomly). Half of the participants will receive standard-dose immunoglobulin, the other half will commence low-dose immunoglobulin replacement therapy. If eligible to participate in a domain of the RATIONAL-PT, your active study participation in that domain will last for 13 months and all participants will return to the hospital for a study visit every 3 months (4 more in-person visits after Day 1). During each month of the 12-month treatment period except the months in which you are attending in-person study visits, you will receive a phone call from your treating clinical team to check your progress (8 calls in total). Even if you are recommended to, or choose to, stop your domain treatment during the 12-month treatment period, you will be asked to continue attending study visits and having phone calls until the end of the trial period (13 months in total) because we are still interested in your outcomes. At the end of your participation on the study, your doctor will decide if you still require treatment to prevent infection, and if you do, whether to continue on the treatment you received during the study (standard-dose or low-dose immunoglobulin). The results of this trial will inform clinical decision making about the use of immunoglobulin and oral antibiotics for patients with blood cancers. Your participation may help doctors who treat patients with blood diseases in the future to know what dose of immunoglobulins should be prescribed to try to prevent the onset of serious infections.

This study is being conducted to find out how safe and effective different strategies of infection prevention are in comparison to each other, for preventing infection in patients with blood cancers. Who is it for? Patients with a blood cancer and low levels of certain antibodies (immunoglobulins) in the blood. Your treating doctor will check your eligibility to participate in this study. You will need to undergo screening assessments to find out if it is safe for you to be involved in the study. Study details: This research project uses an Adaptive Platform Design. This design allows the researchers to compare multiple infection prevention strategies within the same trial at the same time (rather than running separate trials), to analyse results as the trial occurs and to add new research questions during the course of the trial. The treatments that you may receive as part of the study will be determined by which domain(s) of the platform you participate in. Depending on the domain you are participating in, you may be assigned to a study treatment by chance (randomly). Following randomisation (if applicable), you will be asked to complete your Day 1 assessments. If eligible to participate in a domain of the RATIONAL-PT, your active study participation in that domain will last for 13 months and all participants will return to the hospital for a study visit every 3 months (4 more in-person visits after Day 1). During each month of the 12-month treatment period except the months in which you are attending in-person study visits, you will receive a phone call from your treating clinical team to check your progress (8 calls in total). Even if you are recommended to, or choose to, stop your domain treatment during the 12-month treatment period, you will be asked to continue attending study visits and having phone calls until the end of the trial period (13 months in total) because we are still interested in your outcomes. At the end of your participation on the study, your doctor will decide if you still require treatment to prevent infection, and if you do, whether to continue on the treatment you received during the study (immunoglobulins, antibiotics or none). The results of this trial will inform clinical decision making about the use of immunoglobulin and oral antibiotics for patients with blood cancers. Your participation may help doctors who treat patients with blood diseases in the future to know which treatment to prescribe to try to prevent serious infections.

Multi-centre pilot randomised controlled trial to assess the efficacy of oral Azithromycin in eliminating Amniotic fluid sludge as a surrogate outcome for preterm birth. We hope that the results from this study will help up develop a bigger trial which will directly assess the impact of azithromycin in reducing the risk of preterm birth.