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Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Dosing Immunoglobulin (Dose Ig)
Expand descriptionThis 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. The best way to find out this information is to directly compare the effect of different treatment strategies in patients with blood cancers. We want to know how these different treatments impact on your health and your use of healthcare services. 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. By combining data collected within each domain as part of the platform, the researchers can investigate and compare treatment strategies and infection outcomes across a broader range of participants.
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Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)
Expand descriptionThis is an adaptive platform study to find out how safe and effective different strategies are in comparison to each other, for preventing infection in patients with blood cancers. It is a comparison between Immunoglobulin and antibiotics use.
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A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis
Expand descriptionThis study is open to people aged 40 years or older who have at least 1 family member with pulmonary fibrosis. Pulmonary fibrosis is a condition where lung tissue becomes scarred, making it harder to breathe. People can join if a lung scan shows early changes in the lung, called interstitial lung abnormalities, which may lead to lung scarring. People with family members who have pulmonary fibrosis are more likely to develop it themselves. That is why it is important to check early for lung changes and find ways to prevent the condition from getting worse. The purpose of this study is to find out whether a medicine called nerandomilast can help slow down changes in the lung in people with a family history of pulmonary fibrosis. Participants are put into one of 2 groups randomly, which means the group is chosen by chance. One group takes nerandomilast tablets, and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet twice a day for about 2 to 3 years. There is a 3 out of 5 chance that participants will receive nerandomilast instead of the placebo. Participants are in the study for about 2 to 3 years. Participants visit the study site multiple times: more frequently during the first 2 years (about every 3 months), and then every 6 months thereafter. In the 3rd year, participants also have phone calls with the site staff every 3 months. Doctors regularly test lung function and take chest scans to see if the treatment works. The results are compared between the 2 groups to see if nerandomilast helps. The doctors also check participants' health and take note of any unwanted effects.
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Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants
Expand descriptionThis open-label, Phase I study will assess the safety and tolerability of surovatamig and characterise its PK and PD following subcutaneous administration to participants with RA or SLE.
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A Study of YL242 in Subjects With Advanced Solid Tumors
Expand descriptionThis is a multicenter, open-label study to evaluate the safety and tolerability of YL242 monotherapy and combination in participants with advanced solid malignant tumors.
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Phase 3 Study to Assess Safety and Efficacy of 177Lu-TLX250 in Advanced Relapsed or Recurrent ccRCC
Expand descriptionMulticenter Phase 3 study of 177Lu-TLX250 in adult participants with CAIX-expressing advanced, relapsed or recurrent clear cell renal cell carcinoma (ccRCC). Part 1 will evaluate two dosing regimens to determine the recommended Phase 3 dose (RP3D). Part 2 will compare 177Lu-TLX250 with investigator's choice of monotherapy aligned with Australian standard-of-care.
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The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial
Expand descriptionThe goal of this clinical trial is to learn if ARD-101 works to treat hyperphagia-related behavior in patients with Prader-Willi syndrome (PWS) when used in a long term setting. It will also teach us about the safety of ARD-101. The main questions it aims to answer are: What medical problems do participants have when taking ARD-101 in a long term setting Does ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)? Eligible participants will: Have completed treatment on the AVK-101-301 study through Week 12/End of Treatment Take ARD-101 every day for up to 12 months. Visit the clinic at Months 1, 3, 6 and 12 during dosing and then have tele-visits at Week 2, Months 3 and 9, then 4 weeks after stopping the ARD-101. Patients/Caregivers will keep a daily diary.
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A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis
Expand descriptionThe purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).
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A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
Expand descriptionThe purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).
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A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Expand descriptionThe primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.