[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Monash University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":563},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,46,78,106,131,159,201,224,261,278,294,310,331,353,378,407,435,458,484,503,536],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100640289","pulmonary-artery-catheters-in-cardiac-surgery-100640289",false,"NCT07612683","Pulmonary Artery Catheters in Cardiac Surgery","Pulmonary Artery Catheters in Adults Undergoing Cardiac Surgery (PUMA): an International, Multicentre, Bayesian, Non-Inferiority Randomised Trial.","PUMA","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Undergoing cardiac surgery or surgery of the thoracic aorta\n\nExclusion Criteria:\n\n* Predicted operative mortality ≥ 3% based on the EuroSCORE II\n* Emergency surgery, defined as surgery that must be performed within 24 hours of the decision to operate or before the start of the next business day, whichever is sooner\n* Severe left ventricular systolic impairment (ejection fraction \\\u003C30%)\n* Pulmonary hypertension, defined hierarchically as:\n\n  * Mean pulmonary artery pressure (mPAP) ≥ 20 mmHg based on the most recent formal right heart catheterisation (RHC) study conducted pre-operatively; else, if no RHC performed\n  * Peak tricuspid regurgitant velocity (TRV) ≥ 2.9 m.s-1 on the most recent pre-operative transthoracic echocardiogram;45,46 else, if TRV not reported\n  * Right ventricular systolic pressure (RVSP) ≥ 40 mmHg on the most recent pre-operative transthoracic echocardiogram\n* Right ventricular systolic impairment. May be identified by cardiologist reported right ventricular systolic dysfunction, TAPSE \\\u003C 15mm, or RVFAC \\\u003C 35% on pre-operative transthoracic echocardiography\n* Endovascular-only procedures\n* Cardiac transplantation\n* Contraindication to pulmonary artery catheterisation (e.g. severe tricuspid or pulmonary stenosis, right heart tumour, large atrial or ventricular septal defects)\n* Contraindication to transesophageal echocardiography (e.g. prior oesophagectomy, oesophageal pathology (tumour, stricture, perforation, diverticulum), active upper GI bleed)\n* Patients previously enrolled and randomized in PUMA.","ALL","18 Years",{"count":20,"type":21},1600,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn whether avoiding a pulmonary artery catheter (PAC), a type of invasive monitoring tool, is no worse than using one in adults undergoing open heart surgery.\n\nThe main questions it will answer are:\n\n1. Does avoiding routine PAC use lead to recovery that is no worse than routine PAC use, measured by days alive and at home during the first 30 days after surgery?\n2. How do the 2 strategies compare for kidney injury, major complications, survival, disability-free survival, quality of life, and healthcare use?\n\nResearchers will compare routine PAC use with no routine PAC use (using a standard central venous catheter instead) to see whether patients recover as well without a PAC.\n\nParticipants will:\n\nBe randomly assigned to have either a PAC or no PAC at the start of their surgery Receive usual care from their treating team Be followed up at about 30 days and 180 days after surgery, mainly by telephone and review of medical records\n\nNo extra in-person study visits or additional tests are required as part of this trial.",[27],"Cardiac Surgery",[27,29,30,31,32,33],"Cardiac Anesthesiology","Pulmonary Artery Catheters","Hemodynamic Monitoring","Pragmatic Clinical Trials","Intensive Care Medicine","NOT_YET_RECRUITING","2026-05-24",{"date":37,"type":38},"2026-05-29","ACTUAL",{"date":40,"type":21},"2026-06",{"date":42,"type":21},"2030-01",{"name":44,"class":45},"Monash University","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100607290","phase-4-perioperative-medicine-platform-trial-100607290","NCT07186634","PeRiOperative Medicine Platform Trial","Domain-Specific Appendix: OXYGEN","PROMPT","PROMPT - Inclusion Criteria:\n\n* Adult patient (≥18 years of age at time of admission)\n* Scheduled to undergo a surgical procedure involving a skin incision, with an expected duration of at least 2 hours, and a planned overnight hospital stay of at least 1 night (including, but not limited to, cardiac surgery, orthopedic surgery, obstetric, or gynecological surgery).\n\nPROMPT - Exclusion Criteria:\n\n* ASA physical status 5 (moribund, not expected to survive with or without an operation)\n* Inability to provide informed consent\n* Previous participation in PROMPT within the prior 30 days.\n\nDSA 02 - PROMPT - Exclusion Criteria:\n\n* ASA physical status 1 or 2\n* Undergoing cardiac surgery\n* Undergoing thoracic surgery if one-lung ventilation is required\n* Currently suspected or proven infection\n* Advanced lung disease requiring home oxygen therapy\n* Previous bleomycin therapy\n* Known or suspected pregnancy",{"count":55,"type":21},7800,[57],"PHASE4","Our specific aims are to investigate whether conservative (≤30%), intermediate (50%), or liberal (80%) inspired oxygen during and immediately after surgery: Aim 1: Reduces surgical site infections (SSIs or \"wound infections\") and other healthcare-associated infections (pneumonia and sepsis). Aim 2: Reduces a pooled composite of serious postoperative complications, leading to a faster and more complete recovery after surgery, and thus increases \"days alive and at home up to 30 days after surgery\" (DAH30). Primary hypothesis: Liberal (80%) oxygen concentration delivered with anesthesia in patients undergoing major surgery reduces the incidence of SSIs after surgery compared to conservative (≤30%) or intermediate (50%) oxygen concentration. Secondary hypothesis: Hyperoxia (50-80%) delivered with anesthesia in patients undergoing major surgery increases the incidence of pulmonary and other complications after surgery compared to conservative (≤30%) oxygen concentration, resulting in fewer Days At Home (DAH). PROMPT enrolls patients undergoing elective or semi-elective surgery.",[60,61,62,63,64],"Surgical Site Infection After Major Surgery","Anaesthesia","Major Complications","Quality of Recovery (QoR-15)","Quality of Life",[66,67],"Anaesthesiology, complications, oxygen, surgery","platform trial","RECRUITING","2026-04-14",{"date":71,"type":38},"2026-04-17",{"date":73,"type":38},"2026-04-06",{"date":75,"type":21},"2035-12",{"name":44,"class":45},2,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100616026","treponemal-shedding-load-and-viability-in-women-and-men-who-have-sex-with-women-only-with-early-infectious-syphilis-implications-for-transmission-100616026","NCT07300254","Treponemal Shedding, Load, and Viability, in Women and Men-who-have-sex-with-women-only With Early Infectious Syphilis: Implications for Transmission","Treponemal Shedding, Load, and Viability, in Women and Men-who-have-sex-with-women Only With Early Infectious Syphilis: Implications for Transmission","SOS Global","Inclusion Criteria:\n\n\\- 1. Any cis-woman, cis-MSW, or nonbinary individuals with a penis who have sex with women only, (who meet all other study criteria) 2. Aged ≥18 years of age, 3. At least one sexual partner in the last 12 months 4. One of either:\n\na. Untreated clinically suspected primary or secondary syphilis. i. Must have rash or lesion(s) clinically suggestive of early infectious syphilis infection.\n\nii. May have positive PCR result, positive Dark-ground Microscopy result, positive syphilis serology or positive point-of-care syphilis test, but these are not necessary at the time of enrolment.\n\nb. Untreated early latent (no clinical signs indicative of primary or secondary syphilis) syphilis with positive syphilis serology or positive point-of-care test, and one or more of the following(11): i. A documented syphilis seroconversion within the prior 12 months. ii. A sustained (longer than 2 weeks) fourfold or greater increase in the titre in the prior 12 months in a person previously treated for syphilis.\n\niii. Unequivocal symptoms of primary or secondary syphilis within the prior 12 months.\n\niv. Contact in the prior 12 months with a sex partner who had untreated primary, secondary, or early latent syphilis.\n\nv. Documented reactive nontreponemal and treponemal tests, and the only possible exposure occurred during the previous 12 months vi. RPR\u002FVDRL titre \\>= 1:64 5. Be willing and able to complete study procedures, including physical examination 6. Receiving syphilis treatment on the day of recruitment 7. Have sufficient language proficiency to understand the requirements of the study 8. Provide informed consent as per individual site's local ethics requirements\n\nExclusion Criteria:\n\n1. Men, transwomen, or other people, with a penis, who have had any sexual contact, including kissing, oral sex or anal sex, with men (or any other individual with a penis) in the previous one year.\n2. Individuals who have received antibiotic treatment within 1 month prior to enrolment, with the EXCEPTION of metronidazole.\n3. Diagnosis of late latent syphilis (\\>1 year) or latent syphilis of unknown duration.",{"count":87,"type":21},480,"OBSERVATIONAL","How syphilis is transmitted between sexual partners is unclear. Asymptomatic detection i.e. detection of syphilis bacteria (Tp) from anatomical sites without lesions, in patients with syphilis infection, suggests that asymptomatic transmission from these sites may play a role. However, no existing studies have established whether the syphilis bacteria (Tp) detected was viable. This means it is not known if the bacteria at this anatomical site is alive and therefore able to transmit the infection. Further, studies have focused mostly on men who have sex with men, resulting in a lack of evidence regarding anal shedding in men-who-have-sex-with-women only and women (regardless of sexual behaviour), and no data on asymptomatic vaginal shedding in women. This study will explore:\n\n1. Patterns of Tp detection in women and men-who-have-sex-with-women only.\n2. Whether detected Tp from each asymptomatic anatomical sites is viable\n3. Duration of Tp detection and viability (alive and transmissible bacteria). Patients presenting to a participating sexual health service (overseas only) for management of suspected\u002Fconfirmed early infectious syphilis will be eligible. During the routine clinical examination, participants will have additional oral and anal swabs, urine, vaginal swab (where relevant), penile skin swab (where relevant) and blood sample collected, in addition to the routine samples taken from the same sites and routine serology collected when syphilis is diagnosed.",[91],"Syphilis",[93,94,95,96],"syphilis","sexual health","syphilis transmission","asymptomatic shedding","2026-04-01",{"date":99,"type":38},"2026-04-03",{"date":101,"type":38},"2025-12-02",{"date":103,"type":21},"2028-12-31",{"name":44,"class":45},9,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100473643","phase-4-duration-of-cardiac-antimicrobial-prophylaxis-outcomes-study-100473643","NCT05447559","Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study","Multicentre, Adaptive, Double-blind, Three-arm, Placebo-controlled, Noninferiority Trial Examining Antimicrobial Prophylaxis Duration in Cardiac Surgery","CALIPSO","Inclusion Criteria:\n\n\\- Adult patients undergoing cardiac surgery involving a median sternotomy\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* American Society of Anesthesiology (ASA) 5\n* Subjects with GFR \\\u003C40mL\u002Fmin\u002F1.73m2 or those requiring continuous renal replacement therapy, haemodialysis or peritoneal dialysis\n* Surgery for suspected or proven endocarditis or deep sternal wound infection\n* Documented cefazolin hypersensitivity\n* Documented methicillin resistant Staphylococcus aureus (MRSA) colonisation or infection in the 12-months prior to index surgery\n* Cardiac transplantation\n* Procedures involving insertion ventricular assist device or mechanical circulatory support device\n* Procedures not involving a median sternotomy\n* Patients previously enrolled and randomised to the CALIPSO trial",{"count":115,"type":21},9180,[57],"This multicentre, adaptive, pragmatic, double-blind, three-arm, placebo-controlled, randomised, non-inferiority clinical trial will compare the incidence of surgical site infection and other healthcare associated infections, health economic and microbiological impact after intraoperative only (Arm A), to 24 hours (Arm B) and, to 48 hours (Arm C) of IV cefazolin and placebo postoperative surgical antimicrobial prophylaxis in patients undergoing cardiac surgery",[119],"Surgical Site Infection",[121],"Cardiac surgery","2026-03-22",{"date":124,"type":38},"2026-03-25",{"date":126,"type":38},"2023-02-07",{"date":128,"type":21},"2028-06",{"name":44,"class":45},27,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":138,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":143,"conditions":144,"keywords":149,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},"100444813","phase-3-long-term-outcomes-of-lidocaine-infusions-for-post-operative-pain-lolipop-trial-100444813","NCT05072314","Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial","LOLIPOP","Inclusion Criteria:\n\n* Consenting adult female patients (≥18 years) undergoing mastectomy (unilateral or bilateral) or breast conserving surgery (unilateral or bilateral) for the primary excision of confirmed or suspected primary breast cancer under general anaesthesia (including those with simultaneous insertion of tissue expanders or implants)\\*. \\* this specifically excludes patients undergoing surgery for locoregional recurrence\n* American Society of Anaesthesiologist (ASA) physical scale 1-3\n\nExclusion Criteria:\n\n* Mastectomy or breast conserving surgery with add on procedures e.g laparoscopic salpingectomy\n* Where surgery is being performed for locoregional recurrence of breast cancer\n* Pre-existing pain at site of surgery, axilla, ipsilateral side of chest wall or the ipsilateral upper arm (at diagnosis prior to any tumor locating procedures)\n* Re-excision procedures where the margins at the index surgery have been deemed insufficient\n* When immediate autologous reconstruction surgery is planned\n* Where delayed autologous reconstruction surgery on the operative breast within one year is planned\n* Planned use of regional analgesia infusions\n* Impaired cognition\n* Pregnant or lactating females\n* Transgender patients\n* Known metastatic disease\n* History of anaphylaxis, sensitivity or known contraindication to lidocaine (or other amide local anaesthetic agents e.g. other amide local anaesthetic agents: ropivacaine, bupivacaine, mepivacaine, prilocaine, etidocaine), including patients with porphyria or methaemoglobinaemia\n* History of epilepsy\n* Baseline heart rate \\< 50 bpm or systolic blood pressure \\< 100mmHg.\n* Acute coronary event in the last three months\n* Cardiac conduction abnormalities, including; Atrial fibrillation, Heart block (all degrees), Bundle Branch Block or Fascicular block, Prolonged QT interval, Wolf Parkinson White syndrome, channelopathy such as Brugada syndrome. A preoperative Electrocardiogram (ECG) is not mandatory, unless clinically indicated\n* Abnormal serum potassium concentration (based upon site laboratory reference ranges)\n* Active liver disease e.g. viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, haemochromatosis, other rarer causes)\n* Medications within the last 7 days which are known \u002F suspected to slow lidocaine metabolism (amiodarone, beta blockers, cimetidine, fluoroquinolones, fluvoxamine, imidazoles, macrolides, verapamil, HIV drugs)\n* Cardiac Failure (any documented heart failure at peroperative assessment or GP records)\n* Severe Renal Failure (Creatinine Clearance of less than 30ml\u002Fmin or dialysis dependent)\n* Co-administration of lidocaine within 24 hours prior to surgery for other reasons (e.g. lidocaine patches","FEMALE",{"count":140,"type":21},4300,[142],"PHASE3","The LOLIPOP Trial is a large (n=4,300 patients) pragmatic, international, multicentre, prospective, randomised, double blind, placebo-controlled, parallel assessment, safety and effectiveness superiority study.",[145,146,147,148],"Breast Cancer","Breast Cancer Female","Breast Conserving Surgery","Mastectomy",[61,150,151],"Local Anaesthesia","Chronic Post Surgical Pain",{"date":124,"type":38},{"date":154,"type":38},"2022-07-27",{"date":156,"type":21},"2028-07",{"name":44,"class":45},47,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},"100625887","phase-1-a-study-of-stx-1150-in-participants-with-elevated-low-density-lipoprotein-cholesterol-ldl-c-100625887","NCT07428473","A Study of STX-1150 in Participants With Elevated Low-Density Lipoprotein Cholesterol (LDL-C)","A Phase 1 Open-Label Single Ascending Dose (Part 1) and Single or Multi-Dose Expansion (Part 2) Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of STX-1150 in Participants With Elevated Low-Density Lipoprotein Cholesterol (LDL-C)","STX-1150-01","Inclusion Criteria:\n\n* Elevated serum LDL-C with or without LDL-C lowering medication\n* Willing and able to give informed consent before initiation of any study-related procedures and willing to comply with all required study procedures\n\nExclusion Criteria:\n\n* Patients with history of an ASCVD event \\\u003C\u002F= 6 months.\n* Any uncontrolled or serious disease, or any medical or surgical condition that may interfere with participation\n* Diagnosis of familial hypercholesterolemia\n* Active or history of liver disease\n* Previous treatment with PCSK9-inhibitor or other prior treatment within a specified timeframe\n* Clinically significant abnormal laboratory values","70 Years",{"count":169,"type":21},64,[171],"PHASE1","STX-1150 is an investigational therapy designed to lower LDL-C by silencing a gene called PCSK9 in the liver. STX-1150 does not edit or permanently change the gene. STX-1150 comprises an mRNA and guide RNA (gRNA) delivered via lipid nanoparticles (LNP) for intravenous infusion. The mRNA produces a protein that switches off the PCSK9 gene expression without altering the DNA sequence. This process leverages natural mechanisms that regulate gene activity.\n\nThe study will enroll up to 64 participants with elevated LDL-C across sites in Australia and New Zealand. The follow-up period will be up to 1- year post-treatment.",[174],"Elevated LDL-C and High Cholesterol",[176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191],"LDL-C","PCSK9","Cardiovascular Disease","ASCVD","CMD","Genomic medicine","Gene Therapy","Atherosclerosis","Cholesterol","Heart Attack","Hypertension","Hypercholesterolemia","CVM","Cardiometabolic Disease","Epigenetic","CRISPR","2026-02-24",{"date":194,"type":38},"2026-02-27",{"date":196,"type":21},"2026-06-01",{"date":198,"type":21},"2028-12-30",{"name":44,"class":45},1,{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":138,"minAge":18,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":209,"conditions":210,"keywords":214,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":221,"leadSponsor":223,"locationsCount":4},"100556944","unravelling-the-interplay-of-weight-stigma-and-pregnancy-outcomes-a-prospective-cohort-study-100556944","NCT06531694","Unravelling the Interplay of Weight Stigma and Pregnancy Outcomes: A Prospective Cohort Study","Inclusion Criteria:\n\n* Pregnant between 10-22 weeks' gestation\n* Greater or equal than 18 years of age\n* Booked to give birth at Adelaide Women's and Children's Hospital or Royal Women's and Children's Brisbane\n* Access to the Internet to complete the survey\n* Consents to the extraction of hospital electronic medical record data about the woman and relevant to the study.\n* Ability to read and understand English\n\nExclusion Criteria:\n\n* Pregnant with multiple gestation\n* Insufficient English language skills to consent and complete the questionnaires.",{"count":208,"type":21},800,"The goal of this prospective cohort study is to investigate the contribution of stigma and discrimination due to body size to adverse pregnancy outcomes. We also aim to explore the role of psychological and social factors in this relationship. The specific objectives of this study are:\n\nObjective 1: Explore weight stigma as a mediator of the association between BMI ≥30 kg\u002Fm2 and adverse pregnancy outcomes.\n\nObjective 2: Explore confounding factors not previously considered such as weight cycling, trauma, eating disorders, and internalised weight bias as mediators in the relationship between obesity and adverse pregnancy outcomes.",[211,212,213],"Weight Stigma","Pregnancy Outcomes","Overweight and Obesity",[215,216],"Prenatal care","Healthcare","2026-02-01",{"date":219,"type":38},"2026-02-04",{"date":40,"type":21},{"date":222,"type":21},"2028-12",{"name":44,"class":45},{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":235,"conditions":236,"keywords":240,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},"100608479","phase-2-role-of-antibiotic-therapy-or-immunoglobulin-on-infections-in-haematology-immunoglobulin-stopping-or-extension-stop-ig-100608479","NCT07202091","Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Immunoglobulin Stopping or Extension (Stop Ig)","Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy (Stop-Ig)","Inclusion Criteria:\n\n1. Patients must be receiving Ig (IV or subcutaneous - SCIg) replacement for prevention of bacterial infections due to hypogammaglobulinaemia for at least 6 consecutive months.\n2. Patient is eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.\n3. Patient is willing and able to comply with each of the treatment arms.\n\nExclusion Criteria:\n\n1. Prior or planned allogeneic haematopoietic stem cell transplantation.\n2. Major infection (Grade 3 or higher) in preceding 3 months, and\u002For current active infection requiring systemic antimicrobial treatment.\n3. Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal and PJP prophylaxis).\n4. Intolerance of all trial antibiotic options in either arm A or arm B.\n5. Communication, compliance or logistical issues that are likely to limit patient's ability to take prophylactic or emergency antibiotics, or to obtain urgent medical attention for symptoms of infection.\n6. Pregnant or breastfeeding.\n7. Severe renal impairment (estimated or measured creatinine clearance of \\\u003C 30 mL\u002Fmin).\n8. Previous splenectomy.\n9. Previous participation in this domain.\n10. Treating team deems enrolment in the domain is not in the best interests of the patient.",{"count":232,"type":21},900,[234,142],"PHASE2","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. 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.\n\nThis 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.\n\nThe 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.",[237,238,239],"Myeloma","Leukemia","Non Hodgkin's Lymphoma",[241,242,243,244,245,246,247,248,249,250,251],"immunoglobulin","antibiotics","myeloma","leukaemia","lymphoma","non Hodgkins","infection","infections","blood","cancer","haematology","2025-10-01",{"date":254,"type":38},"2025-10-07",{"date":256,"type":38},"2025-05-06",{"date":258,"type":21},"2027-03-31",{"name":44,"class":45},3,{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":270,"conditions":271,"keywords":273,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":276,"leadSponsor":277,"locationsCount":260},"100608476","phase-2-role-of-antibiotic-therapy-or-immunoglobulin-on-infections-in-haematology-platform-trial-rational-pt-100608476","NCT07202052","Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)","A Randomised Platform Trial Evaluating the Role of Interventions to Prevent Infection in Patients With Acquired Hypogammaglobulinemia Secondary to Haematological Malignancies - RATIONAL-PT (Core)","Inclusion Criteria:\n\n1. Aged greater than or equal to 18 years of age\n2. Diagnosis of haematological malignancy, including (CLL) chronic lymphocytic leukemia, (MM) multiple myeloma or (NHL) non-Hodgkin's lymphoma.\n3. Eligible to receive or currently receiving Ig (IV or subcutaneous - SCIg) replacement for history of recurrent or severe infection(s) and IgG less than the lower limit of the reference range (excluding paraprotein) OR IgG\\\u003C4g\u002FL (excluding paraprotein)\n4. Life expectancy \\> 12 months\n5. Able to give informed consent\n\nExclusion Criteria:\n\n1\\. Treating team deems enrolment in the study is not in the best interests of the patient.",{"count":232,"type":21},[234,142],"This 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.\n\nIt is a comparison between Immunoglobulin and antibiotics use.",[237,272,238],"Non-Hodgkin's Lymphoma",[241,242,243,244,245,246,247,248,249,250,251],{"date":254,"type":38},{"date":256,"type":38},{"date":258,"type":21},{"name":44,"class":45},{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":235,"conditions":287,"keywords":288,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":293,"locationsCount":260},"100608478","phase-2-role-of-antibiotic-therapy-or-immunoglobulin-on-infections-in-haematology-starting-immunoglobulin-start-ig-100608478","NCT07202078","Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Starting Immunoglobulin (Start Ig)","Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy (Start Ig)","Inclusion Criteria:\n\n* None.\n\nExclusion Criteria:\n\n1. Prior or planned allogeneic haematopoietic stem cell transplantation.\n2. Already receiving systemic antibiotic prophylaxis for the purpose of preventing bacterial infection (NB: patients may receive antiviral, antifungal and PJP prophylaxis).\n3. Received immunoglobulin replacement in the preceding three months.\n4. Objection to receiving immunoglobulin products.\n5. Known history of IgA deficiency with anti-IgA.\n6. History of severe allergy to immunoglobulin products.\n7. Current active infection requiring systemic antibiotics.\n8. Allergy or intolerance of all domain antibiotic options.\n9. Pregnant or breastfeeding.\n10. Severe renal impairment (estimated or measured creatinine clearance of \\\u003C 30 mL\u002Fmin).\n11. Previous splenectomy.\n12. Previous participation in this domain.\n13. Treating team deems enrolment in the domain is not in the best interest of the patient.",{"count":232,"type":21},[234,142],[237,239,238],[241,242,243,244,245,246,247,248,249,250,251],{"date":254,"type":38},{"date":291,"type":38},"2025-05-07",{"date":258,"type":21},{"name":44,"class":45},{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":302,"briefSummary":235,"conditions":303,"keywords":304,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":309,"locationsCount":260},"100608477","phase-2-role-of-antibiotic-therapy-or-immunoglobulin-on-infections-in-haematology-dosing-immunoglobulin-dose-ig-100608477","NCT07202065","Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Dosing Immunoglobulin (Dose Ig)","Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy (Dose-Ig)","Inclusion Criteria:\n\n1. Patients must be receiving IVIg replacement at standard dose for prevention of bacterial infections due to hypogammaglobulinaemia for at least 6 consecutive months.\n2. Patient is not eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.\n\nExclusion Criteria:\n\n1. Prior or planned allogeneic haematopoietic stem cell transplantation.\n2. Major infection (Grade 3 or higher) in preceding 3 months, and or current active infection requiring systemic antimicrobial treatment.\n3. Previous splenectomy.\n4. Known history of bronchiectasis.\n5. Previous participation in this domain.\n6. Treating team deems enrolment in the domain is not in the best interest of the patient.",{"count":232,"type":21},[234,142],[237,239,238],[241,242,243,244,245,246,247,248,249,250,251],{"date":254,"type":38},{"date":307,"type":38},"2025-04-28",{"date":258,"type":21},{"name":44,"class":45},{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":17,"minAge":317,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":329,"locationsCount":330},"100453162","statins-and-progression-of-coronary-atherosclerosis-in-melanoma-patients-treated-with-checkpoint-inhibitors-100453162","NCT05180942","Statins and prOgression of Coronary atheRosclerosis in melanomA Patients Treated With chEckpoint inhibitorS","SOCRATES","Inclusion Criteria:\n\n* Capable of providing informed consent and willing to adhere to all protocol requirements\n* patients aged \\> or equal to 40 years\n* Histologically confirmed melanoma of any stage planned for, commenced, or completed treatment with ICI\n* having acceptable imaging quality deemed by the core laboratory\n* Investigator believes that the participant is willing to adhere to all protocol requirements, including returning for follow up CTCA.\n\nExclusion Criteria:\n\n* Known clinically manifest cardiovascular disease\n* Female participants must not be pregnant, breastfeeding or plan to become pregnant during the study.\n* Estimated glomerular filtration rate of \\\u003C45 mL\u002Fmin calculated using the Chronic Kidney Disease Epidemiology Collaboration equation\n* Severe liver disease or cirrhosis\n* History of any other malignancy within the past 5 years in addition to melanoma with the exception of non-melanoma skin cancers\n* Prognostic factors associated with an expected survival less than 18 months at Investigators' discretion (e.g. unresectable brain metastases)\n* Evidence of any other clinically significant non-cardiac disease or condition that, in the opinion of the Investigator, would preclude participation in the study\n* Major allergy to iodine\n* Participation in another clinical trial that does not allow participation in multiple trials at the same time","40 Years",{"count":319,"type":21},130,"This study is a prospective observational study evaluating the natural history of coronary plaque burden in participants with melanoma treated with ICI. The study will be conducted at various sites across Australia.",[322,183],"Melanoma","2025-08-20",{"date":325,"type":38},"2025-08-27",{"date":327,"type":38},"2022-11-07",{"date":40,"type":21},{"name":44,"class":45},12,{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":17,"minAge":317,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":200},"100599951","evaluation-of-polygenic-scores-and-ct-imaging-in-risk-factor-modification-in-patients-with-diabetes-100599951","NCT07091162","EValuation Of poLygenic Scores and CT imAging In Risk Factor Modification in Patients With diabEtes","VOLTAIRE","Inclusion Criteria:\n\n* Age 40 years or older\n* Established diagnosis of T2DM\n* Having acceptable imaging quality as deemed by the VHI-AICL\n* Able to have a PRS calculated\n\nExclusion Criteria:\n\n* Unable to provide written informed consent.\n* Unwilling to be followed for serial evaluation\n* Clinically manifest CV disease\n* Evidence of clinically significant coronary disease on CT that would preclude masking from participant's treating clinician for the duration of the study on the grounds of safety, including but not limited to, equal\u002Fgreater than 50% in the left main coronary artery or equal\u002Fgreater than 70% in any epicardial coronary artery\n* Unable to participate in the study or complete protocol required assessments in the opinion of the Investigator",{"count":339,"type":21},90,[24],"This study is a three-arm, parallel-group, randomised controlled trial evaluating the effect of using cardiac CT imaging or polygenic risk score in cardiovascular risk factor modification in patients with diabetes.",[343,344],"Cardiovascular Diseases","Type 2 Diabetes Mellitus (T2DM)","2025-07-21",{"date":347,"type":38},"2025-07-29",{"date":349,"type":38},"2023-07-25",{"date":351,"type":21},"2026-08",{"name":44,"class":45},{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":361,"sex":138,"minAge":18,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":22,"phases":364,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":330},"100489302","phase-3-antenatal-melatonin-supplementation-for-neuroprotection-in-fetal-growth-restriction-100489302","NCT05651347","Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction","A Triple-blinded, Randomized, Parallel-group Placebo-controlled Trial to Assess the Impact of Maternal Antenatal Melatonin Supplementation on Early Childhood Neurodevelopmental Outcomes in the Setting of Severe Preterm Fetal Growth Restriction","PROTECTMe","Inclusion Criteria:\n\n1. Singleton Pregnancy\n2. Severe fetal growth restriction, defined as:\n\n   * Abdominal circumference ≤3rd centile for gestational age according to charts supplied that have been adapted from Westerway et al; or\n   * Abdominal circumference \\\u003C10th centile in combination with at least one abnormal fetoplacental Doppler study, being:\n\n     * Uterine artery (raised pulsatility index ≥95th centile)\n     * Umbilical artery (pulsatility index ≥95th centile or absent\u002Freversed end-diastolic flow)\n3. Confirmed 23+0 - 31+6 weeks' gestation\n4. Age ≥18 years\n5. Understand English\n\nExclusion Criteria:\n\n1. A fetus with a known chromosomal, major structural anomaly or non-placental cause of fetal growth restriction\n2. Pregnancies requiring immediate delivery (e.g. absent A wave in ductus venosus, preterminal CTG or biophysical profile)\n3. Co-recruitment in another clinical trial where a pharmaceutical product or nutritional supplement impacting on oxidative stress is the trial intervention.\n4. Currently prescribed Fluvoxamine",true,{"count":363,"type":21},336,[142],"Fetal growth restriction (FGR) is a significant health care issue, affecting 20,000 Australian pregnancies every year. Undetected FGR is one of the key risk factors for stillbirth, but FGR can also cause significant impairments in short and long-term health outcomes for the child.\n\nIt is a major risk factor for preterm birth and is a recognised causal pathway to the neurodevelopmental injury underlying cognitive and behavioural impairment and cerebral palsy. Current obstetric care is focused on the detection of the growth restricted fetus and then ultrasound assessment of fetal wellbeing to guide timing of delivery. This approach seeks to maximize the gestational age of the fetus at delivery to minimise the risks of prematurity, while delivering the fetus in time to reduce the likelihood of stillbirth. Currently, no therapies exist that can maximize fetal wellbeing in the setting of growth restriction and minimise the frequency of antenatally acquired brain injury due to in-utero hypoxia.\n\nThis triple-blind, randomized, parallel group, placebo-controlled trial will administer maternal melatonin or placebo supplementation antenatally in the setting of early-onset severe FGR to determine whether melatonin can PROTECT the fetal brain and lead to improved neurodevelopmental outcomes.",[367,368,369],"Fetal Growth Retardation","Stillbirth and Fetal Death","Pregnancy Preterm","2025-06-03",{"date":372,"type":38},"2025-06-06",{"date":374,"type":38},"2019-05-29",{"date":376,"type":21},"2027-04-30",{"name":44,"class":45},{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":388,"conditions":389,"keywords":392,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":77},"100542155","neurofilament-light-chain-and-voice-acoustic-analyses-in-dementia-diagnosis-100542155","NCT06339190","Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis","A Blood Test for Dementia? A Cohort Study to Assess the Diagnostic Utility of Plasma Neurofilament Light Chain Protein in All-cause Dementia","NAVAIDD","Inclusion Criteria:\n\n* All patients presenting to Eastern Health services with a cognitive complaint or potential neurodegenerative disorder\n\nExclusion Criteria:\n\n* Prognosis \\\u003C12 months\n* No cognitive complaint\n* Patients not involved within the single healthcare network",{"count":387,"type":21},1000,"This cohort study aims to determine if a blood test can aid with diagnosing dementia in anyone presenting with cognitive complaints to a single healthcare network. The investigators will measure levels of a brain protein, Neurofilament light chain (Nfl), and assess changes in language using speech tests.\n\nParticipants will have a single blood test and speech test, and will be followed up at 12-months to complete questionnaires and cognitive scales over the phone. The speech test will also be completed again at 12-months.\n\nIndividuals at risk of a Fronto-temporal dementia syndrome will be eligible to complete optional genetic testing involving an 'at home' saliva sample.",[390,391],"Neurodegenerative Diseases","Dementia",[393,391,394,395,396,397,398],"Alzheimer's disease","Neurofilament light chain","Speech","Neurodegeneration","Biomarker","Health care disparity","2025-05-29",{"date":401,"type":38},"2025-05-30",{"date":403,"type":38},"2021-08-01",{"date":405,"type":21},"2027-12",{"name":44,"class":45},{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":11,"sex":17,"minAge":414,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":22,"phases":417,"briefSummary":418,"conditions":419,"keywords":422,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":434},"100585346","evaluation-of-a-residential-in-reach-program-in-regional-and-rural-australia-100585346","NCT06901167","Evaluation of a Residential In-Reach Program in Regional and Rural Australia","Evaluation of a Region-wide Residential In-Reach (RIR) Program in Regional and Rural Health Services: A Stepped-wedge Trial","Inclusion Criteria:\n\n* Health services that have emergency departments and\u002For emergency care centres that admit residents from residential aged care homes (RACH)\n* RACHs that do not currently have access to RIR programs\n* health service staff who have been involved with the set-up and delivery of the RIR program,\n* RACH staff who have experience of or accessing the RIR service for residents at least once,\n* residents living at a RACH who has experienced receiving medical care from the RIR program and can provide informed consent, or a family member of the resident,\n* general practitioners whose case load includes residents from RACHs.\n\nExclusion Criteria:\n\n• RACHs that already have access to a RIR program will be excluded","65 Years",{"count":416,"type":21},100,[24],"Residential In-Reach (RIR) programs are designed to provide responsive care for residents in residential aged care homes (RACH) with the aim of avoiding unnecessary hospital transfers. The evidence for their clinical and cost-effectiveness and implementation has been established in urban settings, but there is a small amount of low-quality evidence for rural and regional settings. The Grampians Region Health Service Partnership Resi-In-Reach Redesign Committee will be implementing a new RIR program to be offered to all RACHs in the Grampians region, this project aims to evaluate the clinical and cost-effectiveness of this program, and its implementation in the rural and regional setting. A stepped-wedge trial will be conducted so that as the RIR program is gradually rolled-out across the region, outcomes can be compared in the same facilities across time and between different facilities. The primary outcome measure will be presentation to emergency departments and urgent care centres, and data will also be collected on other clinical outcomes and barriers and enablers of implementing the program. It is anticipated that there will be a reduction in hospital presentations, and a range of barriers and enablers unique to the rural and regional setting will emerge.",[420,421],"Aged","Acute Disease",[423,424,425,426],"stepped-wedge trial","residential aged care home","residential in reach","hospital avoidance","2025-05-25",{"date":401,"type":38},{"date":430,"type":38},"2025-05-01",{"date":432,"type":21},"2026-06-30",{"name":44,"class":45},8,{"id":436,"slug":437,"hasResults":11,"nctId":438,"briefTitle":439,"officialTitle":439,"acronym":440,"eligibilityCriteria":441,"healthyVolunteers":11,"sex":138,"minAge":18,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":444,"conditions":445,"keywords":448,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":200},"100572045","study-investigating-the-role-of-routine-screening-and-molecular-characterisation-of-brain-metastasis-in-the-management-of-high-risk-metastatic-breast-cancer-100572045","NCT06728150","Study Investigating the Role of Routine Screening and Molecular Characterisation of Brain Metastasis in the Management of High-risk Metastatic Breast Cancer","STORM","Inclusion Criteria:\n\n* Metastatic breast cancer with visceral, nodal or bone metastasis\n* Human epidermal growth factor type2 (HER2-positive disease)\n* Triple negative breast cancer (TNBC) with metastatic disease\n* Oestrogen Receptor Positive disease (ER-positive disease) after second-line therapy and cyclin dependent kinase 4\u002F6 inhibitors (CDK4\u002F6 inhibitors), plus more than two sites of bone metastasis or visceral metastasis\n* Diagnosis of metastatic disease in the last 3 months and free of symptoms or disease (with brain MRI confirmation) • Medicare Eligible\n\nExclusion Criteria:\n\n* Symptomatic brain metastasis\n* Inability to provide consent\n* Inadequate organ function\n* Pregnancy.",{"count":443,"type":21},45,"The purpose of this study is to improve outcome of breast cancer patients who develop brain metastases. This will investigate the benefits of early detection of brain metastases using brain imaging.\n\nIn patients diagnosed and currently being treated for advanced or metastatic breast cancer, current guidelines do not recommend routine brain imaging. However, there is emerging evidence suggesting that patients diagnosed without symptoms of brain metastases may have a better outcome than those with symptoms such as headache, vomiting and weakness.\n\nIn current practice, if signs and symptoms suggestive of brain metastases are to develop, then the doctor will arrange imaging of the brain, which may be a computerised tomography (CT scan) and\u002For a magnetic resonance imaging (MRI) scan. Should brain metastasis be detected, local radiotherapy, chemotherapy or targeted treatments will be offered.\n\nWhen initially diagnosed with metastatic or advanced breast cancer, participant will or would have undergone a brain scan by either MRI or CT during normal standard full-body CT scan (chest, abdomen and pelvis) imaging. In this study, each time participants have a regular full-body CT scans to assess treatment progress, they will also have an additional CT scan of the brain.\n\nParticipants will have a total of 12 extra brain scans, with scans taking place every three months for the first 2 years, and every 6 months for the following years. These scans will occur at the same location as your current treatment. There will be no extra costs involved in the study and participants will be in the study for 4 years and following their follow-up details will be collected from medical records.\n\nSome participants who develop brain metastases during the followup will have neurosurgery to remove these metastases. The investigators will collect either fresh or archived tissues and a cerebrospinal fluid (CSF) sample at the time of surgery from those patients.\n\nIf the treating investigators do not think neurosurgery is an option, they will ask participants to have a lumbar puncture for the collection of CSF. The purpose of this optional CSF collection is to take a liquid biopsy to check for markers (or biomarkers) potentially expressed by the breast cancer tumour cells in the brain. Participants will also be asked to provide a blood sample as well as old tumour from breast surgery (other metastatic tumour tissue).\n\nThe information obtained from this component of the study will not impact a parcipants current management, but it will help researchers to develop better treatments for breast cancer brain metastases in the future.",[446,447],"Breast Cancer Metastatic","Brain Metastasases",[449],"Breast cancer brain metastases","2024-12-10",{"date":452,"type":38},"2024-12-11",{"date":454,"type":21},"2024-12-01",{"date":456,"type":21},"2029-12-31",{"name":44,"class":45},{"id":459,"slug":460,"hasResults":11,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":361,"sex":17,"minAge":466,"maxAge":467,"enrollmentInfo":468,"targetDuration":470,"studyType":88,"phases":4,"briefSummary":471,"conditions":472,"keywords":474,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":200},"100319644","the-bariatric-surgery-registry-100319644","NCT03441451","The Bariatric Surgery Registry","Establishment of a Bariatric Surgery Clinical Quality Registry","BSR","Inclusion Criteria:\n\n* Body Mass Index (BMI) \\>30 kg\u002Fm2\n\nExclusion Criteria:\n\n* Pregnant women","2 Years","95 Years",{"count":469,"type":21},250000,"10 Years","Persons with obesity are more likely to suffer from many other serious health conditions and are more likely to die young. Lifestyle interventions have not been found to be an effective long-term solution for treating obesity. When usual weight loss measures are not successful, bariatric, or 'weight loss,' surgery may be considered. Bariatric surgery is performed to help people with obesity achieve weight loss which they can maintain. Weight loss following bariatric surgery leads to improvement in health and well-being, and patients have been shown to live longer. It is invasive surgery which has surgical risks and potential side effects, including death. Since people are having this surgery to improve their health, it is important that the surgery is performed with a minimum of side effects, otherwise it cannot be justified. Information is collected about the surgery, any complications after the surgery, weight at various time points, and if the patient has diabetes and how it is is treated. Patient details are needed to be able to identify patients on the registry and track their progress through data linkages. Participants have information about their bariatric surgery provided to the registry by their surgeon or hospital. They may also be contacted directly by the registry staff to see if they had any complications and if the surgery had any effect on their health (if they have diabetes), weight, and well-being. The Registry will hold their identifiable information as it aims to follow each patient for ten years after their first bariatric operation. By systematically collecting information on every procedure performed in Australia and New Zealand, the registry will help to identify when surgeons, hospitals or procedures not performing to the expected standard. A Bariatric Surgery Registry should also be able to demonstrate how effectively bariatric surgery results in weight loss and improved health (using diabetes as a marker of health) across the two countries.",[473],"Obesity",[475],"Bariatric Surgery","2024-12-09",{"date":478,"type":38},"2024-12-12",{"date":480,"type":38},"2012-01",{"date":482,"type":21},"2025-12",{"name":44,"class":45},{"id":485,"slug":486,"hasResults":11,"nctId":487,"briefTitle":488,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":491,"targetDuration":470,"studyType":88,"phases":4,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":496,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":502},"100296434","validation-of-the-lupus-low-disease-activity-state-lldas-in-the-asia-pacific-region-100296434","NCT03138941","Validation of the Lupus Low Disease Activity State (LLDAS) in the Asia Pacific Region","APLCLLDAS","Inclusion Criteria:\n\n* All patients have to meet either the 1997 American College of Rheumatology (ACR) Modified Classification Criteria for SLE, with at least four of the 11 items; or alternatively, fulfil the Systemic Lupus International Collaborating Clinics (SLICC) 2012 Classification Criteria, with at least four of the 17 items (at least one clinical and one immunological criterion) or with lupus nephritis in the presence of at least one immunological criteria. Patients can be either newly diagnosed or longstanding lupus patients.\n\nAll patients must be over the age of 18 and competent to provide written consent.\n\nExclusion Criteria:\n\n* Patients less than 18 years of age and patients who are unable to consent are excluded from the study.",{"count":492,"type":21},5000,"Lupus Low Disease Activity State (LLDAS) study is an international, multi-centre prospective study, developed by the Asia Pacific Lupus Collaboration (APLC) to investigate whether the attainment of LLDAS is associated with improved outcomes in patients with Systemic Lupus Erythematosus (SLE).\n\nSLE, or lupus, is the archetypal multisystem autoimmune disease, with an estimated incidence of 5-50 cases per 100,000 people. Patients with SLE, usually young women, suffer a marked loss of life expectancy, and severe morbidity, due to a heterogeneous range of clinical manifestations caused by autoimmune-mediated inflammation of multiple organs. The most severe manifestations of SLE are the accrual of irreversible organ damage, especially renal and central nervous system (CNS) involvement. As there is no effective targeted monotherapy for SLE, patients also suffer severe toxicity from the use of glucocorticoids and broad-spectrum immunosuppressive therapies. Despite combination therapy with current drugs, many studies show that the majority of patients suffer inadequate disease control and inexorably accrue permanent organ damage over time.\n\nThe diversity of clinical features of active SLE has made quantification of disease activity problematic. Although there are a number of published systems in use to measure SLE disease activity, there are widely acknowledged problems with these instruments. Published definitions of remission are so stringent that they are met by less than 5% of patients. This lead to the realisation that rather than lupus remission, a lupus low disease activity state target may be more feasible, and that patients with low disease activity are more homogeneous than patients with active disease. Thus, the development of a definition of lupus low disease activity, which is feasible and has face validity, escapes the complexity of attempts to quantify heterogeneous states of active disease.\n\nIn this study, the investigators will prospectively collect longitudinal data on consecutive SLE patients at each centre to evaluate the LLDAS definition. Protection from organ damage accrual as the primary endpoint.",[495],"Systemic Lupus Erythematosus",{"date":478,"type":38},{"date":498,"type":38},"2013-09-01",{"date":500,"type":21},"2032-12-31",{"name":44,"class":45},20,{"id":504,"slug":505,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":22,"phases":513,"briefSummary":514,"conditions":515,"keywords":518,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":535},"100491399","phase-2-role-of-antibiotic-therapy-or-immunoglobulin-on-infections-in-haematology-immunoglobulin-stopping-or-extension-100491399","NCT05678621","Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Immunoglobulin Stopping or Extension","A Randomised Controlled Trial of Continuing Immunoglobulin Therapy, or Stopping With or Without Prophylactic Antibiotics, on Infection Rate in Patients With Acquired Hypogammaglobulinemia Secondary to Haematological Malignancies.","RATIONALISE","Inclusion Criteria:\n\n1. Aged greater than or equal to 18 years of age\n2. Diagnosis of chronic lymphocytic leukaemia (CLL), multiple myeloma (MM) or non-Hodgkin lymphoma (NHL).\n3. Patients must be receiving Ig (IV or subcutaneous - SCIg) replacement for prevention of bacterial infections due to hypogammaglobulinaemia for longer than 6 consecutive months.\n4. Patient is eligible for trial of Ig cessation in the opinion of the treating clinician and local investigator.\n5. Life expectancy greater than 12 months.\n6. Able to give informed consent, and willing and able to comply with each of the treatment arms.\n\nExclusion Criteria:\n\n1. Prior or planned allogeneic haematopoietic stem cell transplantation.\n2. Major infection (Grade 3 or higher) in preceding 3 months, and\u002For current active infection requiring antimicrobial treatment.\n3. Already receiving daily antibiotic prophylaxis for the purpose of preventing bacterial infection (Note: patients may receive antiviral, antifungal and Pneumocystis jirovecii pneumonia (PJP) prophylaxis).\n4. Intolerance of all trial antibiotic options in either arm A or arm B.\n5. Communication, compliance or logistical issues that are likely to limit patient's ability to take prophylactic or emergency antibiotics, or to obtain urgent medical attention for symptoms of infection.\n6. Pregnant or breastfeeding.\n7. Severe renal impairment (estimated or measured creatinine clearance of less than 30 mL\u002Fmin).\n8. Previous splenectomy.\n9. Previous participation in this trial.\n10. Treating team deems enrolment in the study is not in the best interests of the patient.",{"count":512,"type":21},300,[234,142],"The aim of the study is to find out if patients with blood cancers receiving immunoglobulin (Ig) for the purpose of preventing infections can safety stop immunoglobulin after six months of therapy, and take oral antibiotics instead to prevent serious infections.\n\nPatients may be eligible to join this study if they are aged 18 years or above, have an acquired hypogammaglobulinaemia secondary to a haematological malignancy, and have been receiving intravenous or subcutaneous Ig for longer than 6 consecutive months.\n\nParticipants will be randomised (allocated by chance) to one of three treatment groups, as follows:\n\n* Stop immunoglobulin (IVIg or SCIg) and be given oral antibiotics to take every day (ARM A)\n* Stop immunoglobulin (IVIg or SCIg) and be given oral antibiotics to keep at home to use as soon as symptoms of an infection develop (ARM B)\n* Continue receiving immunoglobulin (IVIg or SCIg) - this is the usual care group (ARM C)\n\nThe duration of each treatment is for 12 months from study entry.\n\nParticipants will be asked to attend a screening\u002Fbaseline visit so that their treating clinician can assess their eligibility for the trial and collect baseline data. If eligible for the trial, participants will then be randomly allocated to one of the three treatment groups.\n\nOnce randomised, active participation in the study will last for 13 months. During this period, participants will be asked to return to the hospital for a study visit every 3 months, with monthly telephone visits to check-in on your progress between each in-person visit. Participants will also be asked to complete a study diary, recording treatment compliance and signs\u002Fsymptoms of infection experienced throughout the study period.\n\nTypes of assessments and data collected will include: Medical history, demographics, physical examination, blood tests, stool sample, quality of life questionnaires, information about your general health, hospitalisations, medications and procedures. In order to assess and compare the cost-effectiveness of the treatment groups, the study team will also request authorisation from participants to access their Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS), and Australian Immunisation Register (AIR) data.",[516,517],"Haematological Malignancy","Hypogammaglobulinemia",[237,519,520,521,522,523,524,525,526],"Lymphoma","Leukaemia","Blood cancer","Malignancy","Infection","Antibiotic","Anti-infective agent","Immunoglobulin","2024-04-17",{"date":529,"type":38},"2024-04-19",{"date":531,"type":38},"2022-11-30",{"date":533,"type":21},"2027-04",{"name":44,"class":45},7,{"id":537,"slug":538,"hasResults":11,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":544,"targetDuration":546,"studyType":88,"phases":4,"briefSummary":547,"conditions":548,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":562,"locationsCount":200},"100275283","australian-and-new-zealand-massive-transfusion-registry-100275283","NCT02863250","Australian and New Zealand Massive Transfusion Registry","Improving Outcomes for Patients With Critical Bleeding Requiring Massive Transfusion","ANZ-MTR","Inclusion Criteria:\n\n* aged 18 years or over\n* 5 or more units of red blood cells in any 4 hour period\n\nExclusion Criteria:\n\n* nil",{"count":545,"type":21},50000,"1 Year","Severe and un-stopped blood loss can occur for a number of different reasons including after a serious injury, delivery of a baby and following other medical and surgical emergencies. The investigators understanding of how to best treat people with serious bleeding is still incomplete, with many questions remaining. These include questions regarding how many people have serious bleeding events, what happens to them and the best way to treat them.\n\nThe Massive Transfusion Registry (MTR) is a register of patients who have experienced major blood loss that required a massive transfusion in any clinical setting.\n\nThe MTR uses electronic data extraction and data linkage methodologies. Pre-existing clinical data from hospital data sources, including Laboratory Information Systems (for transfusion history and laboratory results) and Health Information Services databases (for Patient demographics and admission data), are electronically extracted by staff employed at the participating hospitals. The data is then sent to the MTR Research Team, located at Monash University, where it is then linked, analysed and stored.\n\nThe establishment of a Massive Transfusion Registry will be a unique and important resource for clinicians in Australia, New Zealand and internationally, for Blood Services and for the broader community. It will provide valuable observational data regarding the types and frequency of conditions associated with critical bleeding requiring massive transfusion, the use of blood component therapy (i.e. ratios and quantities of different types of red cell to non- red cell components) and patient outcomes.",[549,550,551,552,553,554,555],"Massive Transfusion","Trauma","Cardiothoracic Surgery","Gastrointestinal Bleeding","Vascular Surgery","Obstetric Bleeding","Liver Transplant","2020-08-31",{"date":558,"type":38},"2020-09-02",{"date":560,"type":4},"2011-03",{"date":103,"type":21},{"name":44,"class":45},""]