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Набира участници

Prospective Study Evaluating the Treatment Outcomes for Localised Recurrent, Resectable Retroperitoneal Liposarcoma

Retroperitoneal Liposarcoma

The aim of the study is to collect prospective data on the treatment outcomes in patients with first localized, resectable recurrent retroperitoneal well-differentiated and/or dedifferentiated liposarcoma undergoing curative intent treatment. Patients enrolled in this study will form a validation cohort of the TARPSWG recurrent RPS nomogram. The treatment decision (surgery alone, or preoperative RT +/- chemotherapy followed by surgery) is per the institutional multidisciplinary team recommendation.

Начало: 05.09.2024 Край: 01.12.2032 Възраст: от 18 г.

Australia, Belgium, Brazil +2 Australia and New Zealand Sarcoma Association NCT07377747

Набира участници Фаза 2

A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)

Lupus Erythematosus, Systemic Lupus Nephritis

The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active, refractory lupus nephritis (LN).

Начало: 04.09.2024 Край: 06.02.2032 Възраст: 18–75 г. Лечение

Australia, Brazil, Czechia +17 Novartis Pharmaceuticals NCT06581198

Набира участници Фаза 2

A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)

Pulmonary Hypertension Heart Failure With Preserved Ejection Fraction

TX000045-003 is a double-blind, randomized, parallel group, placebo-controlled, proof- of-concept (POC) study, evaluating 2 dose regimens of TX000045 over the course of a 24-week treatment period (the APEX study).

Начало: 04.09.2024 Край: 20.11.2026 Възраст: 18–83 г. Лечение

Armenia, Australia, Belgium +12 Tectonic Therapeutic NCT06616974

Набира участници Фаза 3

The Chronic Kidney Disease Adaptive Platform Trial Investigating Various Agents for Therapeutic Effect

Chronic Kidney Diseases

CAPTIVATE is an international, multi-centre, Phase III, adaptive, platform, randomised controlled trial in people with chronic kidney disease (CKD). CAPTIVATE aims to find the best treatment, or combination of treatments, that slow the progression of CKD so that fewer people develop kidney failure. CAPTIVATE provides a research platform that allows many treatment-related questions to be answered within a common trial set-up.

Начало: 04.09.2024 Край: 31.03.2029 Възраст: от 18 г. Лечение

Australia, India, New Zealand +2 The George Institute NCT06058585

Набира участници Фаза 1/2

First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors

Solid Tumor, Adult

A Phase 1/2a First-in-Human Study of DB-1419 in Advanced/Metastatic Solid Tumors

Начало: 03.09.2024 Край: 01.02.2027 Възраст: от 18 г. Лечение

Australia, China, United States DualityBio Inc. NCT06554795

Набира участници

Frequency of Selected Single Nucleotide Polymorphisms in Huntington Disease Gene Expansion Carriers

Huntington Disease

For participation in this epidemiological study, a single-day visit at the study site is required. Participants will be recruited from Huntington Disease clinics, and they will be asked to answer questions regarding their demographics, including sex, age, race and ethnicity, and their medical and medication history. At the end of the visit, a blood sample will be drawn to allow testing with a sequencing assay that is specifically designed for phasing single nucleotide polymorphisms (SNPs) on the wild-type Huntington (wtHTT) and mutant Huntington (mHTT) alleles.

Начало: 02.09.2024 Край: 24.09.2028 Възраст: 25–60 г.

Argentina, Australia, Canada +7 Hoffmann-La Roche NCT06667414

Набира участници

Respiratory Sinus Arrhythmia Pacing Post-CABG Surgery in Patients With HFrEF

Heart Failure With Reduced Ejection Fraction

The goal of this clinical trial is to test a new type of pacemaker in heart failure patients following a heart bypass operation. The new pacemaker restores respiratory sinus arrhythmia which is a natural pattern where the heart rate increases when the participants breathe in and slows down when participants breathe out. The main questions the trial aims to answer are: * Is the new type of pacemaker safe? * Does the new type of pacemaker improve how patients' hearts work (also known as cardiac output)? Participants will have a range of tests before their operation and during their recovery in hospital while participants have the new type of pacemaker in place, and will be monitored very closely. Participants will also receive a phone call 1 month after their surgery. Researchers will compare the new type of heart pacing against standard treatment to see if it is as safe, and if it is any better for patients.

Начало: 02.09.2024 Край: 01.04.2026 Възраст: от 22 г. Лечение

Australia, New Zealand Ceryx Medical Australia NCT06384963

Набира участници Фаза 1

Study With [225Ac]Ac-FL-020 in mCRPC Participants

Metastatic Castration-resistant Prostate Cancer

The purpose of this study is to evaluate the safety, therapeutic effect, and pharmacokinetics of \[225Ac\]Ac-FL-020 in participants with metastatic castration-resistant prostate cancer (mCRPC).

Начало: 30.08.2024 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia, China, Turkey (Türkiye) +1 Full-Life Technologies GmbH NCT06492122

Набира участници Фаза 3

A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

Advanced Non-small Cell Lung Cancer HER2 Mutation

Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division. The study treatment, sevabertinib, is expected to block the mutated HER2 protein which may stop the spread of NSCLC. The main purpose of this study is to learn how well sevabertinib works and how safe it is compared with standard treatment, in participants who have advanced NSCLC with specific genetic changes called HER2 mutations. The study participants will receive one of the study treatments: * Sevabertinib twice every day as a tablet by mouth, or * Standard treatment in cycles of 21 days via infusion ("drip") into the vein. * Participants will continue their assigned treatment for as long as they benefit from it and do not experience severe side effects, or until they or their doctor decide to stop treatment. When a participant receiving the standard treatment has their disease get worse (this is called "disease progression"), they may have the opportunity to switch ("cross over") to receive sevabertinib. * Participants who switch to sevabertinib will continue this treatment until their disease gets worse again, they have side effects that are too severe, or they or their doctor decide to stop treatment. During the study, the doctors and their study team will: * take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the body to study the spread of cancer * check the overall health of the participants by performing tests such as blood and urine tests, and checking * heart health using an electrocardiogram (ECG) * perform pregnancy tests for women * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.

Начало: 28.08.2024 Край: 27.06.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +29 Bayer NCT06452277

Набира участници Фаза 2/3

KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis

Myasthenia Gravis Generalized Myasthenia Gravis

A Study of the Anti-CD 19 Chimeric Antigen Receptor T Cell Therapy for Patients with Myasthenia Gravis

Начало: 28.08.2024 Край: 01.09.2028 Възраст: 18–75 г. Лечение

Australia, Brazil, Germany +1 Kyverna Therapeutics NCT06193889

Набира участници Фаза 1/2

First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS)

Amyotrophic Lateral Sclerosis (ALS) Mutation in the Superoxide Dismutase-1 (SOD1) Gene

This study is researching an experimental drug called ALN-SOD (called "study drug"). This study is focused on people with Amyotrophic Lateral Sclerosis (ALS) caused by a change in a gene called the Superoxide Dismutase-1 (SOD1) gene. This type of ALS is known as "SOD1-ALS". This is the first time that ALN-SOD will be given to people. The aim of the study is to see how safe and tolerable the study drug is. The study is looking at several other research questions, including: * The effect the study drug has on specific biomarkers, which are substances in the blood or in the fluid that surrounds the brain and spinal cord, known as Cerebrospinal Fluid (CSF) * How much study drug is in the blood and in the CSF, at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) * What effects the study drug has on ALS symptoms

Начало: 28.08.2024 Край: 05.06.2031 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +3 Regeneron Pharmaceuticals NCT06351592

Набира участници Фаза 3

Silexan in the Treatment Of Posttraumatic Stress Disorder Trial

Post Traumatic Stress Disorder

Posttraumatic stress disorder (PTSD) is a common and debilitating mental illness. Current treatments for PTSD include psychotherapy and antidepressant medications. Many patients are unable to tolerate psychotherapy for PTSD and drop out of it. In addition, its effectiveness is limited. Up to 50 percent of patients who receive psychotherapy do not benefit from it. Antidepressant medications have only small benefits in PTSD. They also have unpleasant side effects that can make patients unwilling to take them. There is an urgent need to develop new treatments for PTSD that work and are well-tolerated. Silexan has the potential to provide an important alternative treatment for PTSD. Silexan is derived from lavender oil. It is taken orally in the form of capsules. It is currently available over-the-counter in 14 countries, including Australia and the United States. Previous research has shown that it is an effective treatment for anxiety disorders, including Generalized Anxiety Disorder. It is also well-tolerated by patients. The only side effects that have been identified so far are mild gastrointestinal symptoms (including burping and breath odour) and these are uncommon. The results of a small pilot study suggest that Silexan may also be effective and well-tolerated in PTSD. The STOP trial is a clinical trial that aims to investigate whether adding Silexan to treatment-as-usual improves PTSD symptoms in adults with PTSD. The trial will recruit 278 participants. Participants will be randomly assigned to take Silexan or a placebo (look-alike dummy pills) daily in addition to their usual medications for 12 weeks. The severity of their PTSD symptoms will be assessed prior to and at the end of this 12-week period. The STOP trial has the potential to obtain definitive evidence regarding whether Silexan helps treat symptoms of PTSD. If Silexan is found to be an effective treatment for PTSD, the pool of patients who could potentially benefit from this treatment includes any adults with PTSD. Silexan is already available over-the-counter at a relatively low cost so there will be few barriers to accessing this treatment.

Начало: 26.08.2024 Край: 01.06.2027 Възраст: от 18 г. Лечение

Australia Deakin University NCT06412757

Набира участници

Nutrition Practice in Critically Ill Adults

Critical Illness

To determine the role of nutrition in recovery from critical illness, current practice must first be understood. However, no benchmarking process currently exists for nutrition practice during critical illness, from ICU admission to hospital discharge. This vital gap requires addressing. The aim of this study is to inform and re-design models of nutrition care and generate research priorities for the future by obtaining data on nutrition provision and practice and that of consumer preference for nutrition care.

Начало: 26.08.2024 Край: 31.12.2027 Възраст: от 18 г.

Australia Australian and New Zealand Intensive Care Research Cent NCT06576895

Набира участници Фаза 3

A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma

Multiple Myeloma

The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and an immunomodulatory drug. The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus SOCT in participants with RRMM.

Начало: 23.08.2024 Край: 01.07.2031 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +11 Kite, A Gilead Company NCT06413498

Набира участници Фаза 1

A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors

Cancer Breast Cancer Endometrial Cancer Metastatic Cancer +1

The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.

Начало: 22.08.2024 Край: 29.12.2027 Възраст: от 18 г. Лечение

Australia, France, Japan +5 Alterome Therapeutics, Inc. NCT06533059

Набира участници

Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)

Uterine Fibroid

This is a prospective, multicenter, observational, post-market clinical follow-up study in subjects treated with Bearing nsPVA Embolization Particles for uterine fibroid embolization. Data collection will include safety and performance outcome relating to the use of Bearing nsPVA, through 6 months.

Начало: 22.08.2024 Край: 01.12.2026 Възраст: от 18 г.

Australia, United Kingdom, United States Merit Medical Systems, Inc. NCT06153667

Набира участници Фаза 1

Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)

Antiphospholipid Syndrome (APS) Bullous Pemphigoid (BP) Behçet's Syndrome (BS) Dermatomyositis (DM) +2

This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose administration in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM) and immune thrombocytopenia (ITP).

Начало: 19.08.2024 Край: 30.06.2026 Възраст: 18–85 г. Лечение

Australia, Bulgaria, Canada +15 Chugai Pharmaceutical NCT06371417

Набира участници Фаза 3

A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis

Atopic Dermatitis

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Topical therapies applied over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in pediatric participants with moderate to severe AD who are candidates for systemic therapy. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for treating AD patients aged 12 or older. Participants will receive upadacitinib (given as daily dose) or dupilumab (given at label indicated dose every 2 or 4 weeks). Participants will be stratified depending on disease severity, age and response to previous treatment. There is 1 in 5 chance for participants to receive dupilumab during the randomized cohort. Approximately 675 participants aged 2 to less than 12 years of age will be enrolled in this study at approximately 150 sites worldwide. The study population (As defined by participants age or prior treatment) to be enrolled in the study is dependent on local regulatory requirement and/or agreement. Participants will receive upadacitinib oral tablets once daily (or oral solution twice a day) for 160 weeks, or dupilumab as per its label for 52 weeks, and followed for 30 days after the last dose of upadacitinib and at least 12 weeks after the last dose of dupilumab. There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by clinical assessments, blood tests, checking for side effects and completing questionnaires.

Начало: 19.08.2024 Край: 01.07.2030 Възраст: 2–11 г. Лечение

Argentina, Australia, Brazil +21 AbbVie NCT06461897

Набира участници Фаза 1/2

Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)

B-cell Acute Lymphoblastic Leukemia Diffuse Large B-cell Lymphoma Burkitt Lymphoma Neuroblastoma +1

Substudy 01A is part of a platform study. The purpose of this study is to assess the efficacy and safety of zilovertamab vedotin in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL)/Burkitt lymphoma, or neuroblastoma and in pediatric and young adult participants with Ewing sarcoma.

Начало: 16.08.2024 Край: 31.03.2029 Възраст: 6–25 г. Лечение

Australia, Belgium, Brazil +19 Merck Sharp & Dohme LLC NCT06395103

Набира участници

EarGenie MVP Performance Evaluation

Hearing Impaired Children

This is a single-group clinical trial to evaluate the performance of the EarGenie minimum viable product (MVP) in normal hearing infants. The EarGenie MVP tests for detection and discrimination of sounds will be administered, and the sensitivity and specificity of the tests will be estimated for a range of sound levels (detection) and speech sound contrasts (discrimination).

Начало: 15.08.2024 Край: 15.12.2025 Възраст: 1–24 г. Диагностика

Australia The Bionics Institute of Australia NCT06406088

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