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Набира участници Фаза 3

A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

Glioblastoma GBM Brain Neoplasms, Adult, Malignant Brain Tumor

The goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM). The main question it aims to answer is: Does niraparib improve overall survival (OS) compared to TMZ? Participants will be randomly assigned to one of two treatment arms: niraparib or TMZ. * study drug (Niraparib) or * comparator drug (Temozolomide - which is the standard approved treatment for MGMT unmethylated glioblastoma). The study medication will be taken daily while receiving standard of care radiation therapy (RT) for 6-7 weeks. Participants may continue to take the niraparib or TMZ adjuvantly as long as the cancer does not get worse or completion of 6 cycles of treatment (TMZ). A total of 450 participants will be enrolled in the study. Participants' tasks will include: * Complete study visits as scheduled * Complete a diary to record study medication

Начало: 19.06.2024 Край: 01.03.2028 Възраст: от 18 г. Лечение

Australia, Canada, France +8 Ivy Brain Tumor Center NCT06388733

Набира участници Ранна Фаза 1

AMT-676 in Patients With Advanced Solid Tumors

Advanced Solid Tumors

This is a first-in-human, non-randomized, open-label, multicenter Phase 1 study will evaluate the Maximum tolerated dose (MTD)/the recommended Phase 2 Dose (RP2D), safety, tolerability, anti-drug activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-676 in Patients with Advanced Solid Tumors.

Начало: 18.06.2024 Край: 14.02.2026 Възраст: от 18 г. Лечение

American Samoa, Australia, China Multitude Therapeutics Inc. NCT06400485

Набира участници Фаза 1/2

Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over

Shingles Herpes Zoster Vaccine-Preventable Diseases

This is a randomized, active-controlled, observer-blinded, dose-escalation multi-center trial of 2 doses of an investigational HZ vaccine (Z-1018) in approximately 764 healthy adults.

Начало: 17.06.2024 Край: 01.11.2031 Възраст: от 50 г. Превенция

Australia, New Zealand Dynavax Technologies Corporation NCT06569823

Набира участници Фаза 3

TREAT-SC: Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children

Rheumatic Fever Sydenham Chorea

The purpose of this study is to find out whether an early three-day course of an oral steroid medication (dexamethasone) can improve the physical and mental recovery and wellbeing for children with Sydenham's chorea. Sydenham's chorea is a condition that impacts approximately 12% of children with acute rheumatic fever. It is caused by inflammation in the brain following an abnormal immune response to Group A streptococcus bacterial infection. Sydenham's chorea is a movement disorder that causes children's faces, hands, and feet to move quickly and uncontrollably, and can also affect mood and concentration. The physical recovery from Sydenham's chorea can take two to six months but the mental recovery (e.g. mood and concentration) can take longer to resolve. Sydenham's chorea remains endemic in Māori, Pacific Islander, Aboriginal and Torres Strait Islander children in New Zealand and Australia. There is limited evidence to direct treatment of Sydenham's chorea, and clinical practice differs widely around the world. Dexamethasone is an oral steroid which targets the abnormal immune response and successfully treats other immune-mediated brain disorders, with good tolerability. TREAT-SC is a randomized, double-blinded, placebo-controlled trial which will investigate whether a three day course of oral dexamethasone safely and effectively treats the movement disorder and psychiatric symptoms of Sydenham's chorea. The trial will recruit 80 participants from study sites in Australia and New Zealand.

Начало: 17.06.2024 Край: 01.05.2028 Възраст: 4–17 г. Лечение

Australia, New Zealand Starship Child Health, Te Toka Tumai Auckland NCT06259006

Набира участници Фаза 3

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure

Heart Failure

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

Начало: 17.06.2024 Край: 22.05.2028 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +27 Boehringer Ingelheim NCT06424288

Набира участници

CTNNB1 Neurodevelopmental Syndrome - Natural History Study

CTNNB1 Neurodevelopmental Syndrome

The aim of the Dragonfly study is to characterise and monitor the neurodevelopment of children and adults diagnosed with CTNNB1 syndrome through an international collaborative effort. Gaining comprehensive understanding of the mental, physical and social development of people with CTNNB1 neurodevelopmental syndrome and how their symptoms and abilities change over time will help improve and standardize care for these patients, as well as facilitate future research and clinical trials design.

Начало: 14.06.2024 Край: 01.01.2030

Australia, Slovenia University Medical Centre Ljubljana NCT07167732

Набира участници Фаза 1

Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients

Healthy Volunteers Type 1 Diabetes

First in human study to understand the potential side effects of MTX-101, how long MTX-101 lasts in the human body, and how MTX-101 affects specific human immune cells.

Начало: 13.06.2024 Край: 30.06.2027 Възраст: 18–65 г. Фундаментална наука

Australia Mozart Therapeutics Australia Pty Ltd NCT06324604

Набира участници Фаза 3

A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious Infections

Neutropenia

The purpose of this study is to demonstrate the efficacy and evaluate the safety and tolerability of mavorixafor in participants with congenital or acquired primary autoimmune and idiopathic chronic neutropenic disorders who are experiencing recurrent and/or serious infections as assessed by demonstrating its clinical benefit and increasing levels of circulating neutrophils.

Начало: 06.06.2024 Край: 01.11.2027 Възраст: от 12 г. Лечение

Argentina, Australia, Canada +21 X4 Pharmaceuticals NCT06056297

Набира участници

Calibr-Ì: Comparative Evaluation of Phantomless Calibration Methods to Quantify Bone Mineral Density for Opportunistic Analysis of CT Scans

Osteoporosis

Osteoporosis is a systemic disease characterized by a reduction in bone mineral density (BMD) and qualitative alteration of the skeleton, resulting in increased bone fragility and fracture risk. The epidemiological impact of osteoporosis is extremely high. Proper diagnosis and clinical management of osteoporosis are critical to reducing the incidence of fragility fractures and preventing their complications. The diagnosis is generally confirmed by instrumental analysis of bone mineral density. The standard method is X-ray bone densitometry (DXA), which allows diagnosis based on criteria defined by the World Health Organization (WHO) by virtue of the T-score. DXA is a relatively quick and inexpensive examination with low exposure to ionizing radiation. However, this method has limitations in detecting fracture risk, and in addition, not all patients are properly referred for DXA services, which, among other things, require specific criteria to be reimbursed by the National Health System. Currently, computed tomography (CT) scanning is the most widely used three-dimensional diagnostic modality in clinical practice, and the number of investigations performed in high-income countries is continuously growing. Quantitative assessment of bone mineral density by CT is possible by proper calibration of the machine for the purpose of converting the CT numbers (or Hounsfield units) measured by the scanner into BMD units.

Начало: 06.06.2024 Край: 01.06.2026 Възраст: от 18 г.

Italy, New Zealand Istituto Ortopedico Rizzoli NCT06454617

Набира участници

Prospective Clinical Assessment Study in Children With Hypochondroplasia

Hypochondroplasia

This is a long-term, multicenter, non-interventional study of children ages 2.5 to \

Начало: 05.06.2024 Край: 01.10.2026 Възраст: 30–16 г.

Australia, Canada, France +7 QED Therapeutics, a BridgeBio company NCT06410976

Набира участници Фаза 3

IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

Advanced Melanoma

This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A\*02:01-positive participants with previously untreated advanced melanoma.

Начало: 05.06.2024 Край: 16.10.2027 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +19 Immunocore Ltd NCT06112314

Набира участници Фаза 1

A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS

Acute Myeloid Leukemia Refractory Myelodysplastic Syndrome Acute Myeloid Leukemia Myelodysplastic Syndrome With Excess Blasts Acute Myeloid Leukemia, in Relapse +1

This is an open-label, Phase 1 study to determine the safety, tolerability, and efficacy of APL-4098 alone, and in combination with azacitidine, and in combination with azacitidine plus venetoclax for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)/AML and MDS-excess blasts (EB).

Начало: 04.06.2024 Край: 01.05.2027 Възраст: от 18 г. Лечение

Australia, United Kingdom Apollo Therapeutics Ltd NCT06372717

Набира участници Фаза 3

Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

Myelofibrosis Post-PV MF Post-ET Myelofibrosis Primary Myelofibrosis +1

This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone. Subjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.

Начало: 03.06.2024 Край: 31.12.2028 Възраст: от 18 г. Лечение

Australia, Belgium, Croatia +14 Kartos Therapeutics, Inc. NCT06479135

Набира участници Ранна Фаза 1

177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors

PDL1 Gene Mutation Non Small Cell Lung Cancer Small Cell Lung Cancer ( SCLC ) TNBC, Triple Negative Breast Cancer +5

This is a Phase 0/1, First-in-Human (FIH), study to evaluate safety, tolerability, biodistribution, radiation dosimetry and preliminary anti-tumour activities of 177Lu-RAD204 in participants with selected solid tumours, to identify the MTDs/ recommended doses of 177Lu-RAD204 for future exploration. The study will consist of a Pre-screening Period (if applicable for PD-L1 testing), a Screening Period of up to 4 weeks, followed by a Phase 0 (Imaging) Period for imaging and dosimetry to 177Lu-RAD204im and a Phase I (Treatment) Period for 177Lu-RAD204tr dose escalation.

Начало: 03.06.2024 Край: 01.12.2027 Възраст: от 18 г. Лечение

Australia Radiopharm Theranostics, Ltd NCT06305962

Набира участници

A Randomised Clinical Trial of a Digital Self-management Package for People With Interstitial Lung Disease

Lung Diseases, Interstitial Pulmonary Fibrosis

The goal of this clinical trial is to compare REBUILD-SM (a purpose-built smartphone app and self-management package) with standard care in people with interstitial lung disease (ILD). The main question it aims to answer is: • Does REBUILD-SM improve health-related quality of life, symptoms, anxiety, self-efficacy and physical activity for people with ILD? Participants in the intervention group will work through the self-management package with support from a healthcare professional via phone or Zoom. They will also enter deidentified health data into the RE-BUILD smartphone app to track their progress over time. Participants in the control group will use a reduced functionality version of the smartphone app only. Researchers will compare both groups to see if there is any difference in health-related quality of life, symptoms, anxiety, self-efficacy and level of physical activity.

Начало: 03.06.2024 Край: 01.08.2027 Възраст: от 18 г. Поддържаща грижа

Australia University of Sydney NCT06122233

Набира участници Фаза 4

Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression

Treatment Resistant Depression

The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are: * How the two formulations compare in terms of their effectiveness in treating TRD. * How the two formulations compare in their acceptability to patients, safety, effects on patient quality of life and function, and cost effectiveness. Participants will be randomised to receive either Spravato® or racemic ketamine treatment and asked to complete some questionnaires to assess the effects on mood, treatment acceptability, side effects, quality of life and function, and health economic outcomes.

Начало: 03.06.2024 Край: 01.04.2027 Възраст: от 18 г. Лечение

Australia The George Institute NCT06278779

Набира участници

Fibrinolysis Resistance in Infection and Trauma

Sepsis and Septic Shock Trauma

Blood coagulation disorders are often seen in critically ill patients e.g. with severe infection or following extensive injury, that can lead to life threatening events as a result of excessive blood clot formation leading to organ failure. This study aims to use Viscoelastic Testing (VET) technology to detect patients at risk of excessive blood blot formation at the bedside, test new blood coagulation drugs, and guide life-saving use of blood modifying treatments.

Начало: 01.06.2024 Край: 01.06.2026 Възраст: от 18 г.

Australia Anders Aneman NCT06680180

Набира участници Фаза 2/3

Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke

Ischemic Stroke, Acute Cerebrovascular Disorders Brain Disorder Central Nervous System Diseases

Multicentre, prospective, Multi-arm Multi-stage (MAMS) seamless phase 2b/3 interventional randomized placebo-controlled double-blinded parallel-assignment (2 arms with 1:1 randomization) efficacy and safety trial to test intra-arterial tenecteplase at the completion of thrombectomy versus best practice in participants with anterior circulation LVO receiving mechanical thrombectomy within 24 hours of symptoms onset.

Начало: 01.06.2024 Край: 30.11.2027 Възраст: от 18 г. Лечение

Australia University of Melbourne NCT05892510

Набира участници Фаза 2

A Randomised Controlled Trial, Of N-Acetyl Cysteine (NAC), for Premanifest Huntingtin Gene Expansion Carriers

Huntington Disease

NAC-preHD is a phase II randomized placebo controlled study of oral NAC among premanifest HD gene expansion carriers, with clinical and radiological outcome at three years.

Начало: 01.06.2024 Край: 01.05.2027 Възраст: от 18 г. Лечение

Australia Western Sydney Local Health District NCT05509153

Набира участници Фаза 1/2

A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease

Thyroid Eye Disease

The primary objective of Part A of this study is to investigate the safety and tolerability of AMG 732 after single subcutaneous (SC) doses. The primary objective of Part B of this study is to investigate the efficacy of AMG 732 in participants with Thyroid Eye Disease (TED) after multiple SC doses.

Начало: 30.05.2024 Край: 13.08.2027 Възраст: 18–65 г. Лечение

Australia, Canada, France +8 Amgen NCT06401044

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