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Набира участници Фаза 3

Platform Trial to Assess the Efficacy of Multiple Drugs in Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic Lateral Sclerosis

The objective of this phase III, placebo-controlled platform study is to investigate the efficacy of drugs for patients with ALS (Amyotrophic lateral sclerosis).

Начало: 09.08.2021 Край: 01.06.2026 Възраст: от 18 г. Лечение

Australia, Belgium, Netherlands +3 Stichting TRICALS Foundation NCT06008249

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Neurofilament Light Chain And Voice Acoustic Analyses In Dementia Diagnosis

Neurodegenerative Diseases Dementia

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. Participants 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. Individuals at risk of a Fronto-temporal dementia syndrome will be eligible to complete optional genetic testing involving an 'at home' saliva sample.

Начало: 01.08.2021 Край: 01.12.2027

Australia Monash University NCT06339190

Набира участници Фаза 2

Adaptive RadioTherapy for OroPharynx Cancer

Oropharynx Cancer Radiotherapy; Complications Radiotherapy Side Effect Dysphagia +1

This is a phase II randomized trial, where patients with histologically proven squamous cell carcinoma of oropharynx that have primary tumor (T3 - T4) in place, treated with curative intent chemoradiation, will be randomized to systematic mid-treatment MRI-based radiotherapy adaptation vs. standard of care. The primary objective is to compare patient-rated dysphagia (as assessed by the MD Anderson Dysphagia Inventory composite score at 6 months post-treatment in patients undergoing routine mid-treatment MR-guided radiotherapy adaptation vs. in patients receiving the current standard of care.

Начало: 30.07.2021 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia, Canada Centre hospitalier de l'Université de Montréal (CHUM) NCT04901234

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Zimmer Biomet Shoulder Arthroplasty PMCF

Shoulder Fractures Shoulder Arthritis Shoulder Osteoarthritis Shoulder Deformity +2

The objectives of this study are to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation in primary or revision shoulder arthroplasty. These objectives will be assessed using standard scoring systems, radiographic evidence, and adverse event records. Safety of the system will be assessed by monitoring the frequency an incidence of adverse events.

Начало: 28.07.2021 Край: 15.08.2033 Възраст: от 20 г. Лечение

Japan, New Zealand, United States Zimmer Biomet NCT04984291

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Phase I/II Clinical Trial Stem Cell Gene Therapy in RAG1-Deficient SCID

Severe Combined Immunodeficiency Due to RAG1 Deficiency

This study is a prospective, non-randomized, open-label, two-centre phase I/II intervention study designed to treat children up to 24 months of age with RAG1-deficient SCID with an indication for allogeneic hematopoietic stem cell transplantation but lacking an HLA-matched donor. The study involves infusion of autologous CD34+ cells transduced with the pCCL.MND.coRAG1.wpre lentiviral vector (hereafter called RAG1 LV CD34+ cells) in five patients with RAG1-deficient SCID.

Начало: 23.07.2021 Край: 31.12.2029 Възраст: 8–24 г. Лечение

Australia, Italy, Netherlands +4 Leiden University Medical Center NCT04797260

Набира участници Фаза 1/2

Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)

Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Endometrial Neoplasms Ovarian Neoplasms +2

The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years.

Начало: 19.07.2021 Край: 01.04.2027 Възраст: от 18 г. Лечение

Australia, Canada, France +3 Eli Lilly and Company NCT04956640

Набира участници Фаза 3

The Direct Oral Anticoagulation Versus Vitamin K Antagonist After Cardiac Surgery Trial

Bleeding Post Cardiac Surgery Indication for Anticoagulation

The DANCE Trial is a multi-centre, randomized controlled trial comparing the safety of direct oral anticoagulants (DOAC) versus vitamin K antagonists (VKA) in the early period (30 days) after cardiac surgery in patients with atrial fibrillation requiring oral anticoagulation.

Начало: 18.07.2021 Край: 01.06.2027 Възраст: от 18 г. Лечение

Australia, Canada, Germany Population Health Research Institute NCT04284839

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Targeted Therapy to Increase RAI Uptake in Metastatic DTC

Papillary Thyroid Cancer Pediatric Cancer Differentiated Thyroid Cancer

Papillary thyroid cancer (PTC) is a common type of differentiated thyroid cancer (DTC) in children and represents the second most common cancer in adolescent females. Recently targeted drugs that block many of the genetic drivers of DTC have become available. While Investigators know that these drugs shrink DTC tumors in many cases, the impact on radioactive iodine (RAI) avidity has not been systematically studied.

Начало: 16.07.2021 Край: 01.02.2033

Australia, United States Children's Hospital of Philadelphia NCT05024929

Набира участници Фаза 3

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Myasthenia Gravis

The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). The purpose of the subcutaneous substudy is to evaluate how well it works in the body (pharmacodynamic \[PD\]) when given as an injection under the skin (subcutaneous) compared to when given through a vein (intravenous) in participants with gMG.

Начало: 15.07.2021 Край: 30.03.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +13 Janssen Research & Development, LLC NCT04951622

Набира участници Фаза 2

Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults

Critical Illness Osteoporosis

The Bone Zone trial is a prospective, multi-centre, double-blind, phase II, randomised controlled trial evaluating the effect of denosumab or zoledronic acid compared to placebo on change in bone mineral density over one year in women aged 50 years or older and men aged 70 years or older requiring admission to intensive care for greater than 24 hours. 450 women aged 50 years or older and men aged 70 years or older, admitted to intensive care for greater than 24 hours will be recruited into the study from participating study centres.

Начало: 15.07.2021 Край: 28.02.2027 Възраст: от 50 г. Лечение

Australia, New Zealand Australian and New Zealand Intensive Care Research Cent NCT04608630

Набира участници Фаза 2

A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT

Central Nervous System Nongerminomatous Germ Cell Tumor Choriocarcinoma Embryonal Carcinoma Immature Teratoma +6

This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.

Начало: 13.07.2021 Край: 21.12.2029 Възраст: 3–29 г. Лечение

Australia, Canada, New Zealand +1 Children's Oncology Group NCT04684368

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Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications and outComEs

Liver Diseases Liver Cirrhosis Acute-On-Chronic Liver Failure Liver Transplant; Complications

Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Alternative strategies, as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potential life-threatening complications in the donor.

Начало: 08.07.2021 Край: 31.12.2026 Възраст: 18–80 г.

Argentina, Australia, Belgium +21 European Foundation for Study of Chronic Liver Failure NCT04613921

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HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve

Mitral Regurgitation

Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system

Начало: 01.07.2021 Край: 01.02.2031 Възраст: от 18 г. Лечение

Australia, Belgium, France +3 HighLife SAS NCT04888247

Набира участници Фаза 2

Antidepressant Effects of Nitrous Oxide

Major Depressive Disorder Treatment Resistant Depression

To evaluate the acute and sustained antidepressant effects of nitrous oxide in people with major depressive disorder; and further evaluate these effects by identifying the optimal dose and regimen to guide current practice, and to plan a future large pragmatic trial.

Начало: 30.06.2021 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia, United States University of Chicago NCT05357040

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Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System

Pulmonary Embolism

The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).

Начало: 25.06.2021 Край: 01.02.2028 Възраст: от 18 г.

Australia, Brazil, Germany +7 Penumbra Inc. NCT04798261

Набира участници Фаза 1/2

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer

Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer

This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with breast cancer. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population. Cohort 1 will focus on participants with inoperable, locally advanced or metastatic, estrogen receptor-positive (ER+), HER2-negative breast cancer who had disease progression during or following treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i; e.g., palbociclib, ribociclib, abemaciclib) in the first- or second-line setting. Cohort 2 will focus on inoperable, locally advanced or metastatic, ER+, HER2-positive breast cancer with previous progression to standard-of-care anti-HER2 therapies, of which one was a trastuzumab-and-taxane-based systemic therapy (including in the early setting if recurrence occurred within 6 months of finishing adjuvant therapy) and one was a HER2-targeting antibody-drug conjugate (ADC; e.g., ado-trastuzumab emtansine or trastuzumab-deruxtecan) or a HER2-targeting tyrosine kinase inhibitor (TKI; e.g., tucatinib, lapatinib, pyrotinib, or neratinib). Cohort 3 will focus on inoperable, locally advanced or metastatic, ER+, HER2-negative, PIK3CA-mutated breast cancer with resistance to adjuvant endocrine therapy.

Начало: 22.06.2021 Край: 30.05.2029 Възраст: от 18 г. Лечение

Australia, Israel, South Korea +2 Hoffmann-La Roche NCT04802759

Набира участници Фаза 2

DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Relapsed Diffuse Large B-cell Lymphoma Refractory Diffuse Large B-cell Lymphoma

This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL.

Начало: 18.06.2021 Край: 01.04.2025 Възраст: от 18 г. Лечение

Australia, Canada, France +7 ImmunoVaccine Technologies, Inc. (IMV Inc.) NCT04920617

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Personalised Immunotherapy Platform

Melanoma Cutaneous Squamous Cell Carcinoma Basal Cell Carcinoma Merkel Cell Carcinoma +1

This is a non-interventional study to prospectively test a suite of predictive biomarker models of immunotherapy resistance in patients with melanoma, non-melanoma skin cancers and other solid tumours. The study will evaluate the documentation, processes, accuracy and utility of the predictive biomarker model in clinical practice.

Начало: 08.06.2021 Край: 01.06.2037 Възраст: от 18 г.

Australia Melanoma Institute Australia NCT06536257

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Nutrition in Paediatric Critical Care

ICU Nutrition Paediatric

This is a multi-centre prospective cohort study of nutrition in paediatric critical care in Australia and New Zealand. The study is planned to run in parallel with the adult ICU cohort study, NUTRIENT. Two study periods are proposed with the first in late 2024 and the second in 2026. This observational study seeks to determine the following (although not limited to) descriptive outcomes of interest: 1. Nutritional outcomes, including route of nutrition support (oral, enteral and/or parenteral), energy and protein prescription and provision, and anthropometric measures 2. Patient-centred outcomes, including duration of invasive respiratory support and hospitalisation, and mortality 3. Nutrition service delivery in the PICU and ward settings

Начало: 07.06.2021 Край: 01.12.2027 Възраст: до 18 г.

Australia, New Zealand Australian and New Zealand Intensive Care Research Cent NCT06695078

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Trifecta-Heart cfDNA-MMDx Study

Heart Transplant Rejection

Demonstrate the relationship between DD-cfDNA levels and HLA antibodies in blood transplant recipient and the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from heart transplants.

Начало: 01.06.2021 Край: 01.07.2027

Australia, Canada, Czechia +4 University of Alberta NCT04707872

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