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Набира участници Фаза 4

Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.

Fluid Overload

This study evaluates the benefits and harms of goal directed fluid removal with furosemide versus placebo in critical ill adult patients with fluid overload in the intensive care unit. Half of the patients will receive furosemide and the other half placebo. The treatment will continue until the excess fluid is excreted.

Начало: 17.08.2020 Край: 15.03.2028 Възраст: от 18 г. Лечение

Australia, Denmark, Finland +4 Morten H. Bestle NCT04180397

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AutoInflammatory Disease Alliance Registry (AIDA)

Hereditary Autoinflammatory Diseases Schnitzler Syndrome Behcet Syndrome PFAPA Syndrome +7

Autoinflammatory diseases (AID) are clinical entities characterized by recurrent inflammatory attacks in absence of infection, neoplasm or deregulation of the adaptive immune system. Among them, hereditary periodic syndromes, also known as monogenic AID, represent the prototype of this disease group, caused by mutations in genes involved in the regulation of innate immunity, inflammation and cell death. Based on recent experimental acquisitions in the field of monogenic AID, several immunologic disorders have been reclassified as polygenic/multifactorial AID, sharing pathogenetic and clinical features with hereditary periodic fevers. This has paved the way to new treatment targets for patients suffering from rare diseases of unknown origin, including Behçet's disease, Still disease, Schnitzler's disease, PFAPA (periodic fever, aphthous stomatitis, pharyngitis and cervical adenitis) syndrome, chronic recurrent multifocal osteomyelitis (CRMO), non-infectious uveitis and scleritis. Gathering information on such rare conditions is made difficult by the small number of patients, along with the difficulty of obtaining an accurate diagnosis in non-specialized clinical settings. In this context, the AIDA project promotes international collaboration among clinical centres to develop a permanent registry aimed at collecting demographic, genetic, clinical and therapeutic data of patients affected by monogenic and polygenic AID, in order to expand the current knowledge of these rare conditions.

Начало: 06.08.2020 Край: 06.08.2030

Algeria, Australia, Belgium +18 University of Siena NCT05200715

Набира участници Фаза 3

A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations

Acute Myeloid Leukemia

This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.

Начало: 21.07.2020 Край: 30.06.2029 Възраст: до 21 г. Лечение

Australia, Canada, Puerto Rico +1 Children's Oncology Group NCT04293562

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International CIPN Assessment and Validation Study

Chemotherapy-induced Peripheral Neuropathy Quality of Life

This is an observational study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients to be investigated prospectively in order to assess responsiveness of a set of outcome measures in an international multi-center study.

Начало: 08.06.2020 Край: 31.12.2025 Възраст: от 18 г.

Australia, Bangladesh, Brazil +11 University of Milano Bicocca NCT04633655

Набира участници Фаза 1

Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors

Head and Neck Squamous Cell Carcinoma Squamous Cell Carcinoma of Anal Canal Colorectal Cancer Squamous Cell Carcinoma of the Lung +7

The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.

Начало: 01.06.2020 Край: 01.06.2027 Възраст: от 18 г. Лечение

Australia, Canada, United States Bicara Therapeutics NCT04429542

Набира участници Фаза 1/2

INFORM2 Study Uses Nivolumab and Entinostat in Children and Adolescents With High-risk Refractory Malignancies

CNS Tumor Solid Tumor

The aim of this trial is to determine preliminary activity of the combination treatment with nivolumab and entinostat in children and adolescents with high risk refractory/relapsed/progressive tumors harboring a high mutational load, focal MYC(N) amplification or ATRT-MYC subgroup as well as tumors with high tumor infiltrating lymphocytes (TILs) or a tertiary lymphoid structure (TLS).

Начало: 26.05.2020 Край: 30.06.2027 Възраст: 2–21 г. Лечение

Australia, France, Germany +2 University Hospital Heidelberg NCT03838042

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Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.

Начало: 03.04.2020 Край: 31.03.2030

Argentina, Australia, Belgium +20 Bayer NCT04142437

Набира участници Фаза 1/2

A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

Locally Advanced Solid Tumors Metastatic Solid Tumors Lymphoma Primary CNS Tumors

Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D). Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations.

Начало: 12.03.2020 Край: 30.09.2027 Възраст: до 25 г. Лечение

Australia, Canada, Denmark +8 Turning Point Therapeutics, Inc. NCT04094610

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The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study

Aortic Stenosis

Aortic stenosis (AS) affects approximately 5% of individuals \>65 years old, with \~3% of people \>75 years having moderate to severe disease. The prevalence of AS is rising rapidly due to an ageing population and is projected to double in the next two decades. Increasingly clinicians face the dilemma of how to best manage this growing population of mainly elderly patients, many of whom are asymptomatic but have been identified as having severe AS, often as an incidental finding. Reduced aortic valve opening progresses over decades without any apparent symptoms because the heart compensates for the AS. Ultimately, compensatory mechanisms fail resulting in angina, syncope or heart failure. If these symptomatic patients with severe AS remain untreated, they have a dire prognosis. In this situation the only effective treatment is AVR, either surgically or using TAVI. Conversely, conventional teaching and clinical practice in cardiology has been that, in the absence of symptoms, the prognosis is usually excellent and, except in a few very specific circumstances, conservative management and regular review (expectant management) is recommended. This advice is reflected in current international guidelines but is based largely on historical precedent. There has never been a randomised controlled trial to address the relative benefits of early AVR versus expectant management in patients with severe asymptomatic AS. The relative benefits of a strategy of early AVR/TAVI versus expectant management in patients with asymptomatic severe AS are unclear. There is clinical equipoise but it remains one of the few areas of cardiovascular medicine where no randomised controlled trials (RCT) have been performed. The EASY-AS study will provide crucial data on the relative merits of these differing approaches to management, in terms of important patient orientated outcomes, conventional cardiovascular end-points and cost effectiveness.

Начало: 10.03.2020 Край: 01.04.2031 Възраст: от 18 г. Превенция

Australia, Belgium, Netherlands +4 University of Leicester NCT04204915

Набира участници Фаза 1

Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer

Prostate Cancer

The overall aim of the trial is to evaluate the safety, tolerability, and pharmacokinetics (PK) of AMG 509 (monotherapy and in combination with abiraterone acetate and enzalutamide) and to evaluate preliminary efficacy. As of Protocol Amendment 10 (09 July 2025), only Parts 4A expansion, 6, and 7 are open to accrual.

Начало: 04.03.2020 Край: 21.03.2032 Възраст: от 18 г. Лечение

Australia, China, Germany +7 Amgen NCT04221542

Набира участници Фаза 1

Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents for CLL/SLL

CLL/SLL

Assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of lisaftoclax.

Начало: 02.03.2020 Край: 30.06.2027 Възраст: 18–85 г. Лечение

Australia, United States Ascentage Pharma Group Inc. NCT04215809

Набира участници Фаза 2/3

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Pulmonary Disease Due to Mycobacteria (Diagnosis)

Mycobacterium abscessus (MABS) is a group of rapid-growing, multi-drug resistant non-tuberculous mycobacteria (NTM) causing infections in humans. MABS pulmonary disease (MABS-PD) can result in significant morbidity, increased healthcare utilisation, accelerated lung function decline, impaired quality of life, more challenging lung transplantation, and increased mortality. While the overall numbers affected is small, the prevalence of infections is increasing worldwide. The Finding the Optimal Regimen for Mycobacterium abscessus Treatment (FORMaT) trial aims to produce high quality evidence for the best treatment regimens to maximise health outcomes and minimise toxicity and treatment burden, as well as developing biomarkers (serology, gene expression signatures, and radiology) to guide decisions for starting treatment and measuring disease severity in patients with MABS PD.

Начало: 02.03.2020 Край: 30.06.2030 Лечение

Australia, Denmark, Israel +4 The University of Queensland NCT04310930

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TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention

BRCA1 Gene Mutation BRCA2 Gene Mutation RAD51C Gene Mutation RAD51D Gene Mutation +2

The aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.

Начало: 01.03.2020 Край: 17.02.2040 Възраст: 25–50 г. Превенция

Australia, Belgium, Brazil +12 University Medical Center Nijmegen NCT04294927

Набира участници Фаза 2

A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer

Neoplasms Child Adolescent

The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol. Individual clinical trials under this master protocol define drug/disease-specific research goals and activities to test them. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts.

Начало: 22.01.2020 Край: 01.05.2027 Възраст: 1–39 г. Лечение

Australia, Belgium, France +7 Eli Lilly and Company NCT05999994

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Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency

Chronic Venous Insufficiency

This objective of this feasibility study is to evaluate the safety of the InnoVein Valve and Delivery System for treatment of chronic venous insufficiency.

Начало: 15.01.2020 Край: 15.01.2027 Възраст: от 18 г. Лечение

Australia InnoVein NCT04253301

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Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery (OnCoPRO Value)

Breast Cancer Breast Carcinoma in Situ Breast Cancer Invasive Breast Asymmetry

The study aspires to provide outcomes on surgery, quality of life and time-to-event outcomes following the development and validation of a standardised surgical assessment tool in a shared decision-making framework for patients with pre-invasive or invasive breast cancer with breast conservation.

Начало: 01.01.2020 Край: 30.12.2032 Възраст: от 18 г.

Australia, Sweden, United Kingdom Uppsala University NCT06401304

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Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma

Cutaneous Melanoma, Stage II

Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.

Начало: 17.12.2019 Край: 31.12.2034 Възраст: от 18 г. Лечение

Australia, Canada, Ireland +7 Melanoma and Skin Cancer Trials Limited NCT03860883

Набира участници Фаза 1/2

A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis

Myelofibrosis

This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary MF.

Начало: 16.12.2019 Край: 30.04.2030 Възраст: от 18 г. Лечение

Australia, Belgium, Canada +5 Sumitomo Pharma America, Inc. NCT04176198

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Patient Experience and Acceptance of Horizontal Rotation

Cancer

Patients will complete validated psychometric questionnaires to quantify their experience of being rotated at different speeds using the Nano-X patient rotation system.

Начало: 14.12.2019 Край: 01.06.2025 Възраст: от 18 г. Фундаментална наука

Australia University of Sydney NCT02995603

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Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)

Kidney Failure, Chronic Hyperphosphatemia

During end-stage kidney disease, clinical guidelines suggest reducing elevated phosphate levels in the blood. However, the effect of lowering blood phosphate levels on important patient-centred outcomes has never been tested. This trial will evaluate whether compared to high levels, lowering blood phosphate levels would reduce death or major events due to heart disease, improve physical health, and be cost-effective.

Начало: 10.12.2019 Край: 31.12.2028 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +5 The University of Queensland NCT03573089

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