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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

Набира участници Фаза 2

ATEMPT 2.0: Adjuvant T-DM1 vs TH

Breast Cancer HER2-positive Breast Cancer

This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery. The name of the study drugs involved are: * Trastuzumab-emtansine (T-DM1, Kadcyla) * Trastuzumab SC (Herceptin Hylecta) * Paclitaxel

Начало: 16.06.2021 Край: 01.05.2028 Възраст: от 18 г.

United States Dana-Farber Cancer Institute NCT04893109

Набира участници

Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcomes in Ovarian Cancer

Ovarian Cancer

This prospective non-interventional study is intended to generate new data and insights into first-line (1L) treatment of newly diagnosed advanced high-grade epithelial Ovarian cancer (OC) in Germany relevant for patients, physicians and payers. It will capture the influence of 1L Poly ADP ribose polymerase inhibitor (PARPi) maintenance treatment (MTX) on medical routine in Germany, especially on: * outcome of the 3-steps 1L treatment phase (including surgery, Chemotherapy (CTX) and MTX) including the potential of patients with primary advanced OC to be cured, * patient's follow-up (FU) during and after MTX therapy, * patient-reported outcomes (PROs), experiences and needs, * physician's experience, * BRCA/HRD and genomic scar testing behavior at diagnosis/during 1L therapy, * patient selection for different 1L systemic treatment approaches, * use and safety of drugs, * treatment sequence in case of recurrence

Начало: 15.06.2021 Край: 31.03.2033 Възраст: 18–130 г.

Germany AstraZeneca NCT04830709

Набира участници

Diagnostic Efficacy of CNN in Predicting Intraoperative Complications and Postoperative Outcomes in SMILE

Deep Convolutional Neural Network Small-incision Lenticule Extraction (SMILE) Surgery Intraoperative Complications Postoperative Outcomes

To evaluate the diagnostic efficiency of the neural network in predicting complications of Small Incision Lenticule Extraction in a multi-center cross-sectional study.

Начало: 15.06.2021 Край: 01.12.2027 Възраст: 18–45 г.

China Second Affiliated Hospital of Nanchang University NCT06204926

Набира участници

Device Global Registry for the IlluminOss Bone Stabilization System

Traumatic Fracture Pathological Fracture

This is a multi-center, observational patient registry. The primary objective of the study is to collect safety and performance data on the IlluminOss Device when used to provide stabilization and alignment for the treatment of traumatic or impending and pathologic fractures.

Начало: 11.06.2021 Край: 01.12.2026 Възраст: от 50 г.

Germany, United States IlluminOss Medical, Inc. NCT05206981

Набира участници

ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer

Breast Cancer Chemotherapy Sentinel Lymph Node Axillary Lymph Nodes Dissection +1

In the case of primary surgery, in patients with sentinel node involvement, it has already been shown that omitting axillary lymph node dissection (ALND), often combining axillary radiotherapy (RT), does not worsen the prognosis and does significantly reduce the appearance of lymphedema. However, patients who have received neoadjuvant systemic treatment cannot benefit from this option, even though in the majority of those who have responded well to treatment, a residual disease in the armpit is low, but there are no studies yet published that supports the possibility of not performing lymphadenectomy. The primary endpoint is to evaluate wether axillary radiotherapy (ART) presents a lower risk of lymphedema with respect to lymphadenectomy (ALND) in patients with breast cancer who, after neoadjuvant systemic treatment (NST), present the sentinel node affected. Likewise, we will evaluate recurrences and overall survival in both groups. Finally, we will analyze the quality of life of these patients.

Начало: 11.06.2021 Край: 31.12.2028 Възраст: от 18 г. Лечение

Australia, Spain Hospital Universitari de Bellvitge NCT04889924

Набира участници Фаза 3

Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability

Metastatic Lung Small Cell Carcinoma Metastatic Malignant Neoplasm in the Brain Recurrent Lung Small Cell Carcinoma Stage IV Lung Cancer AJCC v8

This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The drug, memantine, is also often given with whole brain radiotherapy because it may decrease the risk of side effects related to thinking and memory. Stereotactic radiosurgery may decrease side effects related to memory and thinking compared to standard of care HA-WBRT plus memantine.

Начало: 08.06.2021 Край: 01.07.2030 Възраст: от 18 г.

Canada, United States NRG Oncology NCT04804644

Набира участници

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

Набира участници

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

Набира участници

Influence of Cerebral Oedema in Intracerebral Haemorrhage

Stroke Intra Cerebral Hemorrhage

In 2020, IntraCerebral Haemorraghe (ICH) remains the most devastating type of stroke. Besides stroke unit care, no specific treatment has been proven effective yet. Perihaematomal oedema (PHO) could be a promising therapeutic target. However, the mechanisms, the natural history as well as the clinical impact of this PHO remain unclear. The COPITCH study has been designed to answer these questions

Начало: 04.06.2021 Край: 03.12.2027 Възраст: от 18 г.

France University Hospital, Lille NCT04621357

Набира участници Ранна Фаза 1

Concomitant Renal and Urinary Bladder Allograft Transplantation

Chronic Kidney Diseases Bladder Dysfunction Bladder Absence Posterior Urethral Valve +5

The purpose of this study is to establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.

Начало: 01.06.2021 Край: 01.08.2026 Възраст: 1–60 г.

United States Mayo Clinic NCT04626167

Набира участници

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

Набира участници Фаза 4

BonE and Joint Infections - Simplifying Treatment in Children Trial

Bone Infection Septic Arthritis Bone and Joint Infection Osteomyelitis

This is a multi- centre trial of children with bone and joint infections (BJIs) at eight major paediatric hospitals in Australia and New Zealand. The primary objective is to establish if in children with acute, uncomplicated BJIs, entirely oral antibiotic treatment is not inferior to initial intravenous (IV) treatment for 1 to 7 days followed by an oral antibiotic course in achieving full recovery 3 months after presentation. Children will be randomly allocated to the 'entirely oral antibiotic' group or the 'standard treatment' group.

Начало: 01.06.2021 Край: 01.12.2026 Възраст: 1–18 г. Лечение

Australia, New Zealand Murdoch Childrens Research Institute NCT04538053

Набира участници

Advanced Techniques For Single-fraction Palliative Radiotherapy Versus Standard Multi Fraction Radiation

Palliative Radiotherapy

The aim of the study is to determine if single fraction dose escalated palliative radiotherapy results in a prolonged duration of benefit for patients otherwise suitable for Multifraction (5-10#) palliative radiation. The primary endpointis to determine the percentage of patients who have achieved a substantial benefit from palliative radiotherapy and have not redeveloped symptoms by 12 months post treatment

Начало: 31.05.2021 Край: 30.06.2026 Лечение

Australia Royal North Shore Hospital NCT04649125

Набира участници Фаза 1/2

A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

Cervical Cancer Gastric/Gastroesophageal Junction Adenocarcinoma Microsatellite Stable Colorectal Cancer Non-Small-Cell Lung Cancer +7

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

Начало: 27.05.2021 Край: 07.07.2028 Възраст: от 18 г. Лечение

Australia, Canada, China +6 Bristol-Myers Squibb NCT04895709

Набира участници Фаза 3

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

Ulcerative Colitis Ulcerative Colitis Chronic Inflammatory Bowel Diseases Crohn's Disease

The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.

Начало: 26.05.2021 Край: 01.12.2030 Възраст: 2–19 г.

Austria, Belgium, Brazil +13 Eli Lilly and Company NCT04844606

Набира участници Фаза 1

CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)

Lymphoma, Non-Hodgkin Relapsed Non Hodgkin Lymphoma Refractory B-Cell Non-Hodgkin Lymphoma Non Hodgkin Lymphoma +3

CB010A is a study evaluating safety, emerging efficacy, pharmacokinetics and immunogenicity of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma after lymphodepletion consisting of cyclophosphamide and fludarabine.

Начало: 26.05.2021 Край: 01.09.2025 Възраст: от 18 г. Лечение

Australia, Israel, United States Caribou Biosciences, Inc. NCT04637763

Набира участници Фаза 1

Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma

Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System

This phase I trial tests the safety, side effects, best dose and effectiveness of lenalidomide when added to nivolumab and the usual drugs (rituximab and methotrexate) in patients with primary central nervous system (CNS) lymphoma. Lenalidomide may stop or slow primary CNS lymphoma by blocking the growth of new blood vessels necessary for tumor growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Methotrexate is frequently combined with other chemotherapy agents to improve response. This study may help increase the understanding of lenalidomide and nivolumab use in primary CNS lymphoma treatment. In addition, it may help researchers see whether the control of CNS lymphoma can be extended by using these study drugs as maintenance (prolonged therapy) after control is achieved with the initial chemotherapy regimen (induction).

Начало: 24.05.2021 Край: 01.04.2027 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT04609046

Набира участници Фаза 1/2

A Study of BGB-11417 in Participants With Myeloid Malignancies

Acute Myeloid Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasm

The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS/myeloproliferative neoplasm (MPN) .

Начало: 24.05.2021 Край: 08.02.2028 Възраст: от 18 г. Лечение

Australia, China, France +7 BeiGene NCT04771130

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