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Набира участници Фаза 1

Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors

Renal Cell Carcinoma (RCC) Metastatic Castration-Resistant Prostate Cancer (mCRPC) Urothelial Carcinoma (UC) Solid Tumor +6

This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in participants with advanced solid tumors. In the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.

Начало: 14.12.2021 Край: 28.06.2030 Възраст: от 18 г. Лечение

Australia, Belgium, France +9 Exelixis NCT05176483

Набира участници Фаза 1

PARP Inhibitor With 177Lu-DOTA-Octreotate PRRT in Patients With Neuroendocrine Tumours

Neuroendocrine Tumors

This phase 1 dose-escalation study is designed to evaluate the safety and tolerability of talazoparib in combination with 177Lu-DOTA-Octreotate peptide receptor radionuclide therapy (PRRT) in patients with metastatic pancreatic or midgut neuroendocrine tumour (NET).

Начало: 08.12.2021 Край: 30.06.2029 Възраст: от 18 г. Лечение

Australia Peter MacCallum Cancer Centre, Australia NCT05053854

Набира участници Фаза 1

First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer

PIK3CA Mutation Solid Tumor, Adult HER2-negative Breast Cancer Breast Cancer +3

This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor patients with a Phosphatidylinositol-4,5-bisphosphate-3 kinase, catalytic subunit alpha (PIK3CA) mutation in blood and/or tumor per local assessment. The study will evaluate RLY-2608 as a single agent for patients with unresectable or metastatic solid tumors. It will also evaluate RLY-2608 in combination RLY-2608 + fulvestrant and in triple combination RLY-2608 + fulvestrant + CDK4/6 inhibitor (palbociclib or ribociclib) or CDK4 inhibitor (PF-07220060) for patients with HR+ HER2- locally advanced or metastatic breast cancer. The RLY-2608 single agent arm, RLY-2608 + fulvestrant combination arm, and triple combination arms will have 2 parts: a dose escalation (Part 1) and a dose expansion (Part 2).

Начало: 08.12.2021 Край: 30.04.2027 Възраст: от 18 г. Лечение

Australia, France, Italy +2 Relay Therapeutics, Inc. NCT05216432

Набира участници Фаза 2

A Trial of Palliative Chemotherapy, Radiation and Immune Treatment for Oesophageal Cancer: PALEO Study

Esophageal Cancer

The purpose of this study is to investigate the effects of the addition of the stereotactic body radiotherapy and durvalumab to a well tolerated 2 week chemotherapy and radiation treatment regimen in people with esophageal cancer that is locally advanced or has spread to another area of the body (metastasized).

Начало: 08.12.2021 Край: 31.07.2029 Възраст: от 18 г. Лечение

Australia, New Zealand Australasian Gastro-Intestinal Trials Group NCT06290505

Набира участници Фаза 3

A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

Stereotypical Prolonged Seizures

The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.

Начало: 07.12.2021 Край: 01.04.2026 Възраст: от 12 г. Лечение

Australia, Bulgaria, China +10 UCB Biopharma SRL NCT05077904

Набира участници

The National Australian HCV Point-of-Care Testing Program - Minimal Dataset

Hepatitis C

The National Australian HCV Point-of-Care Testing Program will establish an observational cohort to evaluate whether scale-up of finger-stick point-of-care HCV testing increases diagnosis and treatment for HCV infection. Participants will be recruited from settings providing services to people with a risk factor for the acquisition of HCV infection (including drug treatment clinics, needle and syringe programs, homelessness settings, mental health services, prisons, and mobile outreach). All participants who undergo HCV point-of-care testing at the study site will be included in the data collection. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care.

Начало: 01.12.2021 Край: 01.12.2026 Възраст: от 18 г.

Australia Kirby Institute NCT05248555

Набира участници

The Use of Remote Monitoring for Orthodontic Retention Review

Orthodontic Relapse

To assess whether using retainers and an artificial intelligence supported remote monitoring system maintains a more stable orthodontic treatment result than using retainers with in-office review appointments.

Начало: 01.12.2021 Край: 22.09.2025 Възраст: от 12 г. Превенция

Australia Sydney Local Health District NCT05006339

Набира участници

Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer

Lung Cancer Radiation-Induced Disorder Radiation Pneumonitis Pulmonary Disease +1

Study aims to determine if functional lung avoidance based on perfusion single photon emission (SPECT)/CT scan, improves toxicity outcomes for patients with advanced lung cancer undergoing chemo-radiotherapy. Functional avoidance implies a dose plan that takes functional distribution in the lung into account, and avoids highly functional lung volumes sparing them from radiation.

Начало: 01.12.2021 Край: 01.12.2028 Възраст: от 18 г. Лечение

Australia, Denmark University of Aarhus NCT04676828

Набира участници Фаза 2/3

Extending the Time Window for Tenecteplase by Recanalization of Basilar Artery Occlusion in Posterior Circulation Stroke

Basilar Artery Occlusion

Patients presenting to the emergency department with an acute ischemic stroke due to basilar artery occlusion within 24 hours of stroke onset will be assessed to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomised 50:50 using a central computerised allocation process to either standard of care (no intravenous thrombolytic treatment or intravenous alteplase 0.9mg/kg) or tenecteplase 0.25mg/kg before undergoing mechanical thrombectomy as required at treating clinician's discretion. The trial is Multi-arm, Multi-stage, prospective, randomised, open-label, blinded endpoint (PROBE) design with seamless phase 2b/3 transition if the intermediate endpoint (recanalization without symptomatic intracerebral hemorrhage) is met in analysis of the first 202 patients. Adaptive sample size re-estimation (Mehta and Pocock) will be performed when 240 patients have completed 3 month follow-up (minimum sample size 320, maximum sample size 688).

Начало: 29.11.2021 Край: 01.12.2026 Възраст: от 18 г. Лечение

Australia University of Melbourne NCT05105633

Набира участници

Virtual Walking Intervention for Neuropathic Pain in Spinal Cord Injury

Spinal Cord Injuries Neuropathic Pain

The purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with chronic spinal cord injury.

Начало: 23.11.2021 Край: 01.09.2026 Възраст: от 18 г. Лечение

Australia, United States Texas A&M University NCT05005026

Набира участници

HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial

Hip Fractures Myocardial Injury

The HIP ATTACK-2 trial is a multicentre, international, parallel group randomized controlled trial to determine whether accelerated surgery for hip fracture in patients with acute myocardial injury is superior to standard care in reducing death at 90 days after randomization. The trial will also assess secondary outcomes at 90 days after randomization: inability to independently walk 3 metres, time to first mobilization (first standing and first full weight bear), composite and individual assessment of major complications (e.g., mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke), delirium, length of stay, pain, and quality of life.

Начало: 22.11.2021 Край: 31.05.2027 Възраст: от 45 г. Лечение

Australia, Belgium, Brazil +15 Population Health Research Institute NCT04743765

Набира участници

Effect of Chitodex Gel in Tympanoplasty Surgery

Tympanic Membrane Perforation Tympanic Membrane Inflammation Surgery Otitis Media

The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty, ossiculoplasty and mastoidectomy procedures.

Начало: 20.11.2021 Край: 13.05.2025 Възраст: от 18 г. Лечение

Australia Central Adelaide Local Health Network Incorporated NCT06260618

Набира участници

Persistent Cardiovascular Effects of COVID-19 Viral Infection Trial (PERCEIVE)

Heart Failure

This is a prospective study in which a process of identifying and improving a reduction of functional capacity in COVID-19 survivors \>50 years old. The overall goal of this study to identify the feasibility and value of risk-guided medical therapy and exercise intervention in COVID-19 survivors.

Начало: 18.11.2021 Край: 30.12.2025 Възраст: 50–85 г. Скрининг

Australia Baker Heart and Diabetes Institute NCT04983823

Набира участници Фаза 3

Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors

Hemophilia A Hemophilia B

Study B7841007 is an open-label extension study to assess the long-term safety, tolerability, and efficacy of prophylaxis treatment with marstacimab in participants who did not require "Early Termination" from the Phase 3 Study B7841005 and from the Phase 3 Study B7841008. Study B7841005: approximately 145 adolescent and adult participants 12 to \

Начало: 17.11.2021 Край: 31.07.2030 Възраст: 1–74 г. Лечение

Argentina, Australia, Brazil +21 Pfizer NCT05145127

Набира участници Фаза 3

High Dose Steroids in Children With Stroke

Paediatric Stroke

This clinical trial deals with focal cerebral arteriopathy and childhood stroke, a rare but devastating condition. Focal cerebral arteriopathy (FCA) is an inflammatory vessel wall disease provoked by infection and there is increasing evidence that inflammatory processes play a crucial role in childhood stroke, influencing the outcome of the disease. Analysis of existing data suggests that outcomes are improved and that there is less stroke recurrence in children treated with steroids to reduce the acute inflammatory processes. This clinical trial will be conducted in over 20 hospitals in several countries in order to investigate this. Participants will be randomly separated into two groups. The first group will be treated with standard of care (including aspirin) combined with high dose steroids. The second group will be treated with standard of care (including aspirin) but without steroid treatment. The objective is to investigate if children treated with a combination of high dose steroid and aspirin will have a better and quicker recovery of FCA, better clinical functional outcome, and less recurrence compared to children treated with aspirin alone. This project has been identified by international pediatric stroke experts as the most important topic for a clinical trial in the field and is as well one of the most important research priorities identified by parents. The study results will also provide insight into the evolution of inflammatory vessel disease.

Начало: 16.11.2021 Край: 01.07.2026 Възраст: 6–17 г. Лечение

Australia, Denmark, France +2 Insel Gruppe AG, University Hospital Bern NCT04873583

Набира участници Фаза 3

Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia

Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy.

Начало: 02.11.2021 Край: 01.07.2031 Възраст: 40–100 г. Лечение

Australia, Belgium, Brazil +26 Amgen NCT04994717

Набира участници

The CARMA Technique Study

Colonic Polyp Colonic Sessile Serrated Lesion

Colonoscopic removal of polyps is an important and well-established tool in the prevention of colorectal cancers. However, high polyp recurrence rates after endoscopic resection, with resultant development of interval cancers, remains a problem; this most commonly stems from unrecognised incomplete polyp resection. Thus, a standardised endoscopic technique is needed that will allow endoscopists to consistently achieve a clear margin of resection. The investigators believe the Cap Assisted Resection Margin Assessment (CARMA) technique will address this problem. This novel technique focuses on a standardised assessment of the resection margin after endoscopic polypectomy utilising available standard high-definition video endoscopes with imaging features including narrow band imaging (NBI) and magnification endoscopy.

Начало: 01.11.2021 Край: 01.11.2026 Възраст: от 16 г. Лечение

Australia Princess Alexandra Hospital, Brisbane, Australia NCT05099432

Набира участници

Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

Disorder Heart Postoperative Cardiac Surgery

TRICS-IV is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in moderate to high risk patients who are 65 years of age or younger undergoing cardiac surgery on cardiopulmonary bypass, using a superiority trial design.

Начало: 01.11.2021 Край: 01.06.2026 Възраст: 18–65 г. Лечение

Australia, Canada, Colombia +13 Unity Health Toronto NCT04754022

Набира участници Фаза 1

A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

Metastatic Colorectal Cancer

This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.

Начало: 22.10.2021 Край: 31.08.2030 Възраст: от 18 г. Лечение

Australia, Canada, Denmark +7 Hoffmann-La Roche NCT04929223

Набира участници Фаза 2

Combination Therapy for the Treatment of Diffuse Midline Gliomas

Diffuse Intrinsic Pontine Glioma Diffuse Midline Glioma, H3 K27M-Mutant Recurrent Diffuse Intrinsic Pontine Glioma Recurrent Diffuse Midline Glioma, H3 K27M-Mutant +2

This phase II trial determines if the combination of ONC201 with different drugs is effective for treating participants with diffuse midline gliomas (DMGs). Despite years of research, little to no progress has been made to improve outcomes for participants with DMGs, and there are few treatment options. This trial will utilize an adaptive platform design in that the different treatment arms for each cohort will be opened and closed based on ongoing preclinical investigation as well as evolving outcome data from the trial. Novel agents will be continuously added to this study as pre-clinical data emerge to suggest additive or synergistic activity when combined ONC201. Should a novel agent not have an RP2D at the time of incorporation into this study, a phase 1 lead-in will be performed prior to initiation of combination therapy (via study amendment).

Начало: 20.10.2021 Край: 30.06.2029 Възраст: 2–39 г. Лечение

Australia, Israel, Netherlands +3 University of California, San Francisco NCT05009992

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