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NCT ID: NCT06335849 Not yet recruiting - Herpes Zoster Clinical Trials

A Safety and Immunogenicity Trial of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years

Start date: April 2024
Phase: Phase 1
Study type: Interventional

This phase 1 study in Australia will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine (CHO Cell), LYB004 in Adults Aged 50 to 70 Years.

NCT ID: NCT06334211 Not yet recruiting - Healthy Clinical Trials

Safety, Tolerability, and Pharmacokinetics, of Single and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers

Start date: April 30, 2024
Phase: Phase 1
Study type: Interventional

This is a study to Investigate the Safety, Tolerability, and Pharmacokinetics, of Single (including Food Effect) and Multiple Ascending Doses of FP-020 in Healthy Adult Volunteers.

NCT ID: NCT06333899 Not yet recruiting - Glioblastoma Clinical Trials

Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion

Start date: September 1, 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy.

NCT ID: NCT06325202 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 1

Closed Loop and Education for Hypoglycemia Awareness Restoration

CLEAR
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The purpose of the CLEAR study is to determine the effect on counterregulatory responses (CRR) of intervening (by attempting to strictly avoid hypoglycemia) to improve awareness of hypoglycemic symptoms among adults with type 1 diabetes (T1D) who have impaired awareness of hypoglycemia (IAH). IAH affects 20-25% of adults with T1D, and rises with increasing duration of T1D.

NCT ID: NCT06324877 Not yet recruiting - Clinical trials for Ataxia Telangiectasia

Ataxia-telangiectasia: Treating Mitochondrial Dysfunction With Nicotinamide Riboside

ATNAD
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Study design: Single arm open-label clinical trial in ataxia-telangiectasia to test the effects of nicotinamide riboside on ataxia scales, immune function, and neurofilament light chain. Study population: 6-10 patients with Ataxia-Telangiectasia. Dose: Nicotinamide riboside 25 mg/kg/day in 3 equal divided doses. Primary endpoint: Scales for assessment and rating of ataxia (SARA), and International Cooperative Ataxia Rating Scale (ICARS). Improvement of at least ½ standard deviation in key clinical scales which includes either; a) significant improvement in total combined scores from the SARA and ICARS scales, and /or b) significant improvements any aspects of the SARA and ICARS scales individually, especially pertaining to; Postural and gait improvements, Improved syllable speed and articulation, Improved fine motor skills. Secondary endpoints: Serum analysis of neurofilament light chain (Nfl), Type 1 Interferon (INFs) epigenetic signature

NCT ID: NCT06324604 Not yet recruiting - Healthy Volunteers Clinical Trials

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

Start date: June 2024
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT06324188 Not yet recruiting - Atrial Fibrillation Clinical Trials

Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)

Start date: June 2024
Phase: N/A
Study type: Interventional

EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial). The objective of EASThigh-AFNET 11 is to investigate whether early atrial fibrillation ablation in patients with atrial fibrillation (AF) and a high comorbidity burden (CHA2DS2-VASc ≥4) reduces cardiovascular events (stroke, cardiovascular death, or heart failure events) compared to usual care.

NCT ID: NCT06320431 Not yet recruiting - Stroke Acute Clinical Trials

ACT-GLOBAL THROMBOLYSIS (ACT-WHEN-001) Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632

ACT-WHEN
Start date: June 15, 2024
Phase: Phase 3
Study type: Interventional

This domain has a prospective, randomized, controlled, open-label, parallel group with blinded endpoint assessment (PROBE) design. Up to 4,000 patients with presumed acute ischemic stroke (AIS) will be followed for 90 days (or until death, if prior to 90 days). The end of the trial is defined as the date that all participants have completed their Day 90 assessment. This domain aim is to efficiently, reliably, and simultaneously, determine the comparative effectiveness of intravenous thrombolysis (IVT) using standard-dose intravenous tenecteplase (0.25 mg/kg body weight), vs. low-dose intravenous tenecteplase (0.18 mg/kg body weight) in all patients who present to hospital with acute ischemic stroke and are considered for intravenous thrombolysis. In addition, this domain also seeks to study standard-dose intravenous tenecteplase (0.25 mg/kg body weight), vs. low-dose intravenous tenecteplase (0.18 mg/kg body weight) vs. no TNK upfront with rescue IA TNK if necessary (in those eligible for emergency EVT) and no TNK upfront in those who have taken DOACs during the preceding 24 hours. This domain therefore seeks to generate more robust randomized evidence to guide clinicians in their decisions over the balance of risks and treatment with intravenous thrombolysis with tenecteplase wherever such evidence is currently insufficient. This domain will currently evaluate four research questions in relation to the use of IVT with tenecteplase: 1. In patients with recent (24 hours) intake of a standard-dose direct oral anticoagulant (DOAC), how should IVT be used? - Use standard-dose (0.25 mg/kg body weight) or low-dose tenecteplase (0.18 mg/kg) or not at all. 2. In patients planned to be treated with endovascular thrombectomy, how should tenecteplase be used? -Treat with IV tenecteplase (standard- or low-dose) or not at all. 3. In any patient receiving IVT, what is the optimal dose of tenecteplase? - use standard-dose (0.25 mg/kg body weight) or low-dose tenecteplase (0.18 mg/kg). 4. To what extent is the treatment effect of standard- vs. low-dose tenecteplase modified by key patient characteristics, such as diabetes, prior antiplatelet therapy, renal failure, or frailty, old age or having a heavy burden of cerebral small vessel disease on brain imaging.

NCT ID: NCT06307015 Not yet recruiting - Clinical trials for HPV Positive Oropharyngeal Squamous Cell Carcinoma

De-escalation of Radiation Dose in HPV-associated OPC Utilising FMISO PET (DE-RADIATE)

DE-RADIATE
Start date: April 2024
Phase: N/A
Study type: Interventional

The goal of this prospective clinical trial is to determine if HPV-associated oropharyngeal squamous cell carcinoma that is non-hypoxic on FMISO PET can be successfully treated with a lower dose of radiation therapy. The main questions it aims to answer are: 1. What is the pathologic complete response rate in patients selected for radiation dose de-escalation and neck dissection? 2. What is the correlation between MRI and FMISO PET assessment of hypoxia before and during RT? 3. What are the acute and late toxicities in patients selected for radiation dose de-escalation? 4. What are the quality of life scores in patients selected for radiation dose de-escalation? 5. What are the local, regional and distant failure rates of patients selected for radiation dose de-escalation? Patients with cT1-2N1-2b (AJCC 7th edition) oropharyngeal tumours will undergo surgical resection of the primary tumour. Following this, they will be allocated to standard radiation therapy (70Gy with concurrent cisplatin chemotherapy) or de-escalation radiation therapy (30Gy with concurrent cisplatin chemotherapy) based on the results of FMISO PET. Patients with non-hypoxic tumours at baseline OR after two weeks of radiation therapy will be allocated to the de-escalated group. 3-4 months after completion of radiation therapy, all patients in the de-escalated group will undergo mandatory neck dissection to assess pathologic response. Researchers will assess the pathologic response rate after surgery in the de-escalation group. They will also compare the outcomes (oncological outcomes and quality of life) between the group receiving the standard treatment (70Gy) and the group receiving de-escalated radiation therapy (30Gy).

NCT ID: NCT06302426 Not yet recruiting - Clinical trials for Advanced Solid Tumor

Trial of INI-4001 in Patients With Advanced Solid Tumours

Start date: March 29, 2024
Phase: Phase 1
Study type: Interventional

Phase 1 open-label, dose-escalation and dose-expansion study of INI-4001 as a single agent and in combination with approved checkpoint inhibitors in subjects with advanced solid tumors.