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NCT ID: NCT04085666 Completed - Phenylketonuria Clinical Trials

Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of CDX-6114 in Patients With Phenylketonuria (PKU)

Start date: June 1, 2019
Phase: Phase 1
Study type: Interventional

This study is an international, multi-center, randomized, double-blind, placebo-controlled, two-treatment, two-period cross-over study to evaluate the pharmacodynamics, safety, tolerability and pharmacokinetics of a single oral dose of CDX-6114 in patients with phenylketonuria (PKU).

NCT ID: NCT04077411 Completed - Clinical trials for Severe Traumatic Brain Injury

Approaches and Decisions for Acute Pediatric TBI Trial

ADAPT
Start date: February 20, 2014
Phase:
Study type: Observational

Approaches and Decisions in Acute Pediatric TBI Trial (ADAPT) is an international research study designed to evaluate the impact of interventions on the outcomes of children with severe traumatic brain injury. Pediatric traumatic brain injury (TBI) is the leading killer of children, resulting in more than 7000 deaths and $2 billion in acute care costs each year. Despite this large burden of disease, advances in the field have been limited due to weak evidenced-based guidelines and the limitations of randomized, controlled trials (RCTs) to demonstrate efficacy of single treatment strategies due to wide treatment variability. ADAPT is a practical study design in a novel approach - an observational cohort study designed to evaluate the association of 6 aspects of pediatric TBI care with outcomes using statistical modeling to correct for confounding variables. Completion of this study will provide compelling evidence to change clinical practices, provide evidence for new Level II recommendations for future guidelines and lead to improved research protocols that would limit variability in TBI treatments - helping children immediately through better clinical practices and ultimately through more effective investigation.

NCT ID: NCT04075604 Completed - Breast Cancer Clinical Trials

A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer

CheckMate 7A8
Start date: October 18, 2019
Phase: Phase 2
Study type: Interventional

A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer

NCT ID: NCT04074759 Completed - Clinical trials for Advanced Solid Tumors

FPT155 in Patients With Advanced Solid Tumors

FPT155-001
Start date: November 14, 2018
Phase: Phase 1
Study type: Interventional

This study is a Phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and activity of FPT155 as monotherapy in patients with advanced solid tumors.

NCT ID: NCT04074460 Completed - Cancer, Breast Clinical Trials

Volatile Anaesthesia and Perioperative Outcomes Related to Cancer Feasibility Study

VAPOR-C
Start date: August 27, 2017
Phase: Phase 4
Study type: Interventional

A multicentre, prospective randomized, active-controlled feasibility trial of volatile-based anaesthesia vs. propofol-based total intravenous anaesthesia to investigate the impact of anaesthesia on long-term (i.e. 5-years) patient cancer outcomes in patients undergoing elective major cancer surgery.

NCT ID: NCT04072887 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients

Start date: September 12, 2019
Phase: Phase 2
Study type: Interventional

This clinical study was designed to support the dose selection for future studies by evaluating efficacy and safety of different QBW251 doses in Chronic obstructive pulmonary disease (COPD) patients with chronic bronchitis and a history of exacerbations, compared to placebo, when added to a triple inhaled therapy of LABA, LAMA and ICS.

NCT ID: NCT04071613 Completed - Clinical trials for Stroke, Acute, Stroke Ischemic

Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance

TASTEa
Start date: June 20, 2019
Phase: Phase 2
Study type: Interventional

Ischemic stroke is a major health burden globally and in Australia. Treatment for ischemic stroke is time critical and is significantly more effective if administered within the first 90 minutes of symptom onset. This clinical trial will identify if early administration of oral thrombolytic agent, tenecteplase prior to hospital can improve outcomes from stroke, and reduce costs compared to standard care of IV alteplase in hospital

NCT ID: NCT04070586 Completed - Cancer, Lung Clinical Trials

Adaptive CT Acquisition for Personalised Thoracic Imaging

ADAPT
Start date: August 21, 2019
Phase:
Study type: Observational

In this trial, Respiratory Motion Guided (RMG) 4DCBCT will be implemented for the first time on lung cancer patients. RMG-4DCBCT adapts the image acquisition as the patient's breathing changes (i.e. if the patient breathes faster, imaging data is acquired faster). By adapting the acquisition to the dynamic patient, personalised images of a patients lungs are able to be acquired for radiotherapy treatments.

NCT ID: NCT04069156 Completed - Heart Failure Clinical Trials

The ARIES HeartMate 3 Pump IDE Study

Start date: July 14, 2020
Phase: N/A
Study type: Interventional

Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo

NCT ID: NCT04068181 Completed - Melanoma Clinical Trials

Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).

Start date: January 22, 2020
Phase: Phase 2
Study type: Interventional

This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-programmed cell death protein (anti-PD-1) therapy in unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting. Subjects will be treated with talimogene laherparepvec and pembrolizumab until confirmed complete response, disappearance of all injectable lesions, documented confirmed disease progression per modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST), intolerance of study treatment, or 102 weeks from the first dose of talimogene laherparepvec and/or pembrolizumab, whichever occurs first.