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NCT ID: NCT02746172 Completed - Hearing Loss Clinical Trials

Clinical Metrics for Assessing Cochlear Implant Recipient MAPs

Start date: November 16, 2015
Phase: N/A
Study type: Interventional

The aim of this research is to investigate the potential use of specific metrics in assessing the quality and optimising an individual's cochlear implant fitting. Assessment of the sensitivity and specificity of specific metrics that are potential predictors of inaccurate T-levels and C-levels is important to determining best methods for streamlined high quality fitting, providing the potential for feedback to the individual and clinic, as well as automated adjustments for optimisation. Ultimately the objective is to increase clinical capacity for managing both the installed base and new candidates for cochlear implantation.

NCT ID: NCT02745080 Completed - Psoriatic Arthritis Clinical Trials

Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis

EXCEED 1
Start date: April 3, 2017
Phase: Phase 3
Study type: Interventional

This was a randomized, double-blind, active controlled, multicenter, parallel-group study evaluating secukinumab monotherapy and adalimumab monotherapy in approximately 850 patients with active psoriatic arthritis (PsA) who are naïve to biologic therapy and are intolerant or having inadequate response to conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs).

NCT ID: NCT02745041 Completed - Trauma Clinical Trials

Fibrinogen Early In Severe Trauma studY

FEISTY
Start date: December 2016
Phase: Phase 2
Study type: Interventional

- Haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in trauma patients - Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma - Hypo/dysfibrinogenaemia plays an important role in TIC - Early replacement of fibrinogen may improve outcomes - Fibrinogen replacement is potentially inadequate in standard fixed ratio Major Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate - The majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a MHP - Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio MHP - It is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - CRASH 2 and PROPPR studies - Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not supported by high level evidence - Benefits of FC - viral inactivation, known dose, easily reconstituted, can be administered quickly in high dose and stored at room temperature in the trauma resuscitation bay - No previous studies comparing FC and Cryoprecipitate in bleeding trauma patients - Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment algorithm - It will be a pilot, multi-centre randomised controlled trial comparing FC to Cryoprecipitate (current standard practise in fibrinogen supplementation) - Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate - It is imperative that robust and clinically relevant trials are performed to investigate fibrinogen supplementation in trauma before widespread adoption makes performing such studies unfeasible

NCT ID: NCT02743221 Completed - Clinical trials for Metastatic Colorectal Cancer

A Study Evaluating S 95005 Plus Bevacizumab and Capecitabine Plus Bevacizumab in Patients With Previously Untreated Colorectal Cancer Who Are Non-eligible for Intensive Therapy

TASCO1
Start date: April 29, 2016
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the progression-free survival (PFS) in patients receiving S 95005 + bevacizumab (experimental arm) or capecitabine + bevacizumab (control arm) as first-line treatment for unresectable metastatic colorectal cancer in patients non-eligible for intensive therapy.

NCT ID: NCT02742766 Completed - Healthy Volunteers Clinical Trials

Safety, Tolerability and Preliminary Pharmacokinetics (PK) and Pharmacodynamics (PD) of Single and Repeat Oral Doses of GSK3008356 in Healthy and Obese Subjects

Start date: March 14, 2016
Phase: Phase 1
Study type: Interventional

This study is a phase I, randomized, placebo-controlled, double-blind (sponsor unblind), three part study. The primary objective of the study is to characterize the safety, and tolerability of GSK3008356 single dose, 14 daily repeat doses in healthy subjects and 28 daily repeat doses in obese subjects. The study has three parts. Part 1, will be a single and multiple-dose, dose-rising study in healthy subjects. Part 2, will be a 14-day, repeat-dose, dose-rising study in healthy subjects, and part 3 will be a 28-day, repeat-dose study in obese subjects. For Parts 1 and 2, data from prior doses cohorts will be available prior to escalation decisions. Data from Parts 1 and 2 will be available prior to initiation of the three parallel cohorts in Part 3. A dose escalation meeting will be held to review these data and document the decision to proceed as planned or make any alterations in dosing, if indicated. Part 1, Part 2 and Part 3 study will have approximately 88, 24 and 30 subjects, respectively.

NCT ID: NCT02742623 Completed - Clinical trials for Venous Thrombosis and Pulmonary Embolism

A Non-interventional Study on Xarelto for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer

COSIMO
Start date: October 11, 2016
Phase:
Study type: Observational

This study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).

NCT ID: NCT02741570 Completed - Clinical trials for Head and Neck Cancer

Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

CheckMate 651
Start date: October 5, 2016
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to compare nivolumab and ipilimumab with the extreme regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer

NCT ID: NCT02737501 Completed - Lung Cancer Clinical Trials

ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants

ALTA-1L
Start date: May 26, 2016
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic non-small cell lung cancer (NSCLC) participants naive to ALK inhibitors, as evidenced by progression-free survival (PFS).

NCT ID: NCT02733055 Completed - Postural Balance Clinical Trials

Posturography as Biomarker of Oculomotor and Postural Control Integration

Start date: April 1, 2016
Phase: N/A
Study type: Interventional

Determine the effects looking in certain direction or moving the eyes in a certain way have on the ability of a subject to maintain equilibrium in different circumstances (eyes open/closed, and standing on hard or compliant surface, with the head straight or rotated right or left, flexed or extended).

NCT ID: NCT02731911 Completed - Clinical trials for Diabetic Macular Oedema

Study of OZURDEX® in the Treatment of Diabetic Macular Oedema (DME) in Australia - The AUSSIEDEX Study

Start date: April 29, 2016
Phase:
Study type: Observational

This prospective study will assess Ozurdex in the treatment of Diabetic Macular Oedema in clinical practice.