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NCT ID: NCT02162719 Completed - Breast Neoplasms Clinical Trials

A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors

LOTUS
Start date: August 19, 2014
Phase: Phase 2
Study type: Interventional

This multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors.

NCT ID: NCT02161341 Completed - Dry Eye Clinical Trials

Ocular Surface Microbiome in Dry Eye Patients

Start date: June 2014
Phase:
Study type: Observational

The ocular surface is the first line of defence of the eye, it is therefore where external threats are sensed, and potential insults neutralised. Over the course of evolution, various microbes, especially bacteriae, have come to colonise the ocular surface as commensals. The commensals have a role to maintain the homeostasis of the ocular surface. 1 The innate immunity of the ocular surface is very active, and consists of active mechanisms to suppress inflammation 2. For example, there exist macrophages, dendritic cells, suppressor cells, regulatory cells, B cells, IgA, lysozyme, anti-microbial peptides and barriers against external agents. The normal commensals of the ocular surface maintain a basal level of activation of innate defence by stimulating the pattern recognition receptors on ocular surface epithelial cells. This normal composition of microbes is important since inflammation and infection will result if there is introduction of a pathogenic strain that overcomes the flora, or if a dominant strain secretes excessively immunogenic products, such as the exotoxin A of Staphylococcus which triggers marginal keratitis, a form of type IV hypersensitivity. The flora load of microbiome could also influence tear function as a higher flora load was found to be associated with increased mucin degradation 3 and reduced globet cell densitiy 4. Previous studies [I'm not sure which studies these are] at SERI/SNEC also point to the importance of microbes. For example, in dry eye patients, there is increased lysophospholipids in the tear, and this may contribute to inflammatory mediators such as arachidonic acid and other metabolites. The lysophospholipids are formed by phospholipase A2 reactions, and the latter may be microbial in origin. Since dry eye is a known inflammatory disease of the ocular surface, this is one way that microbes can contribute to the pathology.

NCT ID: NCT02160769 Completed - Dry Eye Clinical Trials

Tear Layer Lipid Thickness in Pterygium Patient Before and After Surgery

Start date: November 2013
Phase:
Study type: Observational

The investigators study aims to capture the objective effects of pterygium surgery on tear layer lipid thickness and the tear layer. Previous objective studies of the tear film has been limited to corneal staining grading, tear break up time and Schirmer's test which have been shown to poor to moderate repeatability. The effect of pterygiums on tear layer lipid thickness (LLT) has not previously been explored. With the LipiView Ocular Surface Interferometer, the investigators have the ability to assess the optical coherence interference pattern produced by light reflected off the tear film in a safe and non-invasive manner. Software analysis of the image then measures the tear LLT which can be used to objectively quantify the diagnosis of lipid-deficient dry eye.

NCT ID: NCT02159768 Completed - Anaesthesia Clinical Trials

Visualization of the Larynx With the Airtraq Laryngoscope and Image Transmission

Start date: August 2013
Phase: N/A
Study type: Interventional

The Airtraq is a battery powered single use optical laryngoscope with a channel to hold and guide the tracheal tube into the trachea. It enables tracheal intubation in patients with normal and difficult airways, by enabling laryngoscopy without neck movement. As a single use device, it is cost effective to have these placed in emergency equipment kits, and for use by emergency and military personnel. However, it does have several limitations. The Airtraq requires the user to place his/her eye to the eyepiece in order to see the advancement of the laryngoscope and the tracheal tube, which may be difficult if the patient is on the ground or in emergency scenarios. Only the user can see through the eyepiece and any assistants are unable to view the larynx, this makes it difficult for assistants to help the operator. Many handphones now incorporate high quality cameras. In this study, we will evaluate the effectiveness of using the iPhone to aid laryngoscopy with the Airtraq optical laryngoscope during laryngoscopy and intubation in 30 patients presenting for elective surgery under general anaesthesia. We have manufactured an attachment that fits over the eyepiece of the Airtraq, to hold an iPhone to the eyepiece. This will enable to operator and assistants to simultaneously view the insertion of the Airtraq, view the larynx and view the passage of the tracheal tube into the trachea.

NCT ID: NCT02151188 Completed - Obesity Clinical Trials

Liquid Protein Preloads With Different Carbohydrate Types Effects on the Glycaemic and Insulinaemic Response

Start date: March 2014
Phase: N/A
Study type: Interventional

This study hypothesizes that milk protein consumed together or shortly before a white rice or white bread carbohydrate meal exerts different influence on the glycaemic, insulinaemic responses.

NCT ID: NCT02144038 Completed - Clinical trials for Relapsed and Refractory Multiple Myeloma

Study of the Safety and Effectiveness of LGH447 and BYL719 in Patients With Relapsed and Refractory Multiple Myeloma

Start date: July 23, 2014
Phase: Phase 1
Study type: Interventional

This is a Phase Ib/II study with the primary purpose of the Phase Ib part being to estimate the MTD and/or recommended phase 2 dose (RP2D) of the combination of LGH447 and BYL719 when administered orally to adult patients with relapsed and refractory multiple myeloma. Once the MTD and/or RP2D is determined for the combination of LGH447 and BYL719, additional patients will be enrolled in the Phase II part to determine whether the combination of LGH447 and BYL719 exhibits improved anti-multiple myeloma activity compared to single agent LGH447. This trial never made it to the Phase II part of the this trial.

NCT ID: NCT02143635 Completed - Clinical trials for Advanced Solid and Hematological TP53wt Tumors

Study to Determine and Evaluate a Safe and Tolerated Dose of HDM201 in Patients With Selected Advanced Tumors That Are TP53wt

Start date: July 7, 2014
Phase: Phase 1
Study type: Interventional

To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53.

NCT ID: NCT02141672 Completed - Lupus Nephritis Clinical Trials

AURA-LV: Aurinia Urinary Protein Reduction Active - Lupus With Voclosporin (AURA-LV)

AURA-LV
Start date: June 2014
Phase: Phase 2
Study type: Interventional

To assess the efficacy of 2 doses of voclosporin compared to placebo in achieving complete remission after 24 weeks of therapy in subjects with active lupus nephritis.

NCT ID: NCT02139800 Completed - Preterm Birth Clinical Trials

Sustained Aeration of Infant Lungs Trial

SAIL
Start date: August 27, 2014
Phase: N/A
Study type: Interventional

This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants. Specifically we will determine in 600 infants of 23-26 weeks gestational age (GA) requiring respiratory support at birth which of two lung opening strategies - either a standard PEEP/CPAP of 5-7 cm H2O in the delivery room (DR), as compared to early lung recruitment using Sustained Inflation (SI) in the DR, will result in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia (BPD) at 36 weeks gestational age. Hypotheses: 1. Early lung recruitment with SI superimposed upon standard PEEP/CPAP in the DR will reduce the need for mechanical ventilation in the first seven days of life, and reduce need for surfactant use; and 2. A policy of DR SI on standard PEEP/CPAP recruitment will confer better outcomes at 36 weeks post-menstrual age (PMA) than standard PEEP/CPAP

NCT ID: NCT02136069 Completed - Ulcerative Colitis Clinical Trials

A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors

GARDENIA
Start date: December 24, 2014
Phase: Phase 3
Study type: Interventional

This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1 ratio to receive either etrolizumab 105 milligrams (mg) by subcutaneous (SC) injection once every 4 weeks (Q4W) + placebo (intravenous [IV] infusion at Weeks 0, 2, and 6, then once every 8 weeks [Q8W]) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then Q8W) + placebo (SC Q4W). Time on treatment is 54 weeks.