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NCT ID: NCT02749175 Completed - Clinical trials for Pulmonary Aspiration of Gastric Contents

SMART Study (Sellick's Maneuver Assisted Real Time) to Deliver Target Cricoid Pressure in Simulated Environment

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

Cricoid force is applied during airway management to prevent pulmonary aspiration of regurgitated gastric contents. This force is usually applied by a nurse or anaesthesia assistant. Currently this is performed WITHOUT monitoring and the force applied is determined by the individual's "educated hand" that is derived from his/her experience from past training and practice. Studies have shown that the actual force applied by nurse and anaesthesia assistant is inconsistent and deviates from the optimal force. Under application of cricoid force results in ineffective cricoid pressure and the risk of pulmonary aspiration. Consequences of pulmonary aspiration include lung injury and infection, hypoxia, long Intensive Care Unit stay and even death. Over exertion of cricoid force results in distortion of the larynx (leading to difficult bag mask, difficult tracheal tube insertion and hypoxia). Preliminary results from previous study (IRB 2014/437/D), an observation crossover pilot was carried out comparing the amount of cricoid force applied by 16 nurses on manikin with and without direct feedback. Nurses were instructed to apply a range of force of 30-44 Newtons on a marked site on the neck region of manikin. A flexiforce load sensor was used. Unblinded nurses performed significantly better with feedback using the load sensor then blinded nurses. With Funding from a National grant, a real-time measurement of cricoid force is developed to give feedback and guide the operator to exert and maintain the TARGET cricoid pressure during rapid sequence induction (RSI). In this study we aim to verify the sensor system with a manikin and compare the forces applied by nurses with the sensor system and without.

NCT ID: NCT02746159 Completed - Clinical trials for Arteriovenous Fistula

Lutonix® Global AV Registry Investigating Lutonix Drug Coated Balloon for Treatment of Native and Synthetic AV Fistulae

AVR
Start date: June 7, 2016
Phase:
Study type: Observational [Patient Registry]

The purpose of this Registry is to enroll patients presenting with clinical and hemodynamic abnormalities in native or synthetic (grafts) arteriovenous (AV) fistulae located in the arm. Subjects will be treated with the Lutonix DCB carrying the CE Mark per current IFU and followed clinically for a minimum of 12 months.

NCT ID: NCT02740270 Completed - Solid Tumors Clinical Trials

Phase I/Ib Study of GWN323 Alone and in Combination With PDR001 in Patients With Advanced Malignancies and Lymphomas

Start date: July 22, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this trial is to explore the clinical utility of two investigational antibodies in patients with advanced cancer or lymphomas. This is a multi-center, open-label Phase I/Ib study. The study consists of two dose escalation parts and two dose expansion parts testing GWN323 as a single agent or GWN323 in combination with PDR001. The dose escalation parts will estimate the MTD and/or RDE and test different dosing schedules. The dose expansion parts of the study will use the MTD/RDE determined in the dose escalation part to assess the activity, safety and tolerability of the investigational products in patients with specific types of cancer and lymphomas. Approximately 264 adult patients with advanced solid tumors or lymphomas will be enrolled.

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: NCT02736305 Completed - Ovarian Neoplasms Clinical Trials

Use of Regorafenib in Recurrent Epithelial Ovarian Cancer

Start date: February 3, 2016
Phase: Phase 2
Study type: Interventional

Regorafenib is an oral multikinase inhibitor that blocks the activity of kinases involved in angiogenesis (VEGFR 1,2,3 and TEK), oncogenesis (KIT, Ret Proto-Oncogene (RET), Raf-1 Proto-Oncogene, Serine/Threonine Kinase (RAF1) and BRAF) and tumour growth (PDGFR and FGFR). Epithelial ovarian cancer (EOC) cell lines frequently express high levels of vascular endothelial growth factor (VEGF) and in vivo preclinical studies evaluating Regorafenib have shown promising activity in ovarian cancer. In the clinic, anti-angiogenesis therapy with bevacizumab (a monoclonal antibody to VEGF) has already emerged as an important cornerstone in the management of ovarian cancer both as part of frontline adjuvant treatment and as second-line therapy for platinum-sensitive recurrent disease. Whilst Regorafenib has been FDA approved for the treatment of patients with metastatic colorectal cancer who have failed prior bevacizumab, it's role in the management of ovarian cancer remains to be defined.

NCT ID: NCT02735889 Completed - Gastric Emptying Clinical Trials

Fizzy Drinks Study

Start date: December 2015
Phase: N/A
Study type: Interventional

The objective of this study is to compare the effect of different levels of carbonation isocaloric beverages on glycemic response (using protocol based on standardized glycemic index testing methodology), gastric emptying and satiety. It is hypothesized that carbon dioxide will delay gastric emptying, and in turn, attenuate glycemic response and enhance satiety. The use of a non-nutrient (gas) in improving glycemic response and satiety would have important health implications for the beverage industry.

NCT ID: NCT02715323 Completed - Dry Eye Syndrome Clinical Trials

Exploring Immune Cell Signatures in Autoimmunity and Dry Eye Syndrome

Start date: May 2016
Phase:
Study type: Observational

Ocular surface disease, especially dry eye and scleritis, commonly affects patients with autoimmune diseases. Ocular surface immune cells are increased in autoimmune disease; however the full subset of immune cells activated is unknown. Recent experimental studies show that dendritic cells and T cells in the cornea are critically associated with corneal nerve innervation. Corneal confocal microscopy (CCM) allows rapid non-invasive in vivo imaging of dendritic cells and corneal nerves. The investigators propose to investigate how ocular surface health, conjunctival immune cells and corneal nerve/dendritic cell morphology interact in 3 rheumatological conditions: Sjogren's syndrome (SS), Rheumatoid arthritis (RA), Systemic lupus erythematosus (SLE). The preliminary flow cytometric studies show that various immune cells (eg: T cells, B cells, and dendritic cells) can be quantified using minimally invasive impression membranes (Eyeprim). Clinically, the research team is experienced in measuring features of ocular surface inflammation (conjunctival redness, tear breakup times) with Oculus keratograph5M. The investigators also aim to harvest conjunctival immune cells using impression cytology and quantify specific cell types with flow cytometry. Corneal nerve morphology and dendritic cell density and distribution will be assessed using CCM; in collaboration with the group who have pioneered this technique. The investigator anticipate that alterations in corneal nerve and dendritic cell parameters will correlate with immune activation/inflammation, deterioration of tear function and increased systemic severity of the rheumatological disease. In addition, the investigators hypothesize that the lower the corneal nerve density, the higher the number of corneal dendritic cells and conjunctival inflammatory cells. Studying these relationships may allow a better mechanistic understanding of local corneal and systemic immune activation and the development of a non-invasive ophthalmic surrogate marker of dendritic cell activation and nerve fibre loss to aid earlier diagnosis, risk stratification and the development of new therapies in autoimmune patients with severe dry eye.

NCT ID: NCT02712762 Completed - Dry Eye Clinical Trials

Ocular Surface Disease in Chronic Graft-Versus-Host Disease (GVHD) Patients

Start date: June 2016
Phase:
Study type: Observational

This study aims to profile the ocular surface inflammation of chronic Graft-Versus-Host Disease patients by investigating conjunctival cells, and clinical imaging for conjunctival redness and tear stability. Hence, the investigators expect to find an increased in inflammatory cell population in GVHD conjunctival samples.

NCT ID: NCT02703987 Completed - Lactose Intolerance Clinical Trials

HYBRID: Hydrogen Breath Test in Lactose Digestion

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

The purpose of this study is to investigate the effect of a fermented infant formula on lactose digestion in lactose intolerant adults.

NCT ID: NCT02702726 Completed - Clinical trials for Glycaemic Response and Energy Balance

The Oil, Fats and Oleogel Study

OFO
Start date: January 12, 2016
Phase: N/A
Study type: Interventional

The aim of this study is to compare the effects of dietary fats, ingested in two physical forms, on acute energy balance, appetitive, and glycemic responses of healthy normal (BMI 18-24.9 kgm-2) or overweight (BMI>25kgm-2) adults.