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NCT ID: NCT02907788 Completed - Cystic Fibrosis Clinical Trials

Inflammatory Markers in Broncho-alveolar Lavage Fluid as Risk Factors for Lung Disease in Infants With Cystic Fibrosis: the I-BALL Study

I-BALL
Start date: September 2014
Phase:
Study type: Observational [Patient Registry]

Airway disease, featuring intense inflammation, is the main cause of morbidity and mortality in cystic fibrosis (CF). Mechanisms of CF airway inflammation remain unclear, hampering development of better treatments.This time-sensitive ancillary study leverages a unique longitudinal cohort of CF infants, assessing the early phase of airway disease. Through the use of innovative cell and fluid based tools for in vivo profiling and in vitro testing of BALF samples, this translational effort will yield unprecedented insights into mechanisms of PMN dysfunction in CF, and assess new paths for early intervention.

NCT ID: NCT02907463 Completed - Aortic Stenosis Clinical Trials

EDWARDS INTUITY Elite Valve System

MISSION
Start date: February 2016
Phase:
Study type: Observational

The purpose of this active, observational, open-label, non-randomized, post-market surveillance study is to confirm that EDWARDS INTUITY Elite reduces cross clamp time (XCT) in MIS setting when compared to published data with a conventional valve within the MIS setting. The published dataset will used as a control group. Then to describe short term (30 days) and long term (6 months) clinical safety, to assess and compare hemodynamic data with EDWARDS INTUITY Elite to a conventional valve at discharge and at 6 months post AVR, to assess Quality of Life at baseline, and at 6 months post AVR to assess NYHA functional class at baseline, discharge, 1 month and at 6 months post AVR to assess Fitness for hospital discharge.

NCT ID: NCT02907281 Completed - Multiple Sclerosis Clinical Trials

Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis

OCTIMS
Start date: May 29, 2012
Phase: N/A
Study type: Observational

This is a 3-year, pharmacologically non-interventional study to evaluate OCT as an outcome measure in patients with relapsing remitting multiple sclerosis (RRMS). Approximately 350 RRMS patients, either untreated or treated with an approved MS disease-modifying therapy and approximately 70 reference subjects without ophthalmologic or neurologic disease are enrolled. No study medications are provided. Patients on disease-modifying therapy are treated according to the local prescribing information. For each MS patient and each reference subject, the study consists of Screening (up to 1 month), Baseline, and a 36-month longitudinal data collection phase. Eligibility will be confirmed during Screening.

NCT ID: NCT02904889 Completed - Clinical trials for Community-dwelling Older Adults

Stimulating Engagement in Daily and Physical Activities Among Older Adults Receiving Homecare Services (Part of Basic Care Revisited)

Start date: September 2016
Phase: N/A
Study type: Interventional

Most older adults want to stay at home for as long as possible. To reach this aim it is important to maintain their mobility and self-care abilities. However, many older adults are at risk to lose their abilities, as they have an inactive lifestyle. In this study, homecare professionals learn to motivate their clients to be more active in daily and physical activities. Examples of these activities are washing and dressing, household chores or going for a walk. The primary aim of this exploratory study is to evaluate the implementation of the 'Stay Active at Home' program (process evaluation). The secondary aim is to get insight into the potential effectiveness of the program with regard to several primary and secondary outcomes measures (effect evaluation). The tertiary aim is to test the feasibility of the proposed study design.

NCT ID: NCT02904239 Completed - Clinical trials for Coronary Artery Disease

Cardiac Pathologies in Standard Thoracic CT Imaging

CaPaCT
Start date: July 2016
Phase:
Study type: Observational

Modern high-end CT scanners with faster scan acquisition times now allow for routine assessment of cardiac pathologies, which could result in numerous incidental cardiac findings on standard thoracic CT angiography (CTA) scans. The CaPaCT-study aims to assesses the presence, management and possible clinical impact of incidental cardiac pathologies which are becoming visible on standard thoracic CT scans performed on new high-end scanners.

NCT ID: NCT02903966 Completed - Colitis, Ulcerative Clinical Trials

GSK2982772 Study in Subjects With Ulcerative Colitis

Start date: November 15, 2016
Phase: Phase 2
Study type: Interventional

This study is the first experience with GSK2982772, a receptor-interacting protein-1 (RIP1) kinase inhibitor, in subjects with active ulcerative colitis (UC). The primary objective will be to investigate the safety and tolerability of repeat oral doses of GSK2982772 60 mg or placebo three times daily for 42 days (Part A) followed by open label with GSK298772 60 mg three times daily for 42 days (Part B). In addition to pharmacokinetics (PK), a number of experimental and clinical endpoints will be employed to obtain information on the pharmacodynamics (PD), and preliminary efficacy in subjects with active UC. Although no formal hypothesis will be tested, these endpoints will enable a broader understanding of the mechanism of action and potential for clinical efficacy of GSK2982772 in UC. Within 30 Days of screening visit, subjects will be randomized to receive either GSK2982772 60 mg or placebo orally three times daily for 42 Days (6 weeks) in a 2:1 ratio in Part A study. Subjects who complete the Part A study will move to open label Part B study to receive GSK2982772 60 mg three times daily for an additional 42 Days (6 weeks). After the open label (Part B) treatment period, subjects will enter the Follow-up period which lasts for 28 Days (+/- 3 Days) post the last administration of study medication. The total duration of participation in the study will be approximately 20 Weeks from screening to the last study visit.

NCT ID: NCT02903914 Completed - Lung Cancer Clinical Trials

Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors

Start date: September 14, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This study is an open-label Phase 1/Phase 2 evaluation of INCB001158 as a single agent and in combination with immune checkpoint therapy in patients with advanced/metastatic solid tumors.

NCT ID: NCT02902601 Completed - Clinical trials for Depressive Disorder, Major

A Study to Investigate the Safety, Tolerability, and Pharmacodynamics of JNJ-54175446 in Participants With Major Depressive Disorder

Start date: October 17, 2016
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to investigate the safety and tolerability of JNJ 54175446 in participants with Major Depressive Disorder (MDD).

NCT ID: NCT02902549 Completed - Clinical trials for Complications of Perfusion

Real-time Quantitative Optical Perfusion Imaging in Surgery

Start date: October 2015
Phase: N/A
Study type: Observational

Surgeons are nowadays unable to visualize and quantitatively evaluate microvascularisation in real-time during surgery. Complications due to vascular compromise are a major problem, especially in reconstructive surgery. Poor blood perfusion leads to ischemia and even tissue necrosis. If, however, perfusion and ischemia could be monitored during surgery, then surgeons could change their reconstructive design and the anaesthesiologists could improve perfusion with fluids, inotropes or vasopressors, if necessary. Surgeons therefore need a tool that is able to image in high resolution (microvascularisation), direct, intra-operative, in 3D (to image thrombosis, luminal narrowing or distinct overlaying vessels) and that produces quantitative data to objectify image interpretation. Optical techniques, based on the interaction of light with tissue, are able to image tissue at high resolution and in real-time. These techniques are FDA-approved and have emerged as powerful diagnostic tools in different departments of medicine, such as ophthalmology for visualizing retina vascularisation and dermatology for skin diagnostics. In this study, investigators hypothesize that four novel optical technologies: Fluorescence Imaging, Laser Speckle Contrast Imaging, Optical Coherence Tomography and Sidestream Darkfield Microscopy are able to quantitatively image perfusion in real-time during surgery.

NCT ID: NCT02900378 Completed - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction

randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure

OUTSTEP-HF
Start date: December 20, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this randomized, actively controlled, double-blind study with prospective data collection was to assess differences between sacubitril/valsartan versus enalapril in increasing exercise capacity and non-sedentary physical activity in HFrEF patients. Physical activity was assessed by the 6 minute walk test, and daily physical activity was continuously measured by means of a wrist-worn accelerometry device from 2 weeks before until 12 weeks after start of study therapy (sacubitril/valsartan or enalapril).