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NCT ID: NCT02914561 Completed - Crohn's Disease Clinical Trials

Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease

DIVERSITY1
Start date: October 31, 2016
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).

NCT ID: NCT02914522 Completed - Ulcerative Colitis Clinical Trials

Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis

SELECTION
Start date: November 14, 2016
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).

NCT ID: NCT02913053 Completed - Clinical trials for Mild Cognitive Impairment

The Effects of an Extensive Exercise Program on the Progression of Mild Cognitive Impairment

NeuroExercise
Start date: June 2015
Phase: N/A
Study type: Interventional

Exercise interventions to prevent dementia and delay cognitive decline have gained considerable attention in recent years. Human and animal studies have demonstrated that regular physical activity targets brain function by increasing cognitive reserve. Although initial studies indicate enhanced cognitive performance in patients with mild cognitive impairment (MCI) following an exercise intervention, little is known about the effect of an extensive, controlled and regular exercise regimen on the neuropathology of patients with MCI. The aim of this study is to compare a 12- month aerobic exercise programme versus a stretching and toning (non-aerobic) programme versus a control group on the progression of cognitive decline in MCI. It is hypothesized that MCI-related decreases in cognitive and psychomotor functioning will show less progression or even be improved after a one-year aerobic exercise intervention compared to a group of patients undergoing stretching and toning exercise as well as to a control group provided with no intervention.

NCT ID: NCT02901171 Completed - Smoking Clinical Trials

The Contribution of a Smartphone Application to Acceptance and Commitment Therapy Group Treatment for Smoking Cessation

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

The purpose of this study is to evaluate the efficacy of a smartphone application in enhancing Acceptance and Commitment Therapy group treatment for smoking cessation. This study also aims to elucidate the processes through which the treatment promotes smoking cessation and for whom it is most effective.

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).

NCT ID: NCT02898610 Completed - Stroke Clinical Trials

Colchicine for Prevention of Vascular Inflammation in Non-cardio Embolic Stroke

CONVINCE
Start date: December 12, 2016
Phase: Phase 3
Study type: Interventional

This study evaluates the use of Colchicine in adults over 40 years of age who have suffered an ischaemic stroke or transient ischaemic attack NOT caused by cardiac embolism or other defined causes. Patients will be randomised to 0.5 mg/day of Colchicine plus usual care, or to usual care alone. To investigate the efficacy of low dose colchicine (0.5mg/day) plus usual care (defined as antiplatelet, lipid-lowering, antihypertensive treatment, and appropriate lifestyle advice) compared with usual care alone to prevent non-fatal recurrent ischaemic stroke, myocardial infarction, cardiac arrest, hospitalization for unstable angina and vascular death after ischaemic stroke or transient ischaemic attack (TIA) not caused by cardiac embolism or other defined causes unrelated to atherosclerosis

NCT ID: NCT02897934 Completed - Breast Cancer Clinical Trials

CWI and Discharge After Breast Cancer Surgery

Start date: August 2016
Phase:
Study type: Observational

The objectives of this work are threefold: 1. To evaluate the analgesic efficacy of CWI in women discharged within 23 hours of major breast cancer surgery 2. To evaluate objective indices of patient recovery following anaesthesia and surgery in a 23 hour model of care 3. To evaluate patient satisfaction with their care pathway

NCT ID: NCT02893228 Completed - Phrenic Nerve Palsy Clinical Trials

Does Saline Injection Around Phrenic Nerve Reduce Incidence of Diaphragmatic Paresis Following Interscalene Block?

Start date: October 2016
Phase: Phase 4
Study type: Interventional

Hemi-diaphragmatic palsy is a common undesirable effect of interscalene block, with an incidence of up to 100%. Mechanism of palsy is thought to be related to spread of local anaesthetic anterior to the anterior scalene muscle. We hypothesize that by injecting saline in this anatomical location prior to performing an interscalene block the incidence of phrenic palsy will be reduced.

NCT ID: NCT02889796 Completed - Clinical trials for Rheumatoid Arthritis

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

FINCH 1
Start date: August 30, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.

NCT ID: NCT02886754 Completed - Performance Clinical Trials

Proficiency-Based Progression Training for Clinical Communication

Start date: September 14, 2016
Phase: N/A
Study type: Interventional

Importance: Clinical communication is an important source of medical error and preventable adverse events. Objective: To determine the effectiveness of proficiency-based progression (PBP) simulation training for ISBAR (Identify, Situation, Background, Assessment, Recommendation) communication in the deteriorating patient. Setting: The study will be conducted in University College Cork, Ireland. Participants: Third year undergraduate nursing and fifth year medical students, who are scheduled to undertake ISBAR training as part of the National Early Warning Score (NEWS) programme. Intervention: Participants will be prospectively randomized to one of three groups before undertaking a performance assessment of an ISBAR communication relevant to a deteriorating patient in a high fidelity simulation laboratory: HSE group (the national e-learning programme only); S group (national e- learning plus simulation training) and PBP group (national e-learning plus proficiency-based progression simulation). Main outcome and measures: A proficiency benchmark on the performance of ISBAR communication in the context of an acutely deteriorating patient.