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NCT ID: NCT02597933 Completed - Clinical trials for Scleroderma, Systemic

A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis

Start date: November 12, 2015
Phase: Phase 3
Study type: Interventional

Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.

NCT ID: NCT02597920 Completed - Atrial Fibrillation Clinical Trials

Patient Convenience Study

Start date: November 11, 2015
Phase:
Study type: Observational

The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa® to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its approved indication in the approved dosages of 110 mg or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).

NCT ID: NCT02597439 Completed - Clinical trials for Ultra High Risk for Psychosis

Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe

PURPOSE
Start date: September 30, 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether omega-3 fatty acids are effective in the prevention of psychosis in individuals at ultra-high risk for psychosis.

NCT ID: NCT02597127 Completed - Diabetes Clinical Trials

Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C)

ORION-1
Start date: January 2016
Phase: Phase 2
Study type: Interventional

This study is a Phase II, placebo-controlled, double-blind, randomized trial in 480 participants with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (for example, diabetes and familial hypercholesterolemia) and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of ALN-PCSSC injection(s).

NCT ID: NCT02596542 Completed - Clinical trials for Post-exercise Cold Water Immersion

Cold Water Immersion and Recovery

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

Cold-water immersion (CWI) is a frequently applied strategy to accelerate post-exercise recovery in both recreational as well as professional athletes. However, the effect of repeated post-exercise CWI on other recovery strategies remains unclear.

NCT ID: NCT02596230 Completed - Clinical trials for Venous Thromboembolism

RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism

Start date: November 5, 2015
Phase:
Study type: Observational

RE-COVERY is a large, multi-national, multi-center observational study based on new data collection. The study will enroll and characterize patients within 30 days of being diagnosed with an acute DVT and/or PE. The study has two main objectives. Objective 1 will characterize the DVT / PE patient population. All patients with a DVT and/or PE will be enrolled for cross-sectional characterization of the VTE patient population. Objective 2 will compare the safety and effectiveness of dabigatran etexilate regimens for treatment of VTE in comparison to VKA regimens. Patients treated with dabigatran etexilate or VKA will be followed up for the occurrence of outcome events for up to one year.

NCT ID: NCT02596074 Completed - Clinical trials for Usual Type Vulval Intraepithelial Neoplasia (uVIN)

Pharmacodynamics, Safety/Tolerability and Efficacy of Topical Omiganan in Patients With uVIN

Start date: November 2015
Phase: Phase 2
Study type: Interventional

To assess the pharmacodynamics, safety/tolerability and efficacy of topical Omiganan (CLS001) in patients with usual type vulvar intraepithelial neoplasia (uVIN).

NCT ID: NCT02594865 Completed - Clinical trials for Disorder of Glucose Regulation

The Glycaemic Effects of Glucerna® in Critically Ill Patients.

GluCip
Start date: September 2015
Phase: N/A
Study type: Interventional

To investigate whether the administration of Glucerna achieves less glycaemic variability, defined as the mean absolute glucose (MAG) change, and better glycaemic control compared to a standard high-carbohydrate enteral formula. Continuous glucose monitoring technology will be used to evaluate glycaemic variability and glycaemic control.

NCT ID: NCT02594553 Completed - Infection Clinical Trials

Optimizing Management and Medication of Febrile Children in Out-of-hours Primary Care: CHILI Cluster RCT

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

The CHILI cluster randomised controlled trial (RCT) will investigate whether the use of an interactive information booklet during consultations for febrile children at General Practice (GP) out-of-hours centres can reduce the number of antibiotic prescriptions, improve parental satisfaction and reduce intention to reconsult for childhood fever episodes.

NCT ID: NCT02593877 Completed - Trauma Clinical Trials

Implementing Treatment Algorithms for the Correction of Trauma Induced Coagulopathy

iTACTIC
Start date: June 1, 2016
Phase: Phase 2
Study type: Interventional

This trial compares the haemostatic effect of viscoelastic haemostatic assay (VHA)-guided transfusion strategy versus non-VHA guided transfusion strategy in haemorrhaging trauma patients. Half of the randomised patients will receive VHA-led management of bleeding, whilst the other half will receive massive transfusion protocol resuscitation using conventional coagulation tests.