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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: NCT02596893 Terminated - Crohn Disease Clinical Trials

Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease

Start date: December 8, 2015
Phase: Phase 3
Study type: Interventional

The purpose of study is to test the effects of an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease. The study will test GED-0301 compared to placebo for 52 weeks. The study treatment is blinded which means that patients and the study doctor will not know which treatment has been assigned. Patients in this study will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids, immunosupressants and antibiotics for the treatment of Crohn's disease. After 12 weeks in the study until the end of the study, patients who do not have an improvement in their Crohns disease symptoms will have the option to enter a long term active treatment study. Participants who discontinued the study anytime or completed the study at Week 52 were then observed for an additional 4 weeks.

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: NCT02596529 Recruiting - Clinical trials for Trimalleolar Fracture

Fixation of the Posterior Malleolus in Medium-sized Trimalleolar AO Weber-B Fractures.

POSTFIX
Start date: January 2014
Phase: N/A
Study type: Interventional

The optimal treatment of ankle fractures with involvement of the posterior malleolus remains a subject of debate. Despite a large amount of literature on the role of the posterior malleolus in a so-called trimalleolar fracture, there are no clear guidelines for its treatment. Its size is the leading indication whether fixation of the fragment is necessary or not. Most orthopedic surgeons consider a posterior malleolar fracture fragment larger than 25% to 33% an indication for fixation. Interestingly, after careful evaluation of the available literature, there does not seem to be hard evidence for these numbers. It is generally accepted that restoration of a normal anatomic mortise and normal tibiotalar contact area are key elements for a good functional outcome. Inadequate reduction of the posterior fragment may alter the tibiotalar contact area and the joint biomechanics with altered stresses in parts of the joint, leading to the development of osteoarthritis and worse functional outcome. Traditionally, reduction of these larger fragments is indirectly, followed by percutaneous screw fixation in anterior-posterior direction. Disadvantages are that it is hard to achieve an anatomical reduction, and that fixation of smaller fragments is very difficult. Recently, a direct exposure of the posterior tibia via a posterolateral approach in prone position, followed by open reduction and fixation with screws in posterior-anterior direction or antiglide plate is advocated by several authors. This approach allows perfect visualization of the fracture, articular anatomical reduction, and strong fixation. Another advantage is that even small posterior fragments can be addressed. Several case series are published, which describe minimal major wound complications, good functional outcomes, and minimal need for reoperation. Since 2 years, in our institution we perform an open, anatomical reduction and fixation of all medium-sized posterior fragments via this approach. Although not thoroughly investigated yet, it seems to lead to better clinical outcomes than described in the literature and our retrospective cohort study.

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: NCT02595814 Terminated - Acute Heart Failure Clinical Trials

Global Non-interventional Heart Failure Disease Registry

REPORT-HF
Start date: July 23, 2014
Phase:
Study type: Observational [Patient Registry]

The clinical characteristics, initial presentation, management, and outcomes of patients hospitalized with new-onset (first diagnosis) heart failure (HF) or decompensation of chronic HF are poorly understood worldwide. REPORT-HF is a global, prospective, and observational HF disease registry designed to characterize patient trajectories longitudinally during and following an index hospitalization for acute HF.

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.