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NCT ID: NCT03510884 Completed - Clinical trials for Hypercholesterolaemia

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Start date: May 31, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) and every 4 weeks (Q4W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in participants with heterozygous familial hypercholesterolemia (heFH) 8 to 17 years of age on optimal stable daily dose of statin therapy ± other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins. Secondary Objectives: - To evaluate the efficacy of alirocumab versus placebo on LDL-C levels. - To evaluate the effects of alirocumab versus placebo on other lipid parameters. - To evaluate the safety and tolerability of alirocumab in comparison with placebo. - To evaluate the efficacy, safety, and tolerability of alirocumab after open label treatment. - To evaluate the development of anti-alirocumab antibodies.

NCT ID: NCT03510715 Completed - Clinical trials for Hypercholesterolemia

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia

Start date: August 31, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of alirocumab (75 or 150 milligrams [mg] depending on body weight [BW]), administered every 2 weeks (Q2W), on low-density lipoprotein cholesterol (LDL-C) levels at Week 12 of treatment in children and adolescents with homozygous familial hypercholesterolemia (hoFH) of 8 to 17 years of age on top of background treatments. Secondary Objectives: - To evaluate the efficacy of alirocumab after 24 and 48 weeks of treatment on LDL-C levels. - To evaluate the effects of alirocumab on other lipid parameters (eg, apolipoprotein B [Apo B], non-high density lipoprotein cholesterol [non-HDL-C], total cholesterol [Total-C], high density lipoprotein cholesterol [HDL-C], lipoprotein a [Lp (a)], triglycerides [TG], apolipoprotein A-1 [Apo A-1] levels) after 12, 24, and 48 weeks of treatment. - To evaluate the safety and tolerability of alirocumab up to 48 weeks of treatment.

NCT ID: NCT03510494 Completed - Physical Activity Clinical Trials

The Svendborg-project

CHAMPS-DK
Start date: August 2008
Phase: N/A
Study type: Interventional

The main aim of this study is to describe differences in development of health and motor performance over time in relation to type of school and other background variables.

NCT ID: NCT03509454 Completed - Clinical trials for Diabetes Mellitus, Type 1

PeRsOnalising Treatment Of Diabetic Nephropathy:

PROTON
Start date: April 1, 2016
Phase:
Study type: Observational

Background: Today diabetic nephropathy is a frequent, and the most lethal and costly complication of diabetes. Although treating blood pressure with agents blocking renin angiotensin system has improved outcome, the prognosis is still poor and no new interventions have been successful during the past decade. There is an urgent need for discovery of new pathways behind the development and progression of diabetic nephropathy as well as of biomarkers which can identify subjects at risk of developing adverse events. Objective: By using a multidimensional 'omics' approach, we aim to search for novel proteins, metabolites and pathways that will point to the putative new mechanisms which underlie the early renal decline. Design: Cross-sectional study, with long-term register-based follow-up. Study population: 160 patients with type 1 diabetes recruited from Steno Diabetes Center Copenhagen stratified based on stage of diabetic kidney disease, and 50 healthy non-diabetic controls. Endpoints: Primary endpoint: Glycocalyx thickness, assessed as perfused boundary region. Secondary endpoints: Gut microbiome characterisation and markers of gastrointestinal inflammation, autonomic and periphery neuropathy, urine and plasma Flow Cytometry Analysis (FACS), metabolomics and proteomics in plasma and urine, and other potential biomarkers.

NCT ID: NCT03507777 Completed - Clinical trials for Coronary Artery Disease

ILUMIEN IV: OPTIMAL PCI

Start date: May 17, 2018
Phase: N/A
Study type: Interventional

The objective of this prospective, single-blind clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.

NCT ID: NCT03506789 Completed - Postoperative Pain Clinical Trials

Dexamethasone Twice for Pain Treatment of Total Knee Arthroplasty

DEX-2-TKA
Start date: September 14, 2018
Phase: Phase 4
Study type: Interventional

Dexamethasone twice for pain treatment after total knee arthroplasty - A Placebo-controlled, randomised, parallel 3-group multicentre trial of one and two doses of dexamethasone for postoperative treatment

NCT ID: NCT03505918 Completed - Surgery Clinical Trials

Supervised Physical Therapy Versus Unsupervised Home Exercise After Surgery for Lumbar Disc Herniation

Start date: October 1, 2015
Phase: N/A
Study type: Interventional

This is a randomized controlled trial evaluation effect of postoperative rehabilitation after surgery for lumbar disc herniation. The primary aim of this study is to evaluate the effect of unsupervised home exercises compared to supervised physical rehabilitation. Secondary aims of this study are to determine if there is a difference in cost-effectiveness in patients undergoing supervised physical rehabilitation in patients after surgery for lumbar disc herniation compared to unsupervised home exercises.

NCT ID: NCT03505723 Completed - Venous Thrombosis Clinical Trials

PeriOperative ISchemic Evaluation-3 Trial

POISE-3
Start date: June 27, 2018
Phase: Phase 3
Study type: Interventional

This study is a multicentre, international, randomized controlled trial of tranexamic acid (TXA) versus placebo and, using a partial factorial design, of a perioperative hypotension-avoidance versus hypertension-avoidance strategy.

NCT ID: NCT03504306 Completed - Healthy Clinical Trials

Validation of Ventriject Determined Maximal Oxygen Uptake

Start date: April 23, 2018
Phase:
Study type: Observational

This study aims to validate the use of the Ventriject product to estimate VO2 max, through a non-physically active test using ECG, echoseismography and echosonography.

NCT ID: NCT03504020 Completed - Heart Failure Clinical Trials

ECG Belt for CRT Response

Start date: July 13, 2018
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling.