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NCT ID: NCT02221869 Completed - Clinical trials for Narcolepsy With Cataplexy

A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy

Start date: October 1, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics subjects with narcolepsy that includes cataplexy.

NCT ID: NCT02221791 Completed - Clinical trials for Endothelial Dysfunction

Comparison of Pure Epicatechin and Cocoa on Markers of Vascular Function

FLAVO2
Start date: June 2014
Phase: N/A
Study type: Interventional

Intervention studies support a protective effect of flavonoid-rich foods such as chocolate and tea on cardiovascular disease risk. In a previous study we found that pure epicatechin improves markers of vascular function and insulin resistance although the results were less pronounced than the majority of chocolate intervention studies. The food matrix of chocolate or other compounds present in chocolate could play a role in the bioavailability of flavonoids, resulting in these heightened improvements in vascular function. In this study we aim to compare the acute effects of pure epicatechin and high-flavonoid chocolate on markers of vascular function.

NCT ID: NCT02221505 Terminated - AML Clinical Trials

Phase 1 Study of LOP628 in Adult Patients With cKit-positive Solid Tumors and Acute Myeloid Leukemia

Start date: December 2014
Phase: Phase 1
Study type: Interventional

LOP628 is an antibody-drug conjugate (ADC) consisting of an anti-cKit humanized IgG1/κ antibody conjugated to a maytansine payload via a non-cleavable linker. LOP628 provides an opportunity to target cKit overexpressing tumors.

NCT ID: NCT02220543 Completed - Chronic Pain Clinical Trials

Chronic Low Back Pain Rehabilitation in Primary Care: an RCT

Start date: August 2014
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effectiveness and cost-effectiveness of a new primary care intervention "Back on Track" as compared to usual primary care in patients with non-specific chronic low back pain in which disability levels are moderate and the role of psychosocial factors to this disability is at maximum low (classified as WPN2).

NCT ID: NCT02219932 Completed - Multiple Sclerosis Clinical Trials

Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis

ENHANCE
Start date: September 2014
Phase: Phase 3
Study type: Interventional

The primary objective is to determine whether prolonged-release fampridine (10 mg twice daily) has a clinically meaningful effect on patient-reported walking ability over a 24-week study period. The secondary objectives are: To determine whether prolonged-release fampridine 10 mg taken twice daily (BID) has a clinically meaningful effect on dynamic and static balance, physical impact of Multiple Sclerosis (MS), and upper extremity function over a 24-week study period; To evaluate criteria for early assessment of response to fampridine that can predict clinically meaningful benefits in walking ability and balance; To assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily over a 24-week treatment period.

NCT ID: NCT02219802 Not yet recruiting - Clinical trials for Coronary Artery Disease

Drug-coated Balloon Versus Drug-eluting Stent in Acute Myocardial Infarction

REVELATION
Start date: August 2014
Phase: N/A
Study type: Interventional

Rationale: Compared with balloon angioplasty, implantation of bare metal stents (BMS) and drug eluting stents (DES) have shown to reduce repeat target lesion revascularization in primary percutaneous coronary intervention (PPCI). However, this did not result in a reduction of mortality or recurrent myocardial infarction. Furthermore, there are concerns of the occurrence of stent thrombosis. The PAPPA-pilot study, evaluating safety and feasibility of using a drug-coated balloon (DCB) only strategy in PPCI, showed good short- and long-term clinical results, with sustained safety and efficacy at 12 months follow-up. To date little is known about the long-term effects of this treatment modality in STEMI. Besides, angiographic follow-up is of great clinical importance by giving insight on the treated infarct lesion and to assess the functional angioplasty result. Objective: This randomized controlled, non-inferiority trial is mainly designed to prospectively assess the safety and efficacy of a CE-marked paclitaxel-eluting balloon only strategy vs. third generation DES in the setting of a ST-elevation myocardial infarction (STEMI).

NCT ID: NCT02219490 Completed - Clinical trials for Chronic Hepatitis C Virus (HCV) Infection Genotype 1

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

TOPAZ-I
Start date: October 30, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.

NCT ID: NCT02218957 Completed - Morbid Obesity Clinical Trials

Extended Pouch Roux-en-Y Gastric Bypass Study

Start date: July 2014
Phase: N/A
Study type: Interventional

Morbid obesity is an increasing medical problem in the western countries. It's related to comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese patients. A part of these patients will have disappointing results, and have weight regain on the long term. Some studies show more weight reduction by increasing the biliopancreatic limb in patients with morbid obesity. The objective of this study is to investigate the effect of a restrictive/extended pouch on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that the restrictive/extended pouch results in more weight reduction. The study design is a prospective, randomized control trial. The patients will be randomized in 2 groups: a standard RYGB (normal pouch) and restrictive/extended pouch RYGB.

NCT ID: NCT02218801 Completed - Clinical trials for Colorectal Carcinoma

A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program

CLIMB
Start date: May 2015
Phase:
Study type: Observational [Patient Registry]

This prospective database has two main objectives; - to evaluate the complication rates, 30-day and 90-day mortality from different surgical strategies for unresectable, borderline resectable or initially unresectable liver metastasis from colorectal cancer. - to establish baseline quality parameters for different surgical strategies for unresectable, borderline and initially unresectable colorectal liver metastasis (CRLM) patients.

NCT ID: NCT02218502 Terminated - Ovarian Cancer Clinical Trials

Study Into a New Diagnostic Tool (Simple Ultrasound-based Rules) in Patients With Adnexal Masses

SUBSONiC
Start date: September 2014
Phase: N/A
Study type: Interventional

This study is performed to compare the diagnostic performance and cost-effectiveness of different diagnostic methods for differentiating benign from malignant adnexal (ovary or Fallopian tube) masses: the Risk of Malignancy Index (RMI) will be compared with a two-step triage test called "simple ultrasound-based rules" supplemented -if necessary- with either subjective assessment by an expert sonographer or Diffusion Weighted - Magnetic Resonance Imaging (DW-MRI). The investigators will test the hypothesis that this two-step triage test will have better diagnostic accuracy than the RMI and therefore will improve the management of women with adnexal masses.