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NCT ID: NCT03190473 Terminated - Clinical trials for Acute Coronary Syndrome

OPTIMIZE IDE for the Treatment of ACS

OPTIMIZE
Start date: January 2, 2018
Phase: N/A
Study type: Interventional

Indication for use: "The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length with a reference vessel diameter of 2.25 mm - 4.00 mm

NCT ID: NCT03190096 Recruiting - Clinical trials for Paroxysmal Atrial Fibrillation

Safety and Feasibility of Electrical Isolation of the Superior Vena Cava for Paroxysmal Atrial Fibrillation

SAFE-SVC
Start date: June 7, 2017
Phase: N/A
Study type: Observational

The present study is designed as a observational prospective, multicentre, international. The main aim of this study is to evaluate the safety and feasibility of SVC isolation with the CB in a prospective manner.

NCT ID: NCT03189303 Completed - Clinical trials for Osteoarthritis; Rheumatoid Arthritis; Post Traumatic Arthritis

Cup Position in THA With Standard Instruments

Start date: September 7, 2017
Phase:
Study type: Observational

Prospective, global, multicenter study to assess cup position in THA. After written informed consent has been obtained, study evaluations will be collected from the pre-op clinic visit, the operative visit (including discharge), and 6 and 12 weeks postoperatively.

NCT ID: NCT03188666 Completed - Clinical trials for Fibrodysplasia Ossificans Progressiva

A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva

LUMINA-1
Start date: February 26, 2018
Phase: Phase 2
Study type: Interventional

This is a three period study design consisting of a 6-month, randomized, double-blind placebo-controlled treatment (period 1) followed by a 6-month, open-label treatment (period 2) and a follow-up treatment period (period 3). Primary safety objective of the study is to assess the safety and tolerability of REGN2477 in male and female patients with fibrodysplasia ossificans progressiva (FOP). Primary efficacy objective of the study is to assess the effect of REGN2477 versus placebo on the change from baseline in heterotopic ossification (HO) in patients with FOP, as determined by 18-NaF uptake in HO lesions by positron emission tomography (PET) and in total volume of HO lesions by computed tomography (CT). Key Secondary objectives are: - To compare the effect of REGN2477 versus placebo on pain due to FOP, as measured by the area under the curve (AUC) for pain based on daily pain numeric rating scale (NRS) scores - To assess the effect of REGN2477 versus placebo on the change from baseline in HO, as determined by the number of new HO lesions identified by 18F-NaF PET or by CT - To assess the effect of REGN2477 versus placebo on the change from baseline in 18F-NaF standardized uptake value maximum (SUVmax) of individual active HO site(s) by PET - To assess the effect of REGN2477, between week 28 and week 56, on the number, activity, and volume of HO lesions identified by 18F-NaF PET or by CT in patients who switch from placebo to REGN2477 at week 28 versus the same patients between baseline and week 28 - To assess the effect of REGN2477 versus placebo on the change from baseline in biochemical markers of bone formation - To characterize the concentrations of total activin A at baseline and over time following the first dose of study drug - To characterize the concentration-time profile (pharmacokinetics [PK]) of REGN2477 in patients with FOP - To assess the immunogenicity of REGN2477

NCT ID: NCT03187522 Terminated - Clinical trials for Aortic Aneurysm, Abdominal

An European Union (EU) Post-Approval Registry of the TREO® Stent-Graft

Start date: June 22, 2017
Phase: N/A
Study type: Interventional

This is an EU sponsored trial and independent of the US trial registered under Clinicaltrials.gov ID NCT02009644. The purpose of this registry is to gather clinical data on the safety and performance of the TREO Stent-Graft in patients with infrarenal abdominal aortic aneurysms. The registry is part of TREO's EU post-market surveillance plan providing long-term systematic clinical follow-up.

NCT ID: NCT03186989 Completed - Clinical trials for Mild Alzheimer's Disease

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimer's Disease

Start date: October 12, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IONIS-MAPTRx in patients with Mild Alzheimer's Disease

NCT ID: NCT03184623 Completed - Muscle Loss Clinical Trials

Muscle Mass and Body Composition

Start date: June 9, 2017
Phase: N/A
Study type: Observational

ICUacquired weakness is a common complication of critical illness, particularly in patients receiving mechanical ventilation and/or suffering from conditions leading to the systemic inflammatory response syndrome.

NCT ID: NCT03184194 Completed - Myeloma Clinical Trials

Nivolumab Combined With Daratumumab With or Without Low-dose Cyclophosphamide

Start date: February 21, 2018
Phase: Phase 2
Study type: Interventional

Evaluation of the effect of nivolumab and daratumumab with or without low-dose cyclophosphamide in patients with relapsed/refractory multiple myeloma.

NCT ID: NCT03183895 Active, not recruiting - Heart Failure Clinical Trials

Evaluate the Safety and Performance of the AccuCinch® Ventricular Repair System - The CorCinch-EU Study

Start date: January 15, 2019
Phase: N/A
Study type: Interventional

This is prospective, non-randomized, single-arm, international, multicenter, clinical safety and performance clinical investigation to evaluate the AccuCinch® Ventricular Repair System for the treatment of heart failure, with or without functional mitral regurgitation due to dilated ischemic or non-ischemic cardiomyopathy

NCT ID: NCT03183583 Recruiting - Knee Osteoarthritis Clinical Trials

Tissue Adhesive in Hip and Knee Arthroplasty, A Cost -Effectiveness Analysis

Start date: January 23, 2017
Phase: N/A
Study type: Observational

Prolonged wound drainage after total hip or knee arthroplasty is a very undesirable complication, both from medical as patients view. Wound drainage prolongs hospital admission and is associated with an increased risk of infection (1) post-operative wound drainage of more than 48 hours is associated with an increased infection risk of 42 percent a day in hip arthroplasty and 27 percent a day in knee arthroplasty. (2) Patient organizations report that wound drainage is considered as one of the most undesirable complications. In our hospital, patients undergoing hip or knee arthroplasty are treated according to a "fast track" protocol, in most cases resulting in a hospital admission of only two days. This increases the chance that patient's release from hospital will be delayed due to wound drainage. The fact that our department recently started to perform hip and knee arthroplasty in a daycare setting increases this chance substantially. In hemiarthroplasty of the knee, tissue adhesive was used in addition to conventional wound closure techniques with monocryl sutures. Resorbable monocryl sutures were used so that the usual visit to our outpatient department to remove the sutures was no longer necessary. However, we experienced an increase in wound drainage and complications using only monocryl. The addition of a tissue adhesive decreased the post-operative wound complication drastically. This in mind, we started to use tissue adhesive in regular hip and knee arthroplasty as well. With tissue adhesive in addition to conventional staples, we noticed good results. These results however, were subjective and not officially recorded. In a previous study, good results are reported in decreasing wound drainage with the use of a tissue adhesive in addition to staples. Clinical relevance was not reported and the study design lacked a cost-effectiveness analysis (3) The increase in cost for the use of the tissue adhesive involved was noted by our board of directors. Because lack of a clear medical of financial benefit, we were asked to minimize the use of tissue adhesive, resulting in usage of tissue adhesive solely in a day care setting, which comprises only 5 to 10 percent of our treated population. Previous study reported a decrease in post-operative wound drainage when tissue adhesive was used in addition to staples in knee arthroplasty. However, no financial benefit is known, therefore this treatment has not been accepted into daily practice. In our department, prolonged hospital admission due to wound drainage is not found to be uncommon. Our hypothesis is that the addition of tissue adhesive in wound closure after hip and knee arthroplasty will significantly decrease post-operative wound drainage, leading to a reduced number of admission days. In addition, we expect less patients to return to our outpatient clinic for non-regular visits due to wound complications. Expensive bandages are used in our standard treatment protocol. Less wound drainage would mean less bandages. All these things combined will lead to a reduction in overall health care costs