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NCT ID: NCT03355742 Completed - Clinical trials for Coronary Artery Disease

XIENCE 28 Global Study

Start date: February 9, 2018
Phase: N/A
Study type: Interventional

XIENCE 28 Global Study is a prospective, single arm, multi-center, open label, non-randomized trial to further evaluate the safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family (XIENCE Xpedition Everolimus Eluting Coronary Stent System [EECSS], XIENCE Alpine EECSS, XIENCE PROX EECSS, XIENCE ProA EECSS or XIENCE Sierra EECSS of coronary drug-eluting stents

NCT ID: NCT03355586 Completed - Lung Cancer Clinical Trials

CT‐Controlled Advanced Navigation Techniques for Transbronchial Pulmonary Lesion Access; Evaluation of Electromagnetic Navigation Based Diagnostic Yield

CONTROL-E
Start date: December 21, 2017
Phase:
Study type: Observational

In this clinical trial we will investigate the diagnostic yield of a combination of commercially available imaging and navigation techniques for reaching peripheral lung lesions. The two investigated techniques will herein be the rEBUS imaging modality combined with electromagnetic based navigation. Confirmation of reaching the lung lesion will be by means of CT (fluoroscopic) imaging. Rapid On‐Site Evaluation (ROSE) of cytopathology will be used for obtaining a per‐procedural outcome on tissue biopsy representativeness. All data will be prospectively collected. In case tissue biopsy is found to be malignant or benign, it will be termed representative. In case tissue biopsy is found to be non‐representative (=blood, anatomical lung tissue, unreachable), conventional followup of CT guided TTNA, follow‐up monitoring and/or surgical biopsy will serve as golden standard for obtaining tissue diagnosis. For verification of reaching the target lesion, another study parameter of interest, (cb)CT imaging will be performed for verification that instruments are within the nodule (per‐procedurally available).

NCT ID: NCT03355209 Active, not recruiting - Clinical trials for Lennox Gastaut Syndrome

A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome

Start date: November 27, 2017
Phase: Phase 3
Study type: Interventional

This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).

NCT ID: NCT03355196 Completed - Clinical trials for Patients With Moderate Knee Osteoarthritis (30 - 65 Years)

First-in-human, Safety, Tolerability and Pharmacokinetics Study of LRX712 in Osteoarthritic Patients

Start date: November 20, 2017
Phase: Phase 1
Study type: Interventional

This study is designed to evaluate, for the first time in humans, safety and tolerability of single ascending doses of intra-articular (i.a.) injections of LRX712 into the knee of patients with moderate osteoarthritis (OA), in order to support the further clinical development. This study will also allow establishment of the systemic and local pharmacokinetics (PK) of LRX712 and the exploration of biomarkers of cartilage breakdown and regeneration in OA patients.

NCT ID: NCT03354572 Completed - Postoperative Pain Clinical Trials

Pilot Study: Postoperative Pain Reduction by Pre Emptive N-Acetylcysteine

Start date: October 20, 2017
Phase: Phase 4
Study type: Interventional

Despite current available analgesic drugs, post-surgical pain management remains challenging. A potential new target for analgesic drugs are group-II metabotropic glutamate receptors subtypes (mGlu2 and mGlu3 receptors), since growing evidence from animal models show that activation of these receptors produce s analgesic effects in inflammatory and in neuropathic pain states. . N-Acetylcysteine (NAC) is a safe agent and with little to no side effects. NAC can induce analgesia by activating the glutamate:cystein antiporter, causing endogenous activation of the mGlu 2/3 receptors. However, this has only been investigated once in the peri-operative setting, were it showed preliminary promising result of reduction in opiate necessity. In healthy subjects there was a significant reduction in pain ratings to laser stimuli and amplitudes of laser evoked potentials after NAC. Based on these promising results, we hypothesize that pre emptive intravenous NAC can reduce postoperative pain and thereby cause less necessity for escape analgesics like opiates.

NCT ID: NCT03354273 Completed - Clinical trials for Coronary Artery Disease (CAD)

An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)

Start date: June 5, 2018
Phase: Phase 3
Study type: Interventional

This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.

NCT ID: NCT03354156 Completed - Atherosclerosis Clinical Trials

The Effect of Statin Treatment on Trained Innate Immunity

SIMPEL
Start date: January 2015
Phase: N/A
Study type: Observational

The innate immune system plays a pivotal role in the development and progression of atherosclerosis. Recently, it was reported that monocytes can develop a long-lasting immunological memory after stimulation with various microorganisms, which has been termed 'trained innate immunity'. This memory is induced by epigenetic reprogramming, in particular trimethylation of lysine 4 at histone 3 (H3K4me3). In this study, the investigators aim to investigate the immunophenotype of circulating monocytes in patients with elevated LDL cholesterol levels and the effect of statins on this phenotype.

NCT ID: NCT03354039 Completed - Clinical trials for Duchenne Muscular Dystrophy

Tamoxifen in Duchenne Muscular Dystrophy

TAMDMD
Start date: June 12, 2018
Phase: Phase 3
Study type: Interventional

A randomised, double blind, placebo controlled, 48-week clinical trial with a core population (group A) of 79 ambulant 6.5 to 12 years old Duchenne's muscular dystrophy (DMD) patients that are under stable standard treatment of care with glucocorticoids. Furthermore, the investigators plan to include 6-20 non-ambulant patients who do not receive glucocorticoids (as parallel group B), 10 to 16 years old, to obtain efficacy and safety data in a broader DMD population. All patients will receive 20 mg of tamoxifen (TAM) or placebo once daily during 48 weeks. An open label extension (OLE) trial for participants of the TAMDMD main study will be performed. All TAMDMD patients on TAM or placebo are offered to enter this OLE.

NCT ID: NCT03353753 Completed - Clinical trials for Gastrointestinal Stromal Tumors

Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies

INVICTUS
Start date: February 27, 2018
Phase: Phase 3
Study type: Interventional

This is a 2-arm, randomized, placebo-controlled, double-blind, international, multicenter study comparing the efficacy of ripretinib (DCC-2618) to placebo in patients who have received treatment with prior anticancer therapies. Prior anticancer therapies must include imatinib, sunitinib, and regorafenib (3 prior therapies). Approximately 120 patients were randomized in a 2:1 ratio to ripretinib 150 mg QD or placebo

NCT ID: NCT03350620 Active, not recruiting - Myopia Clinical Trials

CHAMP: Study of NVK-002 in Children With Myopia

Start date: November 20, 2017
Phase: Phase 3
Study type: Interventional

Stage 1: To evaluate the safety and efficacy of 2 concentrations of NVK-002 compared to Vehicle (placebo) for slowing the progression of myopia in children over a 3 year treatment period. Stage 2: To observe safety and efficacy in subjects re-randomized to one (1) year of treatment with NVK-002 or Vehicle following 3 years of treatment in children with progressive myopia.