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NCT ID: NCT03922516 Completed - Lung Diseases Clinical Trials

Accuracy of Ultra-Low-Dose-CT of the Chest Compared to Plain Film in an Unfiltered Emergency Department Patient Cohort

UP-Chest
Start date: May 2, 2019
Phase: N/A
Study type: Interventional

This trial compares the accuracy provided by plain film as well as ultra-low-dose-computed-tomography (ULDCT) of the chest. It also aims to analyze differences in diagnostic confidence and therapeutic consequence offered by these two imaging modalities.

NCT ID: NCT03921541 Completed - Hyperargininemia Clinical Trials

Efficacy and Safety of Pegzilarginase in Patients With Arginase 1 Deficiency

Start date: April 10, 2019
Phase: Phase 3
Study type: Interventional

CAEB1102-300A is a multi-center randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of pegzilarginase in patients with ARG1-D. This study will consist of a screening period; a randomized, double-blind treatment period; a long-term extension; and a follow up visit for final safety assessments.

NCT ID: NCT03921372 Completed - Mean Blur Ratio Clinical Trials

Isometric Exercise in NTG

Start date: July 26, 2018
Phase: N/A
Study type: Interventional

Glaucoma is the second leading cause of blindness worldwide. Literature shows increasing evidence that dysfunction of ocular microcirculation in the optic nerve influences the progression of glaucoma. It has been shown that flicker light-induced vasodilatation of retinal veins is diminished in patients with glaucoma. Also previous studies indicate that the blood flow autoregulation is impaired in patients with glaucoma. Therefor the ocular perfusion pressure can not be maintained stable during changes of the systemic arterial blood pressure. Laser speckle flowgraphy (LSFG) represents a non-invasive method to quantify ocular perfusion also at the ONH. LSFG enables noninvasive quantification of microcirculation of the optic disc in Japanese glaucoma patients. Study Objectives: To assess the changes in LSFG parameters in patients with normal tension glaucoma, compared to healthy subjects during flicker light stimulation and isometric exercises.

NCT ID: NCT03920293 Completed - Clinical trials for Generalized Myasthenia Gravis

Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis

Start date: March 12, 2019
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).

NCT ID: NCT03907865 Completed - Dry Eye Clinical Trials

Clinical Efficacy of Topical Hydrocortisone 0.335% (Softacort®) in Patients With Chronic Dry Eye Disease and Associated Ocular Surface Inflammation

Start date: March 27, 2018
Phase: Phase 4
Study type: Interventional

Dry eye disease (DED) is a highly prevalent ocular condition and induces a significant burden to the affected patients. Regardless of the underlying etiology, DED is associated with increased inflammation of the entire ocular surface including the adnexa, conjunctiva and cornea. As such, there is evidence from in vitro, animal and clinical studies that this inflammatory response of the ocular surface plays a pathophysiological key role in the development of DED. The Dry Eye Workshop 2007 (DEWS) therefore suggests the use of anti-inflammatory drugs such as corticosteroids, cyclosporine or others when topical lubricants alone are not sufficient. Recently, Softacort® eye drops containing 0.335% hydrocortisone have gained marketing authorization for the treatment of ocular surface inflammation. This formulation offers several advantages that make them potentially interesting for the treatment of DED. First, the formulation is preservative-free, which is of special importance in patients with DED, since it has been shown that preservatives are detrimental for the ocular surface. Further, hydrocortisone has the advantage that in comparison to other glucocorticoid derivatives, it features poor solubility. This means that corneal penetration is low, which is a desired effect in the treatment of ocular surface inflammation. Because of the poor penetration through thecornea, elevation of intraocular pressure and cataract formation, which are common side effect of corticosteroid treatment, have not been observed with Softacort® to date, also favoring the use of this agent in DED. The aim of the present study is to investigate whether treatment with Softacort® improves ocular surface inflammation as well as clinical signs and symptoms associated with DED in patients who are already taking topical lubricants for at least three months.

NCT ID: NCT03907163 Completed - Retinal Blood Flow Clinical Trials

The Effect of Tetrahydrocannabinol on Ocular Hemodynamics in Healthy Subjects

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

Glaucoma is among the leading causes for irreversible blindness worldwide. While lowering intraocular pressure (IOP) remains the mainstay of therapy, there are still some patients who progress despite wellcontrolled IOP. There is evidence from several studies that ocular blood flow and its regulation is impaired in patients with glaucoma. Tetrahydrocannabinol (THC) has been used in the treatment for glaucoma in some countries for several years due to its IOP lowering effect. In addition, there is also evidence that THC features neuroprotective effects and improves ocular hemodynamics. Dronabinol is a synthetic THC that is legally available in several European countries. It has the advantage that exact dosing of THC is possible in contrast to previously applied administration forms such as smoking. Due to its legal status in the past, data about the effect of THC on ocular blood flow and its regulation are sparse. This holds true for basic research in healthy subjects as well as in patients with glaucoma.The aim of the present study therefore is to investigate whether single administration of THC alters optic nerve head (ONH) blood flow in healthy subjects. In addition, other parameters for ocular blood flow will be measured, in particular retinal blood flow, retinal oxygen saturation and retinal neurovascular coupling. The study will be conducted in a randomized, double-masked, placebocontrolled, two-way cross-over design. Subjects will receive 5mg dronabinol on one study day. This dose is the recommended starting dose for some indications in clinical practice. Other studies investigating retinal hemodynamics or IOP after administration of THC also have used similar or slightly higher doses.

NCT ID: NCT03906656 Completed - Clinical trials for Pareses, Lower Extremity

Clinical Trial Comparing C-Brace to Knee Ankle Foot Orthosis (KAFO)/Stance Control Orthosis (SCO)

Start date: March 11, 2019
Phase: N/A
Study type: Interventional

Prospective, international, multi-center, open-labeled, randomized, controlled cross-over trial to evaluate effectiveness and benefits in patients with lower limb impairment in activities of daily living comparing the C-Brace microprocessor-controlled stance and swing orthosis to standard of care use of knee ankle foot orthosis/stance control orthoses

NCT ID: NCT03905525 Completed - Sjögren Syndrome Clinical Trials

Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome

TWINSS
Start date: October 1, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome.

NCT ID: NCT03905330 Completed - Clinical trials for Progressive Familial Intrahepatic Cholestasis (PFIC)

A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)

MARCH-PFIC
Start date: July 9, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).

NCT ID: NCT03905265 Completed - Scabies Clinical Trials

Dose-finding Study of Moxidectin for Treatment of Scabies

Start date: January 13, 2020
Phase: Phase 2
Study type: Interventional

The effective dose of moxidectin to treat human scabies is not known. This study aims to provide proof of concept that a single dose of moxidectin is effective in eliminating the scabies parasite in humans and to enable the determination of an optimal dose of moxidectin for treatment of scabies for further clinical studies.