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NCT ID: NCT03403205 Not yet recruiting - Wilson Disease Clinical Trials

Efficacy and Safety of WTX101 Administered for 48 Weeks Versus Standard of Care in Wilson Disease Subjects

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

Wilson Disease (WD) is an autosomal recessive disorder of impaired copper (CU) transport caused by mutations in the ATP7B gene. WTX101 (bis-choline tetrathiomolybdate) is a first-in-class copper-protein-binding agent with a unique mechanism of action, under investigation as a novel therapy for WD. It is formulated as an enteric coated tablet (15 mg strength) for oral administration. The purpose of this study is to evaluate the efficacy of WTX101 administered for 48 weeks compared to standard of care (SOC) in WD subjects aged 18 and older.

NCT ID: NCT03402841 Not yet recruiting - Clinical trials for Non-Germline BRCA Mutated Ovarian Cancer

Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients

OPINION
Start date: January 20, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the efficacy and safety of single-agent olaparib as a maintenance treatment in patients with relapsed High Grade Serous Ovarian Cancer (including patients with primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer who do not have known deleterious or suspected deleterious germline BRCA mutations (non-gBRCAm) and who had responded following platinum based chemotherapy.

NCT ID: NCT03401892 Recruiting - Clinical trials for Anterior Ischemic Optic Neuropathy

Retinal Neuro-vascular Coupling in Patients With Non-arteritic Anterior Ischemic Optic Neuropathy

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

Ischemic optic neuropathy is among the most common causes of serious impaired vision in the middle-aged and elderly population in the western world. The current study focuses on a subgroup of ischemic optic neuropathy, the so-called non-arteritic ischemic optic neuropathy (NAION). Although the exact pathogenesis of NAION has not been fully clarified it is known that patients with cardio-vascular risk factors such as hypertension, diabetes mellitus and dyslipidemia have also an increased risk to develop NAION. Along this line of thought it has been shown that patients with a history of NAION in one eye have an increased risk to develop NAION also on the contralateral eye. However, clinical studies investigating ocular perfusion abnormalities in patients with NAION are sparse and even contradicting. Thus, the current study seeks to measure ocular blood flow parameters in patients with a history of NAION and compare it to healthy age-matched subjects.

NCT ID: NCT03401879 Recruiting - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis

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

Multiple sclerosis (MS) affects approximately 2.3 million patients worldwide, with a global median prevalence of 33 per 100,000. MS is diagnosed at an average of 30 years and affects twice as many women as men. MS is traditionally diagnosed by the presentation of lesions of the central nervous system, disseminated in time and in space, proven by clinical examination and magnetic resonance imaging. Several anatomical parameters in the eye, both vascular and neural, have been found to be altered in MS patients. Because of its unique optical properties, the eye offers the possibility of the non-invasive assessment of both structural and functional alterations in neuronal tissue. As the neuro-retina is part of the brain, it does not come as a surprise that neuro-degenerative changes in the brain are accompanied by structural and possibly also functional changes in the neuro-retina and the ocular vasculature. The current study seeks to test the hypothesis that beside the known anatomical changes, also functional changes can be detected in the retina of patients with MS. For this purpose, flicker light induced hyperemia will be measured in the retina as a functional test to assess the coupling between neural activity and blood flow. Further, structural parameters such as retinal nerve fiber layer thickness and function parameters such as ocular blood flow and retinal oxygenation will be assessed and compared to age and sex matched controls.

NCT ID: NCT03401229 Not yet recruiting - Nasal Polyposis Clinical Trials

Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis

OSTRO
Start date: January 15, 2018
Phase: Phase 3
Study type: Interventional

The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing.

NCT ID: NCT03399968 Recruiting - Clinical trials for Spinal Cord Injuries

Extracorporeal Shockwave Therapy (ESWT) to Improve Function in Chronic ASIA-A Patients

Start date: March 26, 2015
Phase: N/A
Study type: Interventional

The global prevalence of spinal cord injury is estimated between 236 to 4187/Million. A spontaneous recovery of the sense-motoric function is decreasing with the time after injury and is only seen sporadically after 1 to 2 years. Treatment options are mainly limited to improvement of the quality of life. The present prospective randomized study is intended as a double-blind, placebo controlled multi-center investigation. Patients suffering from chronic paraplegia (lesion between THII and THX, ASIA A = complete central lesion) at least for 1 year after the initial trauma without spontaneous remission of the last 6 months are considered to be included in the study. Meeting the inclusion criteria and signing the informed consent, patients are treated in one of the two study centers. At study inclusion, a baseline evaluation comprising neurological, neurophysiological, functional and clinical investigation is performed. Patients dedicated to the ESWT intervention group will be treated once a week over 6 weeks with local non-invasive low energy extracorporeal shockwave therapy (=6 treatments with an electrohydraulic device). The follow-up will include neurological, neurophysiological, clinical as well as functional evaluation at the time points 6 weeks, 3 months and 6 months. Additionally, patients will be provided with a diary for documentation of drug adaptation, grade of spasticity and pain. Those patients dedicated to the Placebo ESWT group, will receive the identical scheme in treatment (but without application of shockwaves) and follow-up as the patients in the ESWT group. However, after positive completion of the study, these patients will be offered ESWT as well.

NCT ID: NCT03399292 Recruiting - Dry Eye Syndromes Clinical Trials

Effect of Lipid Based Eye Drops on Tear Film Lipid Layer Thickness

Start date: April 12, 2017
Phase: N/A
Study type: Observational

Dry eye disease (DED) is a common ocular disease, especially in the elderly population. Despite many treatment approaches, instillation of topical lubricants remains the mainstay of therapy. However, most of the topical lubricants available are not very well characterised and data about efficacy is sparse. The aim of the present pilot study is to investigate the effect of topically administered lipid based eye drops on tear film lipid layer thickness in subjects with dry eye disease, Meibomian gland dysfunction, blepharospasm and healthy subjects. Tear film lipid layer and tear film thickness will be assessed using the Lipiview II interferometer and OCT. Measurements will be performed before instillation of the eye drops and every 10 minutes after instillation for one hour. One eye will receive lipid based eye drops, the other eye will receive no eye drops and will be used as control. The study eye will be chosen randomly. In addition, Dynamic Meibomian gland imaging, Schirmer I test, corneal fluorescein staining and determination of tear break up time (BUT) will be performed

NCT ID: NCT03398616 Enrolling by invitation - Retinal Bloodflow Clinical Trials

Regulation of Retinal Bloodflow Pressure

Start date: February 1, 2018
Phase: N/A
Study type: Observational

Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance to changes in perfusion pressure. In the eye, several studies have reported that retinal blood flow is autoregulated over a wide range of ocular perfusion pressures. Large scale studies have shown that reduced ocular perfusion pressure is an important risk factor for the prevalence, the incidence and the progression of primary open angle glaucoma. There is also evidence that autoregulation is impaired in patients with primary open angle glaucoma. To gain more insight into these phenomena in humans is the primary goal of the present study. The present study aims to investigate the pressure/flow relationship as a measure for retinal blood flow autoregulation during an experimental increase in intraocular pressure by the use of the suction cup technique. Retinal blood flow will be measured by Doppler OCT.

NCT ID: NCT03395548 Recruiting - Microbiota Clinical Trials

Stability of the Microbiome in IBD and IBS

Start date: August 25, 2017
Phase: N/A
Study type: Interventional

In this study the investigators aim to investigate the changes of the intestinal microbiome in three different cohorts (IBD, IBS, healthy) after applying the uniform disruptive factor of osmotic diarrhea induced by macrogol. The investigators hypothesis is that ill people will show more severe changes of the microbiome than healthy people and that these changes persist longer.

NCT ID: NCT03393442 Recruiting - Clinical trials for Gd-based Contrast Media Exposure During Breast MRI Scans

Evaluation of Gadolinium Deposits in Healthy Women Participating in a High Risk Screening Program for Early Breast Cancer Detection

Start date: November 25, 2017
Phase: N/A
Study type: Interventional

Purpose: To determine whether patients at high risk to develop breast cancer having received at least 6 cumulative dosages of macrocyclic Gd-based contrast media in the context of breast cancer screening by means of contrast-enhanced MRI. Methods: Diagnostic study encompassing two arms: first, 50 patients having received ≥6 dosages of macrocyclic Gd-based contrast media in the course of MRI-based breast cancer screening will undergo brain MRI assessment for signal alterations due to Gd-deposits. The second arm consists of 50 healthy volunteers that never received Gd-based contrast agents, and undergoes the same brain MRI assessment as the patient-based arm 1 of the study. Signal intensities will be compared to assess the potential presence or absence of macrocyclic Gd-based contrast agent deposits in the brain. In case of presence of signal alterations in arm 1 these will be further stratified by number of previously administered macrocyclic Gd-contrast agent doses. Projected outcome: High cumulative dosages of macrocyclic Gd-based contrast agent either result or do not result in brain MRI signal alterations in healthy women participating in a high-risk screening program for the early detection of breast cancer that necessitates Gd-contrast agent enhanced breast MRI at regular intervals.