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NCT ID: NCT03766035 Completed - Clinical trials for Primary Sclerosing Cholangitis (PSC)

Cholangioscopy in Primary Sclerosing Cholangitis (PSC)

Start date: December 6, 2018
Phase:
Study type: Observational

To demonstrate the clinical utility of the addition of per oral cholangioscopy (POCS) to standard endoscopic retrograde cholangiopancreatography (ERCP) with brushing cytology for diagnosis and early detection of cholangiocarcinoma in patients diagnosed with primary sclerosing cholangitis (PSC).

NCT ID: NCT03764618 Completed - Clinical trials for Warm Antibody Autoimmune Hemolytic Anemia

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA

Start date: April 24, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

NCT ID: NCT03764449 Completed - Healthy Volunteers Clinical Trials

A Study Investigating the Absolute Oral Bioavailability of Balovaptan After Single and Multiple Daily Oral Doses of Balovaptan in Healthy Volunteers

Start date: January 10, 2019
Phase: Phase 1
Study type: Interventional

This study was a non-randomized, open-label, parallel group, two-treatment study in healthy volunteers to investigate the absolute oral bioavailability of balovaptan. The study was conducted at 1 site in the Netherlands.

NCT ID: NCT03763721 Completed - Vision Disorders Clinical Trials

The ADVISE Study: Advanced Visualization In Corneal Surgery Evaluation

ADVISE
Start date: November 13, 2018
Phase: N/A
Study type: Interventional

Rationale: Intra-operative optical coherence tomography (iOCT) is a new technology that incorporates advanced imaging techniques in the ophthalmic operating theatre. This allows surgeons to visualize tissues in a way previously impossible We conceptualized an iOCT-guided surgical protocol for the treatment of endothelial cell dysfunction, that refrains from the current practice of over-pressurizing the eye at the end of surgery. Objective: The aim of this study is to assess the clinical value of intraoperative OCT (iOCT) for Descemet Membrane Endothelial Keratoplasty (DMEK) by comparing an iOCT-optimized surgical protocol with current practice, where the eye is over-pressurized for a set period of time, in terms of surgical efficiency, clinical outcomes, and adverse events. Study design: International multicentre non-inferiority randomized clinical trial Study population: Patients scheduled for posterior lamellar corneal surgery for endothelial cell dysfunction above the age of 18 years. Intervention: Both groups will undergo Descemet Membrane Endothelial Keratoplasty. Patients will be randomized for either the iOCT optimized surgical protocol or current standard surgical protocol using 8 minutes of overpressure to facilitate graft adherence. Both groups will be evaluated with iOCT at the end of surgery. Main study parameters/endpoints: The main study parameter is the rate of adverse events (particularly graft dislocations). Secondary parameters/endpoints are surgical time, the recovery of visual acuity and endothelial graft quality at 3 and 6 months follow-up, and a detailed evaluation of the extent/duration of surgical tissue manipulations. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The use of iOCT during surgery does not entail additional risk to the patient. Participants to this study will adhere to the standard of care after corneal transplant surgery. In addition, they will receive study specific measurements and questionnaires. The additional measurements and questionnaires will be combined with regular follow up moments.

NCT ID: NCT03762525 Completed - Angiography Clinical Trials

Iliac Branch Device Movement During Cardiac Cycle (IBD-dynamics)

Start date: October 5, 2016
Phase: N/A
Study type: Interventional

The incidence of isolated common iliac artery (CIA) aneurysms is low, but in combination with an abdominal aortic aneurysm (AAA) they are found in approximately 20-40% of cases. Basically, two different endovascular strategies can be applied to treat a CIA aneurysm with, including 1. the coverage and 2. the preservation of blood flow to the internal iliac artery (IIA). Coil and coverage of the IIA is related to ischemic complications, including buttock claudication, erectile dysfunction and the more severe spinal and colonic ischemia. Iliac branched devices (IBD) have been developed to exclude CIA aneurysms preserving the IIA and currently three alternatives are on the market. Clinical results of these devices are promising but loss of patency is not uncommon. The major difference between the two devices is the IIA component. The Cook IBD uses a -non-dedicated IIA component, while in the GORE® EXCLUDER® Iliac Branch Endoprosthesis (Gore IBE device) a dedicated self expanding stent is used. Stresses and forces exerted onto the endograft by aortic pulsatility may have an effect on the durability and functioning of the endograft. Intermittent hinchpoints could also have an effect on stent integrity and stenosis. By evaluating endograft movement during the cardiac cycle (ECG-gated CTA) it is possible to assess the stress and force exerted onto the endograft. This might help gain insight into mechanisms underlying potential endograft failure, and aid procedural planning and the development of future devices with long-term durability. The choice for device is not part of this study.

NCT ID: NCT03761849 Completed - Huntingtons Disease Clinical Trials

A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease

Start date: January 23, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042) compared with placebo in participants with manifest Huntington's disease (HD)

NCT ID: NCT03759392 Completed - Clinical trials for Heart Failure With Reduced Ejection Fraction

Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure

METEORIC-HF
Start date: April 9, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of treatment with omecamtiv mecarbil compared with placebo on exercise capacity as determined by cardiopulmonary exercise testing following 20 weeks of treatment with omecamtiv mecarbil or placebo

NCT ID: NCT03759366 Completed - Myasthenia Gravis Clinical Trials

A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)

Start date: December 21, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of eculizumab in the treatment of pediatric refractory gMG based on change from Baseline in the Quantitative Myasthenia Gravis (QMG) score for disease severity.

NCT ID: NCT03757767 Completed - Fasting Clinical Trials

The Fasting Study - Unraveling the Mechanistic Effects of Prolonged Fasting in Humans.

Start date: November 12, 2018
Phase: N/A
Study type: Interventional

Elevated levels of plasma triglycerides are increasingly recognized as an important causal risk factor for cardiovascular disease and associated pathologies. Lowering plasma triglycerides may therefore be a therapeutic target to lower cardiovascular disease risk. With this study the investigators want to examine the effects of fasting on adipose tissue metabolism in humans.

NCT ID: NCT03757325 Completed - Alzheimer Disease Clinical Trials

Study to Evaluate DNL747 in Subjects With Alzheimer's Disease

Start date: February 13, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of DNL747 in subjects with Alzheimer's disease when administered for 29 days in a cross-over design