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NCT ID: NCT04574076 Enrolling by invitation - Haemophilia A Clinical Trials

A Study Following Males With Haemophilia A on Prophylaxis With Esperoct®

pathfinder9
Start date: October 23, 2020
Phase:
Study type: Observational

This study will collect information on side effects and how well Esperoct® (turoctocog alfa pegol (N8-GP)) works during long-term treatment (prophylaxis) in males with haemophilia A. Participants in this study will get the same treatment as they would normally get, if they were not participating in the study. All visits at the clinic are done in the same way as participants are used to, when visiting their doctor. During visits at the clinic participants might be asked for some relevant tests if considered useful by the study doctor. During the visits the study doctor might ask if participants had any side effects since the last study visit. Participants will be asked to note down in their own diary the number of bleeds and how these were treated, as well as their regular prophylaxis. Participation in the study will last for about 5-7 years, depending on when participants join the study. Participants are free to leave the study at any time and for any reason. This will not affect their current and future medical care.

NCT ID: NCT04545112 Enrolling by invitation - Clinical trials for Multi Vessel Coronary Artery Disease

Xeltis Coronary Artery Bypass Graft (XABG) First in Human (FIH)

XABG-FIH
Start date: October 22, 2020
Phase: N/A
Study type: Interventional

A FIH study to collect preliminary device safety, feasibility and performance data of the XABG in patients with symptomatic coronary artery disease (SCAD), with suitable multi vessel disease (MVD) and selected by the local Heart Team for elective coronary artery bypass grafts surgery of at least 3 bypass grafts (minimally 1 artery and 2 veins or 2 arteries and 1 vein).

NCT ID: NCT04544410 Active, not recruiting - Clinical trials for Congenital Adrenal Hyperplasia

A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAH

Start date: September 29, 2020
Phase: Phase 2
Study type: Interventional

An investigation of the ability of Tildacerfont to reduce supraphysiologic glucocorticoid dosing in classic CAH subjects up to 76 weeks of treatment. Optional open label extension up to 240 weeks.

NCT ID: NCT04542902 Recruiting - Allergic Asthma Clinical Trials

Non-coding RNAs Analysis of Eosinophil Subtypes in Asthma

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Chronic airway inflammation rich in eosinophils is an important feature seen in asthma. Airway and blood eosinophilia is associated with increased rates of asthma exacerbations and more intense treatment. Recently, the existence of two distinct eosinophils subtypes was revealed-lung-resident eosinophils (rEOS), which maturate independently to interleukin (IL) 5, with the primary function to maintain tissue homeostasis, and inflammatory eosinophils (iEOS), which mature in IL-5-dependent manner and are mainly involved in immune responses. Eosinophils' effect on the airway remodeling in asthma depends not only on the activity but also by their viable number in the lungs. Blood iEOS infiltrate the airways mainly after the environmental stimulus like allergen and leave the airways with bronchial secretions. However, rEOS reside lung tissue for their entire lifetime regulating local immunity. Blood rEOS and iEOS ratio alters in asthma, compared with healthy controls. It is known that the predominant eosinophils subtype in allergic asthma are iEOS, while rEOS are basic subtype in severe eosinophilic asthma patients, moreover, they are different in adhesive properties and survivability as well. Distinct biological properties allows to speculate about their different functions in asthma, however, there are still little information. Data about differently expressed microRNA (miRNA) profiles in eosinophils in asthma suggests, that eosinophils subtypes can be distinct in non-coding RNA (ncRNA) - microRNA (miRNA), piwi-interacting RNA (piRNA) and long non-coding RNA (IncRNA) profiles that could describe their role in asthma pathogenesis and act as biomarkers to discern asthma phenotypes.

NCT ID: NCT04542096 Recruiting - Respiratory Failure Clinical Trials

Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT

Start date: September 29, 2020
Phase:
Study type: Observational

Electric Impedance Tomography (EIT) is a lung monitoring technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance change in a slice of the thorax. It is a real time, radiation free, non-invasive and portable. Neonatal respiratory distress syndrome (RDS) is a respiratory disorder resulting from immaturity of the lung structure and lack of surfactant. It is one the most common conditions in premature infants. Many of these infants require either invasive or non-invasive respiratory support. The goal of the study is to investigate the dynamic changes in pulmonary aeration during assisted breathing in very low birthweight preterm infants using pulmonary electrical impedance tomography. Currently most widely used methods to assess respiratory lung function are either invasive and/or indirect (ABG, pulse oximetry, transcutaneous pCO2 measurement), lacks temporal resolution (lung ultrasound) or emit ionizing radiation (CT). EIT provides information on regional lung aeration without the aforementioned shortcomings.

NCT ID: NCT04538924 Recruiting - Clinical trials for Myocardial Infarction With Nonobstructive Coronary Arteries

Etiologic Mechanisms, Myocardial Changes and Prognosis of Patients With MINOCA

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

This prospective trial will include 150 patients with myocardial infarction with non-obstructive coronary arteries (MINOCA). A thorough clinical, laboratory and imaging evaluation will be performed by novel biomarkers and modern imaging techniques (heart magnetic resonance imaging and noninvasive testing). Moreover, two different treatment groups will be distinguished. Additionally, a retrospective analysis of patients meeting MINOCA criteria will be performed.

NCT ID: NCT04531982 Active, not recruiting - Schizophrenia Clinical Trials

Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia

ADVANCE-2
Start date: August 5, 2020
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of negative symptoms of schizophrenia

NCT ID: NCT04526951 Recruiting - Clinical trials for Central Retinal Artery Occlusion

TENecteplase in Central Retinal Artery Occlusion Stuy (TenCRAOS)

TenCRAOS
Start date: October 30, 2020
Phase: Phase 3
Study type: Interventional

TENecteplase in Central Retinal Artery Occlusion (TenCRAOS): A Prospective, randomized-controlled, double-dummy, double-blind phase 3 multi-centre trial of TNK 0.25 mg/kg + placebo vs. ASA + placebo (2 arms with 1:1 block randomization). A Prospective, randomized-controlled, double-dummy, double-blind phase 3 multi-centre trial of TNK 0.25 mg/kg + placebo vs. ASA + placebo (2 arms with 1:1 block randomization). At all participating centers, ophthalmologists are involved in the diagnosis and visual outcome measurements using a standardized protocol. The patients will be promptly examined by the ophthalmologist. As soon as the CRAO is diagnosed by the ophthalmologist, the patients will be managed in the stroke unit during treatment, monitoring, and medical investigations. After treatment in the stroke unit, the patients will be re-examined by an ophthalmologist and a neurologist as an out-patient at (30 ±5) and 90 (±15) days

NCT ID: NCT04524949 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 1

IMCY-0098 Proof of ACtion in Type 1 Diabetes (IMPACT Study)

IMPACT
Start date: December 29, 2020
Phase: Phase 2
Study type: Interventional

The IMPACT study is a study to test a new experimental drug, IMCY-0098, for the treatment of type 1 diabetes (T1D). In most people with type 1 diabetes, the pancreas loses its ability to make insulin because some cells of the body's own immune system mistakenly attack and destroy the cells in the pancreas that produce insulin (islet beta-cells). The study drug IMCY-0098 is being developed to stop the body's own immune system attacking and destroying the insulin-producing cells. When injected, it will induce new immune cells that will specifically destroy the bad immune cells responsible for the damage to the pancreas. IMCY-0098 has previously been tested on recently diagnosed type 1 diabetes patients in the first clinical study between 2017 and 2019 to collect information on the safety of IMCY-0098. The next step is to test the best dose and the best number of injections that show the drug can give a benefit. Two doses of IMCY-0098 will be tested and they will be compared to a placebo. Safety information will also be collected during the study for all the participants.

NCT ID: NCT04524364 Completed - Atrial Fibrillation Clinical Trials

A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE)

inspIRE
Start date: August 23, 2020
Phase: N/A
Study type: Interventional

The primary objective is to demonstrate safety and long-term effectiveness of the irreversible electroporation (IRE) system (Circular IRE Catheter and IRE Generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).