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NCT ID: NCT03905642 Completed - Cystic Fibrosis Clinical Trials

Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase

Start date: January 8, 2009
Phase: Phase 2
Study type: Interventional

A major factor in the respiratory health of cystic fibrosis (CF) patients is acquisition of chronic Pseudomonas (P.) aeruginosa infections. The infection rate with P. aeruginosa increases with age and by age 18 years, 80% of patients with CF in the U.S. are infected. Liposomal amikacin for inhalation (LAI; Arikayce™) is a sterile aqueous liposomal suspension consisting of amikacin sulfate encapsulated in liposomes. This formulation of amikacin maximizes the achievable dose and delivery to the lungs of infected patients when delivered via a nebulizer. Because liposome particles are small enough to penetrate and diffuse through sputum into the bacterial biofilm, they deposit drug close to the bacterial colonies (Meers, et al., 2008) (Clancy, et al., 2013), thus improving the bioavailability of amikacin at the infection site. The clinically achievable doses of amikacin in the LAI formulation can effectively increase the half-life of the drug in the lungs, and decrease the potential for systemic toxicity. LAI offers several advantages over current therapies in treating patients with CF with chronic infection caused by P. aeruginosa.

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: NCT03903822 Completed - Atopic Dermatitis Clinical Trials

Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis

Start date: May 13, 2019
Phase: Phase 2
Study type: Interventional

This study is being conducted to provide data on efficacy, safety, tolerability and PK of multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the dose and dosing regimen (once daily [QD] vs twice daily [BID] application) for the future clinical development of topical PF-06700841.

NCT ID: NCT03903744 Completed - Syncope, Vasovagal Clinical Trials

Cardioneuroablation for Reflex Syncope

ROMAN
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Aim. To assess the effects of cardioneuroablation (CNA) on cardiac autonomic regulation and syncope recurrences in patients with vasovagal syncope (VVS), and to compare this novel approach with standard non-pharmacological treatment. Measurements. 1. Before CNA: 1. Detailed history taking and assessment of eligibility 2. Baseline 12-lead ECG for heart rate assessment, morphology and duration of the P wave and PR interval 3. 24-hour Holter ECG for heart rhythm (mean, minimal, maximal, pauses) and heart rate variability (HRV) assessment 4. Passive tilt test (70 degrees, 45 minutes) to fulfill inclusion criterion and to assess baseline autonomic parameters such as HRV and baroreflex sensitivity (BRS) using sequential method. These parameters will be calculated from 5 min recordings before and after orthostatic stress (tilt). 5. Atropine test - positive response to intravenous atropine in a dose of 2 mg defined as at least 30% increase in sinus rate compared with baseline value 6. Assessment of quality of life using the SF-36 questionnaire 7. Implantable Loop Recorder (ILR) implantation 2-3 days before CNA 2. During CNA: 1. Heart rate before and immediately after CNA 2. Episodes of bradycardia (sinus arrest or atrio-ventricular block) during application of RF to GP. 3. Standard electrophysiological parameters (sinus node recovery time, corrected sinus recovery time, refractory atrio-ventricular node, atrio-ventricular conduction - Wenckebach point, A-H and H-V intervals) will be assessed before an immediately after CNA 4. Atropine test (2 mg) will be repeated immediately after CNA. 3. After CNA: 1. 1-2 days after CNA standard ECG 2. Follow-up: 3, 12 and 24 months after CNA assessment of symptoms, 12 lead standard ECG, control of ILR, 24-hour Holter ECG, tilt test and atropine test will be performed. Additionally, quality of life will be assessed using SF-36 questionnaire Anticipated results. 1. CNA performed with technique used in the present study is effective in > 90% of patients. 2. CNA-induced changes in analysed ECG and autonomic parameters predict CNA efficacy

NCT ID: NCT03902795 Completed - Retinal Detachment Clinical Trials

Functional and Morphological Results of Rhegmatogenous Retinal Detachment Treated With Vitrectomy

Start date: March 2016
Phase:
Study type: Observational

To examine morphological and functional results after pars plana vitrectomy (PPV) with SF6 gas tamponade due to macula-on and macula-off rhegmatogenous retinal detachment (RRD) during six months of the follow-up.

NCT ID: NCT03902301 Completed - Obesity Clinical Trials

Lactobacillus Rhamnosus and PCOS Treatment

ProjectPCOS
Start date: April 1, 2018
Phase: N/A
Study type: Interventional

The effect of Lactobacillus rhamnosus supplementation on body weight, hyperandrogenism and insulin resistance in overweight and obesity women with Polycystic Ovary Syndrome will be analysed.

NCT ID: NCT03902080 Completed - Overactive Bladder Clinical Trials

Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)

Start date: March 26, 2019
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy of vibegron compared with placebo in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH) as defined by micturition and urgency episodes.

NCT ID: NCT03901729 Completed - Heart Failure (HF) Clinical Trials

A Trial to Study BAY1753011 in Patients With Congestive Heart Failure

AVANTI
Start date: May 29, 2019
Phase: Phase 2
Study type: Interventional

To assess the efficacy of 30 mg of BAY1753011, with or without furosemide, versus furosemide alone in patients with heart failure and objective evidence of congestion.

NCT ID: NCT03899389 Completed - Coronary Disease Clinical Trials

Plasma TMAO (Trimethylamine N-oxide) as a Predictive Marker in Coronary Disease Patients

Start date: February 1, 2017
Phase:
Study type: Observational

The primary aim of the current research project is to determine whether the TMAO concentration in the blood can serve as a prognostic indicator of myocardial infarction. The hypothesis is that in patients with recent myocardial infarction, TMAO concentration in blood is higher than in patients undergoing scheduled coronarography.

NCT ID: NCT03896581 Completed - Psoriatic Arthritis Clinical Trials

A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

BE COMPLETE
Start date: March 28, 2019
Phase: Phase 3
Study type: Interventional

This is a study to demonstrate the clinical efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared with placebo in the treatment of tumor necrosis factor alpha-inadequate responders (TNFα-IR) subjects with active Psoriatic Arthritis (PsA).