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NCT ID: NCT03251742 Completed - Fontan Physiology Clinical Trials

Feasibility and Efficacy of Portable Non-invasive Negative Pressure Ventilation in Fontan Patients

FONTAN-CMR
Start date: November 17, 2017
Phase: Phase 1
Study type: Interventional

The human heart has 4 chambers: 2 collecting chambers (atria) and 2 pumping chambers (ventricles) to allow blood flow within two distinct circuits: "pulmonary" and "systemic". The pulmonary circuit directs the blood to the lungs to receive oxygen and the systemic circuit delivers oxygen-rich blood throughout the body. In children born with a single ventricle, blood from these two circuits mixes within the heart resulting in lower oxygen levels in the blood delivered to the body (cyanosis). The Fontan procedure is a palliative surgery which bypasses the need for a ventricle to deliver blood to the lungs, as blood from the body flows passively to the lungs by a man-made connection (whereby two large body veins [cavae] are sewn to the pulmonary arteries), thereby preventing mixing of blood through restoration of two distinct circuits without mixing of blood. Although the Fontan operation effectively eliminates cyanosis and enables survival into adulthood, increased systemic venous pressure is an unavoidable systemic complication and low cardiac output (CO) is pervasive finding. Despite excellent pediatric surgical results, the risk of late complications and death dramatically increases in the decades following Fontan surgery. A chronically low CO state secondary to decreased forward flow of blood to the lungs can result in end-organ dysfunction and shortened life expectancy. Short of heart transplantation, deemed suitable only for a minority of patients, effective therapies for low CO are largely absent. The investigators aim to investigate a novel, non-invasive, ambulatory therapy which can augment CO. Specifically, external suction is applied intermittently to the chest wall, much like a vacuum, to increase CO, called negative pressure ventilation (NPV) using a Cuirass® ventilator (Hayek Medical). Although used in patients with lung disease, the investigators' proposal is to evaluate this novel, portable, ventilation system would be the first study of its kind in adults with congenital heart disease, specifically those with a Fontan palliation.

NCT ID: NCT03251482 Completed - Clinical trials for VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery

A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery

TEXT-TKR
Start date: November 13, 2017
Phase: Phase 2
Study type: Interventional

The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and minimal bleeding events) for the selection of doses for Part 2. The primary purpose of Part 2 is to assess the efficacy dose response of JNJ-64179375 for the prevention of total venous thromboembolism (VTE) (proximal and/or distal deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic], nonfatal pulmonary embolism [PE], or any death).

NCT ID: NCT03251261 Completed - CMV Clinical Trials

Detection of Cytomegalovirus Virus in Neonates

CMV
Start date: August 2, 2017
Phase:
Study type: Observational

To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of age) saliva swabs

NCT ID: NCT03251092 Completed - Clinical trials for Healthy Volunteer - Complete

Study Designed to Assess the Safety, Tolerability and PK of PTI-808 in Healthy Volunteers and in Adults With Cystic Fibrosis

Start date: July 17, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Part 1 of this trial will enroll healthy volunteers into a single ascending dose (SAD), multiple ascending dose (MAD), and Food Effect (FE) treatment groups. The SAD treatment group is comprised of at least 3 ascending dose level cohorts where healthy adult subjects will be randomized to receive a single dose of either PTI-808 or placebo and will be followed for 7 days post dose. A safety review committee (SRC) will convene after the completion of each cohort to evaluate safety and pharmacokinetic (PK) data. Following the conclusion of the respective SAD level dose groups and after sufficient review of study data and approval by the SRC, a second set of healthy adult subjects will participate in an assigned MAD treatment group. The MAD treatment group is comprised of 3 ascending dose level cohorts where subjects will be randomized to receive either PTI-808 or placebo daily for 7 days and will be followed for 7 days after receiving the last dose. Also following the conclusion of the respective SAD level dose groups, healthy adult subjects will participate in the FE treatment group. Part 2 of this will enroll healthy volunteers to assess the safety, tolerability, and PK of PTI 808 co administered with PTI 801 and PTI 428 to HVs with daily dosing for 7 consecutive days. Part 3 will enroll adult subjects with cystic fibrosis (CF) into a MAD treatment group consisting of 2 cohorts. Subjects will receive PTI-808 co-administered with PTI-801 and PTI-428. PTI-808 will be administered daily for 7 consecutive days followed by PTI-808 + PTI-801 + PTI-428 administered daily for 14 consecutive days. Part 4 will enroll adult subjects with cystic fibrosis (CF) into 28-day cohorts. Subjects will receive PTI-808 co-administered with PTI-801 with or without PTI-428 versus matching placebo.

NCT ID: NCT03250624 Completed - Atopic Dermatitis Clinical Trials

Safety and Efficacy of CD5024 0.3% Cream in Subjects With Atopic Dermatitis

Start date: November 1, 2016
Phase: Phase 2
Study type: Interventional

Exploratory, multi-centric, randomized, vehicle-controlled, investigator-blind, parallel group study, involved participants with chronic lesions of Atopic Dermatitis (AD) to evaluate the local and systemic safety of CD5024 0.3% cream over a 6-week treatment period compared to its vehicle.

NCT ID: NCT03249961 Completed - Motor Learning Clinical Trials

How Many Days Would You Want to Practice a Skill to Achieve it?

Start date: April 20, 2018
Phase: N/A
Study type: Interventional

Practice is required to improve your shot in basketball or to play a musical instrument. The learning of these motor skills can be further enhanced by non-invasively stimulating regions of the brain that control movements with electrical currents. These electric currents can strengthen or weaken connections of the brain, which consequently affects a person's ability to improve their performance on a skill. Non-invasive brain stimulation (NIBS) is widely applied in many disciplines of neuroscience research, and has potential therapeutic application. There are two specific types of NIBS that will be used in this research study: 1) Transcranial Direct Current Stimulation (tDCS), which applies very weak electrical currents via two rubber electrodes on the scalp, and 2) Transcranial Magnetic Stimulation (TMS), which applies magnetic pulses via a coil against the head, to stimulate regions of the brain. Both types of non-invasive brain stimulation (i.e., tDCS, and TMS) are well-tolerated, painless, and safe. The application of tDCS to brain regions that control movements, concurrently with practice of a skill, results in better skill performance, than practice alone with no tDCS. Therefore, in this study, we will be testing different types of brain stimulation and different amounts of practice.

NCT ID: NCT03249948 Completed - Clinical trials for Ventricular Fibrillation

DOuble SEquential External Defibrillation for Refractory VF Pilot Study

DOSE-VF
Start date: March 5, 2018
Phase: N/A
Study type: Interventional

Despite significant advances in resuscitation efforts, there are some patients who remain in refractory ventricular fibrillation (VF) during out-of-hospital cardiac arrest. Double sequential external defibrillation (DSED) and vector change defibrillation have been proposed as a viable option for patients in refractory VF. This pilot cluster randomized trial will compare (1) continued resuscitation using standard defibrillation; (2) resuscitation involving DSED; or (3) resuscitation involving vector change defibrillation, in patients presenting with refractory VF during out-of-hospital cardiac arrest. The results of this pilot study will provide critical data for planning a larger, adequately powered multi-site randomized controlled trial to clinically evaluate DSED and vector change defibrillation compared to standard therapy for patients in refractory VF.

NCT ID: NCT03249584 Completed - Metastasis to Bone Clinical Trials

OsteoCool Tumor Ablation Post-Market Study

OPuS One
Start date: October 12, 2017
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness of the Medtronic OsteoCoolâ„¢ RF Ablation System.

NCT ID: NCT03248882 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

Start date: August 22, 2017
Phase: Phase 2
Study type: Interventional

Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)

NCT ID: NCT03248752 Completed - Physical Activity Clinical Trials

Monitoring Physical Activity (Fitbit)

Start date: July 4, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effect of monitoring and sharing physical activity outcomes (using Fitbit technology) with a domestic partner on physical activity participation. Primary research question: Does sharing physical activity outcomes from wearable technology with a participant's partner improve overall physical activity over 3 months compared to not sharing outcomes? Physical activity will be measured as minutes of moderate to vigorous physical activity per week. Hypothesis: Knowledge that physical activity outcomes are visible to a participant's partner will serve as a proxy-supervision intervention. Awareness of partner's progress will serve as further motivation. Both factors will improve physical activity adherence in comparison to participants without shared outcomes.