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NCT ID: NCT03281122 Terminated - Heart Failure Clinical Trials

A Study of BMS-986224 in Healthy Subjects and Heart Failure Patients With Reduced Ejection Fraction

Start date: September 22, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is test the safety and tolerability of BMS-986224 and its effects on the body in healthy subjects and subjects with chronic heart failure with reduced ejection fraction

NCT ID: NCT03279484 Active, not recruiting - Clinical trials for Arrythmia, Implatable Cardioverter Defibrillation, Lead

Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector

NAVIGATOR
Start date: November 24, 2017
Phase: N/A
Study type: Interventional

The primary objective of this study is to assess the safety and electrical performance of Left ventricular (LV) NAVIGO 4LV leads, pre-shaped (S-shaped&U-shaped: NAVIGO 4LV 2D, NAVIGO 4LV ARC) and Straight (NAVIGO 4LV PILOT), with IS4 connector

NCT ID: NCT03278561 Completed - Asthma Clinical Trials

General Risk Factors and Inflammatory Determinants in Older Patients With Asthma

GRANDMA
Start date: May 8, 2017
Phase:
Study type: Observational

A cross-sectional study in asthma patients to determine if a late age of onset asthma (start symptoms >18 years old), is associated with more persistent airway/systemic inflammation, worse asthma control, more co-morbidity, a different microbiome and poorer quality of life despite the use of optimized asthma therapy.

NCT ID: NCT03278548 Completed - Clinical trials for Hypovolaemia Due to Acute Blood Loss

Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery

PHOENICS
Start date: September 28, 2017
Phase: Phase 4
Study type: Interventional

The aim of the study is to investigate the safety of a 6% HES (Hydroxyethyl Starch) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective abdominal surgery.

NCT ID: NCT03278535 Completed - Healthy Volunteers Clinical Trials

Reference Gait Data for Healthy Subjects

Start date: July 4, 2017
Phase:
Study type: Observational

Three dimensional gait analysis is widely accepted as a general measure of functional ability among individuals as it is related to health, well-being and quality of life. To diagnose subtle changes/deviations in gait and to correctly interpret gait, a reference gait database of healthy subjects is required. Computer Assisted Rehabilitation Environment (Caren) is a new gait analysis system which combines the 3D motion captures system with a split belt force plate instrumented treadmill and a virtual reality environment. This system enables to analyses several successive steps, which is impossible in the standard overground laboratories. Until now, no reference gait database has been created using the Caren system. The aim of this descriptive study is to create a reference database of gait in healthy adults with varying subject characteristics using Caren. This study is a single center descriptive study to build a reference database on gait of healthy adults of different ages. Six age groups are composed existing of 20 males and 20 females. Taken into account that 10% of the volunteers (especially elderly) may drop out due to e.g. disability, a total of 264 subjects will be recruited to ensure that database will include 240 subjects. Inclusion criteria: ambulatory, ability to walk without aid for 30 minutes, age older than 18 years and willing to participate. Exclusion criteria: muscular skeletal, cardiopulmonary disorders or other diseases significantly influencing gait. Medical interventions, such as surgical treatment or botulinium toxin 6 months, which significantly influence gait. Subjects will walk at different walking speeds at Caren while gait is measured. Subjects always wear a safety harness to avoid falling. In addition adults wear standard shoes (gymnastic booties) provided by the lab to avoid shoes effects. All subjects undergo measurement of leg length, body length and body weight in order to retrieve anthropometric parameters. In addition a standard physical examination is performed to get information about a subjects' muscle strength, balance and articular mobility of the hip, knee and ankle. Gait kinematic, kinetic, spatio-temporal and balance parameters are measured.

NCT ID: NCT03278197 Completed - Prostate Cancer Clinical Trials

Evaluation of a Web-based Decision Aid Tool for Prostate Cancer Patients

ProDecA
Start date: January 2015
Phase: N/A
Study type: Interventional

Patients diagnosed with localized prostate cancer may be eligible for different treatment options. MAASTRO Clinic (MAAStricht Radiation Oncology) developed a web-based decision aid tool for these patients. The goal of the tool is to help patients to understand the treatments, and empower the patients to participate in the decision making process. The aim of this study is threefold: (A) user-testing and validation of the tool, by using a systematically development process compliant with the IPDAS (International Patients Decision Aids Standards) criteria (B) establish the impact of the tool on the decision making process; (C) identify barriers and facilitators for the implementation of shared decision making and the tool in clinical practice. The study covers 3 phases: 1. Development phase 1.1 Assess decisional needs of patients and clinicians. 1.2 Test patients' and clinicians' comprehensibility, acceptability and usability on the alpha-version of the tool. 1.3 Value clarification: Delphi study with former prostate cancer patients to determine the most important patient preferences and value clarification aspects the decision aid should include. 2. Implementation phase: Develop an implementation and dissemination plan for shared decision-making which is based on the evaluation of barriers and facilitators for the use of patient decision aid tools in clinical practice. 3. Evaluation phase: Establish the impact of on knowledge, decisional conflict and the shared decision-making process, as well as the extent to which clinicians involve patients in decision-making. A mixed method will be used. It comprises structured interviews combined with think aloud and questionnaires with stakeholders involved in the whole process of development, implementation and evaluation (patients, urologists, radiotherapists, nurses, general practitioners, patient organizations, and insurance companies).

NCT ID: NCT03277690 Completed - Clinical trials for Endogenous Cushing's Syndrome

A Study to Assess the Safety and Efficacy of Levoketoconazole in the Treatment of Endogenous Cushing's Syndrome.

Start date: September 26, 2017
Phase: Phase 3
Study type: Interventional

This is a double-blind, randomized, placebo-controlled withdrawal and rescue/restoration study in subjects with endogenous Cushing's Syndrome (CS) previously treated with single-arm, open-label levoketoconazole that will assess efficacy, safety, tolerability, and pharmacokinetics of levoketoconazole.

NCT ID: NCT03277378 Completed - Clinical trials for Chronic, Intractable Pain of the Trunk and/or Lower Limbs

Evaluating Anatomic Versus Targeted Lead Placement for Burst Stimulation Therapy During the Trial

DELIVERY
Start date: September 22, 2017
Phase: N/A
Study type: Interventional

Prospective, multi-center, randomized, single blind study

NCT ID: NCT03276728 Terminated - Heart Failure Clinical Trials

Study to Evaluate the Safety and Tolerability of AMG 986 in Healthy Volunteers and Heart Failure Patients

Start date: August 12, 2016
Phase: Phase 1
Study type: Interventional

To evaluate the safety and tolerability of ascending single (Part A) and ascending multiple (Part B) doses of AMG 986 in healthy adults and of ascending multiple oral doses of AMG 986 in heart failure patients (Part C).

NCT ID: NCT03275246 Terminated - Knee Osteoarthritis Clinical Trials

Establish Implant Accuracy With X-PSI Knee System

X-PSI
Start date: October 5, 2018
Phase: N/A
Study type: Interventional

The goal of this study is to establish the accuracy of the new X-PSI Knee System guides by analyzing early postoperative (4-6 weeks) imaging data with regards to the mechanical alignment and compare them with preoperative planning imaging data. Mechanical alignment in the hip-knee-ankle (HKA) frontal plane with X-PSI Knee System will be measured and compared with results reported in the literature using a conventional (non-guided) approach. Hypothesis: The use of the new X-PSI Knee System achieves the same accuracy with respect to mechanical alignment as with conventional instrumentation.