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NCT ID: NCT03157115 Completed - Clinical trials for Impaired Left Ventricular Ejection Fraction

Validation of Kinocardiography, New Technology for Cardiac Linear and Torsional Contractility Measurement, to Assess Heart Failure Patient With Low Ejection Fraction

Start date: July 1, 2017
Phase: N/A
Study type: Interventional

Measuring cardiac contractility is commonly realized with gold standard echocardiography or MRI. Portable devices to measure this contractility are not available as for rhythm and electric function assessment. The new Kinocardiography technology could provide a non invasive and portable tool to measure contractility. This device records the electric and mechanic function of the heart simultaneously. With electrodes and adequate electronics, ECG is recorded. 6 degrees of freedom accelerometers are also included in the device to measure the micro accelerations of the body at the body surface when the device is placed on the skin. Using physics principles and adequate calibration, those accelerations allow the investigators to calculate parameters such as kinetics energies related to cardiac contractility. Kinocardiography is a non invasive and portable technology.

NCT ID: NCT03156946 Completed - Infant Premature Clinical Trials

Evaluation of a Peer Counseling Breastfeeding Support Program for Mother-preterm Infant Dyads

ALAIS
Start date: November 5, 2018
Phase: N/A
Study type: Interventional

Breastfeeding has a fundamental impact on the short-, medium- and long-term health of children and has an important impact on women's health. Breastfeeding protects against gastrointestinal and respiratory illnesses and is associated with better cognitive development in childhood, particularly in preterm infants. Despite these potential benefits, preterm infants experience lower rates of breastfeeding initiation and continuation compared to term infants. The use of breastfeeding peer support initiatives, in which advice is given by experienced and trained peer counselors, is an effective way to promote and support breastfeeding, regardless of a woman's socioeconomic status. Several small studies have shown that breastfeeding peer support initiatives were effective for preterm infants and that this efficacy was increased by the co-intervention of lactation consultants. The purpose of this study is to develop and to evaluate the effectiveness of a breastfeeding support program among mother-preterm infant dyads in Europe, by evaluating the impact of the intervention on 1) breastfeeding rates, 2) morbidity and mortality during the hospitalization, 3) children's cognitive development and behavior 4) mothers' mental health, 4) costs benefits. The breastfeeding support program will include peer counselors under the supervision of lactation consultants. Breastfeeding counselors will be voluntary mothers who have had a positive breastfeeding experience with at least one preterm infant. After a training course, they will meet the future or new mothers by face-to-face and share their experiences at least once a week during hospitalization and provide phone support up to 1 month after discharge from hospital. The study design will be a stepped wedge cluster trial conducted in 8 NICU in Europe (France, Switzerland and Belgium). Infants and mothers will be followed up from the time of hospitalization in the maternity and NICU up to 6 months after the discharge. The cost analysis will be performed in a subgroup of mother-preterm infant dyads that will be followed up at 24-months after their discharge

NCT ID: NCT03154060 Completed - Clinical trials for Diabetes Mellitus, Type 1

Evaluation of the Accuracy and Precision of Flash Glucose Monitoring Sensors in Different Sites

OUT OF SIGHT
Start date: May 19, 2017
Phase: N/A
Study type: Interventional

On the first of July 2016, reimbursement for the Freestyle Libre Flash Glucose Monitoring (FGM) was introduced by the Belgian healthcare authority by means of a new diabetes convention. Making this the only way to receive the device in Belgium. Since then, many type 1 diabetes (T1D) patients switched to FGM. But some patients found the sensor on the upper arm too visible. Abbott does not recommend to place the sensor on a different place of the body than the back of the upper arm, because no tests were done yet (besides on the upper arm) to make an accuracy claim. With this study, we want to evaluate the accuracy and the precision of the Freestyle Libre FGM by using three FGM sensors simultaneously on different places of the body and perform regular self-monitoring of blood glucose (SMBG) tests.

NCT ID: NCT03152734 Completed - Mortality Clinical Trials

Periinterventional Outcome Study in the Elderly

POSE
Start date: October 1, 2017
Phase:
Study type: Observational

The POSE study will predict critical stages and outcome in a large sample of all surgical and non-surgical interventional patients ≥80 years of age in Europe.

NCT ID: NCT03151551 Completed - Psoriatic Arthritis Clinical Trials

A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis

SPIRIT-H2H
Start date: August 24, 2017
Phase: Phase 4
Study type: Interventional

The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.

NCT ID: NCT03151486 Completed - Healthy Clinical Trials

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55308942 in Healthy Male and Female Participants

Start date: May 3, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of JNJ-55308942 in healthy participants after administration of single and multiple oral doses.

NCT ID: NCT03148925 Completed - Smoking Cessation Clinical Trials

Safety and Pharmacodynamcis of SELA-070 Nicotine Vaccine in Smokers

Start date: May 11, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and pharmacodynamics of SELA-070. Increasing subcutaneous doses of SELA-070 will be administered to healthy smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be evaluated.

NCT ID: NCT03148795 Completed - Prostate Cancer Clinical Trials

A Study of Talazoparib in Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer

Start date: July 4, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this international, phase 2, open-label, response rate study of talazoparib is to assess the efficacy and safety of talazoparib in men with DNA repair defects metastatic castration-resistant prostate cancer (CRPC) who previously received taxane-based chemotherapy and progressed on at least 1 novel hormonal agent (enzalutamide and/or abiraterone acetate/prednisone).

NCT ID: NCT03148730 Completed - Clinical trials for Postoperative Delirium

Manual vs Automated Anesthesia : Impact On The Incidence Of POCD

Start date: May 10, 2017
Phase: N/A
Study type: Interventional

This study will be the first study to report the combined use of three independent closed-loop systems together to assist clinicians in titrating anesthesia, analgesia, fluid and optimize ventilation in frailty old patients undergoing moderate to high risk surgery. The potential benefits of optimizing the control of these variables by advanced closed loop systems are two-fold. Firstly, this will likely decrease the variance of delivered care and reduce deviation from the established standards, resulting in improved post operative cognitive outcomes in elderly patients. Secondly, this would establish a precedent that automated intraoperative systems have strong clinical significance and are more than "complicated toys", which is unfortunately how they are perceived now. Hypothesis: Automated control of anesthetic depth (minimal episodes of overly deep or light anesthesia) and hemodynamics (via improved volume administration) can decrease the occurrence of postoperative cognitive dysfunction in elderly patients undergoing moderate to high risk surgery (Better MOCA test in the postoperative period compared to the manual group [+ two points in average])

NCT ID: NCT03148457 Completed - Ischaemic Stroke Clinical Trials

Early Versus Late Initiation of Direct Oral Anticoagulants in Post-ischaemic Stroke Patients With Atrial fibrillatioN (ELAN): an International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial

ELAN
Start date: November 6, 2017
Phase: N/A
Study type: Interventional

When to start anticoagulation in patients with an acute ischaemic stroke and atrial fibrillation (AF) is a relevant unanswered question in clinical practice. Direct oral anticoagulants (DOACs) are highly effective for secondary stroke prevention in these patients, but DOACs were never initiated <7 days after stroke onset in recent trials. The ELAN trial will determine the net benefit of early versus late initiation of DOACs in patients with acute ischaemic stroke related to AF. The main objective is to estimate the net benefit of early versus late initiation of DOACs in patients with acute ischaemic stroke related to AF. The secondary objectives are to assess all vascular events and all-cause mortality after early initiation of DOACs in patients with acute ischaemic stroke related to AF compared to late initiation.