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NCT ID: NCT04119193 Completed - Technology Clinical Trials

Agreement and Precision of a Smartphone Application For Continuous Blood Pressure Monitoring

Start date: November 12, 2019
Phase:
Study type: Observational

Evaluation of an novel smartphone algorithm designed to estimate blood pressure based on collected optical signals on patients against the reference method, (radial arterial catheter) in patients admitted in the post anesthesia care unit after major surgeries.

NCT ID: NCT04117152 Completed - Clinical trials for Heart Transplantation

Trajectories of Cardiac Allograft Vasculopathy After Heart Transplantation

TRAJ-CAV
Start date: January 1, 2004
Phase:
Study type: Observational [Patient Registry]

This project aims: i) to identify Cardiac Allograft Vasculopathy (CAV) trajectories after heat transplantation using latent class mixed modeling, ii) to characterize the global and specific determinants of different trajectories and iii) to provide an easily accessible tool to project individual probability of CAV trajectory belonging.

NCT ID: NCT04116034 Completed - Heart Failure Clinical Trials

Alfapump Direct Sodium Removal (DSR) Feasibility Study

RED DESERT
Start date: December 26, 2019
Phase: N/A
Study type: Interventional

First in Human feasibility and sfafety study of the alfapump DSR system in the treatment of Heart failure subects resistant to diuretic therapy. Up to 10 subjects will be enrolled in up to 3 centres in Belgium and Georgia and will be iplanted with the alfapump DSR system. Subjects will undergo DSR titration during a 2 week hospitalisation period, and will continue titrated DSR therapy as outpatients for 4 more weeks.

NCT ID: NCT04111055 Completed - Clinical trials for Hemodynamic (MAP) Stability

Closed-loop Vasopressor Infusion Using Continuous Noninvasive Blood Pressure Monitoring

Start date: June 15, 2018
Phase: N/A
Study type: Interventional

Intraoperative hypotension and blood pressure variability are associated with postoperative complications in surgical patients. The investigators have developed a closed-loop vasopressor (CLV) controller that titrates norepinephrine to correct hypotension. After having tested the system in a small cohort series of patients undergoing major surgeries, the investigators aimed to test the feasibility of the CLV controller guided noninvasively and continuously with the ClearSight system (Edwards Lifesciences, USA) in three high risk patients undergoing renal transplant surgery

NCT ID: NCT04109313 Completed - Clinical trials for Chronic Spontaneous Urticaria

An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU

Start date: October 24, 2019
Phase: Phase 2
Study type: Interventional

The main objective to assess the long-term safety and tolerability of LOU064 in patients with chronic spontaneous urticaria (CSU) who have participated in study CLOU064A2201 (NCT03926611)

NCT ID: NCT04109066 Completed - Breast Cancer Clinical Trials

Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

CheckMate 7FL
Start date: November 20, 2019
Phase: Phase 3
Study type: Interventional

A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.

NCT ID: NCT04107558 Completed - Digital Sedation Clinical Trials

Healthy Volunteer Undergoing Painful Stimuli With and Without Hypnosis and Virtual Reality

SMARTHY
Start date: September 2, 2019
Phase: N/A
Study type: Interventional

The main purposes of this study are as follows: Compare the effect of painful stimuli with and without Hypnosis and Virtual Reality (HVR) on healthy volunteers. - Use of sensors and captors to monitor physiological and neurophysiological changes by painful stimulus - Monitor level of pain and anxiety with and without HVR - Monitor level of unpleasantness of the pain with and without HVR - Monitor level of Anxiety, Absorption, Dissociation, Satisfaction and Comfort with and without HVR

NCT ID: NCT04106791 Completed - Clinical trials for Closed-Loop Communication

Computer Assisted Vasopressor Titration in Critically Ill Patients

Start date: April 26, 2018
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to evaluate the performance of a novel closed-loop (automated) vasopressor administration system that delivers norepinephrine using feedback from standard operating room hemodynamic monitor (EV1000 Monitor-Flotrac Edwards Lifesciences, IRVINE, USA) in 10 to 12 critically ill patients in the intensive care unit.

NCT ID: NCT04106544 Completed - Clinical trials for Sphingomyelin Lipidosis

A Prospective and Retrospective Cohort Study in Patients With Chronic Forms of Acid Sphingomyelinase Deficiency (ASMD)

Start date: September 27, 2019
Phase: N/A
Study type: Interventional

Primary Objective: - To describe the clinical features and their severity at the time of diagnosis and their evolution over time in patients with confirmed chronic visceral and chronic neurovisceral forms of ASMD - To describe Clinician-Reported Outcomes (ClinROs) and Patient-Reported Outcomes (PROs) at enrollment and their evolution over time; disease severity at the time of diagnosis and its evolution over time Secondary Objectives: - To describe abnormal values in laboratory parameters and all values of specific clinical and imaging assessments at the time of diagnosis and their evolution over time - To study the use and applicability towards validation of a newly developed ASMD disease severity scoring system - To study the use and applicability towards validation of a newly developed ASMD PRO tool - To describe ASMD-related disease burden among patients with ASMD, caregivers, and healthcare resource utilization - To describe the association between patient demographics (eg, age, gender, race, Ashkenazi ancestry) and genotype with selected clinical features in patients with confirmed chronic visceral and chronic neurovisceral forms of ASMD

NCT ID: NCT04106297 Completed - Healthy Clinical Trials

A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3970

Start date: September 10, 2019
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the safety and tolerability of GLPG3970 in healthy volunteers after single oral administrations of GLPG3970 (SAD), compared to placebo (part 1 and 1bis) and after multiple (for 14 days) oral administrations of GLPG3970 (MAD), compared to placebo (part 2). The effect of food (FE) (high-fat, high calorie) on the pharmacokinetics of GLPG3970 and the relative bioavailability (rBA) of an oral solution versus a solid formulation will be assessed (part 3 and 3bis). Part 4 of the study is to evaluate the safety and tolerability of GLPG3970 in subjects with moderate to severe psoriasis when administered daily for 6 weeks.