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NCT ID: NCT04464603 Not yet recruiting - Pediatric ALL Clinical Trials

Impact of a mHealth Supportive Tool on Cardiopulmonary Resuscitation' Situational Awareness

InterFACE
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

This study will be a prospective, single-center, randomized controlled trial in a tertiary pediatric emergency department with two parallel groups of voluntary pediatric physicians and nurses. The impact of a mHealth supportive tool will be compared with conventional communication methods on situational awareness, leadership, team communication effectiveness and performance during standardized, simulation-based, pediatric in-hospital cardiac arrest scenario using a high-fidelity manikin. Thirty-six participants will be randomized (1:1). The primary endpoint is the situational awareness score measured with the situation awareness global assessment technique (SAGAT) instrument.

NCT ID: NCT04464434 Recruiting - Systemic Sclerosis Clinical Trials

Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis

UPSIDE
Start date: September 17, 2020
Phase: Phase 4
Study type: Interventional

HSCT has been implemented in (inter)national treatment guidelines for diffuse cutaneous systemic sclerosis (dcSSc) and is offered in clinical care and reimbursed by national health insurance in several European countries. However, data and specific guidelines on the best timing of HSCT in the course of dcSSc are lacking. In particular, it is unclear whether HSCT should be positioned as upfront therapy or as rescue treatment for patients not responding to conventional immunosuppressive therapy. This multicentre, randomized, open label trial aims to compare two treatment strategies used in usual care: upfront autologous HSCT versus usual care with (intravenous (i.v.) cyclophosphamide (CYC) pulse therapy followed by mycophenolate mofetil (MMF) and HSCT as rescue option).

NCT ID: NCT04462536 Completed - Stroke, Acute Clinical Trials

Efficacy and Safety of Nerinetide in Participants With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis

ESCAPE-NEXT
Start date: December 6, 2020
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to determine if a single dose of nerinetide can reduce global disability in people who have had a stroke and are selected for endovascular therapy without the use of a tissue plasminogen activator (alteplase, tenecteplase, or equivalent).

NCT ID: NCT04461834 Completed - Blood Pressure Clinical Trials

Accuracy of the RIVA Digital Blood Pressure Measurement App - a Pilot Study

Start date: June 25, 2020
Phase:
Study type: Observational

The aim of this pilot study is to test the accuracy of the RIVA Digital Blood Pressure Measurement App with and without initial calibration. Additionally, accuracy of the Blood Pressure Measurement 24 hours after calibration will also be tested.

NCT ID: NCT04461821 Recruiting - Type 1 Diabetes Clinical Trials

Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry in Children and Adolescents

EBECA
Start date: September 11, 2020
Phase:
Study type: Observational

This study is to investigate breath analysis (breath metabolomics) combined with established bioinformatic tools as a platform for companion diagnostics.

NCT ID: NCT04461301 Recruiting - Clinical trials for Frail Elderly Syndrome

Multimodal Prehabilitation for Surgery in the Elderly: A Randomised, Prospective, Multicenter, Multidisciplinary Trial

PREHABIL
Start date: February 1, 2022
Phase: N/A
Study type: Interventional

This multicentric, randomised controlled trial is to the investigators knowledge the first implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge from different specialties to lower complications and to increase cost effectiveness after major surgery in elderly, frail patients.

NCT ID: NCT04459858 Completed - Rotator Cuff Tear Clinical Trials

The Influence of the Greater Tuberosity Angle on the Clinical Outcome One Year Postoperative in Patients With a Rotator Cuff Tear

GTA
Start date: June 3, 2020
Phase:
Study type: Observational

This retrospective study is to investigate the influence of the Greater Tuberosity Angle (GTA) in addition to CSA on patient outcome in patients with rotator cuff tear.

NCT ID: NCT04459715 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)

Start date: August 7, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).

NCT ID: NCT04459559 Recruiting - Parkinson Disease Clinical Trials

Usability of a Novel Cueing Device for Patients With Parkinson's Disease

TCP
Start date: November 16, 2020
Phase: N/A
Study type: Interventional

Hypokinetic gait disorder and Freezing of Gait (FOG) are frequent symptoms in the advanced stage of Parkinson's disease (PD). These impair quality of life and significantly increase the risk of falls. External movement pacemakers have been developed to improve gait and avert FOG by cueing strategies. The investigators developed a smart, small and lightweight, easy-to-handle wearable tactile cueing device (TCD), consisting of a control unit, two pulse generators and a battery-driven power supply. The device is programmed via a Graphical User Interface (GUI).

NCT ID: NCT04459117 Active, not recruiting - Extreme Prematurity Clinical Trials

Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen

TREOCAPA
Start date: October 29, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

TREOCAPA is a Phase II/III European Multicentre study concerning the prophylactic treatment by Acetaminophen of extremely preterm infant during the first five days after birth. The Phase II is a dose finding phase in order to assess the minimum effective dose regimen of acetaminophen for the closure of PDA for neonates with a gestational age less than 27 weeks This part of the study will be conducted in 11 NICUs, in 4 countries (France, UK, Finland and Denmark). The Phase III is The phase III is a randomized, multicenter, double-blind, placebo-controlled superiority trial, two arms in a 1:1 ratio, evaluating an increasing of 10% of the percentage of survival without severe morbidity at 36 weeks of post menstrual age. In the intervention arm, 20 mg/kg followed by 7.5 mg/kg quarter in die (QID) will be administered to the 27-28 weeks gestational age group (dosage confirmed through PK/PD data analysis from the previous Finnian study) and the dosage selected after the conclusion of the Phase II will be administered to the 23-26 weeks gestational age group. A group sequential design, with a total of 3 analyses (2 interim analyses and a final) and the O'Brien-Fleming alpha spending function is chosen for the trial. At the same time, a Bayesian sequential analysis is planned for safety endpoints