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NCT ID: NCT05349838 Completed - HIV-1-infection Clinical Trials

An Open-Label, Multi-Centre, Randomised, Switch Study to Evaluate the Virological Efficacy Over 96 Weeks Of 2-Drug Therapy With DTG/RPV FDC in Antiretroviral Treatment-Experienced HIV-1 Infected Subjects Virologically Suppressed With NNRTIs Resistance Mutation K103N

WISARD
Start date: November 5, 2018
Phase: Phase 3
Study type: Interventional

HIV-1 infected subjects that experience virological failure while on non nucleoside reverse-transcriptase inhibitors (NNRTIs), including those with the K103N mutation, are usually switched to a boosted PI-based regimen or other antiretroviral (ARV) combinations. The same is true for subjects who need to start antiretroviral therapy and have acquired virus that is already resistant to antiretrovirals. These "second line" combinations are often associated with numerous issues that can have a potential impact on the quality of life (QoL) of these patients. Therefore a simpler and better tolerated alternative second line treatment option would be a useful tool for the clinical management of these patients. The aim of this study is to assess the efficacy and tolerability of a dual combined therapy of Dolutegravir (DTG) 50 mg OD + Rilpivirine (RPV) 25 mg OD in virologically suppressed participants with previous virological failure with NNRTIs and having the clinically significant mutation K103N. The secondary objective of the study is to assess whether a simplification of the treatment in terms of pill burden, long term metabolic toxicity and potential for drug interactions improves the QOL of the participants. The study will also evaluate DTG & RPV concentrations in the blood plus changes in cell associated virus. In order to compare the first line treatment (boosted PI and/or other antiretroviral combinations) and the DTG+RPV combination, two thirds of study participants will be switched to DTG+RPV immediately and receive DTG+RPV for 96 weeks. The other third will be switched after 48 weeks of continuing on their first line treatment and receive DTG+RPV for 48 weeks. All participants will then be followed up for a further 30 days. Participants will be recruited from sites across Europe, and randomised onto either arm of the study. After randomisation, participants will attend approximately 10 visits over the course of two years.

NCT ID: NCT05345665 Completed - Anesthesia Clinical Trials

Comparison of Three Methods of Anesthesia to Achieve a Nerve Block Anesthesia.

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Evaluation of three methods for the realization of a neuronal blockade.

NCT ID: NCT05337020 Completed - Clinical trials for Cardiovascular Diseases

Survey on the Future of Telemedicine in the Daily Care of Cardiology Patients.

MEDICAR
Start date: March 16, 2022
Phase: N/A
Study type: Interventional

The Cardiology research group at the Jessa Hospital Hasselt and the University Hospital Antwerp (in collaboration with the University of Hasselt and the University of Antwerp) is conducting research into remote patient monitoring (telemedicine). Digital technologies such as smartphones, tablets, fitness trackers, smartwatches,… make it easier to monitor the health of cardio patients between consultations. This would allow for faster intervention when necessary, but consultations can also (partially) take place remotely. For this study, we are looking for patients who have already used such technologies to remotely monitor their health and patients who have never used it before. We would like to find out how these patients feel about telemedicine by means of a questionnaire. This will take approximately 5 to 10 minutes. In this way, we can gain a better understanding of these patients' views and expectations regarding telemedicine. In this way we can further improve healthcare and develop more options to follow up patients even better from your home environment.

NCT ID: NCT05333042 Completed - Pulmonary Embolism Clinical Trials

External Validation of a Deep Learning Based Model for Pulmonary Embolism Detection on Chest CT Scans

Start date: April 1, 2022
Phase:
Study type: Observational

The scope of this study is the external validation of an explainable deep learning-based classifier for the diagnosis and detection of pulmonary embolism in computed tomography pulmonary angiography (CTPA) and contrast enhanced CT scans.

NCT ID: NCT05330260 Completed - Surgery Clinical Trials

Five Years Follow-up of Neurological Outcome After Minimally Invasive Cardiac Surgery

FUNOMICS
Start date: March 25, 2022
Phase:
Study type: Observational [Patient Registry]

A monocenter observational study will be started to investigate postoperative cognitive dysfunction 5 years after minimally invasive cardiac surgery. Postoperative cognitive dysfunction will be evaluated in three groups: an endoscopic-CABG group (endo-CABG), a PCI (Percutaneous Coronary Intervention) group and a healthy control group. It is hypothesized that the endo-CABG group will show a stronger postoperative cognitive dysfunction compared to the PCI group and the healthy control group.

NCT ID: NCT05329220 Completed - COVID-19 Disease Clinical Trials

ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2

Start date: August 31, 2022
Phase: Phase 3
Study type: Interventional

This trial is composed of a randomized, double-blind, active controlled component (Part A) and an open-label, single-arm component (Part B) conducted in parallel. Part A is designed to compare vaccination with a single 100 µg dose of ABNCoV2 to a single 30 µg adult booster dose of Comirnaty (active control) in adult subjects who either previously completed primary vaccination (Cohort 1) or have already received 1 booster dose (Cohort 2) of SARS-CoV-2 locally authorized vaccine(s), and whose last locally authorized SARS-CoV-2 vaccination was at least 3 months prior to the screening visit. Subjects will be randomized in a 1:1 ratio to receive either ABNCoV2 or Comirnaty. Part B is designed to collect ABNCoV2 safety and tolerability data from a larger population of adult subjects, as well as additional immunogenicity data from a subset. Part B involves vaccination with the same single 100 µg dose of ABNCoV2 in the same population of adult subjects as the randomized component, and subjects will similarly be enrolled into 2 cohorts according to whether they have completed primary vaccination only or primary plus booster vaccination.

NCT ID: NCT05326698 Completed - Clinical trials for Cervical Foraminal Stenosis

Evoked Potential Response to Full-endoscopic Cervical Foraminotomy

Start date: February 22, 2022
Phase:
Study type: Observational

Cervical foraminotomy is used to treat recalcitrant foraminal stenosis in the cervical region. This foraminotomy can be performed under endoscopy. The irrigation pressure used to allow adequate visualization of the anatomical structures is usually between 40 and 50 mmHg. This pressure has no adverse effect intraoperatively on motor evoked potentials but its effect on somesthetic evoked potentials has not yet been studied. The purpose of this study is to validate the absence of disruption of somatosensory evoked potentials by endoscopic cervical foraminotomy

NCT ID: NCT05322122 Completed - Obesity Clinical Trials

Creation of Side-to-Side Compression Anastomosis Using the Magnetic Anastomosis System

Start date: November 18, 2021
Phase: N/A
Study type: Interventional

This is an operationally seamless, open-label, multicenter study enrolling up to 50 subjects with obesity and with or without type 2 diabetes at up to 5 study centers across Canada and Europe who will undergo sleeve gastrectomy (revision or de novo) with side-to-side anastomosis duodeno-ileostomy using the MAGNET System and will be followed for 12 months.

NCT ID: NCT05319236 Completed - Clinical trials for Cardiovascular Diseases

Clinical Use Cases Assessment of the Gabi System in Young Children With Underlying Medical Conditions (BRIDGE Study)

BRIDGE
Start date: February 16, 2022
Phase: N/A
Study type: Interventional

Subjects will use the Gabi system on a daily basis for 3 months, each time the subject is resting or asleep. The Gabi system will recording the SpO2, pulse rate, respiratory rate and movements of the subject. The objective of this study is to perform a first assessment of the range of most potentially clinically relevant indications for use of the Gabi system for children < 6 years old with underlying medical conditions. This is performed by asking HCPs to review the data measured by the Gabi system after taking a medical decision independently from the Gabi data and to assess the potential clinical utility of the Gabi system. The usability of the system will also be assessed throughout questionnaires filled out by the HCPs and by the caregivers. *During this study, the data collected by the Gabi system are not intended to be used by caregivers or HCPs to take any (medical) decisions.

NCT ID: NCT05316012 Completed - Incontinence Clinical Trials

The Integration of Sensor Technology Into Incontinence Materials: a Single-group Pretest-posttest Study in a Nursing Home Environment

Smart Diapers
Start date: June 20, 2022
Phase: N/A
Study type: Interventional

The smart diaper aims to (1) detect humidity, (2) be capable of sending real-time indication of the saturation to the healthcare workers when urine loss occurs and (3) generate alerts when the diaper requires changing. Potential benefits of the smart diaper compared to incontinence management products without sensor technology include: workload reduction, increased comfort for residents and staff, more person-centred care, increased quality of care, less skin damage and economic (e.g. less costs due to less excessive diaper changes), and/or environmental (e.g. less waste) gains.