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NCT ID: NCT04755101 Recruiting - Syncope Clinical Trials

Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope

CardNMH3
Start date: March 24, 2021
Phase: N/A
Study type: Interventional

The third study on CardNM (CardNMH3 study) is a multicenter, double-blind, randomized trial with a sham control group investigating the efficacy and safety of a computed tomography (CT)-guided, right-sided ablation of the anterior ganglionated plexus to prevent recurrence of syncope in patients with neurally mediated syncope (NMS). The primary goal of the study is to determine whether a CT-guided, right-sided ablation of the anterior ganglionated plexus safely reduces the risk of recurrent episodes of syncope in patients with a history of recurrent NMS. Two-third of the patients will be randomized to the active arm and one-third to the control arm (sham). The study procedure is described in the 'detailed description' and 'intervention description'. Syncope burden, syncope occurrence and quality of life will be assessed by questionnaires at baseline and at 1, 3, 6 and 12 months. A 24-h rhythm registration will be performed at baseline and at 1-, 3- and 6-month follow-up to investigate the influence of the intervention on heart rate. The effect of CardNM on blood pressure and on chronotropic sinus node function will be evaluated in 2 additional substudies. Patients enrolled in the blood-pressure substudy will undergo a 24-h blood pressure monitoring at baseline and at 1, 3 and 6 months. Participants in the sinus node competence substudy will undergo a bicycle exercise test at baseline and at 1, 3 and 6 months. Investigators aim to achieve complete follow-up for 110 patients who meet the study enrollment criteria. If syncope-free survival (primary endpoint) is significantly different between the 2 arms after the enrollment of fewer than 110 patients (minimum 55 patients), enrollment into the trial will be prematurely stopped. The study may also be terminated prematurely if safety concerns occur.

NCT ID: NCT04750798 Recruiting - Cardiac Arrhythmias Clinical Trials

An Observational Post-marketing Study Using Commercially Approved Biosense Webster (BWI) Medical Devices for the Treatment of Participants With Cardiac Arrhythmias

Start date: February 22, 2021
Phase:
Study type: Observational

The purpose of this study is to prospectively collect clinical data evaluating the ongoing safety and performance during routine-use standard cardiac arrhythmia mapping and/or ablation procedures while using commercial Biosense Webster Inc. (BWI) medical devices. Data generated from the study will be used to confirm safety and performance of BWI medical devices in the marketed phase and to expand the body of evidence on the use of these devices and techniques in treatment of cardiac arrhythmias.

NCT ID: NCT04750291 Recruiting - Popeye Syndrome Clinical Trials

Management of Popeye Sign With Botulinum Toxin After Bicepstenotomy

Start date: August 9, 2021
Phase: Phase 4
Study type: Interventional

Double-blinded randomized controlled trial with 20 people of whom 10 will receive a placebo infiltration and 10 an infiltration with botulinum toxin type A for cramping pain after arthroscopic tenotomy of the long head of the biceps tendon.

NCT ID: NCT04747860 Recruiting - Low Back Pain Clinical Trials

Predictors of Work Resumption After Back Surgery

WABS
Start date: February 23, 2021
Phase:
Study type: Observational [Patient Registry]

This prospective, longitudinal study aims to identify modifiable predictors of return to work after back surgery.

NCT ID: NCT04746729 Recruiting - Neoplasms Clinical Trials

Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy

HARMONIC-RT
Start date: January 11, 2021
Phase:
Study type: Observational [Patient Registry]

The goal of the HARMONIC-RT study is to evaluate late health and social outcomes of contemporary techniques of external beam radiotherapy in paediatric patients, based on the setting-up of a European, long-term registry complemented by a biobank.

NCT ID: NCT04745013 Recruiting - Clinical trials for Heart Failure With Preserved Ejection Fraction

PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart

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

In the PRIORITY study, we aim to provide the clinical evidence base for the use of a new hybrid exercise intervention, which includes remotely guided home-based exercise, as an accessible, clinical and cost-effective treatment to prevent the deleterious effects of sedentary aging on the heart and forestall the development and progression towards overt HFpEF.

NCT ID: NCT04743765 Recruiting - Hip Fractures Clinical Trials

HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial

HIP ATTACK-2
Start date: November 22, 2021
Phase: N/A
Study type: Interventional

The HIP ATTACK-2 trial is a multicentre, international, parallel group randomized controlled trial to determine whether accelerated surgery for hip fracture in patients with acute myocardial injury is superior to standard care in reducing death at 90 days after randomization. The trial will also assess secondary outcomes at 90 days after randomization: inability to independently walk 3 metres, time to first mobilization (first standing and first full weight bear), composite and individual assessment of major complications (e.g., mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke), delirium, length of stay, pain, and quality of life.

NCT ID: NCT04741607 Recruiting - Esthetics Clinical Trials

Immediate Versus Late Placement

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

Patients in need of a single implant in the premaxilla will be invited to participate in this multicenter randomized controlled trial (RCT). Prior to surgery, a small-field low-dose cone beam computed tomography (CBCT) is taken to verify the integrity of the facial bone wall and an adequate amount of apical and palatal bone dimensions. Sixty patients will be randomly allocated to the test group or control group in 6 centers. Each center receives 10 sealed envelopes (5 are internally labelled with 'delayed implant placement' and 5 with 'immediate implant placement'). For each patient a digital planning is performed in implant planning software and a tooth-supported surgical guide is fabricated prior to tooth extraction. In the control group, alveolar ridge preservation is performed following tooth extraction. After a healing period of 4 months, a single implant is installed. In the test group, a single implant is installed immediately after tooth extraction and ridge preservation is performed by filling the gap between the facial bone wall and the implant surface. A provisional crown is placed at the day of implant surgery, which is replaced by a permanent one 3m later. Six months after tooth extraction and subsequent ridge preservation, the need for soft tissue grafting is assessed on the base of predetermined criteria (primary outcome measure). Soft tissue augmentation is performed by inserting a palatal connective tissue graft (CTG) into the buccal mucosa at the implant site. Secondary outcome measures include 3D hard and soft tissue changes as well as clinical, aesthetic, patient-reported and clinician-reported outcomes.

NCT ID: NCT04739605 Recruiting - Colorectal Surgery Clinical Trials

Quality of Recovery Using QoR-15 in Enhanced Recovery After Colorectal Surgery.

Start date: April 1, 2021
Phase:
Study type: Observational [Patient Registry]

This observational study will evaluate the patient reported outcomes and postoperative patient-related quality of recovery in 150 patients undergoing colorectal surgery within an enhanced recovery program at CHU Liège. The QoR15 survey will be performed preoperatively and repeated postoperatively at hospital or via telephone calls on Day + 1, Day +2; Day + 3, Day 7 and Day + 14. The total score and the score at the subsections will be correlated with the medical and surgical characteristics of the patients.

NCT ID: NCT04735900 Recruiting - Clinical trials for Metastatic Colorectal Cancer

lead-in FOLICOLOR Trial: Following Therapy Response Through Liquid Biopsy in Metastatic Colorectal Cancer Patients

Start date: September 14, 2020
Phase: N/A
Study type: Interventional

Detection of progressive disease by neuropeptide Y (NPY) methylation in liquid biopsies in patients with RAS and BRAF wild-type, unresectable, metastatic colorectal cancer receiving first-line treatment FOLFOX/FOLFIRI and panitumumab.