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NCT ID: NCT05805124 Completed - Surgery Clinical Trials

Do Anesthesiologists Follow Belgian KCE Guidelines for Preoperative Evaluation?

Start date: August 1, 2023
Phase:
Study type: Observational

For more than 50 years it has been shown that preoperative evaluations by anesthesiologists include too many unnecessary tests. Many of the tests ordered do not change the management of the patients. One example are preoperative coagulation tests which rarely give relevant information and can be omitted if the patients have a negative structured bleeding questionnaire. This situation has lead to the publication of many guidelines on preoperative evaluation, one of the most comprehensive being the 2022 guidelines by the European Society of Cardiology for the preoperative evaluation of cardiac patients undergoing non-cardiac surgery. In Belgium, an independent center of experts, the Kenniscentrum - Centre d'Expertise (KCE) was created to give expert and independent opinions on healthcare related subjects. These recommendations are often used by Belgian authorities to guide public health law and determine which medical procedures or tests are covered by the social security. The KCE has published an extensive guide on preoperative evaluation of patients undergoing non-cardiac surgery (KCE Reports 280Bs. D/2016/10.273/102.) These guidelines are freely available, either in print version, on the dedicated Website or as an App, and have been extensively spread in the anesthesiology community. Laboratory tests not recommended in these guidelines are not covered by the social security if no solid reason is given in the medical chart. In this retrospective study, adherence to the KCE guidelines on preoperative evaluations will be evaluated in a tertiary University hospital. All patients, scheduled for elective surgery, will be included for a period of 3 month. For every patient the recommended tests will be determined and compared to the actual tests prescribed by the anesthesiologist during the preadmission visit.

NCT ID: NCT05805033 Recruiting - Healthy Subjects Clinical Trials

Peri-Implant Soft Tissue Integration in Humans: Influence of Material

Start date: September 22, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the mucointegration of 2 types of surface roughness of zirconia abutments with titanium. The surface roughness will be machined and ultra-polished.

NCT ID: NCT05804136 Recruiting - Clinical trials for Laparotomy Closure After Abdominal Surgery

Durameshâ„¢ vs Polydioxanone Suture for Laparotomy Closure

MOMENTUM RCT
Start date: March 31, 2023
Phase: N/A
Study type: Interventional

This study is intended to demonstrate the non-inferiority of a Duramesh closure as compared to a polydioxanone closure for early surgical site events (SSE) (< 1 month), and Duramesh superiority to polydioxanone for the development of incisional hernia by 1 year for a laparotomy closure.

NCT ID: NCT05804006 Recruiting - Stroke, Acute Clinical Trials

High-Intensity Interval Training in the Early Subacute Stroke With a Semi-recumbent Bike

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

Although High-intensity interval training (HIIT) exercise has emerged in recent years as a powerful time-efficient alternative to moderate-intensity continuous cardiovascular exercise training (MICT) to enhance neuroplasticity, motor, and cognitive functions, its feasibility remains to be determined early after stroke. Our study aims to investigate the feasibility of the HIIT program and its effects on functional abilities, cognitive function, and quality of life in early post-stroke.

NCT ID: NCT05799352 Recruiting - COPD Clinical Trials

Effects of Endoscopic Lung Volume Reduction on Diaphragm Function and Conformation

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Chronic obstructive lung disease (COPD) is a common disease that is frequently complicated by hyperinflation. The resulting increase in lung volume impairs the diaphragmatic function because of a shortening of the diaphragmatic fibers and an increase in the radius of curvature of the diaphragmatic domes. Lung volume reduction surgery (LVRS) has already shown an improvement in diaphragmatic function that could be explained by a change of the diaphragm conformation. More recently, endoscopic lung volume reduction (ELVR) has shown benefits in terms of respiratory function, exercise capacity and quality of life, but the mechanisms of these improvements are poorly understood. Therefore, we aim to evaluate the evolution of the diaphragmatic function and the changes in diaphragmatic conformation after unilateral ELVR.

NCT ID: NCT05799131 Not yet recruiting - Clinical trials for Peripheral Arterial Disease

Safety and Efficacy of the QBX Peripheral Balloon Expandable Stent System in Peripheral Artery Disease (PAD)

QBX-RADAR
Start date: May 1, 2023
Phase:
Study type: Observational

This study aims to evaluate the safety and performance of the QBX stent system in the treatment of PAD by reporting of peri- and postoperative complications, including major adverse vascular events (MAVE), Vascular Access Site Complications (VASCs) and bleeding at puncture site, and by evaluating the prevalence of Target Vessel Revascularization (TVR), amputations, procedural success, device performance, reduction in percentage diameter stenosis post-procedure compared to pre-procedure, artery patency, return to normal activity, Rutherford and Fontaine classification, quality of life (QoL), Ankle Brachial Index (ABI), and hospital- and patient-related costs in a prospectively maintained database.

NCT ID: NCT05799118 Recruiting - Sickle Cell Disease Clinical Trials

Study of the Role of Genetic Modifiers in Hemoglobinopathies

INHERENT
Start date: October 1, 2022
Phase:
Study type: Observational

This study will investigate the role of genetic modifiers in hemoglobinopathies through a large-scale, multi-ethnic genome-wide association study (GWAS).

NCT ID: NCT05797740 Recruiting - Multiple Sclerosis Clinical Trials

Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)

Start date: August 3, 2023
Phase:
Study type: Observational

This study aims to describe participants characteristics that can predict the safety and effectiveness of cladribine tablets, as assessed by time-to-discontinuation of treatment with cladribine tablets, and to assess other patient-reported, clinical, and imaging outcomes in participants with relapsing multiple sclerosis (RMS) in the long term, in a real-world setting.

NCT ID: NCT05796596 Recruiting - Acute Pain Clinical Trials

Effectiveness of a Virtual Reality Game for Pediatric Pain and Anxiety Management During Skin Prick Testing

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

This study investigated the effectiveness of virtual reality (VR) distraction, compared to book distraction and no distraction, in reducing pain and anxiety during a medical procedure in a pediatric population: the skin prick test. Although this test has many advantages and is considered to be minimally invasive, it causes anxiety and painful discomfort in children. This study concerns children aged 4 to 7 years consulting for an allergic test. Outcome measures include pain score, level of anxiety, VR measures, and satisfaction questionnaires.

NCT ID: NCT05794906 Recruiting - Clinical trials for Biochemically Recurrent Prostate Cancer

A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

ARASTEP
Start date: April 3, 2023
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen [PSMA] positron emission tomography [PET]) /computed tomography [CT]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a "tracer" that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: - take blood and urine samples. - measure PSA and testosterone levels in the blood samples - do physical examinations - check the participants' overall health - examine heart health using electrocardiogram (ECG) - check vital signs - check cancer status using PSMA PET/CT scans, CT, MRI and bone scans - take tumor samples (if required) - ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants' health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first.