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NCT ID: NCT04685369 Completed - Clinical trials for Wet Age-related Macular Degeneration

Effectiveness of Anti-VEGF Treatments in Wet AMD in Active Smokers

Start date: November 10, 2020
Phase:
Study type: Observational

" Wet Age-related Macular Degeneration (wet AMD)" is characterized by the appearance of new choroidal vessels. Several clinical studies have shown the effectiveness of intra-vitreous injections of anti-VEGF (bevacizumab, ranibizumab and aflibercept) against these choroidal neovessels. However, some eyes appear to respond less well or be resistant to anti-VEGF injections, which affects visual acuity. To improve the clinical management of patients with wet AMD, it is important to be able to determine which factors determine the response to anti-VEGF treatment. Non-modifiable factors such as visual acuity or the patient's age at the time of the first injections, the type and size of choroidal neovascularization, as well as certain genetic polymorphisms are known. Two studies, one carried out in Korean patients, the other in different centers in Singapore, New Zealand, Australia and Switzerland showed that active smoking was associated with a poorer response to intra-vitreous injections of ranibizumab, since smoking is also an already well-known modifiable risk factor for the onset of AMD. Another study in the Netherlands shows a poorer visual prognosis after five years of injection treatment in patients who smoke. This study aims to study the effect of active smoking on the visual prognosis of patients with exudative AMD and treated with anti-VEGF injections in a Belgian cohort.

NCT ID: NCT04684771 Completed - Clinical trials for Anterior Cruciate Ligament Rupture

Tolerance, Efficacy, revAlidation, Myostim

Start date: March 23, 2015
Phase: N/A
Study type: Interventional

Evaluation of efficacy and tolerance of a food supplement (MYOSTIM®) versus a placebo in postoperative revalidation of patients after reconstructive surgery of anterior cruciate ligament. The food supplement (MYOSTIM®) has been developped and is supplied as food bars and composed of pomegranate, leucine, creatine, proteins and D vitamin. The aim of this exploratory study is to assess the efficacy and tolerance of MYOSTIM® on muscle performance after ACL reconstructive surgery and in postoperative revalidation phase.

NCT ID: NCT04684433 Completed - Covid19 Clinical Trials

Surgery in the Time of COVID-19 Pandemic

Start date: April 14, 2020
Phase:
Study type: Observational

The ongoing coronavirus disease 2019 (COVID-19) which started in China, was declared on the 11th of March as a global pandemic 2020 by the World Health Organization (WHO). Governments around the world have introduced differing forms of lock downs since the start of the pandemic demanding citizens to confine to their homes and go out only in necessity to minimize exposure to the virus. The response was observed in the emergency departments and the number of patients who presented for non-Covid issues drastically reduced. Hospitals activated their mass casualty management plans and have reorganized and overstretched their capacity to be able to absorb both the influx of patients with the virus and those with other conditions. Part of that reorganization was reducing the surgical activity. The main focus was shifted to patients who are considered urgent and elective surgery were postponed. Hence only surgical emergencies were maintained. Many did not present to the emergency department for fear to contract the virus and from a sense of national and global solidarity against that pandemic. Whereas these measures are essential to prevent the spread of the virus, it may be hypothesized that for non-Covid issues, including surgical emergencies, patients may present late to the emergency department due to fear of contracting the infection in hospital. This would delay their management and lead to a worsened symptomology on presentation requiring a more complex surgical intervention with an increased complication profile. The investigators present initial data from four major hospitals in Belgium, characterizing surgical emergencies that were managed since the start of the pandemic and discuss the repercussion the pandemic has on management of urgent surgical patients and most likely evolution of surgery after the pandemic.

NCT ID: NCT04684316 Completed - Screening Clinical Trials

Economic Evaluation of Periodic Occupational Health Screening

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

In Belgium, Periodic Health Screenings (PHS) are obliged by law for several occupations, including safety functions, jobs with heightened vigilance, work that involves physical, biological or chemical agents or tasks that are an ergonomic or mental burden. Scientifically it remains an open question whether these screenings guarantee the prevention of later health problems or problems with functioning at work. The objective of this study is to compare the cost-effectiveness of PHS with an online health screening tool with selective follow-up. In five Flemish hospitals, the employees eligible for PHS (exempting frequent exposure to ionizing radiation, preparation of cytostatics, or exposure to carcinogens, mutagens, or reprotoxic substances) are randomly assigned to a control group (receiving classical PHS at the occupational physician), or an intervention group (e-tool with selective follow-up by the physician). In the intervention group, 20% of the employees is seen by the occupational physician, based on their responses to the questionnaire. The intervention- and control group complete the questionnaire three times: before the study start (June 2019), in February 2020, and in September 2020. The study ends in March 2021. The survey is developed as part of the study. On the one hand it contains questions for the cost-effectiveness analysis: health care use, absenteeism and presenteeism, and health literacy. On the other hand, a validated questionnaire is developed based on a systematic review of existing validated and reliable instruments, a Delphi panel of occupational physicians, and a pilot- and field study that test the reliability and validity of the survey (and its referral to the occupational physician). For the latter, the employees' health, occupational risks, work ability, and lifestyle (alcohol abuse, drug abuse, physical activity, and nutrition) are surveyed. Access to the occupational physician remains guaranteed by means of an additional question ("Do you wish to discuss the results of your survey with the occupational physician?") and as spontaneous consultations with the occupational physicians remain possible before, during, and after the trial. The survey platform Qualtrics is used for data collection. Researchers have no insight in personal data, nor the medical files of employees, and only analyse the coded data from the surveys. Invitations for the survey are sent by the occupational physician. The coded questionnaires are saved on a KU Leuven survey, following the ISO-9001-procedure and the legal data storage period. The employer has no insight in the data. The study is performed by Jonas Steel, supervised by prof. dr. Jeroen Luyten and prof. dr. Lode Godderis, and financed by the Belgian Association for Occupational Physicians, and three external services for prevention and protection at work: IDEWE, Liantis, and Mensura.

NCT ID: NCT04682639 Completed - Clinical trials for Eosinophilic Esophagitis

A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis

VOYAGE
Start date: December 15, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for active eosinophilic esophagitis (EoE) in adult participants.

NCT ID: NCT04678856 Completed - Sinusitis Clinical Trials

Dupilumab in CRSsNP

Liberty CRSsNP
Start date: December 2, 2020
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan in the dupilumab group only Secondary Objectives: - To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on CT scan and sinus total symptom score (sTSS) compared to placebo - To evaluate the safety and tolerability of dupilumab in CRSsNP patients compared to placebo - To evaluate the pharmacokinetics (PK) of dupilumab in CRSsNP patients compared to placebo - Assessment of immunogenicity to dupilumab over time compared to placebo

NCT ID: NCT04678765 Completed - Surgery Clinical Trials

Efficacy of Ultrasound-guided Axillary Nerve Block Versus Ultrasound-guided Peripheral Forearm Block in Patients Undergoing Hand Surgery

Start date: January 13, 2021
Phase: N/A
Study type: Interventional

By means of an observer-blinded, mono-center, prospective, randomized controlled superiority trial, the total anesthesia-related time (sum of performance and onset times) of an ultrasound-guided distal peripheral nerve block and an ultrasound-guided axillary nerve block will be investigated in patients undergoing hand surgery. The hypothesis is that the onset-time of the ultrasound-guided distal peripheral nerve block will be faster than ultrasound-guided axillary nerve blocks, which is more suitable for hand surgery.

NCT ID: NCT04674761 Completed - Alagille Syndrome Clinical Trials

Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome

ASSERT
Start date: March 19, 2021
Phase: Phase 3
Study type: Interventional

Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in Patients with Alagille Syndrome.

NCT ID: NCT04674007 Completed - Fatigue Clinical Trials

The Effect of Cognitive Dual Task and Mental Fatigue on Landing Biomechanics

Start date: August 1, 2020
Phase:
Study type: Observational [Patient Registry]

In this study, three-dimensional biomechanics , by means of lower limb joint angles and moments (opto-electronic system with synchronised force plate), of landing tasks (anticipated, unanticipated and cognitive dual task) before and after a mental fatigue protocol will be compared in a population of basketball, handball and volleyball players.

NCT ID: NCT04672395 Completed - COVID-19 Clinical Trials

A Controlled Phase 2/3 Study of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Vaccine (SCB-2019) for the Prevention of COVID-19

SCB-2019
Start date: March 24, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this double-blind, randomized, controlled study is to evaluate the efficacy, immunogenicity, reactogenicity and safety of an adjuvanted recombinant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) trimeric spike (S)-protein subunit vaccine (SCB-2019) for the prevention of SARS-CoV-2-mediated COVID-19 in Participants Aged 12 Years and Older.