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NCT ID: NCT06092710 Enrolling by invitation - Clinical trials for Obstructive Sleep Apnea

Predictability of OSA With a Subjective Screening Scale (OSASSS1)

OSASSS1
Start date: January 1, 2023
Phase:
Study type: Observational

the study aims to evaluate the accuracy correlation between subjective perception of the air flow through airways from patients and survey and/or polysomnography they spent, using a brief clinical protocol they answered with a manual therapist

NCT ID: NCT06075537 Enrolling by invitation - Clinical trials for Mucopolysaccharidosis II

An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007

Start date: September 20, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This is a multiregional open-label extension (OLE) to assess the safety, tolerability, and efficacy of long-term treatment with tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant intravenous (IV) enzyme replacement therapy (ERT) for Hunter syndrome (MPS II). Participants who complete at least through the Week 49 visit in Study DNLI-E-0002 and do not discontinue study intervention early and participants who complete Study DNLI-E-0007 will be enrolled in this OLE. All participants will receive DNL310 for up to 5 years from the time of entry in this OLE. Participants, site staff, and the Sponsor will remain blinded to the original treatment assignment for participants entering this OLE from Study DNLI-E-0007.

NCT ID: NCT06073236 Enrolling by invitation - Health Behavior Clinical Trials

A Co-creational Intervention to Engage Preschoolers in Healthy Movement Behaviors

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

Previous research focusing on preschoolers' healthy behaviors looked at developing interventions for separate behaviors, such as physical activity and sedentary behavior. Currently, there is a shift in research towards focusing on an integrated approach regarding the behaviors conducted in a 24-hour day, since targeting multiple behaviors is more effective. Activities in a 24-hour day consist of physical activity, sedentary behavior and sleep. Only very few Belgian preschoolers (10%) meet the guidelines regarding a healthy 24-hour day. Therefore, interventions focusing on all three behaviors with an integrated approach are needed. Since preschool children spend most of their time at school and at home, and engage in playbased learning in those settings, this project will develop and evaluate an intervention focusing on those 24-hour behaviors both at school and at home. The aim of the intervention is to increase the percentage of preschoolers that comply with the guidelines regarding a 24-hour day. Within the project, we will work closely together with both preschoolers' teachers and parents to develop and create the intervention, framed within the Intervention Mapping protocol. The intervention will be evaluated through a cluster randomized controlled trial, using a pretest, posttest and follow-up. Preschoolers' physical activity, sedentary behavior and sleep will be measured using an objective measurement device (accelerometer).

NCT ID: NCT06041906 Enrolling by invitation - Clinical trials for Congenital Porto-Systemic Shunt (CPSS)

International Registry of Congenital Portosystemic Shunt (IRCPSS)

IRCPSS
Start date: April 26, 2018
Phase:
Study type: Observational [Patient Registry]

Congenital Portosystemic Shunt (CPSS) is a rare condition important by the multiplicity and severity of associated complications. CPSS is venous anomaly in which blood coming from the intestines only partially passes through the liver. This leads to the accumulation of potentially toxic factors that cause systemic effects. Complications vary among the individuals, and currently, it is challenging to predict which individuals will develop severe complications. The IRCPSS registry is established with the aim of centralizing detailed clinical follow-up and biological information from participants around the world who suffer from Congenital Portosystemic Shunt (CPSS). A multidisciplinary consortium of experts is collaborating to enhance our understanding of the prevalence, natural history, individual risks, and physiopathology of the disease through the IRCPSS registry.

NCT ID: NCT05987527 Enrolling by invitation - Clinical trials for End Stage Renal Disease

Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)

Start date: August 15, 2023
Phase:
Study type: Observational

This long-term follow-up study is being conducted to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101.

NCT ID: NCT05882955 Enrolling by invitation - Mobile Applications Clinical Trials

Designing a Mixed-initiative Recipe Recommender App for Vegan and Vegetarian Sub-groups

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

The goal of this study is to test the usability and applicability of a mobile application which recommends recipes. We will recruit up to 52 vegan/vegetarian participants in Belgium, and provide them with an iDOO hydroponic plant growing unit (https://www.idooworld.com/products/idoo-20pods-indoor-herb-garden-kit-hydroponics-growing-sy stem-with-led-grow-light) as well as seeds and plant nutrients to grow certain herbs at home. Over a period of 17 weeks, participants will be asked to consume plants from the unit by following the recipes recommended by the app. The participants will then observe changes in their iron and vitamin B12 levels by following up with their GP and report the outcomes back to the researchers at three points during the study (week 0, week 6, and week 17). In addition, the participants will evaluate the usability of the app and the recipes recommended by the app.

NCT ID: NCT05877456 Enrolling by invitation - Colo-rectal Cancer Clinical Trials

Validation of the Global Polypectomy Assessment Tool (GPAT)

GPAT
Start date: March 1, 2023
Phase:
Study type: Observational

Colorectal polypectomy is offten incompletely performed with high variability between endoscopists, resulting in interval cancer or repeated procedures. Current available scoring systems for polypectomy technique are lacking in different areas so the investigators developed the Global Polypectomy Assessment Tool (GPAT) which is an online video-based assessment tool for any colorectal polypectomy. The goal of the study is to assess the validity of GPAT through demonstrating the inter-rater agreement (Fleiss Kappa (κ)). GPAT has 20 items, contains evidence-based statements to aid interpretation, calculates an overall quality score and a complexity score.

NCT ID: NCT05838339 Enrolling by invitation - Sleep Clinical Trials

Are You Daydreaming?

Start date: October 4, 2022
Phase: N/A
Study type: Interventional

Health CASCADE (Marie Skłodowska-Curie grant agreement n° 956501) aims to address complex public health problems by making co-creation a scientifically sound methodology, aided by evidence-based methods, practices, and technologies. The current study, which focuses on co-creation in the school context is part of this overarching European project. Healthy sleep is important for adolescents' mental and physical health and cognitive functioning. However, sleep difficulties are among the top three health complaints in European adolescents. This indicates a need for successful interventions. Co-creation is a promising approach to design tailored interventions. By actively involving all relevant stakeholders, co-creation has been shown to increase self-efficacy, self-consciousness, empowerment, and feelings of ownership. However, co-created interventions are localized and therefore less generalizable to a broader population. Moreover, the process is very time- and cost- consuming. To make co-creation more feasible, research should focus on the upscaling of existing interventions. The investigators propose that the co-creation process is still absolutely vital for intervention success but that it can be shortened. The investigators aim to scale up an existing intervention to promote healthy sleep. This existing intervention was developed using co-creation together with the target group (adolescents aged 13 to 15) and parents, and implemented with support of teachers and fellow students. To investigate whether the shorter co-creation process is needed in order to scale up the intervention to another setting and context, the investigators will use a three-arm cluster controlled trial. This will include one co-creation intervention school, one standard implementation school (this school receives the existing intervention without a shortened co-creation process), and one control school. The co-creation process will be structured by using the Intervention Mapping Protocol to ensure an evidence-based framework. The effect of the intervention will be evaluated using actigraphy and questionnaires, while the process will be evaluated using questionnaires, interviews, and focus groups.

NCT ID: NCT05827601 Enrolling by invitation - Influenza, Human Clinical Trials

Zoonotic Influenza Surveillance in Belgium

ZOOIS
Start date: September 1, 2023
Phase:
Study type: Observational

The project aims at implementing a more pro-active surveillance of potential transmission of influenza viruses to humans (zoonotic transmission). Clinical surveillance of influenza in humans and avian species is well organized and has been operating for decades, but currently there is no pro-active systematic surveillance of potential transmission of animal (avian or swine) influenza viruses to humans, only follow-up of people showing clinical symptoms. People working with potentially infected animals have the highest risk. Moreover, they can represent the first steps in a pandemic: if the virus adapts to humans, infected workers could potentially spread the virus to other people. Currently, highly pathogenic clade2.3.4.4b H5 avian influenza viruses are continuously circulating in wild birds in Belgium and the number of introduction in poultry farms has raised, increasing the contact opportunities with high viral concentrations. Several reports of suspected human infection have been made by different countries. In addition, the virus was detected in sick non-human mammals. The large circulation in wild birds thus represents an increase risk of spill-over to mammalian species, including humans, (by contact directly with wild birds, or via outbreaks in poultry). This increased opportunity for accidental spillover to new host species increases the chances for the avian virus to adapt to mammals, including humans. Likewise, there have also been an increased number of human cases of swine influenza reported by several European countries. A pro-active surveillance aiming at also detecting asymptomatic infections would allow an early detection of transmission that could help to prevent a new pandemic. As a piloting approach during this specific project, some dedicated sentinel networks among at-risk workers will be initiated: people in poultry farms involved with the management of outbreaks of highly pathogenic avian influenza; people working at bird (or more generally wild life) rehabilitation centres or poultry farms; veterinarians working in pig farms/slaughterhouses.

NCT ID: NCT05792072 Enrolling by invitation - Neuropathic Pain Clinical Trials

rTMS for the Treatment of Neuropathic Pain in Diabetic Patients

Start date: May 2, 2023
Phase: N/A
Study type: Interventional

Tis study aims to assess whether multiple sessions of sham-controlled HF-rTMS applied to the motor cortex significantly reduces treatment-resistant neuropathic pain in diabetic patients. This study will also investigate the effect of those rTMS sessions on functional connectivity of the M1 with brain areas involved in pain processing, underlying brain metabolism and brain plasticity using rs-fMRI, MRS and Paired-pulse stimulation respectively in those patients. Subjects will be randomized into two groups to receive real or sham rTMS protocol. A washout period of at least 8 weeks will be respected between protocols to minimize carry-over effects. Sham stimulation will be delivered using a sham coil, providing the same auditory and sensory stimuli. One daily rTMS session for 5 days of HF-rTMS, will be delivered through an H-coil applied to the primary motor area of the leg. Each session will last 20 minutes during which 30 consecutive trains of 50 stimuli will be delivered at 20 Hz at 100% of resting motor threshold (RMT), with an intertrain interval of 30s