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NCT ID: NCT04271280 Completed - Clinical trials for Cardiovascular Diseases

Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events

SANTORINI
Start date: March 17, 2020
Phase:
Study type: Observational

High and Very High Risk cardiovascular patient journeys seems to vary from country to country, and current understanding of the process is incomplete. This real-life observational study which documents meaningful patient journey-related parameters can be expected to provide meaningful insight into the care process, country-by-country.

NCT ID: NCT04264104 Completed - Healthy Clinical Trials

Effect of Nervous System Mobilization on Athletes' Performance

Start date: February 28, 2020
Phase: N/A
Study type: Interventional

This study aims to compare the effects of two diferente doses of nervous system mobilization on athletes performance.

NCT ID: NCT04252846 Completed - Clinical trials for Partial Onset Seizures

A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy

Start date: July 20, 2020
Phase:
Study type: Observational

The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial onset seizures [POS] with or without secondary generalization [SG] or for primary generalized tonic-clonic seizures [PGTCS] associated with idiopathic generalized epilepsy [IGE] as first adjunctive to antiepileptic drug (AED) monotherapy as part of their routine clinical care.

NCT ID: NCT04252742 Completed - Migraine Clinical Trials

Erenumab - Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine

EMBRACE
Start date: September 15, 2020
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity.

NCT ID: NCT04247516 Completed - Cerebral Palsy Clinical Trials

A Study Protocol for an Online Intervention to Promote School Engagement

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

Cerebral Palsy (CP) is a neurological, non-progressive, and permanent developmental disorder that mainly affects movement and posture, with a prevalence of 3 to 4 children per 1000 live births. CP's motor impairments are often accompanied by disturbances of sensation, perception, cognition, communication, and behavior. These impairments echo in the activities of daily life, as well as in the learning process. Importantly, children with CP are especially prone to display working memory and EFs deficits, as well as difficulties in self-regulation, which might help explain some of their social and learning problems. These children have a high risk of showing learning disabilities, which may arise before the schooling years. This risk is not exclusively determined by cognitive impairment, with children with a normative cognitive level still presenting specific learning difficulties (e.g., mathematics, reading). Due to their clinical picture, children with disabilities, including CP, struggle with their difficulties in school. Consequently, they are prone to develop a poor School Engagement (SE) - multidimensional and multifaceted construct involving three interrelated dimensions: students' behaviors, emotions, and cognition. In children with disabilities, one of the factors that contributes to lower SE is their high level of school absenteeism. These children miss, on average, 3 weeks of school in a school year due to health issues, which may hinder their academic performance. The promotion of SE in children with disabilities is, therefore, a priority. To promote SE, Gamification strategies can be used. Gamification is the use of game elements (e.g., points, rewards, feedback) in non-game contexts. The potential of using Gamification is high and constitutes a unique opportunity to engage participants in specific activities, such as in intervention or learning contexts. Therefore, through game mechanics, Gamification can be used as a tool to promote SE. This is because, it offers an attractive learning environment and converts difficult tasks into more appealing ones, motivating individuals to perform. Moreover, it enhances the degree and depth of participant engagement, rises behavior and lifestyle changes, promotes learning opportunities, motivates students, and improves intervention appeal, especially for youngsters. To conclude, this project aims to increase SE through Gamification in children with CP. Literature has highlighted the need to focus interventions on SE and self-regulated learning (SRL) on a specific domain. Because children with CP are at high risk of presenting learning difficulties, especially in mathematics, this project will focus on mathematics performance. Moreover, SE is multidimensional, including behaviors, emotions, and cognitions related to school. Specifically, behavioral SE can be conceptualized in three levels: 1) school attendance and fulfillment of school work, 2) participation in class, and 3) active participation (e.g., doing extra school-work). Emotional SE refers to students' affective reactions and sense of connectedness with school. Finally, cognitive SE is related to personal investment in academic tasks, self-regulation, and value of the learning process. Because SRL may be compromised in children with CP, mainly due to difficulties in planning and setting goals, this project will promote SE in mathematics by developing SRL strategies in these children. SRL processes are key for students to attain their self-set goals and include competences of planning, execution, evaluation, and monitoring of the learning process. SE and SRL will be promoted through Gamification strategies on the Canvas platform. Thus, the main purpose is to assess an intervention program with children with CP to increase SE, and enhance SRL, through Gamification Strategies in mathematics. Specifics aims: - Embed Gamification Strategies (e.g., rewards, collaboration, competition) in the Canvas Platform using the tools already available (e.g., forum/chat); - Develop and assess the efficacy and impact of the intervention in promoting SE, and SRL competences, through an integrated assessment approach (functional, educational, neurocognitive, and neuroimaging).

NCT ID: NCT04241536 Completed - Clinical trials for Age-related Macular Degeneration

Metabolomics: A Novel Tool for Investigating the Pathogenesis of Age-related Macular Degeneration

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

The global aim of this project is to expand the knowledge on the multifactorial pathogenesis of AMD. In addition to age, the multifactorial pathogenesis of AMD includes environmental and genetic risk factors. However, how these interact to promote progression remains largely unknown. AMD is a progressive retinal disease characterized by mostly asymptomatic early phases and progression to potentially blinding late forms (choroidal neovascularization or geographic atrophy). Individuals vary in their rate of progression, with some remaining stable for years. The reasons behind this variability, as well as the triggers and mechanisms of AMD progression, are not well understood. Currently, the standard of care for assessment of the risk of progression is solely based on fundus appearance, and is limited in its prediction ability. Our previous work showed that metabolomics enables the identification of specific plasma metabolomic profiles in AMD, which vary with the severity stages. The investigators hypothesize that the plasma and urinary metabolomic profile of subjects who progress over a five-year period (progressors) is distinct from those who remain at the same AMD severity stage (non-progressors). In this proposal, the investigators will follow our existing cohort over five years, comparing the metabolomic profiles of progressors to non-progressors.

NCT ID: NCT04239365 Completed - Colorectal Cancer Clinical Trials

Follow-up Protocol of Colorectal Endoscopic Mucosal Resection Scars

Start date: January 31, 2020
Phase: N/A
Study type: Interventional

Nowadays endoscopic mucosal resection (EMR) is the gold standard for the removal of large laterally spreading and sessile colorectal lesions ≥ 20 mm. However, recurrence rate after successful EMR (defined by the absence of neoplastic tissue at the completion of the procedure after careful inspection of the post-EMR mucosal defect and margin) is about 15-20%. Consequently, current guidelines recommend a surveillance colonoscopy between 4 and 6 months after resection for detection of residual or recurrent polyp. There are few studies that have examined the accuracy of advanced endoscopic imaging for the prediction of histological recurrence but none of these imaging modalities have been validated for surveillance after EMR. Therefore, current guidelines strongly recommend systematic biopsy of EMR scar. The main aim of this study is to assess the incremental benefit of narrow band imaging (NBI) and white light endoscopy (WLE) randomizing the initial technique for the endoscopic detection of post-EMR recurrence and to asses if this advanced imaging method achieve sufficient diagnostic accuracy to exclude recurrence without the need for biopsy.

NCT ID: NCT04233216 Completed - HIV-1 Infection Clinical Trials

Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)

Start date: March 18, 2020
Phase: Phase 3
Study type: Interventional

This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily treatment-experienced (HTE) participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that the percentage of participants receiving DOR/ISL to achieve ≥0.5 log10 decrease in HIV-1 ribonucleic acid (RNA) from study baseline (Day 1) to Day 8 is superior to placebo, each given in combination with failing antiretroviral therapy (ART).

NCT ID: NCT04224233 Completed - Clinical trials for Interstitial Lung Diseases (ILD)

A Home-based Physical Activity Programme for Patients With Advanced Interstitial Lung Diseases (iLiFE)

iLiFE
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Interstitial lung diseases (ILD) are a highly incapacitating group of chronic respiratory diseases, leading to disabling symptoms and impaired capacity to perform activities of daily living and health-related quality of life (HRQoL). It is known that people with ILD are highly inactive and sedentary, and in a severe stage of the disease, these people spend most of the time at home, increasing dependency on others, and decrease HRQoL. Physical activity is a cost-effective intervention, which increases the HRQoL, exercise capacity and ability to perform activities of daily living in people with chronic respiratory diseases. However, few home-based physical activity programmes are available, especially in people with ILD. Thus, it is urgent to develop innovative models of PA, closer to patients and adjusted to the patients' routines, to engage and change patients' physical activity levels, enhancing HRQoL. iLiFE might be promising as it focuses on establishing new behaviours, within selected contexts to stimulate home-based PA. Therefore, iLiFE will be developed, implemented and evaluated in people with ILD.

NCT ID: NCT04223362 Completed - COPD Clinical Trials

PICk-UP: PersonalIsed CommUnity-based Physical Activities for Patients With Chronic Obstructive Pulmonary Disease

PICk UP
Start date: February 5, 2020
Phase: N/A
Study type: Interventional

Chronic Obstructive Pulmonary Disease (COPD) is a major individual, social and economic burden worldwide. Pulmonary rehabilitation is a fundamental evidence-based intervention to manage COPD. However, pulmonary rehabilitation benefits tend to decline over time and sustaining a long-term physical activity lifestyle is challenging, leading to worse health-related quality of life. Personalised post-pulmonary rehabilitation programmes, combining different physical activities modalities with social interaction, are warranted to enable a shift from a disease-based to a patient-centred model and encourage a sustainable behavioural change. Although such programmes have the potential to sustain pulmonary rehabilitation benefits and promote patients' long-term adherence to physical activity, their availability within the community is scarce. Hence, the investigators will implement a personalised community-based physical activity programme (PICk UP), using the available resources, adapted to patient's needs/preferences. PICk UP will be a sustainable response to support healthy lifestyles and enhance pulmonary rehabilitation benefits of respiratory patients, by integrating them within the community and embracing urban facilities. The aim of this study is to assess the effectiveness of PICk UP, a personalised community-based physical activity programme, tailored to patients' needs and preferences, on their physical activity levels. It is expected that PICk UP will empower patients to remain physically active and foster the maintenance of pulmonary rehabilitation benefits.