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NCT ID: NCT04254705 Withdrawn - Cystic Fibrosis Clinical Trials

Organoid Study R334W

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

In contrary to what is seen in FRT cells, rectal organoids of patients with a R334W mutation do respond to CFTR modulators ivacaftor and lumacaftor. The present study will investigate the response to modulators in organoids of 30 patients with CF and a R334W mutation, to allow further stratificaton for a future clinical trial assessing the clinical effect of ivacaftor/tezacaftor in patients with CF and a R334W mutation.

NCT ID: NCT04253184 Active, not recruiting - Bradycardia Clinical Trials

Micra AV Transcatheter Pacing System Post-Approval Registry

Micra AV PAS
Start date: February 8, 2020
Phase:
Study type: Observational [Patient Registry]

Medtronic is sponsoring the Micra AV Registry using the Micra AV system for continued surveillance of chronic atrioventricular synchronous pacing as intended, through the collection of data based on routine clinical care practice, following commercial release. The Micra AV Registry is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

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: NCT04251832 Recruiting - Shoulder Pain Clinical Trials

Efficacy of Sodium Thiosulfate in Shoulder Pain in Calcific Tendinitis of the Rotator Cuff

Start date: January 1, 2020
Phase: Phase 2
Study type: Interventional

Calcific tendinitis of the rotator cuff is one of the most common causes of shoulder pain. Ultrasound guided percutaneous lavage (UGPL or barbotage or irrigation) of calcific tendinopathy is indicated when conservative treatments (physiotherapy, nonsteroidal anti-inflammatory drugs) have failed. Our hypothesis is that lavage followed by intra-calcic injection of STS could fasten the dissolution of the calcific deposit. In view of the short half-life of this molecule the investigators hypothesize that this would happen within the first month after the procedure. Therefore, the investigatorschose to assess our primary objective at 1 month. Few studies have evaluated the short-term radiographic evolution after lavage.

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: NCT04246463 Recruiting - Surgery Clinical Trials

Terumo Aortic Global Endovascular Registry

TiGER
Start date: December 17, 2019
Phase:
Study type: Observational

Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.

NCT ID: NCT04246177 Active, not recruiting - Clinical trials for Carcinoma, Hepatocellular

Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)

Start date: May 22, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).

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: NCT04241185 Recruiting - Clinical trials for Urinary Bladder Neoplasms

Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)

Start date: May 19, 2020
Phase: Phase 3
Study type: Interventional

This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival.