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NCT ID: NCT04394351 Active, not recruiting - Clinical trials for Eosinophilic Esophagitis (EoE)

Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)

EoE KIDS
Start date: September 1, 2020
Phase: Phase 3
Study type: Interventional

The Primary objective is to demonstrate the efficacy of dupilumab treatment compared with placebo in pediatric patients with active eosinophilic esophagitis (EoE) based on histologic improvement meeting validated histologic criteria. The Secondary objectives are: - To demonstrate the efficacy of dupilumab compared to placebo in pediatric patients with active EoE after 16 weeks of treatment as assessed by endoscopic visual measurements of disease activity using the Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) and histologic abnormalities as measured by the EoE Histology Scoring System (EoE-HSS) - To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 16 weeks in pediatric patients with active EoE - To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation - To study the effects of dupilumab on the type 2 inflammation gene expression signature - To evaluate the concentration-time profile of functional dupilumab in serum in this population - To assess efficacy of long-term (up to 160 weeks) dupilumab treatment - To assess the impact of dupilumab treatment on changes in weight and growth during the extended active period and open-label extension period of the study - To assess safety, tolerability, and immunogenicity of long-term (up to 160 weeks) dupilumab treatment - To evaluate the impact of dupilumab treatment on EoE signs and symptoms

NCT ID: NCT04394312 Completed - Clinical trials for Parent-Child Relations

Parent PLAYSHOP: A Physical Literacy Training Workshop for Parents

Start date: November 27, 2019
Phase: N/A
Study type: Interventional

The objective of this research is to 1) determine the impact of a physical literacy training workshop for parents of preschool children (3-5 years) on their knowledge and confidence levels in regards to engaging in meaningful physical activity with their child(ren) in order to promote physical literacy. 2) Evaluate workshop reach and implementation facilitators and barriers. In this pilot study, interested participants will be randomized into the intervention group or the wait-list control group. Participants will complete two brief surveys regarding their knowledge and confidence in doing physically activities with their children. The intervention group will receive a 75 minute physical literacy workshop at baseline, and complete a 2 month follow-up interview. The wait-list control group will receive the workshop after questionnaires have been completed. Statistical analysis will be conducted to compare change in knowledge and confidence levels in between intervention and control groups. Findings will contribute to promoting and improving parental confidence in providing opportunities for children to develop their physical literacy and advance future research regarding physical activity promotion for children.

NCT ID: NCT04393649 Active, not recruiting - Anxiety Clinical Trials

First Level Socio-geriatric Evaluation: ESOGER Databank

Start date: April 20, 2020
Phase:
Study type: Observational [Patient Registry]

Coronavirus disease 2019 (COVID-19) is an infectious disease. Physical distancing is one of the most effective ways to reduce the spread of COVID-19, but this key prevention intervention may have adverse consequences on older adults living at home. Screening older adults living at home and at risk for adverse consequences of physical and social distancing is, therefore, a priority in order to prevent their occurrence. ESOGER ("Evaluation Social et GERiatrique") is a clinical tool designed to: 1) screen the risk-levels for adverse consequences related to COVID-19 physical distancing and 2) to continue appropriate preventive interventions in older adults living at home including frail older patients and older community dwellers. Experience cumulated during the past two weeks revealed that ESOGER could be improved, in order to be more effective and efficient for the prevention of adverse consequences related to COVID-19 physical distancing. This improvement is based on two key components: 1) Comments of Montreal ESOGER users and 2) Analysis of data. Because at this time no information is saved and stored, there is a need to save and store ESOGER information and create the ESOGER databank.

NCT ID: NCT04392999 Active, not recruiting - Cervical Pain Clinical Trials

Intra-articular Corticosteroid Injections to Platelet Rich Plasma (PRP) for Cervical Facetogenic Pain

PRICE
Start date: February 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Chronic neck pain, either after trauma (e.g. whiplash injury) or due to arthritis, is a significant issue for many Canadians. Steroid injections into the small joints of the neck can provide temporary pain relief, but patients require repeat injections every few months. The investigator will assess whether a different type of injection (platelet-rich plasma, PRP) can provide enhanced and longer-lasting pain relief compared to steroid. PRP is made from the patient's own blood but contains higher levels of components that promote healing. Patients with neck pain will receive either an injection of steroid or PRP into the small joints of the neck, but they won't know which one they are getting. After the injection they will be contacted to answer questions about their pain and function, up to 12 months after injection. The goal of this study is to determine if PRP is a viable alternative to current treatments to help reduce chronic neck pain and improve function after a whiplash injury. PRP may be a more permanent treatment for chronic neck pain which could reduce the need for repeated injections, thus reducing health care costs and wait times.

NCT ID: NCT04392921 Recruiting - Atrial Fibrillation Clinical Trials

Prophylaxis for Patients at Risk to Eliminate Post-operative Atrial Fibrillation

PREP-AF
Start date: March 7, 2022
Phase: N/A
Study type: Interventional

After surgery on the lungs or esophagus, 12-46% of patients experience an irregular heart rhythm called atrial fibrillation. Although usually transient, post-operative atrial fibrillation is associated with longer stay in hospital, greater complications, and increased risk of death. Several medications have been shown to be effective at reducing the risk of atrial fibrillation after their surgery with the greatest effectiveness and safety demonstrated with amiodarone. Nevertheless, amiodarone has potential side effects, and so it is only recommended in patients with increased risk of developing atrial fibrillation. A tool has been developed and validated to identify high-risk patients but no clinical trial has looked at the effectiveness of administering amiodarone in this high-risk group. This study aims to assess the feasibility and safety of conducting a clinical trial where patients are randomized to receive amiodarone or placebo. This is critical before considering a full-scale trial to assess the effectiveness of amiodarone in reducing atrial fibrillation after surgery on the lungs or esophagus.

NCT ID: NCT04392765 Enrolling by invitation - Clinical trials for Sleep Apnea, Obstructive

Efficacy of Intra-oral Neuromuscular Stimulation Training on Snoring and Mild Sleep Apnoea

Start date: May 11, 2020
Phase: N/A
Study type: Interventional

It has been shown that a common cause for snoring and throat obstruction (obstructive sleep apnoea (OSA)) is excessive loss of muscle tone in the throat when the investigators go to sleep. This results in the partial collapse of the throat (snoring) or complete collapse (OSA) during sleep. 45% of the male population snore. Sleep apnoea affects 4 to 6% of the population and is associated with increased incidence of raised blood pressure, heart attacks and strokes. Although there are several lifestyle practices associated with snoring such as smoking, obesity and drinking, a significant proportion of people may snore despite not being associated with these. A solution to this issue is to improve the muscle tone of the throat so that it doesn't collapse so easily. Several studies have shown that certain types of throat exercises can help reduce snoring. Further studies have also shown that using electrical stimulation to exercise the tongue muscles has the same effect. From this, doctors in the United Kingdom (UK) have developed a new type of device, eXciteOSA, that allows a more accurate and comfortable way of delivering this energy to exercise the tongue muscles. The device works by stimulating the tongue muscles during the day so that the tongue is less likely to collapse during sleep. It is a form of "workout" for the tongue and like other physical exercise regimes, it needs to be repeated regularly for a few weeks to take effect. The aim of this study is to see if the eXciteOSA device is as effective as the previous methods and if it can reduce snoring and improve sleep quality. This will be achieved by participants using the eXciteOSA once daily for a six week period. A two night sleep study with watchPAT along with a polysomnography will be completed before and after the therapy to compare results. Questionnaires on sleep quality and quality of life will also be completed pre and post therapy.

NCT ID: NCT04392544 Active, not recruiting - Cystic Fibrosis Clinical Trials

Intestinal Inflammation in CF Patients

Start date: September 11, 2018
Phase:
Study type: Observational

Cystic Fibrosis (CF) is a disease that affects salt and water transport in multiple organs. Many CF patients suffer from abdominal pain and this could be due to intestinal inflammation. However, so far we do not know how many of the CF patients actually do have intestinal inflammation when looking at intestinal specimens. There is a proven connection between chronic inflammation and developing colorectal cancer and over the years more CF patients are developing colorectal cancer. Thus, it becomes increasingly important to look for the presence of intestinal inflammation in CF patients since early treatment may improve their symptoms and reduce the risk for colorectal cancer.

NCT ID: NCT04392154 Active, not recruiting - Atopic Dermatitis Clinical Trials

Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin)

ADjoin
Start date: June 15, 2020
Phase: Phase 3
Study type: Interventional

This is designed to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis. It will last up to 33 months.

NCT ID: NCT04391569 Active, not recruiting - Status Epilepticus Clinical Trials

Randomized Therapy In Status Epilepticus

RAISE
Start date: October 10, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the effectiveness and safety of an investigational product (IP), intravenous (IV) ganaxolone, to treat participants with status epilepticus (SE).

NCT ID: NCT04391465 Recruiting - Clinical trials for Cerebrovascular Circulation

Assessment of the Relationship Between Cerebral Blood Flow and Heart Rate

Start date: August 11, 2021
Phase: N/A
Study type: Interventional

The investigators will seek to determine the relationship between heart rate and middle cerebral artery (MCA) cerebral blood flow (CBF), as well as better understand the hemodynamic determinants of MCA CBF velocity. In order to manipulate heart rate, the investigators will recruit patients already scheduled for clinically indicated elective electrophysiological studies, where temporary pacing catheters placed in the right atrium can be used to artificially pace the heart at controlled rates. MCA CBF will be measured by transcranial Doppler ultrasound.