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NCT ID: NCT05286788 Recruiting - Clinical trials for Recurrent Adamantinomatous Craniopharyngioma

MEKTOVI® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

Start date: April 10, 2023
Phase: Phase 2
Study type: Interventional

MEKTOVI (binimetinib) is an oral, highly selective reversible inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2. The biological activity of binimetinib that has been evaluated bith in vitro and in vivo in a wide variety of tumor types In this Phase II, the drug will be used to treat pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma including patients who have undergone surgery and/or radiation therapy.

NCT ID: NCT05286177 Recruiting - Enteral Feeding Clinical Trials

Does Volume-based Enteral Feeding Improve Nutrient Delivery in Hospitalized Critically Ill Children?

Start date: March 20, 2024
Phase: N/A
Study type: Interventional

Background Some critically ill children have malnutrition which may worsen while they are in hospital and delay their return home. They can recover faster when they are given tube feedings to improve their nutrition. Unfortunately, in the hospital these feedings are often interrupted and so these children do not get all the nutrition they need. The usual procedure is to set hourly rates for the tube feedings and to accept that they get less when feedings are interrupted. The researchers would like to test if children are fed better if the bedside nurses were to check the volume provided through the day and then ensure the child gets closer to the prescribed volumes. Aim To determine the feasibility of performing a Randomized Control Trial assessing the use of a Volume-based feeding algorithm in critically ill children admitted to the Alberta Children's Hospital Pediatric Intensive Care Unit (PICU). Objectives 1. Obtain information to inform sample size calculations for nutrition and clinical outcomes for a larger RCT: energy adequacy and protein adequacy, feed tolerance, infections, changes in anthropometric measurements at transitions of care, 28-day ventilator free days, length of stay, 60-day mortality, and 60-day hospital readmission? 2. Assess adherence of medical staff to the study protocol 3. Evaluate the timing of study enrollment and participant allocation 4. Evaluate the proposed deferred consent strategy. Methods The researchers will conduct a randomized control feasibility trial of critically ill children admitted to the Alberta Children's Hospital (ACH) Pediatric Intensive Care unit who require tube feedings. Children will be randomly assigned to the intervention arm (Volume-based algorithm) or the comparison arm (rate-based algorithm). Significance The proposed study will provide evidence of whether a novel approach to feeding critically ill children is feasible during PICU admission. This trial will inform a larger Randomized Control Trial on this topic that will assess if using a Volume-based feeding algorithm will improve outcomes of clinical importance including energy adequacy, protein adequacy, feed tolerance, infections, changes in anthropometric measurements at transitions of care, 28-day ventilator free days, length of stay in PICU and hospital, 60-day mortality, and 60-day hospital readmission.

NCT ID: NCT05285982 Active, not recruiting - Clinical trials for Lung Diseases, Interstitial

A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON)

Start date: April 4, 2022
Phase: Phase 3
Study type: Interventional

This study is open to children and adolescents with interstitial lung disease (ILD) that causes lung fibrosis. This is a study for people who took part in a previous study (study 1199-0337, InPedILD™) and for people who are between 6 and 17 years old and have fibrosing ILD. This study tests a medicine called nintedanib. Nintedanib is already used to treat different types of lung fibrosis in adults. The purpose of the study is to find out how well long-term treatment with nintedanib is tolerated in children and adolescents. All participants take nintedanib capsules twice a day. Participants are in the study for at least 1 year and 5 months or until nintedanib or other treatment options become available outside of this study. During the first 3 years, they visit the study site about 15 times. Afterwards, they visit the study site every 3 months. The doctors collect information on any health problems of the participants.

NCT ID: NCT05284825 Recruiting - Follicular Lymphoma Clinical Trials

A Phase II Trial of Intermediate Radiation Dose For Lymphoma

Start date: February 28, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the optimal radiation dose fractionation regimen for low grade follicular lymphoma. It is hypothesized that the complete response rate with the use of 12 Gy in 6 daily fractions is 80% (10% total width of the confidence interval) at 3 months. This phase II study will evaluate whether an intermediate dose for follicular lymphoma is associated with excellent response rates while minimizing acute and late toxicity.

NCT ID: NCT05284578 Completed - Clinical trials for Distress Intolerance

The Effects of Expressive Writing and Compassionate Letter Writing on Emotional Distress Intolerance

Start date: July 4, 2021
Phase: N/A
Study type: Interventional

Perceived emotional distress intolerance is a transdiagnostic marker of psychopathology associated with psychological and interpersonal dysfunction, and the development of interventions for perceived emotional distress intolerance is of prime importance. One potential intervention is a behavioural experiment, i.e. a cognitive behaviour therapy technique where clients undergo an exercise designed to test a maladaptive belief, e.g., that negative emotions are unbearable, and adjust their belief to accommodate any disconfirmatory information that arises through the exercise. This study examines the effects of a one-session self-compassion writing behavioural experiment compared to a one-session expressive writing behavioural experiment on low perceived distress tolerance. Participants were recruited from the University of Waterloo and Prolific, and were randomly assigned to the self-compassion condition, expressive writing condition, or a control condition.

NCT ID: NCT05284305 Recruiting - Clinical trials for Pregnancy Complications

Desmoid Tumor and Pregnancy: Effect of Pregnancy on Disease Control and Effect of Diagnosis on Pregnancy History.

Start date: March 1, 2022
Phase:
Study type: Observational

Desmoid tumors (DT) are rare disease of intermediate malignancy with variable and often unpredictable clinical course. There is a growing interest in defining potential risk of recurrence or progression during or after pregnancy and in identifying potential obstetrical risks and infertility rate of desmoid patients. Aim of the study: - to define the impact of pregnancy on diagnosis, progression and recurrence of DT; - to define the risks related to DT of obstetrical risks and decisions to interrupt or avoid pregnancy after the diagnosis of DT.

NCT ID: NCT05284123 Completed - Clinical trials for Psychological Distress

The Impact of a Self-Compassion Intervention on Shame and Mental Health Treatment-Seeking

Start date: November 12, 2021
Phase: N/A
Study type: Interventional

Untreated mental health problems can cause lasting harm to self-esteem, relationships, academics, productivity, and health. It is thus highly worrisome that only 18-36% of university students with significant mental health problems seek help. Many university campuses have responded to this mental health crisis by trying to increase students' mental health literacy (MHL), defined as "knowledge and beliefs about mental disorders which aid their recognition, management, or prevention''. Increasing MHL appears to increase knowledge about mental health services, but it does not increase actual treatment-seeking desire or action. One problem with this approach is that it falsely assumes that students struggling with their mental health will want to pursue services once they have learned more about mental disorders and the associated treatments available. However, most people with mental disorders do not initially recognize that they have a disorder and may dismiss information about mental disorders and mental health treatment as irrelevant. Feelings of shame are elevated in individuals with psychological disorders, and these feelings act as one of the strongest barriers to mental health treatment-seeking.Given the low rate of treatment-seeking on university campuses, research is needed to explore how best to facilitate mental health treatment seeking among distressed students, including those who may not self-identity as having a mental health problem. Research has yet to examine the potential role of self-compassion in relation to treatment-seeking behaviours. Self-compassion (SC) is conceptualized as responding to personal distress with gentleness and kindness in order to alleviate it, and it is negatively associated with shame. However, research has not yet explored whether the perceived benefits of SC in mitigating shame can affect mental health treatment-seeking outcomes. We propose that cultivating SC amongst psychologically distressed students will subsequently decrease shame, and thus, indirectly elevate willingness to seek mental health treatment. Thus, this study will examine the effects of a one-session SC workshop/intervention compared to a one-session MHL intervention on shame and mental health treatment-seeking. Participants will be distressed students recruited from the University of Waterloo, and will be randomly assigned to the SC intervention, MHL intervention, or control intervention.

NCT ID: NCT05283889 Recruiting - Clinical trials for Osteoarthritis, Knee

Genicular Radiofrequency Ablation Following Total Knee Arthroplasty

GRATKA
Start date: May 11, 2022
Phase: N/A
Study type: Interventional

Currently, nearly 1 million total knee arthroplasties (TKA) are performed yearly in the United States. Three million are projected to be performed in 2040. Between 15-30% of all patients who undergo TKA have continued pain, reduced quality of life and functional impairments that cannot be attributed to hardware failure/loosening or infection. Treatment options for persistent post TKA pain (failed TKA) are limited. There is a need for minimally invasive, and effective pain and disability modulating interventions for patients with failed TKA. Genicular radiofrequency ablation (GRFA) has been described, refined, and validated as an effective minimally invasive intervention to control refractory knee pain secondary to knee osteoarthritis (OA) as evidenced by three favorable meta-analyses published in 2021 alone.3-5 GRFA is a minimally invasive percutaneous procedure that utilizes thermal energy to coagulate nerves from the knee. Though sometimes used in practice, there is limited research describing and evaluating GRFA for patients with failed TKA. This will be the first trial to evaluate the safety and efficacy of GRFA in patients with failed TKA using a robust study design and up-to-date, evidence-based selection criteria and technique.

NCT ID: NCT05283070 Recruiting - Chronic Pain Clinical Trials

Correlating Heart Rate Variability and Chronic Pain

Start date: October 1, 2021
Phase:
Study type: Observational

The Canadian Armed Forces (CAF) has limited data on baseline quality of life measures and objective measures of function, for active serving members with chronic pain. This study aims to collect this data using patient reported outcomes and 2 minute walk test (2MWT) while validating the newly created Elevation Movement Lift Off Test (EMLi) and correlating the data with heart rate variability (HRV) while comparing performance to healthy controls

NCT ID: NCT05282446 Completed - Metabolic Syndrome Clinical Trials

A Study to Explore the PK and PD of INV-202 in Metabolic Syndrome

Start date: March 1, 2022
Phase: Phase 1
Study type: Interventional

INV-202-CL-105 is a phase 1B study to examine the safety and tolerability, as well as the pharmacokinetics (PK) pharmacodynamic (PD) effects of INV-202 in subjects with metabolic syndrome over 28 days.