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NCT ID: NCT04980495 Active, not recruiting - Clinical trials for Generalized Myasthenia Gravis

An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis

ADAPT NXT
Start date: December 16, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this open-label study is to investigate the efficacy, safety, and tolerability of a continuous regimen of efgartigimod compared with a cyclic regimen in participants with Generalized Myasthenia Gravis (gMG). Study details include: The study duration will be up to 138 weeks (including screening and a safety follow-up of up to 9 weeks) - Part A (regimen comparison period) - 21 weeks - Part B (extension period) - up to 105 weeks The visit frequency, including virtual visits, will be weekly through Week 21 and every 5 weeks for the remainder of the study.

NCT ID: NCT04975399 Active, not recruiting - Multiple Myeloma Clinical Trials

Study to Evaluate the Safety and Tolerability of CC-92328 in Participants With Relapsed and/or Refractory Multiple Myeloma

Start date: October 5, 2021
Phase: Phase 1
Study type: Interventional

This Phase 1, first-in-human (FIH), clinical study of CC-92328 will explore the safety, tolerability and preliminary biological and clinical activity of CC-92328 as a single-agent in the setting of relapsed and/or refractory multiple myeloma (R/R MM). The study will be conducted in two parts: monotherapy dose escalation (Part A) and monotherapy dose expansion (Part B).

NCT ID: NCT04971785 Active, not recruiting - Clinical trials for Nonalcoholic Steatohepatitis

Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

WAYFIND
Start date: August 9, 2021
Phase: Phase 2
Study type: Interventional

The goals of this clinical study are to learn more about the study drugs, semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR), and understand whether they cause fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in participants with cirrhosis due to NASH.

NCT ID: NCT04971226 Active, not recruiting - Clinical trials for Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

Start date: October 6, 2021
Phase: Phase 3
Study type: Interventional

The study is designed to compare the efficacy of asciminib 80 mg QD versus Investigator selected TKI for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP. The Investigator selected TKI will be one of the following treatment options for first-line treatment of CML-CP - imatinib 400 mg QD or nilotinib 300 mg BID or dasatinib 100 mg QD or bosutinib 400 mg QD.

NCT ID: NCT04968184 Active, not recruiting - Clinical trials for Chronic Kidney Diseases

Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe CKD

Clarion-CKD
Start date: November 5, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3, randomized, Double-blind, placebo-controlled, 2-arm, parallel-group, multicenter study with randomized withdrawal will evaluate the efficacy, safety, and durability of KBP-5074 in adult participants who have stage 3b/4 chronic kidney disease (CKD) (estimated glomerular filtration rate [eGFR] calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula [eGFR {EPI}] ≥15 to ≤44 mL/min/1.73 m^2) and uncontrolled hypertension (systolic blood pressure (SBP) ≥140 and <180 mm Hg and taking 2 or more antihypertensive medications.

NCT ID: NCT04968132 Active, not recruiting - Knee Osteoarthritis Clinical Trials

Opioid Reduction in Orthopaedic Surgery (OREOS) - Knees

OREOS
Start date: March 9, 2022
Phase: N/A
Study type: Interventional

Knee replacements are the second most common surgery in Canada. Most patients recover very well but research consistently shows that 1 in 5 patients still have pain many months after surgery. Doctors often prescribe opioid medications for pain after surgery (e.g. Percocet, hydromorphone, codeine). These medications can be helpful for some people, but they can also be dangerous, particularly when used for a long time. Many patients don't like the way opioids make them feel and would prefer alternative pain management strategies. Some people become addicted to opioids, have a difficult time reducing the dose of opioids, or have lasting health problems after using them. People in this study will be randomized to either have usual care or a new pathway designed to improve pain control and decrease opioid use after knee replacements. This study will have an intervention coordinator who will assess patients before surgery and who will follow up with patients regularly after surgery to make sure their pain is controlled and to avoid long-term opioid use. This study will use education, physiotherapy, psychological therapy, ice/cold, and non-opioid pain medications. As pain medications may work differently in different patients, the coordinator will check on each patient to look for pain control and assist to reduce the amount of opioids used after surgery. This study will help people have safer and more effective pain management after surgery which may lead to better recovery, higher satisfaction, and a lower risk of being harmed by opioids after surgery.

NCT ID: NCT04967807 Active, not recruiting - SARS-CoV-2 Clinical Trials

Myocardial Injury and Outcomes Following COVID-19 Vaccination (MYOVAX Study)

MYOVAX
Start date: August 5, 2021
Phase: N/A
Study type: Interventional

The study will focus on cardiac blood and imaging biomarkers to facilitate early recognition of patients at risk for myocardial injury after COVID-19 vaccination. Ultimately, the intention is to identify patients at risk, reduce adverse events, and determine the need for longer-term follow-up in patients with myocardial injury after vaccination.

NCT ID: NCT04967430 Active, not recruiting - Covid19 Clinical Trials

TOGETHER - Toronto: Trial to Evaluate the Effect of Peginterferon Lambda for the Treatment of COVID-19

Start date: August 27, 2021
Phase: Phase 3
Study type: Interventional

Interferon (IFN) lambda is one of the fundamental responses of the innate immune system. Peginterferon lambda is a long-acting form that has been studied extensively in human trials in viral hepatitis, confirming it safety and tolerability. It is particularly attractive for consideration in the use of acute respiratory illness due to the high expression of the lambda receptor in lung epithelia. We propose to evaluate peginterferon-lambda in ambulatory patients with mild to moderate COVID-19.

NCT ID: NCT04966637 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD

Identifying Early Chronic Obstructive Pulmonary Disease (COPD) Using Health Administrative Data

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

Chronic Obstructive Pulmonary Disease (COPD) affects the airways that causes shortness of breath, cough. COPD gets worse over time, and often leads to emergency department visits, hospital visits, frequent doctor appointments and medications. This means COPD is expensive, and severely impacts patient quality of life. Unfortunately, patients are often not properly diagnosed until their disease is fairly advanced. We know a lot about the health care use of people with COPD once they have been diagnosed, but we do not know much about what happens to them leading up to their diagnosis. Through this project we want to better understand the time period prior to COPD diagnosis, so that we can learn more about what happens to people before they are diagnosed. This project will use health data to find out if we can identify trends in health care use by individuals newly diagnosed with COPD. We will identify people that have COPD based on health records, and look back to find out about their health care use prior to their diagnosis. We will look at data related to doctors' visits, emergency department visits, hospital stays and medications. We want to use these markers to better understand what happens to people before they are diagnosed, and to find out if we can identify risk factors for a COPD diagnosis. We hope by doing this research we can better identify people at risk for COPD and ensure that they receive treatment early, which may improve their health outcomes.

NCT ID: NCT04966104 Active, not recruiting - Heart Failure Clinical Trials

ODYSSEE-vCHAT Pilot Trial for Heart Failure

ODYSSEE-vCHAT
Start date: October 25, 2021
Phase: N/A
Study type: Interventional

INTRODUCTION Psychological distress and reduced quality of life are prevalent within the heart failure (HF) population. The 1-year rehospitalization (40%) and 5-year mortality (45% for women and 60% for men) rates are high. International task force committees report that medical therapy combined with counselling for HF self-care optimizes clinical outcomes. HYPOTHESES At trial completion (median = 8.5 months, range = 2 to 15 months), ODYSSEE-vCHAT versus enhanced usual care (eUC) is predicted to reduce morbidity and mortality rates. Greater engagement with the digital program is also predicted to be linked with improved self-reported mental and physical health at months 4, 8, and 12 and trial completion. RECRUITMENT HF patients who are at least 18 years old were recruited from the University Health Network (UHN), Sunnybrook Hospital, Mount Sinai Hospital, and the community. Accrual of the sample (N = 61) occurred over 13 months. DESIGN ODYSSEE-vCHAT is a double-arm, parallel-group, randomized, controlled (real-world) pilot trial with assessments at baseline, months 4, 8, and 12, and trial completion (median = 8.5 months, range = 2 to 15 months). It is a single-blind trial, with research personnel blinded (excluding the research coordinator). All patients were provided with free access to their respective digital intervention, ODYSSEE-vCHAT or eUC. Subjects were invited by weekly emails to participate in the resources available to their group. eUC patients were provided with access to educational materials for HF self-care that are available to the public on professional heart health websites. Participation in supplementary programs that provide HF self-care education was not restricted, rather it was monitored by self-report during assessments and will be statistically controlled for during outcome assessments. ANALYSIS Separate generalized linear models (GLMs) will evaluate ODYSSEE-vCHAT versus eUC for primary and secondary outcomes. GLMs will be adjusted for baseline assessments and potential covariates. Interactions between treatment arm and gender will be examined for each outcome, using Bonferroni post-hoc comparisons for relevant subgroups. Significance in all tests will be p < 0.05, 2-sided.