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NCT ID: NCT05090384 Recruiting - Adverse Effects Clinical Trials

Pediatric GVHD Low Risk Steroid Taper Trial

Start date: October 20, 2022
Phase: Phase 2
Study type: Interventional

The standard treatment for acute graft-vs-host disease (GVHD) is to suppress the activity of the donor immune cells using steroid medications such as prednisone. Although most GVHD, especially in children, responds well to treatment, sometimes (around 1/3 of the time) there is either no response to steroids or the response does not last. In those cases, the GVHD can become dangerous and even life-threatening. Unfortunately, doctors cannot predict who will have a good response to treatment based on symptom severity or initial response to steroids. As a result, nearly all children who develop GVHD are treated with long courses of high dose steroids even though that means many patients receive more treatment than they probably need. Steroid treatment can cause short-term complications like infections, high blood sugar, high blood pressure, muscle weakness, depression, anxiety, and problems sleeping and long-term complications like bone damage, cataracts in the eyes, and decreased growth. The risk of these complications increases with higher doses of steroids and longer treatment. It is important to find ways to decrease the steroid treatment in patients who do not need long courses. The doctors conducting this research have developed a blood test (GVHD biomarkers) that predicts whether a patient will respond well to steroids. The study team found that children who have low GVHD biomarkers at the start of treatment and for the first two weeks of treatment have a very high response rate to steroids. In this study, the study team will monitor GVHD symptoms and biomarkers during treatment and taper steroids quickly in patients who have GVHD that is expected to respond very well to treatment. The study team will assess how many patients respond well to lower steroid dosing and what steroid complications develop. The study team will also use surveys to obtain the patient's own assessment of their quality of life (down to age 5 years).

NCT ID: NCT05090371 Recruiting - Clinical trials for Relapsing-Remitting Multiple Sclerosis

A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation

SOSTOS
Start date: March 2, 2022
Phase: Phase 4
Study type: Interventional

This study will evaluate if relapsing-remitting MS patients that have not had a relapse in the past year would benefit from a switch to ofatumumab versus staying on their continued current therapy. This study will also look at whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from a switch to ofatumumab.

NCT ID: NCT05089604 Recruiting - Clinical trials for Liver Transplantation

Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release Formulations

LCP-TAC
Start date: January 9, 2023
Phase: Phase 4
Study type: Interventional

This is a randomized open label study in de novo liver transplant recipients that aims to compare the risk of tacrolimus induced tremors with once daily extended-release formulation, Envarsus, versus the twice daily immediate-release formulation. Both formulations of tacrolimus are currently approved for the prevention of rejection in liver transplant patients.

NCT ID: NCT05088863 Recruiting - Clinical trials for Health Claim Implementation

Survey Assessing How Consumers Adapt Their Diet in Response to Health Claim Messaging

Start date: March 3, 2022
Phase: N/A
Study type: Interventional

A survey designed to examine how consumers adapt their diet in response to health claim messaging.

NCT ID: NCT05087693 Recruiting - Ozone Air Pollution Clinical Trials

Salbutamol Use in Ozone Air Pollution by People With Asthma and/or Exercise Induced Bronchoconstriction (EIB)

Start date: November 1, 2021
Phase: Phase 4
Study type: Interventional

Salbutamol use is increased in areas with high levels of ozone pollution and the potential consequences of this are not well known. The purpose of this study is to examine the effect of salbutamol on lung function and inflammation in people with asthma and/or EIB exercising in ozone air pollution. To examine this, we are planning a randomized cross over trial where people with asthma and/or EIB complete sub maximal exercise in four conditions on four separate days. The four condition are: ozone + salbutamol, filtered air + salbutamol, ozone + placebo medication, and filtered air + placebo medication.

NCT ID: NCT05086783 Recruiting - Surgery Clinical Trials

Video-based Coaching (VBC) in Gynecologic Surgery

Start date: October 6, 2021
Phase: N/A
Study type: Interventional

This multi-centre, randomized controlled trial aims to assess the role of video-based coaching (VBC) in residency education in gynecologic and gynecologic oncology surgery. It involves a trainee and a surgical coach, who together review a recording of the trainee performing a surgical skill or procedure and coaching is provided for skill improvement. Resident performance will be evaluated using a standardized scoring scale by two experienced surgeons before and after the intervention and compared to the control group receiving the standard surgical teaching curriculum.

NCT ID: NCT05086692 Recruiting - Ovarian Cancer Clinical Trials

A Beta-only IL-2 ImmunoTherapY Study

ABILITY-1
Start date: August 27, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.

NCT ID: NCT05085860 Recruiting - Atrial Fibrillation Clinical Trials

Acute Responses to Exercise in Females and Males With Symptomatic Atrial Fibrillation

ACUTE-AF
Start date: February 8, 2022
Phase: N/A
Study type: Interventional

The main purpose of this pilot project is to measure the feasibility of conducting a randomized crossover study examining short-term changes in atrial fibrillation (AF) symptoms in symptomatic females and males with paroxysmal or persistent AF when they engage in a standard week of exercise (i.e. moderate-intensity continuous training [MICT] or high-intensity interval training [HIIT]) compared to a control week (i.e. no moderate to vigorous exercise over 7 days).

NCT ID: NCT05085782 Recruiting - Fibromyalgia Clinical Trials

Reconsolidation Therapy With Propranolol as a Treatment for Chronic Pain

Start date: February 7, 2022
Phase: Phase 2
Study type: Interventional

The primary aim of this study is to document the feasibility and acceptability of an intervention consisting of pain neuroscience education and reconsolidation therapy with propranolol in adults suffering from chronic pain (chronic low back pain or fibromyalgia). The secondary aim of the study is to estimate the effect size of the intervention on pain and function one month post-intervention, and to obtain data for sample-size calculation for a subsequent randomized controlled trial.

NCT ID: NCT05085249 Recruiting - Heart Failure Clinical Trials

Improving Goal Directed Medical Therapy for Device Clinic Patients With Reduced EF at UOHI: a QI Initiative (VIGILANT)

VIGILANT
Start date: July 14, 2021
Phase:
Study type: Observational [Patient Registry]

This is a quality improvement initiative with the goal of optimizing heart failure (HF) patients seen through the outpatient cardiac implantable electronic device clinic at the University of Ottawa Heart Institute (UOHI). The UOHI device clinic oversees more than 12,000 in-clinic patient visits annually with over 5000 visits for patients with reduced ejection fraction (EF) and HF. In patients with reduced EF, guideline directed medical therapy compliance (GDMT) is sub-optimal in real world clinical practice. Considering the most recent changes to The Canadian Cardiovascular Society heart failure guideline recommendations, the compliance rate may be even lower than reported rates in the literature. The goal of this study is to optimize GDMT through collaboration between the HF clinic, a HF/arrhythmia nurse practitioner, and application of a nurse run algorithm based pathway to identify patients suitable for medication optimization and guiding the most responsible physician (MRP) for their heart failure (PCP, cardiologist or HF physician) through a letter. The compliance rate will also be re-evaluated to assess improvement in GDMT in this patient population. GDMT will ensure the greatest chance to improve patient outcomes by reducing heart failure hospitalizations, emergency room visits, ventricular arrhythmias, implantable cardioverter defibrillator shocks, clinic visits, and thereby improving patients' quality of life.