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NCT ID: NCT04122170 Completed - Healthy Clinical Trials

Phase 2B Study to Evaluate the Efficacy of Bentracimab (PB2452) in Reversal of Ticagrelor in Subjects Aged 50-80 Years Old

Start date: September 24, 2019
Phase: Phase 2
Study type: Interventional

This phase 2B study is a multi-center, randomized, double-blind, placebo-controlled study. The study is designed to evaluate the efficacy of bentracimab (PB2452) in reversing the anti-platelet effects of ticagrelor as part of a dual antiplatelet regimen and to evaluate the safety and tolerability of bentracimab (PB2452) in subjects aged 50-80 years old. A total of 205 subjects between 50-80 years old will be enrolled in the US or other countries at the discretion of the Sponsor across 5-15 sites. The subjects will be randomized at a ratio of 3:1 receiving either the bentracimab (PB2452) investigational study drug or placebo. Hence, a total of 154 subjects will be receiving bentracimab (PB2452) and approximately 51 subjects will be receiving placebo.

NCT ID: NCT04122105 Withdrawn - Clinical trials for Renal Transplant Failure

PDE5i Use in Renal Transplant Recipients

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Ischemia-reperfusion (IRI) injuries are common in renal transplantation and cause poor patient outcomes. Ischemia occurs after the donor's death and reperfusion occurs after kidney implantation. The donor kidney undergoes warm ischemia (WIT) after blood circulation stops and cold ischemia (CIT) when subjected to cold storage during transportation. Decreased blood flow leads to waste product accumulation and cellular damage. During reperfusion, reactive oxygen radicals and inflammatory processes further damage the kidney. PDE5 inhibitors increase renal blood flow and could protect the kidney during transplantation. Our study assesses the utility of giving these drugs perioperatively to reduce the effects of IRI injury.

NCT ID: NCT04121806 Recruiting - Colitis, Ulcerative Clinical Trials

Diet Intervention Treatment for Active Ulcerative Colitis

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if a sustainable non-elemental diet can be used as a probiotic tool to alter the dysbiotic microbiome found in individuals with ulcerative colitis and thereby decrease disease activity.

NCT ID: NCT04121611 Recruiting - Clinical trials for Optical Coherence Tomography

Optical Coherence Tomography Guided Antithrombotic Treatment After Endovascular Thrombectomy of the Posterior Circulation

Start date: October 14, 2019
Phase: N/A
Study type: Interventional

Evidence regarding the role of early (<24 hours) antithrombotics post-revascularization with either intravenous thrombolysis (IVT), endovascular thrombectomy (EVT), or a combination of both remains scarce. In 2018 the American Heart Association/American Stroke Association changed their recommendation, stating that the risk of antithrombotic therapy within the first 24 hours after treatment with IVT (with or without EVT) is uncertain. This was changed after data emerged that early antithrombotics may be safe and may improve outcomes in select patients undergoing EVT. Recently the investigators showed for the first time that significant residual basilar thrombus can exist after EVT despite complete angiographic revascularization using endovascular optical coherence tomography imaging. This residual thrombus could cause ongoing function-limiting strokes with occlusion of vital basilar perforators after EVT. Therefore, the investigators propose a prospective,non-randomized safety study to evaluate optical coherence tomography guided antithrombotic management for patients with confirmed residual thrombus after EVT for basilar occlusion.

NCT ID: NCT04121468 Recruiting - Clinical trials for Multiple Sclerosis (MS)

A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children With Multiple Sclerosis

Start date: February 24, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

A randomized multiple baseline feasibility trial where participants will start taking metformin at one of 3 randomly determined points (3-months, 6-months or 9 months) during the 12-month trial. All subjects will be on a daily dose of metformin for a minimum of 3 months and a maximum of 9 months.

NCT ID: NCT04121169 Recruiting - Clinical trials for Clostridium Difficile Infection (CDI)

Treatment of Mild-moderate Clostridium Difficile Infection (CDI)

IM-01
Start date: October 4, 2019
Phase: Phase 2
Study type: Interventional

Patients diagnosed to have mild-moderate CDI will be randomized to receive IM-01 egg-derived anti-C. difficile polyclonal antibodies in increasing dosages, twice daily, for a total of 10 - 14 days. Resolution of diarrhea and other symptoms and fecal test parameters will be used to assess clinical effectiveness of Immunotherapy with IM-01 antibodies. Patients will be followed for recurrence of CDI. Subjects who are assessed as non-respondents to IM-01 will be reassessed and treated with standard of care CDI antibiotics for 10 -14 days.

NCT ID: NCT04120324 Completed - Osteoarthritis, Hip Clinical Trials

Incidence of 30 Day Return to Hospital Following Same Day Discharge Total Hip Arthroplasty

Start date: October 15, 2018
Phase:
Study type: Observational

Amongst patients who are discharged home from hospital on the same day as their elective Primary Total Hip Arthroplasty, the Investigators seek to quantify the incidence of return to hospital within 30 days of surgery for assessment &/or treatment of surgical related problems or complications. This incidence rate will be compared to a cohort of patients who are not discharged on the same day as their Primary Total Hip Arthroplasty. The Investigators wish to know if the incidence of 30 day return to hospital is significantly different between these two groups of patients.

NCT ID: NCT04120038 Completed - Clinical trials for Unilateral Trans Tibial/Femoral Lower Limb Amputation

Self-Management for Amputee Rehabilitation Using Technology

SMART
Start date: January 26, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effect of 6 weeks of the SMART Program on the walking capacity and confidence of individuals with unilateral lower limb amputation (LLA). Our primary hypothesis is that SMART can improve walking capacity in individuals with LLA. Our secondary hypothesis is that SMART can improve ambulation confidence, body function, depression, body image, pain, balance confidence, activities of daily living, satisfaction with life and habit formation for skin monitoring and prosthetic cleaning in individuals with LLA. A post-intervention one on one interview will be conducted to understand SMART acceptability. The entirety of the study, including intervention administration, assessment, and interviews will be conducted online.

NCT ID: NCT04119934 Recruiting - Smoking Cessation Clinical Trials

Personalized Smoking Cessation Infographic in COPD

Start date: January 9, 2023
Phase:
Study type: Observational

This study assesses the effect of a personalized smoking cessation infographic on physician smoking cessation counseling rates and smoking cessation pharmacotherapy prescription rates. The study assesses the difference in physician behaviour using an interrupted time series analysis (one-year pre vs. one-year post-intervention). General practitioners, nurse practitioners and respirologists who refer eligible patients (COPD, active smoking) for spirometry at the St. Michael's Hospital Pulmonary Function Lab will receive the infographic. This is a quality improvement initiative. The smoking cessation infographic uses individualized patient data (height, weight, sex, baseline FEV1, etc.) to produce a personalized lung function decline prediction over the next 15 years.

NCT ID: NCT04119492 Recruiting - Clinical trials for Autism Spectrum Disorder

DCD & ASD Imaging Intervention Study

Start date: February 20, 2019
Phase: N/A
Study type: Interventional

Developmental Coordination Disorder (DCD) is a neurodevelopmental disorder that affects a child's ability to learn motor skills, such as tying shoelaces, learning to print, or riding a bicycle (APA 2013). It often co-occurs with other conditions, such as Attention Deficit Hyperactivity Disorder (ADHD). Its high co-occurrence with Autism Spectrum Disorder (ASD) has only been permitted since 2013 so it is less well known. Recent neuroimaging studies have begun to unravel the neural underpinnings of each disorder; however, few brain imaging studies have included children with co-occurring DCD and ASD. The first aim of the proposed project is to understand brain structure and function in children with DCD+/-ASD. Despite high co-occurrence of DCD and ASD (Green 2009), motor impairment and functional problems are rarely the focus of therapy for children with ASD. Current best-practice for improving motor function is an approach called Cognitive Orientation to Occupational Performance (CO-OP). The second aim of this study is to examine effectiveness of this treatment approach for children with DCD+ASD and determine if there are brain changes and improvements in motor skills as a result of intervention. This novel project is the first to integrate brain imaging and motor-based rehabilitation in this population and builds on a current study examining brain changes in children with DCD (with and without co-occurring ADHD). Examining the neural basis of these motor difficulties in the presence or absence of co-occurring conditions will help to determine the neural correlates specific to DCD and whether the response to treatment differs in children with co-occurring conditions.