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NCT ID: NCT02679248 Terminated - Pre-hypertension Clinical Trials

A Study to Investigate the Effect of a Nitric Oxide Supplementation on Pre- and Mildly Hypertensive Adults

15NBHN
Start date: February 3, 2016
Phase: Phase 2
Study type: Interventional

This study will investigate the effect of a nitric oxide supplementation product, Neo40 Daily®, on blood pressure in pre-hypertensive and mildly hypertensive adults. Subjects will take 2 lozenges per day 12 hours apart for 8 weeks. Half of the subjects will receive Neo40 Daily® and the other half of the subjects will receive placebo.

NCT ID: NCT02677714 Terminated - Breast Cancer Clinical Trials

99mTc-rhAnnexin V-128 Imaging and Cardiotoxicity in Patients With Early Breast Cancer

Start date: November 2, 2016
Phase: Phase 2
Study type: Interventional

This was a single center, proof-of-concept (PoC), Phase II study. Patients with histologically confirmed early stage (Stage I, II or III) HER-2 negative breast cancer and scheduled to receive doxorubicin-based (neo)adjuvant therapy to be followed by paclitaxel or docetaxel as per clinical practice. The planned doxorubicin-based chemotherapy treatment consisted of doxorubicin 60 mg/m2 in combination with cyclophosphamide 600 mg/m2 (AC) intravenous (IV) every 2 or 3 weeks for 4 cycles. Patients were scheduled for CMRI and 99mTc-rhAnnexin V-128 imaging (planar and SPECT / CT) at the following visits: 1. Screening/baseline, i.e. 2 weeks prior to initiating AC treatment (Visit 1) 2. After the 2nd and before the 3rd cycle of AC treatment (Visit 2) 3. After the 4th cycle of AC treatment and within 2 weeks (Visit 3) 4. At 12 weeks after the 4th cycle of AC treatment (Visit 4). The imaging procedures were conducted and analyzed. Bloodwork for cardiotoxicity biomarkers (troponin, N terminal pro B-type natriuretic peptide [NT-proBNP]) was performed at each visit.

NCT ID: NCT02674958 Terminated - Clinical trials for Hypertrophic Obstructive Cardiomyopathy

Mobilization of Endothelial Progenitor Cells and Aspirin

TROPHIC 3
Start date: May 2016
Phase: Phase 3
Study type: Interventional

Aspirin at doses used during acute myocardial infarction may inhibit the mobilization of endothelial progenitor cells (EPCs).

NCT ID: NCT02673892 Terminated - Clinical trials for Chronic Obstructive Pulmonary Disease

Patient Oriented Discharge Summary Impact Study

PODS
Start date: February 2016
Phase: N/A
Study type: Interventional

Improving the patient experience has become a major focus of quality improvement efforts in Ontario and in health systems worldwide. However, our existing knowledge base is relatively under-developed, particularly in how patients experience care as they transition from one care setting to another and the relationship between patient experience and clinical outcomes. The Patient Oriented Discharge Summary (PODS) is a discharge instruction tool created by patients, caregivers, health-care providers and design experts. It provides a written template for providers to engage patients and caregivers when reviewing important instructions on medications, activity and diet restrictions, follow-up appointments and worrisome symptoms warranting emergency care following admission to hospital. The PODS also uses plain and simple wording, large fonts, pictograms, and includes white space for patients to take notes and provides the option for translation of major headings into the most common spoken languages. The PODS impact study will study the impact of using the PODS versus usual discharge instructions on patient experience and health outcomes in a provincial-wide randomized study across acute care and rehabilitation hospitals.

NCT ID: NCT02673697 Terminated - Aortic Stenosis Clinical Trials

Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement

PERSIST-AVR
Start date: March 22, 2016
Phase: N/A
Study type: Interventional

Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively. The trial will enroll up to 1234 subjects, but accrual may stop earlier at approximately 900 or 1050 subjects These subjects will be enrolled at approximately 60 worldwide investigational sites where the device is commercially available The primary objective of this trial is to test the safety and efficacy of Perceval versus standard sutured stented bioprosthetic aortic valves among the intended trial population.

NCT ID: NCT02670759 Terminated - Postoperative Pain Clinical Trials

Continuous Thoracic Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery

Start date: March 2016
Phase: N/A
Study type: Interventional

This study is designed to assess: - The impact of continuous thoracic paravertebral nerve blockade compared to intercostal nerve blockade on the intensity of postoperative pain following VATS in subjects having a Patient Controlled Analgesia (PCA) device as their primary analgesic modality. - The impact of continuous thoracic paravertebral analgesia on length of stay, opioid intake, respiratory function, incidence of side-effects and postoperative complications. The basic hypothesis of this study is that continuous thoracic paravertebral nerve blockade will provide superior postoperative analgesia following VATS when compared to intercostal nerve blockade in patients having a PCA device as their primary analgesic modality. Superior quality of analgesia should contribute to preserve pulmonary function, reduce opioid intake and related side-effects and shorten the hospital stay.

NCT ID: NCT02670083 Terminated - Alzheimer's Disease Clinical Trials

A Study Evaluating the Efficacy and Safety of Crenezumab Versus Placebo in Participants With Prodromal to Mild Alzheimer's Disease (AD).

CREAD
Start date: March 22, 2016
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose. Participants will then have the option to enter the Open Label Extension (OLE) study if eligible. Participants who do not enter the OLE study will have additional follow-up visits at 16 and 52 weeks after the last dose, primarily for safety and also for limited efficacy assessments.

NCT ID: NCT02669849 Terminated - Clinical trials for Cervical Spinal Cord Injury

Study to Assess the Efficacy and Safety of VX-210 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

Start date: July 2016
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of VX-210 in subjects with Acute Traumatic Cervical Spinal Cord Injury. Secondary objectives include the specific evaluation of the effects of VX-210 on neurological recovery and daily function after spinal cord injury.

NCT ID: NCT02667457 Terminated - Clinical trials for Carotid Artery Plaque

99mTc-rhAnnexin V-128 Imaging for Carotid Atherosclerosis

Start date: June 23, 2016
Phase: Phase 2
Study type: Interventional

This was a single-center, single-dose, study comprising a Proof of Concept (PoC) part and a subsequent Phase II part. The study was being done to assess the ability of the radiotracer 99mTc-rhAnnexin V-128 to image atherosclerotic plaque that might rupture and break off artery walls. This is caused by apoptosis or cell death in the plaque. These ruptured plaques can block blood circulation in the arteries causing a lack of oxygen to the tissues. Atherosclerotic plaques can build up on any artery in the body.

NCT ID: NCT02667327 Terminated - Clinical trials for Diabetic Foot Ulcers

A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer

Start date: November 21, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Granexin gel is safe and effective in the treatment of diabetic foot ulcers.