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NCT ID: NCT02799693 Completed - Clinical trials for Recurrent Ventricular Tachycardia

Intramural Needle Ablation for Ventricular Tachycardia

Start date: July 2016
Phase:
Study type: Observational

This is a single-arm non-randomized prospective observational cohort study to assess the outcomes of patients undergoing intramural needle catheter ablation of recurrent ventricular tachycardia that has failed antiarrhythmic drug therapy and standard radiofrequency (RF) catheter ablation. Following ablation, patients will be monitored for 6 months. The duration of the study is up to 4 years.

NCT ID: NCT02799615 Completed - Colitis, Ulcerative Clinical Trials

Anti-TNF Therapy for Refractory Colitis in Hospitalized Children

ARCH
Start date: May 2016
Phase:
Study type: Observational

This multicenter study is being conducted to determine whether infliximab exposure after an initial infusion is predictive of early clinical response in hospitalized pediatric patients with severe steroid-refractory UC or IBD-U. This pilot and feasibility study will establish the infrastructure, demonstrate feasibility, and collect preliminary data to support the full study.

NCT ID: NCT02799602 Completed - Clinical trials for Metastatic Hormone-sensitive Prostate Cancer

Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

ARASENS
Start date: November 30, 2016
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide (ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone sensitive prostate cancer.

NCT ID: NCT02799095 Completed - Clinical trials for Advanced Solid Tumors

A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors

Start date: July 2016
Phase: Phase 1/Phase 2
Study type: Interventional

To better understand the safety and tolerability of ALKS 4230 in humans

NCT ID: NCT02799004 Completed - Acute Pain Clinical Trials

How Much Opioids Do You Need After Your Emergency Department Visit

Start date: June 7, 2016
Phase:
Study type: Observational

Pain is one of the most common complaints in emergency department (ED) and is still often poorly managed. A major prospective multicenter study reported that 74% of patients that had a pain complaint at ED triage are discharged in moderate to severe pain. Accordingly, physicians frequently prescribed analgesic after discharged for these patients, and opioid is given in 29% of ED visits involving pain complaints. However, few studies evaluate pain management after ED discharge: the frequency and length of opioids prescriptions, the opioids quantity taken by the patients, are the patients relieved and satisfied by these pain treatments, what are the adverse effects associated with the use of these medications, and what are the chances of developing addiction? The primary aim of this study is to determine the required minimal opioids prescription for patients treated for acute pain after being discharge from the ED. Secondary objectives include: 1) monitor the patients' adverse events during opioids treatment; 2) evaluate the patients' level of pain relief associated with their respective opioids treatment; 3) determine the patients' level of addiction following post-ED opioids treatments. The design of the project is a prospective observational cohort study. A cohort of consecutive ED patients aged 18 or more with an initial pain at triage of 4 or more and discharged from the ED in less than 48 hours with a prescription of opioid will be asked to participate in the study. Patients will be excluded if there is ongoing treatment for a pre-existing chronic pain condition or if they used opioid drugs in the past year. Research nurses will contact the patients by phone at three follow-up time points (1 week, 1 month, and 3 months). Follow-up phone interviews will evaluate pain intensity as well as pain treatment satisfaction (0-10 NRS), monitor adverse events, and investigate possible opioids addiction (SOWS: subjective opioid withdrawal scale). During these interviews, the nurses will also question the patients about their daily opioids usage and if they were relieved from pain. This study will provide the base for future guidelines regarding the prescription of opioids treatment for specific pathology encountered in ED. It will also give indications on how to adjust the treatments according to adverse events and the level of addiction experienced by patients.

NCT ID: NCT02798471 Completed - Pulmonary Embolism Clinical Trials

Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)

Start date: March 27, 2017
Phase: Phase 3
Study type: Interventional

This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE. This study is designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of edoxaban and to compare the efficacy and safety of edoxaban against standard of care in pediatric subjects with confirmed VTE.

NCT ID: NCT02798406 Completed - Glioblastoma Clinical Trials

Combination Adenovirus + Pembrolizumab to Trigger Immune Virus Effects

CAPTIVE
Start date: October 6, 2016
Phase: Phase 2
Study type: Interventional

Glioblastoma (GBM) and gliosarcoma (GS) are the most common and aggressive forms of malignant brain tumor in adults and can be resistant to conventional therapies. The purpose of this Phase II study is to evaluate how well a recurrent glioblastoma or gliosarcoma tumor responds to one injection of DNX-2401, a genetically modified oncolytic adenovirus, when delivered directly into the tumor followed by the administration of intravenous pembrolizumab (an immune checkpoint inhibitor) given every 3 weeks for up to 2 years or until disease progression. Funding Source-FDA OOPD

NCT ID: NCT02798250 Completed - Type 1 Diabetes Clinical Trials

Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation - Part 2

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

In previous studies, investigators have studied if a pre-meal insulin bolus based on estimated carbohydrate meal size would alleviate the burden of carbohydrate counting without a significant degradation in postprandial glucose control. With this strategy, the patient would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular, large or very large). It is however important to establish the safety of this simplified meal bolus approach. The safety of overestimating a meal insulin bolus in the context of closed-loop strategy needs to be assessed. For ethical reasons, only dual-hormone closed-loop will be tested. Investigators hypothesize that dual-hormone closed-loop with overestimated meal size bolus will not increase time below 4.0 mmol/L compared to dual-hormone closed-loop with an adequately estimated meal size bolus.

NCT ID: NCT02798094 Completed - Depressed Clinical Trials

Stress Sensitivity and Reward Responsivity in Depression

CAN-BIND-04
Start date: July 2015
Phase:
Study type: Observational

The goal of this project is to learn more about the different ways in which people process information that is stressful and rewarding, and how abnormalities in these two processes are related to depression.

NCT ID: NCT02797951 Completed - Clinical trials for Chronic Cluster Headache

A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache

Start date: July 13, 2016
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to assess the long-term safety and tolerability of galcanezumab administered up to once monthly in participants with episodic or chronic cluster headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM (NCT02438826).