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NCT ID: NCT02201342 Completed - Clinical trials for Single Ventricle Heart Disease After Fontan Surgery

Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents

Start date: July 2014
Phase: Phase 1/Phase 2
Study type: Interventional

To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular performance, and vascular function.

NCT ID: NCT02201251 Completed - Epilepsy Clinical Trials

A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy

Start date: October 6, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety of topiramate monotherapy compared with levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or recent-onset epilepsy (seizure disorder) on pediatric growth and maturation, bone mineralization, and kidney stone formation in children aged 2 to 15 years.

NCT ID: NCT02201186 Completed - Pouchitis Clinical Trials

To Determine the Effect of Honey Enema in the Treatment of Patients With Acute Pouchitis

Start date: October 2014
Phase: Phase 2
Study type: Interventional

Patients with a bowel condition called ulcerative colitis have bowel surgery in which a portion of their bowel is removed and the reconnected at the small bowel to the anus. Sometimes, after the surgery, this connection part, the pouch, would be inflamed in a condition called Acute Pouchitis. Physicians usually treat them by prescribing antibiotics; however, some patients do not respond and need additional surgery. In this study, we will test an alternative treatment for this complication by performing manuka honey enemas twice a day for 30 days. This is a pilot study and ten patients will undergo enema treatment.

NCT ID: NCT02200796 Completed - Obesity Clinical Trials

Role of Dietary Protein on Satiety, Food Intake and Thermic Effect of Food

Start date: April 2014
Phase: N/A
Study type: Interventional

Objectives: To determine the effect of protein content of familiar breakfast meals on subjective appetite, food intake (FI), glycemic response and Thermic Effect of Food (TEF) in normal weight (NW) and overweight (OW)/obese (OB) children. Specific Objectives: 1a.To determine the effect of familiar breakfast meals (450 kcal containing eggs and varying in protein content (15, 30, and 45g) on subjective appetite, glycemic response and food intake at a test meal 4 h later in NW and. OW/OB children. 1b. To describe the effect of isocaloric (450 kcal) familiar breakfasts either high in protein (optimal protein from Objective 1a) or low in protein on TEF and substrate utilization over 5 h in NW and OW/OB children.

NCT ID: NCT02200770 Completed - Clinical trials for Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders

Start date: April 1, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

To compare the efficacy of inebilizumab (MEDI-551) versus placebo in reducing the risk of an neuromyelitis optica/neuromyelitis optica- spectrum disorders (NMO/NMOSD) attack in participants with NMO/NMOSD.

NCT ID: NCT02200614 Completed - Clinical trials for Castration-Resistant

Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

ARAMIS
Start date: September 12, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.

NCT ID: NCT02200601 Completed - Healthy Clinical Trials

Pre-Market Algorithm Validation Study

Start date: July 2014
Phase: N/A
Study type: Interventional

The study sponsor has developed a patented medical device called Seipher Wellness. This is a non-invasive medical device that assesses heart health based on established cardiac parameters; timing events of the cardiac cycle. These are specific parameters captured and analyzed by the device. A ratio of two specific timing parameters provides an assessment of the subject's overall heart health. The aim of this study is to validate the device algorithm across a range of subjects.

NCT ID: NCT02200419 Completed - Heart Diseases Clinical Trials

POC - Transfusion Algorithm Cardiac Study

TACS
Start date: October 2014
Phase: N/A
Study type: Interventional

This multi-centre study will provide sound, generalizable data on the effectiveness of a POC-based algorithm to determine to what extent this guideline can reduce blood product transfusions. Investigators will study outcomes in 7000 patients undergoing heart surgery at 10 participating hospitals. The proposed trial addresses several important research and clinical issues and has the potential to markedly improve the transfusion management and surgical care in general of cardiac surgery patients. The intervention will be a novel POC-based algorithm that has been shown in a pilot study by us to be associated with a substantial reduction in blood product transfusions. The algorithm will employ viscoelastic and aggregometric POC-tests and an objective measure of blood loss. The primary outcome will be avoidance of red blood cell transfusion during hospitalization. The study has a 90% power to detect a 12% increase in avoidance rate. Secondary outcomes will include avoidance of red blood cell use and other blood products (plasma, platelets, and cryoprecipitate), units of blood products transfused, and adverse clinical outcomes related to transfusion (acute kidney injury, infections, and death). Data will also be collected for future health-economics analyses. Largely due to the limitations of existing evidence, however, such algorithms are rarely used in clinical practice. The proposed trial will provide sound, generalizable data on the effectiveness of a POC-based algorithm to guide their future use. An integrated blood management algorithm that employs POC coagulation tests will reduce blood product transfusions in cardiac surgery, thereby improving clinical outcomes. Does an integrated blood transfusion algorithm that employs POC coagulation tests applied across a network of hospitals reduce blood transfusions and associated adverse outcomes in cardiac surgery?

NCT ID: NCT02200406 Completed - Depression Clinical Trials

Desvenlafaxine in Opioid-Dependent Patients

Start date: July 2014
Phase: Phase 4
Study type: Interventional

Background: Although substitution therapy has been shown to be highly effective to retain opioid-dependent patients in treatment and reduce drug use, this population is afflicted by numerous conditions including depression. Unfortunately, studies published thus far have reported inconsistent or no difference in response between placebo therapy and antidepressants such as selective serotonin reuptake inhibitors. Objective: To assess the feasibility of Desvenlafaxine (DESV) administration among opioid-dependent subjects and explore its effect on depressive symptoms. Methods: Open-label pilot trial of 8 weeks of DESV 50-100 mg/day in 20 methadone-maintained individuals with comorbid depressive symptoms at the Centre hospitalier de l'Université de Montréal. Significance: This pilot study will lay down the foundation on which a larger multisite clinical trial could be conducted to examine DESV as new treatment for opioid-dependent population with comorbid depression.

NCT ID: NCT02200172 Completed - Cancer Clinical Trials

The Preventative Role of Exogenous Melatonin Administration in Patients With Advanced Cancer Who Are at Risk of Delirium: a Feasibility Study

Start date: December 2014
Phase: Phase 2
Study type: Interventional

The purpose of this feasibility study is to inform a larger randomized, placebo-controlled, double blind, parallel-group, single-centre trial of an oral, daily administered single dose of melatonin to prevent delirium in patients with advanced cancer.