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NCT ID: NCT02453256 Completed - Systemic Sclerosis Clinical Trials

A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)

focuSSced
Start date: November 20, 2015
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of tocilizumab compared with placebo in participants with SSc across approximately 120 planned global study sites. The study will consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind treatment with active tocilizumab or matching placebo. In the open-label period, eligible participants from either arm may receive active tocilizumab.

NCT ID: NCT02453100 Completed - Clinical trials for Urinary Incontinence

Managing Urinary Incontinence in Elderly Village Women in Rural Bangladesh

Start date: June 2015
Phase: N/A
Study type: Interventional

An intervention consisting of group and home based exercise will be used over 6 months to assess whether this is helpful in managing urinary incontinence in elderly village women in Bangladesh. This intervention, supplemented by education about managing incontinence, will be used in half the villages in the trial. In the other half women will receive only the education component.

NCT ID: NCT02452931 Completed - Clinical trials for Precocious Puberty, Central

Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty

Start date: August 31, 2015
Phase: Phase 3
Study type: Interventional

This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.

NCT ID: NCT02452762 Completed - Hypovitaminosis D Clinical Trials

Rapid Normalization of Vitamin D in Critically Ill Children: A Phase II Dose Evaluation Randomized Controlled Trial

VITdAL-PICU
Start date: January 2016
Phase: Phase 2
Study type: Interventional

Documented roles for vitamin D in calcium homeostasis, cardiovascular and respiratory health, inflammation, innate immunity, and neuromuscular function have led to the hypothesis that deficiency might represent a modifiable risk factor for outcomes in critical illness. In recent years, dozens of adult studies have reported both high deficiency rates, and associations between lower vitamin D levels and organ dysfunction, health resource utilization, and mortality in the intensive care unit (ICU). More recently, similar observations have been made in critically ill pediatric populations. The cumulative body of basic science and clinical literature demonstrates that deficiency is common in critical illness and rapid normalization of vitamin D status could improve clinical outcomes and/or reduce health care costs. However, before conducting a phase III trial to determine whether restoration of vitamin D status improves outcomes in the PICU, the appropriate dosing regimen must be identified. Consequently, the investigators propose a phase II, double blind randomized controlled trial to determine a loading therapy dosing regimen that can safely and rapidly normalize vitamin D status in critically ill children.

NCT ID: NCT02452190 Completed - Asthma Clinical Trials

Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils

Start date: September 28, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine the effect of reslizumab (110 mg) administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and adolescents with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care asthma therapy.

NCT ID: NCT02451566 Completed - Clinical trials for Abdominal Aortic Aneurysm

TriVascular Canadian LIFE Study: Least Invasive Fast-Track EVAR (Endovascular Aneurysm Repair)

Start date: November 2015
Phase:
Study type: Observational [Patient Registry]

The primary objectives of the LIFE Study are to demonstrate the clinical cost and benefits associated with using the Ovation Prime Abdominal Stent Graft System under the least invasive conditions defined in the Fast-Track EVAR protocol. The key elements of the Fast-Track EVAR protocol include: appropriate patient selection, bilateral percutaneous access, no general anesthesia, no ICU admission post procedure, and next day discharge.

NCT ID: NCT02451332 Completed - Pregnancy Clinical Trials

Prenatal Inflammation and Perinatal Outcomes

Start date: October 2015
Phase: N/A
Study type: Interventional

Preventing poor perinatal outcomes is the goal of all prenatal care, yet just who will go on to develop preeclampsia or have a growth-restricted baby is notoriously difficult to predict. A growing body of evidence suggests inflammatory markers can help predict poor outcomes, even prior to, and beyond, the current pregnancy. Our project will measure the response of one robust inflammatory marker, C-reactive protein (CRP), to a safe immune provocation recommended for all pregnant women (the seasonal influenza vaccine), and to find out whether CRP response is associated with increased risk for gestational hypertension, preeclampsia, preterm delivery, or birth weight. This work will help inform whether inflammatory markers should become part of routine prenatal care.

NCT ID: NCT02451137 Completed - Clinical trials for Diabetes Mellitus, Type 2

A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo (ACHIEVE CONTROL REAL LIFE STUDY PROGRAM)

Start date: June 16, 2015
Phase: Phase 4
Study type: Interventional

Primary Objective: Demonstrate clinical benefit of Toujeo in achieving individualized Healthcare Effectiveness Data and Information Set (HEDIS) glycated hemoglobin (HbA1c) targets (<8% if age >=65 years or with defined comorbidities or otherwise <7%) at 6 months without documented symptomatic (Blood Glucose <=70 mg/deciliter [mg/dL]) and/or severe hypoglycemia at any time of day from baseline to 6 months in uncontrolled insulin naive participants with type 2 diabetes initiating basal insulin therapy in a real world setting. Secondary Objectives: Compare Toujeo to other commercially available basal insulins at 6 months after initiating insulin therapy in a real world setting in terms of: - Participant persistence with assigned basal insulin therapy. - Risk of hypoglycemia including the incidence and rate of documented symptomatic and severe hypoglycemia. - Changes in HbA1c, fasting plasma glucose, body weight - Differences in participant and provider- reported outcomes (including Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs) and (DTSQc), Hypoglycemia Patient Questionnaire, and participant and provider reported Global Effectiveness Scale (GES). - Healthcare resource utilization including hospitalizations and emergency department or other provider visits and healthcare costs.

NCT ID: NCT02450825 Completed - Pneumonia Clinical Trials

Comparison of Three Scores for Ultrasound Assessment and Monitoring of Pulmonary Aeration

Start date: July 2015
Phase: N/A
Study type: Interventional

This study is designed to compare three ultrasound-based aeration scores that were previously validated in specific populations, and to assess their correlation with computed tomographic measurement of pulmonary aeration in a population with different pathologies. Hypothesis: The "Loss of Aeration Score" will be more accurate than a simplified version and another widely used score, the "Lung Ultrasound Score".

NCT ID: NCT02450747 Completed - Presbyopia Clinical Trials

Performance of a Multifocal Contact Lens - Presbyopia Study

Start date: April 2015
Phase: N/A
Study type: Interventional

This is a four week study to evaluate the performance of a multifocal contact lens in habitual wearers of silicone hydrogel multifocal contact lenses.