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NCT ID: NCT02784132 Completed - Fundoscopy Clinical Trials

Video Diversion Improves Success Rate of Fundoscopic Examination in Children

Start date: June 2012
Phase: N/A
Study type: Interventional

Fundoscopy is an important component of the neurological examination as it can detect pathologies such as high intracranial pressure. However, the exam can be challenging in uncooperative children. This study looked at whether playing a video during eye examination, improves the success, duration and ease of pediatric fundoscopy.

NCT ID: NCT02783729 Completed - Insomnia Clinical Trials

Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder (SUNRISE 1)

SUNRISE 1
Start date: May 31, 2016
Phase: Phase 3
Study type: Interventional

This study will be conducted to demonstrate, using polysomnography, that lemborexant 10 milligrams (mg) and 5 mg is superior to placebo on objective sleep onset as assessed by latency to persistent to sleep (LPS) after the last 2 nights of 1 month of treatment in participants 55 years and older with insomnia disorder.

NCT ID: NCT02783482 Completed - Clinical trials for Immunologic Deficiency Syndromes

Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency

Start date: October 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID).

NCT ID: NCT02783313 Completed - Thrombocytopenia Clinical Trials

Pathogen Reduction Evaluation & Predictive Analytical Rating Score

PREPAReS
Start date: November 17, 2010
Phase: N/A
Study type: Interventional

The objective of this study is to determine if pooled buffy coat-derived pathogen reduced plasma-stored platelet concentrates are non-inferior compared to plasma-stored platelet concentrates in terms of WHO bleeding complications in hemato-oncological patients with thrombocytopenia.

NCT ID: NCT02783300 Completed - Neoplasms Clinical Trials

An Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Participants With Solid Tumors and Non-Hodgkin's Lymphoma

Meteor 1
Start date: August 30, 2016
Phase: Phase 1
Study type: Interventional

This first time in human (FTIH) open-label, dose escalation study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in participants with advanced or recurrent solid tumors, as well as clinical activity in participants with a subset of solid tumors and non-Hodgkin's lymphoma (NHL).

NCT ID: NCT02782936 Completed - Work of Breathing Clinical Trials

The Gas Mask: the Effects on Respiration!

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

Background: The gas mask is used to protect military and non-military subjects exposed to respiratory hazards (CBRN agents). The aim of the study was to evaluate the impact of the gas mask on respiratory patterns and indexes of the respiratory effort. Methods: We are completing our study with 14 healthy subjects to evaluate breathing patterns, index of respiratory efforts and blood gases. Seven conditions have been tested in a randomized order: at rest, during effort (on a tread mill, standardized at 7 METs for all subjects) and during induced hypoxemia with and without a mask (C4, Airboss Defence, Bromont, Canada). Airway pressure, inspiratory and expiratory flows were measured. An esophageal catheter was introduced at the beginning of the study to measure esophageal pressure (Peso) and calculate indexes of respiratory effort (PTPeso, WOB). SpO2 was continuously measured and capillary blood bases were drawn at the end of each condition. Each condition lasted 10 minutes, data of the last 2 minutes at a steady state were considered for analyses. Results: The preliminary analyses based on 10 subjects are presented here. Comparing the wearing of the gas mask and without, most of the respiratory index increased in the tested conditions (at rest, during induced hypoxemia and during effort). At rest, in 8 out of 10 healthy subject the indexes of effort were higher with the gas mask, a statistical trend was observed with the WOB (0.22±0.13 vs. 0.28±0.10 J/cycle; p = 0.059), the PTPes (101±35 vs. 122±47 cmH2O*s; p=0.21) and SwingPeso (4.4±2.0 vs. 5.3±2.0 cmH2O; p=0.13). During the effort, the respiratory index increased (WOB 4.0±2.6 vs. 5.6±3.2; p=0.10; PTPeso 406±211 vs. 606±65; p=0.04; SwingPeso 14.8±8.1 vs. 21.8±9.0; p=0.13). There was no difference for the breathing pattern and arterial blood gases data with and without mask. Data for induced hypoxemia are under analysis. We measured on bench the inspiratory and expiratory resistances of the tested gas mask (C4: inspiratory resistances = 3.2 cmH2O at 1 L/sec; expiratory resistances = 0.9 cmH2O at 1 L/sec). This may explain in part the increased work of breathing with masks. Conclusions: This study demonstrated an increase of the indexes of respiratory effort during an exercise with the gas mask. This study is the first to directly assess the indexes of efforts with esophageal pressure in this situation. Our results and method may be used as a reference for evaluating tolerance with different designs of gas masks.

NCT ID: NCT02782741 Completed - Clinical trials for Glycogen Storage Disease Type II;Pompe's Disease

Study to Compare the Efficacy and Safety of Enzyme Replacement Therapies Avalglucosidase Alfa and Alglucosidase Alfa Administered Every Other Week in Patients With Late-onset Pompe Disease Who Have Not Been Previously Treated for Pompe Disease

COMET
Start date: November 2, 2016
Phase: Phase 3
Study type: Interventional

Primary Objective: To determine the effect of avalglucosidase alfa treatment on respiratory muscle strength measured by percent (%) predicted forced vital capacity (FVC) in the upright position, as compared to alglucosidase alfa. Secondary Objective: To determine the safety and effect of avalglucosidase alfa treatment on functional endurance (6-minute walk test, inspiratory muscle strength (maximum inspiratory pressure), expiratory muscle strength (maximum expiratory pressure), lower extremity muscle strength (hand-held dynamometry), motor function (Quick Motor Function Test), and health-related quality of life (Short Form-12).

NCT ID: NCT02782611 Completed - Happiness Clinical Trials

Enduring Happiness and Continued Self-Enhancement

ENHANCE
Start date: April 2016
Phase: N/A
Study type: Interventional

Over the past several decades, a new science of subjective well-being has produced insights into the factors that make people happy—from cultivating strong relationships to pursuing the right goals. Drawing on these empirical findings, the investigators created a comprehensive 12-week intervention program, ENHANCE: Enduring Happiness and Continued Self-Enhancement. The investigators multimodal program is designed to teach people essential skills in order to produce sustainable changes in behavior and, as a result, long-lasting increases in happiness. To test the effectiveness of ENHANCE, the investigators designed a six-month randomized clinical trial. Participants will be assigned to an active treatment group or a waiting group control. They will complete baseline assessments, and follow-up assessment at three and six months after the start of the intervention. These assessments will contain measures of subjective well-being and objective measures of health, as well as a variety of psychological mediators (e.g., psychological needs) and moderators (e.g. personality). The investigators will thus be able to explore not only whether ENHANCE works to improve well-being, but also why and how ENHANCE works.

NCT ID: NCT02782104 Completed - Clinical trials for Depressive Disorder, Treatment-Resistant

A Long-term Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression

SUSTAIN-3
Start date: June 9, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of esketamine nasal spray in participants with treatment-resistant depression (TRD).

NCT ID: NCT02781844 Completed - Hypoparathyroidism Clinical Trials

Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism

PARALLAX
Start date: April 3, 2017
Phase: Phase 1
Study type: Interventional

This study is being conducted to characterize the effects of twice daily administration of rhPTH(1-84) on the way the body handles rhPTH(1-84) as well as its actions and safety and tolerability over the course of 24 hours as compared with the current once daily dosing regimen of marketed rhPTH(1-84) (marketed in the United States as Natpara® and in the EU as Natpar).