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NCT ID: NCT02565576 Completed - Clinical trials for Myasthenia Gravis, Generalized

Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia Gravis

Start date: September 29, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics/pharmacodynamics and efficacy of CFZ533 as an add-on therapy to standard of care in patients with moderate to severe myasthenia gravis (MG).

NCT ID: NCT02565277 Completed - Clinical trials for Systemic Inflammatory Response

The Effect of Influenza Vaccination on the Systemic Inflammatory Response and Myocardial Protection in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial

Start date: September 2015
Phase: Phase 4
Study type: Interventional

To assess the impact of influenza vaccination on the overall systemic inflammatory response in patients undergoing cardiac surgery and investigate functional and clinical outcomes in vaccinated patients postoperatively.

NCT ID: NCT02564809 Completed - Clinical trials for Mild Cognitive Impairment

Cognitive Brain Training in Older Adults

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

The investigators will conduct a 8-week proof-of-concept randomized controlled trial to provide preliminary evidence of efficacy of Fit Brains (Rosetta Stone Canada) training -- a mobile cognitive training program -- on cognitive and brain plasticity in older adults. The investigators will also explore whether Fit Brains training paired with a brief bout of exercise would enhance the potential cognitive benefits of Fit Brains. In addition, the investigators will explore the long-term effects of cognitive training by performing a 1-year follow-up measurement (i.e., 1-year after study completion).

NCT ID: NCT02564705 Completed - Clinical trials for Isthmic Spondylolisthesis

Comparative Study of Anterior vs. Posterior Surgical Treatment for Lumbar Isthmic Spondylolisthesis

I-Spondy
Start date: March 2016
Phase:
Study type: Observational

The aim of this study is to compare outcomes and cost-effectiveness of anterior versus posterior surgical treatment for lumbar Isthmic Spondylolisthesis. The primary objective is to compare treatment effectiveness in terms of functional outcomes as measured by Oswestry Disability Index (ODI) v2.1a and to compare safety outcomes measured by treatment-related adverse events. Secondary objectives are to compare treatments in terms of differences in pain, quality of life, health utilities, and need for re-operation. Finally, a cost-effectiveness analysis will be performed. This analysis will take the form of cost-effectiveness if there is a difference in treatment effects or cost-minimization if there is no difference in treatment efficacy.

NCT ID: NCT02564276 Completed - Clinical trials for Endometrial Neoplasms

Indocyanine Green Versus Blue Dye for Detection of Sentinel Lymph Node In Endometrial Cancer

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

To determine the difference in the proportion of hemipelves with successful detection of Sentinel Lymph Node according to the dye used (indocyanine green with near-infrared imaging vs blue dye) in women with endometrial cancer.

NCT ID: NCT02564055 Completed - Dermatitis, Atopic Clinical Trials

A Dose-Finding Study of GSK2894512 Cream in Subjects With Atopic Dermatitis (AD)

Start date: December 1, 2015
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of two concentrations (0.5 percent [%] and 1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the topical treatment in adolescent and adult subjects with atopic dermatitis. Results from this study will be considered when selecting the most appropriate concentration of GSK2894512 cream and application frequency in future clinical studies. This is a multicenter (United States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled, 6-arm, parallel-group, dose-finding study in adolescent and adult subjects with atopic dermatitis. Two concentrations of GSK2894512 cream (0.5% and 1%) and a vehicle control cream will be equally randomized and evaluated following application to all atopic dermatitis lesions (except on the scalp) once daily (evening) or twice daily (morning and evening) for 12 weeks. This study will consist of 3 periods: up to 4 weeks screening, 12 weeks double-blind treatment, and 4 weeks post-treatment follow-up. The total duration of subject participation will be approximately 16 to 20 weeks. Approximately 270 adolescent and adult males and females subjects with atopic dermatitis will be screened in order to have at least 228 randomized subjects (38 subjects for each of the 6 treatment groups) and approximately 204 evaluable subjects overall. Approximately 30 subjects will be randomized in Japan to achieve at least 24 evaluable Japanese subjects.

NCT ID: NCT02564042 Completed - Psoriasis Clinical Trials

A Dose-Finding Study of GSK2894512 Cream in Subjects With Plaque Psoriasis

Start date: November 23, 2015
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of two concentrations (0.5 percent [%] and 1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the topical treatment in subjects with plaque psoriasis. Results from this study will be considered when selecting the most appropriate concentration of GSK2894512 cream and dosing frequency in future clinical safety and efficacy studies. This is a multicenter (United States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled, 6-arm, parallel-group, dose-finding study. Two concentrations of GSK2894512 cream (0.5% and 1%) and a vehicle control cream will be equally randomized and evaluated following application to all psoriasis lesions (except on the scalp) once daily (evening) or twice daily (morning and evening) for 12 weeks. This study will consist of 3 periods: up to 4 weeks screening, 12 weeks double-blind treatment, and 4 weeks post-treatment follow-up. The total duration of subject participation will be approximately 16 to 20 weeks. Approximately 270 adult males and females subjects with plaque psoriasis will be screened in order to have at least 228 randomized subjects (38 subjects for each of the 6 treatment groups) and approximately 204 evaluable subjects overall. Approximately 30 subjects will be randomized in Japan to achieve at least 24 evaluable Japanese subjects.

NCT ID: NCT02563912 Completed - Healthy Clinical Trials

Pre-calculated Doses of Medication for Pediatric Resuscitation, a Simulation Experimental Trial

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

Dosage errors are common in the stressful situation of a pediatric resuscitation. In addition to that, studies have reported that delays to provide medication is associated to worst survival rate for very sick children. To minimize delays and error, the investigators recently published a resuscitation handbook who provides drug dosages for each weight for children thus eliminating the need for dosage calculation. Once the weight of the patient is known, the physicians only have to open the book at the page corresponding to the weight and all the medications with their calculated dosage are provided. The primary goal of this study is to evaluate the number of dosage error during simulated pediatric resuscitation comparing residents using the handbook vs. utilisation of a chart providing non-calculated dosage. This will be an experimental crossover trial among 40 residents performing four simulated case-scenarios in a high-fidelity simulation lab.

NCT ID: NCT02563899 Completed - Hyperhidrosis Clinical Trials

Pharmacokinetic, Safety, Tolerability, and Clinical Effect of Topical Umeclidinium in Primary Axillary Hyperhidrosis

Start date: November 23, 2015
Phase: Phase 2
Study type: Interventional

This is a double blind (sponsor unblind), repeat dose, randomized, parallel group, placebo controlled study to assess the pharmacokinetic parameters, safety, tolerability, and clinical effect of topically applied umeclidinium following once daily topical administration to axilla for 14 days in subjects with primary axillary hyperhidrosis. This study will determine whether topically applied umeclidinium can decrease hyperhidrosis without systemic anticholinergic effects (ie. in the range or lower to those obtained after inhaled route) at the highest possible concentration. Subjects will be dosed by site staff each night immediately before bedtime for 14 days. Subjects will complete gravimetric and Hyperhidrosis Disease Severity Scale (HDSS) measurements, patient reported outcomes (PRO), safety assessments, and/or pharmacokinetic sampling. Follow up visits will occur on days 15, 16, 19, 23 and 28. The total duration of the study will be approximately 6 to 8 weeks. The study is planned to enroll approximately 24 subjects.

NCT ID: NCT02563106 Completed - Clinical trials for Clostridium Difficile

A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI

Start date: October 2015
Phase: Phase 2
Study type: Interventional

A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of Clostridium difficile Infection (CDI) in Hospitalized Patients receiving IV ceftriaxone with a Diagnosis of a Lower Respiratory Tract Infection (LRTI).