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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: NCT02776735 Completed - Clinical trials for Juvenile Idiopathic Arthritis

An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA)

SKYPP
Start date: September 6, 2016
Phase: Phase 2
Study type: Interventional

Primary Objective: To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 2-17 years with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in order to identify the dose and regimen for adequate treatment of this population Secondary Objective: To describe the pharmacodynamic (PD) profile, the efficacy and the long-term safety of sarilumab in patients with pcJIA.

NCT ID: NCT02773368 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus

DUALTM IX
Start date: May 23, 2016
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of this trial is comparing glycaemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i (sodium-glucose cotransporter 2 inhibitors) in subjects with type 2 diabetes mellitus.

NCT ID: NCT02765399 Completed - Type 2 Diabetes Clinical Trials

The Effect of Liraglutide Treatment on Postprandial Chylomicron and VLDL Kinetics, Liver Fat and de Novo Lipogenesis

Start date: February 1, 2015
Phase: Phase 4
Study type: Interventional

This study aims to evaluate the mechanisms underlying the effect of incretin therapy on lipoprotein metabolism in subjects with type 2 diabetes and to study the effect of liraglutide on hepatic de novo lipogenesis.

NCT ID: NCT02764931 Completed - Clinical trials for Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption

Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 1

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

The research aims to investigate the effects of gluten-free oats to the gastrointestinal health in celiac disease patients and healthy subjects. The effects of gluten-free oats on the several intestinal parameters, on the composition of the gut microbiota as well as on the metabolic profile of celiac patients and healthy controls will be studied. The study is divided into two parts. Part 1 will be conducted as a double-blind, randomized and placebo-controlled cross-over study. Healthy subjects will be recruited to the study. The aim is to recruit 15 participants for the part 1. The study will be conducted with a cross-over setting, where the subjects will go through exposure meals and SmartPill ingestion three times (two different oat products and placebo) in a randomized order. The study meals are identical in appearance and fiber content. After consuming the meal subjects will ingest the SmartPill capsule, which will send data on intestinal pH, pressure and temperature to the external portable device. Before and during the passage of capsule the subjects will fill a symptom and food diary. The capsule will exit the body in 1 to 3 days and the data collected by the external device will be collected and analyzed. Before the oat/placebo exposure the subjects will give a fecal and a blood sample. In addition, 36 hours urine samples will be collected. In part 2 celiac disease patients, non-celiac gluten sensitive subjects and healthy controls will be recruited and they will be divided into four groups: oat-avoiding celiacs (1), oat-consuming celiacs (2), non-celiac gluten sensitive subjects (3) and healthy controls (4). Recruiting aim for each group is 15 subjects. In addition to dietary data, a blood, and a fecal sample will be collected from the subjects. The gut microbiota will be analyzed from the fecal samples. The metabolic products will be analyzed from the fecal, urine and blood samples. The gut microbiota composition will be analyzed with next-generation DNA sequencing techniques.

NCT ID: NCT02764125 Completed - Parkinson's Disease Clinical Trials

Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off (COMPOC)

COMPOC
Start date: April 8, 2016
Phase: Phase 2
Study type: Interventional

This will be a randomised, crossover, double-blind, double-dummy, active-controlled, multicentre, phase II proof-of-concept study in Parkinson's Disease (PD) patients with end-of-dose wearing-off (motor fluctuations).

NCT ID: NCT02761785 Completed - Clinical trials for Unidentified Gastrointestinal Symptoms Following Gluten-free Oats Consumption

Gluten-free Oats and Gastrointestinal Health in Coeliac Disease, Part 2

Start date: May 29, 2017
Phase:
Study type: Observational

The research aims to investigate the effects of gluten-free oats to the gastrointestinal health in celiac disease patients and healthy subjects. The effects of gluten-free oats on the several intestinal parameters, on the composition of the gut microbiota as well as on the metabolic profile of celiac patients and healthy controls will be studied. The study is divided into two parts. Part 1 will be conducted as a double-blind, randomized and placebo-controlled cross-over study. Healthy subjects will be recruited to the study. The aim is to recruit 15 participants for the part 1. The study will be conducted with a cross-over setting, where the subjects will go through exposure meals and SmartPill ingestion three times (two different oat products and placebo) in a randomized order. The study meals are identical in appearance and fiber content. After consuming the meal subjects will ingest the SmartPill capsule, which will send data on intestinal pH, pressure and temperature to the external portable device. Before and during the passage of capsule the subjects will fill a symptom and food diary. The capsule will exit the body in 1 to 3 days and the data collected by the external device will be collected and analyzed. Before the oat/placebo exposure the subjects will give a fecal and a blood sample. In addition, 36 hours urine samples will be collected. In part 2 celiac disease patients, non-celiac gluten sensitive subjects and healthy controls will be recruited and they will be divided into four groups: oat-avoiding celiacs (1), oat-consuming celiacs (2), non-celiac gluten sensitive subjects (3) and healthy controls (4). Recruiting aim for each group is 15 subjects. In addition to dietary data, a blood, and a fecal sample will be collected from the subjects. The gut microbiota will be analyzed from the fecal samples. The metabolic products will be analyzed from the fecal, urine and blood samples. The gut microbiota composition will be analyzed with next-generation DNA sequencing techniques.

NCT ID: NCT02758743 Completed - Smoking Cessation Clinical Trials

The Efficacy of Acetium Lozenges in Intervention for Smoking Cessation

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

The purpose of this study is to validate the novel hypothesis that regular use of Acetium Lozenge is promising novel method to assist in smoking cessation. The aim of this confirmatory study is to affirm the promising results obtained in a previous smoking intervention trial with Acetium lozenge. If successful, the trial gives adequate power to confirm, that the Acetium lozenge represents a breakthrough in the development of smoking intervention methods.

NCT ID: NCT02757573 Completed - Hypercapnia Clinical Trials

The Right Ventricular Responses to Mild Hypercarbia After Mitral Valve Repair Surgery

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

The aims of the study is to investigate the right ventricular responses to mild hypercarbia after mitral valve prolapse repair surgery by the measurements obtained on pulmonary arterial catheter and transesophageal echocardiography.

NCT ID: NCT02757352 Completed - Clinical trials for Axial Spondyloarthritis

A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis

COAST-X
Start date: August 2, 2016
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants with nonradiographic axial spondyloarthritis (nonrad-axSpA).