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NCT ID: NCT02422537 Completed - Healthy Clinical Trials

Effect of Different Bran-based Dietary Platforms on the Colon Metabolism in Healthy Volunteers

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

During this project the effect of 3 different bran-based dietary platforms on the fermentation on a readily fermentable substrate will be investigated using stable isotope techniques.

NCT ID: NCT02422186 Completed - Clinical trials for Depressive Disorder, Treatment-Resistant

A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression

TRANSFORM-3
Start date: August 20, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of switching elderly participants with treatment-resistant depression (TRD) from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.

NCT ID: NCT02421510 Completed - Clinical trials for Type 1 Diabetes Mellitus

Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

inTandem2
Start date: May 2015
Phase: Phase 3
Study type: Interventional

This Phase 3 study was intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.

NCT ID: NCT02421211 Completed - Clinical trials for Hepatitis C, Chronic

A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection

Start date: May 19, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetic interactions between simeprevir and ledipasvir in a treatment regimen consisting of simeprevir (SMV), sofosbuvir (SOF), and ledipasvir (LDV) in treatment-naive participants with chronic hepatitis C virus (HCV) genotype 1 infection.

NCT ID: NCT02418728 Completed - Obesity Clinical Trials

The Role of Atrial Natriuretic Peptide in the Lipolytic Process: Effect of Obesity and Exercise

BALO
Start date: August 2014
Phase: N/A
Study type: Observational

In the developing countries, obesity prevalence is on a dramatic rise. Obesity is related to co-morbidities and as a result, obesity significantly shortens life expectancy and lowers quality of life. To prevent this, participation in exercise or training programs is absolutely necessary, in order to generate adipose tissue mass loss. The amount of adipose tissue mass loss is, amongst others, dependent on lipolysis which is under endocrine regulation by, mainly, catecholamines, insulin and atrial natriuretic peptide. However, large variations in adipose tissue mass loss and gain are likely in obese subjects, possibly due to a decreased lipolytic effect of these hormones (as was shown for catecholamines in the subcutaneous adipose tissue of obese subjects). However, the relative contribution of atrial natriuretic peptide in the lipolytic process remains elusive, particularly in subjects with obesity, which show an increased plasma expression of atrial natriuretic peptide. The aim of the present study is to observe the contribution of atrial natriuretic peptide in the subcutaneous adipose tissue of obese subjects. This will be tested by measurements of extracellular glycerol levels (by microdialysis) in the subcutaneous adipose tissue in situ at rest and during endurance exercise under local beta- and alpha-blockade. Eventually, the knowledge gained from this research will contribute to the optimization of exercise programs for people with obesity.

NCT ID: NCT02417064 Completed - Clinical trials for Treatment-resistant Depression

A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression

TRANSFORM-1
Start date: August 10, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression (TRD) participants from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.

NCT ID: NCT02415400 Completed - Clinical trials for Acute Coronary Syndromes

A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart

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

The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.

NCT ID: NCT02415088 Completed - Pain, Postoperative Clinical Trials

Ultrasound-guided Selective Shoulder Block Versus Ultrasound-guided Interscalene Brachial Plexus Block, an RCT

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

This is a randomised, observer-blinded trial to compare selective shoulder block with interscalene block. Both blocks will be placed using an ultra-sound guided technique. Primary outcome measures will be postoperative pain scores and use of rescue opioids. Secondary outcome measures will be pre- and postoperative occurence of motor deficit of the arm and dyspnea, quality of sleep in the first night after surgery as measured by a numeric rating scale and overall satisfaction with pain therapy as measured by the International Pain Outcomes questionnaire and an NRS-score (0 = not satisfied at all and 10 = very satisfied). Primary and secondary outcome measures will be assessed during the first 24hours after surgery (assessment in the postanesthetic care unit (PACU) directly after admission and before discharge and in the surgical ward at 4, 8 and 24 hours after surgery). Overall satisfaction with pain therapy will be assessed 48hours after surgery. An interscalene block is a block of the plexus brachialis in the interscelene triangle (by injecting a local anesthetic around the nerve plexus). A selective shoulder block is a block of the suprascapular and axillary nerves (by injecting a local anesthetic around these nerves).

NCT ID: NCT02414958 Completed - Clinical trials for Diabetes Mellitus, Type 1

Empagliflozin as Adjunctive to InSulin thErapy Over 52 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-2)

Start date: June 30, 2015
Phase: Phase 3
Study type: Interventional

Comparison of 2 doses of empagliflozin vs placebo in patients already using either an insulin regimen of multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Randomisation to 3 treatments arms (equal assignment) following a screening period, an optimisation period and a run-in period. 52 week double-blind treatment period, and 3 week follow-up period.

NCT ID: NCT02414568 Completed - Clinical trials for Classical Hodgkin Lymphoma

Bendamustine Study in Classical Hodgkin Lymphoma Patients Over 60 Treated by Prednisone, Vinblastine and Doxorubicin

PVAB
Start date: July 17, 2015
Phase: Phase 2
Study type: Interventional

This study evaluates bendamustine in patients aged over 60 years with classical Hodgkin Lymphoma treated by prednisone, vinblastine and doxorubicin. 90 patients will be enrolled in this study.