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NCT ID: NCT02136069 Completed - Ulcerative Colitis Clinical Trials

A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors

GARDENIA
Start date: December 24, 2014
Phase: Phase 3
Study type: Interventional

This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1 ratio to receive either etrolizumab 105 milligrams (mg) by subcutaneous (SC) injection once every 4 weeks (Q4W) + placebo (intravenous [IV] infusion at Weeks 0, 2, and 6, then once every 8 weeks [Q8W]) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then Q8W) + placebo (SC Q4W). Time on treatment is 54 weeks.

NCT ID: NCT02136043 Completed - Clinical trials for Non-allergic Rhinitis.

Kinetic Oscillation Stimulation (KOS) of Nasal Mucosa in Non-allergic Rhinitis: Investigation of Treatment Procedure

Start date: May 2014
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate how treatment with Kinetic Oscillation Stimulation (KOS) in the nasal cavity in patients with non-allergic rhinitis can be optimized to minimize any patient reported discomfort during treatment procedure.

NCT ID: NCT02134730 Completed - Anxiety Disorders Clinical Trials

School-based Universal Prevention for Anxiety and Depression in Sweden: A Cluster-randomized Trial

Start date: September 2013
Phase: N/A
Study type: Interventional

Mental illness is a major health problem in children and young people, and there is evidence that mental illness is increasing among young people in the population. More than 80 % of the cost to society of mental illness in children in Sweden is the cost of treatment and care. Anxiety and depression are the most common psychiatric problems in children and adolescents. In comparison with the treatment of mental disorders, there is relatively limited knowledge about prevention. There are at least two very important reasons to investigate further preventive interventions for anxiety and depression. (1) Only about 20% of children and adolescents with anxiety or depression use health services. (2) Some children stop treatment and almost 40% do still fulfill criteria for the disorder after treatment. FRIENDS for life is one of the most evaluated prevention programs internationally. The program has shown promising results in research. The overall aim of the present study is to evaluate FRIENDS for Life in Sweden.

NCT ID: NCT02134600 Completed - Pediatric Cancer Clinical Trials

OmegaChild - Omega-3 Supplementation to Children Previously Treated for Cancer

OmegaChild
Start date: May 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find an optimal dose of omega-3 that can be given to children who have completed cancer therapy. The future aim is to add omega-3 to conventional cancer treatment modalities and thereby hopefully increase the treatment efficacy, which will have to be addressed in subsequent phase-2 studies.

NCT ID: NCT02133105 Completed - Clinical trials for Cardiorenal Syndrome

Levosimendan Versus Dobutamine for Renal Function in Heart Failure

ELDOR
Start date: April 2014
Phase: Phase 3
Study type: Interventional

Although inotropes have a favorable effect on central hemodynamics in patients with heart failure, their effect on renal hemodynamics is incompletely defined. The purpose of this study is to evaluate the efficacy of a 75 min intravenous infusion of levosimendan compared to a 75 min infusion of dobutamine on renal hemodynamics and function in patients with chronic heart failure and signs of cardiorenal syndrome. The investigators hypothesis is that patients treated with levosimendan will show greater increases in renal blood flow and glomerular filtration rate (GFR) than those treated with dobutamine.

NCT ID: NCT02132702 Completed - Spinal Cord Injury Clinical Trials

Performance Attributes and User Progression While Using Ekso

Start date: August 2014
Phase: N/A
Study type: Interventional

This study is to evaluate the performance attributes and user progression of participants with motor complete and incomplete spinal cord injury (SCI) while utilizing the Ekso robotic exoskeleton in an eight week over ground, locomotor program. We hypothesize an improvement in progression and overall health while using Ekso.

NCT ID: NCT02132624 Completed - B Cell Lymphoma Clinical Trials

CD19-targeting 3rd Generation CAR T Cells for Refractory B Cell Malignancy - a Phase I/IIa Trial.

Start date: April 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

NCT ID: NCT02132416 Completed - Surgery Clinical Trials

Operative Treatment of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma

Start date: May 2014
Phase: N/A
Study type: Interventional

The purpose of this prospective controlled study is to determine whether surgical management of unstable thoracic cage injuries and chest wall deformity in trauma reduces the need for and the time spent on ventilator compared to a group treated without operation.

NCT ID: NCT02131987 Completed - Clinical trials for Femoral Neck Fracture

Radiological Riskfactors for Dislocation of Hip Hemiarthroplasty

RRDHHR
Start date: January 2006
Phase: N/A
Study type: Observational

Between January 1 2006 and December 31 2013, at our department 324 patients underwent hemiarthroplasty (HA) for displaced femoral-neck fracture with a bipolar prosthesis (Variokopf, Link®, Germany) by the use of the posteriolateral approach. Patients with pathological fractures and HA performed with direct lateral approach were excluded. A retrospective cohort study were conducted. Patients with prosthetic dislocation formed one group and patients without dislocation formed the control group. As standard, post surgery radiographs (anteroposterior and lateral) were taken. After these were performed patient started weight bearing as soon as possible. Clinical data regarding patient demographics, details of the surgical procedure and the medical comorbidities were collected by the use of patient and operative records. Radiological analysis with position evaluation was performed using the post surgery radiographs by measuring Wiberg angle, inequality of leg length and femoral offset of the prostheses and compared with non-operated hip joint using the post surgery x-ray images. Our hypothesis were that patients with single- or recurrent dislocations had shortened postoperative leg length, decreased femoral offsed and a Wiberg angle less than 25 degrees.

NCT ID: NCT02131870 Completed - Healthy Clinical Trials

Study of the Iron Absorption From Capsules Containing Lactobacilli and Iron

Start date: n/a
Phase: N/A
Study type: Interventional

The purpose of this study is to study the effect of a probiotic product on iron absorption in healthy females of child-bearing age.