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NCT ID: NCT02513108 Completed - Clinical trials for Coronary Artery Disease

Stavanger UncomPlicatEd Elective PCI Same DaY Discharge Study (SPEEDY Study)

SPEEDY
Start date: December 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to provide information on safety of same day discharge after uncomplicated percutaneous intervention (PCI) for stable angina pectoris in Norwegian clinical practice. The investigators also think that is in patients interest to stay as short time as possible in hospital and this will be measured using standardised quality of life questionnaires.

NCT ID: NCT02509208 Completed - Clinical trials for Cancellous Bone Bleeding

A Study to Assess the Safety and Performance of SurgiClot® in the Treatment of Cancellous Bone Bleeding

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

The purpose of this European study is to demonstrate the safety and performance of the SurgiClot® dressing in the treatment of cancellous bone bleeding.

NCT ID: NCT02504346 Active, not recruiting - Lung Cancer Clinical Trials

AZD9291, an Irreversible EGFR-TKI, in Relapsed EGFR-mutated Non-small Cell Lung Cancer Patients Previously Treated With an EGFR-TKI, Coupled to Extensive Translational Studies

TREM
Start date: August 2015
Phase: Phase 2
Study type: Interventional

Phase II, single-arm study to assess the safety and efficacy of AZD9291 (80 mg, orally, once daily) in second-line (or later) patients with EGFR mutation-positive, locally advanced or metastatic NSCLC, who have progressed following treatment with an approved epidermal growth factor tyrosine kinase inhibitor agent.

NCT ID: NCT02503839 Completed - Tuberculosis Clinical Trials

Therapeutic Vaccination and Immune Modulation - New Treatment Strategies for the MDR Tuberculosis Pandemic

TBCOX2
Start date: November 2015
Phase: Phase 1
Study type: Interventional

Tuberculosis (TB) is a global challenge and for the increasing epidemic of multi-drug resistant (MDR)-TB there is restricted treatment options. This calls for research of new immune-modulating treatment strategies that can strengthen the patients immune system to better fight the TB bacteria. The pro-inflammatory, but still immunosuppressive mediator prostaglandin E2 (PGE2) is produced by cyclooxygenase-2 (COX-2) in inflamed infected tissue. Studies from both human and animal models show that COX-2 inhibitors (COX-2i) can improve the immune system and strengthen vaccines responses. Hypothesis 1. A hyperactive COX-2/PGE2 signal system in active TB causes down-regulated immune responses that favour TB survival, but this can be abrogated by COX-2i. 2. TB-specific immunisation with targeted antigens presented as a therapeutic TB vaccine and enhanced by COX-2i will improve immune-mediated host clearance of TB. 3. Combinations of COX-2i and a therapeutic TB vaccine to conventional anti-TB chemotherapy offer new treatment modalities for TB, including MDR/XDR-TB. Approach to test the hypothesis 1. Study design: 4-arm, open and randomized clinical intervention trial of patients starting treatment for active TB in specialized Norwegian TB centres and where two arms will receive the COX-2i etoricoxib with and without a TB vaccine, one arm vaccine only and the last arm serve as control receiving only standard anti-TB therapy. For safety precautions, only patients bearing sensitive TB strains are included and study arms will be sequentially introduced. 2. In a mouse model examine in more detail the effects of reversion of chronic inflammation with COX-2i locally in tissue and the interplay with TB vaccine responses, immune regulation, correlates of protection and survival in a well-characterized model for TB-exposed mice.

NCT ID: NCT02501161 Completed - Clinical trials for Diabetes Mellitus, Type 2

A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus

DUALâ„¢ VIII
Start date: January 31, 2016
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled with oral anti diabetics.

NCT ID: NCT02501096 Completed - Tumors Clinical Trials

A Trial of Lenvatinib (E7080) Plus Pembrolizumab in Participants With Selected Solid Tumors

Start date: July 22, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label Phase 1b/2 trial of lenvatinib (E7080) plus pembrolizumab in participants with selected solid tumors. Phase 1b will determine and confirm the maximum tolerated dose (MTD) for lenvatinib in combination with 200 milligrams (mg) (intravenous [IV], every 3 weeks [Q3W]) pembrolizumab in participants with selected solid tumors (i.e. non-small cell lung cancer, renal cell carcinoma, endometrial carcinoma, urothelial carcinoma, squamous cell carcinoma of the head and neck, melanoma or leiomyosarcoma). Phase 2 (Expansion) will evaluate the safety and efficacy of the combination in 7 cohorts at the MTD from Phase 1b (lenvatinib 20 mg/day orally + pembrolizumab 200 mg Q3W, IV).

NCT ID: NCT02499302 Completed - Clinical trials for Fatigue Syndrome, Chronic

Mental Training for CFS Following EBV Infection in Adolescents

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

The general aim of this study is to investigate the effect of an individually tailored mental training program in adolescents developing chronic fatigue syndrome (CFS) after an acute Epstein Barr-virus (EBV) infection. Endpoints include physical activity (primary endpoint), symptoms (fatigue, pain, insomnia), cognitive function (executive functions) and markers of disease mechanisms (autonomic, endocrine, and immune responses).

NCT ID: NCT02498093 Completed - Muscle Weakness Clinical Trials

Maximal Strength Training in Patients Undergoing Total Hip Arthroplasty

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

Conventional rehabilitation after total hip arthroplasty (THA) does not seem to restore muscular strength or walking speed. Three-5 years after surgery patients are still not fully rehabilitated. This study evaluates the effects of maximal strength training on the muscular strength in leg press and abduction in patients undergoing THA. Aim of the study is to increase the patients physical function through evidence-based rehabilitation in clinical practice, with gradually less supervision.

NCT ID: NCT02495714 Active, not recruiting - Health Behaviour Clinical Trials

HOPPLearning - Active Learning in Elementary Schools

HOPPLearning
Start date: January 2015
Phase: N/A
Study type: Interventional

HOPP Learning will be implemented in elementary schools in the Horten municipality and will assess the effect of a combined pedagogical approach, active learning, on a large student population. Students are to increase their amount of physical activity with learning, during a school day by one hour.

NCT ID: NCT02495506 Completed - Surgery Clinical Trials

Transfusion of Cold-stored Platelet Concentrates

4CPLT
Start date: March 2015
Phase: N/A
Study type: Interventional

This study will investigate the effects of Leukocyte reduced cold-stored platelet transfusions used in treatment of immediate postoperative blood loss in patients undergoing thoracic surgery in combination with extracorporal circulation. Today platelet concentrates are stored at 22 degrees C . This is a prospective, randomized, unblinded, non-inferiority two-arm study. Aim of study is to compare platelet function in bleeding patients transfused with leukoreduced platelet concentrates stored cold (4 degrees C) and in room temperature (22 degrees C). Storage time for RCT platelet concentrates are up to 7 days. Patients with expected time on extracorporal circulation more than 120 minutes and/or medical platelet inhibitors will be included. Platelet function will be assessed by use of Multiplate Aggregometry, Thromboelastography (TEG) and/or Thromboelastometry (ROTEM). In addition post operative bleeding, and adverse events will be recorded. After completion of recruitment of patients to RCT study of platelet stored cold for up to 7 days, a follow up prospective observational study of platelets stored cold for up to 14 days is performed. Additonal information 2019, May 03: This trial was registered on Clinical Trials.gov with an original plan to use non-inferiority testing of between-group differences in platelet function. Due to lack of evidence needed to set acceptable tolerance margins for the non-inferiority testing, independent reviewers with expertise in clinical trial design recommended they be replaced by standard tests of superiority, commensurate with the early phase of the trial. Further, post-operative chest tube drainage was chosen as the primary outcome to better present the pilot study's focus on the control of clinically significant bleeding.