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NCT ID: NCT01316016 Completed - Obesity Clinical Trials

Antidiabetic Properties of Rose Hip

Start date: April 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether daily intake of a drink containing rose hip powder reduces risk markers of type diabetes and cardiovascular disease.

NCT ID: NCT01315938 Completed - Dermatomyositis Clinical Trials

Abatacept Treatment in Polymyositis and Dermatomyositis

ARTEMIS
Start date: January 2011
Phase: Phase 2
Study type: Interventional

The aim of this study is to investigate the efficacy and safety of abatacept in patients with Dermatomyositis (DM) and polymyositis (PM) refractory to conventional treatment using a randomised trial design with delayed start in one arm. Abatacept will be administered intravenously to participants at a dose based on body weight at the screening visit followed by six follow-up treatments (Active treatment arm). Abatacept will also be administered intravenously to participants at a dose based on body weight starting at 3 months followed by six follow-up treatments (Delayed-onset treatment arm). The International Myositis Assessment and Clinical Studies Group (IMACS) preliminary definition of improvement (DOI) will be used for assessment.

NCT ID: NCT01315886 Terminated - Pain Clinical Trials

Conversion From Fast Acting Oral Opioids to Abstral®

Start date: February 21, 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate safety and efficacy when using a novel dose conversion strategy to switch from immediate release oral opioids to sublingual (SL) fentanyl (Abstral) for treatment of breakthrough cancer pain (BTcP).

NCT ID: NCT01315678 Completed - Clinical trials for Pseudomonas Aeruginosa Infection

Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections

Start date: February 29, 2012
Phase: Phase 3
Study type: Interventional

A major factor in the respiratory health of Cystic Fibrosis (CF) participants is the prevalence of chronic Pseudomonas aeruginosa (Pa) infections. The Pa infection rate in CF patients increases with age and by age 18 years approximately 85% of CF patients in the US are infected. Liposomal amikacin for inhalation (Arikayce™) was developed as a possible treatment for chronic infection due to Pa in CF patients. The purpose of this study is to determine whether Arikayce™ is effective in treating chronic lung infections caused by Pa in CF participants. The effectiveness, safety, and tolerability of Arikayce™ will be compared to Tobramycin TOBI®, an inhalation antibiotic already available for use.

NCT ID: NCT01313988 Completed - Healthy Clinical Trials

Efficacy Study on the Lipid-lowering Effect of Plant Sterols and Fish Oil

Start date: January 2011
Phase: N/A
Study type: Interventional

Plant sterols and fish fatty acids are known to affect the blood lipid profile. This randomized, double-blind, placebo-controlled, parallel efficacy study is designed to investigate the lipid-lowering effect after 4 weeks intervention with the recommended dose of plant sterols and different doses of fish fatty acids when combined in a spread format.

NCT ID: NCT01313689 Completed - Leukaemia Clinical Trials

Ofatumumab vs Physician's Choice in Subjects With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukemia

Start date: April 14, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study was to confirm the clinical benefit observed in the pivotal registration study, Hx-CD20-406. The Committee for Medicinal Products for Human Use (CHMP) required that a randomized study be conducted in CLL patients with bulky fludarabine-refractory disease as a specific obligation for grant of conditional approval for ARZERRA™ in the European Union (EU). This study compared ofatumumab with the physicians' choice of therapy.

NCT ID: NCT01313637 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD

DB2113361
Start date: March 1, 2011
Phase: Phase 3
Study type: Interventional

This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).

NCT ID: NCT01313234 Completed - Neoplasms Clinical Trials

Educational Intervention Targeting Nurses Attitudes and Knowledge About Cancer-related Pain Management

Start date: April 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether an intervention consisting of the implementation of guidelines about daily systematic pain assessment following a theory based education, targeting cancer-related pain and pain treatment, lead to a significantly positive improvement in RNs knowledge of, and attitudes towards their pain management. Furthermore will the interventions targeting the RNs influence the admitted patient's perception of their cancer-related pain?

NCT ID: NCT01312571 Completed - Social Phobia Clinical Trials

Treatment of Social Phobia Over the Internet

SOFIE-8
Start date: August 2010
Phase: N/A
Study type: Interventional

Forty-eight people diagnosed with social phobia in an experimental study that randomized into two treatment groups: 1) Internet-based Cognitive Behavioural Therapy (iCBT) (n = 24) or 2) computerized attention training (n = 24). After nine weeks we change the condition of the two groups of research participants, which should therefore be given both treatments. Pre-and post measurement of functional magnetic resonance imaging (fMRI) will take place in the first round of treatment. Genotyping based on saliva samples takes place before the start of treatment, at the first fMRI measurement, for those who voluntarily leave the sample. Study hypothesis How is the brain activity of emotional processing and anxiety affected after completing an Internet-based CBT compared with computerized attention training? Does the treatment response of an Internet based treatment affects by variations in serotonin-transporter-linked promoter region (5-HTTLPR) and tryptophan hydroxylase-3 (TPH3) genes? How is the genetic variations related to symptoms in social phobia (pre treatment)?

NCT ID: NCT01312298 Completed - Arthritis Clinical Trials

General vs. Intrathecal Anesthesia for Total Knee Arthroplasty

Start date: August 2011
Phase: N/A
Study type: Interventional

Hypothesis: General anesthesia as compared to intrathecal (i.e. spinal anesthesia) anesthesia will result in shorter length of hospital stay for patients undergoing total knee arthroplasty. Primary endpoint: time from end of surgery until the patient is "street ready" Secondary endpoints: will general anesthesia produce less postoperative pain as compared to intrathecal anesthesia? Is there any difference in post operative "dizziness" between the groups.