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NCT ID: NCT01319136 Completed - Clinical trials for Idiopathic Normal Pressure Hydrocephalus

Improved Analysis Methods for Infusion Tests

Start date: March 2009
Phase: N/A
Study type: Observational

Objective: Patients with Idiopathic Normal Pressure Hydrocephalus are improved with shunt surgery. To increase the accuracy of the diagnosis, supplementary tests that characterize the cerebrospinal fluid (CSF) dynamics are used. The infusion test is one of these, used for shunt surgery selection and postoperative evaluation of shunt function. Forty-eight patients that had a preoperative investigation because of communicating hydrocephalus at the university hospitals in Umeå and Uppsala, Sweden, participated in the study. The purpose of this study was to evaluate a new method, with a new infusion protocol and new analysis methods, and compare it to the current method.

NCT ID: NCT01319019 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A 4-week Dose-Ranging, Dose-Interval, Efficacy, Safety and Tolerability Study of GSK961081 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Start date: December 2010
Phase: Phase 2
Study type: Interventional

This study is primarily designed to assess the dose response, dose interval, efficacy and safety of three once daily (QD) doses (100mcg, 400mcg and 800mcg) and three twice daily (BID) doses (100mcg, 200mcg and 400mcg,) of GSK961081 administered via DISKUS™ for 28 days in subjects with moderate/severe COPD versus placebo. Salmeterol 50mcg BID is included in the study as an active comparator.

NCT ID: NCT01317160 Completed - Clinical trials for Venous Thromboembolism

Compression Treatment Effects on Complications and Healing of Achilles Tendon Rupture

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

This prospective randomized study aims to determine whether intermittent pneumatic compression (IPC), 75 patients, beneath functional bracing compared to treatment-as-usual in plaster cast, 75 patients, can reduce the Venous Thromboembolism (VTE) incidence and promote healing of sutured acute Achilles tendon ruptures. At two weeks post surgery, the IPC intervention will be ended and both patient groups will be immobilized in an orthosis until follow-up at six weeks. The endpoint of the first part of the study is VTE events. The primary outcome will be the DVT-incidence at two weeks, assessed using screening compression duplex ultrasound (CDU) by two ultrasonographers masked to the treatment allocation. Secondary outcome will be the DVT-incidence at 6 weeks. 1) Deep Vein Thrombosis (DVT) detected by CDU , 2) isolated calf muscle vein thrombosis (ICMVT) detected by CDU, 3) symptomatic DVT or ICMVT detected by CDU, 4) symptomatic pulmonary embolism detected by computer tomography. The endpoint of the second part of the study is tendon healing quantified at 2 weeks by microdialysis followed by quantification of markers for tendon repair. The endpoint of the third part of the study is the functional outcome of the patients at one year post-operatively using four reliable and valid scores, i.e. the Achilles tendon Total Rupture Score (ATRS), Physical Activity scale (PAS), Foot and Ankle Outcome Score (FAOS) and EuroQol Group's questionnaire (EQ-5D) as well as the validated heel-rise test.

NCT ID: NCT01316588 Completed - Clinical trials for Surgical Wound Infection

Recolonization Following Preoperative Disinfection Plastic Adhesive Drapes

Start date: August 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the time to recolonization intraoperatively after preoperative disinfection with chlorhexidine solution in ethanol and to determine evidence of differential bacterial growth with or without plastic adhesive drape on the chest as well as with or without microbial sealant on the leg.

NCT ID: NCT01316393 Completed - Xerostomia Clinical Trials

Effects of Mucoprotective Product on Xerostomia

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

In the present study with a randomized, cross-over, blind, placebo controlled design, the effects of a salivary substitute product and a new mucoprotective product with similar mechanisms of action but with different composition and characteristics will be evaluated in cancer patients suffering from xerostomia.

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: 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.