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NCT ID: NCT01029652 Completed - Acute Gout Clinical Trials

Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study

ß-RELIEVED
Start date: December 2009
Phase: Phase 3
Study type: Interventional

The purpose of the 12-week core study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or colchicine are contraindicated, not tolerated, or ineffective. The efficacy of canakinumab was compared to the corticosteroid triamcinolone acetonide. The purpose of the first 12-week extension study was to collect additional safety, tolerability and efficacy data in patients who have completed the core study CACZ885H2356. The purpose of the second 48 week open-label extension study was to collect additional long-term safety and tolerability data in patients who have completed the first extension study CACZ885H2356E1.

NCT ID: NCT01029600 Recruiting - Adhesive Capsulitis Clinical Trials

Surgery or Capsular Distention With Steroid in the Treatment of Primary Frozen Shoulder?

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

The purpose of the study is to compare two different treatment regimens for primary frozen shoulder: Arthroscopic capsulotomy and arthrographic distention with steroid.

NCT ID: NCT01029340 Completed - Hemophilia A Clinical Trials

Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A

Leopold I
Start date: December 2009
Phase: Phase 3
Study type: Interventional

The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period (split into two six month treatment periods). The study will compare 2 different methods (assays) for measuring the amount of study drug, the chromogenic substrate assay per European Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted, CS/ADJ). During one six month period patients will receive the study drug where the dose has been measured using the" (CS/EP) and during the other six months period the dose will be measured based on the Chromogenic Substrate Adjusted assay CS/ADJ)

NCT ID: NCT01027026 Recruiting - Clinical trials for Acute Coronary Syndrome

The Acute Coronary Syndrome Study

ACS
Start date: February 2009
Phase: N/A
Study type: Interventional

The investigators will make a prospective study in which they will look at the economics and security of the treatment of patients with acute coronary syndrome. The investigators want to do a randomized trial. One group will be treated as they have been treated at Ullevål University Hospital (UUS) in recent years, and the other group will be returned to their refering hospital the same day. The objective of this study will be to provide increased knowledge about whether the rapid discharge from the intervention center is associated with differences in costs or security.

NCT ID: NCT01025804 Completed - Leukemia Clinical Trials

Pharmacokinetics of Asparaginase and Antibody Formation in Interfant-06

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

Asparaginase is an important drug in the treatment of childhood leukemia including in infant (<1 year). The prognosis for infants is bad. Information about drug metabolism in neonates and infants is scarce as well as the reactions of an immature immune system to foreign proteins. The aims of this study is to describe the metabolism (pharmacokinetics) of asparaginase after administration intramuscularly and to evaluate the formation of antibodies against the drug (enzyme) during treatment in order to optimize the asparaginase treatment in infants in the future.

NCT ID: NCT01025362 Completed - Lactation Clinical Trials

Baby-Friendly Community Health Services Evaluation

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

The Norwegian Action Plan on Nutrition aim at increasing the prevalence of breastfeeding. The initiative "Baby-Friendly Community Health Services (BFCHS)" is an initiative to reach this goal. BFCHS is developed from the concept "The Baby-Friendly Hospital Initiative" by WHO/UNICEF, and the intention is to increase the quality of breastfeeding counseling at Norwegian well-baby clinics. The purpose of the study The study seeks to answer the following research questions: - What effect does the process of being certified as a BFCHS have on the proportion of mothers who exclusively breastfeed their children for 5 months? - What effect does the process of being certified as a BFCHS have on the proportion of mothers who exclusively breastfeed for 4 months? - What effect does the certification process have on the proportion of mothers who breastfeed at 11 months of age? - What effect does the certification process have on the differences in breastfeeding due to social inequality? - What effect does the certification process have on the mothers impression of the quality of the well-baby clinics lactation counseling? - What effect does the certification process have on mothers satisfaction with the breastfeeding experience? - What effect does the certification process have on perceived pressure to breastfeed? Methods Cluster randomized controlled study Sampling The survey unit, cluster, will be the community health services. All community health services in six counties in Norway will be invited to participate. Inclusion criteria: Norwegian speaking mothers who have 5 month and 11 month old children. Data collection Respondents are identified through the National Population Register (DSF). The data collection takes place using a postal questionnaire. Baseline: Data collection before the intervention is implemented to assess breastfeeding prevalence and distribution of covariates in the two study arms. Post-survey: The post-survey to assess the effect, will take place about two years after baseline when the community health services have been certified. Sample size It is expected that the project could increase the breastfeeding prevalence with 5 percentage points. This assumption is the basis for the sample size. The initial aim is to recruit about 50 well-baby clinics.

NCT ID: NCT01024036 Completed - Clinical trials for Multicentric Castleman's Disease

A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease

Start date: March 18, 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to demonstrate that CNTO 328 when administered in combination with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic response (complete response or partial response) among patients with Multicentric Castleman's Disease.

NCT ID: NCT01023763 Completed - Infections Clinical Trials

Intravenous Treatment in Nursing Homes

3IV
Start date: November 2009
Phase: Phase 2
Study type: Interventional

The primary objective for the project is to evaluate whether nursing home residents who require intravenous fluids and intravenous antibiotics, can be treated just as well or even better in the nursing home as in the hospital. In Vestfold, Norway, a structured training program in the intravenous treatment of dehydration and infections in nursing homes is planned. The 3IV study will evaluate if this leads to an equal or better patient trajectory and reduced hospital admittance.

NCT ID: NCT01023529 Completed - Prostatic Neoplasms Clinical Trials

Symptoms and Quality of Life (QoL) After Palliative Pelvic Radiation of Prostate and Rectal Cancers

PallRad1
Start date: November 2009
Phase: N/A
Study type: Observational

The purpose of this study is to assess the effect of palliative pelvic radiation on symptoms and quality of life among patients with incurable prostate and rectal cancer.

NCT ID: NCT01023308 Completed - Multiple Myeloma Clinical Trials

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

PANORAMA-1
Start date: December 21, 2009
Phase: Phase 3
Study type: Interventional

Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile. Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.