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NCT ID: NCT01048203 Completed - Healthy Clinical Trials

A Single Dose Metabolism and Mass Balance Study of 14C-ABR-215050 in Healthy Subjects

Start date: January 2009
Phase: Phase 1
Study type: Interventional

This is a single site, open label, single dose, non-randomized study in healthy male and female subjects. The subjects will be evaluated for plasma, urine and feces levels of 14C-ABR-215050 during 21 days.

NCT ID: NCT01048034 Completed - Clinical trials for Myelodysplastic Syndrome

Evaluation of Azacitidine in Transfusion Dependent Patients With Low-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML)

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

Azacitidine has proved prolonged overall survival in patients with high-risk MDS. Minor pilot studies have shown that treatment with Azacitidine can induce transfusion independency in previous transfusion dependent patients with low-risk MDS. This study will evaluate the effect of Azacitidine in transfusion dependent patients with low-risk MDS (IPSS low or int-1) or low risk CMML. Included patients should first have failed, or considered not being eligible to, treatment with EPO +/- G-CSF. Our hypothesis is that Azacitidine can lead to transfusion independency in this group of patients. Those patients who do not respond to treatment with Azacitidine alone, will be given treatment with the combination of Azacitidine and EPO where our hypothesis is that Azacitidine can restore sensitivity to EPO.

NCT ID: NCT01047839 Completed - Encephalitis Clinical Trials

Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries

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

The primary objective is to assess the safety profile of IC51 in a pediatric population from regions where JEV is not endemic

NCT ID: NCT01045603 Completed - Clinical trials for Breakthrough Cancer Pain

Instanyl® Non-Interventional Study

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

The aim of this study is to describe the use of Instanyl® (Intranasal fentanyl spray) in the treatment of breakthrough pain (BTP) in cancer patients by success of dose titration and distribution of dose strength. Data will be collected at three different time points over a 3 month period.

NCT ID: NCT01045447 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes

BOOSTâ„¢
Start date: January 2010
Phase: Phase 3
Study type: Interventional

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the trial.

NCT ID: NCT01045278 Completed - Hepatitis C Clinical Trials

Hepatitis C in a Cohort of Patients With Maintenance Therapy for Opiate Dependence - Prevalence, Severity and Outcome of Antiviral Therapy

Start date: April 2008
Phase: Phase 4
Study type: Interventional

Hepatitis C is the leading cause of chronic liver disease in industrialized countries, and is the most common indication for liver transplantation. In the Western world, the absolute majority of cases of Hepatitis C Virus (HCV) infection are related to the use of injectable narcotic drugs. Most injecting drug users contract HCV infection within the first years after starting injecting drug use. The aim of this study is to study hepatitis C in a cohort of patients registered in clinics providing maintenance therapy for opiate dependence in three metropolitan areas of Sweden. The cohort is defined as all patients registered in these three clinics at the date of study initiation. The study contains four parts: Part I: the first part of the study aims to evaluate the prevalence of HCV exposure in the cohort and the proportion of anti-HCV positive participants with chronic infection. Part II: Patients with chronic HCV infection will be offered further investigation of chronic liver disease, including liver biopsy, for selection of candidates for antiviral therapy and identification of risk factors for development of severe liver disease. Part III: Based on the results of these investigations, patients will be considered for antiviral therapy. Indications for such therapy will mainly be clinical and/or histological signs of chronic liver disease with fibrosis. All patients will receive weight-based doses of pegylated interferon-alfa-2b and ribavirin. Part IV: Study of pharmacokinetic interactions between ribavirin and opiate substitution molecule (methadone or buprenorphine) in patients receiving antiviral therapy according to part III.

NCT ID: NCT01045200 Completed - Rectal Cancer Clinical Trials

Nurse-or Surgeon-led Follow-up After Rectal Cancer

Start date: January 2002
Phase: N/A
Study type: Observational

Follow-up programmes consume a large amount of resources with less time for the surgeon to take on new patients. The aim of this randomised study was to compare patient satisfaction, resource utilisation, and medical safety in patients curatively operated for rectal cancer that were followed-up by a surgeon or a nurse.

NCT ID: NCT01042769 Completed - Clinical trials for Diabetes Mellitus Type 2

A Study With Aleglitazar in Patients With a Recent Acute Coronary Syndrome and Type 2 Diabetes Mellitus

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

This double-blind, parallel, two-arm study will evaluate the potential to reduce cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or placebo once daily as oral doses. The study will last until at least 950 events occur, but time on study treatment will be for at least 2.5 years.

NCT ID: NCT01042340 Completed - Clinical trials for Nutritional Intervention

Energy Dense Oleic Acid Formula to Geriatric Patients

Start date: December 2005
Phase: N/A
Study type: Interventional

Background and aims: Old patients seldom reach energy requirements. The effects of an oleic-acid rich formula on energy intake and appetite were studied. Methods: Recently admitted geriatric patients (n=71), likely to stay more than 1 week were randomised to receive a fat emulsion (Calogen, intervention group (IG)) or to standard care (control group (CG)). Thirty ml of the emulsion were given 3 times daily, i.e. 420 kcal, and was distributed at the regular medication rounds. Food intake and self-rated appetite were registered 2-3 days after admission and on day 8 or the day prior to discharge. Nutritional risk screening (NRS) 2002 and serum lipids and fatty acid profiles were analysed.

NCT ID: NCT01041677 Completed - Obesity Clinical Trials

A Study of the Safety of R256918 in Obese Patients

Start date: February 2008
Phase: Phase 2
Study type: Interventional

This study investigates the safety of 12 weeks of treatment with R256918, in obese patients (JNJ-16269110 and R256918 are different names for the same molecule). The primary objective of the study is to investigate mean changes in Hepatic Triglyceride Content (HTGC), which is the fat content of the liver, from baseline to week 6 and 12 by 1H-Magnetic Resonance Spectroscopy (MRS), a specialized non invasive radiology test. Additional measures include body mass index (BMI), fasting glucose,lipid levels, and blood pressure. Safety assessments performed during the trial include laboratory tests, vital sign measurements, and adverse event reporting.