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NCT ID: NCT00472199 Completed - Clinical trials for Restless Legs Syndrome

Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)

Start date: May 2007
Phase: Phase 4
Study type: Interventional

The primary objective of the current study will be the evaluation of long-term efficacy of a 26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless Legs Syndrome (RLS) in comparison to placebo. The key secondary objectives are to assess the effects on clinical global impressions - global improvement (CGI-I) (based on CGI-I responder rate) and on RLS (based on IRLS responder rate) for 26 weeks under pramipexole in comparison to placebo. Further secondary objectives are to investigate the incidence and severity of augmentation and rebound and to assess the effects on patient global impression (PGI) (based on PGI responder rate), on RLS symptoms (based on the RLS-6 scales), on associated mood disturbance (based on item 10 of the IRLS), on pain in limbs (based on a visual analogue scale (VAS)), on quality of life in RLS (based on Johns Hopkins RLS-QoL), on general quality of life Short Form 36 (SF-36) and on safety (based on adverse events (AE) profile) of pramipexole in comparison to placebo.

NCT ID: NCT00471640 Completed - Pneumonia Clinical Trials

Dexamethasone Infusion in Community-acquired Pneumonia

Ovidius
Start date: November 2007
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether dexamethasone reduces the length of hospital stay in patient with a community-acquired pneumonia.

NCT ID: NCT00471497 Completed - Clinical trials for Myelogenous Leukemia, Chronic

A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

ENESTnd
Start date: July 31, 2007
Phase: Phase 3
Study type: Interventional

In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, were compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP). An extension protocol was included in this study design to allow patients who did not show sufficient response to their assigned treatments the opportunity to receive imatinib 400 mg BID (option available until protocol amendment 7) or nilotinib 400 mg BID, using an abbreviated safety and efficacy assessment schedule.

NCT ID: NCT00471328 Completed - Clinical trials for Gastrointestinal Stromal Tumors

Efficacy and Safety of Nilotinib (AMN107) Compared With Current Treatment Options in Patients With GIST Who Have Failed Both Imatinib and Sunitinib

ENEST
Start date: March 2007
Phase: Phase 3
Study type: Interventional

The study evaluated the safety and efficacy of nilotinib versus current treatment in adults with gastrointestinal stromal tumors (GIST) who have either progressed or who were intolerant to the first and second line treatments.

NCT ID: NCT00471263 Completed - Blood Pressure Clinical Trials

The Effects of Milk Proteins on Blood Pressure

Start date: May 7, 2007
Phase: N/A
Study type: Interventional

The primary purpose of the study is to demonstrate a blood pressure lowering effect of CasiGold and CasiMax in subjects with high-normal blood pressure or mild hypertension. The secondary purpose is to collect human safety data after treatment with CasiGold and CasiMax, to gain insight into potential mechanisms by measurement of renin and angiotensin I and II, and to evaluate the genetic determinants of the individual BP lowering response by measurement of specific genetic polymorphisms.

NCT ID: NCT00471146 Completed - Clinical trials for Carcinoma, Pancreatic Ductal

Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.

Start date: July 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.

NCT ID: NCT00469287 Completed - Obesity Clinical Trials

Early Diagnosis of Diabetes Mellitus Type 2 (DM2)

7348
Start date: June 2007
Phase: N/A
Study type: Observational

Rationale: The global prevalence of diabetes, along with its devastating effects on life expectancy and quality of life, continues to increase. Worldwide, the total number of people with diabetes is projected to rise from about 171 million in 2000 to 336 million in the year 2030. Type 2 diabetes accounts for about 85 percent to 95 percent of all diagnosed cases of diabetes and is associated with a number of serious long-term complications, which are a major cause of morbidity, hospitalization and mortality in diabetic patients. More evidence is becoming available that both lifestyle and clinical intervention in the pre-diabetic condition are effective in slowing down progression of pre-diabetes to overt diabetes. Over many centuries, several forms of traditional medicine have developed which are often based on fundamental principles that differ from those of "Western" medicine. One of the most prominent characteristics of Traditional Chinese Medicine (TCM), is a more holistic approach to the functioning and disfunctioning of living organisms. Every healthy organism is in a Yin Yang balance and is considered to be a complex interplay between body and mind. Western medicine relies on detailed classification of diseases, empirical investigations and treatments targeting those disorders. However, "Western medicine" is showing an increased interest in traditional forms of medicine. Objectives: The primary objective of the present study is to determine consistency in classification of DM type 2 in three categories as defined by Traditional Chinese Medicine (TCM) in pre-diabetic subjects. Secondary objectives are to find relationships between diagnosis according to TCM and risk profile according to Western approach (fasting glucose and HbA1c in plasma, age, BMI, waist circumference). Another objective is to find relationships between classification of risk for DM type 2 according to TCM and objective parameters.

NCT ID: NCT00469092 Completed - Clinical trials for Diabetes Mellitus, Type 2

Comparison of Biphasic Insulin Aspart 30 Versus Insulin Glargine Both in Combination With Metformin and Glimepiride in Subjects With Type 2 Diabetes

Start date: May 2007
Phase: Phase 4
Study type: Interventional

This trial is conducted in Africa, Asia, Europe, Oceania and South America. This trial aims for a comparison of biphasic insulin aspart 30 once daily versus insulin glargine once daily all in combination with metformin and glimepiride in insulin naive subjects with type 2 diabetes.

NCT ID: NCT00468546 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy

Start date: July 2003
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of rituximab combined with MTX in participants with active RA who have had an inadequate response to anti-TNF alpha therapy. The anticipated time in the study is up to 2 years and the target sample size is 500 participants. Eligible participants may receive re-treatment with rituximab under a separate protocol WA17531.

NCT ID: NCT00468507 Completed - Trauma Clinical Trials

The Anti-inflammatory Effects of High-fat Nutrition; Towards a Clinical Application

Start date: March 2007
Phase: Phase 0
Study type: Interventional

Patients undergoing major surgery, trauma and burns are prone to develop an exacerbated inflammatory response, which is potentially lethal to the individual. Recently our group demonstrated that administration of high fat feeding prior to hemorrhagic shock attenuates severe inflammation, gut barrier loss and hepatic damage. High fat feeding releases cholecystokinin in the gut, which stimulates the autonomous nervous system and subsequently activates the efferent vagus nerve. The activated efferent fibers inhibit tissue macrophages via binding of acetylcholine to the alpha7-nicotinergic receptor. In this study the cholecystokinin release in healthy volunteers is monitored in response to low fat and high fat food products.