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NCT ID: NCT00963833 Completed - Multiple Sclerosis Clinical Trials

Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients With Multiple Sclerosis

Start date: December 17, 2009
Phase: N/A
Study type: Observational

Multiple Sclerosis (MS) is mainly known as a disease of young to middle adulthood but approximately 5% of all MS cases worldwide involve children that are younger than 16 years. The aim of care of children with Multiple Sclerosis is to prevent or at least to delay any neurological and cognitive impairment as well as progression of the disease as far as possible. Therefore, it is very crucial to diagnose the disease at an early stage as immunomodulatory treatments are available that can delay the progression of Multiple SclerosisTreatment with the immunomodulatory agent Betaferon® in children diagnosed with RRMS and being 12 years or older has been approved by the health authorities. The aim of this observational study is to obtain further data on the safety, tolerability, and effectiveness of Betaferon® under daily living conditions. As this is a non-interventional observational study, routine clinical practice is observed. The application of diagnostic measures and medications as well as physician visits follow the normal routine and is decided upon by the treating physician under recognition of the package insert.

NCT ID: NCT00962741 Completed - Clinical trials for Arthritis, Juvenile Idiopathic

Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

CLIPPER
Start date: September 2009
Phase: Phase 3
Study type: Interventional

This study will evaluate the effect of etanercept on the clinical benefit, safety, and physical functioning (ability to function in daily life) in children and adolescent subjects with 3 subtypes of childhood arthritis.

NCT ID: NCT00962442 Completed - Alcoholic Hepatitis Clinical Trials

N-Acetylcysteine in Severe Acute Alcoholic Hepatitis

Start date: September 2000
Phase: Phase 3
Study type: Interventional

Acute alcoholic hepatitis (AAH) is the most severe form of alcoholic liver disease (ALD) and is associated with a high risk of dying in the short term. Corticosteroids are generally recommended in patients with severe AAH, but its use is still controverted and contraindicated in case of active infection or gastrointestinal bleeding. Therefore, alternative therapeutic options are needed.Ethanol consumption results in the depletion of endogenous antioxidant capabilities and patients with ALD have evidence of antioxidant deficiencies.Due to its effects on glutathion stores restoration and as such the limitation of the oxidative stress and its good tolerance and safety profile, N-acetylcysteine (NAC) is an attractive agent for the treatment of AAH.In this context, we hypothesized that NAC might be beneficial in severe AAH.

NCT ID: NCT00960960 Completed - Breast Cancer Clinical Trials

A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, and With Letrozole, in Participants With Locally Recurrent or Metastatic Breast Cancer

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

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) pictilisib administered with letrozole or intravenous (IV) paclitaxel with and without IV bevacizumab or IV trastuzumab in participants with locally recurrent or metastatic breast cancer. The study consists of three parts. Part 1 (pictilisib will be administered in 21+7 schedule along with paclitaxel and/or bevacizumab), Part 2 (pictilisib will be administered in 5+2 schedule along with paclitaxel and/or bevacizumab or trastuzumab) and Part 3 (pictilisib will be administered in combination with letrozole). Part 1 and Part 2 consists of two stages; a dose escalation stage and a cohort-expansion stage.

NCT ID: NCT00960661 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes

Start date: September 2009
Phase: Phase 3
Study type: Interventional

The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.

NCT ID: NCT00960440 Completed - Clinical trials for Arthritis, Rheumatoid

Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors

Start date: October 2009
Phase: Phase 3
Study type: Interventional

This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.

NCT ID: NCT00960128 Completed - Clinical trials for Chronic Kidney Disease

Observational Prospective Study on Patients Treated With Norditropin®

Start date: April 1, 2006
Phase: N/A
Study type: Observational

This observational study is conducted globally. The aim of the study is to investigate the effectiveness and safety of real-life treatment with Norditropin®. The study population will consist of children and adults who are on treatment with Norditropin® in accordance with normal clinical practice.

NCT ID: NCT00959036 Completed - Clinical trials for Active Rheumatoid Arthritis

Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis

Start date: September 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ATN-103 when administered to subjects with active rheumatoid arthritis compared with placebo. All subjects must be on a stable dose and route of methotrexate.

NCT ID: NCT00959010 Completed - Cystic Fibrosis Clinical Trials

Omega 3 Supplementation in Cystic Fibrosis Patients

Start date: October 2008
Phase: Phase 3
Study type: Interventional

Essential fatty acids (EFA) deficiency has been often reported in patients with cystic fibrosis (CF), particularly in those homozygous for the DF508 mutation. Clinical symptoms of CF may be influenced by correcting EFA deficiency. Nevertheless, the value of EFA supplementation in CF remains controversial. Within this multicentric and international randomized placebo-controlled trial it will be evaluated, according to recommendations of Cochrane analysis, beneficial effects of an oral supplementation with polyunsaturated fatty acids on selected biochemical and functional outcome parameters such as inflammatory biomarkers, incorporation into cell membrane phospholipids, lung function, exercise tolerance, clinical and nutritional status and properties of transepithelial ion transport. The study will be undertaken in a cohort of CF patients aged over 6 years old (60 patients), homozygous for the DF508 mutation and treated by Azithromycine. Supplementation will be performed with a triglyceride source at a daily dose of 60 mg/kg of omega-3 polyunsaturated fatty acids (Omega 3 Premiumâ, Laboratoires Ponroy, France). Before enrolled into the trial and during the study, patients will undergo nutritional assessment by evaluation of total and fat dietary intake and overall calorie intake using a 3-days diet records and a food frequency questionnaire. Plasma and erythrocyte membrane EFA profiles and inflammatory markers will be monitored in baseline conditions, at 3, at 6 and 12 months after starting the treatment. Lung function will be performed at each patient visit and an exercise test will be done before and at the end of the treatment. Properties of ion transport will be searched by sweat testing before and at the end of the treatment.

NCT ID: NCT00958503 Completed - Healthy Clinical Trials

Effect of Thiamphenicol on EAAT2 and Other Biomarkers From Nasal Biopsied Tissue

Start date: July 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine if two-weeks of dosing with thiamphenicol is safe and is able to change the levels of certain pre-specified biomarkers in nervous tissue taken from the nasal passages.