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NCT ID: NCT01119859 Completed - Clinical trials for Rheumatoid Arthritis

A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis

Start date: May 2010
Phase: Phase 4
Study type: Interventional

This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.

NCT ID: NCT01117675 Completed - HIV Infection Clinical Trials

A New Telemedicine Approach for Chronic HIV/AIDS Patient Home Care

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

Background: Antiretroviral therapy has changed the natural history of the HIV infection in developed countries becoming a chronic disease. This clinical scenario would need a new approach to control patients, simplifying the follow-up visits and the accessibility to the healthcare professionals. A new home care model using a telemedicine system (Virtual Hospital) was developed.

NCT ID: NCT01117428 Completed - Clinical trials for Metastatic Colorectal Cancer

Sym004 in Patients With Advanced Solid Tumors

Start date: March 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This trial is designed as a multi-centre, open label, dose-escalation, phase I trial and consists of five parts.

NCT ID: NCT01117350 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy Assessment of Insulin Glargine Versus LiraglutidE After Oral Agents Failure

EAGLE
Start date: July 2010
Phase: Phase 4
Study type: Interventional

Primary objective: To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) < 7% at the end of the comparative period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents Secondary objectives of the comparative period (24 weeks): >To assess the effect of insulin glargine in comparison with liraglutide on: - HbA1c level - Percentage of patients whose HbA1c has decreased but remains >= 7% at the end of the comparative period - Percentage of patients whose HbA1c has increased at the end of the comparative period - Fasting Plasma Glucose (FPG) - 7-point Plasma Glucose (PG) profiles - Hypoglycemia occurrence - Body weight - Adverse events Objectives of the extension period (24 weeks): >To assess the effect of insulin glargine in patients not adequately controlled with liraglutide on: - HbA1c level - FPG - 7-point PG profiles - Hypoglycemia occurrence - Body weight - Adverse events

NCT ID: NCT01116856 Completed - Obesity Clinical Trials

Nutrition and Physical Activity for Obesity

PRONAF
Start date: January 2009
Phase: N/A
Study type: Interventional

At the present time, scientific consensus exists on obesity multifactorial etiopatogenia. As well, professionals and researchers agree that the treatment must approach several scopes, such as dietetic, physical activity, pharmacologic and surgical. These two last ones should not be the first election and must be reserved for those cases of morbid obesities or in case the previous ones have failed. The combination of diet and exercise is still not sufficiently studied, in special, the addition of strength training, as we propose in this project, for which established intervention protocols do not exist, and that could suppose an additional benefit in the reduction of risk factors. Therefore, the objectives that we aim in this project are enumerated below: - To discover which are the most effective training protocols and to determine what type of exercise combined with nutrition is more appropriate for obesity intervention programs. - To establish the relationship between markers related with cardiovascular risk (adopokines and lipid profile) and the different intervention protocols proposed. - To describe the influence of nine genetic polymorphisms (selected by their relationship with the energy expense and the physical yield) on the effect of different training protocols. - To determine how important is body composition (fat mass and muscle mass mainly) in total daily energy expenditure. - To establish rules of nutritional and exercise intervention that can be applied in public and private training centers. If the proposed objectives are fulfilled, this would contribute to an improvement in patients health in long term, along with an enormous saving in public health. Therefore, the purpose of this project is to propose new lines of intervention in overweight and obese adults that, until now, little have been investigated. This way, resistance training is proposed in combination with cardiovascular training and endocrinologic treatment. It fits to emphasize that, as far as we know, it is the first project of these characteristics, that puts in touch the public and private sector (hospitals, universities and fitness area), to establish standardized relations protocols to allow a close pursuit of obese patients.

NCT ID: NCT01116817 Completed - HIV Clinical Trials

Study to Compare the Virologic Efficacy in Cerebrospinal Fluid (CSF) and Neurocognitive State in Patients Infected by HIV-1 Long-term Treatment (> 3 Years) With Lopinavir / Ritonavir Monotherapy

Start date: August 2010
Phase: Phase 4
Study type: Interventional

The aim of this study is to describe and compare the percentage of patients infected by HIV-1 to maintain a complete virology suppression at the CSF (CSF CV 1 copy / mL) in patients with CV <50 copies / mL and treated with stable antiretroviral therapy for at least 3 years with LPV / r 400/100 mg twice daily + 2 NRTI.

NCT ID: NCT01115751 Completed - Clinical trials for Metastases, Neoplasm

A Study in Patients With Advanced or Metastatic Cancer

Start date: March 2010
Phase: Phase 1
Study type: Interventional

Study JWAA is a multicenter, nonrandomized, open-label, dose-escalation Phase 1 study of oral LY2780301 in patients with advanced solid tumors.

NCT ID: NCT01115491 Completed - Clinical trials for Glioblastoma Multiforme

A Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme

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

This is a Phase II, national, multicenter, open-label, non-comparative study to investigate the efficacy and safety of bevacizumab and temozolomide in patients with recurrent glioblastoma multiforme (GBM) after a first treatment failure. Patients will receive bevacizumab 10 mg/kg intravenously every two weeks until disease progression, consent withdrawal, or unacceptable toxicity. Anticipated time on study treatment is 12-24 months.

NCT ID: NCT01115374 Completed - Lymphedema Clinical Trials

Lymphedema Therapy With Sound Wave Lymphatic Drainage

Start date: May 2008
Phase: N/A
Study type: Interventional

Lymphedema is a frequent sequela of breast cancer treatment, that can develop up to 40% of patients. Lymphedema is the accumulation of protein-rich fluid (lymph) in the interstitial spaces of the affected body part due to a blockage or malfunction in the lymph system. It can appear in the arm, shoulder, breast, or thoracic area. Lymphedema swelling causes discomfort and sometimes disability. The treatment of lymphedema associated with breast cancer can include complex decongestive physiotherapy, compression therapy, therapeutic exercises, and pharmacotherapy. In this study two treatments will be compared to reduce lymphedema: the manual lymphatic drainage (standard care) versus the low frequency sound waves.

NCT ID: NCT01114906 Completed - Asthma Clinical Trials

Estimating the Use of Resources and the Costs of Treating Patients With Asthma in the Autonomous Community of Valencia

Start date: September 2010
Phase: N/A
Study type: Observational

This study has been conceived in the context of Health Outcomes Research where the outcomes of health interventions in routine clinical practice constitute the main objective of the research process. In the case of asthma in Spain, the investigators do not clearly know the use of resources generated by the patient with asthma, its impact on the effectiveness of the current approach of asthmatic patients and the overall efficiency of health interventions on asthmatic patients. This observational, retrospective and multicenter study aims to estimate the use of health care resources in managing patients with asthma and to determine the management of the disease in the usual clinical practice in Valencia Autonomous Region. The data will be obtained at primary care level from the Electronic Health Record SIA+GAIA data base and at hospital level from allergologists and pneumologists clinical records. The investigators plan to introduce 289 ambulatory patients followed-up in Primary or Specialized Care Services, older than 15 years of age, diagnosed of asthma at least one year before the beginning of the study. The inclusion period will be of 3 months and the retrospective data of 12 previous months of follow-up will be collected. The direct and indirect use of resources will be collected in order to estimate the management and use of health care resources in managing patients with asthma in the Autonomous region of Valencia as primary endpoint and also to estimate the mean cost of asthmatic patient healthcare; to determine the global effectiveness and the efficiency of the actual asthmatic patient healthcare and to model the health budget according to different objectives of effectiveness for the next five years.