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NCT ID: NCT01595724 Completed - Endometriosis Clinical Trials

Daily Practice Treatment and Influence of Visanne on the Patient Assessment of Quality of Life

DIVA
Start date: May 2012
Phase: N/A
Study type: Observational

The study aims to collect data on the influence of a treatment with Visanne (Dienogest 2mg/d) on the Endometriosis related quality of life. These data will be collected using a special patient questionnaire (Endometriosis Health Profile 5, EHP-5). The study will also be used to describe the basic disease status and demographic characteristics of patients searching treatment by a gynecologist because of their endometriosis. In addition, the study will give insight into the typical diagnostic measures the physicians in different countries are using in the field of endometriosis.

NCT ID: NCT01578850 Completed - Clinical trials for Rheumatoid Arthritis

Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening

Start date: July 2012
Phase: Phase 4
Study type: Interventional

To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.

NCT ID: NCT01562665 Completed - Clinical trials for Non Small Cells Lung Cancer

Epidemiological Study to Describe Non Small Cell Lung Cancer Clinical Management Patterns in MENA. Lung-EPICLIN/ Gulf

Lung-EPICLIN/G
Start date: June 2012
Phase: N/A
Study type: Observational

The overall aim of the study is: To provide accurate and reliable information regarding NSCLC clinical management across MENA region in order to detect unmet medical needs of this disease in terms of: - Patient and hospital characteristics. - Diagnostic and treatment approaches: initial and subsequent. - Follow-up patterns in clinical management. - Outcomes: symptoms, death, functionality, quality of life. - Use of resources and burden on patients and health care systems.

NCT ID: NCT01447446 Completed - Clinical trials for Hepatitis C, Chronic

An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C

Start date: September 2011
Phase: N/A
Study type: Observational

This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of peginterferon alfa (e.g. Pegasys) plus ribavirin and treatment regimens containing direct-acting antivirals in patients with chronic hepatitis C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be collected from patients receiving treatment according to current Summary of Product Characteristics and local labeling for the duration of their treatment and a 24-week follow-up.

NCT ID: NCT01435486 Completed - Bronchiolitis Clinical Trials

Caffeine Citrate for the Treatment of Apnea Associated With Bronchiolitis in Young Infants

Start date: November 2011
Phase: N/A
Study type: Interventional

Viral bronchiolitis is the most common lower respiratory tract infection of infancy. Apnea is a complication of bronchiolitis, reported in 16 - 21% of cases. Caffeine, a trimethylxanthine, acts as an antagonist to endogenous adenosine and a potent central nervous system stimulant. In apnea of prematurity, caffeine is believed to work by increasing central respiratory drive. Infants ≤4 months of age, presenting to pediatric emergency center Al-Sadd, from September 2011 to May 2014, with a diagnosis of viral bronchiolitis associated with apnea. A randomized, double-blind, controlled trial with a sample size of 45 patients per group Data Collection methods, instruments used measurements: Randomization: In the emergency department, the patients will be assigned to either one of the two treatments using a computer-generated randomized numbers in a 1:1 ratio. Pharmacy will prepare sequential sealed vials containing the experimental drugs. Randomization code will be revealed only after all patients completed the study. The medical team in addition to the patients will be blinded to the medication delivered. There will be no detectable difference in the color, smell of the two study treatments. Guardians or parents of eligible infants will be approached regarding the study, explaining the purpose and the treatment modalities. Patients will be included after obtaining a verbal and written consent. Study Intervention: Treatment 1: Single stat dose (25 mg per kilogram of body weight) of intravenous caffeine citrate (25mg caffeine citrate equal to 12.5mg caffeine base). Treatment 2: Placebo with an equivalent volume of normal saline. Calculated study medications will be diluted with Dextrose 5% in Water to 20 ml and will be given intravenous over 30 minutes using syringe infusion pump. After random assignment, eligible infants will receive one of the study treatments. Non-pharmacological therapies may be used as necessary to control apnea. Antibiotics and antipyretics may be used as per the discretion of the treating physician. After stabilization of patients as usually done in Pediatric Emergency Center , patients will be admitted to pediatric intensive care unit (PICU) for further monitoring monitoring when indicated.

NCT ID: NCT01415427 Completed - MPS IVA Clinical Trials

Long-Term Efficacy and Safety Extension Study of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)

Start date: July 2011
Phase: Phase 3
Study type: Interventional

This Phase 3 extension study will evaluate the long-term efficacy and safety of BMN 110 2.0 mg/kg/week and/or BMN 110 2.0 mg/kg/every other week in patients with mucopolysaccharidosis IVA (Morquio A Syndrome).

NCT ID: NCT01395589 Completed - Asthma Clinical Trials

Rapid vs Maintenance Vitamin D Supplementation in Deficient Children With Asthma to Prevent Exacerbations.

Start date: February 2011
Phase: Phase 1
Study type: Interventional

The role of vitamin D in respiratory health remains uncertain. Whether vitamin D reduces clinically important exacerbations of childhood asthma remains uncertain. We compared rapid to maintenance vitamin D repletion analyzed by baseline vitamin D level.

NCT ID: NCT01344889 Completed - Clinical trials for Hepatitis C, Chronic

An Observational Study on The Prediction of Adverse Events in Patients With Chronic Hepatitis C Receiving a Long-Acting Interferon Plus Ribavirin (GUARD-C)

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

This observational study will assess factors leading to dose reductions/treatment discontinuations and the effect on sustained virological response in patients with chronic hepatitis C receiving a long-acting interferon (e.g. Pegasys/peginterferon alfa-2a) and ribavirin. Data will be collected from each patient for the duration of their treatment and for up to 6 months thereafter.

NCT ID: NCT01275066 Completed - MPS IV A Clinical Trials

A Double-Blind Study to Evaluate the Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome)

Start date: February 2011
Phase: Phase 3
Study type: Interventional

This Phase 3 study will evaluate the efficacy and safety of 2.0 mg/kg/week BMN 110 and 2.0 mg/kg/every other week BMN 110 in patients with mucopolysaccharidosis IVA (Morquio A Syndrome). There is currently no standard accepted treatment for MPS IVA other than supportive care. Enzyme replacement therapy (ERT) may be a potential new treatment option for MPS IVA patients. BMN 110 is administered to MPS IVA patients by IV infusion, allowing cellular uptake by the mannose-6-phosphate receptor and transportation to the lysosomes. This enzyme uptake into the lysosomes is hypothesized to promote increased catabolism of keratan sulfate (KS) in tissue macrophages, hyaline cartilage, other connective tissues, and heart valve, and reduce the progressive accumulation of KS which is responsible for the clinical manifestations of the disorders.

NCT ID: NCT01230359 Completed - Clinical trials for Autism Spectrum Disorders

Early Nutritional Intervention in Patients With Autism Spectrum Disorders

Start date: April 2010
Phase: N/A
Study type: Interventional

Nutritional supplements like vitamin B6 and magnesium have demonstrated to have beneficial effects in patients with autism spectrum disorders (ASD). The underlying theory for these effects is that specific metabolic pathways in neuronal cells, e.g. the methionine cycle, will be more balanced. Most studies have been focused on the clinical outcome with this treatment. The present proposal will examine the effects on the different intermediates of the methionine cycle (methylation and transulfuration capacity), suggested to play an important role for the pathogenesis of ASD. The design is a prospective pilot study, including 40 patients, aged 2-6 yrs, with newly diagnosed ASD. All participants will receive the supplement (vitamin B6, magnesium; Kirkman formula) and placebo in a cross over design. Metabolites in blood and urine will be measured prior to and at the end of the treatments in the different groups. The results will then provide us with information, which will link clinical outcomes with biological markers. Furthermore, the study has also the potential to shed light on the pathogenesis of ASD.