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NCT ID: NCT01444430 Completed - Asthma Clinical Trials

A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents

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

The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma

NCT ID: NCT01441518 Completed - Clinical trials for Gestational Diabetes Mellitus

Home Versus Hospital Care in Glucose Monitoring of Gestational Diabetes and Mild Gestational Hyperglycemia

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

Pregnancies complicated by diabetes and mild gestational hyperglycemia are associated with increased perinatal and maternal complications. The most serious maternal complication is the risk of developing type 2 diabetes after 10-12 years of the delivery. Perinatal complications include fetal macrosomia with consequent increased risk of obstetrical trauma and hypoxia/asphyxia, high rates of cesarean section, respiratory distress syndrome, and metabolic disorders at birth. Regardless of the diagnosis of diabetes and mild gestational hyperglycemia, the perinatal outcome is directly related to maternal metabolic control. For the tight control of blood glucose, pregnant women are treated as home care (outpatient) or hospital care. Objective: To evaluate the cost-effectiveness and safety of home versus hospital care of gestational diabetes and mild gestational hyperglycemia.

NCT ID: NCT01440374 Active, not recruiting - Thrombocytopaenia Clinical Trials

A Three-part Study of Eltrombopag in Thrombocytopenic Subjects With Myelodysplastic Syndromes or Acute Myeloid Leukemia

ASPIRE
Start date: September 2011
Phase: Phase 2
Study type: Interventional

This is a worldwide, three-part (Part 1: open-label, Part 2: randomized, double-blind, Part 3: extension), multi-center study to evaluate the effect of eltrombopag in subjects with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) who have thrombocytopenia due to bone marrow insufficiency from their underlying disease or prior chemotherapy. This objective will be assessed by a composite primary endpoint that consists of the following: the proportion of ≥Grade 3 hemorrhagic adverse events, or platelet counts <10 Gi/L, or platelet transfusions. Patients with MDS or AML and Grade 4 thrombocytopenia due to bone marrow insufficiency from their underlying disease or prior chemotherapy will be enrolled in the study. No low or intermediate-1 risk MDS subjects will be enrolled in the study. Subjects must have had at least one of the following during the 4 weeks prior to enrolment: platelet count <10 Gi/L, platelet transfusion, or symptomatic hemorrhagic event. Supportive standard of care (SOC), including hydroxyurea, will be allowed as indicated by local practice throughout the study. The study will have 3 sequential parts. Subjects who are enrolled in Part 1 (open-label) cannot be enrolled in Part 2 of the study (randomized, double-blind); however, subjects who complete the treatment period for Part 1 or Part 2 (8 and 12 weeks, respectively) will continue in Part 3 (extension) if the investigator determines that the subject is receiving clinical benefit on treatment.

NCT ID: NCT01439724 Completed - Clinical trials for Squamous Cell Carcinoma of Oropharynx

Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients

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

Oral mucositis remains a limiting factor in in head and neck squamous cell carcinomas patients treated with chemoradiation leading to pain, dysphagia, and weight loss. Low-level laser therapy emerges as a promising, preventive therapy of chemoradiation-induced OM. This study was designed to assess the efficacy of Low Level Laser Therapy (LLLT) in reducing the incidence and/or severity of oral mucositis.

NCT ID: NCT01439438 Completed - Clinical trials for Epilepsy, Tonic-Clonic

Topiramate Bioequivalence Study Brazil - Fast

Start date: July 22, 2011
Phase: Phase 1
Study type: Interventional

This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The volunteers received, in each period, the reference or the test formulation, according to the randomization list, under fasting conditions, in order to evaluate if the reference and test formulations are bioequivalent.

NCT ID: NCT01438489 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus

Start date: January 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard of care treatment for SLE.

NCT ID: NCT01438294 Completed - Asthma Clinical Trials

Exercise Training in Asthma Children

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

The purpose of this study is to assess the effects of a physical training program with active video game in inflammatory markers, quality of life variables , clinical control and physical and functional respiratory assessment of asthmatic children from 5 to 11 years.

NCT ID: NCT01437787 Completed - Clinical trials for Hematopoietic Neoplasm

Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis

JAKARTA
Start date: December 2011
Phase: Phase 3
Study type: Interventional

Primary Objective: - To evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503 (Investigational Medicinal Product, IMP) compared to placebo in the reduction of spleen volume as determined by magnetic resonance imaging (MRI) (or computed tomography scan in patients with contraindications for MRI). Secondary Objectives: - To evaluate the effect on Myelofibrosis (MF)-associated symptoms (key MF symptoms) as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary. - To evaluate the Overall Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo. - To evaluate the Progression Free Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo. - To evaluate the durability of splenic response. - To evaluate the safety of IMP.

NCT ID: NCT01437553 Completed - Clinical trials for Acute Coronary Syndrome

Imaging Whole Coronary Artery With Intravascular Ultrasound (Ivus) And Imap For Plaque Tissue Composition In Patients With Acute Myocardial Infarction

iWONDER
Start date: August 2011
Phase: N/A
Study type: Interventional

The iWONDER trial has the following objective: To analyze the morphological, phenotypic and tissue characteristics of atherosclerotic plaques angiographically considered "culprit" and "not-culprit" in patients undergoing coronary angiography due to STEMI (ST-elevation myocardial infarction).

NCT ID: NCT01436630 Completed - Stroke Clinical Trials

Step Test and Six Minute Walk Test in Stroke

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

The purpose of this study is to investigate the viability of using the Step Test (ST) in stroke patients, and to compare the functional performance of the physiologic variables in stroke patients during ST and Six Minute Walk Test (6MWT).