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NCT ID: NCT02158936 Terminated - Thrombocytopaenia Clinical Trials

A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS)

Start date: June 10, 2014
Phase: Phase 3
Study type: Interventional

Eltrombopag olamine (SB-497115-GR) is an orally bioavailable, small molecule thrombopoietin receptor agonist that may be beneficial in medical disorders associated with thrombocytopenia. Eltrombopag has been shown to increase platelet counts in patients with thrombocytopenia from various etiologies (Idiopathic thrombocytopenic purpura [ITP], liver disease, aplastic anemia and chemotherapy induced thrombocytopenia). Approximately 350 subjects will be randomized in a 1:1 ratio (175 into the eltrombopag arm and 175 into the placebo arm). Approximately 55 subjects will be enrolled into the azacitidine. Subjects with intermediate-1, intermediate-2 or high risk MDS by IPSS, and baseline platelet count of <75 Giga (10^9) per liter (Gi/L) will only be enrolled. This is a randomized, double-blind, parallel group, placebo-controlled study designed to explore the platelet supportive care effects of eltrombopag versus placebo in combination with the standard of care hypomethylating agent, azacitidine. The primary objective of this study is to determine the effect of eltrombopag versus placebo on the proportion of subjects who are platelet transfusion free during the first 4 cycles of azacitidine therapy. Key secondary endpoints include overall survival, disease response, and disease progression.

NCT ID: NCT02158845 Completed - Endometriosis Clinical Trials

Levonorgestrel-releasing Intrauterine System in Patients With Endometriosis

SIU-LNG
Start date: February 2010
Phase: Phase 4
Study type: Interventional

The hemostatic and inflammatory systems may activate each other. Endometriosis is a chronic inflammatory disease affecting 10% of women. The objective of this study is to compare the hemostatic effects of two treatments widely prescribed to women with endometriosis: the levonorgestrel intrauterine system (LNG-IUS) and the gonadotropin-releasing hormone analog (GnRHa) leuprolide acetate. Hypothesis: H0: There is no alteration in hemostatic system with the use of GnRHa or LNG-IUS H1: There is alteration in hemostatic system with the use of GnRHa or LNG-IUS

NCT ID: NCT02158676 Completed - Obesity Clinical Trials

Effect of Prebiotic and Synbiotic Supplementation in Individuals Undergoing Roux-en-y Gastric Bypass.

Start date: October 2013
Phase: N/A
Study type: Interventional

The study will recruit patients submitted to bariatric surgery. Individuals will be supplemented with 6g/day of prebiotic or synbiotic or placebo (maltodextrin) for 15 days. Immunological, metabolic and anthropometric parameters will be assessed before and after the supplementation. Our hypothesis is that prebiotic or synbiotic supplementation modulate plasma concentrations of immunological and metabolic parameters and anthropometric measures of subjects undergoing gastric bypass Roux-Y.

NCT ID: NCT02157428 Completed - Clinical trials for Adverse Effect of Other General Anesthetics

Effect of Flumazenil on Recovery From General Anesthesia With Isoflurane

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

Background and objectives: The inhalational anesthetic isoflurane is widely used in general anesthetics. Its mechanism of action involves interaction with the receptor of gamma-amino butyric acid (GABA), which is also the binding site for benzodiazepines. Flumazenil, benzodiazepine antagonist, reverses the effects of these drugs in GABA receptors and could therefore also reverse the effect of isoflurane. In anesthesia practice, extubation and early anesthetic recovery reduce morbidity and incidence of complications. The objective of this trial is to determine whether the use of flumazenil may contribute to faster recovery from anesthesia. Methods: 40 patients scheduled to undergo general anesthesia with isoflurane were enrolled in this prospective, double-blind, randomized trial. Patients were randomized to receive, at the end of anesthesia, flumazenil or placebo as allocated into two groups. The anesthetic technique was standardized. The groups were compared concerning values of Cerebral State Index (CSI), heart rate, blood pressure and oxygen saturation from the application of flumazenil or placebo until 30 minutes after injection. Data regarding time to extubation, time to reach ten points in the Aldrete-Kroulic score (AK = 10) and Vigilance score (VS = 10) was also collected. ANOVA test was applied to analyze the results, considering p <0.05.

NCT ID: NCT02156635 Not yet recruiting - Stroke Clinical Trials

Stroke Treatment Associate to Rehabilitation Therapy and Transcranial DC Stimulation

START-tDCS
Start date: February 2016
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether active stimulation of the affected hemisphere will be more effective than simulated current in treatment of stroke

NCT ID: NCT02156284 Completed - Clinical trials for Cardiovascular Disease

Nurse Empathic Behaviour to Reduce the Fear in Patients of Preoperative Cardiac Surgery

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

The objective was to compare the frequency and intensity of symptoms of fear in patients of preoperative cardiac surgery who received empathic behaviour from nurse or those who received no specific type of empathic behaviour. This is a randomized clinical trial. The sample consisted of 44 patients in preoperative of cardiac surgery, who were divided in two groups: empathic behaviour by nurses and without specific empathic behaviour. Fear was assessed at two time points: before and after the intervention. The instrument used was developed and validated, comprising 15 defining characteristics of the nursing diagnosis fear. The hypothesis is that the group who received empathic behaviour from nurse will reduce the anxiety.

NCT ID: NCT02155660 Completed - Clinical trials for Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History

TERRANOVA
Start date: June 25, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies.

NCT ID: NCT02155166 Completed - Pain Clinical Trials

Effect of Intracervical on the Pain Associated With the Insertion of the LNG-IUS

Start date: February 2012
Phase: N/A
Study type: Interventional

This study has the objective to evaluate the effect of Injectable intracervical anesthesia in comparison with a non-steroidal anti-inflammatory drug (NSAID) on the pain scores immediately after insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) in women without previous vaginal delivery. H0: There is no difference in terms of pain score between the treatments H1: There will be difference in terms of pain score between treatments

NCT ID: NCT02154893 Completed - Osteoarthritis Clinical Trials

Synergic Effects of Ultrasound and Laser on the Pain Relief and Functionality

Start date: January 2014
Phase: Phase 2
Study type: Interventional

There are several therapeutic effects of the ultrasound (US) or low level laser therapy (LLLT), including pain relief, increase of microcirculation, modulation of inflammatory response and accelerated tissue repair. The investigators hypothesis was that a combination of US, LLLT and therapeutic exercise may maximize clinical outcome.

NCT ID: NCT02154269 Completed - Clinical trials for Chronic Chagasic Myocarditis

Evaluation of G-CSF (Colony Stimulating Factor) in Patients With Chronic Chagas Cardiomyopathy

Start date: September 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of treatment with G-CSF in patients with chronic heart failure secondary to Chagas disease.