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NCT ID: NCT02235909 Completed - Hypertension Clinical Trials

An Efficacy and Safety Study in Children 6 to Less Than 18 Years of Age With Hypertension

Start date: December 19, 2014
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy and safety of the study drug relative to an active comparator losartan which is in the same class of drug and is approved for use in the pediatric population aged 6 years and older. Approximately 260 subjects will participate in a 6-week, double-blind, randomized, treatment phase, followed by a 2-week, double-blind, randomized, placebo-controlled withdrawal phase. A 44-week, open-label extension in which all subjects will receive azilsartan and other antihypertensive medications (if needed). Blood pressure will be assessed throughout the study.

NCT ID: NCT02235467 Completed - Clinical trials for Autism Spectrum Disorders

Multisite Study: Parental Training Using Video Modelling to Develop Social Skills in Children With Autism

Start date: February 2014
Phase: Phase 4
Study type: Interventional

This is a Brazilian multisite study to test the efficacy of an Applied Behavior Analysis (ABA) parent training using video modeling to teach parents of children with Autism techniques to apply to their children in order to improve eye contact and joint attention behaviors. Our hypothesis is that children with Autism whose parents will be trained by videomodeling will have better eye contact and joint attention behaviors compared to children with Autism whose parents will not be trained.

NCT ID: NCT02234843 Completed - Clinical trials for Venous Thromboembolism

EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis

EINSTEIN Jr
Start date: November 13, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.

NCT ID: NCT02234544 Completed - Clinical trials for Vitamin D Deficiency

Effect of an Inhibitor of Cholesterol Absorption on Vitamin D Levels

Start date: October 2014
Phase: Phase 4
Study type: Interventional

Double-blind randomized controlled trial to evaluate the serum levels of 25(OH)D after a single oral dose of cholecalciferol 50,000 IU plus ezetimibe or placebo. Differences between the serum levels of 25(OH)D in response to cholecalciferol plus ezetimibe compared to cholecalciferol plus placebo.

NCT ID: NCT02234323 Completed - Hemophilia A Clinical Trials

An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A

Start date: January 12, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants (PUPs) with severe hemophilia A. The secondary objectives were to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in PUPs, to evaluate rFVIIIFc consumption for the prevention and treatment of bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc for immune tolerance induction (ITI) in participants with inhibitors.

NCT ID: NCT02233452 Completed - Neuropathic Pain Clinical Trials

Methadone and Ketamine for Neuropathic Pain Treatment

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

Methadone and ketamine are effective for neuropathic pain management. However, the benefits of the association of both drugs are uncertain. Here, the investigators conducted a randomized, double-blind, in parallel, active controlled clinical trial to test the hypothesis that methadone combined ketamine (methadone/ketamine) is more effective than methadone or ketamine alone in reducing neuropathic pain.

NCT ID: NCT02232919 Completed - Obesity Clinical Trials

Deep Brain Stimulation for Human Morbid Obesity

BLESS
Start date: April 2014
Phase: Phase 1
Study type: Interventional

The burden of morbid obesity to the circulatory, endocrine, and locomotor systems, as well as the psychological effects and related health-care costs, are well established in the medical literature. Lifestyle and dietary patterns remain critical factors modulating long-term weight control of morbidly obese individuals (bodymass index ≥ 40). Various dietary, pharmacological, and behavioral interventions have largely failed as therapies, often necessitating surgery as the last treatment option. Long term results of bariatric surgery suggest that sustained and substantial weight loss can decrease morbidity related to obesity secondary complications such as diabetes type 2 and cancers, enhancing the role of surgery for morbidly obese subjects. However the adverse effects of bariatric surgery are considerable and impact on quality of life. Its long-term failure rates and complications call for novel and effective long-term therapies, such as neurosurgical interventions. The investigators now propose to enhance our targeting capabilities in a feasibility study of low frequency electrical stimulation using VMH-DBS (ventromedial hypothalamic) in six morbidly obese patients. After successful targeting, DBS stimulation parameters will be systematically evaluated and individually optimized at three-month intervals over a one-year stimulation period. Detailed recording of side effects, weight changes, food intake patterns, metabolic changes, and behavioral evaluations will be obtained throughout the study.

NCT ID: NCT02231593 Completed - Acromegaly Clinical Trials

SAGIT for Classification of Patients With Acromegaly in Clinical Practice

SAGIT Pilot
Start date: February 2013
Phase:
Study type: Observational

The purpose of this pilot study is to test SAGIT (Signs and symptoms - Associated comorbidities - GH concentration level - IGF-1 - Tumour). SAGIT is a Clinician-Reported Outcomes (ClinROs) tool developed to describe patients with acromegaly. This study will determine the potential use of a finalised operational version for patient classification in clinical practice and studies. In addition, this study intends to carry out a qualitative evaluation of the acceptability of SAGIT by the practicing endocrinologist in terms of relevance, ease of use, applicability and usefulness of the tool in practice.

NCT ID: NCT02231216 Completed - Clinical trials for Deviated Nasal Septum

Quality of Life Study About the Role of Turbinectomy in Rhinoseptoplasty

WHOQOL-BREF
Start date: March 2014
Phase: N/A
Study type: Interventional

Research Question: Performing partial turbinectomy associated with rhinoseptoplasty is responsible for an increase in quality of life related to nasal obstruction when compared to no intervention in rhinoseptoplasty inferior turbinate? - Population: patients eligible for functional rhinoseptoplasty and / or aesthetic - Intervention: surgery, turbinectomy of inferior turbinates - Comparison: the absence of intervention in inferior turbinates - Primary endpoint: Quality of life related to nasal obstruction

NCT ID: NCT02230631 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes

Start date: October 2014
Phase: N/A
Study type: Observational

This survey is conducted in South America. The aim of this survey is to investigate hypoglycaemia among Insulin-treated patients with diabetes.